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510K Table of Contents - Medical Device Description

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As part of device description, required by 21 CFR 807.92(a)(4), medical device manufacturers will have to present how the device functions, the scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device, such as device design, materials used, physical, chemical and biological properties.

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Section 7.0: Device Description Section 7.0 Device Description (As required by 21 CFR § 807.92(a)(4)) www.complianceonline.com ©2014 Copyright 2
Section 7.0: Device Description (Cont.) Section 7.0: Device Description Section 7.1: Introduction In this section, as required by 21 CFR 807.92(a)(4), we present how the device functions, the scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device, such as device design, materials used, physical, chemical and biological properties. Section 7.1.1: Regulatory Information • Regulation(s) applicable • Device name (trade name and common name) • Device classification • Product code. The description of the device attributes in detail is shown below. www.complianceonline.com ©2014 Copyright 3
Section 7.0: Device Description (Cont.) 7.2: Device Description 7.2.1: Principle of Operation 7.2.2: Mechanism of Action 7.2.3: Key device Features (labeled diagrams, photographs or pictures, engineering drawings, schematics including all internal and external, assembled and unassembled, interchangeable, parts of the device with their name and function. The length, width, height, diameter, etc., of the device should be included. 7.2.4: Energy Source And Other Device Features 7.3: Device Identification Under this section, the following key device components are described. In addition, all the model numbers (if known) are provided with detailed explanation of the differences among the models. www.complianceonline.com ©2014 Copyright 4
Section 7.0: Device Description (Cont.) 7.4: Device Characteristics 7.4.1: Drugs, If Applicable. 7.4.2: Software, If Applicable. 7.4.3: Biologics, If Applicable. 7.4.4: Coatings, If Applicable. 7.4.5: Single Use, If Applicable. 7.4.6: Metals, If Applicable. 7.4.7: Additives, If Applicable. 7.4.8: (Non)sterile, If Applicable. 7.4.9: Sterilization Method, If Applicable. 7.5: Environment of Use 7.5.1: Healthcare Facility/Hospital 7.5.2: Home, Ambulatory or Other www.complianceonline.com ©2014 Copyright 5
Section 7.0: Device Description (Cont.) 7.6: Materials of Use 7.6.1: General Type of Material Used. • Recombinantly-produced polymer • polymer (e.g., plastic or rubber) • Polysulfone • Metal • Stainless steel, etc. 7.6.2: Duration And Type of Contact. If the FDA recognized consensus standard(s) for medical use are used, provide the info at least (ASTM F####-last-2 numbers of the year). Note: ASTM: American Society for Testing and Materials; Now it is renamed as ASTM International. www.complianceonline.com ©2014 Copyright 6
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510K Table of Contents - Medical Device Description

  • 1. This Training is Brought to you by ComplianceOnline. www.complianceonlie.com ©2010 Copyright © 2014 ComplianceOnline This training session is sponsored by 1 US FDA 510(k): Best Practices for 510(k) Preparation and Submission
  • 2. Section 7.0: Device Description Section 7.0 Device Description (As required by 21 CFR § 807.92(a)(4)) www.complianceonline.com ©2014 Copyright 2
  • 3. Section 7.0: Device Description (Cont.) Section 7.0: Device Description Section 7.1: Introduction In this section, as required by 21 CFR 807.92(a)(4), we present how the device functions, the scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device, such as device design, materials used, physical, chemical and biological properties. Section 7.1.1: Regulatory Information • Regulation(s) applicable • Device name (trade name and common name) • Device classification • Product code. The description of the device attributes in detail is shown below. www.complianceonline.com ©2014 Copyright 3
  • 4. Section 7.0: Device Description (Cont.) 7.2: Device Description 7.2.1: Principle of Operation 7.2.2: Mechanism of Action 7.2.3: Key device Features (labeled diagrams, photographs or pictures, engineering drawings, schematics including all internal and external, assembled and unassembled, interchangeable, parts of the device with their name and function. The length, width, height, diameter, etc., of the device should be included. 7.2.4: Energy Source And Other Device Features 7.3: Device Identification Under this section, the following key device components are described. In addition, all the model numbers (if known) are provided with detailed explanation of the differences among the models. www.complianceonline.com ©2014 Copyright 4
  • 5. Section 7.0: Device Description (Cont.) 7.4: Device Characteristics 7.4.1: Drugs, If Applicable. 7.4.2: Software, If Applicable. 7.4.3: Biologics, If Applicable. 7.4.4: Coatings, If Applicable. 7.4.5: Single Use, If Applicable. 7.4.6: Metals, If Applicable. 7.4.7: Additives, If Applicable. 7.4.8: (Non)sterile, If Applicable. 7.4.9: Sterilization Method, If Applicable. 7.5: Environment of Use 7.5.1: Healthcare Facility/Hospital 7.5.2: Home, Ambulatory or Other www.complianceonline.com ©2014 Copyright 5
  • 6. Section 7.0: Device Description (Cont.) 7.6: Materials of Use 7.6.1: General Type of Material Used. • Recombinantly-produced polymer • polymer (e.g., plastic or rubber) • Polysulfone • Metal • Stainless steel, etc. 7.6.2: Duration And Type of Contact. If the FDA recognized consensus standard(s) for medical use are used, provide the info at least (ASTM F####-last-2 numbers of the year). Note: ASTM: American Society for Testing and Materials; Now it is renamed as ASTM International. www.complianceonline.com ©2014 Copyright 6
  • 7. For more information on Live Webinars and any Other Training Requirements please email us webinarassist@complianceonline.com or Call us at this Toll Free Number: 1- 888-717-2436 Register - http://www.complianceonline.com/510-k-submission-webinar-training-701016-w?channel=Docs-Sharing www.complianceonline.com ©2014 Copyright 7