21 CFR 870.3460 — Endovascular Suturing System
Cardiovascular (CV) · Part 870 Subpart D—Cardiovascular Prosthetic Devices · § 870.3460
Identification
An endovascular suturing system is a medical device intended to provide fixation and sealing between an endovascular graft and the native artery. The system is comprised of the implant device and an endovascular delivery device used to implant the endovascular suture.
Classification Rationale
Class II (special controls). The special controls for this device are:
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| OTD | Endovascular Suturing System | 2 | 7 | Implant |
Special Controls
OTD — Endovascular Suturing System
In addition to the general controls of the Food, Drug & Cosmetic Act, the Endovascular Suturing System is subject to the following special controls: (1) The device should be demonstrated to be biocompatible; (2) Sterility and shelf life testing should demonstrate the sterility of patient-contacting components and the shelf-life of these components; (3) Non-clinical and clinical performance testing should demonstrate substantial equivalence in safety and effectiveness, including durability, compatibility, migration resistance, corrosion resistance, and delivery and deployment; (4) Non-clinical testing should evaluate the compatibility of the device in an MR environment; (5) Appropriate analysis and non-clinical testing should validate electromagnetic compatibility (EMC) and electrical safety; (6) The sale, distribution, and use of the device are restricted to prescription use in accordance with 21 CFR 801.109; and (7) Labeling must bear all information required for the safe and effective use of the device as outlined in 801.109(c), including a detailed summary of the non-clinical and clinical evaluations pertinent to use of the device.
De Novo Order DEN100026
OTD — Endovascular Suturing System
*Classification.* Class II (special controls). The special controls for this device are:(1) The device should be demonstrated to be biocompatible; (2) Sterility and shelf life testing should demonstrate the sterility of patient-contacting components and the shelf-life of these components; (3) Non-clinical and clinical performance testing should demonstrate substantial equivalence in safety and effectiveness, including durability, compatibility, migration resistance, corrosion resistance, and delivery and deployment; (4) Non-clinical testing should evaluate the compatibility of the device in an magnetic resonance (MR) environment; (5) Appropriate analysis and non-clinical testing should validate electromagnetic compatibility (EMC) and electrical safety; (6) The sale, distribution, and use of the device are restricted to prescription use in accordance with 21 CFR 801.109 of this chapter; and (7) Labeling must bear all information required for the safe and effective use of the device as outlined in § 801.109(c) of this chapter, including a detailed summary of the non-clinical and clinical evaluations pertinent to use of the device.
eCFR
OTD — Endovascular Suturing System
(1) The device should be demonstrated to be biocompatible; (2) Sterility and shelf life testing should demonstrate the sterility of patient-contacting components and the shelf-life of these components; (3) Non-clinical and clinical performance testing should demonstrate substantial equivalence in safety and effectiveness, including durability, compatibility, migration resistance, corrosion resistance, and delivery and deployment; (4) Non-clinical testing should evaluate the compatibility of the device in an magnetic resonance (MR) environment; (5) Appropriate analysis and non-clinical testing should validate electromagnetic compatibility (EMC) and electrical safety; (6) The sale, distribution, and use of the device are restricted to prescription use in accordance with 21 CFR 801.109 of this chapter; and (7) Labeling must bear all information required for the safe and effective use of the device as outlined in § 801.109(c) of this chapter, including a detailed summary of the non-clinical and clinical evaluations pertinent to use of the device.
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