(141 days)
The Heartport Cable Bulldog Clamp is intended for the temporary occlusion of a vessel, including the Internal Mammary Artery or vein grafts, and other clamping procedures. The Cable Bulldog Clamp may be introduced to surgical sites through a thoracic port or incision for use during endoscopic cardiac surgical procedures.
The Heartport Cable Bulldog Clamp combines the same functions as the individual predicate devices into a single device.
The provided text is a 510(k) summary for a medical device (Heartport™ Cable Bulldog Clamp). It does not contain information about acceptance criteria for an algorithm/AI study or details of a study that would prove a device meets such criteria. Therefore, I cannot generate the requested table and information.
The document focuses on:
- Device Information: Classification, trade name, common name, product code.
- Equivalent Devices: Listing predicate devices it is substantially equivalent to.
- Intended Use: Temporary occlusion of vessels during endoscopic cardiac surgical procedures.
- Comparison to Predicate Devices: Stating it combines functions of existing devices.
- Non-Clinical Test Results (Performance): It mentions in vitro testing for "clamping force" and states it was "equivalent to the predicate device tested and meets the anticipated clinical requirements." However, it does not provide specific acceptance criteria or detailed results.
- Non-Clinical Test Results (Biocompatibility): States materials are similar to predicates and have proven biocompatibility.
- Conclusion: Substantial equivalence.
This is a regulatory submission for a physical medical device, not an AI/algorithm-based device, and thus the requested AI-specific acceptance criteria and study details are not present.
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NOV - 7 1996
APPENDIX A. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| The assigned 510(k) number is: | K962366 |
|---|---|
| -------------------------------- | --------- |
Applicant Information:
Date Prepared: June 17, 1996 Name: Heartport, Inc. Address: 200 Chesapeake Drive Redwood City, CA 94063 Contact Person: Ms. Isabella R. Abati Director, Regulatory Affairs Phone Number: (415) 306-7900 Fax Number: (415) 306-7905
Device Information:
| Classification | Class II |
|---|---|
| Trade Name: | Heartport™ Cable Bulldog Clamp |
| Common Name: | Cardiovascular Devices - Vascular Clamp, 21 CFR 870.4450 |
| Product Code: | 74DXC |
Equivalent Devices:
The Heartport Cable Bulldog Clamp are substantially equivalent in intended use and/or method of operation to a combination of the following predicate devices:
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- Baxter Healthcare - Fogarty® Spring Clips (Softjaw®, and Double Safejaw® Spring Clips) and Spring Clip Applicators
- Baxter Healthcare EDWARDS Parallel Jaw Spring Clip and Applicator Forceps 2.
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- Baxter Healthcare - EDWARDS Single Softjaw and Double Softjaw Handleless Clamps
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510(k) Summary of Safety and Effectiveness (continued)
Intended Use:
The Heartport Cable Bulldog Clamp is intended for the temporary occlusion of a vessel, including the Internal Mammary Artery or vein grafts, and other clamping procedures. The Cable Bulldog Clamp may be introduced to surgical sites through a thoracic port or incision for use during endoscopic cardiac surgical procedures.
Comparison To Predicate Devices:
The Heartport Cable Bulldog Clamps are equivalent in intended use and operational characteristics to the following devices: (1) Baxter Healthcare - Fogarty® Spring Clips (Softjaw®, Safejaw®, and Double Safejaw® Spring Clips) and Spring Clip Applicators; (2)Baxter Healthcare -EDWARDS Parallel Jaw Spring Clip and Applicator Forceps; and (3) Baxter Healthcare -EDWARDS Single Softjaw and Double Softjaw Handleless Clamps
The Heartport Cable Bulldog Clamp combines the same functions as the individual predicate devices into a single device.
Non-Clinical Test Results:
Performance
The Heartport Cable Bulldog Clamp was evaluated in vitro for clamping force. The performance testing demonstrated that the Heartport Cable Buildog Clamp equivalent to the predicate device tested and meets the anticipated clinical requirements for its intended use.
Biocompatibility
The materials used to fabricate the Heartport Cable Bulldog are similar to the predicate devices. All materials used in the Heartport Cable Bulldog Clamp have proven biocompatibility.
Summary:
Based on the intended use, product information, performance and biocompatibility data provided in this Premarket Notification, Heartport Cable Bulldog Clamps have been shown to be substantially equivalent to currently marketed predicate devices.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).