(141 days)
Not Found
No
The summary describes a mechanical clamping device and does not mention any AI or ML components or functions.
No
The device is intended for temporary occlusion of vessels during surgical procedures, which is a surgical tool function, not providing therapy to treat or cure a disease or condition.
No
Explanation: The device is described as a "clamp" for "temporary occlusion of a vessel" during surgical procedures. Its function is interventional (occluding), not diagnostic (identifying or characterizing a disease or condition).
No
The device description clearly indicates it is a physical clamp intended for surgical procedures, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "temporary occlusion of a vessel... during endoscopic cardiac surgical procedures." This describes a surgical tool used directly on a patient's body during a procedure.
- Device Description: It's described as combining the functions of existing "Bulldog Clamps," which are surgical instruments.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information. The device's function is purely mechanical and procedural.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for 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.
Product codes
74DXC
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessel, Internal Mammary Artery or vein grafts
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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. All materials used in the Heartport Cable Bulldog Clamp have proven biocompatibility.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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:
-
- 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.
-
- Baxter Healthcare - EDWARDS Single Softjaw and Double Softjaw Handleless Clamps
ﺗﻪ
1
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.