(221 days)
The Multifire Clip Applier is designed to automatically deliver small hemostatic clips for ligation of blood vessels. The device is intended for use on vessels, which in the opinion of the surgeon, require a small ligating clip. The Multifire Clip Applier may be used during endoscopic procedures such as the endoscopic harvesting of the Internal Mammary Artery.
The Heartport Multifire Clip Applier is a sterile, use disposable device containing 15 small Titanium ligating clips. The device is designed to automatically deliver small hemostatic clips for ligation of blood vessels.
This document is a 510(k) summary for the Heartport Multifire Clip Applier, submitted in 1996. It details the device's classification, intended use, and comparison to predicate devices, but it heavily lacks the specific information requested in your prompt regarding acceptance criteria and a structured study.
Here's a breakdown of why this document cannot fulfill your request comprehensively:
Missing Information:
- Acceptance Criteria Table: The document states the device "was safe and effective" and "meeting the anticipated clinical requirements," but it does not provide any quantitative acceptance criteria (e.g., success rates, force measurements, specific closure percentages) or numerical performance data to fill a table.
- Detailed Study Information:
- Sample size for the test set: Not specified beyond "in vitro" and "in vivo studies."
- Data provenance: Not mentioned (country of origin, retrospective/prospective).
- Number of experts and qualifications: Not mentioned.
- Adjudication method: Not mentioned.
- MRMC comparative effectiveness study: Not mentioned.
- Standalone algorithm performance: This is a physical device, so "standalone algorithm" doesn't apply in the typical sense of AI software. The performance here refers to the device itself.
- Type of ground truth: Not explicitly stated, though "clip feeding and clip closure" are the performance elements observed.
- Sample size for the training set: Not applicable for a physical device where "training" isn't a discrete software development phase.
- How ground truth for the training set was established: Not applicable.
What can be extracted (and why it's limited):
The document broadly mentions performance testing and biocompatibility.
- Performance: "The Multifire Clip Applier was evaluated in vitro for clip feeding and clip closure In addition, the Clip Applier was evaluated during in vivo studies. functions. Performance testing demonstrated that the Heartport Multifire Clip Applier was safe and effective, while meeting the anticipated clinical requirements for its intended use."
- Biocompatibility: "The patient contacting materials used in the Multifire Clip Applier are identical to those used in the Pilling Weck - Hemoclip S15 Automatic Applier."
Conclusion:
This 1996 510(k) summary is very high-level and focused on demonstrating substantial equivalence to already approved predicate devices. It does not contain the detailed, quantitative acceptance criteria or a structured study description that would be required to complete your request. The standards for regulatory submissions, especially for device performance studies, have evolved significantly since 1996, and a modern submission would likely include much more of this specific information.
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Appendix A. 510(k) Summary of Safety and Effectiveness
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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: _________
Applicant Information:
Date Prepared:
April 5, 1996
Isabella Abati
(415) 306-7900 (415) 306-7905
Name: Address: Heartport, Inc. 200 Chesapeake Drive Redwood City, CA 94063
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Device Information:
| Classification | Class II |
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| Trade Name: | Heartport Multifire Clip Applier |
| Common Name: | Implantable Clip/Vascular Clip/Hemostatic Clip Applier |
| Classification Name: | Surgical Devices: Implantable Clip, 21 CFR 878.4300Cardiovascular Prosthetic Devices:Vascular Clip, 21 CFR 870.3250 |
Equivalent Devices:
The Heartport Multifire Clip Applier is substantially equivalent in intended use and/or method of operation to a combination of the following predicate devices:
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- Pilling Weck -Hemoclip S15 Automatic Applier 2. U.S. Surgical -PREMIUM SURGICLIP Disposable Automatic Clip Applier 3. U.S. Surgical -ENDO CLIP Disposable Appliers 4. Ethicon -LIGACLIP Endoscopic Clip Applier
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510(k) Summary of Safety and Effectiveness (continued)
Intended Use
The Multifire Clip Applier is designed to automatically deliver small hemostatic clips for ligation of blood vessels. The device is intended for use on vessels, which in the opinion of the surgeon, require a small ligating clip. The Multifire Clip Applier may be used during endoscopic procedures such as the endoscopic harvesting of the Internal Mammary Artery.
Comparison To Predicate Devices
The Heartport Multifire Clip Applier is a sterile, use disposable device containing 15 small Titanium ligating clips. The device is designed to automatically deliver small hemostatic clips for ligation of blood vessels. The Multifire Clip Applier is equivalent in intended use and operational characteristics to the following devices: (1) Pilling Weck -Hemoclip S15 Automatic Applier, (2) U.S. Surgical - PREMIUM SURGICLIP Disposable Automatic Clip Applier. (3) U.S. Surgical - ENDO CLIP Disposable Appliers and (4) Ethicon - LIGACLIP Endoscopic Clip Applier. All predicates deliver and close a sequence of ligating clips automatically without the need for manual loading of individual clips. The Heartport Multifire Clip Applier combines the same functions as the individual predicate devices into a single clip applier.
Non-Clinical Test Results
Performance:
The Multifire Clip Applier was evaluated in vitro for clip feeding and clip closure In addition, the Clip Applier was evaluated during in vivo studies. functions. Performance testing demonstrated that the Heartport Multifire Clip Applier was safe and effective, while meeting the anticipated clinical requirements for its intended use.
Biocompatibilitv:
The patient contacting materials used in the Multifire Clip Applier are identical to those used in the Pilling Weck - Hemoclip S15 Automatic Applier.
Summary
Based on the product information, intended use, performance and biocompatibility data provided in this Notification, the Heartport Multifire Clip Applier has been shown to be substantially equivalent to currently marketed predicate devices.
§ 870.3250 Vascular clip.
(a)
Identification. A vascular clip is an implanted extravascular device designed to occlude, by compression, blood flow in small blood vessels other than intracranial vessels.(b)
Classification. Class II (performance standards).