(221 days)
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Not Found
No
The description focuses on a mechanical device for applying clips and does not mention any AI/ML components or functions.
No
The device delivers hemostatic clips for ligation of blood vessels, which is a surgical tool, not a therapeutic device.
No
This device is designed to apply hemostatic clips for ligation of blood vessels, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "sterile, use disposable device containing 15 small Titanium ligating clips," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Multifire Clip Applier is a surgical device used to physically ligate (tie off) blood vessels with clips during surgical procedures. It is used on the patient's body, not on samples taken from the body.
- Intended Use: The intended use clearly states it's for "ligation of blood vessels" and used "during endoscopic procedures." This is a surgical intervention, not a diagnostic test.
Therefore, the Multifire Clip Applier falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
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Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
vessels, Internal Mammary Artery
Indicated Patient Age Range
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Intended User / Care Setting
surgeon
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Pilling Weck -Hemoclip S15 Automatic Applier, U.S. Surgical -PREMIUM SURGICLIP Disposable Automatic Clip Applier, U.S. Surgical -ENDO CLIP Disposable Appliers, Ethicon -LIGACLIP Endoscopic Clip Applier
Reference Device(s):
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
Appendix A. 510(k) Summary of Safety and Effectiveness
Image /page/0/Picture/4 description: The image shows the text "NOV 15 1996". The text appears to be handwritten in black ink. The text is slightly tilted to the right.
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
| Contact Person: |
|---|
| Phone Number: |
| Fax Number: |
Device Information:
| Classification | Class II |
|---|---|
| Trade Name: | Heartport Multifire Clip Applier |
| Common Name: | Implantable Clip/Vascular Clip/Hemostatic Clip Applier |
| Classification Name: | Surgical Devices: Implantable Clip, 21 CFR 878.4300 |
| Cardiovascular 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
1
Image /page/1/Picture/1 description: The image shows the text "K961333" in a bold, sans-serif font. Below this, the word "Appendices" is written in a smaller, less bold font. The text appears to be part of a document or label.
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.