(39 days)
Not Found
No
The document describes a mechanical clip for surgical procedures and does not mention any AI or ML components or functionalities.
No
The device is described as a surgical clip for tissue and prosthetic material approximation and the creation of anastomoses, which is a surgical tool, not a therapeutic device that treats or cures a disease.
No
The device is used for tissue approximation and creating anastomoses, which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly states it is a "single self-closing clip" fabricated from "standard medical and implantable grade materials," indicating it is a physical medical device, not software.
Based on the provided information, the Coalescent Surgical U-Clip™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for tissue and prosthetic material approximation and the creation of anastomoses within the body (in blood vessels, grafts, and other tubular structures).
- Device Description: The description details a surgical clip and needle designed for direct application to tissues and structures during a procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside the body (in vitro) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are typically used to analyze samples like blood, urine, tissue biopsies, etc., in a laboratory setting. The Coalescent Surgical U-Clip™ is a surgical tool used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
The Coalescent Surgical U-Clip™ is intended for endoscopic and non-endoscopic use in tissue and prosthetic material approximation and the creation of anastomoses in blood vessels, grafts and other tubular structures.
Product codes
FZP
Device Description
The Coalescent Surgical U-Clip™ is a single self-closing clip for vascular anastomosis and tissue approximation applications. The U-Clip consists of a specially designed vascular clip with a needle connected to one end via a flexible member. This design allows precise placement of clips prior to closure. The device is fabricated from standard medical and implantable grade materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood vessels, grafts and other tubular structures
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Design analysis and in vitro data confirm that functional characteristics are substantially equivalent to the predicate device cited. Testing included in vitro studies. All data fell well within, both, internal specification requirements, as well as external standard requirements and predicate performance expectations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
KO12317 510(k) Number:
Applicant Information:
- July 16, 2001 Date Prepared:
| Name: | Coalescent Surgical, Inc. |
|---|---|
| Address: | 559 E. Weddell Drive |
| Sunnyvale, CA 94089 | |
| 408-743-9794 |
| Contact Person: | Michael A. Daniel |
|---|---|
| Phone Number: | (415) 407-0223 |
| Facsimile Number: | (925) 932-5706 |
Device Information:
| Classification: | Class II Implantable Clips |
|---|---|
| Trade Name: | Coalescent Surgical U-Clip™ |
| Common Name: | Implantable Clip, Vascular Clip |
| Classification Name: | Surgical Devices: Implantable Clip, 79FZP, 21 CFR 878.4300 |
Predicate Devices:
The Coalescent Surgical U-Clip™ is substantially equivalent in intended use and method of operation to the following predicate devices:
- Coalescent Surgical Sutured-Clip™ 510(k) K994160 .
Device Description:
The Coalescent Surgical U-Clip™ is a single self-closing clip for vascular anastomosis and tissue approximation applications. The U-Clip consists of a specially designed vascular clip with a needle connected to one end via a flexible member. This design allows precise placement of clips prior to closure. The device is fabricated from standard medical and implantable grade materials.
1
510(k) SUMMARY
(Continued)
Intended Use:
The Coalescent Surgical U-Clip™ is intended for endoscopic and non-endoscopic use in tissue and prosthetic material approximation and the creation of anastomoses in blood vessels, grafts and other tubular structures.
Comparison to Predicate Device(s):
The Coalescent Surgical U-Clip™ is substantially equivalent to the Coalescent Surgical Sutured-Clip (K994160). These devices are intended for application of vascular clips to tissue for purposes of performing vascular anastomosis and tissue and graft approximation.
In Vitro Test Data:
Design analysis and in vitro data confirm that functional characteristics are substantially equivalent to the predicate device cited. Testing included in vitro studies. All data fell well within, both, internal specification requirements, as well as external standard requirements and predicate performance expectations.
Summary:
Based upon the product technical information, intended use, performance and biocompatibility information provided in this pre-market notification, the Coalescent Surgical U-Clip™ has been shown to be substantially equivalent to currently marketed predicate device.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name arranged in a circular pattern around a central emblem. The emblem consists of a stylized representation of three human profiles facing right, stacked on top of each other, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 1 2001
Mr. Michael A. Daniel Regulatory and Clinical Affairs Coalescent Surgical 559 East Weddell Drive Sunnyvale, California 94089
Re: K012317
Trade/Device Name: Coalescent Surgical U-Clip™ Regulation Number: 878.4300 Regulatory Class: II Product Code: FZP Dated: July 16, 2001 Received: July 23, 2001
Dear Mr. Daniel:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Michael A. Daniel
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Lise W. L.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): __ TBD
Coalescent Surgical U-Clip™ Device Name:
Indications For Use:
:
The Coalescent Surgical U-Clip™ is intended for endoscopic and non-endoscopic use in The Coalescont Burghout o Onpvessels, grafts and other tubular structures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | |
|---|---|
| ------------------------------------------ | --------------------------------------------------------------------------------------------- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | --------------------------------------------------------------------------------------------- |
(Optional Format 1-2-96)
| (Division Sign-Off) | |
|---|---|
| Division of General, Restorative | |
| and Neurological Devices | |
| 510(k) Number | K012517 |
510(k) Number -
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