(57 days)
Not Found
No
The summary describes a mechanical surgical clip and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is described as a surgical tool for creating anastomoses (connections) in tubular structures, rather than directly treating a disease or condition for therapeutic benefit.
No
The Coalescent Surgical Sutured-Clip™ is described as a surgical device for creating anastomoses and approximating tissue, not for identifying a disease or condition.
No
The device description clearly states it is a physical clip fabricated from medical and implantable grade materials, indicating it is a hardware device.
Based on the provided information, the Coalescent Surgical Sutured-Clip™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. The intended use of the Sutured-Clip™ is for creating anastomoses (connections) in blood vessels, grafts, and other tubular structures within the body during surgical procedures.
- The device description clearly indicates it's a surgical clip for vascular anastomosis and tissue approximation. This is an invasive surgical tool, not a diagnostic test performed on a sample outside the body.
Therefore, the Coalescent Surgical Sutured-Clip™ falls under the category of a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Coalescent Surgical Sutured-Clip™ is intended for endoscopic and non-endoscopic use in the creation of anastomoses in blood vessels, grafts and other tubular structures.
Product codes
FZP
Device Description
The Coalescent Surgical Sutured-Clip™ is a single self-closing clip for vascular anastomosis and tissue approximation applications. The Sutured-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, in vitro, in situ and in vivo data confirm that basic functional characteristics are substantially equivalent to the predicate devices cited. Testing included in vitro, in situ and chronic in vivo 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.
510(k) Number: TBD
Applicant Information:
- Date Prepared: December 1, 1999
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: | (408) 743-9798 |
Device Information:
| Classification: | Class II Implantable Clips |
|---|---|
| Trade Name: | Coalescent Surgical Sutured-Clip™ |
| Common Name: | Implantable Clip, Vascular Clip |
| Classification Name: | Surgical Devices: Implantable Clip, 79FZP, 21 CFR 878.4300 |
| Cardiovascular Prosthetic Devices: Vascular Clip, 74DSS 870.3250 |
Predicate Devices:
The Coalescent Surgical Sutured-Clip™ is substantially equivalent in intended use and/or method of operation to a combination of the following predicate devices:
- Elective Vascular Intervention (EVI) Sutured-Clip™ and Clip Applier 510(k) K971588 1. "
-
- U.S. Surgical, Auto Suture Modified VCSClip and Applier - 510(k) K962043
-
- Ethicon, Endo-Surgery Endoscopic Clip and Applier - 510(k) K771412
Device Description:
The Coalescent Surgical Sutured-Clip™ is a single self-closing clip for vascular anastomosis and tissue approximation applications. The Sutured-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.
5
1
510(k) SUMMARY
(Continued)
Intended Use:
The Coalescent Surgical Sutured-Clip™ is intended for endoscopic and non-endoscopic use in the creation of anastomoses in blood vessels, grafts and other tubular structures.
Comparison to Predicate Device(s):
The Coalescent Surgical Sutured-Clip™ is substantially equivalent to a combination of the EVI Sutured-Clip™ and Sutured-Clip™ Applier and to the US Surgical VCS Clip™ and Clip Applier in terms of intended use. These devices are intended for application of vascular clips to tissue for purposes of performing vascular anastomosis.
The Coalescent Surgical Sutured-Clip™ is substantially equivalent to the EVI Sutured-Clip™ and Sutured-Clip™ Applier in that the Sutured-Clips™ have a needle attached to one end to facilitate precise placement, The Coalescent Surgical Sutured-Clip™ is substantially equivalent to the Ethicon LIGACLIP™ Clip and Clip Applier in terms of the single clip application option.
The Coalescent Surgical, Inc Sutured-Clip™ differs from the currently marketed predicate devices in that it is self-closing and does not require a custom clip applier.
In Vitro. In Situ and In Vivo Test Data:
Design analysis, in vitro, in situ and in vivo data confirm that basic functional characteristics are substantially equivalent to the predicate devices cited. Testing included in vitro, in situ and chronic in vivo 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 Sutured-Clip™ has been shown to be substantially equivalent to currently marketed predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized image of a human figure, represented by three curved lines, which is a common symbol associated with the department.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 4 2000
Mr. Michael A. Daniel Regulatory and Clinical Affairs Coalescent Surgical, Inc. 559 E. Weddell Drive Sunnyvale, California 94089
Re: K994160 Trade Name: Sutured-Clip Regulatory Class: II Product Code: FZP Dated: December 1, 1999 Received: December 9, 1999
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 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 requirement, 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.
3
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) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Niel R.P. Ogden
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K. 994160 400 510(k) Number (if known):
Coalescent Surgical Sutured-Clip™ Device Name:
Indications For Use:
The Coalescent Surgical Sutured-Clip™ is intended for endoscopic and non-endoscopic use in the creation of anastomoses in blood vessels, 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) | |
|---|---|
| (Division Sign-Off) | NRO for JZD |
| Division of General Restorative Devices | K994160 |
| 510(k) Number |
| Prescription Use
| (Per 21 CFR 801.109) | ✓ |
|---|---|
| ------------------------------------------ | -------------- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(Optional Format 1-2-96)
0 0 0 0 0 9
ll