(61 days)
Not Found
No
The description focuses on the mechanical design and function of a surgical clip and does not mention any AI or ML components or capabilities.
No
Explanation: A therapeutic device is one that performs a treatment or therapy. This device is used for approximation/attachment and the creation of anastomoses, which are surgical procedures, not therapies.
No
The device is described as a "single self-closing clip for vascular anastomosis and tissue approximation/attachment applications" and is intended for "tissue and prosthetic material approximation/attachment and the creation of anastomoses." This indicates a therapeutic or surgical function, not a diagnostic one.
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, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for "endoscopic and non-endoscopic tissue and prosthetic material approximation/attachment and the creation of anastomoses in blood vessels, grafts and other tubular structures". This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a "single self-closing clip for vascular anastomosis and tissue approximation/attachment applications". This is a physical implantable device used during surgery.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided description does not mention any testing of samples or analysis of biological markers.
Therefore, the modified Coalescent Surgical U-CLIP™ is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The modified Coalescent Surgical U-CLIP™ is intended for endoscopic and non-endoscopic tissue and prosthetic material approximation/attachment and the creation of anastomoses in blood vessels, grafts and other tubular structures; including use in cardiovascular and coronary artery bypass grafting procedures.
Product codes (comma separated list FDA assigned to the subject device)
FZP
Device Description
The modified Coalescent Surgical U-CLIP™ is a single self-closing clip for vascular anastomosis and tissue approximation/attachment applications. The U-CLIP consists of a specially designed vascular clip connected to needles via flexible members. This design allows precise placement of clips prior to closure and facilitation of an interrupted "suture" technique. The device is fabricated from standard medical and implantable grade materials. Accessories include Clip removal devices and vessel retention tools.
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)
In vitro data confirm that functional characteristics are substantially equivalent to the predicate device cited. All data fell well within, both, internal specification requirements, as well as external standard requirements and device performance expectations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
page 1 of 2
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.
K021407 510(k) Number:
Applicant Information:
April 2, 2002 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-CLIPTM and Accessories |
| Common Name: | Implantable Clip, Vascular Clip |
| Classification Name: | Surgical Devices: Implantable Clip, 79FZP, 21 CFR 878.430 |
Predicate Devices:
The modified Coalescent Surgical U-CLIP™ and accessories is substantially equivalent in intended use, fabrication, design and method of operation to the following predicate device:
- Coalescent Surgical U-CLIP™ 510(k) K013664 ●
Device Description:
The modified Coalescent Surgical U-CLIP™ is a single self-closing clip for vascular anastomosis and tissue approximation/attachment applications. The U-CLIP consists of a specially designed vascular clip connected to needles via flexible members. This design allows precise placement of clips prior to closure and facilitation of an interrupted "suture" technique. The device is fabricated from standard medical and implantable grade materials. Accessories include Clip removal devices and vessel retention tools.
1
Image /page/1/Picture/0 description: The image shows handwritten text on a white background. The text "K021407" is on the first line, and the text "page 2 of 2" is on the second line. The handwriting is clear and legible.
510(k) SUMMARY
(Continued)
Intended Use:
The modified Coalescent Surgical U-CLIP™ is intended for endoscopic and non-endoscopic tissue and prosthetic material approximation/attachment and the creation of anastomoses in blood vessels, grafts and other tubular structures; including use in cardiovascular and coronary artery bypass grafting procedures.
Comparison to Predicate Device(s):
The modified Coalescent Surgical U-CLIP™ and accessories is substantially equivalent to the Coalescent Surgical U-CLIP (K013664).
Test Data:
In vitro data confirm that functional characteristics are substantially equivalent to the predicate device cited. All data fell well within, both, internal specification requirements, as well as external standard requirements and device performance expectations.
Summary:
Based upon the product technical information, intended use and clinical performance information provided in this pre-market notification, the modified Coalescent Surgical U-CLIP™ and accessories has been shown to be substantially equivalent to a currently marketed predicate device.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three stylized human profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 2002 JUL
Coalescent Surgical Michael A. Daniel Regulatory and Clinical Affairs 559 East Weddell Drive Sunnyvale, California 94089
Re: K021407
Trade Name: Coalescent Surgical U-Clip™ Regulation Number: 878.4300 Regulation Name: Implantable Clip, Vascular Clip Regulatory Class: II Product Code: FZP Dated: May 1, 2002 Received: May 3, 2002
Dear Mr. Daniel:
We have reviewed your Section 510(k) premarket 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Michael Daniel
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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 Part 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,
Ney RP Ogle
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
KOZI407 TBD 510(k) Number (if known): ___
Coalescent Surgical U-CLIPTM Device Name:
Indications For Use:
The Coalescent Surgical U-CLIP™ is intended for endoscopic and non-endoscopic tissue and prosthetic material approximation/attachment and the creation of anastomoses in blood vessels, grafts and other tubular structures; including use in cardiovascular and coronary artery bypass grafting procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ARo for Cmu
(Division Sign-Off) Division of General, Restorative and Neurological Devices Over-The-Counter Use OR K021407 510(k) Number
(Optional Format 1-2-96)
Prescription Use
(Per 21 CFR 801.109)
000009