(79 days)
Not Found
No
The summary describes a mechanical clip device and does not mention any software, algorithms, or AI/ML capabilities.
No.
Therapeutic devices are generally used to treat or cure a disease or disorder, or to restore function. This device is used for approximation and anastomosis of tissues and materials, which is a surgical tool rather than a therapeutic treatment itself.
No
The device is described as a surgical clip for tissue approximation and creating anastomoses, which are therapeutic rather than diagnostic functions. Its intended use is for surgical procedures, not for detecting, diagnosing, or monitoring medical conditions.
No
The device description clearly describes a physical, implantable clip made from medical and implantable grade materials, which is a hardware component.
No, 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 Description and Intended Use: The Coalescent Surgical U-CLIP™ is a surgical clip used for tissue and prosthetic material approximation and the creation of anastomoses (connecting structures). It is used during surgical procedures on the body, not for testing samples outside the body.
The description clearly indicates a surgical device used for physical manipulation and connection of tissues and structures within the body. This falls under the category of a surgical or implantable device, not an in vitro diagnostic.
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; including cardiovascular and coronary artery bypass grafting procedures.
Product codes
NCA, 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 and facilitation of an interrupted technique. 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; including cardiovascular
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
Clinical data confirm that functional characteristics are substantially equivalent to the predicate device. The data also confirm that the U-CLIP™ performs within, both, internal specification requirements, as well as device performance expectations.
Key Metrics
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 8 2003
Mr. Michael A. Daniel Regulatory and Clinical Affairs Coalescent Surgical 559 East Weddell Drive Sunnyvale, California 94089
Re: K013664
Trade/Device Name: Coalescent Surgical U-CLIPTM Regulation Number: 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NCA Dated: October 31, 2001 Received: November 6, 2001
Dear Mr. Daniel:
This letter corrects our substantially equivalent letter of January 24, 2002 regarding the Coalescent Surgical U-CLIP™. We are changing the product code from FZP to NCA.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval (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 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.
1
Page 2 - Mr. Michael A. Daniel
This letter will allow you to continue 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 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. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Miriam C. Provost
(ar 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
2
510(k) Number (if known): _ TBD
Coalescent Surgical U-CLIPTM Device Name:
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; including 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)
Prescription Use > (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
for Mark H. Mulhearn
(Division Sign-Off)
Division of General, Restorative
Neurological Devices
510(k) Number
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
3
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: _______________________________________________________________________________________________________________________________________________________________
JAN 2 4 2002
Applicant Information:
- October 31, 2001 Date Prepared:
Coalescent Surgical, Inc. Name: 559 E. Weddell Drive Address: 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 device:
-
Coalescent Surgical U-CLIP™ 510(k) K012317 ●
Predicate devices intended for tissue approximation and the creation of anastomosis that have been cleared for cardiovascular indications include: -
St. Jude Medical, Symmetry Aortic Clip System 510(k) K003446 .
-
Ethicon, Polypropylene, PRONOVA Nonabsorbable Suture 510(k) K001625 .
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 and facilitation of an interrupted technique. The device is fabricated from standard medical and implantable grade materials.
4
510(k) SUMMARY
(Continued)
Intended Use:
The Coalescent Surgical U-CLIP™ is intended for endoscopic and non-endoscopic use in tissues are a The Coalescont Burgiour o CE = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = and prosuletic matchar approximation and coronary artery bypass grafting procedures.
Comparison to Predicate Device(s):
The Coalescent Surgical U-CLIP™ is substantially equivalent to the Coalescent Surgical U-CLIP The Coalescon Burgiour O ODI - - secular clips to tissue for purposes of (KVI2317). These dovises and tissue and graft approximation. The specific performing vasoular unacionsbirantially equivalent to both the St. Jude Symmetry Clip, Cardrovasound the Ethicon PRONOVA Nonabsorbable Suture, K001625.
Test Data:
Clinical data confirm that functional characteristics are substantially equivalent to the predicate Chilical data commini that fallowithin, both, internal specification requirements, as well as device offed. The data it ments and device performance expectations.
Summary:
Based upon the product technical information, intended use and clinical performance information Based upon the product technical monitial.com the Coalescent Surgical U-CLIP™ has been shown to be substantially equivalent to currently marketed predicate devices.