(90 days)
No
The device description and performance studies focus on the mechanical function and material properties of a surgical clip, with no mention of AI or ML.
No
The device is described as a surgical clip for tissue approximation and ligation, which are surgical procedures, not therapeutic interventions designed to treat disease or injury.
No
The device is described as a surgical clip for tissue approximation and ligation, which are therapeutic not diagnostic functions.
No
The device description clearly outlines a physical medical device (clip, needles, flexible members) fabricated from medical and implantable grade materials, along with physical accessories. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general soft tissue approximation and /or ligation, including use in cardiovascular procedures." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is 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: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. The description of the U-CLIP does not involve any such testing of specimens.
Therefore, the Coalescent Surgical U-CLIP™ is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Coalescent Surgical U-CLIP™ and accessories is indicated for use in general soft tissue approximation and /or ligation, including use in cardiovascular procedures.
Product codes
79NJU, 79FZP
Device Description
The Coalescent Surgical U-CLIP™ device is a single self-closing clip for vascular anastomosis and tissue approximation/attachment applications. The U-CLIP consists of a specially designed vascular clip (optionally containing suture) and connected to needles via flexible members (optionally including various types of suture). This design allows precise placement of clips prior to closure and facilitation of an interrupted "suture" technique through elimination of knot tying. 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
soft tissue, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
In vitro and in vivo data confirm that functional characteristics are substantially equivalent to the predicate device cited as well as applicable USP suture testing requirements. 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)
Coalescent Surgical U-CLIP™ K021407, K013664, K012317, K994160, K971588
Reference Device(s)
Ethicon Stainless Steel, Gut, Poly suture K946173 (GAQ)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4495 Stainless steel suture.
(a)
Identification. A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.(b)
Classification. Class II (special controls). The device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
0
2.0 510(k) SUMMARY
DEC 1 8 2002
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:
Applicant Information:
| Date Prepared: | December 18, 2002 |
|---|---|
| Name: | Coalescent Surgical, Inc |
| Address: | 559 E. Weddell Drive |
| Sunnyvale, CA 94089 | |
| 408-743-9780 | |
| Contact Person: | Michael A. Daniel |
Phone Number: (415) 407-0223 Facsimile Number: (925) 254-5187
Device Information:
| Classification: | Class II Implantable Clips / Class II Suture |
|---|---|
| Trade Name: | Coalescent Surgical U-CLIPTM and Accessories |
| Common Name: | Implantable Clip / Vascular Clip / Suture |
| Classification Name: | Surgical Devices: Suture, 79NJU, 21CFR 878.4495 |
| Implantable Clip, 79FZP, 21CFR 278.4300 |
Predicate Devices:
The Coalescent Surgical U-CLIP™ and accessories is substantially equivalent in intended use, fabrication and design to the following predicate device:
- Coalescent Surgical U-CLIP™ K021407, K013664, K012317, K994160 and . K971588
- Ethicon Stainless Steel, Gut, Poly suture K946173 (GAQ) .
1
K023125 page 2/2
510(k) SUMMARY
(Continued)
Device Description:
The Coalescent Surgical U-CLIP™ device is a single self-closing clip for vascular anastomosis and tissue approximation/attachment applications. The U-CLIP consists of a specially designed vascular clip (optionally containing suture) and connected to needles via flexible members (optionally including various types of suture). This design allows precise placement of clips prior to closure and facilitation of an interrupted "suture" technique through elimination of knot tying. The device is fabricated from standard medical and implantable grade materials. Accessories include Clip removal devices and vessel retention tools.
Intended Use:
The Coalescent Surgical U-CLIP™ is indicated for use in general soft tissue approximation and/or ligation, including cardiovascular applications.
Comparison to Predicate Device(s):
The Coalescent Surgical U-CLIP™ and accessories is substantially equivalent to the Coalescent Surgical U-CLIP (K021407) and to Ethicon Stainless Steel, Gut, Poly suture - K946173 (GAO), in terms of materials, use and application.
Test Data:
In vitro and in vivo data confirm that functional characteristics are substantially equivalent to the predicate device cited as well as applicable USP suture testing requirements. 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, in vitro, in vivo and clinical performance information provided in this pre-market notification, the Coalescent Surgical U-CLIP™ and accessories has been shown to be substantially equivalent to currently marketed predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Coalescent Surgical, Inc. Michael A. Daniel Regulatory and Clinical Affairs 559 E. Weddell Drive Sunnyvale, California 94089
Re: K023125
Trade/Device Name: Coalescent Surgical U-CLIPTM and Accessories Regulation Number: 878.4495 Regulation Name: Stainless steel suture Regulatory Class: Class II Product Code: NJU Non-Absorbable nitinal suture Dated: September 16, 2002 Received: September 19, 2002
Dear Mr. Daniel:
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 application (PMA). You may, therefore, market the device, subject to the general controls 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
3
Page 2 - Mr. Michael A. Daniel
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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), 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Proost
Colia 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
4.0 INDICATIONS FOR USE FORM
510(k) Number (if known):
Coalescent Surgical U-CLIPTM and Accessories Device Name:
Indications For Use:
The Coalescent Surgical U-CLIP™ and accessories is indicated for use in general soft ti approximation and /or ligation, including use in cardiovascular procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
- Ston Sign-O vision of Gold al, Restorative Neurological Devices
Prescription Use
(Per 21 CFR 801.109) √
OR
Over-The-Counter Use
(Optional Format 1-2-96)