(25 days)
Not Found
No
The description focuses on the mechanical design and materials of the device, with no mention of AI, ML, image processing, or data-driven functionalities.
No
The device is described as a self-closing clip for approximation, attachment, and ligation of tissues and materials, and for creating anastomoses. These are surgical/mechanical functions, not therapeutic (treating a disease or condition).
No
The device is described as being for approximation/attachment and ligation, and the creation of anastomosis, which are therapeutic or surgical functions, not diagnostic ones.
No
The device description explicitly states it is a physical clip made of Nitinol, connected to surgical needles via flexible members. This is a hardware device, not software.
Based on the provided information, the U-CLIP™ Device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures involving tissue approximation, attachment, ligation, and anastomosis. These are all procedures performed on or within the body of a patient.
- Device Description: The description details a physical clip and needles designed for surgical manipulation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a patient's health status, diagnosis, or treatment.
IVDs are devices used to perform tests on samples taken from the human body to provide information for diagnostic, monitoring, or screening purposes. The U-CLIP™ is a surgical tool used directly in surgical procedures.
N/A
Intended Use / Indications for Use
"The U-CLIP™ Device is intended for endoscopic and non-endoscopic general soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomosis in blood vessels, grafts and other tubular structures."
Product codes
FZP
Device Description
"The U-CLIP™ device is a self-closing clip for anastomosis and tissue and prosthetic material approximation or attachment applications. The U-CLIP" consists of a self-closing Nitinol clip connected to surgical needles via flexible members. These U-CLIPs'" include a Nitinol wire coil surrounding the Nitinol wire core. This design allows precise placement of clips prior to closure, and facilitates an interrupted "suture" technique by eliminating knot tying. The device is manufactured from a standard implantable grade of Nitinol."
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, general soft tissue.
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
"Verification and validation testing confirms that functional characteristics are substantially equivalent to the predicate device cited. This included clip strength and tissue drag forces. All test data obtained satisfied the documented product and performance specifications."
Key Metrics
Not Found
Predicate Device(s)
K024366, K031623, K023125, K021407, K013664, K012317, K994160, K971588
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
053252 p. 1 of 2
U-CLIP™ Devices, Models B140, B160 & B180
510(k) SUMMARY of Safety and Effectiveness
t. Applicant Information:
AND IN FORM AN A LA FOR AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AN
要
| Date Prepared: | November 18, 2005 |
|---|---|
| Submitter: | Medtronic. Inc. |
| Address: | 710 Medtronic Parkway, NE |
| Minneapolis, MN 55432-5604 | |
| Establishment | |
| Registration No. | 2135394 |
| Contact Person: | David D. Cox, Ph.D. |
| Senior Principal Regulatory Affairs Specialist | |
| Telephone Number: | (763) 391-9251 |
| Fax Number: | (763) 391-9279 |
Device Information: 11.
| Trade Name: | U-CLIP™ |
|---|---|
| Common Name: | Implantable clip |
| Classification Name: | Clip, Implantable |
|---|---|
| Classification: | Class II, 21 CFR 878.4300 |
| Product Code: | FZP |
- Coalescent Surgical U-CLIP™ Predicate Device: 510(k) No. K024366, Reg. No. 878.4300; Product Code: FZP
Device Intended Use: The Surgical U-CLIP" is intended for endoscopic and non-endoscopic general soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomosis in blood vessels, grafts and other tubular structures; including cardiovascular and coronary artery bypass grafting procedures.
1
053252-q.2of2
U-CLIP™ Devices, Models B140, B160 & B180
- The U-CLIP™ device is a self-closing clip for anastomosis and Device Description: tissue and prosthetic material approximation or attachment applications. The U-CLIP" consists of a self-closing Nitinol clip connected to surgical needles via flexible members. These U-CLIPs'" include a Nitinol wire coil surrounding the Nitinol wire core. This design allows precise placement of clips prior to closure, and facilitates an interrupted "suture" technique by eliminating knot tying. The device is manufactured from a standard implantable grade of Nitinol.
- The U-CLIP™ Device is intended for endoscopic and non-Intended Use: endoscopic general soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomosis in blood vessels, grafts and other tubular structures.
Do not use for tubal ligation. Contraindications:
Comparison to
- The Medtronic U-CLIP" devices are substantially equivalent to Predicate Device(s): the Coalescent Surgical U-CLIP™ K031623. K024366. K023125, K021407, K013664, K012317, K994160, and K971588 in terms of materials, use and application. The new sizes are a line extension of larger sized clips.
- Verification and validation testing confirms that functional Test Data: characteristics are substantially equivalent to the predicate device cited. This included clip strength and tissue drag forces. All test data obtained satisfied the documented product and performance specifications.
- Based upon the technical information, intended use, in vitro, in Summary: vivo, and clinical performance information provided in previous pre-market notifications, the U-CLIPs" included in this submission have been shown to be substantially equivalent to currently marketed predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three arms or lines extending from the body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 6 2005
Mr. David D. Cox, Ph.D. MIT. Da Principal Regulatory Affairs Specialist Medtronic - Cardiac Surgery 7601 Northland Drive Brooklyn Park, Minesota 55423-1088
Re: K053252
K053252
Trade/Device Name: U-Clip Device, Models B140, B160 and B180 Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: II Product Code: FZP Dated: November 18, 2005 Received: November 21, 2005
Dear Dr. Cox:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 3 IQK) prematic in substantially equivalent (for the indications
referenced above and have determined the device substantially equivalent in int referenced above and have detellinged the devices marketed in interstate for use stated in the enclosure) to regally inanced be of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment the experieines of the Federal Fo commerce prior to May 28, 1976, the enactiven and of the Federal Food. Drug, devices that have been reclassined in accordance was as a proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that do not require approvations provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions of the You may, therefore, market the device, subject to the general registration, listing of
general controls provisions of the Act include requirements for annual misbranding and general controls provisions of the Act mender requirements as answer misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
If your device is classified (see above) mits entire) and in the major regulations affecting your device can
may be subject to such additional controls. Existing major regul may be subject to such additions: Existing major regals be found in the Code of I ederal Regalancial, your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualite of a substination with other requirements of the Act
that FDA has made a determination that your device of the Featurements You must that I'DA has made a determination nial your aceres on ofher Federal agencies. You must or any Federal statutes and regulations administer of only intel to: registration and listing (2)
comply with all the Act's requirements, including, but not programents as se comply with all the Act s requirements, mendant, our not turing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requiremen CFR Part 807); labeling (21 CFR Part 601); good manara20); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 1f applicable forth in the quality systems (QS) regulation (DP OF the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Dr. Cox
This letter will allow you to begin marketing your device as described in your Section 510(k)
Children and Children The TRACT disconferential aquivalence of your device to a This letter will allow you to begin marketing your device of your device of your device to a legally
premarket notification. The FDA indine of substantial equivalevice and t premarket notification. The FDA finding of substanted by of the subserned to your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rstiled. If you desire specific advice for your device on our nooming the regulation entitled,
contact the Office of Compliance at (240) 276-0115. Also, please note the regulation of contact the Office of Compliance at (240) 270-01-2707 Pat 807.97). You may obtain
"Misbranding by reference to premarket notification of Small "Misbranding by reference to premarkst nouthcation " (21 Cr Cr Cr Cr Cr Cr Cr Crem (1) 1)
other general information on your responsibilities under the Act from the Division o other general information on your responsibilities unmber (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-frees .html. Manufacturers, International and Consumer Assistance at 13 con 115 consert/industry/support/index.html.
Sincerely yours,
Barbara Buelum
fo
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Kos 3252 P. I
Indications for Use
510(k) Number (if known):
U-CLIP Device Name:
Indications for Use:
The U-CLIP™ Device is intended for endoscopic and non-endoscopic The U-CLif - Device 15 intended for otterial approximation/attachment general soft tissue and prosthetion material upper in blood vessels, grafts and other tubular structures.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sarbin Buchino for mkm
(Division Sign Off)
Division of General, Restorative, and Neurological Devices
510(k) Number_k053252