(21 days)
No
The device description focuses on the mechanical properties and function of a Nitinol clip and delivery system. There is no mention of AI, ML, image processing, or data-driven decision making. The performance studies are based on functional characteristics like clip strength and deployment, not algorithmic performance.
No.
A therapeutic device is one that treats a disease or condition. This device is used for approximation/attachment and/or ligation and the creation of anastomosis, which are surgical procedures, not treatments in themselves.
No
The device is described as a self-closing clip for tissue approximation, attachment, and ligation, and for creating anastomoses. Its intended uses involve surgical procedures to hold tissues and structures together, not to diagnose conditions.
No
The device description clearly outlines physical components made of Nitinol and stainless steel, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- U-CLIP™ Uni-Fire Function: The description clearly states that the U-CLIP™ Uni-Fire is a surgical device used within the body for tissue approximation, ligation, and creating anastomoses. It is a physical implant/tool used during surgical procedures.
The intended use and device description focus on surgical intervention and manipulation of tissues and structures in vivo, not on analyzing biological samples in vitro.
N/A
Intended Use / Indications for Use
The U-CLIP™ Uni-Fire 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 use in cardiovascular and coronary artery bypass grafting procedures.
Product codes
FZP
Device Description
The U-CLIP™ is a self-closing clip for anastomosis and tissue and prosthetic material approximation or attachment applications. The Model M65 U-CLIP" Uni-Fire device consists of a self-closing Nitinol clip that is constrained in an open position in a stainless steel hypotube until released by the surgeon after placement. The clip is released from a slot in the side of the hypotube. After release, the arms of the clip attempt to regain their preferred, closed configuration, thereby holding the tissue layers together. This design allows precise placement of clips prior to closure, and facilitates an interrupted "suture" technique by eliminating knot tying. The device is manufactured with 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
general soft tissue, 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
Verification and validation testing confirms that functional characteristics are substantially equivalent to the predicate device cited. This included clip strength and clip deployment. All test data obtained satisfied the documented product and performance specifications.
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K31623, K024366, K060400, K023125, K021407, K013664, K012317, K994160, K971588
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
K081082 page 1/2
MAY - 7 2008
U-CLIP™ Uni-Fire, Model M65
510(k) SUMMARY of Safety and Effectiveness
l. Applicant Information:
| Date Prepared: | April 14, 2008 |
|---|---|
| Submitter: | Medtronic, Inc. |
| Address: | 710 Medtronic Parkway, NE |
| Minneapolis, MN 55432-5604 | |
| Establishment | |
| Registration No. | 2135394 |
| Contact Person: | David D. Cox, Ph.D. |
| Regulatory Consultant | |
| Telephone Number: | (651) 247-7900 |
| Fax Number: | (763) 391-9259 |
II. Device Information:
| Trade Name: | U-CLIP™ Uni-Fire |
|---|---|
| Common Name: | Implantable clip |
| Classification Name: | Clip, Implantable |
|---|---|
| Classification: | Class II, 21 CFR 878.4300 |
| Product Code: | FZP |
- Medtronic U-CLIP™, Model NC65 Predicate Device: 510(k) No. K062057, Reg. No. 878.4300; Product Code: FZP
Device Intended 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; including cardiovascular and coronary artery bypass grafting procedures; including use in cardiovascular and coronary artery bypass grafting procedures.
1
U-CLIP™ Uni-Fire, Model M65
Device Description: The U-CLIP™ is a self-closing clip for anastomosis and tissue and prosthetic material approximation or attachment applications. The Model M65 U-CLIP" Uni-Fire device consists of a self-closing Nitinol clip that is constrained in an open position in a stainless steel hypotube until released by the surgeon after placement. The clip is released from a slot in the side of the hypotube. After release, the arms of the clip attempt to regain their preferred, closed configuration, thereby holding the tissue layers together. This design allows precise placement of clips prior to closure, and facilitates an interrupted "suture" technique by eliminating knot tying. The device is manufactured with a standard implantable grade of Nitinol.
- The U-CLIP™ Uni-Fire 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; including use in cardiovascular and coronary artery bypass grafting procedures.
- Contraindications: Do not use for tubal ligation.
Comparison to
Predicate Device(s): The U-CLIP™ Uni-Fire device is substantially equivalent to the U-CLIP" Model NC65 device cleared in K062057 and other U-CLIPs cleared in K31623, K024366, K060400, K023125, K021407, K013664, K012317, K994160, and K971588 in terms of materials, use and application. The new clip is released from the side of the hypotube, just like the predicate device, but it has a flattened end to allow it to be mechanically held prior to release. The new clip is made of the same Nitinol alloy, with the same wire diameter, overall length and closed clip diameter as the predicate device.
- Test Data: Verification and validation testing confirms that functional characteristics are substantially equivalent to the predicate device cited. This included clip strength and clip deployment. 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-CLIP™ Uni-Fire, Model M65 described in this submission has 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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 7 2008
Medtronic, Inc. % Innovatrix, Inc. David D. Cox, Ph.D. 3051 S. Newcombe Way Lakewood, Colorado 80227
Re: K081082
Trade/Device Name: U-CLIP® Uni-Fire, Model M65 Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: FZP Dated: April 14, 2008 Received: April 16, 2008
Dear Dr. Cox:
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 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 - David D. Cox, Ph.D.
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 vour 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Milliman
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
KO81082
U-CLIP® Uni-Fire, Model M65 Device Name:
Indications for Use:
The U-CLIP™ Uni-Fire 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 use in cardiovascular and coronary artery bypass grafting procedures.
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)
Phil R. Ogden for Mayor
Division of General, Restorative, and Neurological Devices
510(k) Number K081082