(13 days)
Not Found
No
The description focuses on the mechanical properties and function of a Nitinol clip and does not mention any AI/ML components or capabilities.
No
The device is described as a surgical tool for tissue approximation and ligation, not for treating or curing a disease or condition.
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 rather than diagnosis.
No
The device description explicitly states it is a physical clip made of Nitinol and stainless steel, which are hardware components.
Based on the provided information, the U-CLIP™ Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body for surgical procedures (tissue approximation, ligation, anastomosis). IVDs are used to examine specimens outside the body (in vitro) to provide information about a patient's health.
- Device Description: The description details a physical clip designed for surgical implantation and manipulation, not for analyzing biological samples.
- Anatomical Site: The anatomical sites listed are all internal body structures.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or providing diagnostic information based on laboratory testing.
Therefore, the U-CLIP™ Device is a surgical implant/instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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; including use in cardiovascular and coronary artery bypass grafting procedures.
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 use in cardiovascular and coronary artery bypass grafting procedures.
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™ is a self-closing Nitinol clip that is constrained in an open position in a stainless steel hypotube until released by the surgeon after being re-registered from a slot in the side of the hypotube. This design allows precise placement of clips prior to closure, and facilitates the "running" and interrupted "suture" technique. 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
soft tissue, blood vessels, grafts, other tubular structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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 angle. All test data obtained satisfied the documented product and performance specifications.
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
K031623, K024366, K060400, 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
AUG 0 2 2006
510(k) SUMMARY of Safety and Effectiveness
Applicant Information: 1.
| Date Prepared: | July 19, 2006 |
|---|---|
| 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 |
II. Device Information:
| Trade Name: | U-CLIPTM |
|---|---|
| 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. K031623, 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; including use in cardiovascular and coronary artery bypass grafting procedures.
1
The U-CLIP™ device is a self-closing clip for anastomosis and Device Description: tissue and prosthetic material approximation or attachment tissue and prostheat Thatehar approximation of a applications.
self-closing Nitinol clip that is constrained in an open position in a stainless steel hypotube until released by the surgeon after a stainless otoor rijpostared from a slot in the side of the placement. This design allows precise placement of clips prior hypotabo. "This dolly": and interrupted "suture" technique by to closure, and faciliated the device is manufactured with 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 approximation/attachmont-ensels, grafts and other tubular structures; including use in cardiovascular and coronary artery bypass grafting procedures.
Do not use for tubal ligation. Contraindications:
Comparison to
1999 - 1999
:
The U-CLIP™ device is substantially equivalent to the U-CLIP" Predicate Device(s): devices cleared in K031623, K024366, K060400, K023125, K021407, K013664, K012317, K994160, and K971588 in terms of materials, use and application. The new clip utilizes a different way of constraining and releasing the implantable Nitinol Clip with stainless steel hypotubes, releasing the clip from a slot in the side of the hypotube as opposed to releasing the clip from the end of the hypotube.
Verification and validation testing confirms that functional Test Data: characteristics are substantially equivalent to the predicate device cited. This included clip strength and clip deployment angle. 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 vivo, and cimical performanos information "" included 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 a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of human figures, with three overlapping profiles facing to the right. The figures are depicted with simple, curved lines. Encircling the figures is text that reads "U.S. Department of Health and Human Services, USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 0 2 2006
Medtronic Cardiac Surgery % David D. Cox, Ph.D. Senior Principal Regulatory Affairs Specialist 7601 Northland Drive Minneapolis, Minnesota 55428-1088
Re: K062057
Trade/Device Name: NC65 U-CLIP Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: FZP Dated: July 19, 2006 Received: July 20, 2006
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. Iisting 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 vour 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
3
Page 2 - David D. Cox, Ph.D.
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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrl/industry/support/index.html.
Sincerely yours,
Herbert Leuner
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
KOG2057 510(k) Number (if known):
NC65 U-CLIP Device Name:
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; 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 Eyaluation (ODE)
Herbert Leuner
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number