(21 days)
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.
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 provided text describes a 510(k) premarket notification for the U-CLIP™ Uni-Fire, Model M65, not a study involving AI or complex performance metrics. The information is solely about demonstrating substantial equivalence to a predicate device based on design, materials, intended use, and general function. Therefore, most of the requested fields are not applicable or cannot be extracted from this document, as they pertain to clinical studies, AI performance, and expert evaluations.
Here's an attempt to answer the questions based only on the provided text, explicitly stating when information is not available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "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."
However, specific quantitative acceptance criteria or reported performance values (e.g., exact clip strength in Newtons, deployment success rate) are not provided in this summary.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Functional Characteristics (e.g., clip strength, clip deployment) | "Substantially equivalent to the predicate device." "All test data obtained satisfied the documented product and performance specifications." (Specific metrics and values not provided.) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text mentions "in vitro, in vivo, and clinical performance information provided in previous pre-market notifications," but no details for this submission's testing.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications:
Not applicable. This is a medical device submission, not an AI or diagnostic tool study requiring expert-established ground truth. The "ground truth" for the device's function would be its physical performance against engineering specifications.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical or image-based diagnostic studies. For this device, performance is likely assessed against engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC study was not done. This device is an implantable clip, not a diagnostic or AI-assisted tool that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:
Not applicable. This is a physical medical device, not an algorithm or software. The "standalone" performance here refers to the device's functional characteristics (clip strength, deployment), which were tested.
7. The Type of Ground Truth Used:
For a medical device like the U-CLIP, the "ground truth" refers to its compliance with fundamental engineering and design specifications (e.g., material properties, dimensions, mechanical strength, deployment mechanism). The text implies its performance was verified against "documented product and performance specifications," which serve as the ground truth for its functional characteristics. No pathology, outcomes data, or expert consensus as a ground truth for performance is mentioned for this particular submission.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI or machine learning device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set.
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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, NEMinneapolis, MN 55432-5604 |
| EstablishmentRegistration 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.
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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.
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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.
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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
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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
§ 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.