(90 days)
The U-CLIP™ Device is intended for endoscopic and non-endoscopic dura mater and prosthetic material approximation/attachment and/or ligation in neurosurgical procedures.
The U-CLIP™ Device is a self-closing clip for dura mater and prosthetic material approximation or attachment applications. The U-CLIP™ consists of a self-closing Nitinol clip connected to surgical needles via flexible members. The U-CLIP™ includes 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 provided document is a 510(k) summary for the U-CLIP™ Device, specifically focusing on its use in neurosurgical procedures. It establishes substantial equivalence to previously cleared U-CLIP™ devices and non-absorbable sutures for dura approximation.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate devices (U-CLIP™ K062057, K053252, K013664, Ethicon PRONOVA Suture K001625, Surgilon/Polyamide Suture K981582) for dura mater and prosthetic material approximation/attachment and/or ligation in neurosurgical procedures. | "In vivo testing confirmed that the U-CLIP Device is comparable to the predicate, standard non-absorbable suture, for dura approximation application." The device design, fabrication, packaging, specifications, and fundamental scientific technology are stated to be identical to previously cleared U-CLIP™ devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for specific in vivo tests. The document refers generally to "in vivo testing."
- Data Provenance: Not specified (e.g., country of origin). The study is described as "in vivo testing," implying a pre-clinical study rather than human clinical data. It is a retrospective notification of previous testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The study does not involve expert readers establishing ground truth for image interpretation or similar diagnostic tasks. It's an in vivo comparability study for a surgical device.
4. Adjudication Method for the Test Set
Not applicable. The study does not involve expert adjudication of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes an "in vivo testing" comparing the device to a predicate, not a study evaluating human reader performance with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study in the form of "in vivo testing" was done to confirm comparability of the U-CLIP™ Device to the predicate non-absorbable suture for dura approximation. This assesses the device's performance directly without human intervention in its function.
7. Type of Ground Truth Used
The ground truth used was the performance of the predicate device (standard non-absorbable suture) in dura approximation applications, as established through "in vivo testing." The study aimed to demonstrate comparability to this established performance.
8. Sample Size for the Training Set
Not applicable. This device is a surgical clip, and the study described is an in vivo comparability test, not an AI/algorithm-based system requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device/study type.
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2006
5. 510(k) Summary
This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Establishment Registration Number: | 2021898 |
|---|---|
| Address of Manufacturer: | Medtronic Neurosurgery125 Cremona DriveGoleta CA, 93117(805) 968-1546 Phone(805) 968-9336 Facsimile |
| Contact Person: | Jeffrey Henderson |
| Date: | September 19, 2006 |
| Trade or Proprietary Name: | U-CLIPTM Device |
Common usual or Classification Name: Clip, Implantable 21CFR878.4300 (FZP)
Description: The U-CLIP™ Device is a self-closing clip for dura mater and prosthetic material approximation or attachment applications. The U-CLIP™ consists of a self-closing Nitinol clip connected to surgical needles via flexible members. The U-CLIP™ includes 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.
Intended Use: The U-CLIP™ Device is intended for endoscopic and non-endoscopic dura mater and prosthetic material approximation/attachment and/or ligation in neurosurgical procedures.
Contraindications: Do not use for tubal ligation.
Predicate Device Identification: The U-CLIP™ Device is substantially equivalent to the following predicate device:
-
U-CLIP™ Device K062057, K053252, K013664 .
The predicate devices intended for tissue approximation have been cleared for neurological applications include: -
Ethicon, Polypropylene, PRONOVA Nonasbsorbable Suture K001625 .
-
Surgilon/Polyamide Nonabsorbable Surgical Suture K981582 .
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Predicate 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.
Comparison to Predicate Device: Medtronic Neurosurgery submits that the device design, fabrication, packaging, specifications, and the fundamental scientific technology of the U-CLIP™ device is identical to the U-CLIP™ (K062057, K053252, and K013664). The specific neurosurgical indication is substantially equivalent to the Ethicon PRONOVA Nonabsorbable Suture (K001625) and the Surgilon/Polyamide Nonabsorbable Surgical Suture (K981582).
Test Data: In vivo testing confirmed that the U-CLIP Device is comparable to the predicate, standard non-absorbable suture, for dura approximation application.
Summary: Based upon the product technical information, intended use, in vitro, in vivo, and clinical performance information provided in this and previous pre-market notifications, the U-CLIP Device 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 stylized eagle or bird symbol on the right side. To the left of the bird symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic Neurosurgery % Mr. Jeffrey Henderson Vice President, Quality & Regulatory Affairs 125 Cremona Drive Goleta, California 93117-5500
DEC 1 9 2006
Re: K062821
Trade/Device Name: U-CLIP™ Device Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: FZP Dated: September 19, 2006 Received: November 8, 2006
Dear Mr. Henderson:
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
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Page 2 -- Mr. Jeffrey Henderson
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.
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/cdrh/industry/support/index.html.
Sincerely vours
Pur Pato V
Mark N. Melkerson
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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4. Indications for Use Statement
510(k) Number (if known): K062821
Device Name: U-CLIP™ Device
Indications for Use:
The U-CLIP™ Device is intended for endoscopic and non-endoscopic dura mater and prosthetic material approximation/attachment and/or ligation in neurosurgical procedures.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign . Off) Division of General, Restorative, and Neurological Devices
510(k) Number. K062821
§ 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.