(25 days)
The LARGE UNI-CLIP® STAPLE is indicated for fixation of bone fractures or for bone reconstruction.
Examples include:
- Arthrodesis in hand or foot surgery
- Fractures management in the foot or hand
- Mono or Bi-cortical osteotomies in the foot or hand
- Distal or proximal metatarsal or metacarpal osteotomies
- Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
The size and number of staple(s) used should be adapted to the specific indication.
The LARGE UNI-CLIP® STAPLE is a staple so that, by widening the diamond shaped opening, mechanical deformation leads to narrowing of the interaxis of the two legs.
The surgeon can obtain a true compression, adjustable and controlled with many choice of size.
The LARGE UNI-CLIP® STAPLE is made from 316L Stainless Steel that conforms to ISO 5832-1 and ASTM F138 & F139 standards.
Here's a breakdown of the acceptance criteria and study information for the LARGE UNI-CLIP® STAPLE based on the provided 510(k) summary:
This device is not an AI/ML device, so many of the requested fields regarding AI/ML specific studies (like MRMC, standalone performance, training set details) are not applicable. The device is a bone fixation staple and the submission focuses on demonstrating substantial equivalence to a predicate device through mechanical testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical properties similar to predicate device (UNI-CLIP® staples, K011716). | "Results have shown that the mechanical properties of the LARGE UNI-CLIP® staples are thus similar to the properties of the unmodified device, UNI-CLIP® staples, K011716." |
Note: The document does not explicitly state numerical acceptance criteria (e.g., minimum tensile strength, maximum deformation). Instead, it relies on a comparative assessment of mechanical properties to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "Mechanical tests have been carried out," implying a set of samples were tested, but the exact number isn't provided.
- Data Provenance: Not specified, but likely laboratory testing conducted by the manufacturer (Newdeal SAS). The document does not indicate country of origin for the data or if it was retrospective/prospective in a clinical context. Given it's mechanical testing of a device, it is typically laboratory-generated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This question is not applicable to this type of device and study. The "ground truth" for mechanical testing is derived from instrumentation and engineering standards, not expert clinical interpretation.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes, not for objective mechanical testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating human performance (e.g., radiologists reading images) with and without AI assistance, which is not applicable to a bone staple.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This is not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used was objective mechanical measurements (e.g., load-to-failure, stiffness, deformation) obtained through laboratory testing, compared against the predicate device.
8. The Sample Size for the Training Set
This is not applicable. There is no AI/ML algorithm involved, so no training set was used.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for an AI/ML algorithm.
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JUL - 3 2006
510(k) SUMMARY
- A. Submitter's Name and Address: Newdeal SAS 10, place d'Helvétie 69006 LYON France Tel.: +33 4 37 47 51 51 Fax: +33 4 37 47 51 52 ESTABLISHMENT REGISTRATION NUMBER: 9615741
B. Contact Person:
Morgane GRENIER Regulatory and Clinical Affairs Manager Newdeal SAS 10, place d'Helvétie 69006 LYON France Tel: +33 4 37 47 51 51 Fax: + 33 4 37 47 51 52
- C. Date Summary Prepared: June 7, 2006
D. Name of Device: Proprietary Name: LARGE UNI-CLIP® STAPLES
Common Name: Staple, fixation, bone
Classification Name and Reference:
Single/multiple component metallic bone fixation appliances and accessories (21 CFR 888.3030)
Device Product Code: JDR
Proposed Regulatory Class: Class II
Panel: Orthopedic
E. Device Description
The LARGE UNI-CLIP® STAPLE is a staple so that, by widening the diamond shaped opening, mechanical deformation leads to narrowing of the interaxis of the two legs.
The surgeon can obtain a true compression, adjustable and controlled with many choice of size.
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The LARGE UNI-CLIP® STAPLE is made from 316L Stainless Steel that conforms to ISO 5832-1 and ASTM F138 & F139 standards.
Indications for Use F.
The LARGE UNI-CLIP® STAPLE is indicated for fixation of bone fractures or for bone reconstruction.
Examples include:
-
Arthrodesis in hand or foot surgery
-
Fractures management in the foot or hand
-
Mono or Bi-cortical osteotomies in the foot or hand
-
Distal or proximal metatarsal or metacarpal osteotomies
-
Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
The size and number of staple(s) used should be adapted to the specific indication.
G. Substantial Equivalence
The new LARGE UNI-CLIP® staples are substantially equivalent to commercially marketed device, UNI-CLIP® staples, K011716.
H. Comparison of Technological Characteristics
The modified device has the same fundamental scientific technology and intended uses as the predicate device.
The modified staple has the following similarities to those which previously received 510(k) concurrence:
- Same intended use ।
- Same materials -
- Same Instructions for Use -
- Same basic design -
- Same manufacturing process -
I. Summarv of Studies
Mechanical tests have been carried out. Results have shown that the mechanical properties of the LARGE UNI-CLIP® staples are thus similar to the properties of the unmodified device, UNI-CLIP® staples, K011716.
J. Conclusion
The new LARGE UNI-CLIP® staples are substantially equivalent to commercially marketed device, UNI-CLIP® staples, K011716.
The modifications do not change the intended use or fundamental scientific technology of the device and do not raise any new issues of safety or effectiveness.
B-002
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird symbol, composed of three curved lines, representing the department's mission. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 3 2006
Newdeal SAS % Integra LifeSciences Corporation Ms. Judith E. O'Grady Sr. Vice President, Regulatory and Clinical Affairs, Quality Assurance 311 Enterprise Drive Plainsboro, New Jersey 08536
Re: K061594 Trade/Device Name: The LARGE UNI-CLIP® Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulation Class: II Product Code: JDR Dated: June 7, 2006 Received: June 9, 2006
Dear Ms. O'Grady:
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 cnactment 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
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Page 2 - Ms. Jennifer Reich
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) 276-0120 . 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 yours,
Surbaye Meelus
Mark N. 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):
Device Name: LARGE UNI-CLIP®
Indications For Use:
The LARGE UNI-CLIP® is indicated for fixation of bone fractures or for bone reconstruction.
Examples include:
- Arthrodesis in hand or foot surgery
- Fractures management in the foot or hand
- Mono or Bi-cortical osteotomies in the foot or hand
- Distal or proximal metatarsal or metacarpal osteotomies
- Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
The size and number of staple(s) used should be adapted to the specific indication.
Prescription Use X (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)
Julian Bucher
Division of General. Restorative. and Neurological Devices
Page 1 of 1
510(k) Number 20161594
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.