THE UNI-CLIP STAPLE

• K Number: K011716
• Device Name: THE UNI-CLIP STAPLE
• Manufacturer: NEWDEAL S.A.
• Date Cleared: 2001-08-30 ( 87 days)
• Product Code: JDR
• Regulation Number: 888.3030
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: K991482 , K993714 , K904220 , K991962
• Predicate For: K061594 , K070688 , K091609 , K112794 , K153395 , K153622 , K182943

Intended Use

The "new" uni-clip® staple is indicated for fixation of bone fracture or for bone reconstraucion, including:

• Arthrodesis in hand or foot surgery .
• Mono or Bi-cortical osteotomies in the foot or hand ●
• Fracture management in the foot or hand ●
• Distal or proximal metatarsal or metacarpal osteotomies .
• Fixation of osteotomies for Hallux Valgus treatment such as . scarf, chevron, etc.

Device Description

The UNI-CLIP® STAPLE is designed so that, by widening the "chamond", mosseon can obtain a true compression, adjustable and controlled, with many choices of size.

AI/ML Overview

The provided text describes a 510(k) submission for the "UNI-CLIP® STAPLE," a bone fixation staple. The submission focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than proving specific performance criteria through a clinical study with detailed metrics like sensitivity, specificity, or AUC.

Therefore, many of the requested details regarding acceptance criteria and study particulars cannot be found in this document.

Here's what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not explicitly stated as quantifiable performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic device).	The new UNI-CLIP® STAPLE is stated to have "the same intended of use and all are the same technologies." It is also made from stainless steel.
Mechanical Performance: Resistance to torsion in compliance with selected standard (implied criterion for predicate device).	Rupture torque of the "new" UNI-CLIP® STAPLE is the same as for the predicate device. Torque of divergence and strength of compression of the "new" UNI-CLIP® STAPLE is the same as for the predicate device.
Material: Biocompatibility (implied from predicate).	Made from stainless steel (same as predicate).

2. Sample size used for the test set and the data provenance:

• This information is not provided. The study mentioned is about comparing mechanical properties to predicate devices, not a clinical test set with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as no clinical test set with ground truth established by experts is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable as no clinical test set with expert adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• This is not an AI/diagnostic device. No MRMC study or AI assistance is mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable as this is a medical device (bone staple), not a diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the mechanical performance comparison, the "ground truth" or reference was the performance of the predicate device (UNI-CLIP® STAPLE (K991482)) based on its stated resistance to torsion, torque of divergence, and strength of compression. This is a technical/engineering "ground truth" rather than clinical.

8. The sample size for the training set:

• Not applicable as this is a bone staple, not a machine learning model.

9. How the ground truth for the training set was established:

• Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo and contact information for a company called "newdeal". The address is listed as NEWDEAL SA, 31 RUE DE LA CONVENTION, PARC D'ACTIVITÉS GARIGLIANO, 38200 VIENNE, FRANCE. The telephone number is (33) 04 74 78 15 15, and the fax number is (33) 04 74 78 15 16. The internet email address is [e-mail].

AUG 3 0 2001

K 0117/6

SUMMARY OF SAFETY AND EFFECTIVENESS

SPONSOR IDENTIFICATION: A. NewDeal SA Parc d'Activitiés Garigliano Rue de la Convention 38 200 VIENNE FRANCE

Tél. : [phone] Fax : [phone]

ESTABLISHMENT REGISTRATION NUMBER: B.

9615741

OFFICIAL CONTACT PERSON C.

Norman F. Estrin, Ph. D., RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac , MD 20854 [e-mail] Tel. : [phone] Fax : [phone]

DATE OF PREPARATION OF THIS SUMMARY: May 31, 2001 D.

UNI-CLIP® STAPLE PROPRIETARY (TRADE) NAME: E.

• Bone fixation staple F. COMMON NAME: True compression, adjustable and controlled.
• CLASSIFICATION NAME AND REFERENCE: ে Staple, Fixation, Bone (21 CFR, Section 888.3040)

SA au capital de 1.000.000 F - Nº Siret 412 111 510 000 19 - NAF 331B - 412 111 510 RCS Vie

000041

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• PROPOSED REGULATORY CLASS: Class II H.
• 87JDR DEVICE PRODUCT CODE: I.
• OR J. PANEL CODE: PANEL CODE:
  DESCRIPTION OF DEVICE: The UNI-CLIP® STAPLE is designed so that, K. DESCAN TION OF OF OF OF Clanical deformation leads to narrowing of the by widening the "chamond", mosseon can obtain a true compression, adjustable and controlled, with many choices of size.
• The UNI-CLIP® STAPLE is implanted for fixation of bone INTENDED USE: L. fractures or for bone reconstructions.
• The "new" UNI-CLIP® STAPLE is INDICATIONS FOR USE: M. INDICATIONS I ON OBE fractures or for bone reconstruction, Examples includeng :
  • Arthrodesis in hand or foot surgery ●
  • Mono or Bi-cortical osteotomies in the foot or hand .
  • Fractures management in the foot or hand .
  • Distal or proximal metatarsal or metacarpal osteotomies .
  • Distal of proximal metadisal of meadarpareatment (such as Scarf, Chevron, etc.) .
• PREDICATE DEVICE: The "new" UNI-CLIP® STAPLE is substantially
  Collections of the Comment Coast 1992 1992 1992 1992 1992 1992 1992 1992 1992 1992 1992 1992 -N. PREDICATE DEVICE: THE TREW UNICOLICAL (K991482), the Memory Staple( DePuy)
  equivalent to the UNI-CLIP® STAPLE (K991482), the Memory Staple(Departic equivalent to the ONF-CDF (Biomedical Ent) (K993714), the EIS Dynamic (K904220), the memograph Stapine) (K991962), the HTO Compression staple Memory Staple (Groupe Leptite) Richards Fixation Staples (Smith and Nephew Richards).

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: 0.

Both the UNI-CLIP® STAPLE have the same intended of use and all are Both the UNFCEII - STAR DE nave also salonies. All are made from stainless steel.

• SUMMARY OF STUDIES: Torque of divergence and strength of compression of P. SUMMARY OF STODIES. " Torque of arrorgents ALE is the same as for the the Rupture torque of the "heve a resistance to torsion in compliance with the selected standard.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 0 2001

NewDeal SA c/o Norman F. Estrin, Ph.D. President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac, Maryland 20854

Re: K011716 Trade Name: Uni-Clip® Staple Regulation Number: 888.3030 Regulatory Class: II Product Code: JDR Dated: May 30, 2001 Received: June 4, 2001

Dear Dr. Estrin:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to vour premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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Page 2 - Norman F. Estrin, Ph.D.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice for your do the same contact the Office of Compliance at additionally 807.10 for m viro diagnestions on the promotion and advertising of your device, [phone]. Additionally, for questions on are particulars of any and one of any of the regulation entitled, «Misbranding by reference to premarket notification» (21CFR 807.97). Other general entitled, "Missuanding by reicher to premarket nowledged from the Division of Small
information on your responsibilities under the Act may be obtained from (900) (30, 2011) a information on your responsibilities and its toll-free number [phone] or
Manufacturers International and Consumer Assistance at its toll-free number in the University Manufacturers International and Sollass "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Mark n Mellema

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K011716

Device Name: Uni-Clip Staple

Indications For Use:

The *new" uni-clip® staple is indicated for fixation of bone fracture or for bone reconstraucion, including:

• Arthrodesis in hand or foot surgery .
• Mono or Bi-cortical osteotomies in the foot or hand ●
• Fracture management in the foot or hand ●
• Distal or proximal metatarsal or metacarpal osteotomies .
• Fixation of osteotomies for Hallux Valgus treatment such as . scarf, chevron, etc.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

lo Mark N Mikkelsen

ivision of General, Restorative and Neurological I

510(k) Number

Koll +16

OR

Over-The-Counter Use_No

Prescription Use Yes (Per 21 CFR 801.109)

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.