NEWDEAL COMPRESSION PLATES

• K Number: K093914
• Device Name: NEWDEAL COMPRESSION PLATES
• Manufacturer: NEWDEAL SAS
• Date Cleared: 2011-04-14 ( 478 days)
• Product Code: HRS
• Regulation Number: 888.3030
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: K070447
• Predicate For: N/A

Intended Use

The Newdeal Compression Plates are intended for fixation of bone fractures or for bone reconstruction.
Examples include:

• Arthrodesis in hand or foot surgery .
• . Fracture 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 Newdeal Uni-CP™ U-Plate is intended for arthrodesis of the second and third cuneo-metatarsal and the inter-cuneiform second and third joints.
  The size and number of the plate(s) used should be adapted to the specific indication.

Device Description

The Newdeal Compression Plates will offer the combination of two concepts:

• By widening the "eye" (diamond shaped opening) on the interaxis of the plate. . mechanical deformation leads to narrowing of the interaxis of the two legs and thus provides compression between the two bone fragments to fuse.
• . The rigidity of the "legs" is obtained using the Newdeal Locking System including a screw and a washer.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device, the "Modified Newdeal® Compression Plates." This type of submission focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving novel effectiveness or meeting specific performance acceptance criteria through clinical studies. Therefore, many of the requested elements for describing acceptance criteria and a study proving device adherence are not directly applicable to this type of regulatory filing.

Here's an analysis based on the provided text, addressing the points where information is available and explaining why other points are not applicable:

1. A table of acceptance criteria and the reported device performance

For a 510(k) submission, the primary acceptance criteria for the modified device are demonstrating mechanical performance at least equivalent to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Strength: Modified Newdeal Compression Plates must demonstrate mechanical properties that are substantially equivalent to the predicate Newdeal Compression Plates (K070447).	"Static and dynamic 4-point bending mechanical tests have been carried out. Results have shown that the mechanical properties of the modified Newdeal Compression Plates are substantially equivalent to the properties of the predicate devices: unmodified Newdeal Compression Plates, K070447, cleared on March 29, 2007."
No change in fundamental scientific technology.	"The proposed device does not change the intended use or fundamental scientific technology of the predicate device..."
No new issues of safety or effectiveness raised.	"...and does not raise any new issues of safety or effectiveness."
Indications for Use remain consistent or comparable to the predicate.	The Indications for Use for the modified device are provided and are consistent with bone fixation and reconstruction. The document states the modified device is substantially equivalent, implying the indications are also equivalent.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size: The document does not specify the exact number of plates or tests performed during the static and dynamic 4-point bending mechanical tests. It only states that tests "have been carried out."
• Data provenance: The document does not explicitly state the country of origin of the mechanical test data. Given the submitter's address is in France (Newdeal SAS), it is likely the testing was conducted in Europe. The testing is prospective in the sense that it was conducted specifically to support this 510(k) submission, not by analyzing past clinical data. This is a pre-clinical (bench-top) study, not a clinical study involving patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This point is not applicable. The "ground truth" concept (e.g., expert consensus on clinical diagnoses) is relevant for studies involving human interpretation or clinical outcomes. This submission is based on mechanical (bench-top) testing, where the "ground truth" is established by engineering standards and measurements, not expert clinical interpretation.

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

This point is not applicable. Adjudication methods are used in clinical trials or studies where human assessment of outcomes or conditions requires agreement or arbitration. Mechanical testing does not involve such human adjudication in the same way.

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 point is not applicable. This submission is for a medical implant (bone plate), not an AI-powered diagnostic device. Therefore, MRMC studies and the concept of human readers improving with AI assistance are irrelevant to this device.

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

This point is not applicable. This is not an algorithm or software device.

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

The "ground truth" in this context refers to the established mechanical properties and performance standards for bone fixation plates, as generally understood in the orthopedic device industry and often guided by international standards (though not explicitly mentioned here) for such testing. The comparison is made against the measured mechanical properties of the predicate device.

8. The sample size for the training set

This point is not applicable. There is no "training set" as this is a physical medical device undergoing mechanical testing, not a machine learning model.

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

This point is not applicable for the same reason as point 8.

Summary

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ewdeal
An Integra LifeSciences Company

APR 1 4 2011

510(k) SUMMARY

Modified Newdeal® Compression Plates

Submitter's name and address:

Newdeal SAS Immeuble Séquoïa 2 97 allée Alexandre Borodine Parc Technologique de la Porte des Alpes 69800 Saint Priest - FRANCE Tel: [phone] Fax: [phone]

Contact person and telephone number

Marilyse Latour

Regulatory Affairs Manager Newdeal SAS Immeuble Séquoïa 2 97 allée Alexandre Borodine Parc Technologique de la Porte des Alpes 69800 Saint Priest - France Tel: [phone] Fax: [phone] Email: [e-mail]

Alternate Contact

Stephen Beier Regulatory, Quality, Clinical Affairs Associate Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536, USA Tel: [phone] Fax: [phone] Email: [e-mail]

Authorized Agent in the United States

Judith E. O'Grady, RN, MSN Sr. Vice President, Regulatory Affairs, Quality Assurance and Clinical Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536, USA Tel: [phone] Fax: [phone] E-mail: [e-mail]

Date Summary was prepared:

March 14, 2011

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K093914

Name of the device:

Proprietary Name:	Newdeal Compression Plates
Common Name:	Plate, Fixation, Bone
Classification Name:	Single/multiple component metallic bone fixation appliances andaccessories (21CFR 888.3030)
Device Product Code:	HRS
Classification Panel:	Orthopedic

Substantial Equivalence:

The modified Newdeal Compression Plates are substantially equivalent to the commercially marketed device, Newdeal Compression Plates, K070447, cleared on March 29, 2007.

Device Description:

The Newdeal Compression Plates will offer the combination of two concepts:

• By widening the "eye" (diamond shaped opening) on the interaxis of the plate. . mechanical deformation leads to narrowing of the interaxis of the two legs and thus provides compression between the two bone fragments to fuse.
• . The rigidity of the "legs" is obtained using the Newdeal Locking System including a screw and a washer.

Indications for Use:

The Newdeal Compression Plates are intended for fixation of bone fractures or for bone reconstruction.

Examples include:

• . Arthrodesis in hand or foot surgerv
• . Fracture 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 Newdeal Uni-CP™ U-Plate is intended for arthrodesis of the second and third cuneometatarsal and the inter-cuneiform second and third joints.

The size and number of the plate(s) used should be adapted to the specific indication.

Testing and Test Results:

Static and dynamic 4-point bending mechanical tests have been carried out. Results have shown that the mechanical properties of the modified Newdeal Compression Plates are substantially equivalent to the properties of the predicate devices: unmodified Newdeal Compression Plates, K070447, cleared on March 29, 2007.

Conclusion

The modified Newdeal Compression Plates are substantially equivalent to the commercially marketed devices, unmodified Newdeal Compression Plates (K070447).

The proposed device does not change the intended use or fundamental scientific technology of the predicate device, and does not raise any new issues of safety or effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest movement or flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Newdeal SAS % Integra LifeSciences Corporation Mr. Frederic Testa Director of Regulatory Affairs 311 Enterprise Drive Plainsboro, New Jersey

APR 1 4 2011

Re: K093914

Trade/Device Name: Newdeal® Compression Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: April 11, 2011 Received: April 12, 2011

Dear Mr. Testa:

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 Foond, Or to 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 - Mr. Frederic Testa

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 not 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); medical device reporting (reporting on modical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1178001/f for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Prat 807.97). For questions regarding the reporting of adverse events under the MDR regulation (11 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/Reportal?roblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Aj. B. R. ha
for

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): N/A

Device Name: Newdeal Compression Plates

Indications For Use:

The Newdeal Compression Plates are intended for fixation of bone fractures or for bone reconstruction.

Examples include:

• Arthrodesis in hand or foot surgery .
• . Fracture 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 Newdeal Uni-CP™ U-Plate is intended for arthrodesis of the second and third cuneo-metatarsal and the inter-cuneiform second and third joints.

The size and number of the plate(s) used should be adapted to the specific indication.

Prescription Use X (Part 21 CFR 80 i 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)

for M. Mulkerson

(Division Sign-Off) Division of Surgical. Orthopedic, and Restorative Devices

510(k) Number K093914

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.