The Newdeal TTC Plates are intended for arthrodesis of the ankle joint and distal tibia, fractures, osteotomies, fusions and replantations of small bones in the foot and ankle.

Device Description

The NEWDEAL® TTC Plates consists of a tibiotalocalcaneal plate, available in different sizes, dedicated to be fixed using NEWDEAL® locking system fixation screws and washers. It is available in different sizes, and is implanted using NEWDEAL® locking system fixation screws and washess. The NEWDEAL® locking system includes as many fixation screws as there are threaded lipped sockets on the plate and as many washers as implanted screws. The NEWDEAL® locking system creates extemporaneously a single implant/screw unit fixed into the bone. The osteosynthesis screws must be driven into the bone through the holes in the plate. The system is locked by means of washers drilled into the threaded lipped socked at the top of each hole, thus blocking each screw head.

AI/ML Overview

This document describes a 510(k) submission for the TTC Plates by Newdeal SAS. The submission is a "traditional" 510(k) given its age, and predominantly focuses on the substantial equivalence of modifications to an already cleared device.

Here's an analysis of the provided information concerning acceptance criteria and the supporting study, formatted to your request:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Criteria/Metric	Reported Device Performance
Mechanical Properties	The modified TTC Plates (with stainless steel locking system) must demonstrate similar mechanical properties to the predicate device (TTC Plates, K060473).	"Results have shown that the mechanical properties of the modified TTC PLATES are thus similar to the properties of the unmodified device, TTC Plates, K060473."
Intended Use	The modifications should not change the intended use of the device.	"The modifications do not change the intended use..."
Fundamental Scientific Technology	The modifications should not change the fundamental scientific technology of the device.	"...or fundamental scientific technology of the device..."
Safety and Effectiveness Issues	The modifications should not raise any new issues of safety or effectiveness.	"...and do not raise any new issues of safety or effectiveness."

Study Details:

This submission is for a modified medical device. The "study" here is a set of mechanical tests designed to demonstrate that the modified device is substantially equivalent to its predicate. It is not a clinical study involving human or animal subjects, nor is it related to AI/algorithm performance.

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for the mechanical tests. The description indicates "mechanical tests have been carried out." For mechanical testing, samples typically refer to a specified number of physical units of the device tested under various conditions to ensure statistical significance, but this specific number is not provided in the summary.
- Data Provenance: The tests were conducted to compare the modified device to the predicate device. The summary does not specify the country of origin for the testing, but the submitting company (Newdeal SAS) is based in France. The data is retrospective in the sense that it's comparing a new version to an existing one, but the mechanical testing itself is a prospective evaluation of the new device's properties.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the "study" involves mechanical testing, not a human-interpreted diagnostic or clinical outcome. Ground truth in this context would be engineering specifications and established testing methodologies.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Mechanical tests generally follow standardized procedures and results are objectively measured, rather than adjudicated by experts.
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:
- Not applicable. This device is a bone fixation plate, not an AI or imaging diagnostic tool. No MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a bone fixation plate, not an AI or algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Mechanical Specifications/Engineering Standards: The ground truth for mechanical tests would be established engineering standards, material properties, and performance benchmarks derived from the predicate device and relevant international standards for bone fixation devices. The goal was to prove "similarity" to the predicate, implying the predicate's performance served as the benchmark.
The sample size for the training set:
- Not applicable. This device is a bone fixation plate, not an AI system that requires a training set.
How the ground truth for the training set was established:
- Not applicable. As above, no training set is relevant for this type of device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Newdeal, an Integra LifeSciences Company. The logo features the word "newdeal" in a bold, sans-serif font, with a circle of dots to the left of the word. Below the word "newdeal" is the text "An Integra LifeSciences Company" in a smaller, sans-serif font. The logo is simple and modern, and it effectively communicates the company's name and affiliation.

510(K) SUMMARY

TTC Plates

FEB 8 2007

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

Contact person and telephone number

Morgane Grenier Regulatory and Clinical Affairs Director Newdeal SAS 10, place d'Helvétie 69006 Lyon, France Tel: +33 4 37 47 51 51 Fax: +33 4 37 47 51 52

Alternate Contacts

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: (609) 936-2311 Fax: (609) 275-9445 E-mail: jogrady@integra-ls.com

Date Summary was prepared:

January 12, 2007.

Name of the device:

Proprietary Name:	TTC Plate
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 TTC Plates (with stainless steel locking system) are substantially equivalent to commercially marketed device, TTC Plates, K060473.

Device Description:

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K070166 Page 2/

The NEWDEAL® locking system includes as many fixation screws as there are threaded lipped sockets on the plate and as many washers as implanted screws.

The NEWDEAL® locking system creates extemporaneously a single implant/screw unit fixed into the bone. The osteosynthesis screws must be driven into the bone through the holes in the plate. The system is locked by means of washers drilled into the threaded lipped socked at the top of each hole, thus blocking each screw head.

Intended Use:

The Newdeal TTC Plates are intended for arthrodesis of the ankle joint and distal tibia, fractures, osteotomies, fusions and replantations of small bones in the foot and ankle.

Testing and Test Results:

Mechanical tests have been carried out. Results have shown that the mechanical properties of the modified TTC PLATES are thus similar to the properties of the unmodified device, TTC Plates, K060473.

Conclusion

The modified TTC Plates (with stainless steel locking system) are substantially equivalent to commercially marketed device, TTC Plates, K060473.

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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized depiction of an eagle or bird-like figure, with three wing-like shapes extending from its body. The logo is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Newdeal SAS % Judith O'Grady, R.N., M.S.N. Senior Vice President, Regulatory Affairs Integra Lifesciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536

8 2007 FFB

Re: K070160

Trade/Device Name: TTC Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: January 16, 2007 Received: January 18, 2007

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 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.

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Page 2 - Judith O'Grady, R.N., M.S.N.

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. 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,

Chabarg Buehup

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): K070160

Device Name: TTC Plates

Indications For Use:

The Newdeal TTC Plates are intended for arthrodesis of the ankle joint and distal tibia, fractures, osteotomies, fusions and replantations of small bones in the foot and ankle.

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)

Barbara Buchum

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K070160

Page 1 of 1

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.