(80 days)
The Newdeal TIBIAXYS System is indicated for fixation of bone fractures or for bone reconstruction, including Arthrodesis, Osteotomies and fractures of ankle joint, distal tibia and fibula.
The Newdeal TIBIAXYS Plates are fixed with the SURFIX ALPHA Locking System 3.5mm diameter screws and Lock screws. Anterior Plates for ankle Arthrodesis have to be fixed with the TIBIAXYS cortical 4mm diameter screws.
The Newdeal TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and fractures of ankle joint, distal tibia and fibula. All plates and screws are manufactured from titanium alloy and are provided either sterile or non-sterile.
The provided 510(k) summary for the Newdeal TIBIAXYS System describes a medical device, a bone plate fixation system, and does not involve AI/ML components typically associated with the requested criteria. Therefore, most of the requested information regarding AI/ML device performance, ground truth, and expert evaluation is not applicable.
However, I can extract the information related to the device's performance based on the general mechanical testing described.
Non-AI/ML Device Acceptance Criteria and Study Details:
The summary states that the device was tested for its mechanical properties to ensure compatibility with its intended uses and compared to predicate devices. The acceptance criteria are implicitly that the device's mechanical properties are compatible with its intended uses and substantially equivalent to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical properties compatible with intended uses | "All the results show that the Newdeal TIBIAXYS System has mechanical properties compatible with their intended uses." |
| Substantial equivalence to predicate devices | "The Newdeal TIBIAXYS System are substantially equivalent to predicate device." |
2. Sample Size for the Test Set and Data Provenance
The document does not specify the sample size (number of mechanical tests or units tested) or the provenance (e.g., country of origin, retrospective/prospective) for the mechanical testing performed. This information is typically detailed in the full test reports, not usually summarized in this section of a 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. This device is a mechanical implant, and its performance is evaluated through engineering tests, not human expert interpretation of data or images. "Ground truth" in this context refers to engineering specifications and performance standards.
4. Adjudication Method for the Test Set
Not applicable. Mechanical testing results are objective measurements and do not require expert adjudication in the way clinical diagnostic interpretations would.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) study was not done. This type of study is relevant for diagnostic devices where human reader performance is being evaluated, often with AI assistance. The Newdeal TIBIAXYS System is a surgical implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used
The ground truth or performance standard for this device is based on engineering specifications and established mechanical performance criteria for bone fixation plates, along with comparison to the performance of legally marketed predicate devices. This includes properties like strength, fatigue resistance, and biocompatibility (though the summary only explicitly mentions "mechanical properties").
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no training set in the AI/ML sense.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no AI/ML training set, this question is not relevant.
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12 1
510(K) SUMMARY
Newdeal TIBIAXYS System
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 Director of Regulatory and Clinical Affairs - EMEA 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:
November 30, 2007
Name of the device:
| Proprietary Name: | Newdeal TIBIAXYS System |
|---|---|
| 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 |
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Substantial Equivalence:
The Newdeal TIBIAXYS System includes three types of plates. The plates include: 1) Anterior plates, 2) Medial or Lateral plates and 3) Fibula plates.
Anterior Plates are substantially equivalent to the Synthes Ankle Arthrodesis Plate, K022255, the Newdeal TTC Plates, K060473.
Medial and Lateral Plates are substantially equivalent to the Acumed Lower Extremity Congruent Plate System, K033639.
Fibula Plates are substantially equivalent to the Acumed Lower Extremity Congruent Plate System, K033639.
Device Description:
The Newdeal TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and fractures of ankle joint, distal tibia and fibula. All plates and screws are manufactured from titanium alloy and are provided either sterile or non-sterile.
Intended Use:
The Newdeal TIBIA XYS System is indicated for fixation of bone fractures or for bone reconstruction including Arthrodesis, Osteotomies and fractures of ankle joint, distal tibia and fibula.
The Newdeal TIBIAXYS Plates have to be fixed with the SURFIX and SURFIX ALPHA 3.5mm diameter Locking System (screws and Lock screws).
Anterior plates for ankle Arthrodesis have to be fixed with the TIBIAXYS 4.0mm diameter cortical screws.
Testing and Test Results:
TIBIA XYS System was tested and compared to the expected in vivo performance and to the predicate devices.
All the results show that the Newdeal TIBIAXYS System has mechanical properties compatible with their intended uses.
Conclusion
The Newdeal TIBIAXYS System are substantially equivalent to predicate device.
The TIBIAXYS Anterior Plate is substantially equivalent to the Synthes Ankle Arthrodesis Plate, K022255, and the Newdeal TTC Plates, K060473.
The TIBIAXYS Medial and Lateral Plates and Fibula Plate are substantially equivalent to the Acumed Lower Extremity Congruent Plate System, K033639.
The Newdeal TIBIAXYS System does not raise any new issues of scientific technology, safety or effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized symbol resembling a bird or abstract human form. The symbol is composed of curved lines and shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Public Health Service
FEB 21 2008
人
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Newdeal SAS % Ms. Judith O'Grady Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536
Re: K073375 Trade/Device Name: Newdeal TIBIAXYS System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS
Dated: November 30, 2007 Received: December 3, 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.
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.
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Page 2 - Ms. Judith O'Grady
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,
Mark N. Milliman
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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INDICATION FOR USE
510(k) Number (if known): 长073375
Device Name: Newdeal TIBIAXYS System
Indications For Use :
The Newdeal TIBIAXYS System is indicated for fixation of bone fractures or for bone reconstruction, including Arthrodesis, Osteotomies and fractures of ankle joint, distal tibia and fibula.
The Newdeal TIBIAXYS Plates are fixed with the SURFIX ALPHA Locking System 3.5mm diameter screws and Lock screws. Anterior Plates for ankle Arthrodesis have to be fixed with the TIBIAXYS cortical 4mm diameter screws.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aubare Buckley
Page 1 of 1
(Division Sign-6 Division of General, Restorative, and Neurological Devices
510(k) Number K073375
§ 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.