(42 days)
The Newdeal Compression Plate 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 plate(s) used should be adapted to the specific indication.
The Newdeal Compression Plate 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. This is the same principle as the UNI-CLIP (K011716) and Newdeal Large UNI-CLIP (K061594).
- . The rigidity of the "legs" is obtained using the Newdeal Locking System including a screw and a washer. This is the same principle as the Locking system of the
- . following predicate device: Surfix Knee Osteotomy system (K041601), Newdeal Lisfranc Plates (K060474), Newdeal Lapidus Plates (K060476) and Newdeal TTC Plates (K060473).
The plate will be available with 2 or 4 holes and with interaxis of 20, 25 or 30 mm.
Fixation of the Newdeal Compression Plate is provided by two or four Screws & washers, which are the same as for the Lapidus Plate (K060474) and Lisfranc Plate (K060476).
Plates, screws and washers will be provided either sterile or non-sterile.
The Locking System (Screw + washer) will be made from Titanium alloy Ti-6Al-4V or 316L Stainless Steel.
The provided text describes a medical device, the "Newdeal Compression Plate," and its regulatory submission (510(k)) to the FDA. The document primarily focuses on demonstrating substantial equivalence to existing predicate devices, rather than an AI-powered device performance study.
Therefore, many of the requested categories about AI device performance will not be applicable.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance (Not an AI Device)
Since this document describes a traditional medical device (compression plate) and not an AI-powered one, the concept of "acceptance criteria" for algorithms and their "reported device performance" in terms of metrics like sensitivity, specificity, or AUC is not applicable. The device's performance is assessed through mechanical tests to demonstrate its physical properties are compatible with its intended use.
| Acceptance Criteria (Mechanical) | Reported Device Performance |
|---|---|
| Mechanical properties compatible with intended use (implicitly, non-inferior to predicate device) | Mechanical tests show compatibility with intended uses and substantial equivalence to predicate devices (Large UNI-CLIP, K061594). |
Study Details (Mechanical Device, Not AI)
-
Sample size used for the test set and the data provenance: Not applicable for an AI device. For the mechanical tests, the specifics of the samples (e.g., number of plates tested, type of mechanical stress applied) are not detailed in this summary. Data provenance is not relevant in the context of mechanical testing of a physical device.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context refers to the physical properties of the device, established through engineering measurements, not expert interpretation.
-
Adjudication method for the test set: Not applicable.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an AI device, so MRMC studies involving human readers and AI assistance are not relevant.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.
-
The type of ground truth used: For the mechanical tests, the "ground truth" would be established by the physical and material science properties measured during testing and compared against established engineering standards or the predicate device's performance.
-
The sample size for the training set: Not applicable. There is no AI model to train.
-
How the ground truth for the training set was established: Not applicable.
Summary of Relevant Information for this Traditional Device:
- Device Type: Newdeal Compression Plate (a metallic bone fixation appliance).
- Purpose of the Submission: To demonstrate substantial equivalence to legally marketed predicate devices.
- Demonstration of Performance: Mechanical tests were carried out, and the results showed that the Newdeal Compression Plate has "mechanical properties compatible with their intended uses." These results were compared with a predicate device, the Large UNI-CLIP (K061594).
- Predicate Devices:
- Conclusion: The device is substantially equivalent to the predicate devices and does not raise new issues of scientific technology, safety, or effectiveness.
This document clearly pertains to a physical medical device and its mechanical testing, not an AI-powered diagnostic or assistive tool.
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K070447 1g 2
510(K) SUMMARY
Newdeal Compression Plates
MAR 2 9 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 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:
February 9, 2007
Name of the device:
| Proprietary Name: | Newdeal Compression 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 Newdeal Compression Plate is substantially equivalent to the Wright Medical Technology Compression Plate, K051908 and the Newdeal Large UNI-CLIP Staple, K061594.
{1}------------------------------------------------
Device Description:
The Newdeal Compression Plate 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. This is the same principle as the UNI-CLIP (K011716) and Newdeal Large UNI-CLIP (K061594).
- . The rigidity of the "legs" is obtained using the Newdeal Locking System including a screw and a washer. This is the same principle as the Locking system of the
- . following predicate device: Surfix Knee Osteotomy system (K041601), Newdeal Lisfranc Plates (K060474), Newdeal Lapidus Plates (K060476) and Newdeal TTC Plates (K060473).
The plate will be available with 2 or 4 holes and with interaxis of 20, 25 or 30 mm.
Fixation of the Newdeal Compression Plate is provided by two or four Screws & washers, which are the same as for the Lapidus Plate (K060474) and Lisfranc Plate (K060476).
Plates, screws and washers will be provided either sterile or non-sterile.
The Locking System (Screw + washer) will be made from Titanium alloy Ti-6Al-4V or 316L Stainless Steel.
Intended Use:
The Newdeal Compression Plate 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 plate(s) used should be adapted to the specific indication.
Testing and Test Results:
Mechanical tests have been carried out and results were compared with the predicate device, Large UNI-CLIP (K061594).
All the results show us that the Newdeal Compression Plate have mechanical properties compatible with their intended uses.
Conclusion
The Newdeal Compression Plate is substantially equivalent to commercially marketed devices, the Wright Medical Technology Compression Plate, K051908 and the Newdeal Large UNI-CLIP Staple, K061594.
The Newdeal Compression Plate does not raise any new issues of scientific technology, safety or effectiveness.
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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 consists of a stylized eagle with three stripes representing the department's services. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Newdeal SAS % Integra LifeSciences Corporation Judith O'Grady, RN, MSN Senior Vice President, Regulatory Affairs, Quality Assurance and Clinical Affairs 311 Enterprise Drive Plainsboro, New Jersey 08536
MAR 2 9 2007
Re: K070447
Trade/Device Name: Newdeal Compression Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: February 9, 2007 Received: February 15, 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
{3}------------------------------------------------
Page 2 - Judith O'Grady, RN, MSN
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 vours.
Reuben Mueller
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):
14070447
Newdeal Compression Plate Device Name:
Indications For Use:
The Newdeal Compression Plate 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 plate(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 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
currence of CDRH, Office of Device Evaluation (ODE)
Choubare buchip
Division Sign-C Division of General, Restorative, and Neurological Devices
510(k) Number K070447
Page 1 of 1
§ 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.