(27 days)
The Newdeal Compression Plate is 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 size and number of the 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 Newdeal Compression Plate (K070447), 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 devices: Surfix Knee Osteotomy System (K041601), Newdeal Lisfranc Plates (K060474), Newdeal Lapidus Plates (K060476), Newdeal TTC Plates (K060473 and Newdeal Compression Plate (K070447).
The provided text describes a submission for a medical device called the "Newdeal Compression Plate," not an AI/ML device. Therefore, the acceptance criteria and study described are related to the mechanical properties and substantial equivalence of a physical orthopedic implant, not to the performance of a software algorithm.
Based on the nature of the submission (510(k) for a medical device) and the content, there is no mention of an AI/ML device or any study that would typically be associated with evaluating AI/ML performance (e.g., diagnostic accuracy, reader study, standalone performance against ground truth).
The document focuses on establishing substantial equivalence to a previously approved predicate device (Newdeal Compression Plate, K070447) based on mechanical testing.
Here's a breakdown of why the requested information for an AI/ML device cannot be provided from this document:
- No AI/ML device: The device is a "Newdeal Compression Plate," a physical orthopedic implant.
- No acceptance criteria for AI/ML performance: The acceptance criteria are implicit in demonstrating substantial equivalence in mechanical properties.
- No study proving AI/ML performance: The study performed was "Mechanical tests" to show the equivalency of the modified plate to the unmodified predicate device.
However, I can extract the relevant information from the document regarding the medical device itself:
Acceptance Criteria and Study for the "Newdeal Compression Plate" (Medical Device - Not AI/ML)
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical properties are equivalent to the predicate device. | "Results have shown that the mechanical properties of the modified Newdeal Compression Plate are equivalent to the properties of the unmodified device, Newdeal Compression Plate, K070447." |
| Does not change intended use or fundamental scientific technology. | "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." |
2. Sample size used for the test set and data provenance:
- Sample Size: Not explicitly stated for the mechanical tests, but mechanical testing typically involves a set number of samples for various load, fatigue, and other biomechanical assessments.
- Data Provenance: Not specified, but generally refers to in-vitro laboratory testing of the physical device.
3. Number of experts used to establish the ground truth for the test set and qualifications:
- Not applicable. For mechanical testing of a physical device, ground truth is established through standardized engineering test methods and measurements, not expert consensus in the clinical sense.
4. Adjudication method for the test set:
- Not applicable. Mechanical testing data is quantitative measurement, not subjective assessment requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done:
- No. This is a medical device (implant) and not a diagnostic or screening tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used:
- For the mechanical tests, the ground truth would be the quantitative measurements obtained from destructive and non-destructive mechanical tests (e.g., tensile strength, fatigue life, compression resistance, torsional resistance) against established engineering standards and comparison data from the predicate device.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is a physical device being evaluated for mechanical equivalence, not an AI/ML model being trained.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
In summary, the provided document details a 510(k) submission for a physical orthopedic implant. It does not pertain to an AI/ML device, and therefore, the specific questions related to AI/ML performance evaluation cannot be answered from this text.
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2091609
Image /page/0/Picture/1 description: The image shows the logo for Newdeal, an Integra LifeSciences Company. The logo features the word "newdeal" in bold, black letters, with a registered trademark symbol to the right of the word. To the left of the word is a circular design with three dots along the circle's edge. Below the word "newdeal" is the text "An Integra LifeSciences Company" in a smaller, italicized font.
510(K) SUMMARY
JUN 3 0 2009
Newdeal Compression Plate
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: +33.4.37.47.51.51 Fax: +33.4.37.47.51.52
Contact person and telephone number
Marilyse Latour Manager of Regulatory Affairs Newdeal SAS Immeuble Séquoïa 2 97 allée Alexandre Borodine Parc Technologique de la Porte des Alpes 69800 Saint Priest - 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:
May 28, 2009
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 |
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Substantial Equivalence:
The modified Newdeal Compression Plate is substantially equivalent to commercially marketed device, Newdeal Compression Plate, K070447.
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 Newdeal Compression Plate (K070447), 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 devices: Surfix Knee Osteotomy System (K041601), Newdeal Lisfranc Plates (K060474), Newdeal Lapidus Plates (K060476), Newdeal TTC Plates (K060473 and Newdeal Compression Plate (K070447).
Intended Use:
The Newdeal Compression Plate is 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 ostcotomies ●
- Fixation of osteotomies for Hallux Valgus treatment (such as Scarf. Chevron, etc) ●
The size and number of the plate(s) used should be adapted to the specific indication.
Testing and Test Results:
Mechanical tests have been carried out. Results have shown that the mechanical properties of the modified Newdeal Compression Plate are equivalent to the properties of the unmodified device, Newdeal Compression Plate, K070447.
Conclusion
The modified Newdeal Compression Plate is substantially equivalent to commercially marketed device, Newdeal Compression Plate, K070447.
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 Department of Health & Human Services (HHS) of the United States. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, representing the department's mission related to health and human welfare. The logo is presented in black and white.
Public Health Service
JUN 30 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Newdeal SAS % Ms. Judith E. O'Grady 311 Enterprise Drive Plainsboro, New Jersey 08536
Re: K091609
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: May 28, 2009 Received: June 03, 3009
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 E. O'Grady
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ 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 Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buchun
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): Kog) b()9
Device Name: Newdeal Compression Plate
Indications For Use:
The Newdeal Compression Plate is 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 size and number of the plate(s) used should be adapted to the specific indication.
Prescription Use (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)
Souther
(Division Sign Off)
Division of Surgical, Orthopedic, A Restorative Devices
Number K091609
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.