(43 days)
The Basal Dorsal Plate is intended for fixation of osteotomy of the basis of the first metatarsal. Examples include: Moderate to severe Hallux Valgus, Hallux varus
The Basal Dorsal Plate is designed for fixation of basal osteotomy of the 1st metatarsal. Characteristics of the plate have taken into account all the requirements associated with basal osteotomy: Anatomical shape adapted to the dorsal curve of the basis of the 1st metatarsal, in two different lengths for better adaptation to the specific anatomy of the patient. Fixation with CALCANEA 3.5mm screws in variable angle design for easier positioning and grip into the bone, and a locking design for better stability of the system. The Basal Dorsal Plate and CALCANEA screws are made from titanium alloy (Ti-6AI-4V ELI), which are color-coded for ease of identification. Fixation of the Basal Dorsal Plate is provided by four CALCANEA screws, already cleared with the CALCANEA Plate and Screws system (510(k) K041786). The plates and screws are provided sterile with the Basal Dorsal Plate.
Here's an analysis of the provided text regarding the Basal Dorsal Plate, focusing on acceptance criteria and supporting studies:
It is important to note that the provided text is a 510(k) summary for a medical device (Basal Dorsal Plate). Such summaries are typically a declaration of substantial equivalence to a predicate device, rather than a detailed report of clinical or advanced performance studies. Therefore, direct "acceptance criteria" as one might see for an AI algorithm or a clinical trial endpoint, and "study that proves the device meets the acceptance criteria" in that context, are not fully present. Instead, the document focuses on mechanical testing and comparison to predicate devices to demonstrate equivalence for market clearance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Mechanical Performance: Bending resistance equivalent to or greater than predicate devices (Synthes Modular Foot System). | An evaluation based on mechanical calculations demonstrated that the bending behavior of the Basal Dorsal Plates will be equivalent or greater than the predicate devices. Mechanical tests were carried out, and all results show that the Basal Dorsal Plates have mechanical properties compatible with their intended uses. |
| Material Compatibility: Manufactured from biocompatible and known materials appropriate for implantation. | Made from titanium alloy (Ti-6AI-4V ELI). This is a standard and well-understood material for implants, implicitly meeting biocompatibility and material strength requirements. |
| Fixation Mechanism Stability: Screws provide stable fixation and a locking design for system stability. | Fixation with CALCANEA™ 3.5mm screws in variable angle design for easier positioning and grip into the bone, and a locking design for better stability of the system. These screws are already indicated for use with the CALCANEA™ Plate and Screws system (510(k) K041786), implying their established performance. |
| Substantial Equivalence: Comparable in intended use, technological characteristics, and safety/effectiveness to predicates. | Substantially equivalent to Newdeal B-BOP Plate, K052152, and Acumed Lower Extremity Congruent Bone Plate System, K033639. The device "do not raise any new issues of scientific technology, safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "sample size" in terms of number of physical plates tested for the mechanical evaluation. It refers to "mechanical calculations" and "mechanical tests." For medical implants, this typically involves a set number of units tested to destruction or to defined limits under various load conditions, following recognized ASTM or ISO standards. However, the exact number is not stated.
- Data Provenance: The mechanical testing data would be generated internally by Newdeal SAS or a contracted testing facility. The country of origin for the device developer is France. The data itself is prospective in the sense that the tests were specifically conducted to support this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of 510(k) submission. For mechanical testing of an implant, "ground truth" is established by engineering specifications, validated test methods (e.g., ASTM standards), and material properties, not by human expert consensus on images or diagnoses.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1 or 3+1) are used in studies involving human interpretation or clinical endpoints where there might be disagreement among experts. For mechanical testing, test results are typically objective measurements, and any "adjudication" would refer to expert engineering review and interpretation of the raw data against predetermined pass/fail criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or reported in this 510(k) summary. This type of study is relevant for diagnostic imaging AI, where human readers interact with AI assistance. The Basal Dorsal Plate is a surgical implant, not a diagnostic tool requiring human interpretation.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
This concept is not applicable to the Basal Dorsal Plate. It is a physical medical device, not an algorithm. The "performance" is its mechanical integrity and function as an implant in the body, which is evaluated through mechanical testing and clinical experience of substantially equivalent predicate devices.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is based on:
- Engineering specifications and material properties: For aspects like bending resistance and material compatibility. These are defined by established biomechanical principles and regulatory standards.
- Performance of predicate devices: The "expected in vivo specifications performance" is benchmarked against the known safe and effective performance of legally marketed predicate devices. This implicitly means that the clinical outcomes and performance data of those predicates serve as the "ground truth" for what constitutes an acceptable device.
8. The Sample Size for the Training Set
This concept is not applicable. There is no "training set" for a physical medical implant like a Basal Dorsal Plate in the context of an AI algorithm. The design and manufacturing process are informed by general engineering principles, biomechanical understanding, and lessons learned from previous similar devices, but not through a formal "training set" like one created for machine learning.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the AI sense, this is not applicable. The design decision-making relies on established engineering principles, biomechanical requirements for the specific anatomical location (1st metatarsal), and understanding of surgical procedures like basal osteotomy.
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CONFIDENTIAL
Newdeal SAS 510(k): PreMarket Notification Basal Dorsal Plate
510(K) SUMMARY V.
BASAL DORSAL Plates
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:
December 18, 2006
Name of the device:
| Proprietary Name: | Basal Dorsal 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 Basal Dorsal Plate is substantially equivalent to the Newdeal B-BOP Plate, K052152 and to the Acumed Lower Extremity Congruent Bone Plate System, K033639.
FFB 7 2007
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CONFIDENTIAL
Newdeal SAS Newucar reMarket Notification Basal Dorsal Plate
Device Description:
The Basal Dorsal Plate is designed for fixation of basal osteotomy of the 15 metatarsal.
In the case of significant deformities of the forefoot (Hallux Valgus, Hallux Varus), the basal In the case of sigments and a generally the more prevalent procedure than the distal osteotomy, of proxing greater corrections of the 1st metatarsal.
Characteristics of the plate have taken into account all the requirements associated with basal osteotomy:
- Anatomical shape adapted to the dorsal curve of the basis of the 1* metatarsal, in . two different lengths for better adaptation to the specific anatomy of the patient.
- Fixation with CALCANEA™ 3.5mm screws in variable angle design for easier . positioning and grip into the bone, and a locking design for better stability of the system.
The Basal Dorsal Plate and CALCANEA™ screws are made from titanium alloy (Ti-6AI-4V ELI), which are color-coded for ease of identification.
Fixation of the Basal Dorsal Plate is provided by four CALCANEA™ screws, already I inditor it with the CALCANEA™ Plate and Screws system (510(k) K041786).
The plates and screws are provided sterile with the Basal Dorsal Plate.
Intended Use:
The Basal Dorsal Plate is intended for fixation of osteotomy of the basis of the first metatarsal. Examples include:
-
Moderate to severe Hallux Valgus
-
Hallux varus
Testing and Test Results:
An evaluation of the bending resistance based upon mechanical calculations has demonstrated that the bending behavior of the Basal Dorsal Plates will be equivalent or greater than the predicate devices (Synthes Modular Foot System).
Mechanical tests have been carried out and results were then compared with the expected in vivo specifications performance.
All the results show us that the Basal Dorsal Plates have mechanical properties compatible with their intended uses.
Conclusion
The Newdeal Basal Dorsal Plates are substantially equivalent to commercially marketed devices, the Newdeal B-BOP Plate, K052152 and the Acumed Lower Extremity Congruent Bone Plate System, K033639.
The Newdeal Basal Dorsal Plates do 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern around the symbol. The logo is 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
2 2007 FR
Re: K063831
Trade/Device Name: Basal Dorsal 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: December 21, 2006 Received: December 27, 2006
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.
Kaubara Buchim
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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IV. Indications for Use
510(k) Number (if known); KO6 3831
Device Name: Basal Dorsal Plate
Indications For Use:
The Basal Dorsal Plate is intended for fixation of osteotomy of the basis of the first metatarsal. Examples include:
Moderate to severe Hallux Valgus ।
Hallux varus
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)
Choubare buelund for mcu
1
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number K063831
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.