(43 days)
No
The device description and performance studies focus on the mechanical properties and design of a bone plate and screws, with no mention of AI or ML.
Yes
The device is described as a Basal Dorsal Plate intended for the fixation of osteotomy of the basis of the first metatarsal, used to treat conditions like Hallux Valgus. This involves surgical implantation to correct a physical condition, which aligns with the definition of a therapeutic device.
No
Explanation: The device is described as a Basal Dorsal Plate for fixation of osteotomy, which is a surgical implant for treatment, not for diagnosis.
No
The device description clearly describes a physical implant (plate and screws) made of titanium alloy, intended for surgical fixation. It does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Basal Dorsal Plate is a surgical implant made of titanium alloy intended for the physical fixation of bone (osteotomy) in the foot. It is a mechanical device used in vivo (within the body) during surgery.
- Intended Use: The intended use is for the fixation of a bone osteotomy, which is a surgical procedure, not a diagnostic test performed on a sample.
The description clearly indicates a surgical implant used for structural support and fixation within the body, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
HRS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
basis of the first metatarsal, forefoot
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 and |
| accessories (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
1
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.
2
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.
3
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
4
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
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