(478 days)
Not Found
No
The summary describes a mechanical bone plate and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as an implant used for fixation of bone fractures or for bone reconstruction, which is a structural or supportive function, not a therapeutic treatment.
No
This device is intended for the fixation of bone fractures and reconstruction, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes physical components (plates, screws, washers) and mechanical properties, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "fixation of bone fractures or for bone reconstruction" and lists specific surgical procedures involving bones in the hand and foot. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details the mechanical function of the plates in providing compression and rigidity for bone fusion. This is a physical intervention, not a test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting markers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to physically stabilize and repair bone.
N/A
Intended Use / Indications for Use
The Newdeal Compression Plates are 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 Newdeal Uni-CP™ U-Plate is intended for arthrodesis of the second and third cuneo-metatarsal and the inter-cuneiform second and third joints.
The size and number of the plate(s) used should be adapted to the specific indication.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The Newdeal Compression Plates 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.
- . The rigidity of the "legs" is obtained using the Newdeal Locking System including a screw and a washer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or foot
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Static and dynamic 4-point bending mechanical tests have been carried out. Results have shown that the mechanical properties of the modified Newdeal Compression Plates are substantially equivalent to the properties of the predicate devices: unmodified Newdeal Compression Plates, K070447, cleared on March 29, 2007.
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.
Not Found
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
ewdeal
An Integra LifeSciences Company
APR 1 4 2011
510(k) SUMMARY
Modified Newdeal® Compression Plates
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
Regulatory Affairs Manager 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 Email: marilyse.latour@Integra-LS.com
Alternate Contact
Stephen Beier Regulatory, Quality, Clinical Affairs Associate Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536, USA Tel: 609.936.5436 Fax: 609.275.9445 Email: stephen.beier@Integra-LS.com
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:
March 14, 2011
1
Name of the device:
| Proprietary Name: | Newdeal Compression Plates |
|---|---|
| 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 modified Newdeal Compression Plates are substantially equivalent to the commercially marketed device, Newdeal Compression Plates, K070447, cleared on March 29, 2007.
Device Description:
The Newdeal Compression Plates 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.
- . The rigidity of the "legs" is obtained using the Newdeal Locking System including a screw and a washer.
Indications for Use:
The Newdeal Compression Plates are intended for fixation of bone fractures or for bone reconstruction.
Examples include:
- . Arthrodesis in hand or foot surgerv
- . 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 Newdeal Uni-CP™ U-Plate is intended for arthrodesis of the second and third cuneometatarsal and the inter-cuneiform second and third joints.
The size and number of the plate(s) used should be adapted to the specific indication.
Testing and Test Results:
Static and dynamic 4-point bending mechanical tests have been carried out. Results have shown that the mechanical properties of the modified Newdeal Compression Plates are substantially equivalent to the properties of the predicate devices: unmodified Newdeal Compression Plates, K070447, cleared on March 29, 2007.
Conclusion
The modified Newdeal Compression Plates are substantially equivalent to the commercially marketed devices, unmodified Newdeal Compression Plates (K070447).
The proposed device does not change the intended use or fundamental scientific technology of the predicate device, and does not raise any new issues of safety or effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest movement or flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Newdeal SAS % Integra LifeSciences Corporation Mr. Frederic Testa Director of Regulatory Affairs 311 Enterprise Drive Plainsboro, New Jersey
APR 1 4 2011
Re: K093914
Trade/Device Name: Newdeal® Compression Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: April 11, 2011 Received: April 12, 2011
Dear Mr. Testa:
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 Foond, Or to 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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.
3
Page 2 - Mr. Frederic Testa
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 not 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 on modical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1178001/f 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 Prat 807.97). For questions regarding the reporting of adverse events under the MDR regulation (11 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/Reportal?roblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Aj. B. R. ha
for
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): N/A
Device Name: Newdeal Compression Plates
Indications For Use:
The Newdeal Compression Plates are 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 Newdeal Uni-CP™ U-Plate is intended for arthrodesis of the second and third cuneo-metatarsal and the inter-cuneiform second and third joints.
The size and number of the plate(s) used should be adapted to the specific indication.
Prescription Use X (Part 21 CFR 80 i 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)
for M. Mulkerson
(Division Sign-Off) Division of Surgical. Orthopedic, and Restorative Devices
510(k) Number K093914