(161 days)
Not Found
No
The device description and other sections do not mention any AI or ML components or functionalities. The device is a mechanical implant.
Yes.
The device is intended for fractures, fusions, osteotomies, and replantations, which are therapeutic interventions.
No
The device is an osteosynthesis plate, which is an implant used for fixation and stabilization of bones, not for diagnosing conditions.
No
The device description clearly states it is an osteosynthesis plate, screws, and washers, which are physical hardware components intended for surgical implantation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The NEWDEAL Lisfranc Plates are described as osteosynthesis plates, screws, and washers. These are implanted directly into the body to fix bones.
- Intended Use: The intended use is for fractures, fusions, osteotomies, and replantations of bones at the tarsometatarsal joints. This is a surgical intervention, not a diagnostic test performed on a sample.
The information provided clearly indicates this is a surgical implant device, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The NEWDEAL Lisfranc Plates are intended to be used for fractures, fusions, osteotomies and replantations of small bones of the tarsometatarsal joints (Lisfranc joints).
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The NEWDEAL® Lisfranc Plate consists of an osteosynthesis plate designed to bridge the tarsometatarsal joints (Lisfranc joints). It is available in different sizes, and is implanted using fixation screws and washers. The NEWDEAL® locking system includes as many fixation screws as there are threaded lipped sockets on the plate and as many washers as implanted screws. The NEWDEAL® screws must be driven into the bone through the holes in the plate. The system is locked by means of washers drilled into the threaded lipped socket at the top of each hole, thus blocking each screw head.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones of the tarsometatarsal joints (Lisfranc joints)
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)
Performance testing was conducted compared to a legally marketed predicate device. The results was in a between the Lisfranc Plates and the predicate device.
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
510(K) SUMMARY
K060474
Lisfranc Plates
AUG - 3 2006
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 Regulatory and Clinical Affairs Director 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:
July 17, 2006
Name of the device:
| Proprietary Name: | Lisfranc 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 Lisfranc Plate is substantially equivalent to the Acumed Lower Extremity Congruent Bone Plate System, K033639, the Synthes Modular Foot System - 2.7 mm Module, K010321 and the Synthes Modular Foot System, K001941.
1
Device Description:
Device Description:
The NEWDEAL® Lisfranc Plate consists of an osteosynthesis plate designed to bridge the The NEWDEAL "Listranc joints). It is available in different sizes, and is implanted using tarsometatisal Journs (Listiane Johns). It is a rand washers. The NEWDEAL® locking system NCWDEAL "focking system manon ove are threaded lipped sockets on the plate and as many includes as mally fixation serews as there are the care a single implant/screw wasners as implanted scrows. The NETH Dis screws must be driven into the bone through the holes in the plate. The system is locked by means of washers drilled into the threaded lipped socket at the top of each hole, thus blocking each screw head.
Intended Use:
The NEWDEAL Lisfranc Plates are intended to be used for fractures, fusions, osteotomies The NEW DEALL Boxmall bones of the tarsometatarsal joints (Lisfranc joints).
Testing and Test Results:
Performance testing was conducted compared to a legally marketed predicate device. The I cronnames results was in a between the Lisfranc Plates and the predicate device.
Conclusion
sion The Newton Lower Extremity Congruent Bone Plate System, K033639 the devices, the Acaned 20ws. Black 2010321 and the Synthes Modular Foot System, K001941.
The Newdeal Lisfranc Plates do not raise any new issues of scientific technology, safety or effectiveness
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 3 2006
Newdeal SA c/o Ms. Judith O'Grady Sr. VP, Regulatory Affairs Integra Lifesciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536
K060474 Re:
Trade/Device Name: Lisfranc Plate Regulation Number: 21 CFR 888.3030 Regulation Namber. 21 OF No 0015 000
Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: July 17, 2006 Received: July 18, 2006
Dear Ms. O'Grady:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications ferenced above und have active development to legally marketed predicate devices marketed in interstate for use stated in the encrosale) to regard mannent date of the Medical Device Amendments, or to comments provision of they 20, 1978, are eccordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). alle Cosment Act (Act) that do not required to the general controls provisions of the Act. The r ou may, mererore, manot the Act include requirements for annual registration, listing of general controls provisions of the rece 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 If your device is classified (600 world). Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FDA an may be subject to suen adatterial resultsions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Couv acements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issualled of a buice complies with other requirements of the Act that IDA has made a decerminations administered by other Federal agencies. You must
3
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,
Herbert Levenson
V Mark N. Melkerson, M.S. 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): K060474
Device Name: Lisfranc Plates
Indications For Use:
The NEWDEAL Lisfranc Plates are intended for fractures, fusions, osteotomies and replantations of small bones at the tarsometatarsal joints (Lisfranc joints)
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)
Herbert Vern Page 1 of 1
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K060474