(44 days)
Not Found
No
The device description and performance studies focus on the mechanical properties of the plate and screws, with no mention of AI or ML technology.
No
This device is an osteosynthesis plate used to stabilize fractures and fusions in the tarsometatarsal joints, which is a structural implant rather than a device that delivers therapy.
No
This device is described as an osteosynthesis plate used for surgical fixation of fractures, fusions, osteotomies, and replantations of small bones. It is an implantable medical device for treatment, not for diagnosing conditions.
No
The device description clearly outlines a physical osteosynthesis plate, screws, and washers, which are hardware components.
No, 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 provided description clearly states that the Newdeal Lisfranc Plates are implanted devices used for surgical fixation of bones at the tarsometatarsal joints. They are a physical implant, not a test performed on a sample outside the body.
- Intended Use: The intended use is for treating fractures, fusions, osteotomies, and replantations, which are surgical procedures involving the musculoskeletal system.
The device is a surgical implant, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Newdeal Lisfranc Plates are intended for fractures, fusions, osteotomies and replantations of small bones at the tarsometarsal 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 NEWDEAL® locking system 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® locking system creates a single implant/screw unit fixed into the bone. The osteosynthesis 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
tarsometatarsal joints (Lisfranc joints)
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)
Mechanical tests have been carried out. Results have shown that the mechanical properties of the modified LISFRANC PLATES are thus similar to the properties of the unmodified device, Lisfranc Plates, K060474.
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
Image /page/0/Picture/1 description: The image shows the logo for Newdeal, an Integra LifeSciences Company. The logo features the word "newdeal" in a bold, sans-serif font, with a registered trademark symbol next to it. To the left of the word is a circle with five black dots around it. Below the word "newdeal" is the text "An Integra LifeSciences Company" in a smaller, sans-serif font.
510(K) SUMMARY
Lisfranc Plates
FEB 8 2007
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:
December 22, 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 modified Lisfranc Plates (with stainless steel locking system) are substantially equivalent to commercially marketed device, Lisfranc Plates, K060474.
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 NEWDEAL® locking system 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
1
implanted screws. The NEWDEAL® locking system creates a single implant/screw unit fixed into the bone. The osteosynthesis 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 for fractures, fusions, osteotomies and replantations of small bones at the tarsometarsal joints (Lisfranc joints).
Testing and Test Results:
Mechanical tests have been carried out. Results have shown that the mechanical properties of the modified LISFRANC PLATES are thus similar to the properties of the unmodified device, Lisfranc Plates, K060474.
Conclusion
The modified Lisfranc Plates (with stainless steel locking system) are substantially equivalent to commercially marketed device, Lisfranc Plates, K060474.
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus 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
FEB 8 2007
Re: K063820
Trade/Device Name: Lisfranc 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: February 2, 2007 Received: February 5, 2007
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,
Barbara Prichin
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K063820
Device Name:
Lisfranc Plates
Indications For Use:
The Newdeal Lisfranc Plates are intended for fractures, fusions, osteotomies and replantations of small bones at the tarsometarsal joints (Lisfranc joints).
Prescription Use __ X (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)
Harbau Rouelum
(Division (Division of General, Restorative, and Neurological Devices
510(k) Number K63820