(44 days)
No
The document describes a titanium plate for bone fixation and does not mention any AI/ML components or functionalities.
Yes
The device, HALLU® PLATES, is an implantable plate intended for fixation of fractures, osteotomies, or arthrodesis of the first metatarso-phalangeal joint to treat conditions like Hallux rigidus, severe hallux valgus, and other deformities, which are therapeutic interventions.
No
This device, the HALLU® PLATES, is an implant intended for surgical fixation of fractures, osteotomies, or arthrodesis, not for diagnosing medical conditions.
No
The device description clearly states it is a "low profile Titanium plate" and is used in conjunction with "SNAP-OFF® screws," indicating it is a physical implantable device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description and Intended Use: The HALLU® PLATES are described as implants intended for fixation of fractures, osteotomies, or arthrodesis of the first metatarsophalangeal joint. This is a surgical implant used within the body to provide structural support and stability.
The information provided clearly indicates a surgical implant, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
The HALLU® PLATES is intended to be implanted for fixation of fractures, osteotomies or arthordesis of the first metatarso-phalangeal joint, including cases of:
- Hallux rigidus
- Severe hallux valgus (IM angle >20° and HV angle >40°)
- Deformity from rheumatoid arthritis
- Failed previous surgical procedure
- Traumatic arthritis
- Neuromuscular instability.
Addition of a screw crossing the joint is strongly recommended for optimal arthrodesis consolidation.
Product codes
HRS
Device Description
The Newdeal HALLU® PLATES is a low profile Titanium plate dedicated to first metatarsophalangeal arthrodesis. The system includes both HALLU" -FIX C plates as well as HALLU -FIX S plates. The plates are used in conjunction with Newdeal SNAP-OFF® screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
first metatarsophalangeal joint
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)
Mechanical tests have been carried out. Results have shown that the mechanical properties of the modified HALLU® PLATES are equivalent to the properties of the unmodified devices, HALLU® PLATES (K021626) and HALLU®-LOCK PLATES (K083154).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 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 four dots around it. Above the logo is the alphanumeric string "K093781".
JAN 22 2010
SPECIAL 510(k) SUMMARY
Modified Newdeal HALLU® 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: December 7, 2009
1
Name of the device:
| Proprietary Name: | Newdeal HALLU® 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 HALLU® PLATES is substantially equivalent to the commercially marketed devices, HALLU® PLATES (K021626) and HALLU®-LOCK PLATES (K083154).
Device Description:
The Newdeal HALLU® PLATES is a low profile Titanium plate dedicated to first metatarsophalangeal arthrodesis. The system includes both HALLU" -FIX C plates as well as HALLU -FIX S plates. The plates are used in conjunction with Newdeal SNAP-OFF® screws.
Indications for Use:
The HALLU® PLATES is intended to be implanted for fixation of fractures, osteotomies or arthordesis of the first metatarso-phalangeal joint, including cases of:
- ー Hallux rigidus
- -Severe hallux valgus (IM angle >20° and HV angle >40°)
- Deformity from rheumatoid arthritis ﺖ
-
- Failed previous surgical procedure
- Traumatic arthritis -
- Neuromuscular instability. ﻴﻪ
These are the same indications for use as previously cleared for the unmodified device, HALLU PLATES (K021626).
Additionally, during the review of 510(k) K083154. Newdeal HALLU® LOCK PLATES, the inclusion of the following statement was requested by the FDA:
Addition of a QWIX® fixation screw crossing the joint is strongly recommended for optimal arthrodesis consolidation.
In order. to be consistent, the following similar statement will also be included in the indications for use for this proposed 510(k) of the modified HALLU® PLATES.
- Addition of a screw crossing the joint is strongly recommended for optimal arthrodesis consolidation.
The statement has now been amended from "addition of a OWIX® fixation screw" to "addition of a screw" to generalize the type of screw utilized to cross the joint, allowing for surgeon preference.
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K093781
Testing and Test Results:
Mechanical tests have been carried out. Results have shown that the mechanical properties of the modified HALLU® PLATES are equivalent to the properties of the unmodified devices, HALLU® PLATES (K021626) and HALLU®-LOCK PLATES (K083154).
Conclusion
The modified HALLU® PLATES is substantially equivalent to commercially marketed devices, HALLU® PLATES (K021626) and HALLU®-LOCK PLATES (K083154).
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.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure. The logo is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Newdeal SAS % Integra LifeSciences Corporation Mr. Stephen Beier 311 Enterprise Drive Plainsboro, New Jersey 08536
JAN 2 2 2010
Re: K093781
Trade/Device Name: Newdeal HALLU 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: January 5, 2010 Received: January 6, 2010
Dear Mr. Beier:
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. 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.
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
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Page 2 - Mr. Stephen Beier
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 of medical 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/ucm115809.htm 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 Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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.
Jaubare Buehler
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number (if known): K093781
Device Name: Newdeal HALLU® PLATES
Indications For Use:
The HALLU® PLATES are intended to be implanted for fixation of fractures, osteotomies or arthrodesis of the first metastarso-phalangeal joint, including cases of.
- Hallux rigidus .
- Severe hallux valgus (IM angle >20° and HV angle >40° ) .
- . Deformity from rheumatoid arthritis
- Failed previous surgical procedure .
- Traumatic arthritis .
- Neuromuscular instability .
Addition of a screw crossing the joint is strongly recommended for optimal arthrodesis consolidation.
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)
Smith for Nixon
(Disson Sign Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093781