(224 days)
No
The description focuses on the material, design, and mechanical properties of a physical implant, with no mention of software, algorithms, or data processing related to AI/ML.
Yes
The device is intended for partial replacement of the distal ulna to alleviate pain and weakness caused by arthritis, which directly treats a medical condition.
No
Explanation: The device is an implant intended for partial replacement of the distal ulna, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical implant constructed from cobalt chromium alloy, intended for surgical implantation. It is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing a part of the distal ulna to treat arthritis. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant made of cobalt chromium alloy, designed for surgical implantation. This is consistent with a medical device used in surgery, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information.
Therefore, the First Choice® Partial Ulnar Head implant is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The First Choice® Partial Ulnar Head implant is intended for partial replacement of the distal ulna for rheumatoid, degenerative, or post-traumatic arthritis presenting with pain and weakness localized to the distal radioulnar joint and not improved by conservative treatment.
The First Choice Partial Ulnar Head implant is intended for press-fit use.
Product codes
KXE
Device Description
The First Choice Partial Ulnar Head implant is a onepiece hemi-arthroplasty device intended to replace the articulating surface of the distal ulnar head. It is constructed from cobalt chromium alloy and replaces the ulnar head while retaining the ulnar neck and styloid. The distal head is polished to a mirror finish for articulation within the distal radioulnar joint and the proximal stem has a roughened grit-blasted surface for uncemented press-fit fixation in the ulnar medullary canal. The First Choice Partial Ulnar Head implant is available in 12 sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal ulna, distal radioulnar 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
The following non-clinical tests and analyses were conducted to support substantial equivalence of the First Choice Partial Ulnar Head implant to the predicate Modular Ulnar Head implant:
- Ulnar Head Biomechanics .
- DRUJ Stem Bend Strength .
Clinical performance data were not necessary to support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis.
(a)
Identification. A wrist joint ulnar (hemi-wrist) polymer prosthesis is a mushroom-shaped device made of a medical grade silicone elastomer or ultra-high molecular weight polyethylene intended to be implanted into the intramedullary canal of the bone and held in place by a suture. Its purpose is to cover the resected end of the distal ulna to control bone overgrowth and to provide an articular surface for the radius and carpus.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the word "INTEGRA" in all capital letters. Below the word "INTEGRA" is the phrase "LIMIT UNCERTAINTY" in smaller letters. To the right of the word "INTEGRA" are three black squares of different sizes stacked on top of each other.
APR - 9 2012
Summary of Safety and Effectiveness
Sponsor:
Contact Person:
Date:
Trade Name:
Common Name:
Product Code:
Classification:
Panel:
Predicate Device:
Device Description:
Intended Use:
Ascension Orthopedics 8700 Cameron Road Austin, TX 78754-3832
Bradley W. Strasser Senior Analyst, Regulatory Affairs 512-836-5001 ext. 1541
06 April 2012
First Choice® Partial Ulnar Head Implant
Ulnar Head Prosthesis
KXE - Prosthesis, Wrist, Hemi-, Ulnar
21 CFR §888.3810 – Wrist joint ulnar (hemi-wrist) polymer prosthesis
Orthopedic
Ascension® Modular Ulnar Head (MUH); K052137, cleared 03 November 2005; manufactured by Ascension Orthopedics, Inc.
The First Choice Partial Ulnar Head implant is a onepiece hemi-arthroplasty device intended to replace the articulating surface of the distal ulnar head. It is constructed from cobalt chromium alloy and replaces the ulnar head while retaining the ulnar neck and styloid. The distal head is polished to a mirror finish for articulation within the distal radioulnar joint and the proximal stem has a roughened grit-blasted surface for uncemented press-fit fixation in the ulnar medullary canal. The First Choice Partial Ulnar Head implant is available in 12 sizes.
The First Choice Partial Ulnar Head implant is intended for partial replacement of the distal ulna for rheumatoid, degenerative, or post-traumatic arthritis presenting with pain and weakness localized to the
1
Non-Clinical Performance Data:
Clinical Performance Data:
Clinical Performance Data.
•
•
distal radioulnar joint and not improved by conservative treatment.
The First Choice Partial Ulnar Head implant is intended for press-fit use.
The First Choice Partial Ulnar Head implant is similar to the First Choice Modular Ulnar Head implant in terms of intended use and fundamental scientific technology. Performance data demonstrates that the subject device design is substantially equivalent to the predicate in terms of strength and function.
The following non-clinical tests and analyses were conducted to support substantial equivalence of the First Choice Partial Ulnar Head implant to the predicate Modular Ulnar Head implant:
- Ulnar Head Biomechanics .
- DRUJ Stem Bend Strength .
Clinical performance data were not necessary to support substantial equivalence.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: This image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Mail Center - WO66-G609, Silver Spring, MD 20993-0002. The text is black and the background is white.
APR - 9 2012
Ascension Orthopedics % Mr. Bradley W. Strasser 8700 Cameron Road Suite 100 Austin, TX 78754-3832
Re: K112481
Trade/Device Name: First Choice Partial Ulnar Head Implant Regulation Number: 21 CFR 888.3810 Regulation Name: Wrist joint ulnar (hemi-wrist) polymer prosthesis Regulatory Class: II Product Code: KXE Dated: March 2, 2012 Received: March 5, 2012
Dear Mr. Strasser:
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 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
3
Page 2 - Mr. Bradley W. Strasser
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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.
Fon Ponto
Def Di
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K112481
Device Name:
First Choice® Partial Ulnar Head Implant
Indications for Use:
The First Choice® Partial Ulnar Head implant is intended for partial replacement of the distal ulna for rheumatoid, degenerative, or post-traumatic arthritis presenting with pain and weakness localized to the distal radioulnar joint and not improved by conservative treatment.
The First Choice Partial Ulnar Head implant is intended for press-fit use.
X Prescription Use (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 OF NEEDED)
Copeut reple of CPRA, Office of Device Evaluation (ODE)
(Division Sign-Oft)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112481