(27 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as being used for "proximal interphalangeal (PIP) joint arthrodesis," which is a medical procedure to fuse a joint. This indicates a therapeutic function.
No
Explanation: The device description and intended use indicate it is an implantable pin for surgical arthrodesis, not a device used to diagnose medical conditions.
No
The device description clearly states it is a physical pin made of Lactosorb® material, which is a resorbable polymer. This is a hardware device, not software.
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. These tests are performed outside of the body (in vitro).
- Device Description: The description clearly states the device is a "Small Hammer Toe Pin" made of a resorbable material. It's a physical implant used for surgical fixation of a joint.
- Intended Use: The intended use is "proximal interphalangeal (PIP) joint arthrodesis," which is a surgical procedure to fuse a joint.
This device is a surgical implant used within the body, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Small Hammer Toe Pin is indicated for proximal interphalangeal (PIP) joint arthrodesis.
Product codes
87HWC
Device Description
The Small Hammer Toe Pin is made out of the oriented Lactosorb® material and is indicated for proximal interphalangeal joint (PIP) joint arthrodesis. LactoSorb® is a polyester derivative of L-Lactic and glycolic acids. Poly Llactic/polyglycolic acid copolymer degrades and resorb IN VIVO by hydrolysis into Llactic and glycolic acids, which are then metabolized by the body. The device has threads on one end and barbs on the other.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal interphalangeal (PIP) 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
Non-Clinical Testing: Non-clinical testing demonstrated statistical equivalence between this device and the predicate.
Clinical Testing: Clinical testing was not used to establish substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
JUL 1 2002
K021828P
Image /page/0/Picture/2 description: The image shows the word "BIOMET" in a stylized, blocky font. The letters are bold and outlined in black, with the interior of the letters being white. The overall design has a geometric and modern feel.
QUARTERS CORPORATE
SUMMARY OF SAFETY AND EFFECTIVENESS
Applicant or Sponsor:
Contact Person:
Biomet Orthopedics, Inc. 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587
Sara B. Shultz Biomet Manufacturing, Corp. 56 East Bell Drive P.O. Box 587 Warsaw, IN 46582 Phone: (574) 267-6639 FAX: (574) 372-1683
Proprietary Name:
Common Name:
Classification Name:
Small Hammer Toe Pin
Arthrodesis pin
Screw, Fixation, Bone, Non-spinal, nonmetallic (888.3040).
Device Product Code:
87HWC
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Resorbable Hammer Toe Pin, Biomet, Inc. (K011137).
Intended Use: The Small Hammer Toe Pin is indicated for proximal interphalangeal (PIP) joint arthrodesis.
Device Description: The Small Hammer Toe Pin is made out of the oriented Lactosorb® material and is indicated for proximal interphalangeal joint (PIP) joint arthrodesis. LactoSorb® is a polyester derivative of L-Lactic and glycolic acids. Poly Llactic/polyglycolic acid copolymer degrades and resorbs IN VIVO by hydrolysis into Llactic and glycolic acids, which are then metabolized by the body. The device has threads on one end and barbs on the other.
Non-Clinical Testing: Non-clinical testing demonstrated statistical equivalence between this device and the predicate.
Clinical Testing: Clinical testing was not used to establish substantial equivalence.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
बाह्य कड़ा बाद में बाद में बाद में बाद में कि में बाद में कि कि
OFFICE 219.267.6639
FAX 219.267.8137
E-MAIL biomet@biomet.com
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 2002
Ms. Sara B. Shultz Regulatory Specialist Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, IN 46581-0587
Re: K021828
Trade/Device Name: Small Hammer Toe Pin Regulation Number: 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: June 3, 2002 Received: June 4, 2002
Dear Ms. Shultz:
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.
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.
2
ッ 無くてもたまあると、いつでもなくなるのです。 このアイティングのシートレール、アイティーの一般になるので、 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Stupt Rhodes
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1 _ .
510 (k) Number (if known) : K021828
Device Name: Small Hammer Toe Pin
. ·
Indications For Use:
· The Small Hammer Toe Pin is indicated for proximal interphalangeal (PIP) joint arthrodesis.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) | |
| OR | |
| Over-The-Counter-Use | |
| (Optional Format 1-2-96) |
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
| 510(k) Number | K021828 |
|---|---|
| --------------- | --------- |
00007