(53 days)
Not Found
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a bioresorbable bone pin, with no mention of AI or ML.
No.
The document describes a bone pin for surgical procedures, which is an implantable medical device, not a therapeutic device in the context of delivering a therapy. It aids in the immobilization and repair of bone structures.
No
The device is a bone pin used for surgical fixation, not for diagnosing medical conditions.
No
The device description explicitly states it is a "Bone Pin" made of bioresorbable polymers, indicating it is a physical implantable 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 describes a surgical implant used for bone fixation in specific anatomical locations (hallux valgus, metacarpal and phalangeal fusion and fractures). This is a therapeutic/surgical application, not a diagnostic test performed on samples outside the body.
- Device Description: The description details the material composition and how the device degrades in vivo (within the body). This further confirms its use as an implant.
- Performance Studies: The performance studies focus on mechanical strength and degradation in vitro (in a lab setting, but likely simulating the in vivo environment) and compare it to other resorbable pins. This is relevant to the structural integrity and performance of a surgical implant, not a diagnostic test.
IVD devices are used to examine specimens (like blood, urine, tissue) from the human body in vitro to provide information for diagnosis, monitoring, or screening. The LactoSorb® Bone Pin does not fit this description.
N/A
Intended Use / Indications for Use
The LactoSorb® Bone Pin is indicated for use in the presence of appropriate immobilization in the following procedures:
-
- correction of hallux valgus (bunion)
-
- repair of metacarpal and phalangeal fusion and fractures
Product codes
87HTY, MAI
Device Description
The LactoSorb® Bone Pin is made of bioresorbable and biocompatible polymers that have been used in surgical procedures for numerous years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic acid (PLLA/PGA) copolymer degrades and resorb IN VIVO by hydrolysis to lactic and glycolic acids, which are then metabolized by the body.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands and feet (metacarpal, phalangeal, hallux valgus)
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)
The effectiveness of the LactoSorb® Bone Pin was determined by In VITRO mechanical comparative testing to currently marketed resorbable pins. The tests showed that the LactoSorb® pins demonstrated adequate initial strength and retained at least 80% of that strength at 8 weeks. In the same test environment at eight weeks, the comparative pins exhibited little or no strength.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
3/23/99
1 of 1
510 (K) Summary of Safety and Effectiveness
| Submitter: | Biomet, Inc.
P.O. Box 587
Airport Industrial Park
Warsaw, Indiana 46581-0587 |
|-----------------|---------------------------------------------------------------------------------------|
| Contact Person: | Michelle L. McKinley |
| Product Code: | 87HTY |
| Device Name: | LactoSorb® Bone Pin |
The LactoSorb® Bone Pin is indicated for use in the presence of appropriate immobilization in the following procedures:
-
- correction of hallux valgus (bunion)
-
- repair of metacarpal and phalangeal fusion and fractures
The LactoSorb® Bone Pin is made of bioresorbable and biocompatible polymers that have been used in surgical procedures for numerous years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic acid (PLLA/PGA) copolymer degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids, which are then metabolized by the body.
The effectiveness of the LactoSorb® Bone Pin was determined by In VITRO mechanical comparative testing to currently marketed resorbable pins. The tests showed that the LactoSorb® pins demonstrated adequate initial strength and retained at least 80% of that strength at 8 weeks. In the same test environment at eight weeks, the comparative pins exhibited little or no strength.
In summary, the LactoSorb® Bone Pin is safe and effective for metacarpel and phalangeal repair. Mechanical testing demonstrated the Lactosorb® Bone Pin to be as effective or better than comparative resorbable bone pins.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 3 1994
Ms. Michelle L. McKinley Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K990291 LactoSorb® Bone Pin Trade Name: Requlatory Class: II Product Codes: HTY and MAI Dated: January 22, 1999 Received: January 29, 1999
Dear Ms. McKinley:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Ms. Michelle L. McKinley
This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page | | of of |
510 (k) NUMBER (IF KNOWN): K99029 /
DEVICE NAME: LactoSorb® Bone Pin
INDICATIONS FOR USE:
The LactoSorb® Bone Pin is indicated for use in the presence of appropriate immobilization in the following procedures:
-
- correction of hallux valgus (bunion)
-
- repair of metacar pal and phalangeal fusion and fractures
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ メ Use (Per 21 CFR 801.109)
OR
Over-The-Counter-
(Optional Format 1-2-96)
Tocòell
(Divisio eneral Restorative Devi 510(k) Numb