(67 days)
The LactoSorb® Hand System is indicated for use in closed noncomminuted diaphyseal metacarpal fractures in the presence of appropriate immobilization.
The LactoSorb® plates and screws are made of bioresorbable and biocompatible polymer that have been used in surgical procedures for a number of years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic (PLLA/PGA) acid copolymer degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids, which are then metabolized by the body. The safety of PLLA/PGA material has been well documented since the early 1970s when the FDA first approved the use of resorbable PLLA/PGA sutures. The LactoSorb® material has been found to be biocompatible in both soft and hard bone tissues.
The provided text describes the LactoSorb® Hand System, a bioresorbable fixation system for metacarpal fractures. The effectiveness of this system was determined by mechanical testing, comparing it to similar metal fixation systems and the LactoSorb® Bone Pin.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Effectiveness (Mechanical Performance) | "as effective as similar metal fixation systems on the market as well as the LactoSorb® Bone Pin." |
| Resorption Time | "completely resorb by 12 months IN VIVO" |
| Biocompatibility | "biocompatible in both soft and hard bone tissues." |
| Safety of Material | "Safety of PLLA/PGA material has been well documented since the early 1970s when the FDA first approved the use of resorbable PLLA/PGA sutures." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for the mechanical testing (test set) or the data provenance (country of origin, retrospective/prospective). It only states that effectiveness was determined by "mechanical testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the effectiveness was determined by mechanical testing, not by expert review of patient data or images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the effectiveness was determined by mechanical testing, not by human adjudication of clinical outcomes or images.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study was not mentioned and is not applicable. The device's effectiveness was established through mechanical testing, not through an assessment of human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to this medical device, which is a physical implant (plate and screws). There is no "algorithm" in the context of device performance as described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for effectiveness was established through mechanical testing. This implies that the performance metrics (e.g., strength, stiffness, fatigue resistance) were measured and compared against established benchmarks or predefined performance standards for similar orthopedic fixation devices. For biocompatibility, reliance was placed on historical data and documentation regarding the PLLA/PGA material.
8. The sample size for the training set
This information is not applicable. The device is a physical implant, not an AI or software device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this type of medical device.
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Summary of Safety and Effectiveness
| Submitter: | Biomet, Inc.P.O. Box 587Airport Industrial ParkWarsaw, Indiana 46581-0587 |
|---|---|
| Contact Person: | Michelle L. McKinley |
| Product Code: | 87 HRS (Plate)87 HWC (Screw) |
| Device Name: | LactoSorb® Hand System |
The LactoSorb® Hand System is indicated for use in closed noncomminuted diaphyseal metacarpal fractures in the presence of appropriate immobilization.
The LactoSorb® plates and screws are made of bioresorbable and biocompatible polymer that have been used in surgical procedures for a number of years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic (PLLA/PGA) acid copolymer degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids, which are then metabolized by the body. The safety of PLLA/PGA material has been well documented since the early 1970s when the FDA first approved the use of resorbable PLLA/PGA sutures. The LactoSorb® material has been found to be biocompatible in both soft and hard bone tissues.
The effectiveness of this resorbable system was determined by mechanical testing. This system is as effective as similar metal fixation systems on the market as well as the LactoSorb® Bone Pin. The devices completely resorb by 12 months IN VIVO eliminating the need for long-term removal.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird with three lines representing its wings and body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 30 1999
Ms. Michelle L. McKinley Regulatory Specialist Biomet Incorporated P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K991763 Trade Name: LactoSorb® Hand System Regulatory Class: II Product Code: HRS, HWC, MAI Dated: May 6, 1999 Received: May 24, 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 control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A 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 regulation 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.
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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
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:
510(k) NUMBER (IF KNOWN): K991763____________________________________________________________________________________________________________________________________________
DEVICE NAME: LactoSorb® Hand System
INDICATIONS FOR USE:
The LactoSorb® Hand System is indicated for surgical fixation of closed
of the success is indicated for any of finatures in the presence of The LactoSorb® Hand System is marcared of the presence of appropriate immobilization.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED.)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -- | -------------------------------------------------------- |
| Prescription Use | X | OR | Over-The-Counter |
|---|---|---|---|
| Use (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
(Division Sign-Off)
Division of General Restorative Devices
K(k) Number K991763
§ 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.