(608 days)
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No
The document describes a bioresorbable implant for bone fixation and does not mention any computational or analytical capabilities, let alone AI/ML.
No.
The product is described as being used in maintaining the position of bony fragments or morselized bone graft. It is a bioresorbable implant, not a device that treats or cures a disease or condition.
No
Explanation: The device, LactoSorb® Panels and Fasteners, is described as maintaining the position of bone fragments or graft in surgical procedures. Its function is structural and supportive, not for identifying, monitoring, or diagnosing diseases or conditions.
No
The device description clearly states it is made of bioresorbable polymers and describes physical components (panels and fasteners), indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for maintaining the position of bone fragments or bone graft in vivo (within the body) during surgical procedures.
- Device Description: The description details the material and how it degrades and is metabolized in vivo.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo as a surgical implant.
N/A
Intended Use / Indications for Use
The LactoSorb® Panels and Fasteners are used in maintaining the position of bony fragments or morselized bone graft in Iliac Crest autograft procedures. This product is not intended for use in the spine or joint space. This product is also not indicated for pelvic fracture fixation.
Product codes
87HRS, 87HRS, 87HWC
Device Description
The LactoSorb® devices are made of bioresorbable and Ine backed activers that have been used in surgical procedures Brocompacible porymers chac have copolymer is synthetic polyester derived from lactic and glycolic acids. polylactic/polyglycolic acid copolymer degrades and resorbs IN vivo by hydrolysis to lactic and glycolic acids, which are then metabolized by the body. The LactoSorb® material has been found meconocible by the both soft tissue and bone tissue. Both co be brocomputible in lostudies have proven the safety and preciliadar and these devices in trauma and reconstructive procedures in the midface and craniofacial skeleton.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Iliac Crest, not intended for use in the spine or joint space, not indicated for pelvic fracture fixation.
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
AUG 7 2000
K984390
510 (k) Summary of Safety and Effectiveness
Biomet, Inc. Submitter: P.O. Box 587 Airport Industrial Park Warsaw, IN 46581-0587
Tracy J. Bickel Contact Person:
Product Code: 87HRS, 87HRS, 87HWC
Device Name: LactoSorb® Panels and Fasteners
The LactoSorb® Panels and Fasteners are used in maintaining the position of bony of bony fragments or morselized bone graft in Iliac Crest autograft procedures. This product is not intended for use in the spine or joint space. This product is also not indicated for pelvic fracture fixation.
The LactoSorb® devices are made of bioresorbable and Ine backed activers that have been used in surgical procedures Brocompacible porymers chac have copolymer is synthetic polyester derived from lactic and glycolic acids. polylactic/polyglycolic acid copolymer degrades and resorbs IN vivo by hydrolysis to lactic and glycolic acids, which are then metabolized by the body. The LactoSorb® material has been found meconocible by the both soft tissue and bone tissue. Both co be brocomputible in lostudies have proven the safety and preciliadar and these devices in trauma and reconstructive procedures in the midface and craniofacial skeleton.
These devices provide equivalent fixation as predicate devices cleared for use in oral-maxillo-craniofacial reconstructive procedures as well as pelvic reconstruction.
1
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 seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 2000 AUG
Ms. Tracy J. Bickel Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K984390
Trade Name: Biomet LactoSorb® Panels and Fasteners Regulatory Class: II Product Code: HRS, HWC, and MAI Dated: May 8, 2000 Received: May 9, 2000
Dear Ms. Bickel:
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.
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.
2
Page 2 - Ms. Tracy J. Bickel
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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Dune R. Lochner
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 _ of _
510(K) NUMBER IF KNOWN: __ K984390
DEVICE NAME: LactoSorb® Panels and Fasteners
INDICATIONS FOR USE:
The LactoSorb® Panels and Fasteners are used in maintaining the position of bony The Lactosoft @ I alles and I assession Iliac crest autograft procedures. This product is not intended for use in the spine or joint space. This product is not intended for pelvic fracture fixation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
or Over the Counter-Use (Optional Format 1-2-96)
Dwna R. Lochner.
(Division Sign-Off) Division of General Restorative Devices 510/2) Number K984390