(78 days)
Not Found
No
The summary describes a physical, bioabsorbable implant for meniscal repair and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as a "fixation device" for meniscal lesions, which implies it directly treats a medical condition by repairing damaged tissue.
No
The device is described as a "fixation device" for repairing meniscal lesions, indicating it is a therapeutic device rather than one used for diagnosis.
No
The device description clearly states it is a physical, bioabsorbable fixation device made of poly(L-lactic acid), which is implanted into the body. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of longitudinal vertical meniscus lesions within the body. This is a surgical procedure performed directly on the patient's tissue.
- Device Description: The device is a fixation device made of a bioabsorbable material, designed to be implanted into the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a person's health. This device does not perform any such diagnostic testing on specimens.
Therefore, the BioStinger™-V Bioabsorbable Meniscal Repair Device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BioStinger™-V Bioabsorbable Meniscal Repair Device provides fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascularized area of the meniscus. Implantation of the device is accomplished through arthroscopy or arthrotomy.
Product codes
MAL, HTY
Device Description
The BioStinger™-V Bioabsorbable Meniscal Repair Device is a cannulated, sterile, single-use fixation device made of an absorbable homopolymer derived from poly(L-lactic acid), similar to that used in bioabsorbable suture and will gradually be absorbed into the body. The device is colored with D&C Violet #2.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
meniscus
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
AJG - 6 -
May 19, 1999
SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the BioStinger™-V Bioabsorbable Meniscal Repair Device.
Submitter A.
Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773
Company Contact B.
Laura Seneff Manager, Requlatory Affairs
Device Name C.
| Trade Name: | BioStinger™-V Bioabsorbable
Meniscal Repair Device |
|------------------------------------|-------------------------------------------------------|
| Common Name: | Meniscal Repair Device |
| Classification Name/
Reference: | None Assigned |
| Proposed Class/ | Class II-87 MAL. Fastener. |
Proposed Class Device Product Code: Fixation, Biodegradable, Soft Tissue
- Predicate/Legally Marketed Devices D. Linvatec Meniscal Repair Device
E. Device Description
.
The BioStinger™-V Bioabsorbable Meniscal Repair Device is a cannulated, sterile, single-use fixation device made of an absorbable homopolymer derived from poly(Llactic acid), similar to that used in bioabsorbable suture and will gradually be absorbed into the body. The device is colored with D&C Violet #2.
1
Summary of Safety and Effectiveness BioStinger™-V Bioabsorbable Meniscal Repair Device 510 (k) # May 19, 1999 Page 2 of 3
F. Intended Use
The BioStinger™-V Bioabsorbable Meniscal Repair Device provides fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascularized area of the meniscus.
Implantation of the fixation device is accomplished through arthroscopy or arthrotomy.
Substantial Equivalence G.
The colored BioStinger™-V Bioabsorbable Meniscal Repair Device is substantially equivalent in design, function and intended use to the Linvatec BioStinger™ Bioabsorbable Meniscal Repair Device.
The similarities/dissimilarities to the predicate are shown in the attached table.
2
Summary of Safety and Effectiveness BioStinger™-V Bioabsorbable Meniscal Repair Device 510 (k) # Page 3 of 3
CHART OF SIMILARITIES AND DISSIMILARITIES
・・・・・
| Company
Name | Device Name | Intended Use | Material | Single-Use
Reusable | Method of
Sterilization | Design |
|----------------------------------------------------------|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|------------------------|-------------------------------|---------------------------------------------------------------------------------------------|
| New Product
Linvatec | BioStinger™-V
Bioabsorbable
Meniscal Repair
Device | Fixation of longitudinal
vertical meniscus lesions
(bucket handle) located in
the vascularized area of the
meniscus. | Poly (L-lactic acid)
with color additive
D&C Violet #2 | Sterile
Single-use | EtO
16-month shelf
life | Cannulated
Barbed tack
with head
Sizes:
1.3mm diameter
x 10mm-16mm
length |
| Predicate
Linvatec
Corporation
510 (k) #K981692 | Linvatec
Meniscal Repair
Device | Fixation of longitudinal
vertical meniscus lesions
(bucket handle) located in
the vascularized area of the
meniscus. | Poly (L-lactic acid) | Sterile
Single-use | EtO
16-month shelf
life | Cannulated
Barbed tack
with head
Sizes:
1.3mm diameter
x 10mm-16mm
length |
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG -6 1999
Ms. Laura Seneff Manager. Regulatory Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908
Re: K991715
Biostinger-V Bioabsorable Meniscal Repair Device Regulatory Class: II Product Code: MAI, HTY Dated: May 19, 1999 Received: May 20, 1999
Dear Ms. Seneff:
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.
4
Page 2 – Ms. Laura Seneff
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,
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
5
May 19, 1999 Date:
1 of ਹ Page
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
BioStinger™-V Bioabsorbable Meniscal Repair Device Name: Device
Indications for Use:
The BioStinger™-V Bioabsorbable Meniscal Repair Device provides fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascularized area of the meniscus.
Implantation of the device is accomplished through arthroscopy or arthrotomy.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_
OR
Over-the-Counter Use__
(Per 21 CFR 801.109)
Asevedo
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K99/715
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