(90 days)
Not Found
No
The description focuses on the material and mechanical properties of the implant and inserter, with no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No
The device provides fixation for meniscus lesions, which is a structural repair function, not primarily a therapeutic function like administering medication or providing energy for healing.
No
Explanation: The device is described as an absorbable implant for fixing meniscus lesions, which is a therapeutic function, not a diagnostic one. While it can be visualized with imaging modalities, this is for monitoring its placement, not for diagnosing a condition.
No
The device description clearly states it is a physical implant made from absorbable material and includes a disposable inserter, indicating it is a hardware device.
Based on the provided information, the BioStinger™ Bioabsorbable Implant is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of meniscus lesions within the body. This is a surgical implant used in vivo (within a living organism).
- Device Description: The device is a physical implant made of absorbable material, designed to be placed inside the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health. The BioStinger™ does not perform this function.
Therefore, the BioStinger™ is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BioStinger™ Bioabsorbable Implant provides fixation of longitudinal vertical meniscus lesions (bucket handle tears) located in the vascular area of the meniscus.
Product codes (comma separated list FDA assigned to the subject device)
MAFHWC, MAI
Device Description
The BioStinger™ Bioabsorbable Meniscal Repair Device is a cannulated, sterile, single-use fixation device made from an absorbable homopolymer derived from Poly (L-lactic) Acid, and will gradually be absorbed into the body. The implant is colored with D&C Violet #2. The implant is preloaded on a single-patient use, sterile, disposable, re-loadable inserter. The implant is radiotranslucent with regard to intraoperative fluoroscopy, but it can be visualized with MRI and CAT scan.
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)
Performance testing has been conducted to show that pre-loading the implant does not raise any new issues regarding safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
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
MAY 0 6 2002
Page 1 of 2
February 4, 2002
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 Pre-Loaded BioStinger Hornet™.
510(k) Number Kosu377
A. Submitter
Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908
Company Contact B.
Laura D. Seneff, RAC Manager, Regulatory Affairs (727) 399-5234 Telephone (727) 399-5264 FAX
C. Device Name
Trade Name: Pre-Loaded BioStinger Hornet™
Common Name: Meniscal Repair Device
Classification Names: Fastener, Fixation, Biodegradable, soft tissue
Proposed Class/Device: Class II, MAFHWC & MAI Product Code
1
page 2 of 2
Summary of Safety and Effectiveness Pre-Loaded BioStinger Hornet TM 510(k) # Kod'U377 February 4, 2002 Page 2 of 2
Predicate/Legally Marketed Devices D. BioStinger-V™ K991715 Linvatec Corporation
ய் Device Description
The BioStinger™ Bioabsorbable Meniscal Repair Device is a cannulated, sterile, single-use fixation device made from an absorbable homopolymer derived from Poly (L-lactic) Acid, and will gradually be absorbed into the body. The implant is colored with D&C Violet #2. The implant is preloaded on a single-patient use, sterile, disposable, re-loadable inserter. The implant is radiotranslucent with regard to intraoperative fluoroscopy, but it can be visualized with MRI and CAT scan.
F. Intended Use
BioStinger™ Bioabsorbable Implant provides fixation of The longitudinal vertical meniscus lesions (bucket handle tears) located in the vascular area of the meniscus.
G. Substantial Equivalence
The Pre-Loaded BioStinger Hornet™ is substantially equivalent in design, technology and intended use to Linvatec's existing BioStinger-V™ implant. Performance testing has been conducted to show that pre-loading the implant does not raise any new issues regarding safety and effectiveness.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0 6 2002
Ms. Laura D. Seneff. RAC Manager. Regulatory Affairs Linvatec Corp. 11311 Concept Boulevard Largo, Florida 33773-4908
Re: K020377
Trade/Device Name: Pre-Loaded BioStinger Hornet™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastner Regulatory Class: Class II Product Code: HWC Dated: February 4, 2002 Received: February 5, 2002
Dear Ms. Seneff:
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.
3
Page 2 - Ms. Laura D. Seneff, RAC
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,
Mark A Milliken
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
4
page 1 of 1
February 4, 2002
510(k) Number (if known): Ko >0377
Device Name: Pre-Loaded BioStinger Hornet™
Indications for Use:
The BioStinger™ Bioabsorbable Implant provides fixation of longitudinal vertical meniscus lesions (bucket handle tears) located in the vascular area of the meniscus.
(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 No
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Mark N. Melbern
Division Sion-Off Division of General, Restorative and Neurological Devices
Page 1.4
510(k) Number K020377