The BioStinger™ Bioabsorbable Implant provides fixation of longitudinal vertical meniscus lesions (bucket handle tears) located in the vascular area of the meniscus.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Pre-Loaded BioStinger Hornet™:

Acceptance Criteria and Device Performance Study (Pre-Loaded BioStinger Hornet™)

Summary: The provided documentation focuses on establishing substantial equivalence for the Pre-Loaded BioStinger Hornet™ to a predicate device, the BioStinger-V™. The key finding is that the act of pre-loading the implant does not introduce new safety or effectiveness concerns, indicating that its performance is comparable to an already approved device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety and Effectiveness (relative to predicate device, BioStinger-V™)	"Performance testing has been conducted to show that pre-loading the implant does not raise any new issues regarding safety and effectiveness." (Implies comparable safety and effectiveness to the predicate device)
Design Equivalence	The device is "substantially equivalent in design" to the BioStinger-V™.
Technology Equivalence	The device is "substantially equivalent in... technology" to the BioStinger-V™.
Intended Use Equivalence	The device is "substantially equivalent in... intended use" to the BioStinger-V™. The intended use is "fixation of longitudinal vertical meniscus lesions (bucket handle tears) located in the vascular area of the meniscus."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The document mentions "Performance testing," but does not provide details on the number of devices or experimental conditions used in distinguishing the "Pre-Loaded BioStinger Hornet™" from the "BioStinger-V™."
Data Provenance: Not explicitly stated. The document indicates that Linvatec Corporation conducted the testing (a US-based company), but no geographic origin of the specific test data or whether it was retrospective or prospective is mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the given text. The document describes engineering/performance testing rather than clinical trials requiring expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. The assessment appears to be based on direct functional performance testing, not on subjective expert review or a consensus process for case adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document describes engineering performance testing to demonstrate substantial equivalence, not a clinical study involving human readers and AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the loop performance) was done

Not applicable. The device is a physical medical implant, not an algorithm or AI system.

7. The type of ground truth used

For the performance testing mentioned, the "ground truth" would likely be objective engineering measurements and criteria related to the physical and mechanical properties of the device (e.g., fixation strength, biodegradation rate, ease of deployment, impact of pre-loading on mechanical integrity). The document asserts that "pre-loading the implant does not raise any new issues regarding safety and effectiveness," implying that the measured performance met pre-determined safety and effectiveness benchmarks, which would constitute the "ground truth" for this engineering assessment.

8. The Sample Size for the Training Set

Not applicable. This device is a physical implant, not an AI model, and therefore does not have a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. As stated above, this is not an AI/algorithm-based device.

Summary

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MAY 0 6 2002

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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

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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

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.

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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.

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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

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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

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510(k) Number K020377

Regulation Number and Section

§ 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.