UNITY BETA ANCHOR SYSTEM

• K Number: K082906
• Device Name: UNITY BETA ANCHOR SYSTEM
• Manufacturer: BONUTTI RESEARCH, INC.
• Date Cleared: 2008-10-30 ( 30 days)
• Product Code: HWC
• Regulation Number: 888.3040
• Type: Special
• Panel: Orthopedic
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Unity Beta Anchor System consists of single patient use absorbable (PLLA) implants intended for use as fasteners (anchors) in the fixation of tissue, ligament, tendon, and bone. The system is indicated in general soft tissue approximation/ligation.

Device Description

The Unity Beta Anchor System is designed for the fixation of tissue, ligament, tendon, and bone. Absorbable poly-L-lactic acid (PLLA) implant materials are ultrasonically joined to secure tissue, ligament, tendon, and bone at a repair site. An electrical generator provides ultrasonic energy to the end effector of a handpiece to weld the two pieces of implant material together and secure tissue, ligament, tendon, and/or bone. The system provides a means of sutureless fixation that facilitates overall, suture management.

AI/ML Overview

The provided text is a 510(k) premarket notification for the Unity Beta Anchor System. This type of document outlines the technical specifications and intended use of a medical device and seeks to demonstrate its substantial equivalence to a legally marketed predicate device.

After reviewing the document, I can say that it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of performance metrics, sample sizes, expert involvement, or statistical analysis typically found in clinical or laboratory performance studies.

Here's why and what information is present:

1. Acceptance Criteria and Reported Device Performance: This information is not explicitly stated in a table format with specific performance metrics (e.g., accuracy, sensitivity, specificity, or mechanical thresholds with acceptance limits). The document mentions "Design verification testing identified and conducted as part of the risk analysis assessment compared the mechanical strengths and failure modes of the Unity Beta Anchor System to predicate devices." However, it does not provide the results, specific acceptance criteria for these comparisons (e.g., "tensile strength must be within X% of the predicate device"), or reported performance values.

2. Sample Size used for the test set and data provenance: Not mentioned.

3. Number of experts used and their qualifications for establishing ground truth: Not applicable, as this is a mechanical fixation device, not one that requires expert interpretation of diagnostic images or data for ground truth.

4. Adjudication method for the test set: Not applicable.

5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This type of study is relevant for diagnostic devices where human readers interpret medical data. This device is a surgical fixation device.

6. Standalone (algorithm only) performance: Not applicable, as this is a mechanical device, not an algorithm.

7. Type of ground truth used: For a mechanical device, "ground truth" would typically refer to validated mechanical testing methods (e.g., ASTM standards for tensile strength, pull-out strength). The document only generally states that "Design verification testing... compared the mechanical strengths and failure modes." Specifics are absent.

8. Sample size for the training set: Not applicable. This document refers to a physical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary of what is in the document:

• Device Name: Unity Beta Anchor System
• Manufacturer: Bonutti Research, Inc.
• Contact Information: Patrick Balsmann, MBA, MS, RAC
• Date Prepared: September 29, 2008
• Common Name: Fixation Device
• Classification Name: Fastener, Fixation, Biodegradable, Soft Tissue.
• Device Description: Absorbable poly-L-lactic acid (PLLA) implants ultrasonically joined for the fixation of tissue, ligament, tendon, and bone. It uses an electrical generator to provide ultrasonic energy to weld the implant materials.
• Indications for Use: Fixation of tissue, ligament, tendon, and bone as fasteners (anchors), indicated in general soft tissue approximation/ligation.
• Predicate Device(s): Existing Bonutti Research, Inc., fixation products and various other suture anchors determined to be substantially equivalent.
• Predicate Comparison: "Design verification testing identified and conducted as part of the risk analysis assessment compared the mechanical strengths and failure modes of the Unity Beta Anchor System to predicate devices." (No specific results or acceptance criteria provided)
• Regulatory Information:
  • 510(k) Number: K082906
  • Regulation Number: 21 CFR 888.3040
  • Regulation Name: Smooth or threaded metallic bone fixation fastener (Note: The product is PLLA, not metallic, but falls under this classification for regulatory purposes).
  • Regulatory Class: Class II

In conclusion, the document serves as a regulatory submission demonstrating substantial equivalence based on design and intended use, and general mechanical comparison to predicate devices, but it does not provide the detailed performance study results and acceptance criteria as outlined in your request.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Bonutti Technologies. The word "BONUTTI" is in large, bold, sans-serif font on the top line. Below that, in a smaller font, is the word "TECHNOLOGIES". The logo is simple and professional.

ham. IL 62401

Phone: [phone] 342 3460

K082906 p. 1/2

Bonutti Research, Inc. Unity Beta Anchor System 510(k) Premarket Notification

OCT 3 0 2008

510(k) SUMMARY

The following information is submitted in accordance with the requirements of 21 CFR 807.92:

Contact Person:	Patrick Balsmann, MBA, MS, RAC
	Director, Regulatory/Clinical Affairs & QA
	Bonutti Research, Inc.,
	P.O. Box 1367
	Effingham, Illinois 62401
	Phone: [phone], ext. 321
	Fax: [phone]

Date Prepared: September 29, 2008

Proprietary Name: Unity Beta Anchor System

Common Name: Fixation Device

Classification Name: Fastener, Fixation, Biodegradable, Soft Tissue.

Device Description: The Unity Beta Anchor System is designed for the fixation of tissue, ligament, tendon, and bone. Absorbable poly-L-lactic acid (PLLA) implant materials are ultrasonically joined to secure tissue, ligament, tendon, and bone at a repair site. An electrical generator provides ultrasonic energy to the end effector of a handpiece to weld the two pieces of implant material together and secure tissue, ligament, tendon, and/or bone. The system provides a means of sutureless fixation that facilitates overall, suture management.

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p. 2/2

Bonutti Research, Inc. - Unity Beta Anchor System 510(k) Summary -- September 29, 2008 Page 2

Indications for Use: The Unity Beta Anchor System consists of single patient use absorbable (PLLA) implants intended for use as fasteners (anchors) in the fixation of tissue, ligament, tendon, and bone. The system is indicated in general soft tissue approximation/ligation.

Predicate Device(s): Unity Beta Anchor System is similar in design and intended use to existing Bonutti Research, Inc., fixation products and various other suture anchors determined to be substantially equivalent and that are commonly used in tissue and bone fixation.

Predicate Comparison: Design verification testing identified and conducted as part of the risk analysis assessment compared the mechanical strengths and failure modes of the Unity Beta Anchor System to predicate devices.

Submitted by:

Walter Bailey

Patrick Balsmann, MBA, MS, RAC Director, Regulatory/Clinical Affairs & QA

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bonutti Research, Inc., % Mr. Patrick Balsmann, MBA, MS, RAC Director, Regulatory/Clinical Affairs & QA P.O. Box 1367 Effingham, Ilinois 62401

OCT 3 0 2008

K082906 Re

Trade/Device Name: Unity Beta Anchor System Regulation Number: 21 CFR 888.3040 Regulation Namc: Smooth or threaded metallic bone fixation fastencr Regulatory Class: Class II Product Code: HWC Dated: September 29, 2008 Received: September 30, 2008

Dear Mr. Balsmann:

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

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Page 2 - Mr. Patrick Balsmann, MBA, MS, RAC

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Wilkerson

Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure .

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PO Box 1367 Effingham, IL 62401 Phone: [phone] Fax: [phone] http://www.bonuttitec.com

Indications for Use

510(k) Number: K082906

Device Name: Unity Beta Anchor System

Indications For Use: The Unity Beta Anchor System consists of single patient use absorbable (PLLA) implants intended for use as fasteners (anchors) in the fixation of tissue, ligament, tendon, and bone. The system is indicated in general soft tissue approximation/ligation.

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use_ U6 (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of _ 1 _

Mark A. Milkersen

(Division Sign-O Division of General, Restorative, and Neurological

510(k) Number K08290

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.