(266 days)
The Unity Ultrasonic System consists of an electrical generator and ultrasonic handpieces. The system is to be used with Unity 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.
The Unity Ultrasonic System with PLLA Fasteners is designed for the fixation of soft tissue, ligament, tendon, and bone. Absorbable poly-L-lactic acid (PLA) implant materials are ultrasonically welded, staked, and/or joined to secure soft tissue, ligament, tendon, and bone at a repair site. An electrical generator provides ultrasonic energy to the end effector of a handpiece to fix the implant materials together and secure soft tissue, ligament, tendon, and/or bone. Energy applied to the trailing end of the implant portion contacting the handpiece end effector joins this implant portion to the other implant portion in securing soft tissue, ligament, tendon, and bone. Ultrasonic handpieces with end effectors designed to accommodate Unity Implants are product specific and include a force sensor mechanism that allows the surgeon feedback on the amount of load they are applying to the handpiece. Feedback is provided to the surgeon through an audible tone.
The provided document describes a 510(k) premarket notification for the "Unity Ultrasonic System with PLLA Fasteners." The submission is primarily focused on demonstrating substantial equivalence to a predicate device, specifically a modification adding a 40 kHz handpiece to an existing ultrasonic system.
Here's an analysis of the provided information concerning acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical strengths and failure modes among the two handpieces and their respective implants when ultrasonically welded are comparable. | "Implant strengths were statistically equivalent among the respective implants tested." |
| Defined electrical safety and EMC test plan with related acceptance criteria met. | "An electrical safety and EMC test plan with related acceptance criteria was defined." (Implies criteria were met as no failure is reported and the device received substantial equivalence.) |
| Risk evaluation of the 40 kHz handpiece to its predicate demonstrates similar design, packaging, labeling, and sterilization techniques that raise no concerns regarding safe and effective use. | "A risk evaluation of the 40 kHz handpiece to its predicate demonstrated similar design, packaging, labeling, and sterilization techniques that raise no concerns regarding the safe and effective use of the Unity Ultrasonic System with PLLA Fasteners." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the mechanical strength testing or the electrical safety/EMC testing. The description "Implant strengths were statistically equivalent" suggests that a sufficient number of implants were tested to perform statistical analysis, but the exact number is not provided.
The data provenance is not explicitly stated (e.g., country of origin). However, given that it is a FDA 510(k) submission, it is assumed the testing was conducted under appropriate regulatory guidelines. The study appears to be prospective as it involves new design verification testing for the modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The device is a medical fixation system, and the testing involves mechanical, electrical, and risk evaluations, not interpretation by medical experts to establish a "ground truth" derived from clinical data or images. "Ground truth" in this context refers to the defined objective standards for device performance.
4. Adjudication Method for the Test Set
This is not applicable as the testing involved objective measurements of mechanical strength and electrical safety, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret medical images. This submission describes a surgical fixation device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical medical device (ultrasonic system and fasteners), not an algorithm or AI system. Therefore, standalone performance in the context of AI is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for the tests performed was based on:
- Defined engineering specifications and performance targets for mechanical strength. The statistical equivalence to the predicate established the acceptable performance.
- Established industry standards and regulatory requirements for electrical safety (EMC test plan).
- Risk assessment methodology to compare the new 40 kHz handpiece against the predicate, focusing on design, packaging, labeling, and sterilization techniques to ensure no new or increased risks.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical medical device and does not involve AI or machine learning, which would typically require a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image displays the logo for "BONUTTI TECHNOLOGIES." The word "BONUTTI" is in large, bold, black letters on the top line. Below it, in smaller, but still bold, black letters, is the word "TECHNOLOGIES." The logo is simple and professional.
O Box 1367 ffingham, IL 62401 Phone: 217.342.3412 217.342.3460 http://www.bonuttitec.com
K093078
Bonutti Research, Inc. Unity Ultrasonic System with PLLA Fasteners June 3, 2010
JUN 23 2010
510(k) SUMMARY
The following information is submitted in accordance with the requirements of 21 CFR 807.92:
| Contact Person: | Patrick Bálsmann, MBA, MS, RAC |
|---|---|
| Director, Regulatory/Clinical Affairs & QA | |
| Bonutti Research, Inc., | |
| P.O. Box 1367 | |
| Effingham, Illinois 62401 | |
| Phone: (217) 342-3412, ext. 321 | |
| Fax: (217) 342-1043 |
Date Prepared: June 3, 2010
Proprietary Name: Unity Ultrasonic System with PLLA Fasteners
Common Name: Fixation Device
Classification Name: Fastener, Fixation, Biodegradable, Soft Tissue.
Device Description: The Unity Ultrasonic System with PLLA Fasteners is designed for the fixation of soft tissue, ligament, tendon, and bone. Absorbable poly-L-lactic acid (PLA) implant materials are ultrasonically welded, staked, and/or joined to secure soft tissue, ligament, tendon, and bone at a repair site. An electrical generator provides ultrasonic energy to the end effector of a handpiece to fix the implant materials together and secure soft tissue, ligament, tendon, and/or bone. Energy applied to the trailing end of the implant portion contacting the handpiece end effector joins this implant portion to the other implant portion in securing soft tissue, ligament, tendon, and bone. Ultrasonic handpieces with end effectors designed to accommodate Unity Implants are product specific and include a force sensor mechanism that allows the surgeon feedback on the amount of load they are applying to the handpiece. Feedback is provided to the surgeon through an audible tone.
Indications for Use: The Unity Ultrasonic System with PLLA Fasteners consists of an electrical generator and ultrasonic handpieces. The system is to be used with Unity 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.
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Bonutti Research, Inc. Unity Ultrasonic System with PLLA Fasteners 510(k) Summary - June 3, 2010 Page 2 of 2
Predicate Device(s): The Unity Ultrasonic System with PLLA Fasteners is similar in design and intended use to existing Bonutti Research, Inc., ultrasonic systems (electrical generators and ultrasonic handpieces) and Unity Implants used in sutureless fixation and previously determined substantially equivalent.
Predicate Comparison: The modification to the Unity Ultrasonic System with PLLA Fasteners to its predicate ultrasonic systems includes the addition of a 40 kHz handpiece to the existing 20 kHz handpiece. Both handpieces are used with the same electrical generator to ultrasonically weld, stake, and/or join absorbable poly-L-lactic acid (PLLA) implant portions together to secure soft tissue, ligament, tendon, and bone at a repair site. The 40 kHz handpiece is similar in design, packaging, and labeling to its opedicate handpiece. Each handpiece has similar cleaning and sterilization techniques.
Predicate Verification: Design verification testing with identified acceptance criteria conducted to determine substantial equivalence among the predicate devices noted in the preceding section included; (1) A comparison of the mechanical strengths and failure modes among the two handpieces and their respective implants when ultrasonically welded. Implant strengths were statistically equivalent among the respective implants tested. (2) An electrical safety and EMC test plan with related acceptance criteria was defined. (3) A risk evaluation of the 40 kHz handpiece to its predicate demonstrated similar design, packaging, labeling, and sterilization techniques that raise no concerns regarding the safe and effective use of the Unity Ultrasonic System with PLLA Fasteners.
Submitted by:
Vito R. Palmieri
Patrick Balsmann, MBA, MS, RAC Director, Regulatory/Clinical Affairs & QA
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 2 3 2010
Bonutti Research, Inc % Mr. Patrick Balsmann, MBA, MS, RAC Director, Regulatory/Clinical Affairs & QA P.O. Box 1367 Effingham, Illinois
Re: K093078
Trade/Device Name: Unity Ultrasonic System with PLLA Fasteners Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MAI Dated: June 3, 2010 Received: June 4, 2010
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Page 2 - Mr. Patrick Balsmann, MBA, MS, RAC
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Sincerely yours,
Mark A. Millburn
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K093078
Device Name: Unity Ultrasonic System with PLLA Fasteners
Indications For Use: The Unity Ultrasonic System consists of an electrical generator and ultrasonic handpieces. The system is to be used with Unity 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)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Sonetu for mcm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093078
§ 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.