(30 days)
The NanoTack Suture Anchor is intended for the fixation of soft tissue to bone in the hip, and is indicated for the reattachment of hip labrum to the acetabulum.
The Pivot NanoTack Suture Anchor 1.4mm is a non-degradable suture anchor manufactured from PEEK-OPTIMA® polymer attached to a non-degradable ultra high molecular weight polyethylene (UHMWPE) blue co-braid #1 suture that is pre-assembled to a Flex stainless steel Inserter. The NanoTack Suture Anchor 1.4mm with Flex Inserter is provided as a single use sterile device.
The Pivot Medical NanoTack Suture Anchor 1.4mm with Flex Inserter is a medical device designed for the fixation of soft tissue to bone in the hip, specifically for the reattachment of the hip labrum to the acetabulum. The device is a "Special 510(k)" submission, meaning it is substantially equivalent to a previously cleared device (NanoTack Suture Anchor 1.4mm - K110473) with minor modifications.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Insertion Strength | Substantially equivalent to the predicate device (NanoTack Suture Anchor 1.4mm) |
| Anchor Strength | Substantially equivalent to the predicate device (NanoTack Suture Anchor 1.4mm) |
2. Sample Size Used for the Test Set and Data Provenance:
The document states that "Pre-clinical testing includes insertion strength and anchor strength." However, it does not specify the sample size used for these tests. The data provenance is also not explicitly mentioned, but "pre-clinical testing" typically implies laboratory or cadaveric studies, not human clinical trials, and would likely be conducted in the country of origin of the manufacturer (USA, given the FDA submission). It is a prospective study as it evaluates the device performance for regulatory submission.
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 document. The testing described (insertion strength and anchor strength) are biomechanical performance tests, not subjective evaluations requiring expert clinicians to establish ground truth in the same way as, for example, image interpretation. Therefore, "ground truth" would be established by the objective measurements obtained during the mechanical testing.
4. Adjudication Method for the Test Set:
This information is not applicable and is not provided. The performance testing involves objective measurements rather than subjective assessments that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret images or data, and the AI's impact on their performance is evaluated. The NanoTack Suture Anchor is a surgical implant, and its evaluation focuses on mechanical performance, not diagnostic accuracy.
6. Standalone (Algorithm Only) Performance Study:
No, a standalone (algorithm only) performance study was not done. The NanoTack Suture Anchor is a physical medical device, not an algorithm. Its performance is assessed through mechanical and material testing.
7. Type of Ground Truth Used:
The ground truth for the performance testing (insertion strength and anchor strength) was established through objective mechanical and material property measurements. For example, force gauges would be used to measure insertion force, and load cells would measure anchor pull-out strength.
8. Sample Size for the Training Set:
This information is not applicable and is not provided. The NanoTack Suture Anchor is not an AI/ML device that requires a training set. Its design and performance are based on engineering principles and materials science.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable, as there is no training set for this type of medical device.
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NanoTack Suture Anchor Premarket Notification - Special 510(k)
Section 5. 510(k) Summary
MAR 1 4 2013
510(k) Owner Pivot Medical Inc. 247 Humboldt Court Sunnyvale CA 94089 Phone: 408-774-1452 Fax: 408-739-4199 Jon Cook Director Regulatory Affairs and Quality Assurance
FDA Contact
Jon Cook Director Regulatory Affairs and Quality Assurance Pivot Medical 247 Humboldt Court Sunnyvale CA 94089 Telephone: (408) 774-1452 Facsimile: (408) 739-4199 Email: jcook@pivotmedical.com
Date Summary Prepared: February 8, 2013
Device Name
Trade Name: NanoTack Suture Anchor 1.4mm with Flex Inserter Common Name: Bone Anchor Classification Name: Smooth or threaded metallic bone fixation fastener Regulation number: 21 CFR888.3040 Product Code: MBI
Predicate Device
NanoTack Suture Anchor 1.4mm - K110473
Device Description
The Pivot NanoTack Suture Anchor 1.4mm is a non-degradable suture anchor manufactured from PEEK-OPTIMA® polymer attached to a non-degradable ultra high molecular weight polyethylene (UHMWPE) blue co-braid #1 suture that is pre-assembled to a Flex stainless steel Inserter. The NanoTack Suture Anchor 1.4mm with Flex Inserter is provided as a single use sterile device.
Intended Use / Indication for Use
The NanoTack Suture Anchor is intended for the fixation of soft tissue to bone in the hip, and is indicated for the reattachment of hip labrum to the acetabulum.
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Summary of Technological Characteristics
The NanoTack Suture Anchor 1.4mm with Flex Inserter is substantially equivalent in design, materials, and function to the NanoTack Suture Anchor 1.4mm with Inserter (K110473). The only difference between the NanoTack Suture Anchor 1.4mm with Flex Inserter and the predicate is the laser cut pattern on the distal end of the Inserter shaft which allows the Inserter to flex through a curved quide.
Summary of Performance Testing
The performance testing conducted demonstrates that the insertion and fixation properties of the NanoTack Suture Anchor 1.4mm with Flex Inserter are substantially equivalent to the predicate device. Pre-clinical testing includes insertion strength and anchor strength.
Summary of Substantial Equivalence
The NanoTack Suture Anchor 1.4mm with Flex Inserter design, materials, and technology is substantially equivalent to the NanoTack Suture Anchor 1.4mm cleared in K110473. The modification to the inserter shaft does not raise new questions regarding the safety and effectiveness of the NanoTack Suture Anchor 1.4mm. Based upon the indications for use, technological characteristics, and comparison to the predicate device, the Pivot NanoTack Suture Anchor 1.4mm with Flex Inserter is substantially equivalent to the predicate device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 14, 2013
Pivot Medical Incorporated % Mr. Jon Cook Director Regulatory Affairs and Quality Assurance 247 Humboldt Court Sunnyvale, California 94089
Re: K130351
Trade/Device Name: NanoTack Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: February 8, 2013 Received: February 12, 2013
Dear Mr. Cook:
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 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
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Page 2 - Mr. Jon Cook
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 yours,
Erin Diceith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Pivot Medical
NanoTack Suture Anchor Premarket Notification - Special 510(k)
Section 4.
Indications for Use
510(k) Number (if known): K | 30351
Device Name: NanoTack Suture Anchor
Indications for Use:
The NanoTack Suture Anchor is indicated for the reattachment of hip labrum to the acetabulum.
Prescription Use × (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)
Casey L. Hanley, Ph.D.
Division of Orthopaedic Devices
§ 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.