(30 days)
Not Found
No
The summary describes a mechanical suture anchor and its inserter, with no mention of software, algorithms, or any AI/ML related terms or concepts.
No
The device is a suture anchor used for the fixation of soft tissue to bone, which is a structural or mechanical function, not generally considered therapeutic in the context of treating disease or restoring health through non-structural means.
No
This device is a surgical implant designed for fixation of soft tissue to bone, not diagnosis. It's a "Suture Anchor" used in hip labrum reattachment.
No
The device description clearly states it is a physical suture anchor made of PEEK polymer and UHMWPE suture, pre-assembled to a stainless steel inserter. It is a single-use sterile device, indicating a physical product.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states the NanoTack Suture Anchor is a physical implant made of PEEK polymer and UHMWPE suture, designed for surgical fixation of soft tissue to bone.
- Intended Use: The intended use is for surgical reattachment of the hip labrum, which is a direct surgical intervention on the body, not an analysis of a specimen.
The information provided describes a surgical implant, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications 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.
Product codes
MBI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, hip labrum, acetabulum
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo for Pivot Medical. The logo consists of the word "pivot" in bold, sans-serif font, with a solid black circle above the "i". To the right of the word "pivot" is a stylized image of a sphere with a horizontal line across it. Below the word "pivot" is the word "MEDICAL" in a smaller, sans-serif font.
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.
1
Image /page/1/Picture/1 description: The image shows the logo for Pivot Medical. The logo is black and white and features the word "pivot" in bold, sans-serif font. The "o" in "pivot" is replaced by a stylized image of a sphere with curved lines. Below the word "pivot" is the word "MEDICAL" in smaller, sans-serif font.
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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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
4
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