(96 days)
Not Found
No
The summary describes a mechanical suture anchor and its performance compared to predicate devices, with no mention of AI or ML technology.
Yes
This device is a therapeutic device because its intended use is for the fixation of soft tissue to bone and the reattachment of hip labrum to the acetabulum, which are treatment actions.
No
The device is described as a "suture anchor" intended for "fixation of soft tissue to bone," specifically for reattaching the hip labrum. Its function is to physically secure tissue, not to diagnose a condition or provide information about a patient's health status.
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 hardware component.
No, 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, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The NanoTack Suture Anchor is a physical implantable device used to fix soft tissue to bone during surgery. It is not used to analyze biological samples.
- Intended Use: The intended use is for surgical fixation of the hip labrum, which is a direct surgical intervention, not a diagnostic test performed on a sample.
The information provided clearly describes a surgical implant, not a device for in vitro diagnostic testing.
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 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 stainless steel Inserter. The NanoTack Suture Anchor with 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, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance testing conducted demonstrates that the insertion and fixation properties of the NanoTack Suture Anchor are substantially equivalent to the Smith and Nephew BioRaptor 2.3PK and the Biomet Sleeve with ZipLoop anchors.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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.
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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 stylized sphere replacing the "o". Below the word "pivot" is the word "MEDICAL" in a smaller, sans-serif font. The logo is black and white.
Section 5. 510(k) Summary
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) 533-3081 Facsimile: (408) 739-4199 Email: icook@pivotmedical.com
Date Summary Prepared: February 16, 2011
Device Name
Trade Name: NanoTack Suture Anchor 1.4mm Common Name: Bone Anchor Classification Name: Smooth or threaded metallic bone fixation fastener Regulation number: 21 CFR888.3040 Product Code: MBI
Predicate Devices
Smith and Nephew BioRaptor 2.3PK Suture Anchor - K071586
Biomet Sleeve with ZipLoop™ Fixation Device - K080088 and K101063
Device Description
The Pivot NanoTack Suture Anchor 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 stainless steel Inserter. The NanoTack Suture Anchor with Inserter is provided as a single-use sterile device.
Intended 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.
Confidential
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Image /page/1/Picture/0 description: The image shows a sequence of handwritten characters and numbers. The sequence reads 'k11 0473'. The characters and numbers are written in black ink on a white background.
Image /page/1/Picture/1 description: The image shows the logo for Pivot Medical. The logo consists of the word "pivot" in a sans-serif font, with the "o" replaced by a stylized sphere. Below the word "pivot" is the word "MEDICAL" in a smaller, sans-serif font. The logo is black and white.
Summary of Technological Characteristics
The Pivot NanoTack Suture Anchor is substantially equivalent in design, materials, and function to the BioRaptor 2.3PK (K071586) and the Biomet Sleeve with ZipLoop (K080088 and K101063) predicate devices. The only difference between the NanoTack Suture Anchor and the BioRaptor 2.3PK is that the NanoTack utilizes a smaller size suture. The only difference between the NanoTack Suture Anchor and the Biomet Sleeve with ZipLoop is that the NanoTack anchor body is PEEK and the Biomet anchor body is polyester suture.
Summary of Performance Testing
The performance testing conducted demonstrates that the insertion and fixation properties of the NanoTack Suture Anchor are substantially equivalent to the Smith and Nephew BioRaptor 2.3PK and the Biomet Sleeve with ZipLoop anchors.
Summary of Substantial Equivalence
Based upon the indications for use, technological characteristics, and comparison to the predicate devices, the Pivot NanoTack Suture Anchor is substantially equivalent to predicate devices.
Confidential
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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a human figure with outstretched arms, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Pivot Medical Inc. % Mr. Jon Cook Director Regulatory Affairs and Quality Assurance 247 Humboldt Court Sunnyvale, California 94089
MAY 25 2011
Re: K110473
Trade/Device Name: NanoTack Suture Anchor 1.4mm Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: May 17, 2011 Received: May 19, 2011
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
E.S.Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Pivot Medical
Indications for Use
510(k) Number (if-known): K110473
NanoTack Suture Anchor Device Name:
・
Indications for Use:
The NanoTack Suture Anchor is indicated for the reattachment of hip labrum to the acetabulum.
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)
El Kutt
(Division Sign-Off) (Division Sign-of-Surgical, Orthopedic, Divisionative Devices
510(k) Number K110473
Confidential