(86 days)
The Pivot Knotless Suture Anchor is indicated for the reattachment of hip labrum to the acetabulum.
The Pivot Knotless Suture Anchor is a non-degradable suture anchor manufactured from PEEK-OPTIMA® LT1 polymer attached to / pre-assembled to a stainless steel Inserter. Non-degradable ultra-high molecular weight polyethylene (UHMWPE) blue co-braid #1 suture is provided in the sterile package with the Knotless Suture Anchor and Inserter. The Knotless Suture Anchor with Inserter and Suture is provided as a single use sterile device.
This document is a 510(k) premarket notification for a medical device (Knotless Suture Anchor). It does not contain acceptance criteria or a study proving device performance against acceptance criteria in the typical sense of a diagnostic or AI device. This type of submission relies on demonstrating "substantial equivalence" to a predicate device already on the market, rather than specific performance metrics against pre-defined acceptance criteria through a clinical trial.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from this document, as they pertain to a different type of device evaluation.
However, I can provide the information that is present and relevant to the "substantial equivalence" claim:
1. A table of acceptance criteria and the reported device performance:
Instead of formal acceptance criteria and quantitative performance metrics like sensitivity/specificity for a diagnostic device, the "acceptance criteria" here is the demonstration of "substantial equivalence" to predicate devices based on technological characteristics and performance testing.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance |
|---|---|
| Indications for Use: Same as predicate devices. | "The Knotless 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." (This is the same as the predicate devices, though not explicitly stated as such in terms of comparison within the provided text, it's inferred from the substantial equivalence claim). |
| Technological Characteristics: Equivalent to predicate devices in materials and design. | "The Knotless Suture Anchor is made of poly-etheretherketone (PEEK) with an accompanying UHMWPE #1 suture." "The Knotless Suture Anchor is equivalent in materials and design to the Pivot NanoTack Suture Anchor device (K110473) and the Smith & Nephew (S&N) Knotless Instability Suture Anchor (K093428)." |
| Performance Testing: Insertion and fixation properties substantially equivalent. | "Pre-clinical testing includes insertion strength, suture strength, and biocompatibility testing." "The performance testing conducted demonstrates that the insertion and fixation properties of the Knotless Suture Anchor are substantially equivalent to the NanoTack Suture Anchor." |
| Biocompatibility: Materials are biocompatible. | "All components of the Knotless Suture Anchor system are made from biocompatible materials, as is the case for the predicate devices cited." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. This document refers to "pre-clinical testing" for insertion strength, suture strength, and biocompatibility, but does not provide details on sample sizes for these tests. There is no "test set" in the context of diagnostic performance evaluation.
- Data Provenance: Not applicable in the context of a retrospective/prospective study for device clinical performance. The pre-clinical testing would have been conducted in a lab setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "ground truth" to be established by experts as this is not a diagnostic device and no clinical efficacy study is detailed in this 510(k) summary. The evaluation focuses on material properties and mechanical performance compared to predicate devices.
4. Adjudication method for the test set:
- Not applicable. See point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI device or a diagnostic device where human reader performance would be a factor.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used:
- Mechanical and Biocompatibility Standards / Predicate Device Performance. The "ground truth" for this type of submission is the established safety and effectiveness of the legally marketed predicate devices, and the demonstration that the new device meets similar performance benchmarks (e.g., strength, biocompatibility).
8. The sample size for the training set:
- Not applicable. There is no "training set" for an AI model or a device of this nature.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
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FEB 2 1 2013
Knotless Suture Anchor Premarket Notification - Traditional 510(k)
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) 774-1452 Facsimile: (408) 739-4199 Email: jcook@pivotmedical.com
Date Summary Prepared: November 21, 2012
Device Name Trade Name: Knotless Suture Anchor Common Name: Bone Anchor Classification Name: Smooth or threaded metallic bone fixation fastener Regulation number: 21 CFR888.3040 Product Code: MBI
Predicate Devices
Pivot Medical NanoTack Suture Anchor - K110473 Smith & Nephew Knotless Instability Suture Anchor - K093428
Device Description
The Pivot Knotless Suture Anchor is a non-degradable suture anchor manufactured from PEEK-OPTIMA® LT1 polymer attached to / pre-assembled to a stainless steel Inserter. Non-degradable ultra-high molecular weight polyethylene (UHMWPE) blue co-braid #1 suture is provided in the sterile package with the Knotless Suture Anchor and Inserter. The Knotless Suture Anchor with Inserter and Suture is provided as a single use sterile device.
Intended Use
The Knotless 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
Pivot Knotless Suture Anchor is an implantable soft tissue fixation device (suture anchor) that allows the physician to secure soft tissue to bone. The Knotless Suture Anchor is made of poly-etheretherketone (PEEK) with an accompanying UHMWPE #1 suture. The Knotless Suture Anchor system includes the Suture Anchor. mounted onto a stainless steel Inserter. The Knotless Suture Anchor is equivalent in materials and design to the Pivot NanoTack Suture Anchor device (K110473) and the Smith & Nephew (S&N) Knotless Instability Suture Anchor (K093428). The only difference between the Knotless Suture Anchor and the Pivot NanoTack Suture Anchor is that the Knotless Suture Anchor has a separate UHMWPE #1 suture while the NanoTack Suture Anchor has a pre-loaded UHMWPE #1 suture. The only difference between the Pivot Knotless Suture Anchor and the S&N Knotless Anchor is that the Pivot Anchor includes the UHMWPE #1 suture within the same package and the S&N does not (provided separately). All components of the Knotless Suture Anchor system are made from biocompatible materials, as is the case for the predicate devices cited,
Summary of Performance Testing
The performance testing conducted demonstrates that the insertion and fixation properties of the Knotless Suture Anchor are substantially equivalent to the NanoTack Suture Anchor.
Pre-clinical testing includes insertion strength, suture strength, and biocompatibility testing.
Summary of Substantial Equivalence
Based upon the indications for use, technological characteristics, and comparison to the predicate devices, the Pivot Knotless Suture Anchor is substantially equivalent to the predicate devices.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 21, 2013
Pivot Medical % Mr. Jon Cook . Director - Ouality Assurance and Regulatory Affairs 247 Humboldt Court Sunnyvale, California 94089
Re: K123651
Trade/Device Name: Knotless 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: November 21, 2012 Received: November 27, 2012
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.
Image /page/3/Picture/6 description: The image shows the name "Erin I. Keith" in a stylized font. The letters "I" and "D" are connected and have a maze-like design. The name is written in black against a white background.
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
K123651 .
Indications for Use
510(k) Number (if known):
Device Name: Knotless Suture Anchor
Indications for Use:
The Pivot Knotless Suture Anchor is indicated for the reattachment of hip labrum to the acetabulum.
Prescription Use × AND / OR (Part 21 CFR 801 Subpart D)
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)
Image /page/4/Picture/11 description: The image shows the name "Anton E. Dmitriev, PhD" and "Division of Orthopedic De". There is also a logo and the date and time "2013.02.19 16:08:58". The logo has the number "05'00'".
§ 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.