(66 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the mechanical properties and equivalence to a predicate device, with no mention of AI or ML.
Yes
The device is a suture anchor used for various repairs and reconstructions of soft tissues in the body, which are explicitly therapeutic interventions.
No
The device description and intended use indicate it is an implantable suture anchor used for repair and reattachment of tissues, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical suture anchor made of PEEK and stainless steel, pre-assembled with UHMWPE suture. It is a sterile, single-use hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for repairing and reattaching tissues in various joints (hip, shoulder, foot & ankle, elbow, wrist & hand, knee). This is a therapeutic/surgical application, not a diagnostic one.
- Device Description: The device is a suture anchor, inserter, and suture. These are all physical components used in surgery.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the mechanical strength and safety of the device for surgical use, not on diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
HIP: Hip capsule repair, Acetabular labrum reattachment
SHOULDER: Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs Biceps tenodesis
FOOT & ANKLE: Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy
ELBOW, WRIST, & HAND: Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair
KNEE: Extra-capsular repairs (Medial collateral ligament, Lateral collateral ligament, Posterioroblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), Iliotiblal band tenodesis
Product codes
MBI
Device Description
Pivot Medical is introducing the CinchLock Flex Knotless Suture Anchor as a line extension to the existing CinchLock Knotless Suture Anchor. The CinchLock Flex Knotless Suture Anchor is a non-degradable PEEK suture anchor that is pre-assembled to a stainless steel inserter. Non-degradable Ultra High Molecular Weight Polyethylene (UHMWPE) suture is provided within the sterile package with the Knotless Suture Anchor and Inserter. The CinchLock Flex Knotless Suture Anchor with Inserter and Suture is provided as a sterile single use device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
HIP, SHOULDER, FOOT & ANKLE, ELBOW, WRIST, & HAND, KNEE
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
Non-clinical verification and validation testing has been performed to verify the efficacy of the CinchLock Flex Knotless Suture Anchor as compared to the predicate. This included Insertion Strength, Anchor Coupling Strength, Ultimate Tensile Strength, Anchor Cinch Force, Inserter Moment Testing, Design Validation, Packaging Validation, Sterilization Validation, Shelf Life/Stability Validation, and Biological Safety Assessment. The results of this testing verified that the subject device is substantially equivalent to the predicate, and raises no new questions of safety or effectiveness. Clinical testing was not required to demonstrate substantial equivalence for this submission.
Key Metrics
Not Found
Predicate Device(s)
CinchLock Knotless Suture Anchor, K131769
Reference Device(s)
No reference devices were used in this submission.
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/1 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 23, 2015
Pivot Medical Ms. Kelly Kucharczyk Regulatory Affairs Associate Manager 247 Humboldt Court Sunnyvale, California 94089
Re: K151314
Trade/Device Name: CinchLock Flex 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: May 14, 2015 Received: May 18, 2015
Dear Ms. Kucharczyk:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
CinchLock Flex Knotless Suture Anchor
Indications for Use (Describe) HIP: Hip capsule repair, Acetabular labrum reattachment
SHOULDER: Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions), Acromioclavicular separation repairs, Rotator cuff tear repairs Bicens tenodesis
FOOT & ANKLE: Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/ reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy
ELBOW, WRIST, & HAND: Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions. Lateral epicondylitis repair
KNEE: Extra-capsular repairs (Medial collateral ligament, Lateral collateral ligament, Posterioroblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), Iliotiblal band tenodesis
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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l. SUBMITTER
Pivot Medical 247 Humboldt Ct Sunnyvale, CA 94049
| Contact Person: | Kelly Kucharczyk, RAC
Associate Manager, Regulatory Affairs |
|-----------------|----------------------------------------------------------------|
| Phone: | 810-813-4672 |
| Fax: | 303-993-6195 |
Date Prepared: June 25, 2015
II. DEVICE
| Name of Device: | CinchLock Flex Knotless Suture Anchor |
|---|---|
| Common Name: | Fastener, Fixation, Nondegradable, Soft Tissue |
| Classification Name: | Smooth or threaded metallic bone fixation fastener (21 |
| CFR 888.3040) | |
| Regulatory Class: | II |
| Product Code: | MBI |
PREDICATE DEVICE lll.
CinchLock Knotless Suture Anchor, K131769 This predicate has not been subject to any recalls since it was introduced to market
No reference devices were used in this submission.
DEVICE DESCRIPTION IV.
Pivot Medical is introducing the CinchLock Flex Knotless Suture Anchor as a line extension to the existing CinchLock Knotless Suture Anchor. The CinchLock Flex Knotless Suture Anchor is a non-degradable PEEK suture anchor that is pre-assembled to a stainless steel inserter. Non-degradable Ultra High Molecular Weight Polyethylene (UHMWPE) suture is provided within the sterile package with the Knotless Suture Anchor and Inserter. The CinchLock Flex Knotless Suture Anchor with Inserter and Suture is provided as a sterile single use device.
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V. INDICATIONS FOR USE
HIP: Hip capsule repair, Acetabular labrum reattachment
SHOULDER: Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs Biceps tenodesis
FOOT & ANKLE: Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy
ELBOW, WRIST, & HAND: Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair
KNEE: Extra-capsular repairs (Medial collateral ligament, Lateral collateral ligament, Posterioroblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), Iliotiblal band tenodesis
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The intent of this premarket notification is to provide the CinchLock Anchor on a flexible delivery system, designated the CinchLock Flex Knotless Suture Anchor. In order to achieve this, modifications have been made to the inserter, handle, and anchor coupling as compared to the predicate device. There have been no changes to material of the implantable portion of the device, and all other materials have been established to be equivalent to the predicate with respect to performance and biological safety. These modifications have been assessed via risk analysis and verification and/or validation activities and determined to not raise any new questions of safety or effectiveness of the subject device. Given this, the CinchLock Flex Knotless Suture Anchor is substantially equivalent to the predicate CinchLock Knotless Suture Anchor in regard to intended use, technological characteristics, performance attributes, and operational principles.
VII. PERFORMANCE DATA
Non-clinical verification and validation testing has been performed to verify the efficacy of the CinchLock Flex Knotless Suture Anchor as compared to the predicate. This included Insertion Strength, Anchor Coupling Strength, Ultimate Tensile Strength, Anchor Cinch Force, Inserter Moment Testing, Design Validation, Packaging Validation, Sterilization Validation, Shelf Life/Stability Validation, and Biological Safety Assessment. The results of this testing verified that the subject device is substantially equivalent to the predicate, and raises no new questions of safety or effectiveness. Clinical testing was not required to demonstrate substantial equivalence for this submission.
CONCLUSIONS VIII.
The information presented within this special 510(k) premarket notification demonstrates that the CinchLock Flex Knotless Suture Anchor is substantially equivalent to the identified predicate device.