(58 days)
No reference devices were used in this submission.
No
The document describes a mechanical fixation device and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is an implantable cortical suspensory fixation device for ligament repair and reconstruction, not a therapeutic device in itself.
No
Explanation: The device is intended for the fixation of bone-to-bone or soft tissue-to-bone in ACL and PCL repair and reconstruction. This is a therapeutic or reconstructive function, not a diagnostic one.
No
The device description explicitly states it is a "cortical suspensory fixation implant that consists of an adjustable nonabsorbable suture loop assembled to a titanium button," indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Stryker ProCinch Adjustable Loop Fixation Device is a surgical implant used to physically fix bone and soft tissue during ACL and PCL repair and reconstruction. It is a mechanical device used in vivo (within the body) during a surgical procedure.
- Lack of Diagnostic Activity: The device does not analyze biological samples or provide any diagnostic information about a patient's health status. Its function is purely structural and mechanical.
Therefore, based on the provided information, the Stryker ProCinch Adjustable Loop Fixation Device is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Stryker ProCinch Adjustable Loop Fixation Device is intended for the fixation of bone-tobone or soft tissue-to-bone as fixation posts, a distribution bridge, or for distributing suture tension during Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) Repair and Reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
HTY
Device Description
Stryker Endoscopy is introducing the Stryker ProCinch Adjustable Loop device for use in orthopedic applications. The Stryker ProCinch Adjustable Loop Device is a cortical suspensory fixation implant that consists of an adjustable nonabsorbable suture loop assembled to a titanium button. The device is offered in two configurations. Standard Tensioning and Reverse Tensioning.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Non-clinical bench testing was performed to verify the efficacy of the Stryker ProCinch Adjustable Loop Device as compared to the predicate. This testing included Cyclic Extension and Ultimate Tensile Strength after cyclic loading. The results of this testing verified that the subject device performs statistically equivalent or better than the predicate device. Clinical testing was not required to demonstrate substantial equivalence for this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Arthrex ACL TightRope, K112990
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are oriented to the right. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in all caps.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 17, 2015
Stryker Endoscopy Ms. Kelly Kucharczyk Associate Manager, Regulatory Affairs 5900 Optical Court San Jose, California 95138
Re: K150416
Trade/Device Name: ProCinch Adjustable Loop Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: February 19, 2015 Received: February 20, 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Kelly Kucharczyk
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 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/Resourcesfor You/Industry/default.htm. 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 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 vours.
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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Indications for Use
510(k) Number (if known): K150416
The Stryker ProCinch Adjustable Loop Fixation Device is intended for the fixation of bone-tobone or soft tissue-to-bone as fixation posts, a distribution bridge, or for distributing suture tension during Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) Repair and Reconstruction.
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) Summary
I. SUBMITTER
Stryker Endoscopy 5900 Optical Ct San Jose, CA 95138
Contact Person: Kelly Kucharczyk, RAC Associate Manager, Regulatory Affairs
Date Prepared: April 16, 2015
Phone: 810-813-4672 Fax: 303-993-6195
II. DEVICE
- Name of Device: Stryker ProCinch Adjustable Loop Device (Models: Standard Tensioning, Reverse Tensioning)
- Common Name: Pin, Fixation, Smooth
- Classification Name: Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040
- Regulatory Class: II
- HTY Product Code:
III. PREDICATE DEVICE
Arthrex ACL TightRope, K112990
This predicate has not been reported by the manufacturer as being subject to a design-related recall.
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
Stryker Endoscopy is introducing the Stryker ProCinch Adjustable Loop device for use in orthopedic applications. The Stryker ProCinch Adjustable Loop Device is a cortical suspensory fixation implant that consists of an adjustable nonabsorbable suture loop assembled to a titanium button. The device is offered in two configurations. Standard Tensioning and Reverse Tensioning.
V. INDICATIONS FOR USE
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The Stryker ProCinch Adjustable Loop Fixation Device is intended for the fixation of bone-to-bone or soft tissue-to-bone as fixation posts, a distribution bridge, or for distributing suture tension during Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) Repair and Reconstruction.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Stryker ProCinch Adjustable Loop Fixation Device is substantially equivalent to other commercially available cortical suspension fixation devices in regard to intended use, design, materials of construct, performance attributes, and operational principles. The Arthrex ACL TightRope Device has been identified as an appropriate predicate.
VII. PERFORMANCE DATA
Non-clinical bench testing was performed to verify the efficacy of the Stryker ProCinch Adjustable Loop Device as compared to the predicate. This testing included Cyclic Extension and Ultimate Tensile Strength after cyclic loading. The results of this testing verified that the subject device performs statistically equivalent or better than the predicate device. Clinical testing was not required to demonstrate substantial equivalence for this submission.
VIII. CONCLUSIONS
The information presented within this traditional premarket submission demonstrate that the Stryker ProCinch Adjustable Loop Device is substantially equivalent to the predicate device and should perform as designed within its intended use.