(86 days)
No
The summary describes a mechanical suture anchor and does not mention any AI or ML components or functionalities.
No
The device, a suture anchor, is used for fixation of suture to bone during repairs, which is a structural and mechanical function rather than a therapeutic one that would directly treat a disease or condition.
No
Explanation: The device description states it is "intended for fixation of suture to bone in rotator cuff repairs and Achilles tendon repairs" and is "designed to attach soft tissues to bone." This indicates a therapeutic or surgical function, not a diagnostic one.
No
The device description clearly states it is a physical "suture anchor" which is a hardware component used in surgical procedures.
Based on the provided information, the KATOR Suture Anchor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "fixation of suture to bone in rotator cuff repairs and Achilles tendon repairs." This describes a surgical procedure involving the physical attachment of tissue to bone.
- Device Description: The device is described as a "device which is preloaded with suture and is designed to attach soft tissues to bone." This further reinforces its role as a surgical implant/tool.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used for diagnostic purposes, analyzing samples to provide information about a patient's health. The KATOR Suture Anchor is a surgical device used for mechanical fixation during a repair procedure.
N/A
Intended Use / Indications for Use
The KATOR Suture Anchor is intended for fixation of suture to bone in rotator cuff repairs and Achilles tendon repairs.
Product codes
MBI
Device Description
The KATOR Suture Anchor is a device which is preloaded with suture and is designed to attach soft tissues to bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Nonclinical Testing: All necessary testing has been performed for the worst-case KATOR Suture Anchor to assure substantial equivalence to the predicate device and demonstrate the device performs as intended. All testing was performed on test units representative of finished devices. Clinical data were not needed to support the safety and effectiveness of the subject device. The device performance was characterized through the following tests: Static and Dynamic Performance, o Suture Knot Strength. Side-by-side performance testing demonstrates the substantial equivalence of the KATOR Suture Anchor to the Corkscrew FT.
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
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 4, 2015
KATOR, LLC Mr. Robert Hov Director of Research 124 South 600 West, Suite 100 Logan, Utah 84321
Re: K152236
Trade/Device Name: KATOR 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: August 7, 2015 Received: August 10, 2015
Dear Mr. Hoy:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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
2
Indications for Use
510(k) Number (if known)
Device Name KATOR Suture Anchor
Indications for Use (Describe)
The KATOR Suture Anchor is intended for fixation of suture to bone in rotator cuff repairs and Achilles tendon repairs.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
3
5. 510(k) Summary
| Device Trade Name: | KATOR Suture Anchor |
|---|---|
| Manufacturer: | KATOR LLC |
| 124 South 600 West, Suite 100 | |
| Logan, UT 84321 | |
| Contact: | Mr. Robert Hoy |
| Director of Research | |
| Phone: (614) 448-6358 | |
| Fax: (435) 213-4878 | |
| bob@surgicalfrontiers.com | |
| Prepared by: | Musculoskeletal Clinical Regulatory Advisers, LLC |
| 1331 H Street NW, 12th Floor | |
| Washington, DC 20005 | |
| Phone: (202) 552-5800 | |
| Fax: (202) 552-5798 | |
| Date Prepared: | August 7, 2015 |
| Common Name: | Fastener, Fixation, Soft Tissue |
| Classification: | 21 CFR 888.3040 |
| Class: | II |
| Product Code: | MBI |
Indications for Use:
The KATOR Suture Anchor is intended for fixation of suture to bone in rotator cuff repairs and Achilles tendon repairs.
Device Description:
The KATOR Suture Anchor is a device which is preloaded with suture and is designed to attach soft tissues to bone.
Predicate Device:
The Arthrex Corkscrew FT (K061665) serves as the predicate device.
4
Technological Characteristics Comparison:
The KATOR Suture Anchor and its predicate device are similar in size and shape. Both devices are generally cylindrical and have features on their outer diameter for engaging bone tunnel walls via an interference fit. In addition, both devices are designed to be deployed in conjunction with suture. The KATOR Suture Anchor and predicate device are both manufactured from polyetheretherketone (PEEK). There are no substantial differences in technological characteristics between the two devices and as such the KATOR Suture Anchor introduces no new issues of safety or effectiveness.
Nonclinical Testing:
All necessary testing has been performed for the worst-case KATOR Suture Anchor to assure substantial equivalence to the predicate device and demonstrate the device performs as intended. All testing was performed on test units representative of finished devices. Clinical data were not needed to support the safety and effectiveness of the subject device.
The device performance was characterized through the following tests:
- Static and Dynamic Performance ●
- o Suture Knot Strength
Conclusion:
The KATOR Suture Anchor is substantially equivalent to the Arthrex Corkscrew FT (K061665) with respect to its indications for use, design, and function. Side-by-side performance testing demonstrates the substantial equivalence of the KATOR Suture Anchor to the Corkscrew FT.