(61 days)
No
The summary describes a mechanical suture anchor and does not mention any computational or data-driven features.
No.
This device is for fixation of suture to bone, which is a structural or mechanical function, not a therapeutic intervention that treats or cures a disease or condition.
No
The device is described as an implant used for fixation of soft tissues to bone during repairs, not for diagnosing conditions.
No
The device description clearly states it consists of an "anchor body" and a "suture locking pin," which are physical hardware components. The performance studies also focus on static and dynamic performance testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 performed directly on the patient's body.
- Device Description: The device is described as an "anchor body that is placed within a bone tunnel and a suture locking pin." This is a physical implant used during surgery.
- 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 patient's health status, diagnosis, or treatment.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used to repair tissue within the body.
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 modified KATOR Suture Anchor is designed to attach soft tissues to bone. It consists of an anchor body that is placed within a bone tunnel and a suture locking pin that secures soft tissue repair sutures or suture tape within the implant.
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
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
The subject device design was evaluated with the following verification tests, using the same methods performed on the predicate device in submission K152236:
- . Static Performance Testing
- Dynamic Performance Testing
The results of this testing as summarized in the Design Control Activities Summary demonstrate that the modified KATOR Suture Anchor met the pre-determined acceptance criteria for the verification activities. Therefore, the differences between the modified and predicate devices introduce no new issues of safety or effectiveness.
Acceptable endotoxin levels were established using limulus amebocyte lysate (LAL) testing. A plan for future endotoxin monitoring was proposed.
Key Metrics
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 features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, abstract manner.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 25, 2016
KATOR LLC Mr. Robert Hoy Director of Research 124 South 600 West, Suite 100 Logan, Utah 84321
Re: K162386
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: September 27, 2016 Received: September 27, 2016
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/ResourcesforYou/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,
Image /page/1/Picture/8 description: The image shows the name "Mark N. Melkerson -S" in a simple, sans-serif font. The text is horizontally aligned and appears to be part of a document or label. The letters are uniformly sized and spaced, creating a clean and legible presentation of the name. The background is plain, ensuring the focus remains on the text.
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)
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)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary 5.
| 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: | October 25, 2016 |
| Common Name: | Screw, Fixation, Bone |
| Classification: | 21 CFR 888.3040, Smooth or threaded metallic bone |
| fixation fastener | |
| 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 modified KATOR Suture Anchor is designed to attach soft tissues to bone. It consists of an anchor body that is placed within a bone tunnel and a suture locking pin that secures soft tissue repair sutures or suture tape within the implant.
Predicate Device:
The KATOR Suture Anchor (K152236) is the predicate device.
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Technological Characteristics Comparison:
The modified KATOR Suture Anchor and its predicate device are offered in the same sizes and have nearly identical shapes. Both devices are generally cylindrical and have rib 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 and contain suture locking pins. The modified 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:
The subject device design was evaluated with the following verification tests, using the same methods performed on the predicate device in submission K152236:
- . Static Performance Testing
- Dynamic Performance Testing
The results of this testing as summarized in the Design Control Activities Summary demonstrate that the modified KATOR Suture Anchor met the pre-determined acceptance criteria for the verification activities. Therefore, the differences between the modified and predicate devices introduce no new issues of safety or effectiveness.
Acceptable endotoxin levels were established using limulus amebocyte lysate (LAL) testing. A plan for future endotoxin monitoring was proposed.
Conclusion:
The modified KATOR Suture Anchor met all specified criteria performing as intended and did not raise any new issues of safety or effectiveness. The Indications/Intended Use and the fundamental scientific technology of the modified KATOR Suture Anchor are the same as those described in the predicate device. Based on similarities to its predicate, the modified KATOR Suture Anchor is substantially equivalent to the predicate KATOR Suture Anchor (K152236).