(71 days)
Not Found
No
The summary describes a mechanical fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for the fixation of soft tissue to bone during rotator cuff repair, which is a therapeutic intervention.
No
This device is described as a system for the fixation of soft tissue to bone during rotator cuff repair, consisting of anchors and a grasper. Its intended use is to perform a surgical fixation, not to diagnose a condition.
No
The device description explicitly lists hardware components such as bone anchors, suture leads, handles, and a targeting grasper.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The KFx Knotless Fixation System is a surgical device used to physically attach soft tissue to bone during rotator cuff repair. It is implanted directly into the body and does not involve the analysis of bodily specimens.
The information provided clearly describes a surgical implant and its associated tools, not a device for analyzing samples outside the body.
N/A
Intended Use / Indications for Use
The KFx Knotless Fixation System is intended for the fixation of soft tissue to bone during rotator cuff repair. The KFx Knotless Fixation System and Accessory Targeting Grasper are intended for the fixation of soft tissue to bone during rotator cuff repair.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The KFx Knotless Fixation System consists of - . KFx Nail Bone Anchor with two suture leads, mounted to a single use handle - KFx Suture Lock Bone Screw Anchor mounted to a single use handle . - Optional KFx Targeting Grasper. .
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)
Results of physical bench testing demonstrate that the KFx Knotless Fixation System meets its specifications and does not raise new issues of safety or effectiveness.
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.
K041713, K041440, K042914, K960516
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.
Not Found
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
KFx Knotless Fixation System
K061294 (pg. 1 of 2)
510(k) Notification
510(k) Summary
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. Date Prepared: September x, 2005
510(k) number:
JUL 1 9 2006
Applicant Information:
KFx Medical 5145 Avenida Encinas Suite C Carlsbad, CA 92008
Contact Person
Malcolm Heaven Phone Number: (619) 270-8475 Fax Number: (760) 602 9252
Device Information:
| Trade Name: | KFx Knotless Fixation System and Targeting Grasper |
|---|---|
| Classification: | Class II |
| Classification Name: | Bone Anchor; Grasper |
Physical Description:
The KFx Knotless Fixation System consists of
- . KFx Nail Bone Anchor with two suture leads, mounted to a single use handle
- KFx Suture Lock Bone Screw Anchor mounted to a single use handle .
- Optional KFx Targeting Grasper. .
Intended Use:
The KFx Knotless Fixation System is intended for the fixation of soft tissue to bone during rotator cuff repair.
Equivalent Device:
The KFx Knotless Fixation System is substantially equivalent to existing suturing devices cleared by the Food and Drug Administration. The Linvatec Super Revo Herculine Suture Anchor (K041713), the Opus Medical Magnum Anchor with Inserter (K041440, K042914), and the Arthrex FASTak Suture Anchor (K960516) devices are examples of substantially equivalent devices with the same intended use, design and technology characteristics requested by KFx Medical. Inc. The intended use of the KFx Knotless Fixation System is substantially equivalent to the intended use of the suturing devices listed above.
1
Test Results:
Performance
Results of physical bench testing demonstrate that the KFx Knotless Fixation System meets its specifications and does not raise new issues of safety or effectiveness.
8061294
Biocompatibility
The materials used in the KFx Knotless Fixation System are biocompatible. The same materials are used in the identified predicates and are also commonly used in similar medical devices.
Summary:
Based on the intended use, product, performance and biocompatibility information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 9 2006
KFx Medical c/o Ms. Beth Bierman Morgan Lewis 1111 Pennsylvania Ave., NW Washington, DC 20004
Re: K061294
Trade/Device Name: KFx Knotless Fixation System and Targeting Grasper Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: May 8, 2006 Received: May 9, 2006
Dear Ms. Bierman:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.
3
Page 2 - Ms. Beth Bierman
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to begin maining of substantial equivalence of your device to a legally promatics motificated. In a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you dosire of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Aubrey Buettner
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KFx Knotless Fixation System
Indications for Use
510(k) Number (if known): _ ҚО61294
Device Name: KFx Knotless Fixation System, Optional KFx Targeting Grasper
Indications for Use:
The KFx Knotless Fixation System and Accessory Targeting Grasper are intended for the fixation of soft tissue to bone during rotator cuff repair.
ﮯ Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Division of General, Restorative, and Neurological Devices
Page of of
510(k) Number K061294
KFx Medical
CONFIDENTIAL
Page 10