(79 days)
The KFx APPIANFx™ PEEK Suture Anchors and APPIANFx™ PEEK Tissue Anchors are intended for the fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow. Specifically: Shoulder: Bankart lesion repairs, SLAP lesion repairs, acromio- clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tenodesis, deltoid repairs Foot and Ankle: Hallux valgus repairs, medial or lateral instability repairs/reconstructions, mid-foot reconstructions, metatarsal ligament repair Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, iliotibial band tenodesis, patellar tendon repair Hand/Wrist/Elbow: Scapholunate ligament reconstructions, ulnar or radial collateral ligament reconstructions, tennis elbow repair, biceps tendon reattachment.
The KFx APPIANFx™ PEEK Suture Anchors consist of a fixation device comprised of a body with deployable legs, a wedge, and a disposable suture loop preloaded in a delivery (insertion) handle. The KFx APPIANFx™ PEEK Tissue Anchors consist of a fixation device comprised of a body with deployable legs and a cleated wedge preloaded in a delivery (insertion) handle. Each device is intended for single use and may be used in arthroscopic and open procedures.
The provided text describes a 510(k) Premarket Notification for medical devices, specifically suture and tissue anchors. It details the device, its intended use, and states that non-clinical testing was performed. However, it does not contain information about formal acceptance criteria, a specific study proving those criteria were met, or any of the detailed aspects typically associated with clinical or performance studies for AI/software devices.
The document primarily focuses on demonstrating substantial equivalence to a predicate device based on material biocompatibility and non-clinical engineering tests.
Therefore, many of the requested categories cannot be filled from the provided text.
Here's a breakdown based on the information available:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or a direct study proving specified performance metrics against such criteria in a clinical context. Instead, it makes a general statement:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and functional performance requirements are satisfied. | "Non-clinical test data (deployment, static pull-out, and cyclic suture retention testing) indicate that the device is safe and satisfies functional performance requirements when used as indicated and do not raise new issues of safety or effectiveness." |
| Substantial equivalence to predicate device. | "The documentation provided demonstrates that the KFx APPIANFx™ PEEK Suture Anchors and KFx APPIANFx™ PEEK Tissue Anchors are substantially equivalent to the currently marketed predicate device and is safe and effective when used as indicated." |
Study Details (Based on available information)
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. The study mentioned is "non-clinical test data (deployment, static pull-out, and cyclic suture retention testing)." These tests are typically conducted on a sample of devices, but the exact number is not provided.
- Data Provenance: Not specified, but given it's non-clinical testing, it would likely be laboratory-generated data rather than patient data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable: The study described is non-clinical (mechanical testing), not involving ground truth derived from expert review of medical images or patient outcomes.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable: No adjudication method mentioned as it's non-clinical mechanical testing, not a clinical study involving human judgment.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No: This is a physical medical device (suture/tissue anchors), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not relevant, and no AI component is involved.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No: See point 4. This is a physical device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Engineering specifications/measurements: For the non-clinical tests (deployment, static pull-out, cyclic suture retention), the "ground truth" would be the measured physical properties and performance characteristics against predefined engineering standards or comparison to the predicate device's performance.
-
The sample size for the training set:
- Not applicable: There is no mention of a training set as this is not an AI/machine learning device.
-
How the ground truth for the training set was established:
- Not applicable: See point 7.
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Special 510(k) Premarket Notification KFx APPIANFx™ PEEK Suture Anchors and KFx APPIANFx™ PEEK Tissue Anchors
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
JUN - 7 2012
APPLICANT INFORMATION
| A. | Company Name: | KFx Medical, Corporation |
|---|---|---|
| B. | Company Address: | 5845 Avenida EncinasSuite 128Carlsbad, CA 92008 |
| C. | Company Phone: | (760) 444-8844 |
| D. | Company Facsimile: | (760) 602-9252 |
| E. | Contact Person: | Gayle HirotaDirector QA/RA |
| DEVICE IDENTIFICATION | ||
| A. | Trade Name: | KFx APPIANFx™ PEEK Suture Anchors and KFxAPPIANFx™ PEEK Tissue Anchors |
| B. | Catalog Number: | KFX-MST-150 (5.0mm Suture Anchor)KFX-MST-160 (6.0mm Suture Anchor)KFX-GTO-160 (6.0mm Tissue Anchor) |
| C. | Common Name: | Bone Anchor |
| D. | Classification Name: | Fastener, Fixation, Nondegradable, Soft Tissue |
| E. | Product Code: | MBI |
| F. | Device Panel: | Orthopedic |
| G. | Device Class: | Class II |
IDENTIFICATION OF MODIFIED DEVICE
The KFx APPIANFx™ PEEK Suture Anchors and KFx APPIANFx™ PEEK Tissue Anchors are substantially equivalent to the KFx PEEK Bone Anchor with Pre-Attached Sutures and Delivery Handle.
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DEVICE DESCRIPTION
The KFx APPIANFx™ PEEK Suture Anchors consist of a fixation device comprised of a body with deployable legs, a wedge, and a disposable suture loop preloaded in a delivery (insertion) handle. The KFx APPIANFx™ PEEK Tissue Anchors consist of a fixation device comprised of a body with deployable legs and a cleated wedge preloaded in a
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delivery (insertion) handle. Each device is intended for single use and may be used in arthroscopic and open procedures.
Devices are provided "STERILE": sterilization is by radiation (E-Beam) and provides a sterility assurance level of 10-6.
INTENDED USE
The intended use of the KFx APPIANFx™ PEEK Suture Anchors and KFx APPIANFx™ PEEK Tissue Anchors are for the fixation of soft tissue to bone in the shoulder, foot, ankle, knee, hand, wrist, and elbow.
BIOCOMPATIBILITY AND PERFORMANCE DATA
The materials used in the KFx APPIANFx™ PEEK Suture Anchors and KFx APPIANFx™ PEEK Tissue Anchors are biocompatible. The same materials are used in a myriad of legally marketed orthopedic devices.
Non-clinical test data (deployment, static pull-out, and cyclic sufure retention testing) indicate that the device is safe and satisfies functional performance requirements when used as indicated and do not raise new issues of safety or effectiveness.
CONCLUSIONS DRAWN FROM STUDIES
The documentation provided demonstrates that the KFx APPIANFx™ PEEK Suture Anchors and KFx APPIANFx™ PEEK Tissue Anchors are substantially equivalent to the currently marketed predicate device and is safe and effective when used as indicated.
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and in a bold, sans-serif font. The words are arranged on a single line and are centered horizontally.
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN - 7 2012
KFx Medical. Corporation % Ms. Gayle Hirota Director, Quality Assurance / Regulatory Affairs 5845 Avenida Encinas, Suite 128 Carlsbad, California 92008
Re: K120841
Trade/Device Name: KFx AppianFx PEEK Suture Anchors and KFx AppianFx PEEK Tissue Anchors
Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: May 8, 2012
Received: May 9, 2012
Dear Ms. Hirota:
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
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Page 2 - Ms. Gayle Hirota
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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 Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| SECTION 1.6 | Indications for Use |
|---|---|
| 510(k) Number (if known): K120841 | |
| Device Name: | KFx APPIANFx™ PEEK Suture Anchors and APPIANFx™ PEEKTissue Anchors |
| Indications For Use: The KFx APPIANFx™ PEEK Suture Anchors and APPIANFx™PEEK Tissue Anchors are intended for the fixation of soft tissue tobone in the shoulder, foot/ankle, knee, hand/wrist, and elbow. | |
| Specifically: | |
| Shoulder: Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular separation repairs, rotator cuff repairs, capsular shift orcapsulolabral reconstructions, biceps tenodesis, deltoid repairs | |
| Foot and Ankle: Hallux valgus repairs, medial or lateral instabilityrepairs/reconstructions, mid-foot reconstructions, metatarsalligament repair | |
| Knee: Medial collateral ligament repair, lateral collateral ligamentrepair, posterior oblique ligament repair, iliotibial band tenodesis,patellar tendon repair | |
| Hand/Wrist/Elbow: Scapholunate ligament reconstructions, ulnar orradial collateral ligament reconstructions, tennis elbow repair, |
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
biceps tendon reattachment.
Over-The-Counter Use (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)
Ant
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
ખ્યત્વે જેવા ત્યારે તાલુકામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામના 510(k) Number .
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CONFIDENTIAL
§ 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.