(86 days)
Not Found
No
The device description and performance studies focus on mechanical properties and surgical fixation techniques, with no mention of AI or ML.
No
The device is a fixation device used to attach soft tissue to bone during surgical repairs and reconstructions, which is a structural rather than therapeutic function.
No
Explanation: The device is an Adjustable Fixation Device used for soft tissue to bone fixation, primarily in reconstructive surgeries such as ACL/PCL repair. Its function is to facilitate repair by placing and retaining soft tissue grafts within bone, not to diagnose conditions.
No
The device description clearly states it consists of a graft suspension loop and a titanium cortical button, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical fixation of soft tissue to bone during various orthopedic procedures. This is a direct intervention on the patient's body.
- Device Description: The description details a physical implant (graft suspension loop and cortical button) used to hold tissue in place within bone. This is a mechanical device for surgical repair.
- 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, diagnose conditions, or monitor treatment.
IVD devices are used to perform tests on samples taken from the body, not to directly repair or reconstruct tissues within the body.
N/A
Intended Use / Indications for Use
The Adjustable Fixation Device is indicated for soft tissue to bone fixation for:
- ACL/PCL repair / reconstruction
- ACL/PCL patellar bone-tendon-bone grafts
- Double-Tunnel ACL reconstruction
- Extracapsular repair: MCL, LCL, and posterior oblique ligament
- Illiotibial band tenodesis
- Patellar tendon repair
- VMO advancement
- Joint capsule closure
Product codes (comma separated list FDA assigned to the Subject Device)
MBI
Device Description
The Adjustable Fixation Device consists of a graft suspension loop and a titanium cortical button. The suspension loop is threaded through the titanium cortical button to form a graft suspension construction. The device facilitates repair through placement and retention of the soft tissue graft within bone.
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
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Bench testing was conducted as follows:
- l Comparative testing of the proposed and predicate devices in which the proposed and predicate devices were inserted into a simulated human bone substrate and subjected to cyclic and static loading.
- I Design Verification testing to demonstrate conformance to design and performance specifications.
All test results confirm that Adjustable Fixation Device is substantially equivalent to the predicate devices. Additionally, the test results confirm that the devices meet their design, performance, and safety specifications.
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.
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
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked one behind the other, representing people. The faces are rendered in a simple, abstract style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 28, 2016
ArthroCare Corporation Ms. Katherine Marcaccio Regulatory Affairs Specialist II 15285 Alton Parkway, Number 200 Irvine, California 92618
Re: K153186
Trade/Device Name: Adjustable Fixation Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: November 2, 2015 Received: November 3, 2015
Dear Ms. Marcaccio:
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 forth in the
1
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" (21 CFR 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 yours,
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)
K153186
Device Name Adjustable Fixation Device
Indications for Use (Describe)
The Adjustable Fixation Device is indicated for soft tissue to bone fixation for:
- · ACL/PCL repair / reconstruction
- · ACL/PCL patellar bone-tendon-bone grafts
- · Double-Tunnel ACL reconstruction
- · Extracapsular repair: MCL, LCL, and posterior oblique ligament
- · Illiotibial band tenodesis
- · Patellar tendon repair
- VMO advancement
- · Joint capsule closure
| 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
ArthroCare® Corporation
Adjustable Fixation Device
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.
General Information
| Submitter Name: | ArthroCare Corporation |
|---|---|
| Address | 15285 Alton Parkway, Suite 200 |
| Irvine, CA 92618 | |
| Contact Person: | Katherine Marcaccio |
| Regulatory Affairs Specialist II | |
| Phone: 508-261-3602 | |
| Fax: 978-749-1443 | |
| Date Prepared: | 2 November 2015 |
Device Name
| Proprietary Name: | Adjustable Fixation Device |
|---|---|
| Common Name: | Fastener, Fixation, Nondegradable, Soft Tissue |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
| Device Class: | II |
| Product Code: | MBI |
| CFR Section: | 888.3040 |
Predicate Devices
The predicate devices for the Adjustable Fixation Device are:
- Biomet ToggleLoc cleared via 510(k) K083070 and subsequently K130033.
- N8TIVE ACL Reconstruction System cleared via 510(k) K133606. ●
Description
The Adjustable Fixation Device consists of a graft suspension loop and a titanium cortical button. The suspension loop is threaded through the titanium cortical button to form a graft suspension construction. The device facilitates repair through placement and retention of the soft tissue graft within bone.
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| Characteristics | Biomet ToggleLoc
K083070, K130033 | N8TIVE ACL
Reconstruction System
K133606 | Adjustable
Fixation Device
Proposed
Device |
|----------------------------|-----------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Intended Use | Fixation of soft tissue to bone | Same | Same |
| How Supplied | Sterile | Same | Same |
| Sterilization Method | Ethylene Oxide | Same | Same |
| Implant Materials | | | |
| • Cortical Button | Titanium (Ti-6AL-4V Alloy) | Same | Same |
| • Suspension Loop | UHMWPE/Polypropylene/
Polyester | UHMWPE/Polyester | Same as
N8TIVE |
| • Suture/Suture Tape | Not Applicable | UHMWPE | Not Applicable |
| • Graft Spacer | Not Applicable | PEEK Optima® | Not Applicable |
| • Screw | Not Applicable | Same | Not Applicable |
| • Sheath | Not Applicable | PEEK Optima | Not Applicable |
| • Tether Sutures | Not Applicable | UHMWPE | Not Applicable |
| Method of Insertion | Inserted into drilled
hole/tunnel | Same | Same |
| Design Technology | Graft suspension loop with
cortical button | Graft Spacer and
Suspension Loop with
Cortical Button | Same as Biomet
ToggleLoc |
| Implant
Size/Dimensions | | | |
| • Cortical Button | 13.2mm x 2.0mm x 1.8mm | 12.1mm x 3.9mm x
1.8mm (Femoral
Implant)
18mm x 11.5mm 6.1mm
(Tibial Implant) | Same as
N8TIVE
Femoral
Implant |
| • Suspension Loop | Adjustable | Same | Same |
| • Graft Spacer | Not Applicable | 23mm x 6mm x 6mm | Not applicable |
| • Screw | Not Applicable | Range of 29 to 36mm
length, 8mm diameter | Not Applicable |
| • Sheath | Not Applicable | Range of 33 to 40mm
length | Not Applicable |
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Intended Use
The Adjustable Fixation Device is indicated for soft tissue to bone fixation for:
- ACL/PCL repair / reconstruction ●
- ACL/PCL patellar bone-tendon-bone grafts
- Double-Tunnel ACL reconstruction
- Extracapsular repair: MCL, LCL, and posterior oblique ligament ●
- Illiotibial band tenodesis
- Patellar tendon repair ●
- VMO advancement
- . Joint capsule closure
Non-Clinical Data
Bench testing was conducted as follows:
- l Comparative testing of the proposed and predicate devices in which the proposed and predicate devices were inserted into a simulated human bone substrate and subjected to cyclic and static loading.
- I Design Verification testing to demonstrate conformance to design and performance specifications.
All test results confirm that Adjustable Fixation Device is substantially equivalent to the predicate devices. Additionally, the test results confirm that the devices meet their design, performance, and safety specifications.
Clinical Data
No clinical or animal data are included in this submission.
Summary
All testing demonstrates that the Adjustable Fixation Device performs as intended and has acceptable mechanical properties when used in accordance with the device labeling.
As the intended use, operating principle, materials, and technological characteristics are comparable to the predicate devices, ArthroCare believes the Adjustable Fixation Device is substantially equivalent to the predicate devices. The minor differences between the ArthroCare devices and their predicate devices do not raise any new questions of safety or effectiveness.