(41 days)
Not Found
No
The document describes a mechanical suture anchor system and its accessory instrumentation. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device is a suture anchor system used for soft tissue to bone fixation, which is a therapeutic intervention aimed at repairing and reconstructing tissues.
No
Explanation: The Q-Fix Suture Anchor is intended for soft tissue to bone fixation and repair, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly states that the Q-Fix Suture Anchor System is a bone anchor with an inserter handle, which are physical components. The submission is for modifications and additions to accessory instrumentation, also physical components. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "soft tissue to bone fixation" in various anatomical locations (Shoulder, Foot & Ankle, Elbow, Knee, Hand & Wrist, Hip). This is a surgical procedure performed in vivo (within the living body).
- Device Description: The device is described as a "bone anchor with inserter handle" and associated instruments for implanting the anchor. This is a surgical implant and its delivery system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the living body) to analyze biological samples. This device is used in vivo for surgical repair.
N/A
Intended Use / Indications for Use
The Q-Fix Suture Anchor is intended to be used for soft tissue to bone fixation for:
Shoulder: Bankart lesion repair; SLAP lesion repair; acromio-clavicular repair; capsular shift/capsulolabral reconstruction; deltoid repair; rotator cuff tear repair; biceps tenodesis
Foot & Ankle: Medial/Lateral repair and reconstruction; midfoot and forefoot repair; Hallux valgus reconstruction; Metatarsal ligament/tendon repair or reconstruction; Achilles tendon repair
Elbow: Ulnar or radial collateral ligament reconstruction; lateral epicondylitis repair; biceps tendon reattachment
Knee: Extra-capsular repair: medial collateral ligament (MCL), lateral collateral ligament (LCL) and posterior oblique ligament; Iliotibial band tenodesis (IBT); patellar tendon repair; vastus medialis obliquus advancement (VMO); joint capsule closure
Hand & Wrist: Collateral ligament repair; Scapholunate ligament reconstruction; Tendon transfers in phalanx; Volar plate reconstruction
Hip: Acetabular labral repair
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The purpose of this subnission is to seek clearance for modifications and additions to the accessory instrumentation used with the previously cleared Q-Fix Suture Anchor System (K132513). There are no changes to the previously cleared indications for use, materials, design, technology, method of anchor insertion and or tissue attachment. The Q-Fix Suture Anchor System (Q-Fix) is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. The Q-Fix consists of two primary parts: a bone anchor inserter, which is preloaded with the anchor. The anchor inserter is a disposable tool. The entire product is packaged in a tray with a Tyvek® Iid, and the finished product is sterilized by ethylene oxide. Both the anchor and inserter are designed for single use only.
The O-Fix Suture Anchor System consists of the bone anchor and associated instruments for implanting the bone anchor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot & Ankle, Elbow, Knee, Hand & Wrist, Hip
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)
Bench testing was performed on both the proposed and predicate devices in accordance with the FDA Guidance Document, Testing Bone Anchors, April 1996. This in vitro testing involved insertion of the anchors into a simulated human bone substrate followed by both static and cyclic fatigue testing. The test results demonstrate that the Q-Fix meets its design, performance, and safety specifications. Based on the test results, the proposed device performs as intended and mechanical properties are substantially equivalent to the predicate devices when used in accordance with labeling. No clinical or animal data are included in this submission. All testing demonstrates that the Q-Fix performs as intended and has acceptable mechanical properties when used in accordance with its labeling.
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/0 description: The image shows the logo for ArthroCare. The logo consists of a stylized wave-like design on the left and the word "ArthroCare" on the right. The wave-like design is made up of several curved lines, and the word "ArthroCare" is in a sans-serif font.
JAN 16 2014
510(k) Summary
ArthroCare® Corporation Q-Fix™ Suture Anchor System
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 | 7000 West William Cannon Drive |
| Austin, TX 78735 | |
| Contact Person: | Laura Kasperowicz |
| Sr. Manager, Regulatory Affairs | |
| Phone: 949-585-2406 | |
| Fax: 949-585-2401 | |
| Date Prepared: | December 5, 2013 |
Device Name
| Proprietary Name: | Q-Fix™ Suture Anchor System |
|---|---|
| Common Name: | Bone Anchor |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
| Device Class: | Class II |
| Product Code: | MBI |
| CFR Section: | 21 CFR 888.3040 |
Predicate Device
ArthroCare Q-Fix™ Suture Anchor: K132513 (cleared September 19, 2013)
Description
The purpose of this subnission is to seek clearance for modifications and additions to the accessory instrumentation used with the previously cleared Q-Fix Suture Anchor System (K132513). There are no changes to the previously cleared indications for use, materials, design, technology, method of anchor insertion and or tissue attachment.
The Q-Fix Suture Anchor System (Q-Fix) is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures.
The Q-Fix consists of two primary parts: a bone anchor inserter, which is preloaded with the anchor. The anchor inserter is a disposable tool.
1
Image /page/1/Picture/1 description: The image shows the logo for ArthroCare. The logo consists of a stylized wave-like design on the left and the word "ArthroCare" on the right. The wave-like design is made up of several curved lines that are arranged in a circular pattern. The word "ArthroCare" is written in a bold, sans-serif font.
it
The entire product is packaged in a tray with a Tyvek® Iid, and the finished product is sterilized by ethylene oxide. Both the anchor and inserter are designed for single use only.
The O-Fix Suture Anchor System consists of the bone anchor and associated instruments for implanting the bone anchor. In accordance with the ArthroCare Product Development Process, testing was performed to demonstrate the proposed device is substantially equivalent to the predicate device. Mechanical testing was performed in accordance with the requirements of the FDA Guidance Document, Testing Bone Anchor Devices, April 1996.
Intended Use/Indications For Use
The O-Fix Suture Anchor is intended to be used for soft tissue to bone fixation for:
| Shoulder: | Bankart lesion repair; SLAP lesion repair; acromio-clavicular repair; capsular
shift/capsulolabral reconstruction; deltoid repair; rotator cuff tear repair; biceps
tenodesis |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Foot & Ankle: | Medial/Lateral repair and reconstruction; midfoot and forefoot repair; Hallux
valgus reconstruction; Metatarsal ligament/tendon repair or reconstruction;
Achilles tendon repair |
| Elbow: | Ulnar or radial collateral ligament reconstruction; lateral epicondylitis repair;
biceps tendon reattachment |
| Knee: | Extra-capsular repair: medial collateral ligament (MCL), lateral collateral ligament
(LCL) and posterior oblique ligament; Iliotibial band tenodesis (IBT); patellar
tendon repair; vastus medialis obliquus advancement (VMO); joint capsule closure |
| Hand & Wrist: | Collateral ligament repair; Scapholunate ligament reconstruction; Tendon transfers
in phalanx; Volar plate reconstruction |
| Hip: | Acetabular labral repair |
Non-Clinical Data
Bench testing was performed on both the proposed and predicate devices in accordance with the FDA Guidance Document, Testing Bone Anchors, April 1996. This in vitro testing involved insertion of the anchors into a simulated human bone substrate followed by both static and cyclic fatigue testing.
The test results demonstrate that the Q-Fix meets its design, performance, and safety specifications. Based on the test results, the proposed device performs as intended and mechanical properties are substantially equivalent to the predicate devices when used in accordance with labeling.
Clinical Data
No clinical or animal data are included in this submission.
Summary
All testing demonstrates that the Q-Fix performs as intended and has acceptable mechanical properties when used in accordance with its labeling.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring. MD 20993-0002
January 16, 2014
ArthroCare Corporation Mr. Mitchell Dhority Vice President, Regulatory Affairs 7000 West William Cannon Drive, Building I Austin. Texas 78735
Re: K133727
Trade/Device Name: Q-Fix™ Suture Anchor System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: December 18, 2013 Received: December 19, 2013
Dear Mr. Dhority:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Mitchell Dhority
forth in the quality systems (OS) 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 Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/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/Safetv/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometries/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/Resourcesfor You/Industrv/default.htm.
Sincerely yours,
Ronald® Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K133727
Device Name: Q-Fix™ Suture Anchor System
Indications for Use:
:
The Q-Fix Suture Anchor is intended to be used for soft tissue to bone fixation for:
| Shoulder: | Bankart lesion repair; SLAP lesion repair; acromio-clavicular repair; capsular
shift/capsulolabral reconstruction; deltoid repair; rotator cuff tear repair; biceps
tenodesis |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Foot & Ankle: | Medial/Lateral repair and reconstruction; midfoot and forefoot repair; Hallux
valgus reconstruction; Metatarsal ligament/tendon repair or reconstruction;
Achilles tendon repair |
| Elbow: | Ulnar or radial collateral ligament reconstruction; lateral epicondylitis repair;
biceps tendon reattachment |
| Knee: | Extra-capsular repair: medial collateral ligament (MCL), lateral collateral ligament
(LCL) and posterior oblique ligament; Iliotibial band tenodesis (IBT); patellar
tendon repair; vastus medialis obliquus advancement (VMO); joint capsule closure |
| Hand & Wrist: | Collateral ligament repair; Scapholunate ligament reconstruction; Tendon transfers
in phalanx; Volar plate reconstruction |
| Hip: | Acetabular labral repair |
Prescription Use X (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth司班rank -S
Division of Orthopedic Devices
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