(38 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and surgical application of a suture anchor, with no mention of AI or ML capabilities.
No.
The device is a bone anchor with an inserter system used for soft tissue to bone fixation during orthopedic and arthroscopic procedures, not a therapeutic device based on energy or drug delivery.
No
Explanation: The Q-Fix Suture Anchor is an implantable device used for soft tissue to bone fixation during surgical procedures. Its purpose is to repair and reconstruct various anatomical structures, not to diagnose medical conditions or analyze data for diagnostic purposes.
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. It also mentions packaging and sterilization, further indicating a hardware device.
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 soft tissue to bone fixation during surgical procedures. This is a mechanical function performed directly on the patient's body.
- Device Description: The device is described as a bone anchor with inserter handle. This is a surgical implant and the tools to place it.
- 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, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) 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 ligament reconstruction; lateral epicondylitis repair;
biceps tendon reattachment |
| Knee: | Extra-capsular repair: medial collateral ligament (MCL), lateral collateral ligament
(LCL) and posterior collateral 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
MBI
Device Description
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 Nchor 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® lid, and the finished product is sterilized by ethylene oxide. Both the anchor and inserter are designed for single use only.
The Q-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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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/0 description: The image shows the logo for ArthroCare. The logo consists of a stylized wave-like design on the left, followed by the word "ArthroCare" in a bold, italicized font. The wave-like design is made up of several curved lines that create a sense of motion. The overall design is simple and modern.
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: | August 9, 2013 |
Date Prepared:
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
Eleven Blade Q-FixTM Suture Anchor: K122336 (cleared January 9, 2013)
Description
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® lid, and the finished product is sterilized by ethylene oxide. Both the anchor and inserter are designed for single use only.
The Q-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
1
Image /page/1/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a stylized graphic to the left of the company name. The graphic is a circular design with several curved lines that resemble waves or arcs. The text "ArthroCare" is written in a bold, sans-serif font to the right of the graphic.
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 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 |
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.
As the intended use, operating principle, materials and technological characteristics are comparable to the predicate device, the Q-Fix Suture Anchor System is substantially equivalent. The minor differences between the Q-Fix and predicate device do not raise any new questions of safety or effectiveness.
2
Image /page/2/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a stylized, abstract symbol on the left and the word "ArthroCare" on the right. The symbol is made up of several curved lines that create a circular shape. The word "ArthroCare" is written in a bold, sans-serif font.
| Comparison of Technological Characteristics | ||
|---|---|---|
| Characteristics | Predicate Device | |
| Eleven Blade Q-Fix | ||
| (K122336) | Proposed Device | |
| ArthroCare Q-Fix | ||
| Intended Use | Fixation of soft tissue to bone | Same |
| Delivery Method | Arthroscopic and Limited Access | Same |
| How Supplied | Packaged in pouch, Sterile (EtO), Single | |
| Use | Packaged in thermoform tray with Tyvek | |
| lid, Sterile (EtO), Single Use | ||
| Suture Material | No. 2 UHMWPE Suture | Same |
| Anchor Material | Braided Polyester | Same |
| Inserter Handle Materials | Medical Grade Plastics and | |
| Surgical Grade Stainless Steels | Same | |
| Method of Anchor Insertion | Inserted into a predrilled hole | Same |
| Bone Locking Mechanism | Expandable Compression Fit | Same |
| Suture Locking Mechanism | Manually tied suture knot | Same |
| # of Suture Legs | Two (1.8mm) & Four (2.8mm) | Same |
| Sizes Offered | 1.8mm & 2.8mm | Same |
| Deployed Length | 15mm for 1.8mm anchor | |
| 20mm for 2.8mm anchor | Same | |
| Bone hole size | 2.1mm (0.083") for 1.8mm anchor | |
| 3.1mm (0.121") for 2.8mm anchor | 2.2mm (0.085") for 1.8mm anchor | |
| 3.1mm (0.123") for 2.8mm anchor | ||
| Accessory Instruments | Drill, Drill Guide, Obturator, | Same |
| Bone Punch, Knot Pusher, | ||
| FirstPass* Suture Punch |
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or other bird-like figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 19, 2013
ArthroCare Corporation Mr. Mitchell Dhority Vice President, Regulatory Affairs 7000 West William Cannon Drive Austin, Texas 78735
Re: K132513
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: August 22, 2013 Received: August 23, 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
4
Page 2 - Mr. Mitchell Dhority
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 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/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 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.
Laurence D. Coyne -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K132513
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 AND/OR (Part 21 CFR 801 Subpart D)
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)
| Casey L. Hanley, Ph.D. |
|---|
| Division of Orthopedic Devices |
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