(30 days)
No
The device description and performance studies focus on the mechanical properties and function of a physical suture anchor and its inserter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a bone anchor used for soft tissue to bone fixation in surgical procedures, not for therapy.
No
The device is a suture anchor used for fixing soft tissue to bone in orthopedic procedures, not for diagnosing medical conditions.
No
The device description clearly states it is a bone anchor with an inserter handle, which are physical hardware components. There is no mention of software as the primary or sole component.
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, designed for implantation into bone to secure soft tissue. This is a surgical implant and associated tool.
- 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) as a surgical implant.
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
MBI
Device Description
The purpose of this submission is to seek clearance for a line extension and additions to the accessory instrumentation used with the previously cleared Q-Fix Suture Anchor (K133727). 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 (Q-Fix) is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. This family of suture anchors previously was available in two sizes, 1.8mm and 2.8mm. This submission proposes an additional size of Q-Fix Suture Anchor, the 1.8mm Q-Fix MINI Suture Anchor.
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 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.
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/2 description: The image shows a logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare and medicine. The caduceus is depicted with three intertwined figures, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF" is partially visible on the left side of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 17, 2017
ArthroCare Corporation Ms. Laura Kasperowicz Principal RA Specialist 15285 Alton Parkway Suite 200 Irvine, California 92618
Re: K172165
Trade/Device Name: Q-Fix Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: July 17, 2017 Received: July 18, 2017
Dear Ms. Kasperowicz:
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 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.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Page 1 of 1
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
| ------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------ |
|---|
Indications for Use
| 510(k) Number (if known) | K172165 |
|---|---|
| Device Name | Q-Fix Suture Anchor |
| Indications for Use (Describe) | 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
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
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and review the collection of information. Send comments regarding this burden estimate or any other aspect
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a circular design on the left and the word "ArthroCare" on the right. The circular design is made up of several curved lines in a maroon color. The word "ArthroCare" is written in a dark gray color.
510(k) Summary
ArthroCare® Corporation
Q-Fix® Suture Anchor
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, a Smith & Nephew Company |
|---|---|
| Address | 15285 Alton Parkway, Suite 200 |
| Irvine, CA. 92618 | |
| Contact Person: | Laura Kasperowicz |
| Principle Regulatory Affairs Specialist | |
| Phone: 949-585-2406 | |
| Fax: 949-585-2401 | |
| Date Prepared: | July 17, 2017 |
Device Name
| Proprietary Name: | Q-Fix® Suture Anchor |
|---|---|
| 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: K133727 (cleared January 16, 2014)
Description
The purpose of this submission is to seek clearance for a line extension and additions to the accessory instrumentation used with the previously cleared Q-Fix Suture Anchor (K133727). 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 (Q-Fix) is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. This family of suture anchors previously was available in two sizes, 1.8mm and 2.8mm. This submission proposes an additional size of Q-Fix Suture Anchor, the 1.8mm Q-Fix MINI Suture Anchor.
4
Image /page/4/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a stylized, circular graphic on the left and the word "ArthroCare" on the right. The graphic is made up of several curved lines in a maroon color, arranged to create a sense of movement or flow. The text "ArthroCare" is written in a dark gray, sans-serif font, with a small registered trademark symbol next to the word "Care".
The O-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 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 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.
5
Image /page/5/Picture/0 description: The image shows the ArthroCare logo. The logo consists of a circular design on the left, made up of several curved red lines. To the right of the design is the company name, "ArthroCare," in a dark gray sans-serif font. A registered trademark symbol is located to the upper right of the word "Care."
Summary
All testing demonstrates that the Q-Fix performs as intended and has acceptable mechanical properties when used in accordance with its labeling.
The minor differences between the Q-Fix system and predicate device system do not raise any new questions of safety or effectiveness.
| Comparison of Technological Characteristics | ||||
|---|---|---|---|---|
| Characteristics | Predicate Devices & System | |||
| 1.8mm Q-Fix & 2.8mm Q-Fix | ||||
| (K133727) | Proposed Devices & System | |||
| 1.8mm Q-Fix, 2.8mm Q-Fix & 1.8mm Q-Fix | ||||
| MINI | ||||
| Intended Use | Fixation of soft tissue to bone | Same | ||
| Delivery Method | Arthroscopic and Limited Access | Same | ||
| How Supplied | Packaged in thermoform tray with Tyvek lid, | |||
| Sterile (EtO), Single Use | Same | |||
| 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 | 1.8mm, 2.8mm & 1.8mm MINI | ||
| Deployed Length | 15mm for 1.8mm Q-Fix Anchor | |||
| 20mm for 2.8mm Q-Fix Anchor | 15mm for 1.8mm Q-Fix Anchor | |||
| 20mm for 2.8mm Q-Fix Anchor | ||||
| 10mm for 1.8mm Q-Fix MINI Anchor | ||||
| Bone hole OD | 2.1mm (0.083") for 1.8mm Q-Fix Anchor | |||
| 3.1mm (0.121") for 2.8mm Q-Fix Anchor | Same | |||
| Bone hole depth | 22.3mm for 1.8mm Q-Fix Anchor | |||
| 26.8mm for 2.8mm Q-Fix Anchor | 22.3mm for 1.8mm Q-Fix Anchor | |||
| 26.8mm for 2.8mm Q-Fix Anchor | ||||
| 17.1mm for 1.8mm Q-Fix MINI Anchor | ||||
| Accessory Instruments | Nonsterile, Reusable Drill, Drill Guide, | |||
| Obturator and Sterile, Disposable Drill, Drill | ||||
| Guide, Obturator | Same | |||
| Bone Punch, Knot Pusher | Same | |||
| 1.8mm & 2.8mm PathFinder® | Same | |||
| FirstPass® Suture Passer | FirstPass® Suture Passer | |||
| FirstPass® ST Suture Passer | ||||
| Accu-Pass® Direct Suture Passer | ||||
| SpeedStitch® Suture Passer |