(100 days)
No
The device description and intended use are for a mechanical suture anchor and its associated inserter, with no mention of software, algorithms, or data processing that would indicate AI/ML. The focus is on expanding the indications for use of an existing, purely mechanical device.
Yes.
The device is a suture anchor intended for the reattachment of soft tissue to bone across various body parts, which is a therapeutic intervention to repair damaged tissues.
No
Explanation: The device is a suture anchor intended for the reattachment of soft tissue to bone. Its function is to secure tissue, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly describes a physical suture anchor and inserter, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "reattachment of soft tissue to bone" for various anatomical sites. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a "suture anchor" and its components, which are physical implants used in surgery.
- 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 for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used to repair tissue within the body.
N/A
Intended Use / Indications for Use
The Cayenne Medical, Inc. Quattro® GL Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:
Hip
- Hip capsule repair
- Acetabular labrum reattachment
Shoulder
- Capsular stabilization
- Bankart repair
- Anterior shoulder instability
- SLAP lesion repairs
- Capsular shift or capsulolabral reconstructions
- Acromioclavicular separation repairs
- Deltoid repairs
- Rotator cuff repairs
- Biceps tenodesis
Elbow, Wrist, and Hand
- Biceps tendon reattachment
- Ulnar or radial collateral ligament reconstruction
- Lateral epicondylitis repair
Knee
- Extra-capsular repairs
- Medial collateral ligament
- Lateral collateral ligament
- Posterior oblique ligament
- Patellar realignment and tendon repairs
- Vastus medials obliquous advancement
- Illiotibial band tenodesis
Foot and Ankle
- Hallux valgus repairs
- Medial or Lateral instability repairs/reconstructions
- Achilles tendon repairs/reconstructions
- Midfoot reconstructions
- Metatarsal ligament/tendon repairs/reconstructions
- Bunionectomy
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
This traditional 501(k) premarket notification is to expand the indications for use for Cayenne Medical Quattro GL Suture Anchor. The Quattro GL (LabraLink) Suture Anchor was cleared per premarket notification K112960. Cayenne seeks to expand the existing indications for use for the subject device to include the indications listed above.
The Quattro® GL Suture Anchor is a sterile, manually operated, single procedure suture anchor. The anchor has two suture eyelets allowing for one or two sutures to be loaded through the eyelets. The suture anchor is mounted on an inserter. The Quattro GL Suture Anchor incorporates design features that facilitate suture anchor placement under arthroscopic, open, or limited access conditions in soft tissue to bone reattachment procedures. The Quattro GL Suture Anchor is only offered in one size, 2.9mm with four suture color options. The anchors are offered in two configurations, single loaded or double loaded sutures. Suture(s) used on the anchor are size # 2 non-absorbable surgical sutures. The Quattro GL inserter has a working length of 25.8 cm with an outer shaft diameter of 3.2 mm. Since the market clearance of this device, the length of the Suture Anchor was decreased from 15mm to 11.4mm. The technological characteristics of the Quattro GL Suture Anchor have not changed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, Shoulder, Elbow, Wrist, Hand, Knee, Foot and Ankle
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)
Mechanical testing (pull-out strength) was performed on the Quattro GL Suture Anchor and the predicate device. Testing showed that the Quattro GL Suture Anchor ultimate pull-out strength was comparable to that of the predicate device.
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.
K040472, K070673, K100506, K092533
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
K131325 (1/3)
Quattro® GL Suture Anchor
510(k) Summary
Cayenne Medical, Inc.
Quattro® GL Suture Anchor
ADMINISTRATIVE INFORMATION
510(k) number:
| Date of summary: | 04-22-2013 |
|---|---|
| Manufacturer Name: | Cayenne Medical, Inc. |
| 16597 N. 92nd St., Suite 101 | |
| Scottsdale, AZ 85260 | |
| Telephone (480) 502-3661 | |
| FAX (480) 502-3670 | |
| Official Contact: | Kereshmeh Shahriari |
| 16597 N. 92nd St., Suite 101 | |
| Scottsdale, AZ 85260 | |
| kshahriari@cayennemedical.com | |
| Telephone (480) 502-3661 | |
| FAX (480) 502-3670 |
DEVICE NAME
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
|---|---|
| Trade/Proprietary Name: | Quattro ® GL Suture Anchor |
AUG 1 6 2013Common Name:
Suture Anchor
DEVICE CLASSIFICATION
FDA has classified bone screws as Class II devices (21 CFR 888.3040). The product code for this suture anchor is MBI -- Fastener, Fixation, Nondegradable, Soft Tissue. These devices are reviewed by the Orthopedic Joint Devices Branch.
INTENDED USE
The Cayenne Medical, Inc. Quattro® GL Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:
1
Hip
- । Hip capsule repair
- o Acetabular labrum reattachment
Shoulder
- Capsular stabilization
- o Bankart repair
- Anterior shoulder instability o
- o SLAP lesion repairs
- Capsular shift or capsulolabral reconstructions o
- Acromioclavicular separation repairs l
- Deltoid repairs -
- Rotator cuff repairs l
- -Biceps tenodesis
Elbow, Wrist, and Hand
- Biceps tendon reattachment —
- l Ulnar or radial collateral ligament reconstruction
- -Lateral epicondylitis repair
Knee
- -Extra-capsular repairs
- o Medial collateral ligament
- o Lateral collateral ligament
- o Posterior oblique ligament
- Patellar realignment and tendon repairs |
- o Vastus medials obliquous advancement
- Illiotibial band tenodesis
Foot and Ankle
- l Hallux valgus repairs
- -Medial or Lateral instability repairs/reconstructions
- Achilles tendon repairs/reconstructions l
- -Midfoot reconstructions
- । Metatarsal ligament/tendon repairs/reconstructions
- । Bunionectomy
DEVICE DESCRIPTION
This traditional 501(k) premarket notification is to expand the indications for use for Cayenne Medical Quattro GL Suture Anchor. The Quattro GL (LabraLink) Suture Anchor was cleared per premarket notification K112960. Cayenne seeks to expand the existing indications for use for the subject device to include the indications listed above.
2
The Quattro® GL Suture Anchor is a sterile, manually operated, single procedure suture anchor. The anchor has two suture eyelets allowing for one or two sutures to be loaded through the eyelets. The suture anchor is mounted on an inserter. The Quattro GL Suture Anchor incorporates design features that facilitate suture anchor placement under arthroscopic, open, or limited access conditions in soft tissue to bone reattachment procedures. The Quattro GL Suture Anchor is only offered in one size, 2.9mm with four suture color options. The anchors are offered in two configurations, single loaded or double loaded sutures. Suture(s) used on the anchor are size # 2 non-absorbable surgical sutures. The Quattro GL inserter has a working length of 25.8 cm with an outer shaft diameter of 3.2 mm. Since the market clearance of this device, the length of the Suture Anchor was decreased from 15mm to 11.4mm. The technological characteristics of the Quattro GL Suture Anchor have not changed.
NON-CLINICAL TESTING
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence is included. Mechanical testing (pull-out strength) was performed on the Quattro GL Suture Anchor and the predicate device. Testing showed that the Quattro GL Suture Anchor ultimate pull-out strength was comparable to that of the predicate device.
EQUIVALENCE TO MARKETED PRODUCT
Cayenne Medical, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the Quattro® GL Suture Anchor is substantially equivalent in indication and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices: Smith & Nephew BIORAPTOR 2.3 PK Suture Anchor (K071586), Quattro® GL (LabraLink) Suture Anchor (K112960), Force Fiber Blue Co-Braid Polyethylene non-absorbable surgical suture (K040472), Force Fiber Black Co-Braid Polyethylene non-absorbable surgical suture (K070673), Force Fiber Green Co-Braid Polyethylene non-absorbable surgical suture (K100506), and Force Fiber Blue Polyethylene non-absorbable surgical suture (K092533). The substantial equivalence of Quattro GL Suture Anchor is based on similarities in indications for use. design features, technology, and materials to the predicate device, Bioraptor 2.3 PK Suture Anchor.
The subject device, Quattro GL Suture Anchor with Inserter, has the same intended use, design, technology, materials, manufacturing processes, packaging, sterilization method, and shelf life as the Cayenne Medical Quattro GL (LabraLink) Suture Anchor with Inserter (K112960) and the expansion of indications for use does not introduce new issues of safety and effectiveness.
3
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 16, 2013
Mr. Kereshmeh Shahriari Senior Director of Regulatory Affairs, Quality Assurance & Compliance Cayenne Medical, Incorporated 16597 North 92nd Street, Suite 101 Scottsdale, Arizona 85260
Re: K131325
Trade/Device Name: Quattro® GL 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: May 17, 2013 Received: May 20, 2013
Dear Mr. Shahriari:
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. Kereshmeh Shahriari
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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" (2)CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (2.1 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.
Sincercly yours,
Erin I. Keith
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Quattro® GL Suture Anchor
Indications for Use
510(k) Number (if known): K131325
Device Name: Quattro® GL Suture Anchor
Indications for Use:
The Cayenne Medical, Inc. Quattro® GL Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:
Hip
- -Hip capsule repair
- o Acetabular labrum reattachment
Shoulder
- Capsular stabilization
- o Bankart repair
- o Anterior shoulder instability
- o SLAP lesion repairs
- 0 Capsular shift or capsulolabral reconstructions
- Acromioclavicular separation repairs -
- Deltoid repairs l
- Rotator cuff repairs ー
- । Biceps tenodesis
Elbow, Wrist, and Hand
- ー Biceps tendon reattachment
- । Ulnar or radial collateral ligament reconstruction
- Lateral epicondylitis repair t
Knee
- ー Extra-capsular repairs
- o Medial collateral ligament
- o Lateral collateral ligament
- o Posterior oblique ligament
- । Patellar realignment and tendon repairs
- o Vastus medials obliquous advancement
- Illiotibial band tenodesis
6
510(k) Premarket Notification
Quattro® GL Suture Anchor
Foot and Ankle
- Hallux valgus repairs
- । Medial or Lateral instability repairs/reconstructions
- Achilles tendon repairs/reconstructions l
- r Midfoot reconstructions
- ເ Metatarsal ligament/tendon repairs/reconstructions
- Bunionectomy ।
Prescription Use _____________________________________________________________________________________________________________________________________________________________ x (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEFLOED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
············································································································································································· ・・・・・ Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
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