(58 days)
Not Found
No
The device description and intended use focus on a mechanical screw for soft tissue reattachment. There is no mention of AI, ML, image processing, or any computational analysis of data. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes
The device is intended to be used for the reattachment of soft tissue to bone for various indications across multiple anatomical sites, which is a therapeutic function.
No
The device is a surgical implant (tenodesis screw) used for reattachment of soft tissue to bone, not for diagnosing medical conditions.
No
The device description clearly states it is a physical screw made of PEEK and a disposable driver made of stainless steel and ABS plastic, intended for surgical procedures. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Quattro® Bolt Tenodesis Screws are intended for the reattachment of soft tissue to bone during surgical procedures. This is a direct surgical intervention on the body, not an examination of a specimen outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic testing, or providing information for diagnosis based on laboratory results.
This device is a surgical implant used for mechanical fixation of tissue to bone.
N/A
Intended Use / Indications for Use
The Cayenne Medical, Inc. Quattro® Bolt Tenodesis Screws are intended to be used for the reattachment of soft tissue to bone for the following indications:
Shoulder
- 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
- 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
The Quattro® Bolt Tenodesis Screw is a sterile (using gamma radiation method), manually operated, single procedure device for reattachment of soft tissue to bone. The Quattro® Bolt screw is preloaded on a disposable driver. Quattro® Bolt device incorporates design features that facilitate screw placement under arthroscopic, open, or limited access conditions in soft tissue to bone reattachment procedures.
The Quattro® Bolt tenodesis screw is offered in 5 different sizes, 5mm×10mm, 6mm×12mm×14mm, 8mm×16mm, 9mm×16mm. The screws are made out of PolyEtherEtherKetone (PEEK).
The disposable driver has a working shaft length of 14cm with an outer shaft diameter of 3.0 mm. The driver shaft is made out of surgical grade stainless steel and the handle is made out of ABS plastic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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® Bolt tenodesis screw and the predicate device. Testing showed that the Quattro® Bolt tenodesis screw 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.
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 features a stylized depiction of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 23, 2015
Cayenne Medical, Incorporated Ms. Shima Hashemian Senior Quality Assurance/Regulatory Affairs Manager 16597 North, 92nd Street Scottsdale, Arizona 85260
Re: K143392
Trade/Device Name: Quattro® Bolt Tenodesis Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: November 25, 2014 Received: November 26, 2014
Dear Ms. Hashemian:
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
1
Page 2 - Ms. Shima Hashemian
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/Resourcesfor You/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 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 vours.
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Device Name: Quattro® Bolt Tenodesis Screw
Indications for Use:
The Cayenne Medical, Inc. Quattro® Bolt Tenodesis Screws are intended to be used for the reattachment of soft tissue to bone for the following indications:
Shoulder
- 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 O
- o Lateral collateral ligament
- о Posterior oblique ligament
- -Patellar realignment and tendon repairs
- 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
3
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
4
510(k) Summary
Cayenne Medical, Inc.
Quattro® Bolt Tenodesis Screw
ADMINISTRATIVE INFORMATION
| Date of summary: | 11/25/2014 |
|---|---|
| Manufacturer Name: | Cayenne Medical, Inc. |
| 16597 N. 92nd St., Suite 101 | |
| Scottsdale, AZ 85260 | |
| Telephone (480) 502-3661 | |
| FAX (480) 502-3670 | |
| Official Contact: | Shima Hashemian |
| 16597 N. 92nd St., Suite 101 | |
| Scottsdale, AZ 85260 | |
| shashemian@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® Bolt Tenodesis Screw |
| Common Name: | Screw |
DEVICE CLASSIFICATION
FDA has classified bone fixation fasteners as Class II devices (21 CFR 888.3040). The product code for fastener, fixation, nondegradable, soft tissue is MBI. These devices are reviewed by the Orthopedic Joint Devices Branch. These devices are reviewed by the Orthopedic Joint Devices Branch.
5
INTENDED USE
The Cayenne Medical, Inc. Quattro® Bolt Tenodesis Screws are intended to be used for the reattachment of soft tissue to bone for the following indications:
Shoulder
- | 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
- o Medial collateral ligament
- o Lateral collateral ligament
- o Posterior oblique ligament
- Patellar realignment and tendon repairs -
- -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
6
DEVICE DESCRIPTION
The Quattro® Bolt Tenodesis Screw is a sterile (using gamma radiation method), manually operated, single procedure device for reattachment of soft tissue to bone. The Quattro® Bolt screw is preloaded on a disposable driver. Quattro® Bolt device incorporates design features that facilitate screw placement under arthroscopic, open, or limited access conditions in soft tissue to bone reattachment procedures.
The Quattro® Bolt tenodesis screw is offered in 5 different sizes, 5mm×10mm, 6mm×12mm×14mm, 8mm×16mm, 9mm×16mm. The screws are made out of PolyEtherEtherKetone (PEEK).
The disposable driver has a working shaft length of 14cm with an outer shaft diameter of 3.0 mm. The driver shaft is made out of surgical grade stainless steel and the handle is made out of ABS plastic.
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® Bolt tenodesis screw and the predicate device. Testing showed that the Quattro® Bolt tenodesis screw 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® Bolt tenodesis screw is substantially equivalent in indication and design principles to predicate device, which has been determined by FDA to be substantially equivalent to preamendment devices: Quattro® Link Knotless Anchor with Inserter (K122314). The substantial equivalence of Quattro® Bolt tenodesis screw is based on similarities in indications for use, intended use, design features, technology, and materials to the predicate device.
The subject Quattro® Bolt device has the same intended use as the predicate device, the Quattro® Link.
This subject device differs from the predicate device, Quattro® Link Knotless Anchor with Inserter, in terms of the implant design and the offered sizes.