(110 days)
Not Found
No
The device description focuses on a mechanical suture anchor and inserter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to reattach soft tissue to bone, stabilize damaged soft tissue, and aid in healing, directly aligning with the definition of a therapeutic device.
No
This device is an all-suture anchor system used to reattach soft tissue to bone in orthopedic surgical procedures; it is a surgical implant, not a diagnostic tool.
No
The device description clearly outlines physical components made of materials like UHMWPE, stainless steel, and ABS plastic, and describes a manual surgical tool. There is no mention of software as a component or function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "reattach soft tissue to bone in orthopedic surgical procedures." This is a surgical device used in vivo (within the body) to physically repair tissue.
- Device Description: The description details a physical anchor and suture system designed for surgical implantation.
- 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 body) to analyze biological samples. This device is clearly designed for surgical intervention in vivo.
N/A
Intended Use / Indications for Use
The Cayenne Medical, Inc. Short SureLock™ All- Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system may be used in either arthroscopic or open surgical procedures. After the anchor is deployed in the bone, the floating sutures can be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
The Cayenne Medical, Inc. Short SureLock™ All-Suture Anchors are intended to be used for the reattachment of soft tissue to bone for the following indications:
Foot and Ankle
- Hallux valgus reconstruction
- Midfoot reconstruction
Hand and Wrist
- Ulnar or lateral collateral ligament reconstruction
- Repair/reconstruction of collateral ligaments
- Flexor and extensor tendon at the PIP, DIP, and MCP joints for all digits
- Scapholunate ligament reconstruction
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Short SureLock™ All-Suture Anchor is a sterile (using ethylene oxide sterilization method), manually operated, single procedure all suture anchor device for reattachment of soft tissue to bone. The all-suture anchor is preloaded with floating suture with needles and loaded on a disposable inserter. Short SureLock™ All-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 Short SureLock™ All-Suture Anchor is offered in two configurations, 1.4mm anchor with one size 0 Ultra High Molecular Weight Polyethylene (UHMWPE) suture strand with attached needles and 1.4mm anchor with one size 2-0 UHMWPE suture strand with attached needles. The anchors and floating sutures are made out of non-absorbable Ultra High Molecular Weight Polyethylene (UHMWPE) surgical sutures. The needles attached to the floating suture are made out of medical grade stainless steel.
The anchor is formed by passing one end of a length of suture perpendicularly back through itself in alternating directions a number of times. This results in a construct resembling a ladder. The four suture tails are cut and trimmed. A floating suture is passed through the loops in the anchor to form the anchor construct.
The disposable inserter has a working shaft length of 4.14 cm with an outer shaft diameter of 4.0 mm. The inserter shaft is made out of surgical grade stainless steel and the handle and knob are made out of ABS plastic. The inserter pushes the suture anchor construct into a hole drilled in the bone. The knob on the inserter handle is rotated to apply tension to the floating suture limbs to expand and deploy the anchor in the bone tunnel. The floating suture limbs with needles are then released from the inserter and the inserter is removed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Foot and Ankle, Hand and Wrist
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Orthopedic surgical procedures (arthroscopic or open surgical procedures)
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)
Non-clinical testing (pull-out strength) was performed. Testing showed that the Short SureLock™ Anchor ultimate pull-out strength was comparable to that of the predicate device. Cayenne Medical tested both predicate and subject devices for the range of the subject device indications using two bone block densities.
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 Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 25, 2015
Cayenne Medical, Incorporated Ms. Shima Hashemian Senior Manager of Regulatory Affairs and Quality Assurance 16597 North 92nd Street Scottsdale, Arizona 85260
Re: K143473
Trade/Device Name: Short SureLock™ All-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: February 16, 2015 Received: February 19, 2015
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: Short SureLock™ All- Suture Anchor
Indications for Use:
The Cayenne Medical, Inc. Short SureLock™ All- Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system may be used in either arthroscopic or open surgical procedures. After the anchor is deployed in the bone, the floating sutures can be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
The Cayenne Medical, Inc. Short SureLock™ All-Suture Anchors are intended to be used for the reattachment of soft tissue to bone for the following indications:
Foot and Ankle
- । Hallux valgus reconstruction
- । Midfoot reconstruction
Hand and Wrist
- -Ulnar or lateral collateral ligament reconstruction
- Repair/reconstruction of collateral ligaments
- Flexor and extensor tendon at the PIP, DIP, and MCP joints for all digits —
- -Scapholunate ligament reconstruction
Prescription Use X 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)
3
510(k) Summary
510(k) Summary
Cayenne Medical, Inc. SureLock™ All- Suture Anchor
ADMINISTRATIVE INFORMATION
| Date of summary: | 12/04/2014 |
|---|---|
| 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: | Short SureLock™ All- Suture Anchor |
| Common Name: | Suture Anchor |
| DEVICE CLASSIFICATION |
FDA has classified bone screws as Class II devices (21 CFR 888.3040). The product code for Fastener, Fixation, Nondegradable, and Soft Tissue is MBI. These devices are reviewed by the Orthopedic Joint Devices Branch.
INTENDED USE
The Cayenne Medical, Inc. Short SureLock™ All- Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system may be used in either arthroscopic or open surgical procedures. After the anchor is deployed in the bone, the floating suture with needles can be used to reattach soft tissue, such as ligaments,
Page 18 of 209
4
510(k) Summary
tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
The Cayenne Medical, Inc. Short SureLock™ All-Suture Anchors are intended to be used for the reattachment of soft tissue to bone for the following indications:
Foot and Ankle
- । Hallux valgus reconstruction
- । Midfoot reconstruction
Hand and Wrist
- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Ulnar or lateral collateral ligament reconstruction
- -Repair/reconstruction of collateral ligaments
- l Flexor and extensor tendon at the PIP, DIP, and MCP joints for all digits
- --Scapholunate ligament reconstruction
DEVICE DESCRIPTION
The Short SureLock™ All-Suture Anchor is a sterile (using ethylene oxide sterilization method), manually operated, single procedure all suture anchor device for reattachment of soft tissue to bone. The all-suture anchor is preloaded with floating suture with needles and loaded on a disposable inserter. Short SureLock™ All-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 Short SureLock™ All-Suture Anchor is offered in two configurations, 1.4mm anchor with one size 0 Ultra High Molecular Weight Polyethylene (UHMWPE) suture strand with attached needles and 1.4mm anchor with one size 2-0 UHMWPE suture strand with attached needles. The anchors and floating sutures are made out of non-absorbable Ultra High Molecular Weight Polyethylene (UHMWPE) surgical sutures. The needles attached to the floating suture are made out of medical grade stainless steel.
The anchor is formed by passing one end of a length of suture perpendicularly back through itself in alternating directions a number of times. This results in a construct resembling a ladder. The four suture tails are cut and trimmed. A floating suture is passed through the loops in the anchor to form the anchor construct.
5
The following table summarizes the two configurations of the All-suture Anchor device.
| Catalog
number | All-Suture
anchor size | Anchor-
suture size
and color | Floating
suture size | Number of
floating
sutures | Floating suture
type and color |
|-------------------|---------------------------|-------------------------------------|-------------------------|----------------------------------|-----------------------------------|
| CM-961400 | 1.4 mm | USP size 2 -
White | USP size 0 | 1 | Co-braid
green/white |
| CM-961420 | 1.4 mm | USP size 2-
White | USP size 2-0 | 1 | Co-braid
blue/white |
The disposable inserter has a working shaft length of 4.14 cm with an outer shaft diameter of 4.0 mm. The inserter shaft is made out of surgical grade stainless steel and the handle and knob are made out of ABS plastic. The inserter pushes the suture anchor construct into a hole drilled in the bone. The knob on the inserter handle is rotated to apply tension to the floating suture limbs to expand and deploy the anchor in the bone tunnel. The floating suture limbs with needles are then released from the inserter and the inserter is removed.
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 Short SureLock™ Anchor and the predicate device. Testing showed that the Short SureLock™ 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 Short SureLock™ 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: Depuy Mitek MINILOK® QuickAnchor® Plus device (K071257) and Riverpoint Medical HS Fiber Polyblend nonabsorbable surgical suture (K100006). The substantial equivalence of Short SureLock™ Anchor is based on similarities in indications for use, intended use, design features, technology, a com and the predicate device.
6
510(k) Premarket Notification
The subject Short SureLock™ device has the same intended use as the predicate device, the Depuy Mitek MINILOK® QuickAnchor® Plus. The subject device has a broader indication for use. The subject device is indicated for repair/reconstruction of collateral ligaments and Flexor and extensor tendon at the PIP, DIP, and MCP joints for all digits in addition to the predicate device indications for use. Cayenne Medical tested both predicate and subject devices for the range of the subject device indications using two bone block densities. The two added indications for use do not raise different questions of safety and effectiveness.
This subject device differs from the predicate device, Depuy Mitek MINILOK® QuickAnchor® Plus, in terms of the material of the anchor, the inserter role during deployment, and the offered sizes.