(108 days)
No
The device description and intended use focus on the mechanical aspects of a suture anchor and its surgical application. There is no mention of software, algorithms, data processing, or any terms related to AI or ML. The performance studies are based on mechanical testing.
Yes.
The device is intended to reattach soft tissue to bone and stabilize it during the healing period, which directly addresses a medical condition (damaged soft tissue) and promotes healing/recovery.
No
The device is a surgical anchor intended to reattach soft tissue to bone, making it a therapeutic device, not a diagnostic one.
No
The device description clearly describes a physical, manually operated surgical anchor made of sutures and an inserter made of stainless steel and plastic. There is no mention of software as a component of the device.
Based on the provided information, 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 directly on the patient's body during a procedure.
- Device Description: The device is a "manually operated, single procedure all suture anchor device for reattachment of soft tissue to bone." It's a physical implant and delivery system.
- Lack of Diagnostic Function: The description does not mention any function related to testing samples from the human body (like blood, urine, tissue, etc.) to provide diagnostic information. IVDs are used to diagnose diseases or conditions.
This device falls under the category of a surgical implant or device used for tissue repair, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Cayenne Medical, Inc. 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. SureLock™ All-Suture Anchors are intended to be used for the reattachment of soft tissue to bone for the following indications:
Shoulder
- | Capsular stabilization
- o Bankart repair
- Anterior shoulder instability o
- o SLAP lesion repairs
- o Capsular shift or capsulolabral reconstructions
- -Acromioclavicular separation repairs
- Deltoid repairs l
- -Rotator cuff repairs
- | Biceps tenodesis
Foot and Ankle
- -Hallux valgus repairs
- Medial or lateral instability repairs/reconstructions --
- Achilles tendon repairs/reconstructions -
- Mid and forefoot reconstructions -
- Metatarsal ligament/tendon repairs/reconstructions -
- Bunionectomy —
Elbow
- -Ulnar or radial collateral ligament reconstruction
- -Lateral epicondylitis repair
- --Biceps tendon repair
Hand and Wrist
- Collateral ligament repair —
- Scapholunate ligament reconstruction -
- Volar plate reconstruction -
- -Tendon transfers in phalanx
Hip
- -Acetabular labral repair
Knee
- -Extra-capsular repairs
- Medial collateral ligament o
- o Lateral collateral ligament
- o Posterior oblique ligament
- Patellar realignment and tendon repairs l
- Illiotibial band tenodesis ।
- VMO advancement
- -Joint capsule closure
Product codes
MBI
Device Description
The 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 and loaded on a disposable inserter. 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 SureLock™ All-Suture Anchor is offered in two different sizes, 1.4mm and 2.2mm. The anchors and floating sutures are made out of non-absorbable Ultra High Molecular Weight Polyethylene (UHMWPE) surgical sutures.
The 1.4mm 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 2.2mm anchor is formed by passing the end of a first length of suture through the core of a second length. Then, one end of the second length is passed through the core of the first length, creating a loop with four suture tails. The loop is twisted alternately a number of times with the floating sutures weaved through each twist to form the anchor construct.
The 1.4mm anchor is pre-loaded with one floating suture and the 2.2mm size is preloaded with two floating sutures.
The disposable inserter has a working shaft length of 22,2 cm with an outer shaft diameter of 2.0 mm for the 1.4mm SureLock anchor and 2.4mm for the 2.2mm SureLock anchor. 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 on the floating suture(s) to expand and deploy the anchor in the bone tunnel. The floating suture limbs 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
Shoulder, Foot and Ankle, Elbow, Hand and Wrist, Hip, Knee
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)
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence is included. Mechanical testing (pull-out strength) was performed on the SureLock™ All-Suture Anchor and the predicate device. Testing showed that the SureLock™ All-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)
ConMed Linvatec Y-Knot™ All-Suture Anchor (K111779)
Reference Device(s)
Riverpoint Medical HS Fiber Polyblend nonabsorbable surgical suture (K100006), Teleflex Medical ForceFiber® sutures (K040472, K070673, K092533, and K100506)
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
510(k) Summary
DEC 30 2013
Cayenne Medical, Inc.
SureLock™ All- Suture Anchor
ADMINISTRATIVE INFORMATION
| Date of summary: | 10/07/2013 |
|---|---|
| Manufacturer Name: | Cayenne Medical, Inc. |
| 16597 N. 92 nd St., Suite 101 | |
| Scottsdale, AZ 85260 | |
| Telephone (480) 502-3661 | |
| FAX (480) 502-3670 | |
| Official Contact: | Shima Hashemian |
| 16597 N. 92 nd 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: | 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. 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
1
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. SureLock™ All-Suture Anchors are intended to be used for the reattachment of soft tissue to bone for the following indications:
Shoulder
- | Capsular stabilization
- o Bankart repair
- Anterior shoulder instability o
- o SLAP lesion repairs
- o Capsular shift or capsulolabral reconstructions
- -Acromioclavicular separation repairs
- Deltoid repairs l
- -Rotator cuff repairs
- | Biceps tenodesis
Foot and Ankle
- -Hallux valgus repairs
- Medial or lateral instability repairs/reconstructions --
- Achilles tendon repairs/reconstructions -
- Mid and forefoot reconstructions -
- Metatarsal ligament/tendon repairs/reconstructions -
- Bunionectomy —
Elbow
- -Ulnar or radial collateral ligament reconstruction
- -Lateral epicondylitis repair
- --Biceps tendon repair
Hand and Wrist
- Collateral ligament repair —
- Scapholunate ligament reconstruction -
- Volar plate reconstruction -
- -Tendon transfers in phalanx
Hip
- -Acetabular labral repair
Knee
- -Extra-capsular repairs
- Medial collateral ligament o
- o Lateral collateral ligament
2
- o Posterior oblique ligament
- Patellar realignment and tendon repairs l
- Illiotibial band tenodesis ।
- VMO advancement
- -Joint capsule closure
DEVICE DESCRIPTION
The 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 and loaded on a disposable inserter. 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 SureLock™ All-Suture Anchor is offered in two different sizes, 1.4mm and 2.2mm. The anchors and floating sutures are made out of non-absorbable Ultra High Molecular Weight Polyethylene (UHMWPE) surgical sutures.
The 1.4mm 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 2.2mm anchor is formed by passing the end of a first length of suture through the core of a second length. Then, one end of the second length is passed through the core of the first length, creating a loop with four suture tails. The loop is twisted alternately a number of times with the floating sutures weaved through each twist to form the anchor construct.
The 1.4mm anchor is pre-loaded with one floating suture and the 2.2mm size is preloaded with two floating sutures.
The following table summarizes the two configurations of the All-suture Anchor device.
3
| Catalog
number | All-Suture
anchor size | Anchor-
suture size
and color | Floating
suture size | Number of
floating
sutures | Floating suture
type and color |
|-------------------|---------------------------|-------------------------------------|-------------------------|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| CM-9614 | 1.4 mm | USP size 2 -
White | USP size 2 | 1 | Co-braid
Black/white, or
co-braid
blue/white, or co-
braid
green/white, or
solid blue |
| CM-9622 | 2.2 mm | USP size 2 -
White | USP size 2 | 2 | a combination of
any two colors;
co-braid
Black/white, or
co-braid
blue/white, or co-
braid
green/white, or
solid blue |
The disposable inserter has a working shaft length of 22,2 cm with an outer shaft diameter of 2.0 mm for the 1.4mm SureLock anchor and 2.4mm for the 2.2mm SureLock anchor. 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 on the floating suture(s) to expand and deploy the anchor in the bone tunnel. The floating suture limbs 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 SureLock™ All-Suture Anchor and the predicate device. Testing showed that the SureLock™ All-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 SureLock™ All-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: ConMed Linvatec Y-Knot™ All-Suture Anchor (K111779), Riverpoint Medical HS Fiber Polyblend nonabsorbable surgical suture (K100006), and Teleflex Medical ForceFiber® sutures
4
(K040472, K070673, K092533, and K100506). The substantial equivalence of SureLock™ All-Suture Anchor is based on similarities in indications for use, intended use. design features, technology, and materials to the predicate device.
The subject SureLock device has the same intended use as the predicate device, the ConMed Linvatec Y-Knot™. The predicate device has a broad indication for use stated as "to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone." The subject device is indicated for a subset of the predicate device's indications for use. The subject device has a narrower indication for use than the predicate device. Cayenne Medical tested both predicate and subject devices for the range of the subject device indications using three bone block densities.
This subject device differs from the predicate device, Conmed Linvatec Y-Knot™, in terms of the All-Suture anchor construction, the inserter role during deployment, and the offered sizes.
5
Image /page/5/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is arranged on a single line and appears to be a header or title. The font is sans-serif and the color is black against a white background.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 30, 2013
Cavenne Medical, Incorporated Ms. Shima Hashemian Quality Engineering Manager 16597 North 92nd Street, Suite 101 Scottsdale, Arizona 85260
Re: K132867
Trade/Device Name: 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: October 2, 2013 Received: October 3, 2013
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 (2 l 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
6
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/Resourcesfor You/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 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/Resourcesfor You/Industry/default.htm.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
Device Name: Surchock™ All- Suture Anchor
Indications for Use:
The Cayenne Medical, Inc. 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. Surchock™ All-Suture Anchors are intended to be used for the reattachment of soft tissue to bone for the following indications:
Shoulder
- । Capsular stabilization
- o Bankart repair
- o Anterior shoulder instability
- O SLAP lesion repairs
- Capsular shift or capsulolabral reconstructions
- Acromioclavicular separation repairs ।
- । Deltoid repairs
- Rotator cuff repairs l
- । Biceps tenodesis
Foot and Ankle
- । Hallux valgus repairs
- Medial or lateral instability repairs/reconstructions -
- Achilles tendon repairs/reconstructions l
- Mid and forefoot reconstructions -
- Metatarsal ligament/tendon repairs/reconstructions -
- Bunionectomy ー
Elbow
- l Ulnar or radial collateral ligament reconstruction
- -Lateral epicondylitis repair
- Biceps tendon repair ।
Hand and Wrist
- । Collateral ligament repair
- Scapholunate ligament reconstruction l
8
510(k) Premarket Notification
- -Volar plate reconstruction
- Tendon transfers in phalanx --
Hip
- Acctabular labral repair -
Knee
- Extra-capsular repairs
- 0 Medial collateral ligament
- o Latcral collateral ligament
- o Posterior oblique ligament
- Patellar realignment and tendon repairs -
- Illiotibial band tenodesis -
- VMO advancement ﺖ
- Joint capsule closure -
Prescription Use X (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)
Image /page/8/Picture/19 description: The image shows a logo with the text "Casey L. Hanley Ph.D." on the top line and "Division of Orthopedic Devices" on the second line. There is a horizontal line separating the two lines of text. The text is surrounded by a geometric design that resembles the letters "FDA".
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