(88 days)
Not Found
No
The description focuses on the mechanical and material properties of a surgical implant and its delivery system. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for the reattachment of soft tissue to bone in rotator cuff repairs, which is a therapeutic purpose.
No
Explanation: The device is an implant used for reattaching soft tissue to bone, specifically in rotator cuff repairs. It is a treatment device, not a diagnostic one.
No
The device description clearly outlines a physical implant made of PEEK, PLGA, and UHMWPE, along with a disposable driver made of stainless steel and ABS plastic. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the reattachment of soft tissue to bone in rotator cuff repairs." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is an implant designed to be placed within the body to facilitate tissue repair. It is a physical device used in a surgical setting.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
This device clearly falls under the category of a surgical implant, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Cayenne Medical, Inc. BioWick™ X Implant is intended to be used for the reattachment of soft tissue to bone in rotator cuff repairs.
Product codes
MBI
Device Description
The BioWick™ X Implant is a sterile, manually operated, single procedure implant device for reattachment of soft tissue to bone. The implant is preloaded with floating suture and loaded on a disposable driver. The BioWick™ X implant incorporates design features that facilitate implant placement under arthroscopic, open, or limited access conditions in soft tissue to bone reattachment procedures.
The BioWick™ X implant is offered in two sizes, 5.5 mm and 6.5 mm. The implant is made out of PolyEtherEtherKetone (PEEK), L-lactide/glycolide copolymer (PLGA), and Ultra High Molecular Weight Polyethylene (UHMWPE). The floating sutures are size 2 non-absorbable Ultra High Molecular Weight Polyethylene (UHMWPE) surgical sutures. The implant is either preloaded with two or three surgical sutures.
The disposable driver has a working shaft length (from handle to distal tip of anchor) of 6.24 in (158mm) with an outer shaft diameter of 0.159 in (4.0mm). The driver shaft is made out of surgical grade stainless steel and the handle is made out of ABS plastic. The driver facilitates the placement of the implant into a hole tapped in the bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone, rotator cuff
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. The subject device was tested to be non-pyrogenic, assessed for biocompatibility, validated sterility, and performed mechanical and cadaveric usability testing.
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
October 16, 2017
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Cayenne Medical, Inc. Ms. Shima Hashemian QA/RA Associate Director 16597 N. 92nd Street. Suite 101 Scottsdale, Arizona 85260
Re: K172186
Trade/Device Name: BioWick™ X Implant with Driver Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: July 19, 2017 Received: July 20, 2017
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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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, Katherine D. Kavlock -5 for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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BioWick™ X Implant with Driver K172186 Page 1 of 1
Indications for Use
Device Name: BioWick™ X Implant with Driver
Indications for Use:
The Cayenne Medical, Inc. BioWick™ X Implant is intended to be used for the reattachment of soft tissue to bone in rotator cuff repairs.
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)
3
510(k) Summary
Cayenne Medical, Inc.
BioWick™ X Implants and Driver
Administrative Information
| Date of summary: | 07/19/2017 |
|---|---|
| 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 | |
| Shima.Hashemian@zimmerbiomet.com | |
| Telephone (480) 502-3661 | |
| FAX (480) 502-3670 |
Device Name
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
|---|---|
| Trade/Proprietary Name: | BioWick™ X Implant with Driver |
| 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.
4
Device Description
The BioWick™ X Implant is a sterile, manually operated, single procedure implant device for reattachment of soft tissue to bone. The implant is preloaded with floating suture and loaded on a disposable driver. The BioWick™ X implant incorporates design features that facilitate implant placement under arthroscopic, open, or limited access conditions in soft tissue to bone reattachment procedures.
The BioWick™ X implant is offered in two sizes, 5.5 mm and 6.5 mm. The implant is made out of PolyEtherEtherKetone (PEEK), L-lactide/glycolide copolymer (PLGA), and Ultra High Molecular Weight Polyethylene (UHMWPE). The floating sutures are size 2 non-absorbable Ultra High Molecular Weight Polyethylene (UHMWPE) surgical sutures. The implant is either preloaded with two or three surgical sutures.
The disposable driver has a working shaft length (from handle to distal tip of anchor) of 6.24 in (158mm) with an outer shaft diameter of 0.159 in (4.0mm). The driver shaft is made out of surgical grade stainless steel and the handle is made out of ABS plastic. The driver facilitates the placement of the implant into a hole tapped in the bone.
Intended use
The Cayenne Medical, Inc. BioWick™ X Implant is intended to be used for the reattachment of soft tissue to bone in rotator cuff repairs.
Technological Differences
The BioWick™ X Implant is similar in its indication for use, intended use, design features, technology, and materials to the predicate device.
The subject BioWick™ X device has the same intended use and indication for use as the predicate device, the Cayenne Medical BioWick™ SureLock® Implant (previously named as SureLock W Suture Anchor).
The subject device differs from the predicate device, Cayenne Medical BioWick™ SureLock®, in terms of design features (number of floating sutures) and the offered sizes.
Non-clinical Testing
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence is included. The subject device was tested to be non-pyrogenic, assessed for biocompatibility, validated sterility, and performed mechanical and cadaveric usability testing.
5
Clinical Testing
Clinical testing was not used to establish substantial equivalence to predicate device.
Equivalence to Marketed Product
Cayenne Medical, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the Biowick™X implant is substantially equivalent in indications and performance to the legally marketed predicate device, K151068 SureLock W Suture Anchor. The substantial equivalence of Biowick™ X implant is based on similarities in indications for use, intended use, design features, technology, and materials to the predicate device.