(22 days)
Not Found
No
The device description focuses on the physical components and materials of a surgical anchor, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is indicated for shoulder rotator cuff repair and is designed to secure soft tissue to bone, which constitutes a therapeutic intervention.
No
The device description indicates it is a surgical implant for rotator cuff repair, not a tool for diagnosis.
No
The device description clearly states it is a "partially bioabsorbable three-part polymer implant" and includes physical components like a tapered tip, sleeve, inner suture pin, sutures, needle, trocar, and Delivery Gun. This indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "shoulder rotator cuff repair," which is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical implant designed to secure soft tissue to bone. It is used in a surgical setting.
- 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 about a physiological state, health, or disease.
IVDs are used to perform tests on samples taken from the body to diagnose, monitor, or screen for conditions. This device is a surgical implant used for repair within the body.
N/A
Intended Use / Indications for Use
The CUFFLOK Anchor is indicated for shoulder rotator cuff repair.
Product codes (comma separated list FDA assigned to the subject device)
MAI, GAT
Device Description
The CUFFLOK Anchor is a partially bioabsorbable three-part polymer implant designed for use in shoulder rotator cuff repair and is used to secure soft tissue to bone. The three components of the implant are a tapered tip (PLA with blue dye #6), a sleeve (polypropylene blue) and an inner suture pin (PLA with blue dye #6). The anchor is also provided with ETHIBOND non-absorbable sutures and a stainless steel needle.
Similar to the currently marketed CUFFTACK Anchor, the implant is mounted on a stainless steel trocar and placement of the implant is facilitated via use of a Delivery Gun.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder
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)
Biocompatibility studies have demonstrated the CUFFLOK Anchor to be non-toxic, non-irritating, non-sensitizing, and non-cytotoxic.
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
JUN - 6 2003
SECTION 2 - 510(k) SUMMARY
CUFFLOK Anchor
| Submitter's Name and Address: | Mitek Worldwide a division of ETHICON Inc. a Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, MA 02062 |
|---|---|
| Contact Person | Ruth C. Forstadt Senior Regulatory Affairs Associate Mitek Worldwide a division of ETHICON Inc. a Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, MA 02062 |
| Telephone: | 781-251-3188 |
| Facsimile: | 781-278-9578 |
| e-mail: | rcforstad@ethus.jnj.com |
| Name of Medical Device | |
| Classification Name: | Fastener, Fixation, Biodegradable, Soft Tissue |
| Common/Usual Name: | Bone Anchor |
| Proprietary Name: | CUFFLOK Anchor |
| Substantial Equivalence | CUFFLOK Anchor is substantially equivalent to: CUTTACK Anchor (K003076) manufactured by Mitek Worldwide, a division of Ethicon, Inc., a Johnson & Johnson Company, 249 Vanderbilt Avenue, Norwood, MA 02062. |
| Device Classification | Bone anchors/screws are classified by FDA as a Class II Medical Devices under the generic category of Single/Multiple Component Metallic Bone Fixation Appliances, Orthopedic Devices Panel (reference 21 CFR §888.3030). Product code MAI. |
| Device Description | The CUFFLOK Anchor is a partially bioabsorbable three-part polymer implant designed for use in shoulder rotator cuff repair and is used to secure soft tissue to bone. The three components of the implant are a |
1
tapered tip (PLA with blue dye #6), a sleeve (polypropylene blue) and an inner suture pin (PLA with blue dye #6). The anchor is also provided with ETHIBOND non-absorbable sutures and a stainless steel needle.
Similar to the currently marketed CUFFTACK Anchor, the implant is mounted on a stainless steel trocar and placement of the implant is facilitated via use of a Delivery Gun.
The CUFFLOK Anchor is indicated for shoulder rotator cuff repair. Indications for Use の 2007年 10月 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時
Safety
Biocompatibility studies have demonstrated the CUFFLOK Anchor to be non-toxic, non-irritating, non-sensitizing, and non-cytotoxic.
CONFIDENTIAL
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
JUN - 6 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Ruth C. Forstadt Senior Regulatory Affairs Associate Mitek Worldwide A division of ETHICON Incorporated A Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, Massachusetts 02062
K031519 Re:
Trade Name: CUFFLOK Anchor Regulation Number: 21 CFR 888.3030, 21 CFR 878.5000 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories, Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II
Product Code: MAI, GAT Dated: May 14, 2003 Received: May 19, 2003
Dear Ms. Forstadt:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Ms. Ruth C. Forstadt
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address: http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Miriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): K 43 3 15 19
Device Name: CUFFLOK Anchor
Indications for Use:
The CUFFLOK Anchor is indicated for shoulder rotator cuff repair.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________
or
Over-the-Counter Use -------
:
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K03/5/9
CONFIDENTIAL