(21 days)
No
The device description and performance studies focus on the mechanical properties and surgical application of a suture anchor, with no mention of AI or ML technologies.
Yes
The device is a metallic suture anchor/inserter assembly intended for rotator cuff repair, which is a therapeutic intervention involving the repair of soft tissue to bone.
No
The device is a surgical anchor used for rotator cuff repair, which is a treatment procedure, not a diagnostic one.
No
The device description clearly states it is a "preloaded metallic disposable suture anchor/ inserter assembly," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Rotator cuff repair." This is a surgical procedure performed on a patient's body, not a test performed on a sample taken from a patient outside the body.
- Device Description: The device is a "preloaded metallic disposable suture anchor/ inserter assembly designed to allow soft tissue repair to bone." This is a surgical implant and delivery system.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly a surgical tool and implant used for repairing a physical injury. IVDs are used to provide information about a patient's health status through the analysis of samples.
N/A
Intended Use / Indications for Use
The Mitek Rotator Cuff QuickAnchor® Plus is indicated for Rotator cuff repair.
Product codes
HWC
Device Description
Rotator Cuff Quickanchor Plus (with ORTHOCORD) is a preloaded metallic disposable suture anchor/ inserter assembly designed to allow soft tissue repair to bone. The metal anchor is an identical anchor as that of the Rotator Cuff Quickanchor Plus in design, configuration and dimensions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The determination of substantial equivalence for this device was based on a detailed device description, and conformance to consensus and voluntary standards. Bench testing was performed demonstrating that the ORTHOCORD suture conformed to the USP monograph for absorbable sutures, and the suture compatibility and deployment met predetermined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
NDA 17-804, NDA 17-809, K964345, K040004, K043298
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
K052630 p/2
OCT 1 7 2005
510(k) SUMMARY
Rotator Cuff Quickanchor Plus
| Submitter's Name and
Address: | DePuy Mitek
a Johnson & Johnson company
249 Vanderbilt Avenue
Norwood, MA 02062 |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Denise Luciano
Senior Regulatory Affairs Specialist
DePuy Mitek
a Johnson & Johnson company
249 Vanderbilt Avenue
Norwood, MA 02062
Telephone:
781-251-2794
Facsimile:
781-278-9578
e-mail:
dluciano@depuy.jnj.com |
| Name of Medical Device | Classification Name:
Screw, Fixation, Bone Staple |
| | Common Usual Name:
Smooth or threaded metallic bone fixation
fastener |
| | Proprietary Name:
Rotator Cuff Quickanchor Plus |
| Substantial Equivalence | Rotator Cuff Quickanchor Plus (with ORTHOCORD) is substantially
equivalent to:
Rotator Cuff Quickanchor Plus, K992611, manufactured by DePuy
Mitek. |
| Device Classification | Bone anchors/screws are classified by the FDA as Class II Medical
Devices under the generic category of Smooth or threaded metallic
bone fixation fasteners. |
| | Rotator Cuff Quickanchor Plus carry FDA product code HWC, and is
classified as a fixation fastener under 21 CFR 888.3040. |
| Device Description | Rotator Cuff Quickanchor Plus (with ORTHOCORD) is a preloaded
metallic disposable suture anchor/ inserter assembly designed to allow
soft tissue repair to bone. The metal anchor is an identical anchor as
that of the Rotator Cuff Quickanchor Plus in design, configuration and |
| 510(k) Premarket Notification: Special
Rotator Cuff Quickanchor Plus | Confidential |
1
5263
The anchor system may be sold with Ethibond Suture dimensions. (NDA 17-804 and 17-809), Panacryl Suture (K964345), or Orthocord Suture (K040004 and K043298).
Indications for Use
The Mitek Rotator Cuff QuickAnchor" Plus is indicated for Rotator cuff repair.
Safety and Performance
The determination of substantial equivalence for this device was based on a detailed device description, and conformance to consensus and voluntary standards. Bench testing was performed demonstrating that the ORTHOCORD suture conformed to the USP monograph for absorbable sutures, and the suture compatibility and deployment met predetermined acceptance criteria.
Based on the indications for use, technological characteristics, and comparison to predicate devices, the Rotator Cuff Quickanchor Plus has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
510(k) Premarket Notification: Special
Rotator Cuff Quickanchor Plus
Confidential
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing movement or connection.
OCT 1 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Denise Luciano Senior Regulatory Affairs Specialist DePuy Mitek a Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, Massachusetts 02062
Re: K052630
Trade/Device Name: Rotator Cuff Quickanchor Plus Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: September 23, 2005 Received: September 26, 2005
Dear Ms. Luciano:
We have reviewed your Section 510(k) premarket notification of intent to market the device w f nave roviewed your 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 for assumer to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner to rial to 1125 2011 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 r ou mays arouse 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 If your de rice to such additional controls. Existing major regulations affecting your device can may or subject to data are are a 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 or any I 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 Or A rate 80 7) its extens (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.
3
Page 2-Denise Luciano
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ough maning of substantial equivalence of your device to a legally prematics notification: "The 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), please If you desire specific advice 101 your as (240) 276-0120. Also, please note the regulation entitled, Comacs the Office of Compullier and (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, international and Octess http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
2
SaMark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤
Device Names: Rotator Cuff Quickanchor Plus
Indications for Use:
The Mitek Rotator Cuff QuickAnchor® Plus is indicated for Rotator cuff repair.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
~~
(Division Sign-Off) (Division of General, Restorative, and Neurological Devices
Page 1 of
510(k) Number_________________________________________________________________________________________________________________________________________________________________
510(k) Premarket Notification: Special Rotator Cuff Quickanchor Plus
Confidential