(29 days)
Not Found
No
The device description and intended use are purely mechanical, focusing on surgical fixation with a metallic anchor and suture. There is no mention of any computational or analytical capabilities, let alone AI/ML.
No
The device is a metallic anchor used for fixation of suture to bone, assisting in the reattachment of soft tissue to bone. While it aids in the repair of injuries, its primary function is mechanical support rather than directly treating a disease or condition in a therapeutic manner.
No
The device is described as an anchor intended for the fixation of suture to bone for various repairs in the shoulder, ankle, and knee. There is no mention of the device performing any diagnostic function.
No
The device description clearly states the device is a metallic anchor and inserter, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "fixation of USP size #2 through #5 suture to bone" for various surgical repairs in the shoulder, ankle, and knee. This is a surgical implant used in vivo (within the body) to physically attach tissue to bone.
- Device Description: The description details a metallic anchor and inserter system used to assist in reattaching soft tissue to bone. This is a physical device for surgical procedures.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any analysis of biological specimens.
Therefore, the Mitek Super QUICKANCHOR Anchor Plus is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Mitek Super QUICKANCHOR Anchor Plus is intended for fixation of USP size #2 through #5 suture to bone for the indications listed below.
Shoulder: Rotator cuff repair; capsular repair; biceps repair; deltoid repair.
Ankle: Achilles tendon repair/reconstruction.
Knee: Extra capsular repairs; Reattachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.
Product codes (comma separated list FDA assigned to the subject device)
MBI, JDR
Device Description
The Super Quick Anchor Plus is intended as an upgrade of the current Super QuickAnchor. The new system includes enhanced ergonomics, and improved visualization. The product will be offered with both Ethibond and Panacryl suture. The ergonomics are improved by allowing a single-handed operation. In addition, the visualization of the anchor is improved by increasing the length of the inserter shafts. The Super QuickAnchor is a metallic (6Al-4V ELI Titanium base and NiTi Titanium Alloy arcs) anchor and is used to assist in the reattachment of soft tissue to bone. The anchor is identical to the currently marketed Mitek SuperAnchor QuickAnchor (K930893).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Ankle, 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)
Not Found
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
K04 1116
Pg 1 of 2
MAY 2 8 2004
510(k) Summary – Super QuickAnchor Plus
| Submitter's Name and
Address: | DePuy Mitek
a Johnson & Johnson company
249 Vanderbilt Avenue
Norwood, MA 02062 |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Allyson Barford
Regulatory Affairs Associate
DePuy Mitek
a Johnson & Johnson company
249 Vanderbilt Avenue
Norwood, MA 02062
Telephone: 781-251-2794
Facsimile: 781-278-9578
e-mail: abarford@dpyus.jnj.com |
| Name of Medical Device | Device Regulation:
Staple, Fixation, Bone
(21 CFR 888.3030)
Product code: MBI
Common/Usual Name:
Staple, Fixation, Bone
Proprietary Name:
Super QuickAnchor Plus |
| Device Classification | Staple, Fixation, Bone devices have been classified as Class II, MBI
according to 21 CFR 888.3030. No performance standards have been
established under Section 514 of the Food, Drug and Cosmetic Act for
Staple, Fixation, Bone devices. |
| Indications for Use | The Mitek Super QUICKANCHOR Anchor Plus is intended for
fixation of USP size #2 through #5 suture to bone for the indications
listed below.
Shoulder: Rotator cuff repair; capsular repair; biceps repair; deltoid
repair.
Ankle: Achilles tendon repair/reconstruction. |
| | Knee: Extra capsular repairs; Reattachment of: medial collateral
ligament, lateral collateral ligament, posterior oblique ligament or joint |
| Special 510(k) Premarket Notification: Super QuickAnchor Plus | CONFIDENTIAL |
DePuy Mitek
1
pg. 2 of 2.
capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.
| Device Description | The Super Quick Anchor Plus is intended as an upgrade of the current Super QuickAnchor. The new system includes enhanced ergonomics, and improved visualization. The product will be offered with both Ethibond and Panacryl suture. The ergonomics are improved by allowing a single-handed operation. In addition, the visualization of the anchor is improved by increasing the length of the inserter shafts. The Super QuickAnchor is a metallic (6Al-4V ELI Titanium base and NiTi Titanium Alloy arcs) anchor and is used to assist in the reattachment of soft tissue to bone. The anchor is identical to the currently marketed Mitek SuperAnchor QuickAnchor (K930893). |
|---|---|
| Substantial Equivalence | Based on the type of changes being made and the fact that the Super QuickAnchor Plus represents the same fundamental scientific technology as the existing SuperAnchor QuickAnchor; Mitek believe that Super QuickAnchor Plus is substantially equivalent to Mitek's existing SuperAnchor QuickAnchor (K980893). |
| Safety | Biocompatibility studies have demonstrated the Super Anchor QuickAnchor Plus to be non-toxic, non-irritating, and non-cytotoxic. |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures.
Public Health Service
MAY 2 8 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Allyson Barford Regulatory Affairs Associate Depuy Mitek a Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, Massachusetts 02062
Re: K041116 Trade/Device Name: Super Quick Anchor Plus Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: JDR Dated: April 5, 2004 Received: April 29, 2004
Dear Ms. Barford:
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 markcted 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 cither 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I·DA 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 (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 - Allyson Barford
This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter with a a not of your finding of substantial equivalence of your device to a legally promated prodicate 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), please rryou decire of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A Milkman
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
4
INDICATIONS FOR USE
510(k) Number (if known):
Device Names:
Super QuickAnchor Plus
Indications for Use:
The Mitek Super QUICKANCHOR Anchor Plus is intended for fixation of USP size #2 through #5 suture to bone for the indications listed below.
Shoulder: Rotator cuff repair; capsular repair; biceps repair; deltoid repair.
KO4 1116
Ankle: Achilles tendon repair/reconstruction.
Knee: Extra capsular repairs; Reattachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendor avulsions.
Mark N Milkers
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K041116
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OT
Over-the-Counter Use
Special 510(k) Premarket Notification: Super QuickAnchor Plus DePuy Mitek
CONFIDENTIAL