(25 days)
No
The document describes a mechanical suture anchor and inserter assembly, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a medical implant (suture anchor) used for fixation of suture to bone, not a device directly applying therapy.
No
Explanation: The device description and intended use clearly state that the Super QUICKANCHOR Anchor Plus is a surgical implant designed for fixation of suture to bone for various repairs. There is no mention of it being used for the purpose of diagnosing a condition or disease.
No
The device description clearly states it is a "preloaded, metallic disposable suture anchor/ inserter assembly," which are physical 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 the indications listed below." These indications are all related to surgical repair of soft tissues to bone in the shoulder, ankle, and knee. This is a surgical device used in vivo (within the body).
- Device Description: The description details a "preloaded, metallic disposable suture anchor/ inserter assembly." This is a physical implantable device used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information about a patient's health status.
IVD devices are used to perform tests on samples taken from the body to diagnose diseases, monitor conditions, or screen for health issues. This device is a surgical tool used to physically repair damaged tissue.
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)
JDR
Device Description
Super 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 Super Quickanchor Plus in design, configuration and dimensions. The anchor system may be sold with Ethibond Suture (NDA 17-804 and 17-809), Panacryl Suture (K964345), or Orthocord Suture (K040004 and K043298).
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Super Quickanchor Plus has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
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.
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
OCT 2 1 2005
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 | 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@dpyus.jnj.com |
| Name of Medical Device | Classification Name: Screw, Fixation, Bone Staple
Common/Usual Name: Appliance for reconstruction of soft tissue to bone
Proprietary Name: Super Quickanchor Plus |
| Substantial Equivalence | Super Quickanchor Plus (with ORTHOCORD) is substantially
equivalent to:
Super Quickanchor Plus, K041116, manufactured by DePuy Mitek. |
| Device Classification | Bone anchors/screws are classified by the FDA as Class II Medical
Devices under the generic category of Single/Multiple component
metallic bone fixation appliances and accessories.
Super Quickanchor Plus carry FDA product code JDR, and is classified
as a fixation screw/bone staple under 21 CFR 888.3030. |
| Device Description | Super 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 Super Quickanchor Plus in design, configuration and dimensions.
The anchor system may be sold with Ethibond Suture (NDA 17-804 |
| 510(k) Premarket Notification: Special
Super Quickanchor Plus | Confidential |
1
| and 17-809), Panacryl Suture (K964345), or Orthocord Suture (K040004 and K043298). | |
|---|---|
| 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. | |
| 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 Super Quickanchor Plus has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act. |
.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular fashion around the graphic.
OCT 2 1 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: K052631
Trade/Device Name: Super QuickAnchor 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: September 22, 2005 Received: September 26, 2005
Dear Ms. Luciano:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rovewed four be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use based in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conimered province with the provisions of the provisions of the Federal Food, Drug, do nots may been require approval of a premarket approval 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 rr your de rice 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 r hat 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 1 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
Page2-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 orgin mailing of substantial equivalence of your device to a legally prematics notincation: The PDF interessification 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 arrive 10. Jour 2019) 276-0120. 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 other general mionnal 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/industry/support/index.html
Sincerely yours,
Mark 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): K082631
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.
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.
Prescription Use (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: K052431
510(k) Premarket Notification: Special Super Quickanchor Plus
Confidential