(14 days)
No
The device description and intended use are for a mechanical suture anchor and inserter assembly. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are bench tests related to the mechanical properties of the suture and anchor.
Yes
The device is described as a suture anchor system intended for soft tissue repair to bone for various indications like Bankart repair, rotator cuff repair, and ligament reattachment, which are therapeutic interventions.
No
This device, the Mitek GII Anchor (QUICKANCHOR), is described as a suture anchor/inserter assembly intended for the fixation of sutures to bone for various soft tissue repairs. Its purpose is to physically fix tissue, not to diagnose conditions or diseases.
No
The device description clearly states it is a "preloaded, metallic disposable suture anchor/ inserter assembly," which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for fixation of suture to bone for various surgical repairs in different anatomical locations. This is a surgical device used in vivo (within the body) during a procedure.
- Device Description: The description details a "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 derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo to physically repair tissue to bone.
N/A
Intended Use / Indications for Use
The Mitek GII Anchor (QUICKANCHOR) is intended for fixation of USP size #2 suture to bone for the indications listed below.
Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulo-labral reconstruction, biceps tenodesis, deltoid repair.
Ankle: Lateral instability, medial instability, achilles tendon repair/reconstruction, midfoot reconstruction.
Foot: Hallux valgus reconstruction.
Wrist: Scapholunate ligament.
Hand: Ulnar or lateral collateral ligament reconstruction.
Elbow: Tennis elbow repair, biceps tendon reattachment.
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
JDR
Device Description
GII 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 GII 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, Foot, Wrist, Hand, Elbow, 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)
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 GII 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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K051989 page 142
AUG 5 - 2005
510(k) SUMMARY
GII 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: GII Quickanchor Plus |
| Substantial Equivalence | GII Quickanchor Plus (with ORTHOCORD) is substantially equivalent
to:
GII Quickanchor Plus, K041115, 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.
GII Quickanchor Plus carry FDA product code JDR, and is classified as
a fixation screw/bone staple under 21 CFR 888.3030. |
| Device Description | GII 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 GII Quickanchor Plus in design, configuration and dimensions.
The anchor system may be sold with Ethibond Suture (NDA 17-804 |
| Indications for Use | The Mitek GII Anchor (QUICKANCHOR) is intended for fixation of
USP size #2 suture to bone for the indications listed below. |
| | Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular
separation, rotator cuff repair, capsule shift/capsulo-labral
reconstruction, biceps tenodesis, deltoid repair. |
| | Ankle: Lateral instability, medial instability, achilles tendon
repair/reconstruction, midfoot reconstruction. |
| | Foot: Hallux valgus reconstruction. |
| | Wrist: Scapholunate ligament. |
| | Hand: Ulnar or lateral collateral ligament reconstruction. |
| | Elbow: Tennis elbow repair, biceps tendon reattachment. |
| | 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 GII Quickanchor Plus has been
shown to be substantially equivalent to predicate devices under the
Federal Food, Drug and Cosmetic Act. |
1
Page 2/2
and 17-809), Panacryl Suture (K964345), or Orthocord Suture (K040004 and K043298).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is black and white.
AUG 5 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Denise Luciano Senior Regulatory Affairs Specialist 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 DePuv Mitek a Johnson & Johnson company 249 Vanderbilt Avenue Norwood. Massachusetts 02062
K051989 Re: Trade/Device Name: GII 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: July 21, 2005 Received: July 22, 2005
Dear Ms. Luciano:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications forchered a do re and more sure) to legally marketed predicate devices marketed in interstate for use sured in the May 28, 1976, the enactment date of the Medical Device Amendments, or to esminered prior to may 2011-11-11 accordance with the provisions of the Federal Food, Drug, de necs mat have been rout do not require approval of a premarket approval application (PMA). and Coometer Fee (110) market the device, subject to the general controls provisions of the Act. The I ou may a me securitions 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.
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 (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 – Ms. Denise Luciano
This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will anow you to begin manistang your antial equivalence of your device to a legally premarket notification. The PDF Innaing of basification 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 for your aconcerner of 2012 . Also, please note the regulation entitled, and colliation of Compilance w (21 to 10 millication" (21CFR Part 807.97). You may obtain "Misbranding by Telefence to premained nothlited.com "(2) the Act may from the Division of Small other general information on your responsible in total-free number (800) 638-2041 or 10-Manufacturers, International and Colisanter Fibraw. For.gov/cdrh/industry/support/index.html
Sincerely yours,
Sturt Murkeron
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): K0851989
Device Names: GII Quickanchor Plus
Indications for Use:
The Mitek GII Anchor (QUICKANCHOR) is intended for fixation of USP size #2 suture to bone for the indications listed below.
Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulo-labral reconstruction, biceps tenodesis, deltoid repair.
Ankle: Lateral instability, medial instability, achilles tendon repair/reconstruction, midfoot reconstruction.
Foot: Hallux valgus reconstruction.
Wrist: Scapholunate ligament.
Hand: Ulnar or lateral collateral ligament reconstruction.
Elbow: Tennis elbow repair, biceps tendon reattachment.
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)
Htyt Rhodes
storative. Page 1 of and Neurologic
Confidential