(87 days)
Not Found
No
The summary describes a mechanical anchor device and does not mention any AI or ML components or functionalities.
No.
The device is described as a surgical anchor for soft tissue-to-bone fixation, which is a physical intervention, not a therapeutic device in the sense of delivering therapy (e.g., medication, radiation) or diagnostic capability.
No
The device is described as an anchor/inserter assembly intended for the fixation of soft tissue to bone, which is a surgical tool, not a diagnostic one.
No
The device description explicitly states it is a "preloaded disposable Device Description anchor/inserter assembly," which are physical 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 states the device is for "fixation of soft tissue to bone, using suture". This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a "bone anchor/inserter assembly" designed for "delivery and installation... into bone". This further confirms its use in a surgical context.
- 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 treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for surgical fixation.
N/A
Intended Use / Indications for Use
The MINILOK QuickAnchor Plus is intended for fixation of soft tissue to bone, using suture, for the indications listed below: Ankle: Mid-foot reconstruction Foot: Hallux valgus reconstruction Hand: Ulnar or lateral collateral ligament reconstruction Wrist: Scapholunate ligament reconstruction
Product codes
MAI, HWC
Device Description
The MINILOK QuickAnchor Plus is preloaded disposable Device Description anchor/inserter assembly designed to facilitate the delivery and installation of the MINILOK QuickAnchor Plus into bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ankle, Foot, Hand, Wrist
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)
K930892, K992487, K992623, K0224115, K022234
Reference Device(s)
Not Found
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
K030995 pge 1/2
JUN 2 6 2003
SECTION 2 -- 510(k) SUMMARY
MINILOK QuickAnchor Plus
| 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: MINILOK QuickAnchor Plus |
| Substantial Equivalence | MINILOK QuickAnchor Plus is substantially equivalent to:
Mini QuickAnchor Plus (K930892, K992487 and K992623) and
MicroFix QuickAnchor Plus (K0224115) manufactured by Mitek
Worldwide, a division of Ethicon, Inc., a Johnson & Johnson
Company, 249 Vanderbilt Avenue, Norwood, MA 02062. In addition,
the MINILOK QuickAnchor Plus is substantially equivalent to the
absorbable Mini Bio-Anchor, K022234, manufactured by Arthrex,
Inc., in Naples, Florida. |
| 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. |
1
The MINILOK QuickAnchor Plus is preloaded disposable Device Description anchor/inserter assembly designed to facilitate the delivery and installation of the MINILOK QuickAnchor Plus into bone. Indications for Use The MINILOK QuickAnchor Plus is intended for fixation of soft tissue to bone, using suture, for the indications listed below: Ankle: Mid-foot reconstruction Foot: Hallux valgus reconstruction Hand: Ulnar or lateral collateral ligament reconstruction Wrist: Scapholunate ligament reconstruction Safety Biocompatibility studies have demonstrated the MINILOK QuickAnchor Plus to be non-toxic, non-irritating, non-sensitizing, 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 and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
Public Health Service
JUN 2 6 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Ruth C. Forstadt Senior Regulatory Affairs Associate Mitek Worldwide 249 Vanderbilt Ave. Norwood, MA 02062
Re: K030995
Trade/Device Name: MINILOK Anchor Plus Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: March 28, 2003 Received: March 31, 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.
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
3
Page 2 - Ms. Ruth C. Forstadt
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. 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), 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) you may obtain. 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,
R. Mark McMullen
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): K610995
Device Name: MINILOK QuickAnchor Plus
Indications for Use:
MINILOK QuickAnchor Plus is intended for fixation of soft tissue to bone, using suture, for the indications listed below:
Ankle: Mid-foot reconstruction Foot: Hallux Valgus reconstruction Hand: Ulnar or lateral collateral ligament reconstruction Wrist: Scapholunate ligament reconstruction
(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 No
/ Mark M
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K030995