(49 days)
Not Found
No
The summary describes a physical implant (titanium alloy anchor) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as an implant used to anchor or lock suture within bony sites for securing soft tissue to bone. While it aids in a surgical procedure, its primary function is mechanical fixation rather than directly treating or curing a disease or condition. It facilitates repair rather than providing therapy itself.
No
The device description indicates it is an implant for attaching sutures to bone, and its intended use is for suspension of the nasal valve or attaching suture to bone at the lower orbital rim. This describes a surgical/therapeutic function, not a diagnostic one. There is no mention of analysis, detection, or assessment for diagnostic purposes.
No
The device description clearly states it is a titanium alloy implant, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to attach suture into bone for surgical procedures (suspension of the nasal valve, attachment at the lower orbital rim). This is a surgical implant used directly on the patient's body.
- Device Description: The device is described as a titanium alloy implant used to anchor suture within bony sites. This is a physical device for surgical fixation.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health. The description of the MITEK Micro QuickAnchor does not involve any such testing of specimens.
Therefore, the MITEK Micro QuickAnchor is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
MITEK Micro QuickAnchor is intended to attach suture into bone for the suspension of the nasal valve. MITEK Micro QuickAnchor is intended to attach suture into bone at the lower orbital rim.
Product codes
NOV
Device Description
MITEK anchors are titanium alloy implants used to anchor or lock suture within bony sites for firmly securing soft-tissue to bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone, nasal valve, lower orbital rim
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)
Reference Device(s)
Not Found
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
AUG 2 5 2003
SECTION 2 -- 510(k) SUMMARY
MITEK Micro QuickAnchor
| Submitter's Name and
Address: | MITEK Worldwide
a Division of Ethicon Inc.,
a Johnson & Johnson Company
249 Vanderbilt Avenue
Norwood, MA 02062 |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Sergio Gadaleta, PhD
Manager, Regulatory Affairs
MITEK Worldwide
a Division of Ethicon Inc.,
a Johnson & Johnson Company
249 Vanderbilt Avenue
Norwood, MA 02062
Telephone: 781-251-2018
Facsimile: 781-278-9578
e-mail: sgadalet@ethus.jnj.com |
| Name of Medical Device | Classification Name: Staple, Fixation, Bone
Common/Usual Name: Suture Anchor
Proprietary Name: Micro QuickAnchor |
| Substantial Equivalence | Micro Quick Anchor has been cleared by FDA:
K962793, K962511, K982420 |
| Device Classification | Suture Anchors are Class II devices. |
| Device Description | MITEK anchors are titanium alloy implants used to anchor or lock
suture within bony sites for firmly securing soft-tissue to bone. |
MITEK Micro Quickanchor
1
Indications for Use MITEK Micro QuickAnchor is intended to attach suture into bone for the suspension of the nasal valve. MITEK Micro QuickAnchor is intended to attach suture into bone at the lower orbital rim. and the same of the same of the same of the season of the season of the season of the season Safety This product has been cleared through pre-market notification: K962793, K962511, K982420. Safety data may be referenced in the 510(k) documents.
MITEK Micro Quickanchor
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized symbol that resembles an abstract eagle or bird in flight.
AUG 2 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mitek Worldwide c/o Sergio J. Gadaleta Manager, Regulatory Affairs Division of Ethicon Inc., a Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, MA 02062
Re: K032078
Trade/Device Name: MITEK Micro QuickAnchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accesories Regulatory Class: Class II Product Code: NOV Dated: June 26, 2003 Received: July 8, 2003
Dear Mr. Gadaleta:
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 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.
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Page 2 - Sergio J. Gadaleta
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) 594-4613. 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,
A. Palagi Fiorentino
A. Ralph Rosenthal, M.D Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE
510(k) Number (if known): 上032078
Device Name: MITEK Micro QuickAnchor
Indications for Use:
MITEK Micro QuickAnchor is intended to attach suture into bone for the suspension of the nasal valve.
MITEK Micro QuickAnchor is intended to attach suture into bone at the lower orbital rim.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________ or
Karin Bohn
(Division Sig Nose and Throat Devis
:10(k) Number K031728
MITEK Micro Quickanchor
MITEK Worldwide Worldwide, a Division of Ethicon Inc. a Johnson & Johnson Company
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