(49 days)
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.
MITEK anchors are titanium alloy implants used to anchor or lock suture within bony sites for firmly securing soft-tissue to bone.
The provided text is a 510(k) summary for the MITEK Micro QuickAnchor, a medical device. This document focuses on establishing substantial equivalence to previously cleared devices rather than presenting a novel study to determine acceptance criteria and device performance in the way a new diagnostic or AI-driven device might.
Therefore, many of the requested elements (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth used) are not applicable or extractable from this type of regulatory submission. The 510(k) process primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often by comparing design, materials, and intended use.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly stated in the provided 510(k) summary in terms of quantitative performance metrics or acceptance criteria for a new study. The document focuses on regulatory clearance by demonstrating "substantial equivalence" to previously cleared devices.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/provided. This device is a physical implant, not a diagnostic or AI algorithm that would typically involve a "test set" of data in this context. The substantial equivalence is based on device design, materials, and use, not a clinical data-driven performance study in the traditional sense for a new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable/provided. "Ground truth" in this context (a physical implant) would refer to clinical outcomes, which are not detailed as part of this 510(k) summary’s comparison to predicate devices.
4. Adjudication Method for the Test Set
Not applicable/provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
Not applicable/provided. MRMC studies are typically for diagnostic imaging interpretation or similar medical AI applications, not for physical implants.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable/provided. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
Not explicitly stated or applicable as for a diagnostic device. The "ground truth" for a physical implant would relate to its safety and effectiveness in surgical applications, which is typically addressed through clinical experience with similar predicate devices and, if necessary, clinical trials (though not detailed here for a 510(k)).
8. The Sample Size for the Training Set
Not applicable/provided. This is a physical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable/provided.
Summary of Extracted Information:
Acceptance Criteria and Device Performance:
- Acceptance Criteria: The primary "acceptance criteria" for this 510(k) submission are that the MITEK Micro QuickAnchor is "substantially equivalent" in terms of safety and effectiveness to predicate devices already on the market. This is a regulatory standard rather than a specific performance metric.
- Reported Device Performance: The document does not report specific performance metrics for the MITEK Micro QuickAnchor from a new study. Instead, its safety is referenced by its clearance through pre-market notifications (K962793, K962511, K982420) for its predicate devices, implying similar expected performance.
Study Type and Design:
- The text describes a 510(k) premarket notification process, which aims to demonstrate "substantial equivalence" to legally marketed predicate devices, rather than a de novo clinical study with specific acceptance criteria as you might see for a completely novel device or an AI/diagnostic tool.
- Predicates Referenced: K962793, K962511, K982420.
Device Description:
- Device Name: MITEK Micro QuickAnchor
- Classification Name: Staple, Fixation, Bone
- Common/Usual Name: Suture Anchor
- Device Description: Titanium alloy implants used to anchor or lock suture within bony sites for firmly securing soft-tissue to bone.
- Intended Use: To attach suture into bone for the suspension of the nasal valve and at the lower orbital rim.
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AUG 2 5 2003
SECTION 2 -- 510(k) SUMMARY
MITEK Micro QuickAnchor
| Submitter's Name andAddress: | MITEK Worldwidea Division of Ethicon Inc.,a Johnson & Johnson Company249 Vanderbilt AvenueNorwood, MA 02062 |
|---|---|
| Contact Person | Sergio Gadaleta, PhDManager, Regulatory AffairsMITEK Worldwidea Division of Ethicon Inc.,a Johnson & Johnson Company249 Vanderbilt AvenueNorwood, MA 02062Telephone: 781-251-2018Facsimile: 781-278-9578e-mail: sgadalet@ethus.jnj.com |
| Name of Medical Device | Classification Name: Staple, Fixation, BoneCommon/Usual Name: Suture AnchorProprietary 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 locksuture within bony sites for firmly securing soft-tissue to bone. |
MITEK Micro Quickanchor
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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
V
§ 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.