(69 days)
The ReSolve ™ QuickAnchor is used for the fixation of absorbable monofilament polydioxanone surgical suture to bone. This product is intended for the following indications:
Cranio/Maxillofacial:
Repair, reconstruction or reattachment of tendons, ligaments, muscles and soft tissue flaps to the parietal, temporal ridge, frontal, mandible, maxilla, zygoma and periorbital bones of the skull.
The device described in this 510(k) is a sterile implant used to anchor or lock suture within pre-drilled bone sites and firmly secure soft tissue to bone.
The provided document describes a medical device, the ReSolve™ QuickAnchor, and its 510(k) premarket notification. It outlines performance data related to its safety and mechanical characteristics, rather than diagnostic or AI-driven performance. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable as they relate to studies of diagnostic accuracy or AI system performance.
Here's an analysis of the available information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance/Testing |
|---|---|
| Sufficient pullout force for intended use | Pullout force testing (preserved human cadaver skull) |
| Comparable strength to predicate devices | Strength comparison (ReSolve vs. Mitek Micro Anchor) |
| Appropriate for skull thickness | Skull thickness measurements |
| Biocompatibility | Not explicitly detailed in the performance section, but mentioned as having "similarities" to predicate devices, implying compliance. |
| Sterilization method | Not explicitly detailed in the performance section, but mentioned as having "similarities" to predicate devices, implying compliance. |
| Design and Operating Principle | Mentioned as having "similarities" to predicate devices, implying compliance. |
| Materials | Mentioned as having "similarities" to predicate devices, implying compliance. |
Study Proving Acceptance Criteria:
The study conducted to prove the device meets acceptance criteria involved several mechanical and material tests.
1. Table of Acceptance Criteria and Reported Device Performance (as above)
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "preserved human cadaver skull" for pullout force testing but does not provide the number of specimens or tests conducted.
- Data Provenance: The pullout force testing was conducted on "preserved human cadaver skull," indicating the use of human anatomical specimens, likely from the country where the testing was performed (not specified). This is a prospective study in terms of testing the device, but the cadaver material itself is "retrospective" in the sense that it's from deceased individuals.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This device is a mechanical implant, not a diagnostic tool or AI algorithm. Ground truth, in this context, would be established by physical measurements and engineering standards, not expert interpretation of outputs.
4. Adjudication method for the test set:
- Not Applicable. As this is a mechanical device being tested for physical properties, there is no "adjudication method" in the sense of reconciling subjective expert interpretations. Results would be based on quantitative measurements.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, an effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is not a diagnostic device or AI system that involves human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for the performance testing of this device is derived from direct physical measurements and mechanical properties. For example:
- Pullout force: Measured by applying a force until the anchor disengages, compared against established biomechanical requirements for similar devices or anatomical structures.
- Strength comparison: Directly comparing measured forces/strengths of the ReSolve™ QuickAnchor against those of predicate devices.
- Skull thickness measurements: Direct physical measurements of skull bone thickness to ensure the device is compatible with the intended anatomical sites.
- It is based on objective, quantifiable engineering and biomechanical principles, not expert consensus, pathology, or outcomes data in the traditional sense of diagnostic validation.
8. The sample size for the training set:
- Not Applicable. This is a physical device, not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established:
- Not Applicable. This is a physical device, not an AI algorithm.
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DEC 2 9 1999
Mitek Products ReSolve™ QuickAnchor® Cranio/Maxillofacial
Image /page/0/Picture/2 description: The image shows a handwritten text string that appears to be a code or identifier. The string is "K993575" with a horizontal line above the last digit. The text is written in a cursive style, and the image is a close-up of the text.
510(k) Premarket Notification October 20, 1999
| Trade Name: | ReSolve™ QuickAnchor |
|---|---|
| Sponsor: | Mitek Products |
| 60 Glacier Drive | |
| Westwood, MA 02090 | |
| Registration #1221934 | |
| Contact: | Paula E. Bulger |
| Regulatory Affairs Project Manager | |
| Mitek Products | |
| 60 Glacier Drive | |
| Westwood, MA 02090 | |
| Phone: (781) 251-2700 | |
| Fax: (781) 461-9166 | |
| Device Generic Name: | Staple, Fixation, Bone |
| Classification: | According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II. |
| Product Code: | JDR (21 CFR 888.3030) |
| Predicate Devices: | K970896 - Mitek Panalok Anchor |
| K962511, K982420 - Mitek Micro Anchor | |
| K992611 - Mitek Rotator Cuff QuickAnchor Plus |
Product Description: The device described in this 510(k) is a sterile implant used to anchor or lock suture within pre-drilled bone sites and firmly secure soft tissue to bone.
Indications for Use:
The ReSolve™ QuickAnchor is used for the fixation of absorbable monofilament surgical suture to bone. This product is intended for the following indications:
Cranio/Maxillofacial:
Repair, reconstruction or reattachment of tendons, ligaments, muscles and soft tissue flaps to the parietal, temporal ridge, frontal, mandible, maxilla, zygoma and periorbital bones of the skull.
Safety and Performance:
The following safety and performance data has been provided to support substantial equivalence of ReSolve™ QuickAnchor:
| Performance testing: | Pullout force (preserved human cadaver skull) |
|---|---|
| Strength comparison (ReSolve vs. Mitek Micro Anchor | |
| Skull thickness measurements |
Conclusion:
Based on safety and performance data, similarities in design, operating principle, materials, biocompatibility and sterilization method, the ReSolve™ QuickAnchor has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird's body and wings. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 9 1999
Ms. Paula E. Bulger Requlatory Affairs Project Manager Mitek Products Ethicon, Inc. 60 Glacier Drive Westwood, MA 02090
K993575 Re : Resolve™ QuickAnchor (Cranio/Maxillofacial) Trade Name: Regulatory Class: II Product Code: DZL October 20, 1999 Dated: Received: October 21, 1999
Dear Ms. Bulger:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Page 2 - Ms. Bulger
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your sit with puivalence of your device to a legally marketed predicate device results in a classification for your markets processor mits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Gerald W. Sheppan
for Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Premarket Notification October 20, 1999
Page 1 of of
510(k) Number (if known): K993575
Device Name: ReSolve™ QuickAnchor
Indications for Use:
The ReSolve ™ QuickAnchor is used for the fixation of absorbable monofilament polydioxanone surgical suture to bone. This product is intended for the following indications:
Cranio/Maxillofacial:
Repair, reconstruction or reattachment of tendons, ligaments, muscles and soft tissue flaps to the parietal, temporal ridge, frontal, mandible, maxilla, zygoma and periorbital bones of the skull.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-the -Counter Use
(Division Sign-Off) 4 and Division of Dental, Infection and General Hospital Devic 510(k) Number_K993
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§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.