(29 days)
The Mitek Super QUICKANCHOR Anchor Plus is intended for fixation of USP size #2 through #5 suture to bone for the indications listed below.
Shoulder: Rotator cuff repair; capsular repair; biceps repair; deltoid repair.
Ankle: Achilles tendon repair/reconstruction.
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.
The Super Quick Anchor Plus is intended as an upgrade of the current Super QuickAnchor. The new system includes enhanced ergonomics, and improved visualization. The product will be offered with both Ethibond and Panacryl suture. The ergonomics are improved by allowing a single-handed operation. In addition, the visualization of the anchor is improved by increasing the length of the inserter shafts. The Super QuickAnchor is a metallic (6Al-4V ELI Titanium base and NiTi Titanium Alloy arcs) anchor and is used to assist in the reattachment of soft tissue to bone. The anchor is identical to the currently marketed Mitek SuperAnchor QuickAnchor (K930893).
This document is a 510(k) summary for a medical device called "Super QuickAnchor Plus." It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission does not typically include detailed studies proving acceptance criteria in the same way a new, high-risk device might. Instead, it focuses on demonstrating that the new device is as safe and effective as an existing one.
Based on the provided text, here's an analysis against your requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance data in the traditional sense of a clinical trial or performance study for a novel device. Instead, the core "acceptance criteria" here is demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria (Implicit for 510(k)) | Reported Device Performance |
|---|---|
| Functional Equivalence: Performs the same intended use. | The "Super QuickAnchor Plus" is intended for "fixation of USP size #2 through #5 suture to bone" for shoulder, ankle, and knee indications, which aligns with the general function of bone fixation anchors. The predicate device (Mitek SuperAnchor QuickAnchor, K980893 and K930893) performs the same function. |
| Technological Equivalence: Similar technological characteristics. | The "Super QuickAnchor Plus" is described as an "upgrade of the current Super QuickAnchor." The anchor itself is "identical to the currently marketed Mitek SuperAnchor QuickAnchor (K930893)" in terms of materials (6Al-4V ELI Titanium base and NiTi Titanium Alloy arcs). The "improvements" are in "enhanced ergonomics, and improved visualization" through single-handed operation and increased inserter shaft length, which are considered design refinements, not fundamental technology changes. |
| Safety and Effectiveness Equivalence: No new questions of safety or effectiveness. | The document states: "Biocompatibility studies have demonstrated the Super Anchor QuickAnchor Plus to be non-toxic, non-irritating, and non-cytotoxic." This confirms that the materials used (which are the same as the predicate's anchor) meet biocompatibility standards. The functional and technological similarities, coupled with biocompatibility, are used to argue that the device is as safe and effective as the predicate. The FDA's letter states they "have determined the device is substantially equivalent... to legally marketed predicate devices." This is the ultimate "performance" metric for a 510(k). |
2. Sample size used for the test set and the data provenance
- Sample size: Not applicable in the context of this 510(k) submission. This document does not describe a clinical performance study using a "test set" of patients or cases. The biocompatibility studies would typically involve in-vitro or in-vivo testing on material samples, not a patient "test set". The document does not specify their sample sizes.
- Data provenance: Not applicable for a clinical test set. The biocompatibility studies' provenance is not detailed (e.g., country of origin, retrospective/prospective). These are typically laboratory studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not present. A clinical ground truth for a test set is not established in this type of submission.
4. Adjudication method for the test set
- This information is not present, as no clinical test set is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This information is not present. This device is a bone fixation anchor, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance is irrelevant and not conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This information is not present. This device is a surgical implant and delivery system, not an algorithm or software. Therefore, standalone algorithm performance is irrelevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the core claim of "substantial equivalence," the "ground truth" is established by the existing, legally marketed predicate device (Mitek SuperAnchor QuickAnchor K980893 and K930893). The new device is compared against the characteristics and performance of this predicate.
- For biocompatibility, the "ground truth" would be established by standard biological safety testing methods to determine non-toxicity, non-irritation, and non-cytotoxicity, as per ISO 10993 or equivalent standards. The results of these tests (stated as having "demonstrated" the device is safe) are the ground truth for that specific safety aspect.
8. The sample size for the training set
- This information is not present. There is no "training set" in the context of this medical device submission, as it is a physical implant and not a machine learning model.
9. How the ground truth for the training set was established
- This information is not present, as there is no "training set" for this device.
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K04 1116
Pg 1 of 2
MAY 2 8 2004
510(k) Summary – Super QuickAnchor Plus
| Submitter's Name andAddress: | DePuy Miteka Johnson & Johnson company249 Vanderbilt AvenueNorwood, MA 02062 |
|---|---|
| Contact Person | Allyson BarfordRegulatory Affairs AssociateDePuy Miteka Johnson & Johnson company249 Vanderbilt AvenueNorwood, MA 02062Telephone: 781-251-2794Facsimile: 781-278-9578e-mail: abarford@dpyus.jnj.com |
| Name of Medical Device | Device Regulation:Staple, Fixation, Bone(21 CFR 888.3030)Product code: MBICommon/Usual Name:Staple, Fixation, BoneProprietary Name:Super QuickAnchor Plus |
| Device Classification | Staple, Fixation, Bone devices have been classified as Class II, MBIaccording to 21 CFR 888.3030. No performance standards have beenestablished under Section 514 of the Food, Drug and Cosmetic Act forStaple, Fixation, Bone devices. |
| Indications for Use | The Mitek Super QUICKANCHOR Anchor Plus is intended forfixation of USP size #2 through #5 suture to bone for the indicationslisted below.Shoulder: Rotator cuff repair; capsular repair; biceps repair; deltoidrepair.Ankle: Achilles tendon repair/reconstruction. |
| Knee: Extra capsular repairs; Reattachment of: medial collateralligament, lateral collateral ligament, posterior oblique ligament or joint | |
| Special 510(k) Premarket Notification: Super QuickAnchor Plus | CONFIDENTIAL |
DePuy Mitek
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pg. 2 of 2.
capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.
| Device Description | The Super Quick Anchor Plus is intended as an upgrade of the current Super QuickAnchor. The new system includes enhanced ergonomics, and improved visualization. The product will be offered with both Ethibond and Panacryl suture. The ergonomics are improved by allowing a single-handed operation. In addition, the visualization of the anchor is improved by increasing the length of the inserter shafts. The Super QuickAnchor is a metallic (6Al-4V ELI Titanium base and NiTi Titanium Alloy arcs) anchor and is used to assist in the reattachment of soft tissue to bone. The anchor is identical to the currently marketed Mitek SuperAnchor QuickAnchor (K930893). |
|---|---|
| Substantial Equivalence | Based on the type of changes being made and the fact that the Super QuickAnchor Plus represents the same fundamental scientific technology as the existing SuperAnchor QuickAnchor; Mitek believe that Super QuickAnchor Plus is substantially equivalent to Mitek's existing SuperAnchor QuickAnchor (K980893). |
| Safety | Biocompatibility studies have demonstrated the Super Anchor QuickAnchor Plus to be non-toxic, non-irritating, and non-cytotoxic. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures.
Public Health Service
MAY 2 8 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Allyson Barford Regulatory Affairs Associate Depuy Mitek a Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, Massachusetts 02062
Re: K041116 Trade/Device Name: Super Quick Anchor 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: April 5, 2004 Received: April 29, 2004
Dear Ms. Barford:
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 markcted 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 cither 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 I·DA 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 - Allyson Barford
This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter with a a not of your finding of substantial equivalence of your device to a legally promated prodicate 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 rryou decire of Compliance at (301) 594-4659. 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,
Mark A Milkman
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
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INDICATIONS FOR USE
510(k) Number (if known):
Device Names:
Super QuickAnchor Plus
Indications for Use:
The Mitek Super QUICKANCHOR Anchor Plus is intended for fixation of USP size #2 through #5 suture to bone for the indications listed below.
Shoulder: Rotator cuff repair; capsular repair; biceps repair; deltoid repair.
KO4 1116
Ankle: Achilles tendon repair/reconstruction.
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 tendor avulsions.
Mark N Milkers
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K041116
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OT
Over-the-Counter Use
Special 510(k) Premarket Notification: Super QuickAnchor Plus DePuy Mitek
CONFIDENTIAL
§ 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.