(30 days)
Micro QuickAnchor Plus (Micro QA+ Anchor): The Micro QuickAnchor Plus is indicated for fixation of non-absorbable braided polyester or partially absorbable braided composite surgical suture to bone. This product is intended for the indications listed below: Hand: Repair / reconstruction of collateral ligaments, flexor and extensor tendon at the PIP (proximal interphalaangeal), DIP ( distal interphalaaangeal), and MCP (metacarpal interphalangeal) joints for all digits. Skull: Lateral canthoplasty.
Microfix QuickAnchor Plus (Microfix QA+ Anchor): The Microfix QuickAnchor Plus is indicated for fixationof soft tissue to bone, using suture for the in dications listed below. Hand: Hand: Repair / reconstruction of collateral ligaments, flexor and extensor tendon at the PIP (proximal interphalaangeal), DIP ( distal interphalaaangeal), and MCP (metacarpal interphalangeal) joints for all digits. Skull: Soft tissue attached to the parietal. Temporal ridge, frontal, mandible, maxilla, zygoma, and periobital bones of the skull.
Micro QA + with #3-0 Orthocord or #4-0 Orthocord / Microfix QA+ with #3-0 Orthocord or #4-0 Orthocord are a preloaded, disposable suture anchors/ inserters assembly for soft tissue repair to bone in the hand and skull. The anchor is dimensionally identical anchor to that of the Micro QA+ Anchor with Ethibond #3-0 Orthocord or 4-0 Orthocord / Microfix QA+ Anchor with Ethibond #3-0 Orthocord or 4-0 Orthocord.
The provided text describes a 510(k) summary for a medical device, the Micro QA+ Anchor / Microfix QA+ Anchor. It details the device's description, indications for use, and a statement about safety and performance. However, it does not contain the specific information required to fill out a table of acceptance criteria and reported device performance, nor does it describe a study using a test set with details like sample size, ground truth, expert qualifications, or adjudication methods.
The relevant section in the document states:
"Bench testing was performed demonstrating that the Micro QA+ Anchor with #3-0 and #4-0 Orthocord / Microfix QA+ Anchor with #3-0 and #4-0 Orthocord met predetermined acceptance criteria."
This confirms that bench testing was done and met predetermined acceptance criteria, but it does not specify what those criteria were or what the performance results were in detail. It also doesn't mention a study designed to evaluate performance using a test set in the way a clinical or AI-based study would.
Therefore, for most of your requested points, the information is not available in the provided text.
Here is what can be inferred or explicitly stated from the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Specified | Met predetermined acceptance criteria (details not provided) |
Reasoning: The document states "Bench testing was performed demonstrating that the Micro QA+ Anchor with #3-0 and #4-0 Orthocord / Microfix QA+ Anchor with #3-0 and #4-0 Orthocord met predetermined acceptance criteria." However, it does not provide the specific criteria (e.g., tensile strength, pull-out force thresholds) or the quantitative results of the tests.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document mentions "bench testing" but does not give sample sizes or details about the number of anchors or tests performed.
- Data Provenance: Not applicable. This was bench testing, not a study involving human data or clinical outcomes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable. Ground truth as typically defined in clinical or AI studies (e.g., expert consensus on images or pathology) is not relevant for bench testing of a medical device's physical properties.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. As this was bench testing for physical properties, an adjudication method for interpreting results is not mentioned or typically used in the same way as in clinical image review.
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
- MRMC Study Done: No. This document describes a physical medical device (suture anchors), not an AI algorithm or diagnostic tool. A MRMC study is not relevant.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Test: No. This document describes a physical medical device and its bench testing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For the "bench testing," the "ground truth" would be the engineering specifications and established test methods used to determine performance (e.g., material strength standards, mechanical testing protocols). It is not expert consensus, pathology, or outcomes data.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This document describes a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable. This document describes a physical medical device, not a machine learning model.
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K08035-2 page-f2
510(k) SUMMARY
MAR 1 2 2008
Micro QA+ with #3-0, #4-0 Orthocord Anchor / Microfix QA+ with #3-0, #4-0 Orthocord Anchor
| Submitter's Name andAddress: | DePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767 |
|---|---|
| Contact Person | Kristine ChristoSenior Regulatory Affairs SpecialistDePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767Telephone:508-828-3359Facsimile:508-977-6955e-mail:KChristo@Dpyus.jnj.com |
| Name of Medical Device | Classification Name: screw, fixation, boneCommon/Usual Name: Appliance for reconstruction of soft tissue to boneProprietary Name: Micro QA+ Anchor / Microfix QA+ Anchor |
| Substantial Equivalence | Micro QA+ Anchor with Orthocrod is substantially equivalent to:Micro QA+ Anchor, K032078, K982420, K962793 and K962511,manufactured by DePuy Mitek.Microfix QA+ Anchor with Orthocord is substantially equivalent to:Microfix QA+ Anchor, K024115, manufactured by DePuy Mitek |
| Device Classification | Bone anchors/screws are classified by the FDA as Class II MedicalDevices under the generic category of* Single/Multiple component metallic bone fixation appliances andaccessories* Smooth or threaded metallic bone fixation fattenerMicro QA+ : Single / multiple component metallic bone fixation |
| Device Description | Micro QA + with #3-0 Orthocord or #4-0 Orthcord / Microfix QA+ with#3-0 Orthocord or #4-0 Orthcord are a preloaded, disposable sutureanchors/ inserters assembly for soft tissue repair to bone in the hand andskull.The anchor is dimensionally identical anchor to that of the Micro QA+Anchor with Ethibond #3-0 Orthocord or 4-0 Orthocord / Microfix QA+Anchor with Ethibond #3-0 Orthocord or 4-0 Orthocord |
| Indications for Use | Microfix QA+: The Microfix QuickAnchor Plus is indicated forfixationof soft tissue to bone, using suture for the indications listed below.Hand: Hand: Repair / reconstruction of collateral ligaments, flexorand extensor tendon at the PIP (proximal interphalaangeal), DIP(distal interphalaaangeal), and MCP (metacarpal interphalangeal)joints for all digits.Skull: Soft tissue attached to the parietal. Temporal ridge, frontal,mandible, maxilla, zygoma, and periobital bones of the skull.Micro QA+: The Micro QuickAnchor Plus(Micro QA+) is indicated forfixation of non-absorbable braided polyester or partially absorbablebraided composite surgical suture to bone. This product is intended for theindications listed below:Hand: Repair / reconstruction of collateral ligaments, flexor andextensor tendon at the PIP (proximal interphalaangeal), DIP ( distalinterphalaaangeal), and MCP (metacarpal interphalangeal) joints forall digits.Skull: Lateral canthoplasty |
| Safety and Performance | The determination of substantial equivalence for this device was based ona detailed device description, and conformance to consensus and voluntarystandards. Bench testing was performed demonstrating that the MicroQA+ Anchor with #3-0 and #4-0 Orthocord / Microfix QA+ Anchor with#3-0 and #4-0 Orthocord met predetermined acceptance criteria.Based on the indications for use, technological characteristics, andcomparison to predicate devices, the Micro QA+Anchor and MicrofixQA+ Anchor has been shown to be substantially equivalent to predicatedevices under the Federal Food, Drug and Cosmetic Act |
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Microfix QA+: Smooth or threaded metallic bone fixation fattener under 21CRF 888.3040. Product Code: HWC
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with outstretched wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Mitek % A Johnson & Johnson Company Ms. Kristine Christo Senior Regulatory Affairs Specialist 325 Paramount Drive Raynham, MA 02767
MAR 1 2 2008
K080352 Trade/Device Name: Micro QuickAnchor Plus and Microfix QuickAnchor Plus Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, JDR, MAI Dated: February 8, 2008 Received: February 11, 2008
Dear Ms. Christo:
Re:
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 - Ms. Kristine Christo
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark W. Milliman
Mark N. Melkerson 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): _Kofo3 52
Device Name(s): Micro QuickAnchor Plus (Micro QA+ Anchor)
Indications for Use:
The Micro QuickAnchor Plus is indicated for fixation of non-absorbable braided polyester or partially absorbable braided composite surgical suture to bone. This product is intended for the indications listed below:
Hand: Repair / reconstruction of collateral ligaments, flexor and extensor tendon at the PIP (proximal interphalaangeal), DIP ( distal interphalaaangeal), and MCP (metacarpal interphalangeal) joints for all digits.
Skull: Lateral canthoplasty
Device Name(s): Microfix QuickAnchor Plus (Microfix QA+ Anchor)
Indications for Use:
The Microfix QuickAnchor Plus is indicated for fixationof soft tissue to bone, using suture for the in dications listed below.
Hand: Hand: Repair / reconstruction of collateral ligaments, flexor and extensor tendon at the PIP (proximal interphalaangeal), DIP ( distal interphalaaangeal), and MCP (metacarpal interphalangeal) joints for all digits.
Skull: Soft tissue attached to the parietal. Temporal ridge, frontal, mandible, maxilla, zygoma, and periobital bones of the skull,
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use No (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
Concurrence of CDRH, Office of Device Evaluation (ODE) Division of General, Restorative, Page 1 of ____________________________________________________________________________________________________________________________________________________________________ and Neurological Devices
510(k) Number K080352
§ 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.