(30 days)
Not Found
No
The 510(k) summary describes a mechanical suture anchor and inserter assembly. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are limited to bench testing of mechanical properties.
No
The device is a suture anchor used for the mechanical fixation of soft tissue or suture to bone, which aids in repair/reconstruction but does not directly provide a therapeutic effect itself; it is a surgical aid.
No
The "Intended Use / Indications for Use" and "Device Description" sections state that the device is a suture anchor and inserter assembly for fixation of surgical suture or soft tissue to bone, used for repair and reconstruction. This describes a surgical implant/device, not a device used to diagnose a medical condition.
No
The device description explicitly states it is a "preloaded, disposable suture anchors/ inserters assembly," which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that this device is a "preloaded, disposable suture anchors/inserters assembly for soft tissue repair to bone in the hand and skull." Its intended use is for "fixation of non-absorbable braided polyester or partially absorbable braided composite surgical suture to bone" and "fixation of soft tissue to bone, using suture."
- Mechanism of Action: The device is a physical implant used to anchor sutures to bone during surgical repair. It does not perform any tests on biological samples.
Therefore, the function and purpose of this device fall under the category of surgical implants and instruments, not in vitro diagnostics.
N/A
Intended Use / 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
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,
Product codes (comma separated list FDA assigned to the subject device)
HWC, JDR, MAI
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 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand, Skull
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K032078, K982420, K962793, K962511, K024115
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 and
Address: | DePuy Mitek
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Kristine Christo
Senior Regulatory Affairs Specialist
DePuy Mitek
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767
Telephone:
508-828-3359
Facsimile:
508-977-6955
e-mail:
KChristo@Dpyus.jnj.com |
| Name of Medical Device | Classification Name: screw, fixation, bone
Common/Usual Name: Appliance for reconstruction of soft tissue to bone
Proprietary 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 Medical
Devices under the generic category of
- Single/Multiple component metallic bone fixation appliances and
accessories - Smooth or threaded metallic bone fixation fattener
Micro 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 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 |
| Indications for Use | Microfix QA+: The Microfix QuickAnchor Plus is indicated for
fixationof soft tissue to bone, using suture for the indications 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+: The Micro QuickAnchor Plus(Micro QA+) 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 |
| Safety and Performance | The determination of substantial equivalence for this device was based on
a detailed device description, and conformance to consensus and voluntary
standards. 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.
Based on the indications for use, technological characteristics, and
comparison to predicate devices, the Micro QA+Anchor and Microfix
QA+ Anchor has been shown to be substantially equivalent to predicate
devices under the Federal Food, Drug and Cosmetic Act |
1
Microfix QA+: Smooth or threaded metallic bone fixation fattener under 21CRF 888.3040. Product Code: HWC
2
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.
3
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
4
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