(104 days)
Not Found
No
The device description and intended use are purely mechanical and do not mention any computational or data-driven components. The "Not Found" entries for AI/ML mentions and performance studies further support this.
Yes
This device is intended to fixate or stabilize guided tissue regeneration membranes to bone at the surgical site, indicating a therapeutic purpose.
No
The device description states its intended use is to "fixate or stabilize guided tissue regeneration membranes to bone at the surgical site," which is a treatment or surgical function, not a diagnostic one.
No
The device description explicitly states it consists of physical components like titanium alloy tacks and stainless steel instruments, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "fixate or stabilize guided tissue regeneration membranes to bone at the surgical site." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of tacks and surgical instruments used for implantation. These are physical devices used in a surgical setting.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during a surgical procedure.
N/A
Intended Use / Indications for Use
Miltex® Membrane Tack Kit is intended to fixate or stabilize guided tissue regeneration membranes to bone at the surgical site.
Product codes (comma separated list FDA assigned to the subject device)
DZL
Device Description
The Miltex® Membrane Tack Kit consists of non-sterile, single use titanium alloy tacks available in 3 mm or 5 mm lengths. Membrane Tacks are used in conjunction with the following accessories and reusable stainless steel instruments for implantation: Tack Membrane Probe, Tack Applicator, Perforation Raspatory, Kirsch Sinus 7 Double-ended Spoon and Plugger, Sinus Elevator, Mixing Cup with Plastic Lid, Tack Storage Box for 15 Tacks and Tack Wash Tray with Lid.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
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.
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
§ 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.
0
Miltex.
Redefining Excellence
DEC 2 9 2009
589 Davies Drive
York, PA 17402
phone 717 840-9335
toll-free 800 221-1344-
fax 717 840-8347
510(k) Summary
Submitted by:
Miltex, Inc. 589 Davies Drive York, PA 17402 USA
Contact Person:
Jennifer Bosley, Regulatory Affairs Manager Integra Medical Instrument Group 589 Davies Drive York, PA 17402 USA Phone: (717) 840-9335 Fax: (717) 840-3509
Date Prepared: September 15, 2009
| Device Trade Name: | Miltex® Membrane Tack Kit |
|---|---|
| Common/Usual Name: | Dental Membrane Tack |
| Proposed Classification: | Screw, Fixation, Intraosseous |
| 21 CFR 872.4880 Class II, 76 DZL - Dental |
Device Description:
The Miltex® Membrane Tack Kit consists of non-sterile, single use titanium alloy tacks available in 3 mm or 5 mm lengths. Membrane Tacks are used in conjunction with the following accessories and reusable stainless steel instruments for implantation: Tack Membrane Probe, Tack Applicator, Perforation Raspatory, Kirsch Sinus 7 Double-ended Spoon and Plugger, Sinus Elevator, Mixing Cup with Plastic Lid, Tack Storage Box for 15 Tacks and Tack Wash Tray with Lid.
Indications For Use:
Miltex® Membrane Tack Kit is intended to fixate or stabilize guided tissue regeneration membranes to bone at the surgical site.
Predicate Devices:
| 510(k) # | Device | Manufacturer |
|---|---|---|
| K973180 | IMTEC Bone Tac | IMTEC Corporation |
| K022790 | AutoTacTM System Titanium Tack | BioHorizons Implant Systems, Inc. |
Substantial Equivalence:
Miltex® Membrane Tack Kit is substantially equivalent to the legally marketed predicate devices with respect to intended use, fundamental technology, design and material.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle contains a stylized image of a human figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Ms. Jennifer Bosley Regulatory Affairs Manager Miltex. Incorporated Integra Medical Instrument Group 589 Davies Drive York, Pennsylvania 17402
DEC & & 2009
Re: K092855
Trade/Device Name: Miltex® Membrane Tack Kit Regulation Number: 21CFR 872.4880 Regulation Name: Intraosseous Fixation Screw or Wire Regulatory Class: II Product Code: DZL Dated: December 16, 2009 Received: December 17, 2009
Dear Ms. Bosley:
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 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.
2
Page 2- Ms. Bosley
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Antmon O. an
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
161
Indications For Use
510(k) Number (if known): __
Device Name:
Miltex® Membrane Tack Kit
Indications for Use:
Miltex® Membrane Tack Kit is intended to fixate or stabilize guided tissue regeneration membranes to bone at the surgical site.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter-Use_ (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Kag 2855 510(k) Number:
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