(147 days)
Not Found
No
The device description and performance studies focus on the physical components and functional performance of a fluid delivery system, with no mention of AI or ML.
No
The device is described as an irrigation tubing set intended for providing passage of irrigating fluid to a dental handpiece, facilitating a procedure rather than directly providing therapy to a patient.
No
This device is for delivering irrigating fluid to a dental handpiece, facilitating a procedure, rather than diagnosing a condition.
No
The device description explicitly lists physical components such as inlet spikes, drip chamber, PVC plastic tubes, clamps, silicone tube, and caps, indicating it is a hardware device.
Based on the provided information, the IMM™ Dental Irrigation Tubing Set is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide passage of irrigating fluid to a dental handpiece. This is a mechanical function for delivering fluid during a dental procedure.
- Device Description: The description details components like tubing, clamps, and spikes, which are typical for fluid delivery systems, not for analyzing biological samples.
- 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, etc.) to provide information for diagnosis, monitoring, or treatment.
- Performance Studies: The performance studies focus on functional requirements and biocompatibility for a device that comes into contact with tissue/bone/dentin, not on analytical performance related to biological samples.
- Predicate Device: The predicate device is also an "Irrigation Tubing Set," further indicating its function is fluid delivery, not in vitro diagnostics.
In summary, the device's purpose is to facilitate the delivery of fluid during a dental procedure, which falls under the category of a medical device used for treatment or procedural support, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The IMM™ Dental Irrigation Tubing Set is intended for providing passage of irrigating fluid from a solution reservoir to a dental handpiece.
Product codes (comma separated list FDA assigned to the subject device)
EBW
Device Description
The IMM™ Dental Irrigation Tubing Set is to be used for providing passage of irrigating fluid t from a solution reservoir to a dental hand piece. The device consists of one or more inlet spikes, drip chamber, PVC plastic tubes, clamps, silicone tube, consists of only caps.
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)
The functional and performance tests demonstrated that IMM™ Dental Irrigation Tubing Set meets specific requirements established in voluntary standards: ISO8536-4 and ISO8536-9. Biocompatibility test indicated that the device meets the requirements per ISO10993 for "limited exposure, tissue/bone/dentin contact, external communicating" devices.
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
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.
0
090727
AUG 1 3 2009
Pre-market Notification for IMMTM Dental Irrigation Tubing Set
510(k) Summary
1. Submitter's Name:
INNOVATIVE MEDICAL MAUFACTURING COMPANY 107, 181 Lane, Sect. 1 Yong Jane Road Chunan, Miaoli, 350 TAIWAN (ROC)
Contact:
J. P. Lee, General Manager Tel: +886-37-620236 Fax: +886-37-620239
2. Name of Device
Common/Usual Name: Proprietary Name: Classification Name: Product Code: Regulation Number:
Irrigation Tubing Set IMMTM Dental Irrigation Tubing Set Dental handpiece and accessories EBW 21CFR872.4200
3. Predicate Device
| Trade Name | 510(k) Number | Decision Date |
|---|---|---|
| W&H Irrigation Tubing Set | K041124 | 06/07/2004 |
4. Device Description
The IMM™ Dental Irrigation Tubing Set is to be used for providing passage of irrigating fluid t from a solution reservoir to a dental hand piece. The device consists of one or more inlet spikes, drip chamber, PVC plastic tubes, clamps, silicone tube, consists of only caps.
5. Indication for Use
The IMM™ Dental Irrigation Tubing Set is intended for providing passage of irrigating fluid from a solution reservoir to a dental handpiece.
6. Technological Characteristics
The IMM™ Dental Irrigation Tubing Set is a single use device, and is delivered sterile. The device can be readily connected to a dental handpiece in irrigation or fluid delivery.
7. Performance Summary
1
The functional and performance tests demonstrated that IMM™ Dental Irrigation Tubing Set meets specific requirements established in voluntary standards: ISO8536-4 and ISO8536-9. Biocompatibility test indicated that the device meets the requirements per ISO10993 for "limited exposure, tissue/bone/dentin contact, external communicating" devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of an abstract human figure with three flowing lines representing the body and arms. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Innovative Medical Manufacturing Company C/O Joseph J. Chang, Ph.D., P.E. Consultant Innomedtech LLC 7128 Staffordshire Street Houston, Texas 77030
AUG 1 3 2009
Re: K090727
Trade/Device Name: IMM™ Dental Irrigation Tubing Set Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: II Product Code: EBW Dated: July 21, 2009 Received: July 23, 2009
Dear Dr. Chang:
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.
3
Page 2- Dr. Chang
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.htm 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Anthony C. m
Susan Purser D.D.S. M.A.
Susan Runner, D.D.S., M. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
1090727 510(k) Number (if known):
Device Name: IMMTM Dental Irrigation Tubing Set
Indications for Use:
The IMM™ Dental Irrigation Tubing Set is intended for providing passage of irrigating fluid from a solution reservoir to a dental handpiece .
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
Rein Hulsey for MSR
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K090727