(147 days)
The IMM™ Dental Irrigation Tubing Set is intended for providing passage of irrigating fluid from a solution reservoir to a dental handpiece.
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.
The document provided is a 510(k) summary for the IMMTM Dental Irrigation Tubing Set. It describes a medical device, its intended use, and its equivalence to a predicate device. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with specific acceptance criteria in the way an AI/ML device would.
Therefore, the information requested in your prompt regarding acceptance criteria and performance studies, particularly those relevant to AI/ML devices (e.g., sample size for test set, experts for ground truth, MRMC studies, standalone performance, training set details), is not applicable to this traditional medical device submission.
However, I can extract the information that is present concerning performance and testing from the provided text.
Here's a summary based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Criteria Type | Standard/Requirements | Reported Device Performance |
|---|---|---|
| Functional & Performance | ISO 8536-4 (Infusion equipment for medical use -- Part 4: Infusion sets for single use, gravity feed) | Meets specific requirements established in these standards |
| ISO 8536-9 (Infusion equipment for medical use -- Part 9: Fluid-driven infusion pumps) | Meets specific requirements established in these standards | |
| Biocompatibility | ISO 10993 (Biological evaluation of medical devices) | Meets requirements for "limited exposure, tissue/bone/dentin contact, external communicating" devices |
2. Sample size used for the test set and the data provenance:
- Not Applicable. The document does not describe a "test set" in the context of an AI/ML study. The testing performed was primarily functional, performance, and biocompatibility testing on the device itself, not on a dataset. Data provenance (country of origin, retrospective/prospective) is also not applicable for this type of device testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. The concept of "ground truth" established by experts for a test set is specific to AI/ML performance evaluation, not to the functional and biocompatibility testing of a physical medical device like an irrigation tubing set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations within an AI/ML study's ground truth establishment. This is not pertinent to the present device.
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:
- Not Applicable. An MRMC study is used to evaluate the impact of an AI system on human reader performance. This device is a passive tubing set and does not involve human "readers" or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. Standalone performance refers to the performance of an AI algorithm independent of human interaction. This device is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not Applicable. Ground truth, in the context of AI/ML, refers to the verified correct answers for a dataset. For this device, "ground truth" aligns with the objective measurements and adherence to the specified ISO standards for functional performance and biocompatibility.
8. The sample size for the training set:
- Not Applicable. A training set is used for machine learning models. This device does not involve machine learning.
9. How the ground truth for the training set was established:
- Not Applicable. Not an AI/ML device.
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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
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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.
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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.
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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
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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
§ 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.