(115 days)
The device is an air-powered dental handpiece for use in general dentistry.
The CROMAX Turbine Handpiece is an air-driven high-speed dental handpiece. It has an airdriven turbine with appropriate power and speed for use with dental carbide burrs and diamond cutting instruments. Construction is stainless steel for corrosion resistance. It has water spray for cooling of the cutting burr. One model has push-button chucking mechanism to grip cutting instrument with ISO standard shanks. The CROMAX Turbine Handpiece may be sterilized by the steam autoclave method. The bearing are sealed. Technically supported and adopted key components of rotor and ball bearing from § •››Air, Switzerland. Foshion produced CROMAX turbine handpiece and powered by Bien -- ir.
The CROMAX Turbine Handpiece, an air-powered dental handpiece, received 510(k) clearance based on its substantial equivalence to predicate devices, namely the T1 Line Dental Handpieces (K972436) and the Rapidd Highspeed Dental Handpiece (K003518). As a Class I device, the regulatory pathway relies on demonstrating substantial equivalence rather than extensive clinical studies with specific acceptance criteria and performance metrics typically associated with higher-risk devices or novel technologies.
Therefore, the provided document does not contain the detailed information requested for acceptance criteria and a study proving the device meets them, such as a table of acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, or details on standalone or MRMC studies.
Instead, the submission focuses on demonstrating that the CROMAX Turbine Handpiece is as safe and effective as existing legally marketed devices. The key elements for establishing substantial equivalence are described as follows:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document as it is a 510(k) submission for a Class I device based on substantial equivalence. Performance data in the context of specific quantitative acceptance criteria is not a requirement for this type of submission. The 'performance' is implicitly deemed acceptable if it is substantially equivalent to the predicate devices.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not applicable/not provided. The 510(k) submission for this Class I device does not involve a specific clinical "test set" in the context of performance studies with sample sizes. Substantial equivalence is demonstrated through comparison of technical characteristics and compliance with recognized standards.
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):
This information is not applicable/not provided. The concept of "ground truth established by experts" for a test set is typically relevant for diagnostic or image analysis devices undergoing performance validation, not for a dental handpiece demonstrating substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable/not provided. Adjudication methods are used in clinical trials or performance studies involving interpretation, which is not the basis of this 510(k) submission.
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:
This information is not applicable/not provided. This device is a mechanical dental handpiece, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and "human readers improve with AI" metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable/not provided. The device is a mechanical tool and does not involve any algorithms or standalone performance testing in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable/not provided. The regulatory process for this device did not involve defining a "ground truth" as would be done for diagnostic accuracy studies.
8. The sample size for the training set:
This information is not applicable/not provided. There is no "training set" for this type of mechanical device submission.
9. How the ground truth for the training set was established:
This information is not applicable/not provided. No training set or associated ground truth was established for this device.
Summary of Substantial Equivalence and Safety/Effectiveness Demonstration:
The safety and effectiveness of the CROMAX Turbine Handpiece are established through its substantial equivalence to already legally marketed predicate devices. The document highlights the following points to support this claim:
- Construction and Materials: "The handpiece is constructed of the same specifications as the predicate device to ensure biocompatibility." It is made of stainless steel for corrosion resistance.
- Operating Mechanism: It is an air-driven high-speed dental handpiece with an air-driven turbine, similar to the predicate devices.
- Functionality: It provides appropriate power and speed for use with dental carbide burrs and diamond cutting instruments, and includes water spray for cooling.
- Sterilization: It can be sterilized by the steam autoclave method, a common method for dental instruments.
- Key Components: It uses "technically supported and adopted key components of rotor and ball bearing from Bien-Air, Switzerland."
- Standards Compliance: "The handpiece conforms to applicable ISO standards." This is a crucial element for demonstrating safety and performance in line with internationally recognized benchmarks.
In essence, the "study" demonstrating the device meets the "acceptance criteria" here is the 510(k) review process itself, where the FDA determined that the CROMAX Turbine Handpiece has the same intended use and fundamentally similar technological characteristics to the predicate devices, and that any differences do not raise new questions of safety or effectiveness. The "acceptance criteria" are implicitly met by successfully demonstrating substantial equivalence through comparison to the predicate devices and adherence to relevant standards.
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OCT 2 2 2004
Summary
510(k) Summary of safety and effectiveness
Date: 6/17/2004
| Submission By: | JR Medical Technologies, Inc.6650 Cottage Hill Road, Suite 307Mobile, AL 36695 |
|---|---|
| Manufactured by: | Shanghai Foshion Medical Instrument Co.,Ltd.Buld.15, NO. 1515 Yuandong Rd(N)Fengxian District,Shanghai 201401China |
| Contact: | John Rhim251-895-0303251-479-7777 Faxjohnrhim@hotmail.com |
| Device Name: | CROMAX turbine handpiece |
| Common Name: | Handpiece, air-powered, dental |
| Classification Name: | Dental handpiece |
| Device Class: | Class I |
| Product Code: | 76 EFB |
| Code of Federal Regulations: | 21 CFR § 872.4200 |
| Indications for Use: | The device is an air-powered dentalhandpiece for use in general dentistry. |
| Predicate Device Name: | T1 Line Dental Handpieces, K972436 andRapidd Highspeed Dental HandpieceK003518 |
Description of Device:
The CROMAX Turbine Handpiece is an air-driven high-speed dental handpiece. It has an airdriven turbine with appropriate power and speed for use with dental carbide burrs and diamond cutting instruments. Construction is stainless steel for corrosion resistance. It has water spray for cooling of the cutting burr. One model has push-button chucking mechanism to grip cutting instrument with ISO standard shanks.
The CROMAX Turbine Handpiece may be sterilized by the steam autoclave method. The bearing are sealed.
Technically supported and adopted key components of rotor and ball bearing from § •››Air, Switzerland. Foshion produced CROMAX turbine handpiece and powered by Bien -- ir.
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Substantially Equivalence - Safety and Effectiveness:
CROMAX Turbine Handpiece is substantially equivalent to one or are air-powered dental handpieces currently marketed in the USA. The handpiece is constructed of the same specifications as the predicate device to ensure biocompatibility. The handpiece conforms to applicable ISO standards.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three overlapping lines forming a wing-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 2 2004
J.R. Medical Technologies, Incorporated C/O Mr. J. Harvey Knauss Contract Consultant Delphi Consulting Group 11874 South Evelyn Circle Houston, Texas 77071-3404
Re: K041755
Trade/Device Name: CROMAX Turbine Handpiece Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: October 14, 2004 Received: October 18, 2004
Dear Mr. Knauss:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becamined 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 Interstate commerce prior to fray are been reclassified in accordance with the provisions of Amendinens, or to active and Cosmetic Act (Act) that do not require approval of a premarket the Federal 1 600; Drag, Drag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of the stration, 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 (1 Wry, It may be basyon 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 – Mr. Knauss
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA S Issualled of a sacceantles with other requirements mean that FDA has made a decemination that your and ministered by other Federal agencies.
of the Act or any Federal statutes and regulations and real that and the registratio of the Act of any rederal statutes and registements, including, but not limited to: registration
You must comply with all the Act's requirements, including and manufacturing You must comply with an the Act 3 required interest 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gract 820'; and i and listing (21 CFR Part 807), laboring (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 821, 542 of the Ar requirements as set form in the quality systems (Sections 531-542 of the Act);
applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maticeming your alence of your device to an premarket nothleation. The I Dr Intellig of obserm.
Iegally 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), If you desire specific advice for your de recognize . Also, please note the regulation prease contact the Other of Other of Comphariet notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Illay obtain other general micromational and Consumer Assistance at its toll-free Division of Bircason or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Qurs
Chiu Lin, Ph.D. 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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Indications for Use
510(k) Number
Device Name: CROMAX Turbine Handpiece
Indications for Use: The device is an air-powered dental handpiece for use in general dentistry.
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)
Sumana
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Continess Control Dental Devices Division of Anesthesionogy,
510(k) Number:
§ 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.