(152 days)
The Smart 2940D Er:YAG Laser system is indicated to be used for ablation, incision, excision, vaporization and coagulation of hard and soft intraoral tissue. The procedures include caries removal, cavity preparation and enamal etching.
Smart 2940D is a Er:YAG laser, having a Er:YAG crystal rod as the lasing medium. It is a laser with a wavelength of 2,940 nm. Laser activation is by footswitch. Overall weight of the laser is 47 Kg, and the size is 145x23x65 cm (HxWxD). Electrical requirement is 230 VAC, 15A, 50-60 Hz, single phase.
This device, the Smart 2940D Laser, did not undergo a study to prove its performance against specific acceptance criteria in the sense of a typical diagnostic algorithm. The provided information is a 510(k) summary for a medical laser system seeking substantial equivalence to existing devices, not a study evaluating an AI device's performance.
Here's an analysis of the provided information in the context of your questions, explaining why many of those questions are not applicable to this submission:
1. A table of acceptance criteria and the reported device performance
- Not applicable. This submission is for a medical device (a laser) and not a diagnostic algorithm. Therefore, there are no "acceptance criteria" related to diagnostic performance metrics (like sensitivity, specificity, or AUC) that would be reported for an AI/algorithm-based device. The "performance" for such a device is typically assessed through safety and efficacy, often by comparing it to 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)
- Not applicable. No clinical test set data is presented or required for this type of 510(k) submission. The "Nonclinical Performance Data" and "Clinical Performance Data" sections explicitly state "none." Substantial equivalence in this case is primarily based on comparison of the device's characteristics and intended use to legally marketed predicate devices.
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)
- Not applicable. As there is no test set or diagnostic performance evaluation, there is no ground truth to be established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or diagnostic performance evaluation was conducted.
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. This device is a laser for surgical applications, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reading improvement with AI is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware medical device (a laser), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. As there is no diagnostic algorithm being evaluated, there is no ground truth of this nature required.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set was used for this device.
Summary of the K031389 510(k) Submission:
The K031389 submission for the Cynosure Smart 2940D Laser is a 510(k) Premarket Notification seeking to demonstrate substantial equivalence to predicate devices already on the market (Fotona Fidelis & American Dental Technologies Pulsemaster Er:Y:YAG).
The basis for substantial equivalence is documented as follows:
- Intended Use: The Smart 2940D is indicated for ablation, incision, excision, coagulation, and vaporization of intraoral hard and soft tissue, with specific procedures including caries removal, cavity preparation, and enamel etching. This is equivalent to the intended uses of the predicate devices.
- Principle of Operation: The device is an Er:YAG laser with a wavelength of 2,940 nm, operating on the same principle as the predicate devices.
- Wavelength: 2,940 nm, which is the same as the predicate devices.
- Pulse Energy Range: Essentially the same as the predicate devices.
- Performance Data: The submission explicitly states "Nonclinical Performance Data: none" and "Clinical Performance Data: none." This indicates that the FDA did not require new performance studies for this particular 510(k) submission, likely because the device's characteristics and intended use were sufficiently similar to the legally marketed predicate devices to warrant a determination of substantial equivalence based on technical specifications and comparison.
In conclusion, the questions posed are designed for the evaluation of AI/algorithm-driven diagnostic devices. The Smart 2940D Laser is a conventional medical laser system, and its approval through the 510(k) process relied on demonstrating substantial equivalence to pre-existing, legally marketed devices rather than undergoing de novo clinical performance studies or AI-specific validation.
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OCT = 1 2003
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510(K) Summary
| Submitter: | Cynosure, Inc.10 Elizabeth DriveChelmsford, MA 01824 |
|---|---|
| Contact: | George ChoSenior Vice President of Medical Technology |
| Date Summary Prepared: | May 1, 2003 |
| Device Trade Name: | Smart 2940D Laser |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser79-GEX21 CFR 878.48 |
| Equivalent Device: | Fotona Fidelis & American Dental Technologies Pulsemaster Er:Y:YAG |
| Device Description: | Smart 2940D is a Er:YAG laser, having a Er:YAG crystal rod as thelasing medium. It is a laser with a wavelength of 2,940 nm. |
| Laser activation is by footswitch. Overall weight of the laser is 47 Kg,and the size is 145x23x65 cm (HxWxD). | |
| Electrical requirement is 230 VAC, 15A, 50-60 Hz, single phase. | |
| Intended Use: | The Smart 2940D is indicated for ablation, incision, excision,coagulation and vaporization of intraoral hard and soft tissue. |
| Comparison: | The Smart 2940D laser has an equivalent indication for uses, the sameprinciple of operation, the same wavelength and essentially the samepulse energy range as the predicate devices. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The Smart 2940D laser is another safe and effective device forintraoral hard and soft tissue applications. |
| Additional Information: | none |
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines that resemble a ribbon or wave. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
OCT - 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. George Cho Senior Vice President of Medical Technology Cynosure, Inc. 10 Elizabeth Drive Chelmsford, Massachusetts 01824
Re: K031389 Trade/Device Name: Smart 2940D Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: August 15, 2003 Received: August 18, 2003
Dear Mr. Cho:
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 cither 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. George Cho
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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Miriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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<031380 510(k) Number (if known):
Device Name: _Cynosure Smart 2940D Laser
Indications For Use:
The Smart 2940D Er:YAG Laser system is indicated to be used for ablation, incision, excision, vaporization and coagulation of hard and soft intraoral tissue.
The procedures include caries removal, cavity preparation and enamal etching.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K031389
Prescription Use
OR
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.