(148 days)
The Smart CO₂ surgical laser is indicated for the incision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, endoscopic/laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic surgery, and urology for surgical and aesthetic applications.
Smart CO₂ is a CO₂ laser, having a sealed CO₂ gas tube as the lasing medium. It is a laser with a wavelength of 10.6 µm. Laser activation is by foot switch. Overall weight of the laser is 25 Kg, and the size is 180x62x42 cm (HxWxD). Electrical requirement is 110 VAC, 15A, 50-60 Hz, single phase.
The provided text mentions "Nonclinical Performance Data: none" and "Clinical Performance Data: none". This indicates that no specific studies were submitted to establish acceptance criteria or demonstrate device performance for the Smart CO2 laser. The 510(k) clearance was based on substantial equivalence to predicate devices, not on direct performance studies of the Smart CO2 itself.
Therefore, I cannot provide the information requested in the prompt based on the provided text.
Here's why each point cannot be addressed:
- A table of acceptance criteria and the reported device performance: No performance data or acceptance criteria are reported for the Smart CO2.
- Sample sized used for the test set and the data provenance: No test set was used for performance evaluation of the Smart CO2.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No test set was used.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: No test set was used.
- 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: No such study was conducted, as this device is a medical laser, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical laser, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth was established as no performance studies were conducted for the Smart CO2.
- The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
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OCT = 1 2003
:
KD31440 1 of 1
510(K) Summary
| Submitter: | Cynosure, Inc.10 Elizabeth DriveChelmsford, MA 01824 |
|---|---|
| Contact: | George ChoSenior Vice President of Medical Technology |
| Date Summary Prepared: | May 5, 2003 |
| Device Trade Name: | Smart CO₂ |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser79-GEX21 CFR 878.48 |
| Equivalent Device: | Luxar NovaPulse and Asclepion Multipulse |
| Device Description: | Smart CO₂ is a CO₂ laser, having a sealed CO₂ gas tube as the lasingmedium. It is a laser with a wavelength of 10.6 µm. |
| Laser activation is by foot switch. Overall weight of the laser is 25Kg, and the size is 180x62x42 cm (HxWxD). | |
| Electrical requirement is 110 VAC, 15A, 50-60 Hz, single phase. | |
| Intended Use: | The Smart CO₂ laser is indicated for incision, excision, ablation,vaporization and coagulation of body soft tissues including intraoraltissues. |
| Comparison: | The Smart CO₂ laser is substantially equivalent to the LuxarNovaPulse and Asclepion Multipulse laser, with the same principle ofoperation, the same wavelength and essentially the same power rangeas the predicate devices for the same indications for uses. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The Smart CO₂ laser is another safe and effective device for body softtissue, including intraoral soft tissue applications. |
| Additional Information: | none |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of a human profile with three overlapping faces, suggesting a sense of community and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the image, emphasizing the organization's name and national affiliation. The logo is presented in black and white, giving it a clean and professional appearance.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 1 2003
Mr. George Cho Senior Vice President of Medical Technology Cynosure, Inc. 10 Elizabeth Drive Chelmsford, Massachusetts 01824
Re: K031440 Trade/Device Name: Smart CO2 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 22, 2003 Received: August 25, 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 either 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 lisung (21 CFR Part 807); labeling (21 CFR Part 801); 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.
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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
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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510(k) Number (if known): _ KO31440
Device Name: Smart CO2 (Smart US 20D, Smart Clinic) Laser
Indications For Use:
The Smart CO, surgical laser is indicated for the incision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, endoscopic/laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic surgery, and urology for surgical and aesthetic applications.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K631440
Prescription Use
Over-The-Counter Use_
§ 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.