(90 days)
The Cell Robotics, Inc. Ultra-Light laser system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthamology.
The Cell Robotics Ultra-Light Laser System is an Er: Y AG laser producing emission at a wavelength of 2940nm. The laser consists of two interconnected sections: The cabinet which houses the power supply, the cooling system and the electronics, and; the umbilical cables and the handpiece, which houses the laser.
This 510(k) summary for the Cell Robotics Ultra-Light Laser System states "Nonclinical Performance Data: None Required" and "Clinical Performance Data: None Required". Therefore, a study proving the device meets acceptance criteria was not part of this submission, nor were acceptance criteria explicitly defined in terms of device performance metrics.
The FDA's decision to clear the device was based on a finding of substantial equivalence to legally marketed predicate devices, rather than on new performance data demonstrating its adherence to specific acceptance criteria.
Therefore, most of the information requested in your prompt cannot be provided from the given document, as no performance study was conducted or submitted:
Here's what can be inferred or explicitly stated based on the provided text:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as performance metrics. The implicit acceptance criterion for this 510(k) submission was "substantial equivalence" to predicate devices.
- Reported Device Performance: No specific performance data (e.g., accuracy, precision) was reported or required for this 510(k) submission.
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, as no performance study was conducted.
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 no performance study was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as no performance study 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 system, not an AI diagnostic tool, and no clinical performance studies were required or submitted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a laser system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable, as no performance study was conducted.
8. The sample size for the training set:
- Not applicable, as no performance study was conducted.
9. How the ground truth for the training set was established:
- Not applicable, as no performance study was conducted.
Summary from the document:
The Cell Robotics Ultra-Light Laser System was cleared based on its substantial equivalence to three legally marketed predicate devices:
- Schwartz Electro-Optics TriLase2940, K# 954013
- Cell Robotics Er: YAG Laser System, K# 970461
- Asceplion-Meditec Dermastar Er: YAG Laser System, K#014057
The FDA determined that "Nonclinical Performance Data: None Required" and "Clinical Performance Data: None Required" for this submission, indicating that the device's technological characteristics and intended use were sufficiently similar to the predicates that new performance studies were not deemed necessary to establish safety and effectiveness.
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Attachment I
510(K) Summary Cell Robotics Ultra-Light Laser System
This 510(K) Summary of safety and effectiveness for the Cell Robotics Ultra-Light Laser System is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
| Applicant: | Cell Robotics, Inc. |
|---|---|
| Address: | 2715 Broadbent Parkway NEAlbuquerque, NM 87107 |
| Contact Person: | Glen Goff, Manager of Regulatory Affairs |
| Telephone:Telefax: | (505) 343-1131 Ext. 124(505) 344-8112 |
| Preparation Date: | 05/21/02 |
| Device Trade Name: | Cell Robotics Ultra-Light Laser System |
| Common Name: | Erbium:YAG laser device |
| Classification Name: | Instrument, Powered, Laser79-GEX21 CFR 878-48 |
| Legally Marketed PredicateDevice: | Schwartz Electro-Optics TriLase2940, K# 954013Cell Robotics Er: YAG Laser System, K# 970461Asceplion-Meditec Dermastar Er: Y AG Laser System,K#014057 |
| Description of the Device | The Cell Robotics Ultra-Light Laser System is an Er: Y AGlaser producing emission at a wavelength of 2940nm. Thelaser consists of two interconnected sections: The cabinetwhich houses the power supply, the cooling system andthe electronics, and; the umbilical cables and thehandpiece, which houses the laser. |
| Intended Use of the Device | The Cell Robotics, Inc. Ultra-Light Laser System isintended for coagulation, vaporization, ablation, or cuttingof soft tissue (skin) in dermatology, plastic surgery(including aesthetic surgery), oral surgery, andophthamology. |
| Nonclinical PerformanceData: | None Required |
| Clinical Performance Data: | None Required |
| Conclusion: | The Cell Robotics Ultra-Light Laser System issubstantially equivalent to other existing legally marketedlaser systems currently in commercial distribution. |
| Additional Information: | None requested at this time |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a design that suggests forward movement or progress.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cell Robotics, Inc. Glen Goff Manager of Regulatory Affairs 2715 Broadbent Parkway, NE Albuquerque, New Mexico 87107
Re: K021946
Trade/Device Name: Cell Robotics Ultra-Light Laser System Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: June 12, 2002 Received: June 13, 2002
Dear Mr. Goff:
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. Ilsting 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 listing (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. Glen Goff
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
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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INDICATION FOR USE STATEMENT
K 621946 510(k) Number: .
Device Name: Cell Robotics Ultra-Light Laser System
Indications for Use:
The Cell Robotics, Inc. Ultra-Light laser system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthamology.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Styplurth
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K021946
Prescription Use
(per 21 CFR 801.109)
OR
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.