(155 days)
The Cell Robotics, Inc. unnamed Er: YAG Surgical laser is indicated for use in small and large joint Arthroscopy, including microdiscectomies, endoscopic procedures and general surgical procedures for cutting (incision / excision), vaporizing and coagulation of soft tissues, including skin, subcutaneous tissue, muscle, meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
The Cell Robotics Er:YAG Surgical Laser is an Er:YAG laser producing laser emission at 2940nm. The laser consists of three interconnected sections: The cabinet which houses the power supply, the cooling system and the microcontroller, the swing arm and the handpiece, which houses the laser.
The provided text is a 510(k) summary for the Cell Robotics Er:YAG Pulsed Surgical Laser System. It focuses on establishing substantial equivalence to a predicate device and does not contain specific details about acceptance criteria, a study proving device performance against those criteria, or the methodology of such a study.
Therefore, most of the requested information cannot be extracted from this document.
Here's what can be inferred or stated based on the provided text:
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A table of acceptance criteria and the reported device performance
- Not applicable / Not provided. The document states "Nonclinical Performance Data: None" and "Clinical Performance Data: None". The basis for clearance is substantial equivalence to a predicate device, not performance against specific acceptance criteria presented in a study within this document.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. No test set or performance data is mentioned.
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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 / Not provided. No ground truth or expert involvement for test data is mentioned.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No adjudication method for test data is mentioned.
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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 / Not provided. This device is a surgical laser, not an AI-assisted diagnostic tool. No MRMC study is mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This is a physical surgical device, not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable / Not provided. No ground truth data is mentioned or used for device performance assessment in this submission. The "ground truth" for regulatory clearance is the substantial equivalence to a legally marketed predicate device.
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The sample size for the training set
- Not applicable / Not provided. There is no indication of a training set as this is not a machine learning device, nor is a study involving performance data mentioned.
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How the ground truth for the training set was established
- Not applicable / Not provided. No training set is mentioned.
Summary based on the document:
The Cell Robotics Er:YAG Pulsed Surgical Laser System was cleared based on its substantial equivalence to a predicate device, the Schwartz Electro-Optics TriLase2940 (K954013). The submission explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None." Therefore, the document does not describe acceptance criteria, a study proving the device meets acceptance criteria, or any associated data regarding sample sizes, ground truth, or expert involvement.
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K9 70461
JUL 1 1 1997
1 1 1 1 1 1 1 1 1
Attachment I 510(K) Summary Cell Robotics Er:YAG Pulsed Surgical Laser System
This 510(K) Summary of safety and effectiveness for the Cell Robotics Er:YAG Surgical 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 NE.Albuquerque, NM 87107 |
| Contact Person: | Connie White, Manager of Regulatory Affairs |
| Telephone: | (505) 343-1131 Ext. 108(505) 344-8112 |
| Preparation Date: | 1-31-97 |
| Device Trade Name: | Cell Robotics Er:YAG Surgical Laser (to be determined) |
| Common Name: | Er: YAG Pulsed Surgical Laser |
| Classification Name: | Instrument, Surgical, Powered, laser79-GEX21 CFR 878-48 |
| Legally Marketed Predicate Device: | Schwartz Electro-Optics TriLase2940510(K) # K 954013 |
| Description of the Cell Robotics Er:YAGSurgical Laser: | The Cell Robotics Er:YAG Surgical Laser is an Er:YAGlaser producing laser emission at 2940nm. The laser consistsof three interconnected sections: The cabinet which housesthe power supply, the cooling system and the microcontroller,the swing arm and the handpiece, which houses the laser. |
| Intended use of the Cell Robotics Er:YAGSurgical Laser: | The Cell Robotics, Inc. unnamed Er:YAG Surgical laser isindicated for use in small and large joint Arthroscopy,including microdiscectomies, endoscopic procedures andgeneral surgical procedures for cutting (incision / excision),vaporizing and coagulation of soft tissues, including skin,subcutaneous tissue, muscle, meniscus, mucous membrane, ,lymph vessels and nodes, organs and glands. |
| Nonclinical Performance Data:Clinical Performance Data: | NoneNone |
| Conclusion: | The Cell Robotics Er:YAG Surgical Laser System issubstantially equivalent to other existing surgical lasersystems in commercial distribution for dermatologytreatments such as skin resurfacing and dermabrasion.None requested at this time |
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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 image of three human profiles facing to the right. The profiles are stacked on top of each other, with the bottom profile having a curved shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Connie White Cell Robotics, Inc. 2715 Broadbent Parkway, NE --------Albuquerque, New Mexico 87107
JUL 11 1997
Re : K970461 Cell Robotics Er:YAG Surgical Laser Requlatory Class: II Product Code: GEX Dated: May 21, 1997 Received: May 28, 1997
Dear Ms. White:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory
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Page 2 - Ms. Connie White
In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
[signature]
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE STATEMENT
510(k) Number:
Device Name: Cell Robotics Er: Y AG Surgical Laser
Indications for Use: '
The Cell Robotics, Inc. unnamed Er: YAG Surgical laser is indicated for use in small and large joint Arthroscopy, including microdiscectomies, endoscopic procedures and general surgical procedures for cutting (incision / excision), vaporizing and coagulation of soft tissues, including skin, subcutaneous tissue, muscle, meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
totte
VDivision Sign-Off
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K970461
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.