(155 days)
K 954013
Not Found
No
The document describes a laser device and its intended uses, but there is no mention of AI, ML, image processing, or any related concepts.
Yes
The device is indicated for use in surgical procedures (cutting, vaporizing, and coagulation of soft tissues), which directly treats medical conditions or alters the body's structure or function.
No
Explanation: The "Intended Use" section describes the device for surgical procedures like cutting, vaporizing, and coagulation of tissues. This indicates therapeutic functions, not diagnostic ones.
No
The device description explicitly states it consists of hardware components: a cabinet housing power supply, cooling system, and microcontroller, a swing arm, and a handpiece housing the laser.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical laser for cutting, vaporizing, and coagulating soft tissues during various surgical procedures. This is a therapeutic and surgical application, not a diagnostic one.
- Device Description: The device description details a surgical laser system, not a device designed to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body. This device is used in vivo (within the body) for surgical intervention.
N/A
Intended Use / 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.
Product codes
GEX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small and large joints, soft tissues (skin, subcutaneous tissue, muscle, meniscus, mucous membrane, lymph vessels and nodes, organs and glands).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Nonclinical Performance Data: None
Clinical Performance Data: None
Key Metrics
Not Found
Predicate Device(s)
K 954013
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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, laser |
| 79-GEX | |
| 21 CFR 878-48 | |
| Legally Marketed Predicate Device: | Schwartz Electro-Optics TriLase2940 |
| 510(K) # K 954013 | |
| Description of the Cell Robotics Er:YAG | |
| Surgical Laser: | 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. | |
| Intended use of the Cell Robotics Er:YAG | |
| Surgical Laser: | 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. | |
| Nonclinical Performance Data: | |
| Clinical Performance Data: | None |
| None | |
| Conclusion: | The Cell Robotics Er:YAG Surgical Laser System is |
| substantially equivalent to other existing surgical laser | |
| systems in commercial distribution for dermatology | |
| treatments such as skin resurfacing and dermabrasion. | |
| None requested at this time |
1
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
2
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
3
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__________________________________________________________________________________________________________________________________________________________