(234 days)
Not Found
Not Found
No
The description focuses on the laser technology and its physical effects, with no mention of AI or ML for analysis, control, or any other function.
No
The device is described as creating a small hole for blood sampling, which is a diagnostic purpose, not a therapeutic one. Its function is to facilitate the collection of blood for subsequent determination of blood glucose concentration and hematocrit, which are diagnostic measurements.
No
The device is used for skin perforation and establishing capillary blood access for blood sampling, which is a step preceding diagnostic measurements (glucose and hematocrit determination), but it does not perform the diagnostic measurement itself.
No
The device description explicitly states it is a "portable battery operated laser device" and details its hardware components (laser, battery, shields).
Based on the provided information, the Cell Robotics Lasette is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "skin perforation and establishing capillary blood access for blood sampling." This describes a device used to obtain a sample, not a device used to test a sample.
- Device Description: The device description focuses on the mechanism of creating a hole in the skin using a laser. It doesn't describe any components or processes related to analyzing biological samples.
- Performance Studies: The performance studies mentioned focus on the effect of using the device on the reliability of subsequent analytical results (glucose and hematocrit determinations) and the device's physical performance (energy calibration and penetration depth). They do not describe studies evaluating the device's ability to diagnose or provide information about a patient's health status based on the analysis of a sample.
- Predicate Devices: The predicate devices listed are "commercially available blood lancet devices" and "commercially available solid state laser devices for dermatological surgery." Blood lancets are used for obtaining blood samples, not for in vitro diagnosis. Dermatological lasers are used for treating skin conditions, not for in vitro diagnosis.
An IVD device is specifically designed to be used in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Cell Robotics Lasette's function is to facilitate the collection of a sample, which is then used with an IVD device (like a glucose meter or hematocrit analyzer) for diagnosis or monitoring.
Therefore, the Cell Robotics Lasette is a device used for sample collection, which is a step that precedes the use of an IVD device.
N/A
Intended Use / Indications for Use
The Cell Robotics Lasette is intended for use for skin perforation and establishing capillary blood access for blood sampling.
The Cell Robotics Lasette is indicated for use by qualified healthcare workers for perforation of the skin to draw capillary blood from healthy adult patients for subsequent determination of blood glucose concentration and hematocrit using colorimetric measurements.
Product codes
GEX
Device Description
The Cell Robotics Lasette laser skin perforator is a portable battery operated laser device. The device produces a single pulse of laser light which ablates a small hole in a patient's fingertip comparable to that produced by commonly used stainless steel blood lancets. The complete Lasette product includes the Lasette. its labeling and manual, and single-use sanitary (non-sterile) plastic iqns shelds. The Lasette uses a small convection-cooled erbium: YAG solid state laser with a maximum output energy of 0.5 J per pulse at a wavelength of 2.94 micrometers and a pulse width of 300 microsconds. This energy is focused on a target spot with a diameter of 300 micrometers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin (fingertip)
Indicated Patient Age Range
adult patients
Intended User / Care Setting
qualified healthcare workers
Prescription Use
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
The subject device has been investigated in a Performance Data: human clinical trial directed toward determining the effect of use upon reliability of apalyncal results. The study data supports a conclusion that results of glucose and hematocht determinations are not significantly affected by use of the device. Certain in vite testing has been done to establish reliability of output energy calibration and depth of penetration. These tests support a conclusion that the device energy indicator represents the output energy to within 20% of the indicated value and that penetration depth is approximately half of the depth predicted by the equation d=H/F, where d is wound depth H is the heat of ablation for water in Joules per unit volume, and F is the energy fluence projected by the device onto the skin.
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
Aud 1 4 1997
965124
2715 Broadbent Pa Albuquerque, NM 87107 Telephone: (505) 343-1131 Fax: (505) 344-811 http://www.cellrobotics.com/c
Contact Ms. Connie White Regulatory Affairs Officer
CELL ROBOTICS' LASETTE™ LASER SKIN PERFORATOR 510(k) SUMMARY
| 1. Date of Preparation: | August 13, 1997(Rev. 3) |
|---|---|
| 2. Device Name: | |
| .1 Common Name: | Laser Skin Perforator |
| .2 Tradename: | Lasette |
| 3. Intended Use: | The Cell Robotics Lasette is intended for use for skin perforation and establishing capillary blood access for blood sampling. |
| 4. Indications for Use: | The Cell Robotics Lasette is indicated for use by qualified healthcare workers for perforation of the skin to draw capillary blood from healthy adult patients for subsequent determination of blood glucose concentration and hematocrit using colorimetric measurements. |
| 6. FDA Device Classification: | Not classified under 21 CFR 862-892 or listed in CDRH publication #95-4246. Applicant suggests Class II. |
| 10. Applicant's FDA Registration Number: | (not yet received) |
- Applicant's FDA Registration Number: (not yet received)
The Cell Robotics Lasette laser skin 1 | Brief Product Description: perforator is a portable battery operated laser device. The device produces a single pulse of laser light which ablates a small hole in a patient's fingertip comparable to that produced by commonly used stainless steel blood lancets. The complete Lasette product includes the Lasette. its labeling and manual, and single-use sanitary (non-sterile) plastic iqns shelds. The Lasette uses a small convection-cooled erbium: YAG solid state laser with a maximum output energy of 0.5 J per pulse at a wavelength of 2.94 micrometers and a pulse width of 300 microsconds. This energy is focused on a target spot with a diameter of 300 micrometers.
1
The laser aspects of the Lasette are 11. Performance Standards: consistent with classification as a Class IV medical laser product and the device has been designed to comply with performance standard regulations under 21 CFR 1040.10 and 1040.11.
The Lasette is substantially equivalent, with 13. Substantial Equivalence: regard to aspects of therapeutic function and effect, to commercially available blood lancel devices. The Lasette is substantially equivalent, with regard to aspects of its technological characteristics, to commercially available solid state laser devices for dermatological surgery.
The subject device has been investigated in a Performance Data: ﻬﻮﺩ ﺍﻟﻤﻮﺿﻮﻋﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ haman clinical trial directed toward determining the effect of use upon reliability of apalyncal results. The study data supports a conclusion that results of glucose and hematocht determinations are not significantly affected by use of the device. Certain in vite testing has been done to establish reliability of output energy calibration and depth of penetration. These tests support a conclusion that the device energy indicator represents the output energy to within 20% of the indicated value and that penetration depth is approximately half of the depth predicted by the equation d=H/F, where d is wound depth H is the heat of ablation for water in Joules per unit volume, and F is the energy fluence projected by the device onto the skin.
2
Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is a stylized image of an eagle or bird-like figure, depicted with flowing lines to suggest movement or flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Connie White Manager of Regulatory Affairs Cell Robotics, Inc. ................................................................................. 2715 Broadbent Parkway, NE Albuquerque, New Mexico 87107
AUG 1 4 1097
Re: K965124 Trade Name: Lasette Laser Skin Perforator Regulatory Class: II Product Code: GEX Dated: May 15, 1997 Received: May 16, 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) 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 action. In addition, FDA may publish further announcements 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.
3
Page 2 - Ms. Connie White
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,
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
4
INDICATION FOR USE STATEMENT
510(k) Number : K965124
Device Name: Lasene laser skin perforator
Indications for Use:
12 11
Friday
The Cell Robotics Lasette is indicated for use by qualified healthcare workers for perforation of the skin to draw capillary blood from healthy adult patients for subsequent determination of blood glucose concentration and hematocrit using colorimetric measurements.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Acoole
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K965124
Prescription Use
(per 21 CFR 801.109)
OR
Over-the-Counter Use__
(Optional Format 1-2-96)