(234 days)
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.
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.
The provided text describes the "Lasette™ LASER SKIN PERFORATOR" and its 510(k) summary, but it primarily focuses on establishing substantial equivalence to existing devices and performance standards for laser products. It does not contain a detailed study with specific acceptance criteria and reported device performance in the format requested.
However, based on the information provided regarding the "Performance Data," I can infer and construct a response to the best of my ability, highlighting what is present and what is missing.
Here's an analysis based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria in a table format, nor does it provide detailed numerical results for each criterion. It broadly states conclusions from the studies.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Clinical Performance: | |
| Effect on reliability of analytical results (blood glucose, hematocrit) | Results of glucose and hematocrit determinations are not significantly affected by use of the device. |
| Technical Performance (In Vitro): | |
| Accuracy of output energy indicator | Represents output energy to within 20% of the indicated value. |
| Penetration depth | Approximately half of the depth predicted by the equation d=H/F. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for either the clinical human trial or the in vitro testing.
- Data Provenance:
- Clinical Trial: A "human clinical trial" was directed toward determining the effect of use upon reliability of analytical results. The country of origin is not specified, but the applicant (Cell Robotics, Inc.) is based in Albuquerque, New Mexico, USA, suggesting a US-based study is likely. The text implies a prospective study since it was "directed toward determining."
- In Vitro Testing: "Certain in vitro testing has been done to establish reliability of output energy calibration and depth of penetration." Details on specific provenance are not given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the text. The concept of "experts" and "ground truth" in the context of reading clinical data (like blood glucose or hematocrit) is not discussed. The clinical trial focused on whether the device's use affected the reliability of subsequent measurements, implying the measurements themselves (glucose, hematocrit) were performed by standard laboratory methods, not interpreted by experts in the context of device performance.
4. Adjudication method for the test set:
- This information is not provided as the nature of the study (determining effect on analytical results and technical specifications) does not typically involve adjudication in the way image analysis or diagnostic studies might.
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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a laser skin perforator, not an AI-powered diagnostic or interpretive tool that human readers would use or improve with.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable to the Lasette device as described. It is a physical medical device for blood sampling, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Clinical Trial: The "ground truth" implicitly refers to the accurate determination of blood glucose concentration and hematocrit using established colorimetric measurements. The study aimed to show that the Lasette's use did not alter these standard measurements.
- Technical Testing: For output energy, the ground truth would be a calibrated measurement of the laser's actual energy output. For penetration depth, it would be a physical measurement of the wound depth post-ablation.
8. The sample size for the training set:
- This information is not provided and is not applicable. The Lasette is a physical device, not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established:
- This information is not provided and is not applicable, as there is no "training set" for this type of device.
Summary of the Study:
The "Performance Data" section describes two main types of studies:
-
Human Clinical Trial:
- Purpose: To determine if using the Lasette impacts the reliability of subsequent blood glucose and hematocrit measurements.
- Finding: "Results of glucose and hematocrit determinations are not significantly affected by use of the device."
- Missing Information: Sample size, details of study design, precise methodology, statistical significance levels, country of origin, and whether it was prospective/retrospective are not explicitly detailed beyond the general statement.
-
In Vitro Testing:
- Purpose: To establish reliability of output energy calibration and depth of penetration.
- Findings:
- Output energy indicator is within 20% of the indicated value.
- Penetration depth is approximately half of the depth predicted by a theoretical equation (d=H/F).
- Missing Information: Sample size for these tests, specific methods used for calibration and depth measurement.
In conclusion, the document provides high-level summaries of performance data but lacks the granular detail of specific acceptance criteria and study methodologies often found in more comprehensive technical reports or clinical trial summaries. The focus of the 510(k) submission is on demonstrating "substantial equivalence" and adherence to laser safety standards rather than extensive clinical efficacy or detailed performance metrics against quantitative acceptance criteria for blood sampling.
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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.
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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.
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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.
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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
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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)
§ 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.