(203 days)
The Cell Robotics Lasette Laser Skin Perforator is indicated for obtaining capillary blood samples for subsequent analysis of blood glucose concentration, in both institutional and at-home settings.
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 the patient's fingertip comparable to that produced by commonly used stainless steel blood lancets.
The provided 510(k) summary for the Cell Robotics' Lasette Laser Skin Perforator states that no acceptance criteria are explicitly defined within this document. The summary only mentions that two human clinical trials were conducted, and their results "indicate that the device is safe and effective." However, it does not provide specific performance metrics or thresholds for what constitutes "safe" or "effective."
Therefore, much of the requested information cannot be extracted directly from this document.
Here's the information that can be extracted, and where the document is lacking:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "Results from the clinical trials indicate that the device is safe and effective." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified. The document only mentions "two human clinical trials."
- Data provenance: Not specified (e.g., country of origin). The trials were "human clinical trials relating to use in an at-home setting." It implies prospective data collection, but this is not explicitly stated.
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/Not specified. The device is a physical tool for obtaining blood samples. Ground truth in this context would likely relate to the quantity and quality of blood samples obtained and patient experience (e.g., pain, ease of use), rather than expert interpretation of images or data. No information about experts establishing ground truth is provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. Adjudication methods are typically relevant for studies involving subjective interpretations (e.g., image reading by multiple experts). This document describes performance in obtaining capillary blood samples, which would involve objective measurements and patient feedback.
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 skin perforator, not an AI-assisted diagnostic tool. Therefore, an MRMC study or assessment of human reader improvement with AI is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical device, not an algorithm. Its performance is always with human interaction (the user applying the device).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated. Given the device's function, ground truth would likely involve:
- Successful blood sample acquisition: Was enough blood obtained for analysis?
- Pain assessment: Patient-reported pain levels compared to traditional lancets.
- Ease of use: User feedback.
- Safety outcomes: Adverse events (e.g., skin reactions, infections, though none are mentioned).
- The summary states "Results from the clinical trials indicate that the device is safe and effective," implying these types of outcomes were measured.
8. The sample size for the training set
- Not applicable. The concept of a "training set" is relevant for machine learning algorithms. This device is a physical medical device, not an AI system.
9. How the ground truth for the training set was established
- Not applicable for the same reason as point 8.
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DEC 7 1998
981746
510(K) Summary Cell Robotic's Lasette Laser Skin Perforator
This 510(K) Summary of safety and effectiveness for the Cell Robotic's Lasette Laser Skin Perforator is This 91Q(x) Banakage 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: | Connie White, Manager of Regulatory Affairs |
| Telephone: | Phone: (505) 343-1131 Ext. 108telefax: (505) 344-8112 |
| Preparation Date: | 5-13-98 |
| Device Trade Name: | Cell Robotics' Lasette |
| Common Name: | Laser skin perforator |
| Classification: | Class II |
| Legally Marketed Predicate Device: | Glucolet Steel Lancet Mfg. By Bayer DiagnosticsFeather-Touch Steel Lancet Mfg. by Ulster ScientificTenderlett Steel lances Mfg. By International TechnidyneTriLase 2940 Mfg. by Schwartz Electro-OpticsMedlite Mfg. by Continuum BiomedicalProtégé Mfg. By Xintec Corp. |
| Description of the Cell Robotic's LasetteLaser Skin Perforator | The Cell Robotics Lasette laser skin perforator is a portablebattery operated laser device. The device produces a singlepulse of laser light which ablates a small hole in the patient'sfingertip comparable to that produced by commonly usedstainless steel blood lancets. |
| Intended use | Ablation of skin tissue to establish capillary blood access. |
| Indications for use | The Cell Robotics Lasette Laser Skin Perforator is indicatedfor obtaining capillary blood samples for subsequent analysisof blood glucose concentration, in both institutional and at-home settings. |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | The subject device has been investigated in two humanclinical trials relating to use in an at-home setting. Resultsfrom the clinical trials indicate that the device is safe andeffective. |
| Conclusion: | The Cell Robotic's Lasette Laser Skin Perforator issubstantially equivalent to the predicate devices. |
| Additional Information: | None requested at this time |
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Image /page/1/Picture/2 description: The image shows a black and white logo of the Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 7 1998
Ms. Connie White Manager of Regulatory Affairs Cell Robotics, Inc. 2715 Broadbent Parkway, North East Albuquerque, New Mexico 87107
Re: K981746 Trade Name: Lasette Laser Skin Perforator Regulatory Class: II Product Code: GEX Dated: September 2, 1998 Received: September 8, 1998
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 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 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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This letter will allow you to begin marketing your device as described in your 510(k) I has letter wifi anow your your 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,
Celia M. Witten, Ph 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: K981746
Device Name: Lasette laser skin perforator
Indications for Use:
(per 21 CFR 801.109)
The Cell Robotics Lasette Laser Skin Perforator is indicated for obtaining capillary blood samples for subsequent analysis of blood glucose concentration, in both institutional and at-home settings.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K981746 |
| Prescription Use | 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.