(48 days)
The Cell Robotics Lasette Laser Skin Perforator is intended for use by qualified healthcare professionals for collecting capillary blood samples from adult patients, for subsequent determination of blood glucose concentration and hematocrit using optically based measurement techniques.
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 text does not contain specific acceptance criteria or detailed results from the clinical studies. It merely states that "Results from the clinical trials indicate that the device is safe and effective." Therefore, I cannot complete a table of acceptance criteria and reported device performance, nor can I provide detailed answers to most of the other questions.
Here's a breakdown of what can and cannot be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in text | 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: Not specified.
- Data Provenance: The text states the device was investigated in "two human clinical trials under approved Investigational Device Exemptions." This implies prospective data collection, likely within the United States given the FDA context, but the country of origin 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 specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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
- The device is a laser skin perforator, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study is not applicable, and no effect size would be relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This question is not applicable as the device is a physical medical device (laser skin perforator) and not an algorithm. Its performance is inherent to its mechanical and optical function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The purpose of the device is to "ablate skin tissue to establish capillary blood access" for collecting samples for glucose and hematocrit determination. The ground truth for safety and effectiveness would likely involve measures such as:
- Successful blood collection rate: The ability to consistently obtain a sufficient capillary blood sample.
- Pain assessment: Patient-reported pain levels compared to traditional lancets.
- Ablation characteristics: Depth, diameter, and consistency of the perforation.
- Healing time/side effects: Observation of the skin after perforation.
- Blood sample quality: Comparison of blood glucose and hematocrit results with those obtained via venous draws or standard lancets.
- The text does not specify which of these were used, only that the device was found "safe and effective."
8. The sample size for the training set
- Not applicable. The device is a hardware product, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable (as above).
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OCT 2 8 1997
Appcadix B 510(K) Summary Cell Robotic's Lasette Laser Skin Perforator
This 510(K) Summary of safety and effectiveness for the Cell Robotic's Laser Skin Perforator is I his JTO(K) Sunnika y of saley and encourt 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: | (505) 343-1131 Ext. 108(505) 344-8112 |
| Preparation Date: | 9 4 97 |
| 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 TechnidyneTriLasc 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 of the Cell Robotic's LasetteLaser Skin Perforator | Ablation of skin tissue to establish capillary blood access. |
| Indications for use | The Cell Robotics Lasette Laser Skin Perforator is intendedfor use by qualified healthcare professionals for collectingcapillary blood samples from adult patients, for subsequentdetermination of blood glucose concentration and hematocritusing optically based measurement techniques. |
| Contraindications for Use | The Lasette should not be used to collect samples for use inanalyzers that require complex sample transfer procedures. |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | The subject device has been investigated in two humanclinical trials under approved Investigational DeviceExemptions. Results from the clinical trials indicate that thedevice is safe and effective. |
| 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/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three legs, representing health, hope, and service. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
OCT 28 1997
Ms. Connie White Manager of Regulatory Affairs Cell Robotics, Inc. 2715 Broadbent Parkway, NE Albuquerque, New Mexico 87107
Re: K973431 Trade Name: Cell Robotics Lasette Regulatory Class: II Product Code: GEX Dated: September 5, 1997 Received: September 10, 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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,
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: K973431
Device Name: Lasette laser skin perforator
Indications for Use:
The Cell Robotics Laser Skin Perforator is intended for use by qualified healthcare professionals for collecting capillary blood samples from adult patients, for subsequent determination of blood using optically based concentration and hematocrit glucose measurement techniques.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
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.