(17 days)
Ablation of skin for collecting capillary blood samples for subsequent analysis.
The Cell Robotic's Lasette Laser Skin Perforator is indicated for use by qualified healthcare professionals for the perforation of skin to draw capillary blood for screening purposes.
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 document is a 510(k) summary for the Cell Robotics' Clinical Lasette P-200 Laser Skin Perforator. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical performance data or detailed acceptance criteria for an AI/algorithm-based device.
Therefore, many of the requested details, particularly those related to acceptance criteria, sample sizes, ground truth establishment, expert involvement, and AI-specific studies (MRMC, standalone), are not applicable to this submission.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (N/A for this type of submission) | Reported Device Performance |
|---|---|
| Not applicable. This submission relies on substantial equivalence to a predicate device. No specific performance metrics or acceptance criteria for this device were reported in the summary in the typical sense of measuring accuracy, sensitivity, or specificity against predefined thresholds. | 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. |
Explanation: In a 510(k) for a device like this, the primary "acceptance criterion" is demonstrating that the new device is substantially equivalent to a legally marketed predicate device in terms of intended use, indications for use, technological characteristics, and safety and effectiveness. The summary explicitly states: "The Cell Robotic's Clinical Lasette P-200 Laser Skin Perforator is substantially equivalent to the predicate device."
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. The submission explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None." This indicates that no new clinical or nonclinical studies were conducted to generate a test set for this 510(k) submission.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No test set was described, and therefore, no expert-established ground truth for a test set was created for this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set was described.
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/algorithm-based diagnostic or assistive system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a laser skin perforator, not an AI/algorithm-based system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No ground truth in the context of diagnostic accuracy was established for this submission. The comparison is to "commonly used stainless steel blood lancets" based on the physiological outcome of creating a comparable perforation.
8. The sample size for the training set:
- Not applicable. This device is not an AI/algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This device is not an AI/algorithm that requires a training set.
Summary of Study (Based on 510(k) Content):
- Study Type: This is a 510(k) Premarket Notification submission, which is not a "study" in the traditional sense of generating new clinical or performance data for the device. Instead, it's a regulatory process to demonstrate substantial equivalence to a legally marketed predicate device.
- Proof of Meeting Acceptance Criteria: The "proof" is the claim of "substantial equivalence" to the predicate device (Cell Robotics, Inc. Lasette Plus). The FDA's letter (K033799) confirms that they reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications.
- Rationale for Substantial Equivalence: The summary indicates the device's functional description (portable, battery-operated, single pulse laser, ablates a small hole comparable to blood lancets) and its intended use/indications (ablation of skin for capillary blood sampling) are equivalent to the predicate. The absence of new nonclinical or clinical performance data implies that the manufacturer relied on the established safety and effectiveness of the predicate device and the new device's similar technological characteristics and performance claims.
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DEC 2 2 2003
K 033799
510(K) Summary
Cell Robotics' Clinical Lasette P-200 Laser Skin Perforator
This 510(K) Summary of safety and effectiveness for the Cell Robotic's Clinical Lasette P-200 Lascr Skin Perforator 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 NEAlbuquerque, NM 87107 |
| Contact Person: | Linda A. Blair, Assistant Quality Manager |
| Telephone: | (505) 343-1131 Ext. 124(505) 344-8112 |
| Preparation Date: | 12-3-03 |
| Device Trade Namc: | Clinical Lasette P-200 |
| Common Name: | Laser skin perforator |
| Classification: | Class II |
| Legally Marketed Predicate Device: | Cell Robotics, Inc. Lasette Plus |
| Description of the Cell Robotic'sLasette Laser Skin Perforator | The Cell Robotics Lasette laser skin perforator is aportable battery operated laser device. The deviceproduces a single pulse of laser light which ablatesa small hole in the patient's fingertip comparable tothat produced by commonly used stainless steelblood lancets. |
| Intended use | Ablation of skin for collecting capillary bloodsamples for subsequent analysis. |
| Indications for use | The Cell Robotic's Lasette Laser Skin Perforator isindicated for use by qualified healthcareprofessionals for the perforation of skin to drawcapillary blood for screening purposes. |
| Contraindications for Use | The Lasette should not be used to collect samplesfor use in analyzers that require complex sampletransfer procedures. |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | None |
| Conclusion: | The Cell Robotic's Clinical Lasette P-200 LaserSkin Perforator is substantially equivalent to thepredicate device. |
| 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are depicted in a simple, abstract manner.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 2 2003
Ms. Linda A. Blair Assistant Quality Manager Cell Robotics, Inc. 2715 Broadbent Parkway NE, Suite A-E Albuquerque, New Mexico 87107
Re: K033799 Trade/Device Name: Clinical Lasette P-200 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: December 3, 2003 Received: December 5, 2003
Dear Ms. Blair:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the elcctronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Linda A. Blair
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Celia M. Witten, Ph.D., M.D.
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE STATEMENT
11 033799 510(k) Number:
Lasette Laser Skin Perforator Device Name: Trade Name: Clinical Lasette P-200
Indications for Use:
The Cell Robotic's Clinical Lasette P-200 Laser Skin Perforator is indicated for use by qualified healthcare professionals for the perforation of skin to draw capillary blood for screening purposes.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Cila W
sion of General, Restorative · Neurological Device
10033799
Prescription Use
(per 21 CFR 801.109)
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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.