(90 days)
The Cell Robotics Lasette Laser Skin Perforator is indicated for use by qualified healthcare professionals for collecting capillary blood samples from all patients (5 years old and above) for subsequent determination of blood glucose concentration and hematocrit.
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.
Here's an analysis of the provided text regarding the Cell Robotic's Lasette Laser Skin Perforator, focusing on acceptance criteria and study details:
Missing Information: It's important to note that the provided 510(k) summary and FDA letter do not contain specific details about acceptance criteria, device performance metrics, or any clinical study results. The document explicitly states "Nonclinical Performance Data: None" in the summary. The FDA letter confirms substantial equivalence but does not describe the data supporting that equivalence.
Therefore, many of the requested details cannot be extracted from the provided text.
Acceptance Criteria and Device Performance (Based on Inferred Information)
Since no specific performance data or acceptance criteria are provided, we can only infer the type of acceptance criteria that would likely be relevant for a device like this based on its intended use and predicate devices (steel lancets).
Inferred Acceptance Criteria Table
| Acceptance Criteria (Inferred) | Reported Device Performance (Not provided in text) |
|---|---|
| Blood Sample Volume: Sufficient for glucose/hematocrit determination | Not specified |
| Pain Level: Comparable to predicate steel lancets | Not specified |
| Ease of Use: Comparable to predicate steel lancets | Not specified |
| Safety: No adverse events (e.g., burns, infections) beyond predicate | Not specified |
| Depth of Perforation: Consistent and adequate | Not specified |
| Time to Obtain Sample: Efficient | Not specified |
Notes on Inferred Criteria:
- Given the device's purpose is "ablation of skin tissue to establish capillary blood access" for glucose and hematocrit determination, key performance metrics would revolve around the quality and quantity of the blood sample, patient comfort, and safety.
- The comparison to "commonly used stainless steel blood lancets" strongly implies that the Lasette needed to demonstrate performance at least equivalent to these predicate devices.
Study Details (Based on Provided Text – Primarily "None" or Not Applicable)
As stated above, no study data or methodologies are detailed in the provided 510(k) summary.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not provided.
- Data Provenance: Not provided (likely domestic, given the US applicant and FDA submission, but no specifics). The document explicitly states "Nonclinical Performance Data: None," implying no formal test set data was submitted in this section.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No test set or ground truth establishment details are provided.
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Adjudication method for the test set:
- Not applicable. No test set or adjudication method details are provided.
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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 diagnostic tool. No MRMC study would be relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device for blood sampling, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. No ground truth is described as no performance data is detailed. For a device like this, relevant "ground truth" might involve successful blood collection determined by laboratory analysis (e.g., sufficient blood volume, accuracy of subsequent glucose/hematocrit readings) or patient feedback on pain.
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The sample size for the training set:
- Not applicable. This is a physical device, not an AI algorithm requiring a training set.
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How the ground truth for the training set was established:
- Not applicable. See point 7.
§ 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.