(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.
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JUN 2 9 1998
K9g 1149
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 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: | Connie White, Manager of Regulatory Affairs |
| Telephone: | (505) 343-1131 Ext. 108(505) 344-8112 |
| Preparation Date: | 3-30-98 |
| 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 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 indicatedfor use by qualified healthcare professionals for collectingcapillary blood samples from all patients (5 years old andabove) for subsequent determination of blood glucoseconcentration and hematocrit. |
| 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 |
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three heads in profile, suggesting a sense of unity or collaboration. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the bird figure, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" curving along the left side and "USA" positioned at the top right.
JUN 2 9 1998
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
Re: K981149 Trade Name: Cell Robotics' Lasette Regulatory Class: II Product Code: GEX Dated: March 30, 1998 Received: March 31, 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.
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.
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Page 2 - Ms. Connie White
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.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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510(k) Cell Robotics Inc. LASETTE
06/26/98
INDICATION FOR USE STATEMENT
510(k) Number: _ k 98 1149
Device Name: Lasette laser skin perforator
Indications for Use:
The Cell Robotics Laser Skin Perforator is indicated for use by qualified healthcare professionals for collecting capillary blood samples from all patients (ages 5 years old and above) for subsequent determination of blood glucose concentration and hematocrit.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
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al Restive Devices K981149.
510(k) Number
Prescription Use (per 21 CFR 801.109)
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.