(177 days)
Ablation of skin tissue to establish capillary blood access. 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 glucose concentration and hematocrit.
The Cell Robotics 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.
This 510(k) summary for the Cell Robotics Lasette Laser Skin Perforator does not explicitly define specific quantitative acceptance criteria or provide a detailed study report with performance metrics against those criteria. Instead, it states that three human clinical trials were conducted, and their "Results from the clinical trials indicate that the device is safe and effective." The conclusion then asserts "The Cell Robotic's Lasette Laser Skin Perforator is substantially equivalent to the predicate devices."
Therefore, I cannot populate the table with specific numerical acceptance criteria and reported device performance from this document. However, I can infer the general purpose of the studies and extract other requested information.
Here's a breakdown of the available information based on your request:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Quantitative/Qualitative) | Reported Device Performance |
|---|---|
| Not explicitly defined in the document. The general acceptance criteria would be that the device is "safe and effective" and "substantially equivalent" to predicate devices for its intended use of collecting capillary blood samples. This implies that the blood samples collected allow for accurate determination of blood glucose concentration and hematocrit. | "Results from the clinical trials indicate that the device is safe and effective." "The Cell Robotic's Lasette Laser Skin Perforator is substantially equivalent to the predicate devices." |
Study Details
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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 in this summary.
- Data Provenance: "three human clinical trials" were conducted. The summary implies these are prospective human trials, and given the applicant's address in New Mexico, USA, it's highly likely the data is from the United States.
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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 in this summary. The ground truth would likely be the standard methods for determining blood glucose concentration and hematocrit from the collected blood samples, compared against established laboratory measurements from traditional methods.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified in this summary.
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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 is a medical device for blood sampling, not an AI-assisted diagnostic imaging device that involves human readers interpreting results.
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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. The "standalone" performance would be the device's ability to, independently, create a perforation and allow blood collection. The summary indicates it does this effectively.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The ground truth would be based on the accuracy of blood glucose concentration and hematocrit measurements obtained from the blood samples collected by the device, likely compared to measurements from blood samples collected via a predicate device or conventional venipuncture methods. This would involve laboratory testing and clinical outcomes related to the quality of the sample for diagnostic purposes.
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The sample size for the training set
- Not applicable. As a physical device rather than a machine learning algorithm, there is no "training set" in the conventional AI sense. The development and testing would involve engineering and clinical validation rather than algorithmic training.
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How the ground truth for the training set was established
- Not applicable for the same reasons as above.
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Appendix 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 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: | 3-24-98 |
| 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 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 Laser Skin Perforator is intendedfor use by qualified healthcare professionals for collectingcapillary blood samples from adult patients, for subsequentdetermination of blood glucose concentration 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 |
| Clinical Performance Data: | The subject device has been investigated in three humanclinical trials under approved Investigational Device |
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Exemptions. Results from the clinical trials indicate that the device is safe and effective.
ੀ ਦਾ ਸਾਹਿਤ ਕਰ ਸਾਰ
Conclusion:
ﮯ ۔
The Cell Robotic's Lasette Laser Skin Perforator is substantially equivalent to the predicate devices.
Additional Information:
None requested at this time
이 대한민국 대학교 대학교 대학교 대학교 대학교
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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 stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 4 1998
Ronald K. Lohrding, Ph.D President & CEO Cell Robotics, Inc. 2715 Broadbent Parkway, NE Albuquerque New Mexico 87107
Re: K982230
Trade Name: Cell Robotic's Lasette Laser Skin Perforator Regulatory Class: II Product Code: GEX Dated: June 29, 1998 Received: July 2, 1998
Dear Dr. Lohrding:
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 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). 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 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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Page 2 - Ronald K. Lohrding, Ph.D
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/dsma/dsmamain.html".
Sincerely yours,
fo oeeef
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: _( 1) 2 ) 30
Device Name: Lasette laser skin perforator
Indications for Use:
The Cell Robotic's Laser Skin Perforator is indicated for use by qualified healthcare professionals for collecting capillary blood samples from adult patients 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)
Prescription Use (per 21 CFR 801.109)
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
NOTICES
§ 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.