(48 days)
Not Found
No
The summary describes a laser device for blood sampling and does not mention any AI or ML components or functionalities.
No.
The device is used for collecting blood samples for diagnostic purposes (determining blood glucose and hematocrit), not for treating a condition.
No.
The device is used for collecting blood samples, which are then used for diagnostic purposes by other optically based measurement techniques. The device itself does not perform any diagnostic function.
No
The device description explicitly states it is a "portable battery operated laser device" and produces a "single pulse of laser light," indicating it is a hardware device.
Based on the provided information, the Cell Robotics Lasette Laser Skin Perforator is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used in vitro (outside the body) to examine specimens derived from the human body. The Lasette device is used in vivo (on the body) to create a hole for collecting a blood sample.
- The intended use of the Lasette is to collect the blood sample. The subsequent determination of blood glucose and hematocrit using optically based measurement techniques is where an IVD device would likely be involved (e.g., a glucose meter or hematocrit analyzer).
- The device description focuses on the mechanism of creating the perforation. It doesn't describe any components or processes for analyzing the blood sample itself.
In summary, the Lasette is a device used to facilitate the collection of a biological sample, which can then be used with an IVD device for diagnostic purposes. It is not the diagnostic device itself.
N/A
Intended Use / Indications for Use
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 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
qualified healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject device has been investigated in two human clinical trials under approved Investigational Device Exemptions. Results from the clinical trials indicate that the device is safe and effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Glucolet Steel Lancet Mfg. By Bayer Diagnostics, Feather Touch Steel Lancet Mfg. by Ulster Scientific, Tenderlett Steel lances Mfg. By International Technidyne, TriLasc 2940 Mfg. by Schwartz Electro-Optics, Medlite Mfg. by Continuum Biomedical, Protégé Mfg. By Xintec Corp.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 NE |
| Albuquerque, 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 Diagnostics |
| Feather Touch Steel Lancet Mfg. by Ulster Scientific | |
| Tenderlett Steel lances Mfg. By International Technidyne | |
| TriLasc 2940 Mfg. by Schwartz Electro-Optics | |
| Medlite Mfg. by Continuum Biomedical | |
| Protégé Mfg. By Xintec Corp. | |
| Description of the Cell Robotic's Lasette | |
| Laser Skin Perforator | 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. | |
| Intended use of the Cell Robotic's Lasette | |
| Laser Skin Perforator | Ablation of skin tissue to establish capillary blood access. |
| Indications for use | 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. | |
| Contraindications for Use | The Lasette should not be used to collect samples for use in |
| analyzers that require complex sample transfer procedures. | |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | The subject device has been investigated in two human |
| clinical trials under approved Investigational Device | |
| Exemptions. Results from the clinical trials indicate that the | |
| device is safe and effective. | |
| Conclusion: | The Cell Robotic's Lasette Laser Skin Perforator is |
| substantially 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)