(177 days)
Not Found
Not Found
No
The summary describes a laser device for skin perforation and does not mention any AI or ML components or functionalities.
No
The device is used to ablate skin tissue for blood sample collection, which is a diagnostic/testing purpose, not for treating a disease or condition. While it causes a physical change (ablation), the primary goal is not therapeutic.
No
Explanation: This device is used to collect blood samples for subsequent determination of blood glucose concentration and hematocrit, but it does not perform the diagnostic analysis itself. It is a sample collection device, not a diagnostic device.
No
The device description explicitly states it is a "portable battery operated laser device," indicating it is a hardware device that uses laser technology for skin ablation.
Based on the provided information, the Cell Robotics Laser Skin Perforator is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: IVDs are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This includes tests for diagnosis, monitoring, or screening.
- Device function: The Cell Robotics Laser Skin Perforator's function is to collect the blood sample by creating a perforation in the skin. It does not perform any analysis or testing on the blood itself.
- Intended Use: The intended use clearly states "Ablation of skin tissue to establish capillary blood access" and "for collecting capillary blood samples... for subsequent determination of blood glucose concentration and hematocrit." The "subsequent determination" is done by a separate device or method, not the laser perforator.
The device is a tool for sample collection, which is a step that precedes the in vitro diagnostic testing, but it is not the IVD itself.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject device has been investigated in three 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.)
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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.
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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.
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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).
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§ 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
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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 NE |
| Albuquerque, 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 Diagnostics |
| Feather-Touch Steel Lancet Mfg. by Ulster Scientific | |
| Tenderlett Steel lances Mfg. By International Technidyne | |
| TriLase 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 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 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. | |
| 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 three human |
| clinical 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
2
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
4
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