(87 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 for skin perforation to draw capillary blood for screening, which is a diagnostic purpose, not a therapeutic one.
No
The device is used to collect blood samples for screening purposes, which is a step in the diagnostic process but not a diagnostic act in itself. It facilitates the collection of a sample for analysis, similar to a lancet, rather than analyzing or interpreting data to make a diagnosis.
No
The device description explicitly states it is a "portable battery operated laser device," indicating it is a hardware device that uses laser technology to perform its intended function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- The Cell Robotics Laser Skin Perforator's intended use is to obtain a sample (capillary blood) from the body, not to analyze that sample. It's a tool for sample collection, similar to a traditional lancet.
While the blood obtained can be used for screening purposes (which might involve IVD tests), the device itself is not performing the diagnostic test. It's facilitating the collection of the sample that will then be used in an IVD test.
N/A
Intended Use / Indications for Use
The Cell Robotic's Lasette Laser Skin Perforator is indicated for use for the perforation of skin to draw capillary blood for screening purposes.
Product codes
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
Not Found
Intended User / Care Setting
Not Found
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 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.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Laser Lancet manufactured by TransMedica International
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K 983673
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 its I his 310(K) Summary of Saley and encerents of the Ser Room 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: | 10-3-98 |
| Device Trade Name: | Lasette |
| Common Name: | Laser skin perforator |
| Classification: | Class II |
| Legally Marketed Predicate Device: | Laser Lancet manufactured by TransMedica International, |
| 323 Center Street, Suite 1100, Little Rock, AR 72201. | |
| 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 | Ablation of skin for collecting capillary blood samples for |
| subsequent analysis | |
| Indications for use | The Cell Robotic's Laser Skin Perforator is indicated |
| for use for the perforation of skin to draw capillary blood for | |
| screening purposes | |
| 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 | |
| Exemptions. Results from the clinical trials indicate that the | |
| device is safe and effective. |
1
Conclusion:
The Cell Robotic's Lasette Laser Skin Perforator is substantially equivalent to the predicate device.
・
Additional Information:
None requested at this time
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, which is a symbol often associated with healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 5 1999
Mr. Ronald K. Lohrding President and Chief Executive Officer Cell Robotics, Inc. 2715 Broadbent Parkway, Northeast Albuquerque, New Mexico 87107
K983673 Re:
Trade Name: Cell Robotics Lasette Laser Skin Perforator Regulatory Class: II Product Code: GEX Dated: October 13, 1998 Received: October 20, 1998
Dear Mr. 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 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.
3
Page 2 - Mr. Ronald K. Lohrding
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 vours.
Sincerely yours,
Jocasta
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
983673 New Submission 510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Lasette Laser Skin Perforator Device Name:
Indications for Use:
The Cell Robotic's Lasette Laser Skin Perforator is indicated for use for the perforation of skin to draw capillary blood for screening purposes.
(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__________________________________________________________________________________________________________________________________________________________
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K983673