CELL ROBOTICS' LASETTE

K981746 · Cell Robotics, Inc. · GEX · Dec 7, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K981746
• Device Name: CELL ROBOTICS' LASETTE
• Applicant: Cell Robotics, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 7, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2

Intended Use

Ablation of skin tissue to establish capillary blood access.

Device Story

Lasette is a portable, battery-operated laser device; produces single pulse of laser light to ablate small hole in patient's fingertip; replaces traditional stainless steel blood lancets for capillary blood access. Used in institutional and at-home settings by patients or clinicians. Output is a skin perforation for blood collection; facilitates blood glucose monitoring. Benefits include non-mechanical skin penetration.

Clinical Evidence

Two human clinical trials conducted in an at-home setting. Results indicated the device is safe and effective for its intended use.

Technological Characteristics

Portable, battery-operated laser device. Produces single pulse of laser light for tissue ablation. Class II device.

Indications for Use

Indicated for obtaining capillary blood samples for subsequent analysis of blood glucose concentration, in both institutional and at-home settings.

Regulatory Classification

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.

Predicate Devices

• Glucolet Steel Lancet (Bayer Diagnostics)
• Feather-Touch Steel Lancet (Ulster Scientific)
• Tenderlett Steel lances (International Technidyne)
• TriLase 2940 (Schwartz Electro-Optics)
• Medlite (Continuum Biomedical)
• Protégé (Xintec Corp.)

Submission Summary (Full Text)

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DEC 7 1998

981746

## 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 This 91Q(x) Banakage 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<br>Albuquerque, NM 87107 |
| Contact Person: | Connie White, Manager of Regulatory Affairs |
| Telephone: | Phone: [phone] Ext. 108<br>telefax: [phone] |
| Preparation Date: | 5-13-98 |
| 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<br>Feather-Touch Steel Lancet Mfg. by Ulster Scientific<br>Tenderlett Steel lances Mfg. By International Technidyne<br>TriLase 2940 Mfg. by Schwartz Electro-Optics<br>Medlite Mfg. by Continuum Biomedical<br>Protégé Mfg. By Xintec Corp. |
| Description of the Cell Robotic's Lasette<br>Laser Skin Perforator | The Cell Robotics Lasette laser skin perforator is a portable<br>battery operated laser device. The device produces a single<br>pulse of laser light which ablates a small hole in the patient's<br>fingertip comparable to that produced by commonly used<br>stainless steel blood lancets. |
| Intended use | Ablation of skin tissue to establish capillary blood access. |
| Indications for use | The Cell Robotics Lasette Laser Skin Perforator is indicated<br>for obtaining capillary blood samples for subsequent analysis<br>of blood glucose concentration, in both institutional and at-<br>home settings. |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | The subject device has been investigated in two human<br>clinical trials relating to use in an at-home setting. Results<br>from the clinical trials indicate that the device is safe and<br>effective. |
| Conclusion: | The Cell Robotic's Lasette Laser Skin Perforator is<br>substantially equivalent to the predicate devices. |
| Additional Information: | None requested at this time |

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Image /page/1/Picture/2 description: The image shows a black and white logo of the Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 7 1998

Ms. Connie White Manager of Regulatory Affairs Cell Robotics, Inc. 2715 Broadbent Parkway, North East Albuquerque, New Mexico 87107

Re: K981746 Trade Name: Lasette Laser Skin Perforator Regulatory Class: II Product Code: GEX Dated: September 2, 1998 Received: September 8, 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.

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This letter will allow you to begin marketing your device as described in your 510(k) I has letter wifi anow your your 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph 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: K981746

Device Name: Lasette laser skin perforator

Indications for Use:

(per 21 CFR 801.109)

The Cell Robotics Lasette Laser Skin Perforator is indicated for obtaining capillary blood samples for subsequent analysis of blood glucose concentration, in both institutional and at-home settings.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K981746 |

| Prescription Use | OR | Over-the-Counter Use |
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