LASETTE LASER SKIN PERFORATOR

K981149 · Cell Robotics, Inc. · GEX · Jun 29, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K981149
• Device Name: LASETTE LASER SKIN PERFORATOR
• Applicant: Cell Robotics, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Ablation of skin tissue to establish capillary blood access.

Device Story

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 collection. Used by healthcare professionals in clinical settings. Output is a skin perforation allowing blood sample collection for glucose and hematocrit testing. Benefits include non-mechanical tissue ablation.

Clinical Evidence

No clinical data provided; nonclinical performance data reported as none.

Technological Characteristics

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

Indications for Use

Indicated for use by qualified healthcare professionals for collecting capillary blood samples from patients 5 years of age and older for determination of blood glucose concentration and hematocrit. Contraindicated for use with analyzers requiring complex sample transfer procedures.

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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JUN 2 9 1998

K9g 1149

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 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<br>Albuquerque, NM 87107 |
| Contact Person: | Connie White, Manager of Regulatory Affairs |
| Telephone: | [phone] Ext. 108<br>[phone] |
| Preparation Date: | 3-30-98 |
| 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 of the Cell Robotic's Lasette<br>Laser Skin Perforator | Ablation of skin tissue to establish capillary blood access. |
| Indications for use | The Cell Robotics Lasette Laser Skin Perforator is indicated<br>for use by qualified healthcare professionals for collecting<br>capillary blood samples from all patients (5 years old and<br>above) for subsequent determination of blood glucose<br>concentration and hematocrit. |
| Contraindications for Use | The Lasette should not be used to collect samples for use in<br>analyzers that require complex sample transfer procedures. |
| Nonclinical Performance Data: | None |

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three heads in profile, suggesting a sense of unity or collaboration. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the bird figure, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" curving along the left side and "USA" positioned at the top right.

JUN 2 9 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K981149 Trade Name: Cell Robotics' Lasette Regulatory Class: II Product Code: GEX Dated: March 30, 1998 Received: March 31, 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.

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.

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Page 2 - Ms. Connie White

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.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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510(k) Cell Robotics Inc. LASETTE

06/26/98

## INDICATION FOR USE STATEMENT

510(k) Number: _ k 98 1149

Device Name: Lasette laser skin perforator

Indications for Use:

The Cell Robotics Laser Skin Perforator is indicated for use by qualified healthcare professionals for collecting capillary blood samples from all patients (ages 5 years old and above) 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)

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510(k) Number

Prescription Use (per 21 CFR 801.109)

OR

Over-the-Counter Use _