LASER LANCET LB100

K980538 · Transmedica Intl., Inc. · GEX · Jul 9, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K980538
• Device Name: LASER LANCET LB100
• Applicant: Transmedica Intl., Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2

Intended Use

The Laser Lancet® is intended for use for the perforation of skin to draw capillary blood for screening purposes.

Device Story

Portable Er:YAG laser device; used for skin perforation to obtain capillary blood samples for clinical chemistry screening. Operator places finger against unit aperture; focused laser beam perforates skin. Used in clinical settings. Provides blood samples equivalent to those obtained via steel lancet; clinical studies confirm effective perforation and healing within 48 hours, even in diabetic patients.

Clinical Evidence

Two clinical studies conducted. Study 1: Compared clinical values of electrolytes and lipids obtained via Laser Lancet vs. steel lancet; results were equivalent. Study 2: Evaluated healing of perforation sites in diabetic patients; sites healed within 48 hours, including after multiple perforations.

Technological Characteristics

Portable Er:YAG laser; beam focused within unit; exits through aperture tube. Class II device (21 CFR 878.4810).

Indications for Use

Indicated for patients requiring capillary blood collection for screening purposes. Includes diabetic patients requiring multiple perforations.

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

• Steel Lancet (K931258)
• Laser Lancet (K955653)

Submission Summary (Full Text)

{0}------------------------------------------------

K980538

APPENDIX F

## 510(k) SUMMARY TRANSMEDICA INTERNATIONAL, INC. LASER LANCET® LB100

This 510(k) summary of safety and effectiveness for the Laser Lancet® LB100 is submitted in I ms Jro(x) battinary of sizer) at the SMDA and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

Applicant:

TRANSMEDICA INTERNATIONAL, INC.

- Address:
323 Central Street Suite 1100 Little Rock, AR 72201

Contact Person:

Vice President of Technology and Business Development

Kevin Marchitto, Ph.D.

- 502-376-3938 Telephone: [phone] (Fax)
February 9, 1998 Preparation Date:

Device Trade Name: Laser Lancet® LB100

Common Name: Er:YAG laser

Classification Name: Surgical Laser (see: 21 CFR 878.4810). Product Code: GEX.

Legally marketed Steel Lancet (as described in K931258), Laser Lancet (as described in predicate device: K955653)

The Laser Lancet® LB100 is a portable Er:YAG laser. The beam is Device Description: focused within the unit and exits through a tube placed in the aperture allowing the focused beam to strike the finger of a patient placed against the unit's tip and perforate the skin. The resulting blood sample is used for clinical chemistry screening purposes.

Intended Use:

The Laser Lancet® is intended for use for the perforation of skin to draw capillary blood for screening purposes.

0532

{1}------------------------------------------------

Performance Data:

Clinical data from two studies demonstrated that the energy output of the Laser Lancet® LB100 is effective in perforating the skin in order to obtain capillary blood for screening tests.

The results of one clinical study demonstrated that the clinical values of electrolytes and lipids were the same whether the capillary blood was obtained after use of the Laser Lancet® LB100 or by a steel lancet.

The results of the second study demonstrated that the perforation sites, including multiple perforations on the same finger of diabetic patients, were healed within 48 hours after use of the Laser Lancet®.

Based on the foregoing and other information in this application, CONCLUSIONS: TransMedica International, Inc. believes that the

- Laser Lancet® LB100, with the specifications as described in this a. notification and under conditions of proposed use, is substantially equivalent to the Laser Lancet® described in K955653,
- clinical data provides reasonable assurance that the Laser Lancet® b. LB100 does not pose undue risks to patients, even after multiple perforations, and
- clinical data provide reasonable assurance that equivalent results are c. obtained for lipids and electrolytes (in addition to the colorimetric analyses approved with the initial 510(k)) whether the capillary blood is collected after perforation with the Laser Lancet® LB100 or with a steel lancet.

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread, with three lines representing the wings. The eagle is facing to the left.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

a 1008 JUL

Kevin Marchitto, Ph.D. ·Transmedica International, Inc. Vice President, Technology and Business Development 323 Center Street, Suite 1100 Little Rock, Arkansas 72201

K980538 Re: Trade Name: Laser Lancet LB100 Regulatory Class: II Product Code: GEX Dated: May 11, 1998 Received: May 12, 1998

Dear Dr. Marchitto:

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 (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.

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.

{3}------------------------------------------------

Page 2 - Dr. Kevin Marchitto

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.

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}------------------------------------------------

## APPENDIX B

## INDICATIONS FOR USE

Application Number (if known): _______________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Laser Lancet® is intended 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*X* OR Over-The-Counter Use__
(Per 21 CFR 801.109)

---

(Division Sign-Off)
Division of General Restorative Devices 19 Bes 38
510(k) Number ***_*****_**