(148 days)
The Laser Lancet® is intended for use for the perforation of skin to draw capillary blood for screening purposes.
The Laser Lancet® LB100 is a portable Er:YAG laser. The beam is 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.
The Laser Lancet® LB100 is a portable Er:YAG laser intended for skin perforation to draw capillary blood for screening purposes. The provided text outlines two clinical studies conducted to demonstrate its effectiveness and safety.
1. Acceptance Criteria and Reported Device Performance:
The acceptance criteria are implied from the study objectives and conclusions. No specific quantitative benchmarks are listed in the provided text, but rather a demonstration of equivalence and effectiveness.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Effectiveness in perforating skin for capillary blood. | 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. |
| Equivalence of clinical values (electrolytes and lipids) from blood obtained with Laser Lancet® LB100 compared to steel lancet. | 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. This also extended to "colorimetric analyses approved with the initial 510(k)". |
| Healing time of perforation sites. | 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®. This provides reasonable assurance that the device "does not pose undue risks to patients, even after multiple perforations". |
2. Sample Size and Data Provenance:
- Sample Size for Test Set: The exact sample size for each study is not specified in the provided text. It merely states "two studies."
- Data Provenance: The text does not explicitly state the country of origin. Given the submission to the FDA (USA), it is highly likely the studies were conducted in the USA. The studies are prospective clinical studies as they involve patient application of the device to demonstrate effectiveness and safety.
3. Number of Experts and Qualifications:
The information regarding the number of experts used to establish ground truth and their qualifications is not provided in the given text.
4. Adjudication Method:
The adjudication method used for the test set is not specified in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted in the context of improving human reader performance with AI. The studies presented compare the Laser Lancet® LB100 to a steel lancet directly in terms of blood collection and resulting clinical values, and also assess healing time.
6. Standalone Performance (Algorithm Only):
This information is not applicable as the Laser Lancet® LB100 is a physical medical device, not an AI algorithm. Its performance is inherent to its physical operation and is evaluated directly through its use on patients.
7. Type of Ground Truth Used:
The ground truth used was:
- Clinical Efficacy/Effectiveness: Demonstraion of successful skin perforation to obtain capillary blood.
- Comparative Clinical Values: Clinical laboratory results for electrolytes and lipids from blood samples obtained by both the Laser Lancet® LB100 and a steel lancet.
- Observed Healing Outcomes: Physical observation of wound healing within a specified timeframe (48 hours).
8. Sample Size for Training Set:
This information is not applicable as the Laser Lancet® LB100 is a physical device and does not involve a "training set" in the context of machine learning or AI algorithms.
9. How Ground Truth for Training Set was Established:
This information is not applicable for the same reasons as above. The device's performance is based on its physical design and operation, not on learned data.
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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: 502-376-3969 (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.
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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.
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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.
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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 (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 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
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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 UseX OR Over-The-Counter Use__
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of General Restorative Devices 19 Bes 38
510(k) Number __
§ 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.