The LAD device is indicated for the rapid production of local dermal anesthesia using topical OTC lidocaine 4%.
The LAD is indicated for the ablation of the outer layer of the skin prior to the application of OTC topical 4% lidocaine cream, for local dermal anesthesia.

Device Description

The Norwood Abbey Model LAD-01 is a portable, battery powered, single pulse Er: Y AG laser. The radiant energy produced by this laser has a wavelength of 2.94 um, duration of approximately 300 us, and a beam diameter or spot-size of 3 mm at the treatment site. The radiation delivered by the device is sufficient to remove the stratum corneum of skin exposed to the treatment.

AI/ML Overview

Here's an analysis of the provided text to extract the requested information about the device's acceptance criteria and the study that proves it meets them:

Device: LAD, Model LAD-01 (Laser surgical instrument for general and plastic surgery and in dermatology)
Intended Use: Rapid production of local dermal anesthesia using topical OTC lidocaine 4%.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Produce a rapid dermal anesthetic effect using topical OTC lidocaine 4%.	Results of the clinical study "revealed that the model LAD-01 can produce a rapid dermal anaesthetic effect using topical OTC lidocaine 4%." The study used full needle insertion as a standard pain stimulus and pain scores were analyzed.
No adverse events over those of the placebo treatment.	Clinical observations from 318 subjects, taken approximately 48 hours after treatment, "revealed no adverse events over those of the placebo treatment."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 320 subjects participated in the IRB, IDE approved study. Clinical observations were reported for 318 subjects.
Data Provenance: The study was conducted over "two centers," suggesting a multi-site clinical trial. The document itself is from Norwood Abbey Limited, located in Australia, but the study is mentioned as being IRB, IDE approved, which implies a regulatory framework often associated with studies conducted in the US or under US regulatory guidance. The "retrospective or prospective" nature is not explicitly stated, but an "IRB, IDE approved study" involving subjects at two centers, with follow-up observations at 48 hours, strongly indicates a prospective clinical study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The study protocols focused on subjective pain ratings by subjects and clinical observations by medical personnel, rather than expert interpretation of diagnostic images or data.

4. Adjudication Method for the Test Set

This information is not provided in the document. The study involved subjects rating their own pain and clinical observations by staff, not an adjudication process by multiple experts for a "ground truth" derived from interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance?

No, an MRMC comparative effectiveness study was not conducted. This device is a laser surgical instrument, not an AI-powered diagnostic tool requiring human reader interpretation or improvement statistics. The study focused on the device's ability to achieve specific physiological and safety effects.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The LAD-01 is a physical device used in a medical procedure, not an algorithm. Its performance is inherent in its operation and interaction with the human body, not an "algorithm only" performance.

7. The Type of Ground Truth Used

Pain Reduction: The "ground truth" for anesthetic efficacy was established by subjective pain ratings provided by the subjects themselves, after a standardized pain stimulus (full needle insertion).
Safety: The "ground truth" for safety was established through clinical observations by medical personnel for adverse events, compared to a placebo.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The LAD-01 is a medical device, not a machine learning model, so there is no concept of a "training set" in the context of this submission. The study described is a clinical validation study, not a model training process.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided for the same reasons as point 8.

Summary

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K021222

510(k) Summary of Safety And Effectiveness for Model LAD-01 1

Submitter Information 1.1

Norwood Abbey Limited.	63 Wells RoadChelsea Heights VIC 3196Australia
Contact Person:	Andrew Ellis
Telephone No.:	+61-3-9782 7344
1.2 Device Name	Laser surgical instrument for general and plastic surgeryand in dermatology
Classification Name:	Laser surgical instrument for general and plastic surgeryand in dermatology

LAD, model LAD-01 Proprietary Name:

Predicate Devices 1.3

Currently marketed Phoresor II Model 900 (K974855) and the LaserLancet LB100 (K980538) were selected as the predicate devices for this submission.

Description of the Device 1.4

I : રે Indications for Use

The LAD device is indicated for the rapid production of local dermal anesthesia using topical OTC lidocaine 4%.

1.6 Safety& Effectiveness

An IRB, IDE approved study was conducted over two centers and involving 320 subjects. Full needle insertion of a 23G 5/8" needle was used as a standard pain stimulus. After needle insertion subjects were asked to rate the pain felt using an accepted pain ever the model; pain scores were tested to rate the pain felt using an accepted pain
evaluation model; pain scores were tested and analyzed as per the approved protocol.
Perc

Results revealed that the model LAD-01 can produce a rapid dermal anaesthetic effect using topical OTC lidocaine 4%.

Analysis of clinical observation c

ual observations from 318 subjects
treatment revealed no

and sisted of clinical observations from 318 subjects taken approximately 48 hours after
treatment revealed no adverse events over those of the placebo treatment statyols of chinical observations from 318 subjects taken approximately and

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus with three intertwined snakes and a human profile in the center. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 0 8 2003

Norwood Abbey Limited c/o Mr. Robert T. Handren, Jr. President Handren Associates, Inc. 5818 Princess Caroline Place Leesburg, Florida 34748

Re: K021222

Trade/Device Name: LAD Model LAD-01 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: October 8, 2002 Received: October 10, 2002

Dear Mr. Handren:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Robert T. Handren, Jr.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1_of 1

510(k) Number (if known): K021222

Device Name:

Indications for Use:

The LAD is indicated for the ablation of the outer layer of the skin prior to the application of OTC topical 4% lidocaine cream, for local dermal anesthesia.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Miriam C. Provost

Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K021222

Regulation Number and Section

§ 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.