(60 days)
LAD-08 is indicated for ablation of the outer layer of the skin prior to the application of OTC topical 4% lidocaine cream, for local dermal anesthesia.
The Norwood Abbey Model LAD-08 is a portable, handheld, battery powered bern hismater The Norwood Abbey Model LAD-60 is a portuois, handelength of 2.94 um and a beam diameter of I he radiant energy produced by thin itsel mas a m. spot-size of 6 mm at the treatment site. The radiation delivered by the device is sufficient to remove the stratum corneum of skin exposed to the treatment.
The provided document describes a medical device, the Norwood Abbey Model LAD-08 (Epiture™ Easytouch), a laser surgical instrument. However, the document explicitly states:
"No additional studies have been performed on the LAD-08."
This means the submission does not include any studies or data proving the device meets specific acceptance criteria. Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred:
1. A table of acceptance criteria and the reported device performance:
Not available. The document does not specify any acceptance criteria or report performance data for the LAD-08.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not available. No studies were performed, so there is no test set or related data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not available. No studies were performed, so no ground truth was established for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not available. No studies were performed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a laser surgical instrument, not an AI-assisted diagnostic tool for human readers. No MRMC studies were conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This refers to algorithm performance, and no algorithms were described or tested for this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not available. No studies were performed.
8. The sample size for the training set:
Not applicable. No training set for an algorithm was mentioned or used.
9. How the ground truth for the training set was established:
Not applicable. No training set for an algorithm was mentioned or used.
Summary based on the provided text:
The submission for the LAD-08 relies on a claim of substantial equivalence to predicate devices (LAD-01/06) rather than new clinical study data for its performance. The FDA cleared the device based on this substantial equivalence.
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510(k) Summary of Safety And Effectiveness for Model LAD-08 13.
| 13.1 Submitter Information | FEB 2 0 2004 |
|---|---|
| Norwood Abbey Limited. | |
| 63 Wells Road | |
| Chelsea Heights Victoria 3196 | |
| Australia |
| Contact Person: | Paul Clark |
|---|---|
| Telephone No.: | +61-3-9782 7308 |
| Fax: | +61-3-9782 7334 |
13.2 Device Name
Laser surgical instrument for general and plastic surgery and in Classification Name: dermatology
LAD, model LAD-08 Proprietary Name:
13.3 Predicate Devices
LAD-01/06
13.4 Description of the Device
The Norwood Abbey Model LAD-08 is a portable, handheld, battery powered bern hismater The Norwood Abbey Model LAD-60 is a portuois, handelength of 2.94 um and a beam diameter of I he radiant energy produced by thin itsel mas a m.
spot-size of 6 mm at the treatment site. The radiation delivered by the device is sufficient to remove the stratum corneum of skin exposed to the treatment.
13.5 Intended Use
The intended use of the LAD-08 is for ablation of the outer layer of the skin prior to the The meended use of the EAD oo in roller and the cream, for local dermal anesthesia.
13.6 Clinical Studies
No additional studies have been performed on the LAD-08.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2, 0 2004
Mr. Paul Clark Quality and Regulatory Affairs Manager Norwood Abbcy Limited 63 Wells Road Chelsea Heights Victoria 3196 Australia
Re: K033962 Trade/Device Name: Epiture™ Easytouch, Model LAD-08 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: December 18, 2003 Received: December 22, 2003
Dear Mr. Clark:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because is retty pe issubstantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate Tor use stated in the encrosure) to regars the Medical Device Amendments, or to comments provide to May 20, 1978, the enable with the provisions of the Federal Food, Drug, devices mat have been reculsentied in assee approval of a premarket approval application (PMA). alla Cosmetic Act (Act) that do not require appt to the general controls provisions of the Act. The r ou may, mercere, manver the act include requirements for annual registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (sce above) into either class II (Special Controls) or class III (PMA), it If your device is classified (soo aoove) the existing major regulations affecting your device can may be subject to subli ductional venisons, Title 21, Parts 800 to 898. In addition, FDA may be found in the Obancements 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 that ITA has made a determinations administered by other Federal agencies. You must of any irederal statutes and regulations and including, but not limited to: registration and listing (21 comply with an the Act 3 requirements, and manufacturing practice requirements as set CFK Part 677), labeling (21 CFR Part 820); and if applicable, the electronic (200); and if applicable, the electronic (200 forth in the quality bytichly (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Paul Clark
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin marketing your article quivalence of your device to a legally premarket notification. The PDA midner of basification 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 If you desire specific advice for your active of the collection of the regulation entitled, Contact the Office of Complance at (301) ->>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> "Misbranding by relevence to premation notification of the Act from the Division of Small other general information on your responsion.com at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-ifremation http:// Manufacturers, International and Combailer Prosservedrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark A. Mikkelson
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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3.2 Statement of Intended Use
Page __ of
510(k) Number (if known): K033962
Device Name: Epiture™ Easytouch, Model LAD-08
Indications for Use:
LAD-08 is indicated for 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)
OR
Prescription Use X (Per 21 CFR 801.109)
Over-The Counter Use
Mark N Millkum
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
03391
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.