(90 days)
The Aramis is intended to be used for incision/excision, ablation, and coagulation (homeostasis) of soft tissue. The Aramis Laser is also indicated for the photocoagulation of dermatological vascular lesions, including photothermolysis of blood vessels (treatment of facial and leg veins) and the treatment of benign pigmented lesions.
The Aramis Dermatologic Laser system is intended to be used for incision/excision, ablation, and coagulation (homeostasis) of soft tissue. The Aramis Laser is also indicated for the removal of pigmented lesions; photocoagulation of dermatological vascular lesions, including photothermolysis of blood vessels (treatment of facial and leg veins).
The Aramis Dermatologic Laser is an Er-glass 1.54 um system. The computer system consists of a laser unit, a cooler, a footswitch, and a 2mm or 4mm hand piece. The 4mm hand piece is gas-cooled to provide actual skin cooling. Laser parameters and other system features are controlled from the touch-buttons on top of the laser unit, which provides an interface to the system computer.
The provided text is a 510(k) summary for the Lumedics's Aramis Dermatologic Laser. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it primarily focuses on comparing the new device's technological characteristics, intended use, and indications for use to a previously approved device.
Crucially, this document does not contain acceptance criteria for device performance in a clinical study, nor does it detail a study performed to prove such criteria were met. Instead, it lists compliance with general electrical, laser, and quality standards.
Therefore, the requested information elements cannot be fully extracted from the provided text. However, based on what is available, here's a breakdown:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No specific clinical acceptance criteria are provided in the document. The submission focuses on substantial equivalence to a predicate device and compliance with general safety standards, rather than new performance criteria established for this specific device. | - Complies with 21 C.F.R. §§ 1040.10 and 1040.11 (Laser Product Performance Standards).- Complies with UL544 (Electrical Leakage).- Complies with IEC 60-601-1 (Power Supply and Enclosure).- Complies with IEC 60-825-01 (Safety of Laser Product).- Complies with IEC 601-2-22 (Therapeutic Laser Equipment Safety).- Complies with 93/42/EEC (European Directive).- Complies with IEC 60-601-1-2 (Electromagnetic Compatibility). |
2. Sample size used for the test set and the data provenance
The document does not mention any clinical test set, sample size, or data provenance from a study specifically conducted for this 510(k) clearance. The submission relies on substantial equivalence to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set with human ground truth establishment is described.
4. Adjudication method for the test set
Not applicable, as no clinical test set or adjudication process is described.
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 dermatologic laser, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study comparing human reader performance with and without AI assistance is not relevant to this device or its submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a laser for medical procedures, not an algorithm. Standalone performance as described in the context of AI is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as no clinical study requiring ground truth for validation is mentioned in this 510(k) submission.
8. The sample size for the training set
Not applicable. As this is not an AI/machine learning device, there is no "training set" in the conventional sense.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI/machine learning device, there is no "training set" with established ground truth.
Summary of Device Approval Process as per the Document:
The Lumedics's Aramis Dermatologic Laser received 510(k) clearance based on its substantial equivalence to the predicate device, Palomar Medical Technologies, Inc. Aramis Dermatologic Laser. The submission details the technological characteristics, intended use, and indications for use, highlighting that "Any minor differences do not raise any new issues of safety or effectiveness."
Instead of presenting new clinical performance data against specific acceptance criteria, the document demonstrates compliance with recognized electrical, laser, and general safety standards (e.g., UL544, IEC 60-601-1, IEC 60-825-01). This type of submission relies on the established safety and efficacy of the predicate device, not on new clinical trials or performance assessments for the submitted device in a clinical setting.
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Attachment 8
NOV 0 5 2001
510(k) SUMMARY
Lumedics's Aramis Dermatologic Laser
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Mitchell J. Robins Lumedics, Ltd. 7567 La Jolla Blvd. La Jolla, CA 92037 Phone: 858-794-6200 Facsimile: 858-551-1215
Mitchell J. Robins Contact Person:
August 6, 2001 Date Prepared:
Name of Device and Name/Address of Sponsor
Lumedics Aramis Dermatologic Laser
Lumedics, Ltd. 7567 La Jolla Blvd. La Jolla, CA 92037
Common or Usual Name
Dermatologic Laser
Classification Name
Powered Laser Surgical Instrument for use in General Dermatological Use
Product Code
GEX Panel: 79
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Predicate Devices
Palomar Medical Technologies, Inc. Aramis Dermatologic Laser
Intended Use
The Aramis is intended to be used for incision/excision, ablation, and coagulation (homeostasis) of soft tissue. The Aramis Laser is also indicated for the photocoagulation of dermatological vascular lesions, including photothermolysis of blood vessels (treatment of facial and leg veins) and the treatment of benign pigmented lesions.
Technological Characteristics and Substantial Equivalence
The Aramis Dermatologic Laser is an Er-glass 1.54 um system. The computer system consists of a laser unit, a cooler, a footswitch, and a 2mm or 4mm hand piece. The 4mm hand piece is gas-cooled to provide actual skin cooling. Laser parameters and other system features are controlled from the touch-buttons on top of the laser unit, which provides an interface to the system computer.
The Aramis is substantially equivalent to the currently marketed Palomar Aramis Dermatologic Laser powered surgical lasers in intended use, indications for use, principles of operation, and technological features. Any minor differences do not raise any new issues of safety or effectiveness.
Performance Data
The Aramis complies with 21 C.F.R. §§ 1040.10 and 1040.11, as well as the following voluntary performance standards:
- UL544; Electrical Leakage ●
- IEC 60-601-1; Power Supply and Enclosure ●
- IEC 60-825-01; Safety of Laser Product .
- IEC 601-2-22; Therapeutic Laser Equipment Safety .
- 93/42/EEC: European Directive .
- IEC 60-601-1-2; Electromagnetic Compatibility .
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an emblem that resembles an eagle or bird with three horizontal lines above it, possibly representing wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 5 2001
Lumedics, Ltd. c/o Mr. Jonathan S. Kahan, Esq. Hogan & Hartson, LLP 555 Thirteenth Street, N.W. Washington, D.C. 20004
Re: K012545
Trade/Device Name: Lumedics, Ltd. Aramis Dermatologic Laser Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: August 6, 2001 Received: August 7, 2001
Dear Mr. Kahan:
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, 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 (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. Jonathan S. Kahan, Esq.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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,
Susan Walkins
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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NOV 0 5 2001
Indications for Use Form
KD12545 510(k) Number (if known): __
Device Name: Lumedics, Ltd. Aramis Dermatologic Laser
Indications for Use:
The Aramis Dermatologic Laser system is intended to be used for incision/excision, ablation, and coagulation (homeostasis) of soft tissue. The Aramis Laser is also indicated for the removal of pigmented lesions; photocoagulation of dermatological vascular lesions, including photothermolysis of blood vessels (treatment of facial and leg veins).
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 C.F.R. 801.109)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Division Sign-Off) (Division Sign-On)
Division of General, Restorative (Optional Format 1-2-96) Division of Neurological Devices
510(k) Number K012545
§ 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.