(180 days)
The Aramis II Dermatological Laser system is intended to be used for incision/excision, ablation, and coagulation (homeostasis) of soft tissue. The Aramis II 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), and for the treatment of periorbital and perioral wrinkles.
The Aramis II Dermatological Laser emits a beam of coherent light at 1540 microns which is delivered to the hand pieces, including a cooling hand piece, through a fiber optic.
The provided text focuses on the 510(k) summary for the Aramis II Dermatological Laser, detailing its indications for use and substantial equivalence to predicate devices, rather than explicit acceptance criteria with numerical targets. Therefore, the requested information, particularly numerical acceptance criteria and a single study demonstrating adherence, is not fully present.
However, based on the provided text, we can infer some aspects and report what is available:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria for device performance. Instead, it relies on the results of pre-clinical and clinical studies to demonstrate safety and effectiveness, leading to a conclusion of substantial equivalence.
| Performance Aspect | Inferred Acceptance Criteria (not explicitly stated as quantitative targets) | Reported Device Performance |
|---|---|---|
| Safety | Low incidence of adverse effects, controlled thermal effects | - Pre-clinical study in rats showed thermal effects need to be controlled to reduce risks of epidermal injury.- Clinical studies reported "no or only a low incidence of complications, such as pain, swelling, erythema, scabbing, or blisters."- Brief erythema linked to cooling noted as the only "unwanted side effect."- Higher doses led to "some erythema, swelling, blistering, and crusting," indicating a need for careful dose management, especially in periorbital areas. |
| Effectiveness (Wrinkle Treatment) | Progressive improvement of skin texture and wrinkles, new collagen synthesis | - Clinical studies showed "progressive improvement of the skin texture and the wrinkles."- Biopsies showed "significant increases in collagen."- Remodeling progresses slowly over several months. |
| Effectiveness (General) | Incision/excision, ablation, coagulation, pigmented and vascular lesion removal | The device is deemed "safe and effective for these applications based on clinical studies" and is substantially equivalent to predicate devices for these indications. |
2. Sample size used for the test set and the data provenance
- Test set (Clinical Studies): A total of 76 patients were involved in the clinical studies.
- One study: 10 patients (dose-response study).
- Other two studies: 66 patients combined.
- Data provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective clinical investigations as they involve follow-ups (e.g., 6 months, 14 months after treatment).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical studies. The "researchers" and "investigators" are mentioned as reporting results and observations.
4. Adjudication method for the test set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) used for the clinical study results.
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
No MRMC study was described. This device is a laser system, not an AI-based diagnostic tool that would typically involve human readers interpreting output.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a laser for medical procedures, not an algorithm.
7. The type of ground truth used
- Clinical effectiveness: Clinical observations by "researchers" and "investigators" regarding improvement in skin texture and wrinkles, incidence of complications.
- Biological effect: Histological results (for animal study) showed new collagen synthesis and fibroblastic proliferation. Biopsies (in human studies) showed significant increases in collagen.
- Safety: Direct observation of adverse events like erythema, swelling, blistering, crusting.
8. The sample size for the training set
The concept of a "training set" is not directly applicable here as it relates to machine learning algorithms. The studies described are clinical investigations of a physical device, not an AI model.
9. How the ground truth for the training set was established
Not applicable.
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SECTION 10
510(k) SUMMARY
This 510(k) summary of safety and effectiveness for the Aramis II Dermatological Laser is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.
| Applicant: | Quantel Medical |
|---|---|
| Address: | QUANTEL MEDICAL21 rue NewtonZI du BREZET63039 Clermont-FerrandCedex 2FRANCE+33 (0)473 745 745+33 (0)473 745 700 (Fax) |
| Contact Person: | Mr. Jean Abascal |
| : | (+33) 169 29 17 25(+33) 169 29 17 29 |
| Preparation Date:(of the Summary) | February 2003 (rev.) |
| Device Name: | Aramis II Dermatological Laser |
| Common Name: | Er:Glass Laser |
| ClassificationName: | Laser surgical instrument for use in general and plastic surgery and indermatology (see: 21 CFR 878.4810).Product Code: GEXPanel: 79 |
| Predicate devices: | The Aramis laser (also Aramis I) - K012545 and K002649The New Star Model 130 - K962791The Smoothbeam Laser System - K013825The CoolTouch and CoolTouch I - K003715 |
| Device description: | The Aramis II Dermatological Laser emits a beam of coherent light at 1540microns which is delivered to the hand pieces, including a cooling handpiece, through a fiber optic. |
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The Aramis II Dermatological Laser system is intended to be used for Indications: incision/excision, ablation, and coagulation (homeostasis) of soft tissue. The Aramis II 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), and for the treatment of periorbital and perioral wrinkles.
The Aramis Dermatological Laser is also labeled: "CAUTION: Federal law restricts the sale to or use by licensed professionals."
Performance Data: The results of pre-clinical and clinical studies were included.
A study of skin remodeling in hairless rats demonstrated that results are dose and temperature cooling dependent. Further, the thermal effects need to be controlled to reduce the risks of injury to the epidermis. Histological results showed new collagen synthesis and marked fibroblastic proliferation.
Three clinical studies in a total of 76 patients. All doses were administered in pulse trains and a cooling hand piece was used to cool the epidermis before treatment.
One clinical investigation was a dose-response study in 10 patients. The researchers reported some erythema, swelling, blistering, and crusting at higher doses. The researchers reported that lower doses should be administered to the periorbital area due to increased risk of side effects in this area.
Researchers in the other two clinical investigations reported results on 66 patients. In one study patients for followed for 6 months after the 3rd treatment; in the other they were followed for 14 months. The researchers reported there were no or only a low incidence of complications, such as pain, swelling, erythema, scabbing, or blisters. Both the periorbital and perioral areas were treated in these investigations.
Scheduled follow-ups in these two investigations, showed progressive improvement of the skin texture and the wrinkles. There were no unwanted side effects except for a brief erythema linked to the cooling. In one study biopsies were taken 6 months after the first treatment and showed significant increases in collagen.
The investigators suggested that the dose be administered as a train of pulses, that the skin should be cooled to 5℃, and that the fluence be controlled to avoid the critical temperature which leads to cell destruction.
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The investigators also suggested that patients be advised that the remodeling progresses slowly over several months and that they should not be disappointed by a lack of immediate effects.
Based on the information in this notification Quantel Medical concludes that CONCLUSION: the Aramis II, when intended to be used for incision/excision, ablation, and coagulation (homeostasis) of soft tissue for the removal of pigmented lesions; photocoagulation of dermatological vascular lesions, including photothermolysis of blood vessels (treatment of facial and leg veins) is substantially equivalent to cited legally marketed predicates.
Quantel further concludes that the Aramis II intended the treatment of periorbital and perioral wrinkles skin remodeling, is safe and effective for these applications based on clinical studies and the ARAMIS II is substantially equivalent to cited legally marketed products.
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.
MAY 0 6 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ouantel Medical c/o Mr. Roger Barnes 342 Sunset Bay Road Hot Springs, Arkansas 71913
Re: K023734
Trade/Device Name: ARAMIS II Dermatological Laser 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: February 10, 2003
Received: February 11, 2003
Dear Mr. Barnes:
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. Roger Barnes
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
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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SECTION 7
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K023734
Device Name: Aramis II Dermatological Laser
Indications for Use Statement:
The Aramis II Dermatological Laser system is intended to be used for incision/excision, ablation, and coagulation (homeostasis) of soft tissue. The Aramis II 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), and for the treatment of periorbital and perioral wrinkles.
The Aramis II Dermatological Laser is also labeled: CAUTION: Federal law restricts the sale to or use by licensed professionals.
uriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
rev. 2/2003
510(k) Number_________________________________________________________________________________________________________________________________________________________________
___ (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The Counter Use ________________________________________________________________________________________________________________________________________________________
§ 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.