(139 days)
The Medicam Evolux, Evostar and Evolight pulsed light systems (and included accessories) are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue. It is intended for use for: Removal of unwanted hair from all skin types (640nm to 1200nm); Treatment of benign pigmented lesions including dyschromia, hyper pigmentation, melasma, ephelides (freckles) (510nm to 1200nm); Removal of benign cutaneous vascular lesions including port wine stains, hemangiomas, rosacea, erythema, leg veins(485 nm to 1200nm); and Treatment of benign cutaneous lesions including warts, scars and striae (420nm to 1200nm). The Medicam Evolase pulsed light system (and included accessories) is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue. It is intended for use for: Treatment of benign pigmented lesions including dyschromia, hyper pigmentation, melasma, ephelides (freckles) (1064nm to 1200nm); and Removal of benign cutaneous vascular lesions including port wine stains, hemangiomas, rosacea, erythema, leg veins (532nm to 1200nm). The devices are intended for prescription use.
Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light Systems emit intense wide spectrum emission with wavelength of 420 - 1200 nm. It includes the following main components: A system console (including software and electronic control boards); A control and color touch screen; and Hand piece with cooling system.
The provided document is a 510(k) summary for the Medicam Evolux, Evostar, Evolight, and Evolase Pulsed Light Systems. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study proving the device meets specific acceptance criteria through performance data.
Therefore, many of the requested sections (Table of acceptance criteria, sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types for test/training sets, and training set sample size) cannot be directly extracted from this document as it does not contain such detailed study information.
Here's an analysis based on the information available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present a table of specific numerical acceptance criteria or reported device performance metrics in the way that would typically be found in a clinical study report. The substantial equivalence argument relies on the device having the "same indications for use, similar design and functional features" as the predicate devices, implying that their performance is expected to be comparable.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document does not describe a clinical study with a test set. This submission is based on substantial equivalence to predicate devices, referencing their established safety and effectiveness.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No new clinical study data with ground truth establishment is described.
4. Adjudication Method for the Test Set
Not applicable. No new clinical study data is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study is not mentioned or described in this document. The submission focuses on substantial equivalence based on indications for use and technological features.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a pulsed light system, not an algorithm. Performance is assessed through its physical characteristics and intended use, primarily compared to predicate devices.
7. The Type of Ground Truth Used
Not applicable. The submission is based on substantial equivalence, implying the "ground truth" for its safety and effectiveness is derived from the established history and performance of the predicate devices for their stated indications.
8. The Sample Size for the Training Set
Not applicable. This document describes a medical device, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is a medical device, not an algorithm requiring a training set.
Summary of Substantial Equivalence Claim (as per document):
The document asserts that the Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light Systems are substantially equivalent to the legally marketed predicate devices (Profile BBL System K032460 and Quantum, Models SR, HR, DL K020839).
The basis for this claim is:
- Indications for Use: The devices share the "same indications for use" as the predicate systems.
- Design and Features: They have "similar design and functional features."
- Technological Equivalence: "Technologically, the Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light Systems are substantially equivalent to the listed predicate devices."
Therefore, the conclusion states: "the risks and benefits for Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light System are comparable to the predicate devices." The acceptance criteria, in this context, are met by demonstrating this substantial equivalence to already cleared devices. No new, independent performance study with explicit numerical acceptance criteria is detailed in this 510(k) summary.
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KIII350
SEP 2 9 2011
· Attachment 5
510(k) Summary
As required by 21 CFR 807.92(c)
| Submitter | MEDICAM INC. |
|---|---|
| Address | 7900 Jean-BrillonMontréal, QCCanadaH8N 2L5 |
| Phone | (514) 737-0404 |
| Fax | (514) 489-0400 |
| Contact Person | Philippe AmarPresident |
| Summary Date | May 5, 2011 |
| Device Trade Name | Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light Systems |
| Device common name | Laser Powered Surgical Instrument (and Accessories) |
| Classification Name | Laser Surgical Instrument for use in General and Plastic Surgery and inDermatology (21 CFR 878.4810) |
| Legally MarketedPredicate Devices | Profile BBL System (K032460)Quantum, Models SR, HR, DL (K020839) |
| System Description | Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light Systems emitintense wide spectrum emission with wavelength of 420 - 1200 nm.It includes the following main components:A system console (including software and electronic control boards);A control and color touch screen; and |
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| Hand piece with cooling system. | |
|---|---|
| Intended Use | The Medicam Evolux, Evostar and Evolight pulsed light systems (and included accessories) are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue. |
| It is intended for use for: | |
| Removal of unwanted hair from all skin types (640nm to 1200nm); | |
| Treatment of benign pigmented lesions including dyschromia, hyper pigmentation, melasma, ephelides (freckles) (510nm to 1200nm); | |
| Removal of benign cutaneous vascular lesions including port wine stains, hemangiomas, rosacea, erythema, leg veins(485 nm to 1200nm); and | |
| Treatment of benign cutaneous lesions including warts, scars and striae (420nm to 1200nm). | |
| The Medicam Evolase pulsed light system (and included accessories) is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue. | |
| It is intended for use for: | |
| Treatment of benign pigmented lesions including dyschromia, hyper pigmentation, melasma, ephelides (freckles) (1064nm to 1200nm); and | |
| Removal of benign cutaneous vascular lesions including port wine stains, hemangiomas, rosacea, erythema, leg veins (532nm to 1200nm). | |
| The devices are intended for prescription use. | |
| Substantial Equivalence | The Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light Systems shares the same indications for use, similar design and functional features and are therefore substantially equivalent to the above legally marketed predicate devices. |
| Safety and Effectiveness Information | The indications for use are based upon the indications for use from Predicate systems. Technologically, the Medicam Evolux, Evostar, Evolight |
KIU3SO- ..
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. •
:
| and Evolase Pulsed Light Systems are substantially equivalent to the listed predicate devices. Therefore, the risks and benefits for Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light System are comparable to the predicate devices. | |
|---|---|
| Conclusion | The Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light Systems share similar indications for use, design features and similar functional features as the currently marketed predicate devices and therefore are substantially equivalent to them. |
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- CHATHAM INVESTMENT PARTNERS, LLC
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Medicam. Inc. % Mr. Philippe Amar President 7900 Jean-Brillon Montreal, Quebec, Canada H8N 2L5
SEP 2 9 2011
Re: K111350
Trade/Device Name: Medicam Evolus, Evostar, Evolight and Evolase Pulsed Light Systems Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: ONF Dated: September 23, 2011 Received: September 26, 2011
Dear Mr. Amar:
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, ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations of eclass of (1 MF).
For discult of the 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.
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Page 2 - Mr. Philippe Amar
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); medical device reporting (reporting (reporting of medical device-related adverse events) (21 CFR 803); 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,
ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/Centers0ffices/CDRH0ffices/ucm/1.se/ucm/1.phease/
the Conter for Designers offices/CDRH/CDRHOffices/ucm/1.5809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regions of artisting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Eric M. Keith
FS Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment IV
Indications for Use Statement
K111350 510(k) Number:
Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light Systems Device Name:
Indications for use:
The Medicam Evolux, Evostar and Evolight pulsed light systems (and included accessories) are indicated for use in surgical, aesthetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue.
It is intended for use for:
- A Removal of unwanted hair from all skin types (640nm to 1200nm);
- A Treatment of benign pigmented lesions including dyschromia, hyper pigmentation, melasma, ephelides (freckles) (510nm to 1200nm);
- A Removal of benign cutaneous vascular lesions including port wine stains, hemangiomas, rosacea, erythema, leg veins(485 nm to 1200nm); and
- A Treatment of benign cutaneous lesions including warts, scars and striae (420nm to 1200nm).
The devices are intended for prescription use.
*** Continued on Following Page ***
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CFRH Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Surgical, Orthopedic, and Restorative Devices |
for mxnPrescription Use X (Per 21CFR801)
OR
Over-the-counter J
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Indications for use:
*** Continued from Previous Page***
The Medicam Evolase pulsed light system (and included accessories) is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue.
It is intended for use for:
-
Treatment of benign pigmented lesions including dyschromia, hyper pigmentation, melasma, ephelides (freckles) (1064nm to 1200nm); and
- Removal of benign cutaneous vascular lesions including port wine stains, hemangiomas, rosacea, A erythema, leg veins (532nm to 1200nm).
The device is intended for prescription use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONȚINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CFRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
| Prescription Use(Per 21CFR801) | X | OR | Over-the-counter Use |
|---|---|---|---|
| 510(k) Number | K111350 |
§ 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.