The McCue Energist ULTRA™ VPL Intense Pulsed Light System is intended for permanent hair reduction and the treatment of mild to moderate inflammatory Acne Vulgaris. It is also indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels and the treatment of benign pigmented lesions.

. Intense Pulsed Light Energy / wavelengths (530 - 950nm)
The 530 - 950nm intense pulsed wavelengths are indicated for:

The treatment of mild to moderate inflammatory Acne Vulgaris.

The treatment of benign pigmented epidermal and cutaneous lesions including warts, scars and striae.

The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins, facial veins and venous malformations.

. Intense Pulsed Light Energy / wavelengths (610 - 950nm)
The 610 - 950nm intense pulsed wavelengths are indicated for:

The removal of unwanted hair from all skin types and to effect stable longterm or permanent 1 hair reduction in skin types I - V through selective targeting of melanin in hair follicles.

11 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.

Device Description

The McCUE Energist ULTRA VPL™ System is a light based medical device that delivers a beam of pulsed non-ionising radiation in the region of 530nm to 950nm. The system is designed to be compact and self contained and includes the following features:

. Control console unit
Display panel .
Power supply .
Cooling system .
Removable handpiece with integrated switch, lamp, filter and glass coupling . block

AI/ML Overview

The provided text is a 510(k) summary for the McCUE Energist ULTRA Variable Pulsed Light (VPL™) System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain the detailed information necessary to answer all sections of your request regarding acceptance criteria and a specific study proving the device meets those criteria.

Here's what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

The document states: "Performance data was provided to demonstrate that the system is capable of providing the outputs necessary to achieve its required treatment parameters."

This is a general statement and does not provide specific acceptance criteria or reported performance data in a table format.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the given text. A 510(k) summary often summarizes extensive testing, but the details of the studies themselves (like sample sizes, data provenance) are typically found in the full 510(k) submission, not the summary.

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)

This information is not provided in the given text.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided in the given text.

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

This device is an Intense Pulsed Light System for dermatological treatments, not an AI-assisted diagnostic or imaging device used by human "readers." Therefore, an MRMC comparative effectiveness study with human readers assisting AI is not applicable and not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This device is a physical light-based medical device, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and not mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Since the specific "performance data" is not detailed, the type of ground truth used to evaluate its efficacy for indications like hair reduction or acne treatment is not explicitly stated. It would likely involve clinical outcomes (e.g., reduction in hair count, reduction in lesion severity), but this is not specified in the document.

8. The sample size for the training set

This information is not provided in the given text. This device is not an AI/ML model that requires a training set in the conventional sense. The "training" for such a device would refer to its manufacturing and calibration against established specifications.

9. How the ground truth for the training set was established

This information is not provided in the given text, and the concept of "ground truth for a training set" as it applies to AI/ML models is not directly relevant to this type of device.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on identical intended use and technological characteristics, with minor modifications to software and high-voltage components. It mentions that "performance data was provided," but it does not elaborate on the specific details of that data, study designs, sample sizes, or how acceptance criteria were met with quantified results.

Summary

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Section 5 - 510(k) Summary

VAR 1 5 2006

This 510(k) summary of safety and effectiveness for the McCUE Energist ULTRA variable pulsed light system has been prepared in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990 and follows relevant Office of Device Evaluation (ODE) guidance concerning the organisation and content of a 510(k) summary.

5.1 Applicant

McCue Plc,

5.2 Address

McCue Plc, Unit 27 Solent Industrial Estate, Hedge End. Southampton, SO30 2FY. UK

5.3 Contact Person

Steven Peach, General and Technical Manager Telephone (44) 1489 795668 Fax number (44) 1489 795670 Email smp@mccueplc.com

5.3.1 US Agent :

McCue Corporation, Inc. 1 Lisa Marie Circle, Larchwood Estate, Warwick, RI 02886

5.3.2 Name and Address of the Manufacturing Facilities :

McCue Pic, Unit 27 Solent Industrial Estate, Hedge End, Southampton, SO30 2FY. UK

5.3.3 Establishment Registration Number :

9617153

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5.4 Preparation Date

January 25th, 2006

5.5 Device Trade Name McCUE Energist ULTRA Variable Pulsed Light (VPL™) System

5.6 Device Common Name

Intense Pulsed Light System

5.7 Device Classification

Laser surgical instrument for use in General and Plastic Surgery and Dermatology Product code: GEX 21 CFR 878.4810

5.8 Legally marketed Predicate Devices

McCue Energist ULTRA™, K040659 Cyden IFL Professional System, K050165

5.9 Device Description

. Control console unit
Display panel .
Power supply .
Cooling system .
Removable handpiece with integrated switch, lamp, filter and glass coupling . block

5.10 Intended Use

The McCUE Energist ULTRA™ VPL Intense Pulsed Light System is intended for permanent hair reduction and the treatment of mild to moderate inflammatory Acne Vulgaris. It is also indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels and the treatment of benign pigmented lesions.

Intense Pulsed Light Energy / wavelengths (530 950nm) .
The 530 - 950nm intense pulsed wavelengths are indicated for:

The treatment of mild to moderate inflammatory Acne Vulgaris.

The treatment of benign pigmented epidermal and cutaneous lesions including warts, scars and striae.

The treatment of benign cutaneous vascular lesions including port wine stains, hemanqiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins, facial veins and venous malformations.

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. Intense Pulsed Light Energy / wavelengths (610 - 950nm)

The 610 - 950nm intense pulsed wavelengths are indicated for:

The removal of unwanted hair from all skin types and to effect stable long-term or permanent 1 hair reduction in skin types I - V through selective targeting of melanin in hair follicles.

1 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.

5.11 Comparison of Technological Characteristics

The McCUE Energist ULTRA VPL System has an identical intended use to the McCue predicate system and identical technological characteristics except for modifications to the device software and high voltage component. These differences do not result in differences in performance or raise new questions of safety and efficacy. The McCUE Energist ULTRA VPL System also has the same principles of operation, mode of action and equivalent energy outputs that are used by the Cyden predicate device to achieve the treatment of Acne Vulgaris. Performance data was provided to demonstrate that the system is capable of providing the outputs necessary to achieve its required treatment parameters. The McCUE Energist ULTRA VPL™ System is therefore concluded to be substantially equivalent to both of the above named predicate devices and minor differences to the systems do not raise additional concerns of safety and efficacy.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles a stylized eagle or bird in flight, composed of three curved lines. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2006

McCue Plc c/o Mr. Steven Peach General and Technical Manager Unit 27 Solent Industrial Estate, Hedge End Southampton, Hampshire SO30 2FY

Re: K060234

Trade/Device Name: McCue Energist ULTRA™ VPL Intense Pulse Light System 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: January 26, 2006 Received: January 30, 2006

Dear Mr. Peach:

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

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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. 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 (240) 276-0115. 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 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 vours.

elmee.

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): //

Device Name: McCue Energist ULTRATM VPL Intense Pulse Light System

Indications for Use:

. Intense Pulsed Light Energy / wavelengths (530 - 950nm)
The 530 - 950nm intense pulsed wavelengths are indicated for:

The treatment of mild to moderate inflammatory Acne Vulgaris.

The treatment of benign pigmented epidermal and cutaneous lesions including warts, scars and striae.

. Intense Pulsed Light Energy / wavelengths (610 - 950nm)
The 610 - 950nm intense pulsed wavelengths are indicated for:

The removal of unwanted hair from all skin types and to effect stable longterm or permanent 1 hair reduction in skin types I - V through selective targeting of melanin in hair follicles.

11 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.

(Over)

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BEL.OW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Elmol
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

Section 4

510(k) Number__KO60234

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.