(81 days)
The McCue Energist ULTRATM VPL Intense Pulsed Light System is intended for permanent hair reduction. 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 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 long-term or permanent " 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.
The McCue Energist ULTRA™ is a light-based medical device that delivers a beam of pulsed non-ionising radiation in the region of 530nm to 950nm. The system has been designed to be compact and self-contained that includes: Control console unit Display panel Power supply Cooling system Removable handpiece with integrated switch, lamp, filter and glass coupling block
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study information for the McCue Energist ULTRA™ Pulsed Light System.
It's important to note that the provided text is a 510(k) Summary, which is a high-level overview. For detailed study protocols, raw data, and comprehensive acceptance criteria, one would typically need to consult a full 510(k) submission or scientific publications.
Acceptance Criteria and Device Performance
The provided 510(k) Summary, K040659 for the McCue Energist ULTRA™ Pulsed Light System, does not explicitly state specific quantitative acceptance criteria or detailed device performance metrics in a table format as might be found in a clinical study report.
Instead, the submission relies on the concept of substantial equivalence to predicate devices. The primary "performance data" statement is qualitative:
"The differences in specifications of the McCue Energist ULTRA™ and the predicate devices do not result in different performance or raise new questions of safety and efficacy."
This indicates that the device is deemed to meet acceptance criteria by demonstrating that its technical specifications and intended uses are similar enough to already legally marketed devices that it does not introduce new safety or efficacy concerns. Therefore, the "acceptance criteria" are implicitly met by being substantially equivalent to the predicates.
Given this, a table of explicit acceptance criteria and corresponding performance cannot be generated directly from the provided text.
Study Information
Based on the provided 510(k) Summary, there is no detailed human or animal clinical study data presented to "prove the device meets acceptance criteria." The submission relies on substantial equivalence to predicate devices, meaning it leverages the established safety and effectiveness of those previously cleared devices.
Here's a breakdown of the requested information, mostly indicating what is not explicitly provided in the summary:
-
A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as quantitative targets (e.g., "90% hair reduction," "lesion clearance in X% of patients"). The acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices.
- Reported Device Performance: Not detailed in quantitative terms for efficacy. The performance is indirectly supported by the statement that "differences in specifications... do not result in different performance or raise new questions of safety and efficacy" compared to the predicate devices.
-
Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- No specific sample size for a test set is mentioned. No clinical study data is detailed in this summary.
- Data Provenance: Not applicable as specific study data is not presented.
-
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 applicable as no specific test set or ground truth establishment based on expert review is described. The assessment is based on comparison to predicate devices and their established safety/efficacy.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as no specific test set requiring adjudication is described.
-
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 done or reported. This device is an Intense Pulsed Light System, not an AI-powered diagnostic tool, so an MRMC study with human readers and AI assistance would not be relevant in this context.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical light-based treatment device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for a new clinical study. The "ground truth" for the device's safety and efficacy is implicitly derived from the existing clearances and performance history of the predicate devices.
-
The sample size for the training set:
- Not applicable as this is a physical medical device, not a machine learning algorithm requiring a training set.
-
How the ground truth for the training set was established:
- Not applicable as this is a physical medical device, not a machine learning algorithm.
Summary of Findings from K040659:
The 510(k) summary for the McCue Energist ULTRA™ Pulsed Light System primarily focuses on demonstrating substantial equivalence to a list of previously cleared predicate devices (Lumenis IPL Quantum, Radiancy SpaTouch/Skin Station, Palomar EsteLux, Alderm/MBC Prolite/Plasmalite).
The basis for this substantial equivalence is the claim that "The differences in specifications of the McCue Energist ULTRA™ and the predicate devices do not result in different performance or raise new questions of safety and efficacy."
Therefore, this submission does not present detailed clinical study data, sample sizes, expert ground truth establishment, or specific performance metrics from a new study of the McCue Energist ULTRA™ itself. Instead, its acceptance is based on the premise that it is sufficiently similar to devices already proven safe and effective.
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JUN - 1 2004
510(k) Summary
McCue Energist ÙLTRA™ Pulsed Light System
This 510(k) summary of safety and effectiveness for the McCue Energist ULTRA pulsed light system by McCue Plc is submitted in accordance with the requirements of the Safe light System by MoSdo 11616 cabinitiations the Office of Device Evaluation (ODE) guidance concerning the organisation and content of a 510(K) summary.
| Applicant: | McCue Plc |
|---|---|
| Address: | Unit 27 Solent Indust. Estate, Hedge End, Southampton. SO23-2FY. England |
| Contact Person: | Steven Peach (General and Technical Manager) |
| Telephone: | 44 1489 795668 |
| Preparation Date: | 19th February 2004 |
| Device Trade Name: | McCue Energist ULTRA™ |
| Common Name: | Intense Pulsed Light System |
| Classification Name: | Laser surgical instrument for use in General and Plastic surgery and Dermatology21 CFR 878.4810Product Code: GEXPanel: 79 |
| Legally-Marketed Predicate Devices: | The McCue Energist ULTRA™ is substantially equivalent to the following currently marketed devices:Lumenis, Inc. IPL Quantum, K020839Radiancy, Inc. SpaTouch, K020856Radiancy, Inc. Skin Station, K030897Palomar, Inc. EsteLux, K020453, K020941Alderm/MBC, Prolite/Plasmalite, K013365, K022568, K023081 |
| System Description: | The McCue Energist ULTRA™ is a light-based medical device that delivers a beam of pulsed non-ionising radiation in the region of 530nm to 950nm. The system has been designed to be compact and self-contained that includes:Control console unitDisplay panelPower supplyCooling systemRemovable handpiece with integrated switch, lamp, filter and glass coupling block |
| Intended Use: | The McCue Energist ULTRA™ VPL Intense Pulsed Light System is intended for permanent hair reduction. 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 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 stablelong-term or permanent1 hair reduction in skin types I - V throughselective targeting of melanin in hair follicles. | |
| 1 Permanent hair reduction is defined as a long-term stable reduction in thenumber of hairs regrowing after a treatment regimen. | |
| PerformanceData: | The differences in specifications of the McCue Energist ULTRA™ and thepredicate devices do not result in different performance or raise new questions ofsafety and efficacy. |
| Conclusion: | Based on the foregoing, the McCue Energist ULTRA™ system is substantiallyequivalent to the legally-marketed predicate devices. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, overlaid on a circle of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 1 2004
McCue PLC c/o Mr. John W. Howlett British Standards Institution Maylands Avenue Hemel Hempstead Herts HP2 4SQ United Kingdom
Re: K040659
K040037
Trade/Device Name: McCue Energist ULTRA™ VPL Intense Pulsed 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: May 12, 2004 Received: May 20, 2004
Dear Mr. Howlett:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your connect the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conninered prices that have been reclassified in accordance with 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 r ou may, dierelevely, mains 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 If your device is exassinod (ional controls. Existing major regulations affecting your device can may be subject to sateral 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 r lease be actived that Fermination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I edolar statuated and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fart 0077, adoning (21 CFR Part 820); and if applicable, the electronic form in the quality by store (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. John W. Howlett
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w yourse of substantial equivalence of your device to a legally premits to the month on 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 If you desire spocente at (301) 594-4659. Also, please note the regulation entitled, Comaci the Office of Companies and (set notification" (21CFR Part 807.97). You may obtain Misolanding of Yeleronoo to premainters with the Act from the Division of Small other general 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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Indications for Use
510(k) Number (if known): __ K040659
Device Name: _ McCue Energist ULTRA™ VPL Intense Pulsed Light System
Indications for Use:
The McCue Energist ULTRATM VPL Intense Pulsed Light System is intended for permanent hair reduction. 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 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 long-term or permanent " 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page I of I
Muriam C. Provost
Division of General, Restorative, and Neurological Devices
510(k) Number K040659
D2
§ 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.