(15 days)
Indications for Use for Fitzpatrick skin types (I to VI)
- The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.
- The treatment of moderate inflammatory acne vulgaris.
- The treatment of benign pigmented epidermal lesions including dyschromia. hyperpigmentation, melasma, ephelides (freckles)
- The treatment of cutaneous lesions including warts, scars, and striae.
- The treatment of benign cutaneous vascular lesions, including port wine stains. hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas, and spider angiomas, poikiloderma of civatte, leg veins and venous malformations.
The integrated thermal cooling is indicated for use in cooling the epidermis at the treatment site prior to, during, and after treatment in general aesthetic dermatologic and plastic surgery procedures. - Reduce pain during and/or with light treatment (via partial anesthesia from cooling)
- Reduce discomfort during and/or associated with light treatment
- Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light treatment, thus reducing possible complications such as scabbing, scarring, hyper - and/or hypopigmentation
- Allow the use of higher light fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions)
- Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions)
The Accelawave is an Intense Pulsed Light-based medical device utilizing xenon flash lamp technology to illuminate the dermis to offer light based therapies as listed in the indications of use. The Accelawave emits light at 420nm to 1200nm via a 15mm x 45mm treatment area at a repetition rate equal to or less than 0.5Hz (operator selective). Light is delivered to the skin surface while a water-cooled heat transfer network cools the contacting surfaces and the epidermis.
This 510(k) summary for the Accelawave System does not contain the detailed information typically found in a study proving a device meets acceptance criteria. A 510(k) submission primarily demonstrates substantial equivalence to a predicate device, rather than providing extensive clinical trial data with specific performance metrics and statistical analyses.
Therefore, many of the requested elements (acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance) are not present in the provided document.
However, based on the information given, here's what can be extracted and what is missing:
Acceptance Criteria and Study to Prove Device Meets Criteria
The provided 510(k) summary for the Accelawave System focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than on providing a detailed study proving specific performance acceptance criteria for a novel algorithm or diagnostic device. As such, the document does not present explicit acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) and a study designed to meet those.
Instead, the "acceptance criteria" can be inferred as fulfilling the requirements for substantial equivalence to the predicate devices (Chromogenex K053324, Sciton K032460, Lumenis K020839) in terms of:
- Technological characteristics
- Performance (as demonstrated by similar output spectrum, output pulse characteristics, and treatment parameters)
- Intended use
- Indications for use
- Operator interface
- Safety (including compliance with European Medical Directive 93/42/EEC and voluntary standard UL60601-1:1996 for electrical safety).
The "study" that proves the device meets these (implied) acceptance criteria is the overall demonstration within the 510(k) submission that the Accelawave System is substantially equivalent to the identified predicate devices. This typically involves technical comparisons, safety testing, and a discussion of similar indications and mechanisms of action.
1. Table of Acceptance Criteria and Reported Device Performance
As noted, explicit, quantifiable acceptance criteria and device performance metrics (like sensitivity, specificity, etc.) are not provided in this type of submission. The document states that the Accelawave System is "substantially equivalent in terms of technological characteristics, performance, intended use, indications for use and operator interface" to its predicates.
| Acceptance Criteria (Inferred from 510(k) requirements for substantial equivalence) | Reported Device Performance (as demonstrated for substantial equivalence) |
|---|---|
| Technological Characteristics: Similar to predicates | Output Spectrum Characteristics: Similar to predicates |
| Output Pulse Characteristics: Similar to, and programmable like, predicates | |
| Treatment Parameters: Similar to, and programmable like, predicates | |
| Performance: Safe and effective for indications, similar to predicates | Device complies with European Medical Directive 93/42/EEC |
| Will comply with UL60601-1:1996 when marketed in the U.S. | |
| Intended Use: Similar to predicates | IPL-based medical device using xenon flash lamp for light-based therapies |
| Indications for Use: Similar to predicates | Indications listed for various skin conditions and cooling functions |
| Operator Interface: Similar to predicates | Not explicitly detailed, but implied by substantial equivalence |
| Safety: Minimize side effects, manage thermal injury | Integrated thermal cooling to reduce pain, discomfort, and thermal injury |
| Potential side effects (red patches, blistering) are disclosed and managed |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable or Not provided. This 510(k) summary for an Intense Pulsed Light (IPL) system does not include clinical efficacy studies with specific "test sets" or data provenance in the way a diagnostic AI device would. The demonstration of safety and effectiveness relies on comparison to predicate devices and adherence to safety standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable or Not provided. As there is no clinical "test set" and ground truth establishment in the context of diagnostic accuracy, this information is not present. The document refers to "Indications for Use for Fitzpatrick skin types (I to VI)" which are general classifications rather than expert-established ground truths for a specific study.
4. Adjudication Method for the Test Set
Not applicable or Not provided. No adjudication method is mentioned as there's no diagnostic test set requiring such.
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. An MRMC study is not applicable and was not done. This device is an IPL system for therapeutic applications (hair removal, acne, pigmented lesions, vascular lesions, etc.), not a diagnostic imaging device with human readers or AI assistance in interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This device is a physical therapeutic system, not a standalone algorithm. Its performance is intrinsically "with human-in-the-loop" as it is operated by a healthcare professional.
7. The Type of Ground Truth Used
Not applicable or Not provided in the context of diagnostic performance. For the therapeutic claims, the "ground truth" would implicitly be the clinical outcomes experienced by patients treated with the device, compared to outcomes from predicate devices or established treatment protocols. However, no specific study data or ground truth definition for clinical outcomes is detailed here.
8. The Sample Size for the Training Set
Not applicable or Not provided. There is no "training set" in the context of this IPL device's development as it is not an AI/ML algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable or Not provided. Not relevant for this type of device submission.
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.
510(k) Summary of Safety and Effectiveness
Accelawave System
510(k) Number KO82484_
| Applicant: | Genesis Biosystems |
|---|---|
| Address: | 1500 Eagle Court Lewisville, TX 75057 |
| Contact Person: | Brian A. Buss, Director of Compliance |
| Telephone: | (972) 315-7888 |
| Fax: | (972) 315-7818 |
| Email: | bbuss@genesisbiosystems.com |
| Date prepared: | 04 / 23 / 2008 |
| Device Trade Name: | Accelawave System |
| Common Name: | Intense Pulsed Light (IPL) |
| Classification Name: | Laser Surgical Instrument 21 C.F.R § 878.4810 |
| Product Classification: | Class II device |
| Product Code: | ONF |
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Image /page/1/Picture/0 description: The image shows the logo for Genesis Biosystems. The word "Genesis" is in a larger, sans-serif font, with a small tree graphic above the "sis" portion of the word. Below "Genesis" is the word "Biosystems" in a smaller font.
| Legally MarketedPredicate Device: | The Accelawave System is substantially equivalent in terms oftechnological characteristics, performance, intended use,indications for use and operator interface to; |
|---|---|
| • Chromogenex (K053324) | |
| • Sciton (K032460) | |
| • Lumenis (K020839) | |
| System Description: | The Accelawave is an Intense Pulsed Light-based medical deviceutilizing xenon flash lamp technology to illuminate the dermis tooffer light based therapies as listed in the indications of use. TheAccelawave emits *light at 420nm to 1200nm via a 15mm x 45mmtreatment area at a repetition rate equal to or less than 0.5Hz(operator selective).*Light is delivered to the skin surface while a water-cooled heattransfer network cools the contacting surfaces and the epidermis. |
| PerformanceStandards: | The device complies with the European Medical Directive93/42/EEC concerning medical devices, and will comply withvoluntary standards UL60601-1:1996 when marketed in the U.S. |
Indications for use: Indications for Use for Fitzpatrick skin types (I to VI)
- The removal of unwanted hair and to effect stable long-term or *permanent hair . reduction. *Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.
- The treatment of moderate inflammatory acne vulgaris .
- o The treatment of benign pigmented epidermal lesions including dyschromia. hyperpigmentation, melasma, ephelides (freckles)
- The treatment of cutaneous lesions including warts, scars, and striae. 0
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Image /page/2/Picture/0 description: The image shows the logo for Genesis Biosystems. The word "Genesis" is in a large, bold font, and the word "Biosystems" is in a smaller font below it. There is a small graphic above the word "Genesis" that looks like a cluster of cells.
-
The treatment of benion cutaneous vascular lesions, including port wine stains. . hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas, and spider angiomas, poikiloderma of civatte, leg veins and venous malformations.
The integrated thermal cooling is indicated for use in cooling the epidermis at the treatment site prior to, during, and after treatment in general aesthetic dermatologic and plastic surgery procedures. -
Reduce pain during and/or with light treatment (via partial anesthesia from cooling) .
-
Reduce discomfort during and/or associated with light treatment .
-
Minimize thermal injury, including thermal necrosis, to non-target skin and skin . structures during and/or associated with light treatment, thus reducing possible complications such as scabbing, scarring, hyper - and/or hypopigmentation
-
Allow the use of higher light fluences for light or laser treatments (such as for hair . removal and the treatment of vascular or pigmented lesions)
-
Reduce potential side effects of light or laser treatments (such as for hair removal and . the treatment of vascular or pigmented lesions)
-
The Accelawave System is substantially equivalent to its predicate Conclusion: devices, based upon predicate similarities. The skin is treated in the same manner as the predicate devices, Intense Pulsed Light and dermal cooling.
| Similarities/Differences | Lumenis Vasculite | Sciton BBL | Chromalight |
|---|---|---|---|
| Output SpectrumCharacteristics | Similar | Similar | Similar |
| Output PulseCharacteristics | Similar,Programmable | Similar,Programmable | Similar,Programmable |
| TreatmentParameters | Similar,Programmable | Similar,Programmable | Similar |
| SkinCooling/EpidermalCooling | Cold Gel vs. ColdContact Cooling(difference) | Similar ColdContact Cooling | none |
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Image /page/3/Picture/0 description: The image shows the logo for Genesis Biosystems. The word "Genesis" is on the top line, and the word "Biosystems" is on the second line. There is a graphic above the word "Genesis" that looks like a tree.
- Side Effects: In extreme cases, effects from treatment can include excessively red patches in the shape of the applicator head and blistering. If this occurs the tissue should be cooled and cared for as would normally be the case with burns to the skin, i.e. do not burst any blister formation, keep clean and covered until healed.
If blisters form, they are usually intra-epidermal in nature and heal without scarring. Inappropriate management of blisters during the healing stage will increase the chance of scarring.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Genesis Biosystems, Inc. % Underwriters Laboratories, Inc. Mr. Casey Conry Senior Project Engineer 1285 Walt Whitman Road Melville, New York 11747
AUG 2 6 2011
Re: K082484
Trade/Device Name: Accelawave 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: ONF
Dated: August 26, 2008 Received: August 28, 2008
Dear Mr. Conry:
This letter corrects our substantially equivalent letter of September 12, 2008.
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 (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 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
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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 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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 regarding the reporting 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-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark A Millikan
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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Image /page/6/Picture/0 description: The image shows the logo for Genesis Biosystems. The word "Genesis" is written in a bold, sans-serif font, with a graphic above the "sis" portion of the word. Below "Genesis" is the word "Biosystems", also in a bold, sans-serif font, but slightly smaller than the word above it. The logo is black and white.
| Indications for Use | ||
|---|---|---|
| 510(k) Number (if known): | K082484 | |
| Device Name: | Accelawave System | (Division Sign-Off)Division of General, Restorative,and Neurological Devices |
| Indications for Use for Fitzpatrick skin types (I to VI) | 510(k) Number | K082484 |
Indications for Use for Fitzpatrick skin types (I to VI)
-
The removal of unwanted hair and to effect stable long-term or "permanent hair ● reduction.
*Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen. -
. The treatment of moderate inflammatory acne vulgaris
-
. The treatment of benign pigmented epidermal lesions including dyschromia. hyperpigmentation, melasma, ephelides (freckles)
-
The treatment of cutaneous lesions including warts, scars, and striae. .
-
The treatment of benign cutaneous vascular lesions, including port wine stains, . hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas, and spider angiomas, poikiloderma of civatte, leg veins and venous malformations.
The integrated thermal cooling is indicated for use in cooling the epidermis at the treatment site prior to, during, and after light treatment in general aesthetic dermatologic and plastic surgery procedures.
- Reduce pain during light treatment (via partial anaesthesia from cooling) ●
- Reduce discomfort during and/or associated with light treatment �
- . Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light treatment, thus reducing possible complications such as scabbing, scarring, hyper - and/or hypo pigmentation
- Allow the use of higher light or laser fluences for light treatments (such as for hair . removal and the treatment of vascular or pigmented lesions)
- Reduce potential side effects of light treatments (such as for hair removal and the . treatment of vascular or pigmented lesions)
Section #5 - 1
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Indications for Use
510(k) Number (if known): K082484
awave Device Name: ACC
Indications For Use:
Indications and Filters vs. Skin Types
| CONDITIONS | FILTER SETTINGS and WAVELENGTH RANGE | I | II | III | IV | V | VI |
|---|---|---|---|---|---|---|---|
| Hair (course) | 640-1200 | 640-1200 | 640-1200 | 640-1200 | 690-1200 | 690-1200 | |
| Hair (fine) | 640-1200 | 640-1200 | 640-1200 | 640-1200 | 690-1200 | 690-1200 | |
| Acne Vulgaris | 420-1200 | 420-1200 | 420-1200 | 420-1200 | 510-1200 | N/A | |
| PigmentedEpidermal Lesions | |||||||
| a) Dyschromia | 510-1200 | 510-1200 | 510-1200 | 560-1200 | 560-1200 | N/A | |
| b) Hyperpigmentation | 510-1200 | 510-1200 | 510-1200 | 560-1200 | 560-1200 | N/A | |
| c) Melasma | 560-1200 | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A | |
| d) Ephelides | 560-1200 | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A | |
| Cutaneous Lesions | |||||||
| a) Warts | 420-1200 | 420-1200 | 420-1200 | 420-1200 | 420-1200 | N/A | |
| b) Scars | 560-1200 | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A | |
| c) Striae | 560-1200 | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A | |
| Cutaneous VascularLesions | |||||||
| a) Port Wine Stain (Child) | 510-1200 | 510-1200 | 510-1200 | 560-1200 | 560-1200 | N/A | |
| b) Port Wine Stain (Adult) | 510-1200 | 510-1200 | 510-1200 | 560-1200 | 560-1200 | N/A | |
| c) Hemangiomas | 560-1200 | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A | |
| d) Telangiectasias | 510-1200 | 510-1200 | 510-1200 | 560-1200 | 560-1200 | N/A | |
| e) Rosacea | 560-1200 | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A | |
| f) Angiomas | 560-1200 | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A | |
| g) Spider Angiomas | 560-1200 | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A | |
| h) Poikiloderma | 510-1200 | 510-1200 | 510-1200 | 560-1200 | 560-1200 | N/A | |
| i) Venous Malformations | 560-1200 | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A | |
| Leg Veins | |||||||
| a) Small | 510-1200 | 510-1200 | 510-1200 | 560-1200 | 560-1200 | N/A | |
| b) Medium | 560-1200 | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A | |
| c) Large | 560-1200 | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A |
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R. Ogle formxn
(Division Sign-Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number K082484
§ 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.