(29 days)
No
The description focuses on the laser technology, optical components, and a standard microprocessor for monitoring and control, with no mention of AI or ML capabilities.
Yes
The device is used for UVB phototherapy to treat various skin conditions, which directly indicates a therapeutic purpose.
No
The device is described as a "compact laser light source" used for "UVB phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma." It delivers monochromatic ultraviolet light to "skin areas affected by disease" for therapeutic purposes, not for identifying or diagnosing a condition.
No
The device description clearly outlines a physical laser light source with hardware components like a sealed chamber, gases, mirrors, shutters, lenses, and optic fibers. While it mentions an on-board microprocessor and software verification, the core functionality is based on hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "UVB phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma." This describes a therapeutic treatment applied directly to the patient's skin.
- Device Description: The device is a laser light source that delivers light to the skin. This is a physical intervention, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
The device is clearly intended for therapeutic use by applying light energy to the affected skin areas of a patient.
N/A
Intended Use / Indications for Use
UVB phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma.
Product codes
GEX
Device Description
The Momentum is a self-contained compact laser light source that operates on standard AC supply power requiring no special power or cooling considerations. A protective interlocked housing encloses the laser source, electronics, and gas storage and distribution system. The XTRAC Momentum Model AL10000 comes in two spatial configurations: a horizontal (Velocity)configuration and a vertical (upright / Momentum) configuration.
A core element of both the Momentum excimer laser and the Velocity is a sealed chamber containing a mixture of pressurized Neon, Xenon, and HCl gases. High-voltage electrical discharges into the gas mixture create unstable XeCl molecules, which dissociate rapidly, creating monochromatic ultraviolet light at a wavelength of 308 nm. The electrical discharges are repeated in a fast sequence, producing a train of light pulses of a nominal duration of 30ns each. The timing of electrical discharges and energy of the produced light are constantly monitored by an on-board microprocessor to ensure safety.
Using a set of optical devices such as mirrors, shutters, lenses, and optic fibers, the produced light is focused and directed by the user to skin areas affected by disease. Each dose delivered by the system is composed of multiple laser pulses delivered at a preset repetition rate for a duration that is managed by the system processor.
Maximum pulse energy delivered to the patient's skin through the fiber optic cable and subsequent hand piece with skin contact tip is 15mJ per pulse or a fluence (radiant exposure) of 3.8 mJ/cm² (non-ablating). The average power delivered to the patient's skin is limited to 6 Watts which is a balance between time to deliver a dose and skin heating effect. Accessories include different tip configurations:
- . Standard Tip: Designed to pass a fixed 4cm2 square beam.
- Short Tip: For use with the iris diaphragm
- Short Hair Scalp Tip: Similar to the standard tip but includes three hollow elongated “teeth” to comb and part the hair in order to expose the scalp.
- Multi-Micro Dose (MMD) Tip: Provides four different dose levels with a single beam application, which can assist the physician in selection of the initial treatment dose.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin areas affected by disease (e.g., psoriasis, vitiligo, atopic dermatitis, leukoderma). Specifically mentions scalp for the Short Hair Scalp Tip.
Indicated Patient Age Range
Adults
Intended User / Care Setting
Healthcare facilities and outpatient dermatology clinics
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data were provided in support of the substantial equivalence determination:
- Biocompatibility - The modifications do not change the materials in patient contact. The patient contacting materials are identical to the predicate and review of the geometry and processing did not raise new or different concerns.
- Electrical Safety and EMC - Electrical safety and EMC testing were conducted on the subject device. The system complies with AAMI ANSI ES 60601-1: 2005 + A1: 2012 and IEC 60601-2-22 Edition 3.1 2012-10 standards for safety and IEC 60601-1-2: 2014 for EMC.
- Software Verification and Validation Testing - Software verification and validation testing were conducted. The software for this device was considered as a "moderate" level of concern.
- Mechanical, Animal, and Clinical Testing - No mechanical, animal or clinical testing was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Strata Skin Sciences, Inc. % Paul Dryden President - consultant to Strata Skin Sciences Strata Skin Sciences, Inc. c/o ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704
Re: K193478
Trade/Device Name: XTRAC Momentum Excimer Laser System, Model AL10000 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: GEX Dated: December 11, 2019 Received: December 16, 2019
Dear Paul Dryden:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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 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.
1
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 and Part 809: medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jessica Mavadia-Shukla, Ph.D. Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Page 2
Enclosure
2
Indications for Use
510(k) Number (if known)
K193478
Device Name
XTRAC Momentum Excimer Laser System, Model AL10000
Indications for Use (Describe)
UVB phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma.
Type of Use (Select one or both, as applicable)
XX Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
PSC Publishing Services (301) 443-6740 EF
3
| Date Prepared: | 14-Jan-2020 |
|---|---|
| I Submitter | |
| Strata Skin Sciences, Inc. | |
| 5 Walnut Grove Drive, Suite 140 | |
| Horsham, PA 19044 | |
| T - 760-602-3300 | |
| Submitter Contact: | Chuck Mierkiewicz |
| Senior Quality / Regulatory Manager | |
| Submission Correspondent: | Paul Dryden |
| ProMedic, LLC | |
| II Device | |
| Proprietary or Trade Name: | XTRAC Momentum Excimer Laser System, Model |
| AL10000 | |
| Common/Usual Name: | Powered laser surgical instrument |
| Classification Name: | Laser surgical instrument for use in general and plast |
| surgery and in dermatology (21 CFR 878.4810) | |
| Regulatory Class: | II |
| Product Code: | GEX |
| III Predicate Device: | |
| K073659 - XTRAC Velocity Excimer Laser System, | |
| Model AL10000 |
IV Device Description:
The Momentum is a self-contained compact laser light source that operates on standard AC supply power requiring no special power or cooling considerations. A protective interlocked housing encloses the laser source, electronics, and gas storage and distribution system. The XTRAC Momentum Model AL10000 comes in two spatial configurations: a horizontal (Velocity)configuration and a vertical (upright / Momentum) configuration.
A core element of both the Momentum excimer laser and the Velocity is a sealed chamber containing a mixture of pressurized Neon, Xenon, and HCl gases. High-voltage electrical discharges into the gas mixture create unstable XeCl molecules, which dissociate rapidly, creating monochromatic ultraviolet light at a wavelength of 308 nm. The electrical discharges are repeated in a fast sequence, producing a train of light pulses of a nominal duration of 30ns each. The timing of electrical discharges and energy of the produced light are constantly monitored by an on-board microprocessor to ensure safety.
Using a set of optical devices such as mirrors, shutters, lenses, and optic fibers, the produced light is focused and directed by the user to skin areas affected by disease. Each dose delivered by the system is composed of multiple laser pulses delivered at a preset repetition rate for a duration that is managed by the system processor.
4
Maximum pulse energy delivered to the patient's skin through the fiber optic cable and subsequent hand piece with skin contact tip is 15mJ per pulse or a fluence (radiant exposure) of 3.8 mJ/cm² (non-ablating). The average power delivered to the patient's skin is limited to 6 Watts which is a balance between time to deliver a dose and skin heating effect. Accessories include different tip configurations:
- . Standard Tip: Designed to pass a fixed 4cm2 square beam.
- Short Tip: For use with the iris diaphragm ●
- Short Hair Scalp Tip: Similar to the standard tip but includes three hollow elongated ● "teeth" to comb and part the hair in order to expose the scalp.
- Multi-Micro Dose (MMD) Tip: Provides four different dose levels with a single beam ● application, which can assist the physician in selection of the initial treatment dose.
V Indications for Use:
UVB phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma.
Environments of use: Healthcare facilities and outpatient dermatology clinics
VI Modifications
The subject device includes modifications to the predicate. These modifications include:
- Mechanical: Change to a vertical the footprint. .
- Short Hair Scalp Tip: A patient-contact accessory Short Hair Scalp Tip is specifically ● designed to treat lesions on the scalp.
- . Finger Switch: A finger switch was added to the handpiece on the liquid-light guide (LLG) so the user could operate the laser by pressing a button rather than stepping on a footswitch.
- . Patient Database: An on-board electronic database was added to store patient treatment data as a complement to the written treatment log template provided by Strata to the clinician.
- MMD Tip Usage: Software updated to accommodate the MMD tip accessory, cleared ● under K181480, is used to help determine the Optimal Therapeutic Dose (OTD) value when treating a new lesion.
- Cool Beam: The cool beam feature provides a means of reducing laser power within a ● treatment session at the clinician's discretion while maintaining the same dose accuracy as nominal laser power.
- . Maximum Dose of 5000 mJ/cm²: The maximum dose level for the predicate Velocity is 4,500ml/cm2 but data regarding a maximum dose level of 5,000 m./cm2 was provided. Dose selection guidelines have not changed, and the accuracy of all dose levels is maintained by the same closed-loop control as the predicate.
VII Comparison of Technological Characteristics and Performance with the Predicate
Table 1 is a comparison - Subject Device vs. the Predicate, K073659 including technological characteristics and performance.
5
| CHARACTERISTIC | Predicate Device | Subject Device |
|---|---|---|
| Device name | XTRAC Velocity Excimer Laser | |
| System Model AL10000 | XTRAC Momentum Excimer | |
| Laser System Model AL10000 | ||
| FDA approval | K073659 | N/A |
| Indications for use | UVB Phototherapy for psoriasis, | |
| vitiligo, atopic dermatitis, and | ||
| leukoderma | UVB Phototherapy for psoriasis, | |
| vitiligo, atopic dermatitis, and | ||
| leukoderma | ||
| Patient population | Adults | Adults |
| Environments for use | Primary healthcare facilities | |
| (typically dermatology clinics | ||
| and offices) | Primary healthcare facilities | |
| (typically dermatology clinics | ||
| and offices) | ||
| Type of use | Prescription | Prescription |
| Technological Characteristics and Performance Specifications | ||
| Photon source | XeCl Excimer laser | XeCl Excimer laser |
| UV spectrum | UVB | UVB |
| Wavelength (nm) | 308 | 308 |
| Optical pulse width – FWHM (ns) | 30 | 30 |
| Maximum power to tissue (W) | 6.0 | 6.0 |
| Maximum Dose | 4,500 mJ/cm² | 5,000 mJ/cm² |
| Maximum pulse repetition rate (Hz) | 400 | 400 |
| Maximum energy to tissue per pulse (mJ) | 15 | 15 |
| Maximum laser energy output (mJ) | 40.0 | 40.0 |
| Delivery system | Liquid fiber-optic (LLG) with | |
| user-directed hand piece | Liquid fiber-optic (LLG) with | |
| user-directed hand piece | ||
| Exposure type | User-directed to target area only | User-directed to target area only |
| Patient-contacting parts | Removable/reusable plastic tip | Removable/reusable plastic tip |
| Exposure control | Microprocessor with hard-wired | |
| switch | Microprocessor with hard-wired | |
| switch |
Table 1: Comparison of the Velocity AL10000 laser to the modified device
6
| FEATURE | PREDICATE
K073659 | Modified
DEVICE | REASON |
|----------------------------------|-----------------------------------------------|--------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Finger-controlled laser exposure | Not available | Integrated into the
delivery handpiece | User preference |
| Footswitch for exposure control | Mandatory | Not available | User preference |
| Device configuration | Horizontal only | Horizontal, Vertical | User preference |
| Short-Hair Scalp tip | Not available | Available | User preference |
| Selectable dose range (mJ/cm2) | 100 - 4,500 | 50 - 5,000 | User preference |
| Power level during treatment | One power level
available
(always ≤ 6W) | Two power levels
available: normal
(always ≤ 6W) and
reduced
(approximately
2.8W) | Enhanced safety (less
heating of the skin) |
| On-board database | Not available | Available | User preference |
| MMD tip support | Not available | Available | User preference |
Table 2: Differences between the Momentum AL10000 laser and the predicate device
VIII Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility -
The modifications do not change the materials in patient contact. The patient contacting materials are identical to the predicate and review of the geometry and processing did not raise new or different concerns.
Electrical Safety and EMC
Electrical safety and EMC testing were conducted on the subject device. The system complies with AAMI ANSI ES 60601-1: 2005 + A1: 2012 and IEC 60601-2-22 Edition 3.1 2012-10 standards for safety and IEC 60601-1-2: 2014 for EMC.
Software Verification and Validation Testing
Software verification and validation testing were conducted. The software for this device was considered as a "moderate" level of concern.
Mechanical, Animal, and Clinical Testing
No mechanical, animal or clinical testing was performed.
IX Conclusions
Discussion of Differences -
The identified differences do not raise new or different concerns of safety or effectiveness relative to the predicate.
Substantial Equivalence Conclusion
The performance testing has demonstrated that the subject devise met the applicable standard performance requirements. The sponsor has demonstrated through performance testing, design
7
and features, and non-clinical testing that the proposed device and predicate have been found to substantially equivalent.