(57 days)
Not Found
No
The description focuses on a physical accessory (MMD Tip) that filters light to provide different dose levels for manual observation and determination of the optimal dose. There is no mention of algorithms, data processing, or automated decision-making based on patient data, which are characteristic of AI/ML.
No.
The document states that the MMD Tip is an accessory used in conjunction with the XTRAC laser system to calculate and individualize the maximum non-blistering dose for a patient. It is used to determine the Optimal Therapeutic Dose ("OTD"), which is described as a power setting for the XTRAC Phototherapy system, not for direct therapeutic use itself. The MMD Tip helps determine the correct dose for therapy, but it does not deliver therapy.
Yes
The device helps in calculating the maximum non-blistering dose for a patient, which is a key step in determining patient-specific treatment, indicating a diagnostic function to assess patient response for therapeutic planning.
No
The device description explicitly states it is a "Tip accessory" and describes its physical construction and connection to a laser system, indicating it is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Multi-Micro Dose (MMD) Tip accessory is used in conjunction with a laser system (XTRAC) to deliver filtered light directly to the patient's skin ("target area"). It's a tool used on the patient, not for testing samples from the patient.
- Intended Use: The intended use is to help determine the optimal therapeutic dose of light for a patient's skin treatment. This is a process performed directly on the patient's body.
- Device Description: The description details how the tip filters and reduces laser output and is applied to the target area. There is no mention of analyzing biological samples.
The device is a therapeutic accessory used in a clinical setting for direct patient treatment planning, not for analyzing samples in a laboratory setting.
N/A
Intended Use / Indications for Use
The Multi-Micro Dose (MMD) Tip accessory is indicated for use in conjunction with the XTRAC laser system to filter the NB-UVB light at delivery in order to calculate the maximum non-blistering dose for a particular patient.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The XTRAC Ultra 2 Excimer Laser System, Model AL 10000 utilizes a hand-piece which contains tips and the subject device attaches in the same manner.
The subject device is the Multi-Micro Dose ("MMD") Tip.
The Multi-Micro Dose ("MMD") tip provides another method, separate of the MED mode, for determining the Optimal Therapeutic Dose ("OTD") for each patient. The OTD is the power setting on the XTRAC Phototherapy system customized for each patient that enables the user to provide patient specific treatment doses. As an alternative to the trial and error method of the MED mode, using the MMD Tip can often determine the optimal XTRAC power setting with a single test application.
The MMD Tip filters and reduces the laser output, providing four different dose levels in a single application. The reaction of the target area to the different dose levels assists in determining the patient specific Optimal Therapeutic Dose ("OTD").
The MMD Tip design places four (5mm x 5mm) square filters in the laser aperture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinical settings
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)
Nonclinical / Bench:
We have performed bench tests and found that the MMD Tip when used with the XTRAC System met all requirements specifications and can be found to be equivalent in comparison to the predicate. Testing included
- Tip Dose Accuracy and Uniformity
- Tip Transmission
- Tip Shelf Life
- Tip Shipping.
In all cases the subject device met its performance criteria.
Biocompatibility:
We assessed the patient contact type and performed the applicable ISO 10993-1 tests which included:
- Cytotoxicity
- Sensitization
- Irritation or Intracutaneous Reactivity
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity.
The test results supported the materials as non-cytotoxic, non-irritants, and non-toxic.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 1, 2018
Strata Skin Sciences, Inc. % Paul Dryden Consultant Strata Skin Sciences, Inc. % ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704
Re: K181480
Trade/Device Name: MMD Tip 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: June 2, 2018 Received: June 5, 2018
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/ofdocs/ofpmn.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.
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
1
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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entiled, "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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer R. Stevenson -S3
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
MMD Tip
Indications for Use (Describe)
The Multi-Micro Dose (MMD) Tip accessory is indicated for use in conjunction with the XTRAC laser system to filter the NB-UVB light at delivery in order to calculate the maximum non-blistering dose for a particular patient.
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)
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FORM FDA 3881 (7/17)
Page 1 of 1
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510(k) Summary 5
We have prepared the 510(k) Summary according 21 CFR 807.92. This regulation has a broad definition of acceptability. We have reviewed other similar Summaries and included the applicable information and details.
4
| Date prepared: | June 2, 2018 |
|---|---|
| Strata Skin Sciences, Inc. | |
| 100 Lakeside Drive, Suite 100 | |
| Horsham, PA 19044 | Tel - 215-619-3200 |
| Official Contact: | Shmuel Gov – VP & General Manager |
| Proprietary or Trade Name: | MMD Tip |
| Common/Usual Name: | Laser surgical instrument for use in general and plastic surgery and in |
| Dermatology | |
| Classification Code/Name: | GEX - Laser surgical instrument for use in general and plastic surgery and in |
| dermatology | |
| 21CFR 878.4810, Class 2 | |
| Device: | Multi-Micro Dose “MMD” Tip |
| Predicate Device: | K073659 - Strata Skin Sciences - XTRAC |
Device Description:
The XTRAC Ultra 2 Excimer Laser System, Model AL 10000 utilizes a hand-piece which contains tips and the subject device attaches in the same manner.
The subject device is the Multi-Micro Dose ("MMD") Tip.
The Multi-Micro Dose ("MMD") tip provides another method, separate of the MED mode, for determining the Optimal Therapeutic Dose ("OTD") for each patient. The OTD is the power setting on the XTRAC Phototherapy system customized for each patient that enables the user to provide patient specific treatment doses. As an alternative to the trial and error method of the MED mode, using the MMD Tip can often determine the optimal XTRAC power setting with a single test application.
The MMD Tip filters and reduces the laser output, providing four different dose levels in a single application. The reaction of the target area to the different dose levels assists in determining the patient specific Optimal Therapeutic Dose ("OTD").
The MMD Tip design places four (5mm x 5mm) square filters in the laser aperture. A drawing of the MMD Tip is shown below in comparison to the existing Standard Tip.
Indications for Use:
The Multi-Micro Dose (MMD) Tip accessory is indicated for use in conjunction with the XTRAC laser system to filter the NB-UVB light at delivery in order to calculate and individualize the maximum nonblistering dose for a particular patient.
We note that the XTRAC system has the following indications:
The XTRAC Excimer Laser Phototherapy System is indicated for use in the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma by the application of targeted UVB light.
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Patient Population: Patients undergoing treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma by the application of targeted UVB light.
Environment of Use: Anywhere a patient may undergo a treatment with the XTRAC system.
Substantial Equivalence Discussion: Table 1 below compares the key features of the proposed device with the predicate.
| Feature | Predicate
K073659
XTRAC system | Subject Device
MMD Tip for use with XTRAC system |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The XTRAC Excimer Laser
Phototherapy System (Model AL10000) is indicated for use in the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma by the application of targeted UVB ultraviolet light. | The XTRAC Excimer Laser Phototherapy System (Model AL10000) is indicated for use in the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma by the application of targeted UVB ultraviolet light.
The Multi-Micro Dose (MMD) Tip accessory is indicated for use in conjunction with the XTRAC laser system to filter the NB-UVB light at delivery in order to calculate and individualize the maximum non-blistering dose for a particular patient. |
| Classification | Laser surgical instrument for use in general and plastic surgery and in dermatology
21CFR 878.4810
Product Code: GEX | Laser surgical instrument for use in general and plastic surgery and in dermatology
An Accessory to this device
21CFR 878.4810
Product Code: GEX |
| Patient Population | Patients needing treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma by the application of targeted UVB ultraviolet light | Patients needing treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma by the application of targeted UVB ultraviolet light |
| Environment of use | Clinical settings | Clinical settings |
| Single Use | Equipment is reusable
Tips are reusable | Tips are Single patient use, disposable |
| Sterile | No | No |
| Mechanism of action | Tip directs the UVB light to the target area.
Dose – 100% | MMD Tip provides four micro-dose outputs
Dose - 94%, 60%, 45% and 30% |
| Biocompatibility | Surface Contact
Skin and Breached
Limited duration (