(195 days)
No
The description focuses on the device's hardware components, user interface, and the application of high-frequency energy. There is no mention of AI, ML, image processing, or data analysis beyond basic parameter setting and display.
Yes.
The device is indicated for the "primary treatment of dermatologic procedures" and applies "therapy" for the "non-invasive treatment of periorbital wrinkles and rhytids," which are all indicators of a therapeutic device.
No
The device is indicated for the "primary treatment of dermatologic procedures for non-invasive treatment of periorbital wrinkles and rhytids," clearly outlining a therapeutic, rather than diagnostic, purpose.
No
The device description clearly outlines multiple hardware components including a control unit, high-frequency electromagnetic energy generator, user interface with a touch screen, and an applicator with a screen and buttons. This indicates it is a physical device, not software-only.
Based on the provided information, the XP200 device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "primary treatment of dermatologic procedures for non-invasive treatment of periorbital wrinkles and rhytids." This describes a therapeutic treatment applied directly to the patient's skin, not a test performed on a sample taken from the body.
- Device Description: The description details a system that applies "high-frequency field" energy to the patient. This is consistent with a therapeutic device, not a diagnostic one that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The XP200 device's function is to deliver energy for therapeutic purposes.
N/A
Intended Use / Indications for Use
The XP200 device is indicated for the primary treatment of dermatologic procedures for non-invasive treatment of periorbital wrinkles and rhytids.
Product codes
GEI
Device Description
The XP200 system is a state-of-the-art device to apply therapy by a non-invasive method of high-frequency field.
The control unit of the device is fitted with a color touch screen, which significantly facilitates the use of the device. The design of the device enables to see the on-screen information from various positions of the operator. In addition, the brightness of the screen can be set to match the lighting in the onscreen information will guide you through the entire therapy by means of easy setting of parameters using touch-screen buttons and knobs/keys on the device. For easier control, the applicator is equipped with buttons, enabling to operate the device during therapy, and a display, which shows the set and indicated parameters.
Any therapeutic parameter can be set easily by simple use of the touch-screen buttons. During the entire therapy time the device informs you about the therapeutic method, the type of the set power, and other necessary data.
The XP200 consists of the following main components:
- · microprocessor-driven control unit
- · high-frequency electromagnetic energy generator
- · user interface with 8.4" color touch screen
- applicator with color screen and control buttons .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periorbital skin area (eye area)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
A clinical study to evaluate the wrinkle-reducing effects of 3.25-MHz radiofrequency (RF) energy delivered by the XP200 system was completed. There were three (3) principal investigators that were part of the clinical investigation. The clinical study was completed with the subject going through treatment of four (4) applications at 5-7 day intervals to the human periorbital skin area (eye area) and grading pre- and 90-days post treatment.
There were no adverse events reported with any patient. The XP200 device performed as intended with no reported occurrences with either the patients or the device performance. The XP200 system at 3.25-MHz RF produces consistent, statistically significant reduction in periorbital wrinkles.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
5. Section 5 - FDA 510(k) Summary
- 5.1 General Information
APR 0 8 2013
Sponsor:
BTL Industries, Inc.
47 Loring Drive Framingham, MA 01702 Tel: +1-508-309-7948 Fax: +1-508-309-7956
Applicant:
EMERGO Group 816 Congress Avenue Suite 1400 Austin, TX 78701 Tel: +1-512-326-9997 Fax: +1-512-327-9998
project.mamagement@emergogroup.com
Contact Person:
Summary Preparation Date:
Richard Vincins EMERGO Group, Vice President, QA 2 April 2013
- Device Names 5.2
Trade/Proprietary Name: XP200 Primary Classification Name: Electrosurgical cutting and coagulation device and accessories Classification Regulation: 878.4400 GEI Product Code:
5.3 Legally Marketed Predicate Devices
The XP200 system is a state-of-the-art high-frequency energy device with accessories, and is substantially equivalent to the current products that are already cleared for USA distribution under the following 510(k) Premarket Notification numbers:
- · EXILIS (K092191)
1
5.4 Table - Predicate Devices
.
| 510(k) number | Not Assigned | K092191 (Attachment 1) | K102698 (K082834)
(Attachment 3) |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | XP200 | EXILIS | Pellevé GlideSafe™ Non-
Ablative Wrinkle Treatment
System |
| Company name | BTL Industries, Inc. | BTL Industries, Inc. | Ellman International |
| Product Code
Regulation | General & Plastic Surgery
21 CFR 878.4400
• GEI, Electrosurgical Cutting
and Coagulation Device &
Accessories. | General & Plastic Surgery
21 CFR 878.4400
• GEI, Electrosurgical Cutting
and Coagulation Device &
Accessories. | General & Plastic Surgery
21 CFR 878.4400
• GEI, Electrosurgical Cutting
and Coagulation Device &
Accessories. |
| Indications for Use | The XP200 device is
indicated for the primary
treatment of dermatologic
procedures for non-invasive
treatment of periorbital
wrinkles and rhytids. | The EXILIS device is indicated
for the primary treatment of
dermatologic and general
surgical procedures for non-
invasive treatment of wrinkles
and rhytids. EXILIS is a state-
of-the-art device to apply
therapy by a non-invasive
method of high-frequency
field. | Non-ablative treatment of mild
to moderate facial wrinkles and
rhytides for skin prototypes I-
IV. |
| Device Technologies | Application of heat to the
tissue w/ RF energy. | Application of heat to the
tissue w/ RF energy. | Application of heat to the
tissue w/ RF energy. |
| Electrical Protection | Class II, BF | Class II, BF | Class I, BF |
| Unit Construction | Constructed of materials that
conform with safety
standards and requirements. | Constructed of materials that
conform with safety standards
and requirements. | Constructed of materials that
conform with safety
standards and requirements. |
| Interface | Touch-screen user applied
interface to program and set
the controls for the patient
application; there is a hand-
piece utilized to deliver the
treatment. | Touch-screen user applied
interface to program and set
the controls for the patient
application; there is a hand-
piece utilized to deliver the
treatment. | Buttons and knobs on the
unit; there is a hand-piece
utilized to deliver the
treatment. |
| Color Touch Screen | 8.4" (21.5 cm) / 640 × 480
pixels | 8.4" (21.5 cm) / 640 × 480
pixels | Not Available |
| Energy Type | Radiofrequency | Radiofrequency | Radiofrequency |
| Modes Of Operation | Monopolar | Monopolar | Monopolar mode used for |
| 510(k) number | Not Assigned | K092191 (Attachment 1) | K102698 (K082834) |
| Device name | XP200 | EXILIS | (Attachment 3)
Pellevé GlideSafe™ Non-
Ablative Wrinkle Treatment
System |
| Company name | BTL Industries, Inc. | BTL Industries, Inc. | Ellman International |
| | | | indications for use: (Non-
ablative treatment of mild to
moderate facial wrinkles and
rhytides for skin prototypes
IV.). Bipolar mode used for
other indications for use. |
| Nominal Operating Power | 120 W | 170 W | 120 W |
| Operating Temperature | 18°C to 30°C | 18°C to 30°C | 10°C to 40°C |
| Operating Humidity | 60% - 75% | 60% - 75% | 30% - 75% |
| Treatment Temperature
Range | 39°C - 42°C | 39°C - 42°C | 39°C-42°C |
| Power Level Adjustable via
Applicator | YES | YES | NO |
| Material of the Generator
Case | Aluminum, Plastic, Stainless
Steel | Aluminum, Plastic, Stainless
Steel | Plastic, Metal |
| Patch Electrode Contact
Quality Monitoring | YES | YES | YES |
| RF Energy Emission
Indicator | YES; Information displayed
on the screen of the
applicator and on the main
screen of the unit. | YES; Information displayed on
the screen of the applicator
and on the main screen of the
unit. | YES |
| Applicator Dimensions | 4.25" × 2.6" × 7"
(11 cm × 7 cm × 18 cm) | 3.5" × 2.8" × 7.1"
(7 cm × 9 cm × 18 cm) | 0.8" × 0.8" × 6.3"
(2 cm × 2 cm × 16 cm) |
| Applicator Weight | 350 g | 500 g (incl. cable) | Less than 100 g |
| Energy Source | 100 - 240 VAC, max 4A,
50 - 60 Hz | 100 - 240 VAC, max 5A, 50 –
60 Hz | 100 - 240 VAC, max 4A,
50 – 60 Hz |
| System Dimensions | 16" × 10.6" × 11.9"
(41 cm × 22 cm × 18 cm) | 39" × 24" × 24"
(100 cm × 60 cm × 60 cm) | 9.5" × 7.1" × 16.5 "
(24 cm × 18 cm × 42 cm) |
| | | | |
2
.
and the comments of the comments of the comments of the comments of
.
:
:
3
Product Description 5.5
The XP200 device is indicated for the primary treatment of dermatologic procedures for non-invasive treatment of periorbital wrinkles and rhytids. The XP200 system is a state-of-the-art device to apply therapy by a non-invasive method of high-frequency field.
The control unit of the device is fitted with a color touch screen, which significantly facilitates the use of the device. The design of the device enables to see the on-screen information from various positions of the operator. In addition, the brightness of the screen can be set to match the lighting in the onscreen information will guide you through the entire therapy by means of easy setting of parameters using touch-screen buttons and knobs/keys on the device. For easier control, the applicator is equipped with buttons, enabling to operate the device during therapy, and a display, which shows the set and indicated parameters.
Any therapeutic parameter can be set easily by simple use of the touch-screen buttons. During the entire therapy time the device informs you about the therapeutic method, the type of the set power, and other necessary data.
The XP200 consists of the following main components:
- · microprocessor-driven control unit
- · high-frequency electromagnetic energy generator
- · user interface with 8.4" color touch screen
- applicator with color screen and control buttons .
5.6 Indications for Use
The XP200 device is indicated for the primary treatment of dermatologic procedures for non-invasive treatment of periorbital wrinkles and rhytids.
5.7 Non-Clinical Testing
The XP200 has been thoroughly evaluated for electromagnetic and mechanical safety. Medical device software life cycle processes have been verified and validated as well as output and biocompatibility. The XP200 has been found to conform with applicable medical device safety standards. The system complies with the following standards:
4
| ISO 14971 | Medical devices - Application of risk management to medical devices |
|---|---|
| IEC 62304 | Medical Device Software - Software Life Cycle Processes |
| Medical Electrical Equipment: | |
| IEC 60601-1 | General requirements for safety |
| IEC 60601-1-2 | Collateral Standard: Electromagnetic compatibility - Requirements and |
| Tests | |
| IEC 60601-2-2 | Particular requirements for the safety of high frequency surgical |
| equipment | |
| IEC 60601-1-6 | General requirements for basic safety and essential performance |
| Collateral standard: Usability |
EMC Requirements for Medical Equipment:
IEC 61000-4-2; IEC 61000-4-3; IEC 61000-4-4; IEC 61000-4-5
Biological Evaluation for Medical Devices:
ISO 10993-1; ISO 10993-5; ISO 10993-10
Performance Testing of the BTL Industries XP200:
- · Frequency Accuracy and Carrier Wave Form: The testing supports that the RF output frequency of the XPS200 device as compared to the predicate devices are within the accuracy for the product specification. The performance testing demonstrated that the XP200 device delivers the transmit carrier wave in a standard sinusoid form.
- · Carrier Wave Nominal Output Power: The measurement of the carrier wave output power produced real-life power output characteristics data that are mutually comparable between the subject device and the predicate devices.
- · Power Fluency: The power fluency characteristics between the XP200 device and the predicate devices are equivalent in the linear calculation. The calculation of the difference in power fluency between the XP200 device and the predicate devices are less than 4.8% at 100Ω and less than 8.8% at 150Ω which is within the acceptance criteria for the change value.
- · Tissue Heating (Temperature Gradient's Maximum at the Skin Surface): The measurement results demonstrated that the thermal performances of the XP200 device and the predicate devices are nearly identical. Measurements made under
5
experimental conditions showed that all devices are able to deliver sufficient energy to reach the temperature of 45°C which is in the acceptance criteria.
- Critical thresholds of resistance between two contact areas of a dual dispersive patch electrode when the . CQM will shut off the energy delivery reacted at the same level for the XPS200 device and the predicate devices. The value obtained in this test for each device were less than described as a safe level in the Operator's Manual.
5.8 Clinical Testing
A clinical study to evaluate the wrinkle-reducing effects of 3.25-MHz radiofrequency (RF) energy delivered by the XP200 system was completed. There were three (3) principal investigators that were part of the clinical investigation. The clinical study was completed with the subject going through treatment of four (4) applications at 5-7 day intervals to the human periorbital skin area (eye area) and grading pre- and 90-days post treatment.
There were no adverse events reported with any patient. The XP200 device performed as intended with no reported occurrences with either the patients or the device performance. The XP200 system at 3.25-MHz RF produces consistent, statistically significant reduction in periorbital wrinkles.
Substantial Equivalence 5.9
Based upon the intended use and technical information provided in this pre-market notification, the XP200 and accessories have been shown to be substantially equivalent to currently marketed predicate devices.
5.10 Conclusion
Based on the aforemention, the XP200 is safe and effective and substantially equivalent to the identified predicate devices.
6
Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is in a sans-serif font.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 8. 2013
BTL Industries. Inc. % EMERGO Group Mr. Richard Vincins 611 West 5th Street, Third Floor Austin, Texas 78701
Re: K122966
Trade/Device Name: XP200 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: March 21, 2013 Received: March 22, 2013
Dear Mr. Vincins:
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. Ilsting 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 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
7
Page 2 -Richard Vincins
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.hum.
Sincerely yours, FOR
Peter Diffiumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Section 4 - Indications for Use Statement
| 510(k) Number (if known): | K122966 |
|---|---|
| Device Name: | XP200 |
| Indications for Use: | The XP200 device is indicated for the primary treatment of dermatologic procedures for non-invasive treatment of periorbital wrinkles and rhytids. |
Prescription Use
AND/OR
イ
Over-The-Counter Use (21 CFR 801 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joshua C 177 ========================================================================================================================================================================== Nipper -S
For
Division of Surgical Devices 510(k) Number: K122966