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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
RF output frequency within product specification.	The testing supports that the RF output frequency of the XP200 device as compared to the predicate devices are within the accuracy for the product specification.
Deliver transmit carrier wave in a standard sinusoid form.	The performance testing demonstrated that the XP200 device delivers the transmit carrier wave in a standard sinusoid form.
Carrier wave output power mutually comparable to predicate devices.	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 difference less than 4.8% at 100Ω and less than 8.8% at 150Ω compared to predicate devices.	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.
Achieve tissue temperature of 45°C.	Measurements made under experimental conditions showed that all devices (XP200 and predicates) are able to deliver sufficient energy to reach the temperature of 45°C, which is in the acceptance criteria.
Critical thresholds of resistance for CQM shut-off at safe level in Operator's Manual.	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 was less than described as a safe level in the Operator's Manual.
No adverse events in clinical use.	There were no adverse events reported with any patient.
Device performs as intended with no reported occurrences.	The XP200 device performed as intended with no reported occurrences with either the patients or the device performance.
Produces consistent, statistically significant reduction in periorbital wrinkles.	The XP200 system at 3.25-MHz RF produces consistent, statistically significant reduction in periorbital wrinkles.

Study Details:

The provided document describes both non-clinical (engineering/performance) testing and a clinical study.

Non-Clinical Testing:

1. Sample sized used for the test set and the data provenance: Not explicitly stated for each specific test, but the tests involved the XP200 device and its predicate devices (EXILIS and Pellevé GlideSafeTM Non-Ablative Wrinkle Treatment System) under experimental conditions. The data provenance is implied to be from laboratory testing.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for non-clinical, objective performance tests. The ground truth would be based on established engineering principles and measurement standards.
3. Adjudication method for the test set: Not applicable for non-clinical objective performance tests.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this was not an MRMC study. These were objective performance tests comparing the device's technical specifications to a set of criteria and predicate devices.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the non-clinical tests assess the device's standalone performance in terms of frequency, power, wave form, tissue heating, and safety shut-off mechanisms.
6. The type of ground truth used: Objective measurements and engineering standards (e.g., standard sinusoid form, specified power levels, documented safe temperature thresholds, established resistance levels for safety shut-off).
7. The sample size for the training set: Not applicable. These are hardware/electrical performance tests.
8. How the ground truth for the training set was established: Not applicable.

Clinical Testing:

1. Sample sized used for the test set and the data provenance:
- Sample Size: Not explicitly stated, but patients were involved. The document states "the subject going through treatment." While not a specific number, it indicates human participants.
- Data Provenance: Prospective, as it involved patients undergoing treatment and subsequent follow-up ("pre- and 90-days post treatment"). The country of origin is not specified but is implied to be within the scope of the FDA submission.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Three (3) principal investigators.
- Qualifications: "principal investigators" are generally qualified medical professionals (e.g., dermatologists or plastic surgeons) experienced in clinical studies and evaluating dermatologic conditions. Specific experience levels are not detailed.
3. Adjudication method for the test set: Not explicitly stated. However, "grading pre- and 90-days post treatment" by principal investigators suggests a subjective assessment by these experts. It doesn't specify if their gradings were pooled, averaged, or adjudicated in cases of disagreement.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not explicitly an MRMC study. It involved multiple investigators, but the focus was on the performance of the single device (XP200) and its effect, not a comparison of human readers with and without AI assistance.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this was a clinical study involving human patients and human operators (principal investigators) using the device.
6. The type of ground truth used: Clinical outcome data, specifically "wrinkle-reducing effects" graded by clinical investigators, and the absence of adverse events. The "statistically significant reduction in periorbital wrinkles" indicates a quantifiable outcome derived from these clinical assessments.
7. The sample size for the training set: Not applicable, as this is a clinical trial, not an AI model training process.
8. How the ground truth for the training set was established: Not applicable.

Summary

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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)

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· Pellevé GlideSafeTM Non-Ablative Wrinkle Treatment System (K102698, K082834)

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 TreatmentSystem
Company name	BTL Industries, Inc.	BTL Industries, Inc.	Ellman International
Product CodeRegulation	General & Plastic Surgery21 CFR 878.4400• GEI, Electrosurgical Cuttingand Coagulation Device &Accessories.	General & Plastic Surgery21 CFR 878.4400• GEI, Electrosurgical Cuttingand Coagulation Device &Accessories.	General & Plastic Surgery21 CFR 878.4400• GEI, Electrosurgical Cuttingand Coagulation Device &Accessories.
Indications for Use	The XP200 device isindicated for the primarytreatment of dermatologicprocedures for non-invasivetreatment of periorbitalwrinkles and rhytids.	The EXILIS device is indicatedfor the primary treatment ofdermatologic and generalsurgical procedures for non-invasive treatment of wrinklesand rhytids. EXILIS is a state-of-the-art device to applytherapy by a non-invasivemethod of high-frequencyfield.	Non-ablative treatment of mildto moderate facial wrinkles andrhytides for skin prototypes I-IV.
Device Technologies	Application of heat to thetissue w/ RF energy.	Application of heat to thetissue w/ RF energy.	Application of heat to thetissue w/ RF energy.
Electrical Protection	Class II, BF	Class II, BF	Class I, BF
Unit Construction	Constructed of materials thatconform with safetystandards and requirements.	Constructed of materials thatconform with safety standardsand requirements.	Constructed of materials thatconform with safetystandards and requirements.
Interface	Touch-screen user appliedinterface to program and setthe controls for the patientapplication; there is a hand-piece utilized to deliver thetreatment.	Touch-screen user appliedinterface to program and setthe controls for the patientapplication; there is a hand-piece utilized to deliver thetreatment.	Buttons and knobs on theunit; there is a hand-pieceutilized to deliver thetreatment.
Color Touch Screen	8.4" (21.5 cm) / 640 × 480pixels	8.4" (21.5 cm) / 640 × 480pixels	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 TreatmentSystem
Company name	BTL Industries, Inc.	BTL Industries, Inc.	Ellman International
			indications for use: (Non-ablative treatment of mild tomoderate facial wrinkles andrhytides for skin prototypesIV.). Bipolar mode used forother 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 TemperatureRange	39°C - 42°C	39°C - 42°C	39°C-42°C
Power Level Adjustable viaApplicator	YES	YES	NO
Material of the GeneratorCase	Aluminum, Plastic, StainlessSteel	Aluminum, Plastic, StainlessSteel	Plastic, Metal
Patch Electrode ContactQuality Monitoring	YES	YES	YES
RF Energy EmissionIndicator	YES; Information displayedon the screen of theapplicator and on the mainscreen of the unit.	YES; Information displayed onthe screen of the applicatorand on the main screen of theunit.	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)

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and the comments of the comments of the comments of the comments of

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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:

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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 andTests
IEC 60601-2-2	Particular requirements for the safety of high frequency surgicalequipment
IEC 60601-1-6	General requirements for basic safety and essential performanceCollateral 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

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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.

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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

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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

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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

Regulation Number and Section

§ 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.