(128 days)
The XP300 device is indicated for the primary treatment of dermatological procedures for non-invasive treatment of periorbital wrinkles and rhytids.
The XP300 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 the operator to see the on-screen information from various angles during the procedure. In addition, the brightness of the screen can be set to match the lighting in the room. The on-screen 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. The XP300 device incorporates the ultrasonic feature for added patient comfort. 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 therapy applied, the set power, and other necessary data. The XP300 consists of the following main components: microprocessor-driven control unit, high-frequency electromagnetic generator and ultrasonic element, user interface with 8.4" colour touch screen, applicator with colour screen and control buttons. The main change between this device and the predicate is the inclusion of the Ultrasonic convenience function which is intended to improve patient's comfort during the procedure.
This document is a FDA 510(k) summary for the BTL Industries XP300 device, an electrosurgical cutting and coagulation device and accessories indicated for the primary treatment of dermatological procedures for non-invasive treatment of periorbital wrinkles and rhytids. The submission is for a modification to the XP200 device, specifically the inclusion of an ultrasonic element to improve patient comfort.
Based on the provided document, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" as performance metrics for clinical efficacy in a table format with reported performance. This 510(k) is a submission for a modification to an already cleared device (XP200), and the primary focus is on demonstrating that the modification (ultrasonic element for patient comfort) does not negatively impact the existing safety and effectiveness, and that the device still meets relevant safety and performance standards.
Instead of clinical performance acceptance criteria, the document focuses on compliance with various electrical, mechanical, and biocompatibility safety standards, and confirms that the technical specifications of the XP300 are equivalent to the predicate XP200, with the only notable difference being the addition of the ultrasonic feature.
Here's a table based on the non-clinical performance data and comparison to the predicate:
| Acceptance Criterion (Implicit) | Reported Device Performance (XP300) |
|---|---|
| Safety and Electrical Standards Compliance: | |
| ISO 14971 (Risk Management) | Complies |
| IEC 62304 (Software Life Cycle) | Complies |
| IEC 60601-1 (General Safety) | Complies |
| IEC 60601-1-2 (EMC) | Complies |
| IEC 60601-2-2 (HF Surgical Equipment Safety) | Complies |
| IEC 60601-1-6 (Usability) | Complies |
| IEC 61000-4-2 (EMC) | Complies |
| IEC 61000-4-3 (EMC) | Complies |
| IEC 61000-4-4 (EMC) | Complies |
| IEC 61000-4-5 (EMC) | Complies |
| Electrical Safety Testing | Passed (Class II, BF) |
| Biocompatibility Standards Compliance: | |
| ISO 10993-1, -5, -10 (Biological Evaluation) | Complies (same as predicate XP200, no impact with change) |
| Performance Testing (Non-Clinical): | |
| Frequency Accuracy and Carrier Wave Form | Confirmed |
| Carrier Wave Nominal Output Power | Confirmed |
| Power Fluency | Confirmed |
| Tissue Heating (simultaneous RF and ultrasound energy safety) | Confirmed safety of simultaneous application. The modified applicator demonstrated convenient patient contact surface temperature. |
| Overall design, biocompatibility, and electrical safety | Meets all requirements, output meets design inputs and specifications. Complies with applicable voluntary standards. |
| Patient Contact Materials | No change to patient contact materials from predicate. |
| Technology/Principle of Operation | No change in principle of operation (high-frequency field for RF energy). The ultrasonic feature is for comfort and does not change the therapeutic principle. |
| Patient Comfort (with ultrasonic feature) | Improved (intended purpose of the ultrasonic convenience function, though no direct quantitative measurement of comfort is provided in this summary, it's stated as the objective of the change). The modified applicator testing ensures convenient patient contact surface temperature. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "There was no clinical testing required to support the XP 300 medical device as the indications for use are equivalent to the predicate device." Therefore, there is no clinical test set, sample size, or clinical data provenance discussed for the XP300's primary indication.
The "testing" mentioned refers to non-clinical performance and safety testing (electrical, EMC, biocompatibility, software validation, and tissue heating related to the combined RF and ultrasound). These tests are typically conducted in a laboratory setting, not with human subjects, and thus terms like "sample size" for a test set in the clinical sense are not applicable. The document does not specify the number of units or test configurations used for these non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As no clinical test set was required or performed, there was no need for experts to establish ground truth in a clinical context. The "ground truth" for non-clinical testing is established by compliance with international standards and engineering specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set was used.
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
Not applicable. The XP300 is an electrosurgical device for dermatological procedures, not an imaging or diagnostic AI device. Therefore, MRMC studies and "human readers improving with AI assistance" are irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The XP300 is a hardware device with software controls, not an algorithm for standalone performance evaluation in the context of diagnostics or AI. Its performance is evaluated through compliance with electrical, mechanical, and safety standards, and its ability to deliver specified energy (RF and ultrasound) safely.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this submission, the "ground truth" is primarily based on:
- Compliance with international and national safety standards: IEC 60601 series, ISO 14971, ISO 10993 series, etc.
- Engineering specifications and design inputs: The device's electrical, mechanical, and software parameters conforming to its intended design.
- Performance confirmation of the physical outputs: E.g., accurate frequency, nominal output power, power fluency, and safe tissue heating.
8. The sample size for the training set
Not applicable. This is a hardware device; "training set" typically refers to data used to train machine learning models, which is not relevant here.
9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned or implied for this device.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting hair or wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 10, 2015
BTL Industries Incorporated Mr. Jan Zarsky Director 47 Loring Drive Framingham, Massachusetts 01702
Re: K143109 Trade/Device Name: XP300 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical, Cutting & Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: February 4, 2015 Received: February 9, 2015
Dear Mr. Zarsky:
This letter corrects our substantially equivalent letter of March 6, 2015.
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, 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 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 (reporting of medical
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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 8, please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Jennifer R. Stevenson -S
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
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Indications for Use
510(k) Number (if known)
Device Name XP300
Indications for Use (Describe)
The XP300 device is indicated for the primary treatment of dermatological procedures for non-invasive treatment of periorbital wrinkles and rhytids.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
for
XP300
1. Submission Sponsor
BTL Industries, 47 Loring Drive Framington MA, 01702 USA Phone: 866.285.1656 Fax: 866.499.2502 Contact: Jan Zarsky, Director
- Submission Correspondent
Mr. Jan Zarsky Director BTL Industries 47 Loring Drive Framington, MA 01702 USA Email: zarsky@btlnet.com
-
- Date Prepared
January 15, 2015
- Date Prepared
-
- Device Identification
| Trade/Proprietary Name: | XP300 |
|---|---|
| Common/Usual Name: | Electrosurgical, cutting & coagulation & accessories |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| Classification Regulation: | 21 CFR 878.4400 |
| Product Code: | GEI |
| Device Class: | Class II |
| Classification Panel: | General & Plastic Surgery |
-
- Legally Marketed Predicate Device(s)
| Trade/Proprietary Name: | XP200 |
|---|---|
| Common/Usual Name: | Electrosurgical, cutting & coagulation & accessories |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| Classification Regulation: | 21 CFR 878.4400 |
| Product Code: | GEI |
| Device Class: | Class II |
| Classification Panel: | General & Plastic Surgery |
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6. Device Description
The XP300 device is indicated for the primary treatment of dermatologic procedures for noninvasive treatment of periorbital wrinkles and rhytids. The XP300 system is a state-of-theart 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 the operator to see the on-screen information from various angles during the procedure. In addition, the brightness of the screen can be set to match the lighting in the room. The on-screen 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. The XP300 device incorporates the ultrasonic feature for added patient comfort.
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 therapy applied, the set power, and other necessary data.
The XP300 consists of the following main components:
- . microprocessor-driven control unit
- . high-frequency electromagnetic generator and ultrasonic element
- . user interface with 8.4" colour touch screen
- applicator with colour screen and control buttons .
The main change between this device and the predicate is the inclusion of the Ultrasonic convenience function which is intended to improve patient's comfort during the procedure
-
- Indication for Use Statement
The XP300 is indicated for the primary treatment of dermatological procedure for noninvasive treatment of periorbital wrinkles and rhytids.
- Indication for Use Statement
-
- Substantial Equivalence Discussion
The following table compares the XP300 to the predicate device, XP200, with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.
- Substantial Equivalence Discussion
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| Manufacturer | BTL Industries, Inc. | BLT Industries, Inc. | SIGNIFICANTDIFFERENCES |
|---|---|---|---|
| Trade Name | XP300 | XP200 | n/a |
| 510(k) Number | Unknown | K122966 | n/a |
| Product Code | GEI | GEI | No difference |
| RegulationNumber | 21 CFR 878.4400 | 21 CFR 878.4400 | No difference |
| Regulation Name | Electrosurgical cuttingand coagulation deviceand accessories | Electrosurgical cuttingand coagulation deviceand accessories | No difference |
| Intended Use | Application of heat tothe tissue w/RF energy | Application of heat to thetissue w/RF energy | No difference |
| Indications for Use | The XP300 is indicatedfor the primarytreatment ofdermatologicalprocedure for non-invasive treatment ofperiorbital wrinkles andrhytids. | The XP200 is indicatedfor the primarytreatment ofdermatologicalprocedure for non-invasive treatment ofperiorbital wrinkles andrhytids. | No difference |
| Material | The unit is constructedof material that conformwith safety standardsand requirements. | The unit is constructed ofmaterial that conformwith safety standardsand requirements. | No difference |
| Sterile | No | No | No difference |
| Single-Use | No | No | No difference |
| Interface | Touch-Screen userapplied interface toprogram and set thecontrols for the patientapplication; there is ahand-piece utilized todeliver the treatment. | Touch-Screen userapplied interface toprogram and set thecontrols for the patientapplication; there is ahand-piece utilized todeliver the treatment. | No difference. |
| The ultrasonicconvenienceFunction | Yes | No | No significantdifference.The change is beingintroduced to improvepatient's comfortduring the application.There is no change tothe principle ofoperation. |
| Table 5A – Comparison of Characteristics | |
|---|---|
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| Manufacturer | BTL Industries, Inc. | BLT Industries, Inc. | SIGNIFICANTDIFFERENCES |
|---|---|---|---|
| Trade Name | XP300 | XP200 | n/a |
| Color Touch Screen | 8.4" (2.15 cm)/640x480 pixels | 8.4" (2.15 cm)/640x480 pixels | No difference |
| Energy Type | Radiofrequency | Radiofrequency | No difference |
| Modes of Operation | Monopolar | Monopolar | No difference |
| Nominal Operating power | 120 W | 120 W | No difference |
| Operating temperature | 18°C to 30°C | 18°C to 30°C | No difference |
| Operating Humidity | 60%-75% | 60%-75% | No difference |
| Temperature Treatment Range | 39°C to 42°C | 39°C to 42°C | No difference |
| Power Level Adjustable via Applicator | Yes | Yes | No difference |
| Patch Electrode Contact Quality Monitoring | Yes | Yes | No difference |
| 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. | No difference |
| Applicator Dimensions | 4.25" x 2.6" x 7"(11cm x 7cm x18cm) | 4.25" x 2.6" x 7"(11cm x 7cm x18cm) | No difference |
| Complies with ISO 10993-1 | Yes | Yes | No difference |
| Electrical Safety Testing Passed | Class II, BF | Class II, BF | No difference |
| Energy Source | 100-240 VAC, max 4A,50-60 Hz | 100-240 VAC, max 4A,50-60 Hz | No difference |
| System Dimensions | 16" X 10.6" x 11.9"(41cm x 22cm x 18cm) | 16" X 10.6" x 11.9"(41cm x 22cm x 18cm) | No difference |
| System Weight | 16lb (7.3kg) | 16lb (7.3kg) | No difference |
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Non-Clinical Performance Data 9.
This Special 510(k) proposes a modification to the applicator by incorporating an ultrasonic element to improve patient's comfort during the application.
This proposed change does not impact the indications for use, technology, principle of operation, patient contact materials, or packaging of the device. Testing has been performed on the modified applicator to demonstrate that treatment heads applied to the patient shall have a convenient patient contact surface temperature.
The change only applies to the applicator therefore XP300 continues to conform to the medical device safety standards applicable to both XP300 and XP200. The device has been evaluated to demonstrate electrical, electromagnetic and mechanical safety. Medical device software life cycle processes have been verified and validated as well as output and biocompatibility.
The system complies with the following standards:
ISO 14971 Medical devices - Application of risk management to medical devices IEC 62304 Medical Device Software - Software Life Cycle Processes
MedicalElectricalEquipment:
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
EMCRequirements for Medical Equipment: IEC 61000-4-2; IEC 61000-4-3; IEC 61000-4-4; IEC 61000-4-5
BiologicalEvaluationforMedicalDevices: ISO 10993-1; ISO 10993-5; ISO 10993-10
PerformanceTesting:
- Frequency Accuracy and Carrier Wave Form .
- . Carrier Wave Nominal Output Power
- Power Fluency
- Tissue Heating:
The performance testing confirmed safety of simultaneous application of radiofrequency and ultrasound energy.
The XP300 meets all the requirements for overall design, biocompatibility, and electrical safety confirms that the output meets the design inputs and specifications. The XP300 complies with the applicable voluntary standards for biocompatibility.
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10. Clinical Performance Data
There was no clinical testing required to support the XP 300 medical device as the indications for use are equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
11. Biocompatibility and Sterilization/Shelf-life
The change does not impact the biological safety of the device. The XP200 device biocompatibility was tested according to the ISO 10993-1; ISO 10993-5; ISO 10993-10.
There are no changes in the product life and shelf life compared to that of XP200 device. The device shelf life is 5 years. The product life is 5 years.
The device is not intended to be sterile and is not intended to be sterilized by the user.
12. Statement of Substantial Equivalence
It has been shown in this 510(k) submission that the differences between the XP300 and the predicate device do not raise any questions regarding its safety and effectiveness. The XP300, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device; XP200.
§ 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.