The BTL-9000 device is a low level laser system that can be used for the non-invasive temporary reduction of waist circumference by the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for non-invasive aesthetic use.

Device Description

The BTL-9000 consists of a control unit, connection lead to a BTL-9000 Laser Applicator and other accessories. (A full list of system contents is included in the operator's manual). The Laser Applicator is containing four cold red (660 nm) laser-emitting diodes and is designed to be placed on the skin. The output of the diode (four per applicator) is limited to 50mW ± 15% by a power limiting PCB from the central processing unit. The system can operate using 1 applicator that is connected to the control unit. The control unit is an electrically powered unit (100-240V, 50-60Hz auto-ranging). Once enabled it is controlled using a touchscreen interface. When the Laser Applicator is placed on the skin, the cold red laser beams penetrate the skin just deep enough to reach the layers of fat. When the light hits the fat cells, a rapid chain of events takes place. Firstly, pores form on the cells causing them to spill out. The water, Glycerol and fatty acids move into the interstitial space beneath the fatty layer in the skin. Then further water, fatty acids and Glycerol spill out. The adipocyte cells and therefore reduced in size. The BTL-9000 is a stand-alone device which can be used together with other modalities which are not part of this submission.

AI/ML Overview

Here's an analysis of the provided text regarding the BTL-9000 device, focusing on acceptance criteria and the supporting study:

Acceptance Criteria and Device Performance

The core acceptance criterion for the BTL-9000 device is the temporary reduction of waist circumference by a minimum of 3 cm at a 30-day follow-up as compared to the baseline evaluation.

Table 1: Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (Treatment Group)
Minimum of 3 cm reduction in waist circumference at 30-day follow-up as compared to baseline evaluation.	Average recorded loss: 3.53 ± 0.40 cm (meeting and exceeding the 3 cm criterion)
Statistical significance of waist circumference reduction.	Statistically significant difference between Treatment and Placebo Groups (pre-treatment vs. 30-day follow-up).
No adverse events.	No adverse events were experienced by any subjects.

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: 30 subjects (15 in the BTL-9000 LLLT treatment group and 15 in the placebo group).
- Data Provenance: The document does not specify the country of origin. It indicates it was a prospective, double-blind clinical study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The study focuses on objective measurements of waist circumference and patient-reported adverse events. There is no mention of experts being used to establish a subjective "ground truth" for the test set; the ground truth is derived from direct anthropometric measurements.
Adjudication method for the test set:
- Not applicable as the ground truth is based on objective measurements (waist circumference) and adverse event reporting, not on expert interpretation requiring adjudication.
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:
- No, this was not an MRMC comparative effectiveness study and does not involve AI or human readers for diagnostic interpretation. It's a clinical trial comparing a medical device to a placebo for a therapeutic outcome.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a medical device (low-level laser system) used for treatment, not an algorithm, and its performance is assessed directly on human subjects.
The type of ground truth used:
- The ground truth was based on objective anthropometric measurements of waist circumference (in centimeters) and observation of adverse events.
The sample size for the training set:
- Not applicable. This device is a hardware-based low-level laser system, not an AI or machine learning algorithm that requires a "training set" of data.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.

Summary of the Study:

The study was a double-blind clinical trial designed to assess the effectiveness and safety of the BTL-9000 device for temporary waist circumference reduction. It involved 30 subjects randomly assigned to either a treatment group (receiving BTL-9000 LLLT) or a placebo group. Both groups received 8 twice-a-week treatments. Waist circumference and weight were measured at baseline, after the 8th treatment, and at a 30-day follow-up. The primary endpoint measured was the change in waist circumference. The results demonstrated a statistically significant reduction in waist circumference in the treatment group compared to the placebo group, meeting the internal acceptance criterion of a minimum 3 cm reduction at 30-day follow-up. No adverse events were reported.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 12, 2014

MMP Medical Associates, LLC Michail M. Pankratov, MD, PhD Regulatory Consultant for BLT Industries, Ltd. 16 Appleton Street Waltham, Massachusetts 02453

Re: K134040

Trade/Device Name: BTL-9000 Regulation Number: 21 CFR 878.5400 Regulation Name: Low Level Laser System for Aesthetic use Regulatory Class: Class II Product Code: OLI Dated: August 8, 2014 Received: August 11, 2014

Dear Mr. Pankratov:

This letter corrects our substantially equivalent letter of September 10, 2014.

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

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Page 2 - Michail M. Pankratov. MD. PhD

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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,

David Krause -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) K134040

Device Name BTL-9000

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Neil R Ogden -S 2014.09.09 16:06:09 -04'00

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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:

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SECTION 5: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

As required by section 807.92(c)

I. General Information

Submitter:	BTL Industries, Ltd30 Peshtersko Shouse BlvdPlovdiv 4002, BulgariaTel: +359 32 622 252Fax: +359 32 307 890
Contact Person:	Michail M. Pankratov, MD, PhDMMP Medical Associates, LLC16 Appleton StreetWaltham, MA 02453clregconsult@aol.comTel: 617-480-4543Fax: 781-207-4676
Summary Preparation Date:	August 8, 2014

II. Device Information

Trade Name:	BTL-9000
Common/Usual Name:	Low level Laser System for Aesthetic Use
Classification:	Class II21 CFR 878.5400
Product Code:	OLI
Classification Name:	Low level Laser System for Aesthetic Use
Device Panel:	General & Plastic Surgery

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Predicate Devices lll.

Device name	BTL-9000	Strawberry & Cream Low LevelLaser System
Companyname	BTL Industries, Ltd.	Laser Lipo, Ltd.
510(k)reference	K134040	K130341
Devicedescription	Device consists of an electricallypowered control unit usingtouchscreen interface. The systemcan operate using laser applicatorthat is connected to the controlunit. A laser applicator is a devicecontaining 4 cold laser red laseremitting diodes.	Device consists of an electricallypowered control unit usingtouchscreen interface. The system canoperate using 4, 6, 8 or 10 paddlesthat are connected to the control unit.A paddle is a device containing 6 coldred laser emitting diodes.
Class	II	II
Product Code	OLI	OLI
Indications foruse	The BTL-9000 device is a low levellaser system that can be used forthe non-invasive temporaryreduction of waist circumferenceby the disruption of adipocyte cellswithin the fat layer for the releaseof fat and lipids from these cellsfor non-invasive aesthetic use.	Strawberry & Cream Low Level LaserSystem can be used for the non-invasive temporary reduction of waistcircumference by the disruption ofadipocyte cells within the fat layer forthe release of fat and lipids from thesecells for non-invasive aesthetic use.
MechanismofAction	Disruption of adipocyte cells withinthe fat layer for the release of fatand lipids from these cells for non-invasive aesthetic use.	Disruption of adipocyte cells within thefat layer for the release of fat andlipids from these cells for non-invasiveaesthetic use.
Power	200 mW per applicator	240 mW per paddle
DimensionsW x H x D	560 x 980 x 560 mm	275 x 185 x 315 mm
Configuration	Cabinet-mounted with wheels	Table top
Deviceclassification	Class II, OLI, 878.5400	Class II, OLI, 878.5400

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IV. Intended Use

The BTL-9000 device is a low level laser system that can be used for the noninvasive temporary reduction of waist circumference by the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for non-invasive aesthetic use.

V. Device Description

VI . Materials

All materials used in the manufacture of the BTL-9000 have been demonstrated to meet strict design requirements, including requirements for durability and biocompatibility, and therefore suitable for use under the anticipated conditions of use associated with the device. There are no changes in materials that raise questions of safety or effectiveness.

VII. Testing

Based on the risk assessment of the modifications, bench testing and clinical testing were performed to ensure continued conformance to all product specifications, and equivalence to the predicate device.

The BTL-9000 module has been shown to conform to the applicable requirements of the following:

IEC 60601-2-22:1995 Ed.2

Medical Electrical Equipment - Part 2-22: Particular Requirements For The Safety Of Diagnostic And Therapeutic Laser Equipment.

IEC 60825-1:2007 Ed.2

Safety Of Laser Products - Part 1: Equipment Classification, And Requirements.

IEC 60601-1:1988 + A1:1991-11 +A2:1995

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Confidential

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IEC 60601-1-2:2001 + A1:2004

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility – Requirements and tests

IEC 60601-1-4:2000 Consol. Ed. 1.1

Medical electrical equipment - Part 1-4: General requirements for safety -Collateral Standard: Programmable electrical medical systems

ISO 10993-5:2009

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity ISO 10993-10:2010

Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization

ISO 14971:2007

Medical devices - Application of risk management to medical devices

For the BTL-9000 laser wavelength and output has been demonstrated (see SECTION 18) to be capable and substantially equivalent to the predicate device (Strawberry & Cream Low Level Laser System, Laser Lipo, Ltd ; K130341).

Clinical Testing VIII.

Clinical study: A double blind clinical study was conducted using 30 subjects: 15 subjects received BTL-9000 LLLT treatments, and other 15 subjects received placebo treatments. Subjects in both groups received 8 twice-a-week treatments. Their waist circumference and weight were evaluated at the baseline, at the end of the 8th treatment and at 30-day follow-up after the last treatment.

Results: No adverse events were experienced by any of the subjects. All subjects in BTL-9000 LLLT met the primary endpoint of a temporary waist circumference reduction (at the height of the iliac crest) of a minimum of 3 cm at 30-day follow up as compared to the baseline evaluation. The average recorded loss was 3.53 cm vs. -0.13 cm in Placebo group and was statistically significant. This procedure also produced, average 2.13 cm reduction in waist circumference immediately posttreatment vs. -0.1 in Placebo group that was also statistically significant. The reductions were also statistically significant within the treatment group: baseline vs. post-treatment, baseline vs. 30-day follow up, and post-treatment vs. 30-day follow up.

Table VIII-1. Subjects in Treatment Group - Mean Waist Circumference and Mean Change in Waist Circumference

		Waist Circumference (cm)			Change in WaistCircumference (cm)
	Age	Pre-Tx	Post-Tx	30-dayFU	Pre-Txvs.Post-Tx	Pre-Txvs.30dFU	Post-Tx vs.30dFU
Mean±SD	44.73±11.39	91.37±13.14	89.23±12.95	87.83±13.14	2.13±0.61	3.53±0.40	1.40±0.60

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Median	43	89	87.5	85.5	2	3.5	1.5
(Min-Max)	(30-68)	(69-118)	(66-115)	(66.5-114.5)	(1-3)	(3.0 - 4.5)	(0.5 - 2.5)

Table VIII-2. Subjects in Placebo Group - Mean Waist Circumference and Mean Change in Waist Circumference

		Waist Circumference(cm)			Change in WaistCircumference (cm)
	Age	Pre-Tx	Post-Tx	30-dayFU	Pre-Txvs.Post-Tx	Pre-Txvs.30d FU	Post-Tx vs.30dFU
Mean±SD	45.13±13.24	92.5±9.69	92.6±9.49	92.63±9.58	-0.1±0.69	-0.13±0.61	-0.03±0.44
Median	46	91.5	91.5	91.5	0	-0.5	0
(Min- Max)	(27-65)	(74.5-107)	(75-107.5)	(75-107.5)	(-1-1.5)	(-0.5-1.5)	(-1 - 0.5)

Conclusions: The 8 twice-a-week treatments with BTL-9000 at maximum power produce reliable reduction in waist circumference. There was statistically significant difference between the Treatment and Placebo Groups in change in waist circumference from pre- to post-treatment, from pre-treatment to 30-day follow up, from port-treatment to 30-day follow up.

I X. Substantial Equivalence

The BTL-9000 is substantially equivalent to its predicate device when used according to its intended use. This is based on the information provided in this 510(k) Premarket Notification which demonstrates that the BTL-9000 shares the same technological characteristics, mechanism of action, intended use and physical properties when compared to its predicates.

X. Conclusion

Based on similar intended use, technological characteristics, and technical and clinical performance characteristics, the BTL-9000 is substantially equivalent to its respective predicate device.

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Confidential

Regulation Number and Section

§ 878.5400 Low level laser system for aesthetic use

(a)
Identification. A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.