Relieves minor muscle aches and pains; Relieve muscle spasm; Temporarily Improve local circulation; Temporarily reduces the appearance of cellulite; Relieves minor muscle aches and pains, relieves muscle spasm and improves local circulation during Burn rehabilitation

Device Description

The LPG devices are intended for practitioners who work in specific fields but all are substantially equivalent devices: ES1 for Endermologie; Cellu M6 for Endermologie and therapeutic applications; S6 sport for sport applications, before, after exercise and rehabilitation after injuries; ES/M60 for therapeutic applications and cosmetic applications on the face or on small area; LPG Equine for animal treatment. These devices are substantially equivalent to the ES1 therapeutic massager because the mode of operation and operating parameters and specifications are basically the same. Each LPG device comprises a main console housing a vacuum pump and a computerized regulation system. All of them contain treatment heads (from 5 to 12), that are designed to accommodate all parts of the body. ES1, Cellu M6, S6, LPG Equine devices have a main motorized head, the other device contain auxiliary heads (non-motorized) only. The equine device head is the largest in order to be able to be applied on the horse's body surface. The suction power of all these machines range from 50mBar to 500mBar which is represented by a scale from 1 to 10; for a specific machine and application, the suction power must be cyclically interrupted to provide vibration to the skin which is another stimulation for the tissues.

AI/ML Overview

The provided text describes a 510(k) summary for the LPG Therapeutic Massager/Vibrator, which details its substantial equivalence to existing devices and its intended uses. However, it does not contain the kind of detailed study information (like acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC study results) that would be needed to fill out the requested table and answer all questions directly.

The document states, "Our objective is not to substantiate new claims but to prove that the exempt claims are appropriate for the burn victim and that the product is safe and effective for its general uses when used in burn rehabilitation." This indicates that the 510(k) submission primarily relies on demonstrating substantial equivalence to predicates for its claims, rather than presenting a novel clinical study with explicit acceptance criteria for device performance.

One study is mentioned: "Doctor Gavroy compared treatment on burn victim with LPG and rhythmicity and LPG without rhythmicity." However, no details about the study design, sample size, methodology, or results are provided to determine how it would "prove" the device meets specific acceptance criteria.

Therefore, many of the requested fields cannot be filled from the provided document.

Here's an attempt to answer based on the available information, with explanations for what cannot be provided:

Acceptance Criteria and Device Performance Study for LPG Therapeutic Massager/Vibrator

The provided 510(k) summary for the LPG Therapeutic Massager/Vibrator (K990445) does not explicitly define acceptance criteria in terms of specific performance metrics that the device had to meet in a study. The submission relies on demonstrating substantial equivalence to legally marketed predicate devices for its intended uses. The "performance" is implicitly demonstrated through the device's adherence to the established indications for use of the predicate devices and its design and specifications being comparable.

The objective stated is: "Our objective is not to substantiate new claims but to prove that the exempt claims are appropriate for the burn victim and that the product is safe and effective for its general uses when used in burn rehabilitation." This suggests the efficacy for established claims is taken as given based on substantial equivalence, with a specific focus on the applicability of these claims to burn rehabilitation.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Claim	Acceptance Criteria (Implied by Substantial Equivalence to Predicates)	Reported Device Performance (Implied by Substantial Equivalence and Mentioned Study)
Relieves minor muscle aches and pains	Equivalent to predicate devices (G5-GK1 Vibrator, VIBRATOUCH™ II) in ability to relieve minor muscle pain.	The device's mode of operation, operating parameters, and specifications are basically the same as or comparable to the predicates, thus considered substantially equivalent in performing this function. The literature also cites the effectiveness of vibration for pain.
Relieve muscle spasm	Equivalent to predicate devices in ability to relieve muscle spasm.	Substantially equivalent to predicates. The literature also cites the effectiveness of vibration for muscle spasm.
Temporarily improves local circulation / Temp. increase of local circulation	Equivalent to predicate devices in ability to temporarily improve local circulation.	Substantially equivalent to predicates. The literature also cites the effectiveness of vibration for microcirculation.
Temporarily reduces the appearance of cellulite (as of April 1998)	Demonstrated efficacy through the "Endermologie" methodology with specific parameters.	The company designed a specific methodology ("Endermologie") involving torso massage, tissue mobilization, adjusted suction power, and an average of fourteen sessions. Results on the appearance of cellulite were "so significant" that LPG decided to market the product for this effect. This claim was permitted in April 1998.
Relieves minor muscle aches and pains, relieves muscle spasm and improves local circulation during Burn rehabilitation	Safety and effectiveness for these claims when applied in burn rehabilitation settings.	Objective: "to prove that the exempt claims are appropriate for the burn victim and that the product is safe and effective for its general uses when used in burn rehabilitation." A study by "Doctor Gavroy compared treatment on burn victim with LPG and rhythmicity and LPG without rhythmicity." (No results or detailed effectiveness metrics for this study are provided).
Ground Current Leakage	<50 microamp. (for LPG Massager/Vibrator) and <75 microamp. (for G5-GK1 Vibrator).	LPG Massager/Vibrator: <50 microamp. (Meets the specified safety parameter, which is better than one predicate).

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not explicitly stated for any formal clinical trial or test set in the document.
Data Provenance: The general context indicates the company is French (LPG Systems Technoparc de la Plaine, France), and the inventor is Louis Paul Guitay. One study mentions "Doctor Gavroy compared treatment on burn victim with LPG and rhythmicity and LPG without rhythmicity," but the country of origin of this study or its retrospective/prospective nature is not specified. The claim for cellulite reduction is based on observing results in female patients being treated for low back pain, described as part of a "specific methodology based on physiological and pathological data" rather than a formal test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not specified. The document primarily relies on substantial equivalence and a methodology ("Endermologie") with observed "significant" results for the cellulite claim. The "Doctor Gavroy" study details are absent.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not specified.

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/Not mentioned. The device is a therapeutic massager, not an AI-assisted diagnostic or imaging device where "human readers" or AI assistance in that context would typically apply.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical therapeutic device, not an algorithm. Its operation is "standalone" in the sense that it performs its physical function, but it is applied by a practitioner ("licensed physician" per caution, or "practitioners" in general).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For claims of relieving pain, muscle spasm, and improving circulation, the ground truth is implied by the established efficacy of the predicate devices and general scientific literature on vibration therapy.
For the cellulite reduction claim, the ground truth was based on observed outcomes ("noticed that their patients were showing an improvement...Results on the appearance of cellulite were so significant"). This was formulated into a "specific methodology based on physiological and pathological data."
For burn rehabilitation, the ground truth relies on a comparison study by "Doctor Gavroy," but the specific type of ground truth measured (e.g., pain scales, circulation markers, recovery rates) is not detailed.

8. The sample size for the training set:

Not applicable/Not specified. This is a physical device, and the "Endermologie" methodology evolved from clinical observations rather than a computational "training set."

9. How the ground truth for the training set was established:

Not applicable for a "training set" in the computational sense. The efficacy for the claims is rooted in the perceived effects of the LPG technique and its substantial equivalence to predicate devices. For the cellulite claim, it was established through observation of "significant" improvement in patients over an average of fourteen sessions during development of the "Endermologie" methodology. This seems to be a form of empirical observation from initial clinical use rather than a formally established ground truth for a defined training dataset.

Summary

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K99 0445

JAN 18 2000

510 (k) Summary

Applicant's Name: LPG USA

Applicant's Address: 3101 North Federal Highway (Suite (301) Fort Lauderdale, FL 33306

Contact Person: Walter L. Wasserman

Phone Number/contact person: (954)568-5005 Fax Number/contact person: (954)568-6611

Address of manufacturing site: LPG Systems Technoparc de la Plaine 30 Rue du Docteur Abel BP 35-26902 Valence Cedex 9, France

Date Summary Prepared: January 18, 2000

This summary includes sections 2 through 8.

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2. Device Name

Therapeutic Massager (21 CFR 890.5660) .
Proprietary names LPG Therapeutic Massager Models ES1 .
Therapeutic Massager/Vibrator (21 CFR 890.5660 and 890.5975) .
Proprietary names LPG Therapeutic Massager/ Vibrator Models Cellu M6; ES/M60; S6; and LPG . Equine

3. Establishment registration number

1062948

Classification of device 4.
- . Class I
- Product codes 89 ISA and 89 IRO .
- . Panel - Physical medicine
ડ . Performance standards

There are no performance standards established under section 514

6. Labeling

6.1 Indications for use

Relieves minor muscle aches and pains ●
. Relieve muscle spasm
. Temporary improvement in local circulation
. Temporarily reduces the appearance of cellulite
Relieves minor muscle aches and pains, relieves muscle spasm and temporarily improves local . circulation during Burn rehabilitation

Contraindications

. Known sensitivity to the device
Do not treat over open wounds .
Skin cancer in the treated area .
. Do not treat HIV positive patients

Caution

Federal law restricts thus device for sale to or use under of a licensed physician

Precautions;

When treating patients for burn rehabilitation care should be taken to carefully follow the instruction manual and not to exceed suction levels that would be obviously uncomfortable for the patient.

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510(k) Number K99045 Device Name: LPG Therapeutic Massager/Vibrator

Intended uses

Relieves minor muscle aches and pains .
Relieve muscle spasm ●
. Temporarily Improve local circulation
Temporarily reduces the appearance of cellulite .
Relieves minor muscle aches and pains, relieves muscle spasm and improves local circulation during . Burn rehabilitation

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use (Per 21 CFR 801.109) OR

Over-The-Counter-Use

(Optional Format 1-2-96)

6.2

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7. Substantial equivalence comparison

This product is substantially equivalent to a product already on the market LPG Therapeutic Massager (21 CFR 890.5660). The LPG technique involves a mobilization of the tissue accomplished with the LPG devices. All models with the exception of the ES1 and LPG Equine have both continuous and cyclic or pulsating modes of action. This pulsating function is equivalent to Therapeutic Vibrators (21 CFR 890.5975). And as such Substantial Equivalence is also claimed to the following legally marketed devices, which are also Class I.

G5-GK1 K850851 .
VIBRATOUCH™ II K912383 .

Table of Comparison

Device	Indications	Design	Specifications
LPG Massager/Vibrator	Minor muscle painRelieve muscle spasm; Temp.improvement in appearance ofcellulite; Temp. increase oflocal circulation; Burn Rehab.	5 models5 applicators12 treatment heads3 motorized heads	Ground currentLeakage <50micamp.
G5-GK1 Vibrator	Minor muscle pain	17 applicators3 modelshand held	12'x3'x3' - 3.8 lbs.; 0.25HP110V, 60 cycle<75 micamp. groundcurrent leakage
VIBRATOUCH II	Minor muscle pain	2 speeds; Battery Power	not specified

Our objective is not to substantiate new claims but to prove that the exempt claims are appropriate for the burn victim and that the product is safe and effective for its general uses when used in burn rehabilitation.

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1. 1. 1. 9

The LPG Technique:

The LPG technique involves mobilization of tissue accomplished with the LPG devices.

LPG stands for Louis Paul Guitay inventor of these therapeutic massagers.

LPG after a car accident that had left scars on his body was receiving treatments from a physical therapist using a tissue mobilization technique called Skin Fold Rolling. After a number of treatments, LPG noticed a difference in the Skin Fold Technique due to the practitioner performing the maneuvers or the time of the treatment. LPG had the idea to make the technique more consistent and replicable using vacuum power to lift the skin and make a fold that is mobilized by two motorized rollers.

The LPG devices:

Based on similar concepts, the LPG devices are intended for practitioners who work in specific fields but all are substantially equivalent devices:

ES1 for Endermologie ●
Cellu M6 for Endermologie and therapeutic applications ●
S6 sport for sport applications, before, after exercise and rehabilitation after injuries .
ES/M60 for therapeutic applications and cosmetic applications on the face or on small area .
LPG Equine for animal treatment. �

These devices are substantially equivalent to the ES1 therapeutic massager because the mode of operation and operating parameters and specifications are basically the same.

Each LPG device comprises a main console housing a vacuum pump and a computerized regulation system.

All of them contain treatment heads (from 5 to 12), that are designed to accommodate all parts of the body. ES1, Cellu M6, S6, LPG Equine devices have a main motorized head, the other device contain auxiliary heads (non-motorized) only. The equine device head is the largest in order to be able to be applied on the horse's body surface.

The suction power of all these machines range from 50mBar to 500mBar which is represented by a scale from 1 to 10; for a specific machine and application, the suction power must be cyclically interrupted to provide vibration to the skin which is another stimulation for the tissues.

The motorized head:

This patented head (number 4.729.368 US) contains more than 200 individual parts and contains two motorized rollers that move together and apart, at each end of the suction chamber. The two rollers are mobilized in rotation and in sliding back and forth. They provide, to the

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and the comments

head, the capability of creating a fold of skin and subcutaneous fat with a very efficient contact, which allows better mobilization. This is also enhanced by specific maneuvers.

To visualize the reaction of tissue in-vivo, some endoscopic views were recorded within : the main head.

The auxiliary heads:

In addition to the main head, a set of auxiliary heads can be used with two non-motorized rollers on smaller parts of the body, particularly the face, the neck, and all the specific area, which need treatment. These heads are called regarding the size of the rollers: 15, 30, 44 millimeters; the ES/M60 device contains a larger head with specific ergonomic features (i.e. handle on the top of the head) but the same design. Recently, LPG had added small springs at each end of the rollers to provide lateral mobilization of them during the treatment.

Rhythmicity or cyclic pulsation and mobilization:

For a specific machine and application (Cellu M6, S6, M60, and LPG Equine), the suction power is cyclically interrupted to provide vibration to the skin fold between the two rollers, which is another form of stimulation for tissues. Added to the device for the comfort of the patient, the cyclic suction power, according to scientific literature, provides additional effects to the tissue. Because of that, the therapeutic massager that includes vibration could be described as a form of therapeutic vibrator as well.

This cyclic pulsation feature is modulated by two variables:

. Cycle rate

The cycle rate regulates the proportion of time devoted to suction and rest. It is a ratio, the cycle rate ranges from 1 to 9, 1 for 10% suction versus 90% rest, 9 for 90% suction versus 10% rest, 5 for 50% suction versus 50% rest.

Frequency .

The frequency is the number of repetitions of one cycle per second. The frequency range from 0.41 to 19.23 Hz; these numbers appears on the screen as 0.0 for 0.41 Hz to 199 for 19.23 Hz.

In order to apply to the skin fold effective vibration, it is necessary to choose an adjustment with high frequency and low cycle rate or low frequency and high cycle rate. If the chosen adjustment is high frequency and high cycle rate, the skin fold is constantly lifted and the action is equivalent to the constant suction. If the chosen adjustment is low cycle rate and low frequency, the skin fold is mostly relaxed and therefore there will be less or no effectiveness.

This cyclic pulsation should not be considered as a single event but rather as repetitive stimulation that could produce harmonics (additional modes of stimulation). Thus the specific adjustments of the machine are less significant than it appears because of the harmonic summation.

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The literature contains many citations showing the effectiveness of vibration of various frequencies; (i.e. has been shown on microcirculation, on pain and on muscle spasm).

LPG has investigated this area in one studies:

Doctor Gavroy compared treatment on burn victim with LPG and rhythmicity and LPG without rhythmicity.

History of the LPG Technique:

A number of French medical doctors advised Louis Paul Guitay about using the device to treat low back pain, a condition very frequently associated with some types of change in the skin and subcutaneous fat. This is called secondary cellulitis on the back or around the pelvic bone (iliac crest). They also recommended treating neck ache with huge fatty localization around C7 (which is called buffalo hump).

Therapist successfully using the CelluM6 device on female patients suffering low back pain, also noticed that their patients were showing an improvement in the appearance of their cellulite or commonly called orange peel skin.

Results on the appearance of cellulite were so significant that LPG decided to market the product for this effect. The device was then sold for two applications (cosmetic and therapeutic).

When LPG decided to sale the LPG therapeutic Massager for its effect on cellulite, a specific methodology based on physiological and pathological data was designed:

Global methodology involving torso massage designed to improve circulation at the । pelvic and abdominal level
Tissue mobilization with specific maneuvers acting upon the venous system, lymphatic system, blood system which are sensitive to surrounding tissue movements
Adjusted suction power to the sensitivity and the thickness of the tissues -
-An average of fourteen sessions (two sessions per week) without interruption, during 35 to 45 minutes each.

Because this methodology represents a specific and innovative way to tackle this skin condition, the company decided to invent a name for it: the word "Endermologie" was chosen and became a trademark.

Thus, it was evident that Endermologie could be only done with the LPG Therapeutic Massagers because of the specificity of the patented heads.

To date the LPG devices such as therapeutic massagers have got the exempted claims: Relieves minor muscles aches and pain

Temporarily increases local blood circulation

Relaxes muscles spasm

Since, April 1998, the LPG therapeutic massager has been permitted the claim:

Temporary reduction in the appearance of cellulite.

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Image /page/7/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 an eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 18 2000

Mr. Frederic Barthe Vice President LPG USA, Inc. 3101 North Federal Highway Suite 301 Fort Lauderdale, Florida 33306

Re: K990445

Trade Name: LPG Therapeutic Massager Vibrator Regulatory Class: I Product Code: ISA Dated: October 18, 1999 Received: October 20, 1999

Dear Mr. Barthe:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2 - Mr. Frederic Barthe

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

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6.2

510(k) Number K990445 Device Name: LPG Therapeutic Massager/Vibrator

Intended uses

· Relieves minor muscles aches and pains
· Relieve muscle spasm
· Temporarily improves local blood circulation
· Relieves minor muscle aches and pains, relieves pains, relieves muscle spasm and improves local circulation during burn rehabilitation

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use (Per 21 CFR 901.109

Over-the-Counter-Use

(Optional Format 1-2-96)

Acsilla

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K990445

Regulation Number and Section

§ 890.5660 Therapeutic massager.

(a)
Identification. A therapeutic massager is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.