(342 days)
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
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 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 |
§ 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.