Compression Therapy Device Model LGT-2200SP

• K Number: K191862
• Device Name: Compression Therapy Device Model LGT-2200SP
• Manufacturer: Guangzhou Longest Science & Technology Co., Ltd.
• Date Cleared: 2019-10-29 ( 110 days)
• Product Code: IRP
• Regulation Number: 890.5650
• Type: Traditional
• Panel: PM
• Reference & Predicate Devices: K161907 , K160608 , K182668

Intended Use

Compression Therapy Device LGT-2200SP is intended for the temporary relief of minor muscle aches and for the temporary increase in circulation to the treated areas, it can simulate kneading and stroking of tissues by using an inflatable garment.

Device Description

Compression therapy device LGT-2200SP is a powered inflatable tube massager, comprised of an air compressor with intermittent pneumatic controller, 4-chamber sleeves covered with Polyether Nylon Fabric, and a connectable hose for connecting the device to the sleeves. The case of main unit body is made from ABS plastic. The device can be powered by an external power supply, or be powered by an internal lithium ion battery. The sleeves have 4-chambers and different applicable body areas, such as the Arm/ Leg/ Waist, hip and thigh/ Calf and foot. The sleeves can be inflating sequentially to apply the circulating pressure on the target body areas which controlled by the main unit. The device simulates manual kneading and stroking of tissues by sequential inflated sleeves, to temporarily relieve minor muscle aches and/or pains and to temporarily increase circulation to the treated areas.

AI/ML Overview

The provided text is a 510(k) Summary for the Compression Therapy Device Model LGT-2200SP. It asserts substantial equivalence to predicate devices and focuses on technical specifications and adherence to safety standards.

Here's an analysis of the provided text in relation to your request:

The document does not include detailed acceptance criteria or a study that rigorously proves the device meets those criteria in a clinical performance context. Instead, it focuses on demonstrating safety and effectiveness through compliance with recognized standards and comparison to predicate devices.

Let's break down your specific points based on the available information:

1. A table of acceptance criteria and the reported device performance:
   The document doesn't provide a typical "acceptance criteria" table for device performance in a clinical sense (e.g., accuracy, sensitivity, specificity). Instead, it compares the subject device's technical specifications and features to predicate devices, and asserts that differences do not raise new questions of safety or effectiveness.

   Here's a table summarizing the comparison of the device's technical specifications and features to the predicate devices, which act as a form of "acceptance" by demonstrating substantial equivalence:

   Elements of Comparison	Subject Device (LGT-2200SP)	Predicate Device (Primary: NormaTec Pulse/Pro)	Predicate Device (II: Rapid Reboot System)	Predicate Device (III: Senyang Pt 1002)	Verdict (Equivalence Claim)
   Classification Name	Powered inflatable tube massager	Powered inflatable tube massager	Powered inflatable tube massager	Powered inflatable tube massager	Substantially Equivalent (SE)
   Regulation Class	2	2	2	2	SE
   Regulation Number	21 CFR 890.5650	21 CFR 890.5650	21 CFR 890.5650	21 CFR 890.5650	SE
   OTC & Rx	OTC	OTC	OTC	Rx	Minor different (Noted in Remarks below)
   Indications for Use	Temporary relief of minor muscle aches and pains, temporary increase in circulation. Simulates kneading/stroking.	Temporary relief of minor muscle aches/pains, temporary increase in circulation.	Temporary relief of minor muscle aches/pains, temporary increase in circulation in healthy people. Simulates kneading/stroking.	Treating primary lymphedema, edema, venous insufficiencies, lymphedema (Rx use).	Minor different (Noted in Remarks below)
   Power Source	AC100-240V, Battery 11.1V, 6500mAh	12 VDC via IEC 60601-1 PSU, Optional rechargeable battery	110 V, 60Hz	110 V, 60Hz	Minor different (Noted in Remarks below)
   Power Consumption	90VA	14W	30W	30W	Minor different (Noted in Remarks below)
   Dimensions (WHD)	270148129mm	4"*5" *9"	10" x 6.5" x 5"	260170130mm	Minor different (Noted in Remarks below)
   Weight	2.0 Kg (4.4 pounds)	3.6 pounds	5.8 pounds	5.8 pounds	Minor different (Noted in Remarks below)
   Housing Materials	Molded ABS enclosure	Molded ABS enclosure	Molded ABS enclosure	Molded ABS enclosure	SE
   Number of Chambers	4-chamber	5 or less	4 Chambers	4 Chambers	SE
   Sleeve Materials	Polyether Nylon Fabric	200 denier nylon with polyurethane laminate/extrusion	Nylon with a Polyurethane laminate	Thermoplastic Urethane	Minor different (Noted in Remarks below)
   Mode of Compression	Sequential	Sequential	Sequential	Sequential	SE
   Device Pressure Range	30-150mmHg	30-110 mmHg	0-200 mmHg	0-250mmHg	Minor different (Noted in Remarks below)
   Treatment Time	1min-99min, default 30min, step of 5min	Stays on until user turns off or 10mins to continuous	10, 20, or 30 minute, with option to add 10 minutes	0 - 30mins	Minor different (Noted in Remarks below)
   Work Mode	6 modes (SEQUENTIAL, SQUEEZE, FLUSH, FLOW, RELEASE, WAVE)	Sequential, Zone pulses (2 modes)	Model A, Model B (2 modes)	Model A, Model B (2 modes)	Minor different (Noted in Remarks below)
   Patient Contact	Non-conductive appliances	Non-conductive appliances	(Image of Predicate II)	(Image of Predicate III)	SE
   Software/Firmware/Microprocessor Control	Microprocessor	Microprocessor	Microprocessor	Microprocessor	SE
   Technology	Compressor and valve system inflates cells of appliance sequentially	Compressor and valve system inflates cells of appliance sequentially	Compressor and valve system inflates cells of appliance sequentially	Compressor and valve system inflates cells of appliance sequentially	SE
   FDA-Recognized Standards	ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62133, ISO 10993-5, ISO 10993-10	ES 60601-1, IEC 60601-1-2, IEC 60601-1-11	IEC 60601-1:2014, IEC 60601-1-2:2014, EN ISO 10993-5:2009, EN ISO 10993-10:2010	IEC 60601-1, IEC 60601-1-2, ISO10993-5, ISO10993-10	Minor different (Noted in Remarks below)

   Remarks on "Minor different" Verdicts:

   • Indications for Use: The document states, "Although there is a little difference about the indication for use, the meanings are the same. This difference does not affect the safety and effectiveness." (Note 1)
   • Power Source, Consumption, Dimensions, Weight: "Although the subject device design and specification parameter between the predicate are different, they are both complied with ANSI/AAMI ES60601-1. So the minor differences on such parameters do not affect the safety and effectiveness." (Note 2)
   • Sleeve Materials, Sleeves (dimensions/types): "Although the device provides four kind sleeves which have minor difference about size and appearance, the sleeve chamber number are the same and the applicable body areas are included in the predicate... the biocompatibility of sleeves is also complied with ISO 1099-5 and ISO 10993-10. Therefore, the difference would not raise adversely impact on safety and effectiveness." (Note 3)
   • Device Pressure Range: "Although the pressure range of subject devices, the range is smaller and contained by the predicate device (1), so the difference of pressure range would not raise adversely impact on safety and effectiveness." (Note 4). (There seems to be an error in the text where it ambiguously says "range is smaller and contained by the predicate device (1)" when for PD(II) and PD(III) the subject device's range is within a larger range.)
   • Treatment Time: "Although the treatment time range of subject device is to 99mins, which seems to be longer than the predicated with is suitable for daily use. And the treatment time is optionally set by user with 5mins step, which is more exact to the difference of pressure range would not raise adversely impact on safety and effectiveness." (Note 5). (There seems to be an error in the text where it mentions "difference of pressure range" instead of treatment time range).
   • Work Mode: "Although the subject device provides six kinds of work mode, the SEQUENTIAL and FLUSH mode are the same with the other work modes of subject device just have different about the different chambers. The treatment pressure range are the same under different work modes, so the difference of pressure range would not raise adversely impact on safety and effectiveness." (Note 6).
   • FDA-Recognized Standards: "The subject device references more sufficient safety standards than the 'safety of the safety' of the device is verified via tests." (Note 7 - this implies the subject device meets or exceeds the standards referenced by predicates, further supporting SE).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   The document explicitly states: "Clinical performance is not deemed necessary." (Section 7. Summary for clinical test). Therefore, there is no test set, sample size, or data provenance regarding clinical performance. The evaluation was based on bench testing and comparison to predicates.

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):
   As no clinical test set was used, there were no experts establishing ground truth in a clinical context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   As no clinical test set was used, there was no adjudication method.

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:
   This device is a physical therapy device (compression therapy device), not an AI imaging or diagnostic algorithm. Thus, an MRMC study and AI assistance effectiveness are not applicable and were not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   This is a physical therapy device. The concept of "standalone algorithm performance" is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   As no clinical studies were performed, there was no clinical ground truth established (such as expert consensus, pathology, or outcomes data). The "ground truth" for demonstrating substantial equivalence was adherence to recognized safety standards and functional comparison to legally marketed predicate devices.

8. The sample size for the training set:
   As no machine learning or AI component is mentioned, there is no training set, and therefore no associated sample size.

9. How the ground truth for the training set was established:
   As there is no training set for an AI/ML model, this question is not applicable.

Regulation Number and Section

§ 890.5650 Powered inflatable tube massager.

(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).