The device is indicated for use by medical professionals and patient at home, who are under medical supervision, in treating many conditions, such as: Primary lymphedema, edema following trauma and sport injuries, post immobilization edema, venous insufficiencies, lymphedema.

Device Description

The system consists of an air pump, leg sleeves and hoses working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses; one sleeve has 4 compression chambers. The compression massage direction is from limb end to body center by inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor. This software is to control the timing and the pressure reflected by the sensor, it cycles the airflow to reach the function of cycling compression of body parts.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a medical device (Pressure Therapy System, K161907). It aims to demonstrate substantial equivalence to a predicate device, not necessarily to prove the device meets specific performance acceptance criteria through the kind of study described in your request.

The document discusses the device's technical characteristics and how they compare to a predicate device. It also lists the standards a performance test was conducted against to demonstrate safety and effectiveness. However, it does not include the detailed type of study you're asking about (e.g., a multi-reader multi-case clinical study with performance metrics like sensitivity/specificity, specific acceptance criteria for diagnostic performance, or extensive details on ground truth establishment from a clinical dataset).

Here's a breakdown of what the document does provide in relation to your request, and what it does not provide:

1. A table of acceptance criteria and the reported device performance

What's explicitly stated: The document lists standards that the device was tested against. This implies that meeting these standards served as "acceptance criteria" for safety and basic operational performance.
- IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)
- IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests)
- ISO10993-5 (Biological evaluations of medical devices -- Part 5: Tests for In Vitro cytotoxicity)
- ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)
Reported Device Performance: The document states, "The Pt1002 pressure therapy system has been tested and met the following standards." It does not provide specific performance values (e.g., specific pressure accuracy tolerances, cycle time deviations) against quantified acceptance criteria. Instead, it concludes that the device "has substantially equivalent technological and performance characteristics" to the predicate device and "is as safe and effective as the predicate device."
Missing from your request: There are no specific numerical acceptance criteria for diagnostic accuracy or clinical effectiveness (e.g., sensitivity, specificity for detecting a condition) because this is a physical therapy device, not a diagnostic AI.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable/Not Provided: This document describes a submission for a physical therapy device. The testing mentioned (compliance with IEC and ISO standards) would typically involve engineering tests on the device itself and biocompatibility tests on materials, not clinical trials with "test sets" of patient data in the way an AI diagnostic device would. Therefore, sample size for a "test set" and data provenance from patient data are not detailed, as they are not relevant to this type of device submission as described.

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/Not Provided: Ground truth by experts is relevant for diagnostic AI devices, clinical studies, or performance evaluations that require expert interpretation of data (e.g., images, physiological signals). For this physical therapy device, compliance with technical safety and biocompatibility standards does not involve expert-established ground truth in this manner.

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

Not Applicable/Not Provided: As noted, this type of submission for a physical therapy device focuses on engineering and biocompatibility standards, not the adjudication of clinical outcomes or diagnostic interpretations.

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

No: This is not a diagnostic AI device, and therefore, an MRMC study is not relevant or mentioned.

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

Not Applicable: This is a physical therapy device, not an algorithm, so the concept of standalone performance does not apply in the context of AI without human-in-the-loop.

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

Not Applicable/Implicit: For the standards listed, the "ground truth" would be the defined specifications and methodologies within those standards (e.g., a specific electrical resistance value, a specific biocompatibility response under defined lab conditions). This is not "expert consensus" or "pathology" in the clinical sense.

8. The sample size for the training set

Not Applicable/Not Provided: This is not an AI/machine learning device that requires a "training set" of data.

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

Not Applicable/Not Provided: As it's not an AI/machine learning device, the concept of establishing ground truth for a training set does not apply.

In summary:

This 510(k) submission for the "Pressure Therapy System" focuses on demonstrating substantial equivalence to a predicate device by comparing technical specifications and confirming compliance with recognized safety, electromagnetic compatibility, and biocompatibility standards. It does not provide the detailed performance study information with clinical acceptance criteria, test set, ground truth, or expert involvement that would be expected for a diagnostic device or an AI-powered system as detailed in your request.

Summary

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

February 22, 2017

Xiamen Senyang Co., Ltd. % Raymond Luo Technical Manager Shanghai SUNGO Management Consulting Company Limited 4th Floor 1500# Central Avenue Shanghai, Shanghai 200122 CN

Re: K161907

Trade/Device Name: Pressure Therapy System Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: January 26, 2017 Received: January 26, 2017

Dear Mr. Luo:

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 device

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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 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" (21 CFR 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,

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for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use

510(k) Number (if known) K161907

Device Name Pressure Therapy System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(K) Summary

K161907

A. Applicant:

Name: XIAMEN SENYANG CO., LTD. Address: 4-5 FLOOR, XINGBEI INDUSTRY, NO 95-99, WEST 2 ROAD, JIU TIANHU, XINGLIN XIAMEN, 361000, P.R. China

Official Contact Person Information Name: Raymond Luo Tel: 0086-21-68828050 Mail: fda.sungo@gmail.com

B. Subject device:

Trade name:	Pressure Therapy System
Common name:	Powered inflatable Tube Massager
Classification name:	Massager, Powered Inflatable Tube
Regulation Medical Specialty	Physical Medicine
Regulation Number	890.5650
Product Code	IRP
Classification	Class II

c. Predicate device:

K113275 - Compressible Limb Therapy System (Power-Q1000 Premium)

D. Indications for Use:

The device is indicated for use by medical professionals and patient at home, who are under medical supervision, in treating many conditions, such as: Primary lymph edema following trauma and sport injures, Post immobilization edema, Venous insufficiencies, Lymph edema.

E. Device Description:

F. Technical Characteristic:

Name	Pt 1002
------	---------

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Pressure (mmHg)	0~250 mmHg
Mode	Mode A and Mode B selection and the initial is A
Cycle time	30s
Pressure Time	Time 0-30 min, selection (10, 20, 30min)

G. Substantial Equivalence Table:

Device	Subject Device (K161907)	Predicate Device (K113275)
Manufacturer	XIAMEN SENYANG CO., LTD.	BSR KOREA Corp.
Model Name	Pt 1002	Power Q1000 Premium
Classification	Class II Device, IRP (21 CFR890.5650)	Class II Device, IRP (21 CFR890.5650)
Indications for Use	The device is indicated for use bymedical professionals and patient athome, who are under medicalsupervision, in treating manyconditions, such as: Primarylymphedema, edema followingtrauma and sport injures,Post-immobilization edema, Venousinsufficiencies, Lymphedema.	The device is indicated for use by medicalprofessionals and patient at home, who are undermedical supervision, in treating many conditions,such as: Primary lymphedema, edema followingtrauma and sport injures, Post-immobilizationedema, Venous insufficiencies, Lymphedema.
Description	Pt 1002 is a pneumatic pressuretreatment system that repeatsexpansion of sleeves to help bloodcirculation and prevent blood clots orclogs.	Power Q1000 Premium is a pneumatic pressuretreatment system that repeats expansion ofsleeves to help blood circulation and preventblood clots or clogs.
Standard	IEC 60601-1 & IEC 60601-1-2ISO10993-5 & ISO10993-10	EN 60601-1 & EN 60601-1-2
Indications	Primary lymphedema, edemafollowing trauma and sport injures,Post-immobilization edema, Venousinsufficiencies, Lymphedema	Primary lymphedema, edema following traumaand sport injures, Post-immobilization edema,Venous insufficiencies, Lymphedema
Mode ofCompression	Sequential	Sequential
Power Source	110 V, 60Hz	110V, 60Hz
Therapy Time	0 – 30 mins	0 - 99 mins
Max Pressure	0-250mm Hg	0-240mm Hg
Min Pressure
Number ofChambers	4 Chambers for each unit	4 Chambers for each unit
CompressionApplicatorGarments	Thermoplastic Urethane	Nylon
Sleeve Material
Power	30W	30W
consumption
Cycle time	30s	0, 5, 10, 15, 20, 25, 30s selectionInitial is 0s
Size	Size 260170130mmImage: White device with black control panel	Size:150210210mmImage: White and purple device with two knobs
Body areaspecific cuffs	Small Leg Cuff LXW:90X30cmLarge Leg Cuff LXW:110X30cmImage: Blue leg cuff	Leg:Image: Silver leg cuff
Preprogrammedmodes	Model AImage: Diagram of leg cuff model A	Model AImage: Diagram of leg cuff model A
	Model BImage: Diagram of leg cuff model B	Model CImage: Diagram of leg cuff model C

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From the comparison in the form above, the intended use, indication for use and the Mode of Compression,

Power Source, Power consumption of the two devices are same. There are some factors that are different:

1. Biocompatibility: The subject device has different sleeve material than the predicate device but subject device complies to ISO 10993-5 and ISO 10993-10 standards.
1. Therapy Time: For one time use, the max time for this device is 30 min. This is safer than the predicate device's max time of 90 min. If the user wants, he/she can repeat the 30 min cycle.
1. Min Pressure and Max Pressure of the subject device is 250 mmHg which is similar to the max pressure of 240mm Hg in the predicate device.
1. Preprogrammed modes: The subject device only has 2 selections which are within the scope of the predicate device. Model A of the subject device is identical to Model A of the predicate device. Model B of the subject device is identical to Model C of the predicate device.

H. Performance characteristic

The Pt1002 pressure therapy system has been tested and met the following standards: IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

ISO10993-5 Biological evaluations of medical devices -- Part 5: Tests for In Vitro cytotoxicity

ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

-Conclusion

The Pt1002 Pressure Therapy System has substantially equivalent intended use as the cleared Power Q1000 Premium Compression Limb Therapy System and has substantially equivalent technological and performance characteristics. After analyzing laboratory testing to applicable standards, it is concluded that Pt1002 Pressure Therapy System is as safe and effective as the predicate device, has few technological differe are no new indications for use and does not raise any new safety and/or effectiveness concerns. Consequently, it is substantially equivalent to the predicate device.

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).