The device is air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

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 text describes a 510(k) premarket notification for the "Pressure Therapy System PT1003". This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a predetermined set of acceptance criteria for a novel AI/imaging device. As such, many of the requested categories for AI/imaging device studies (like MRMC studies, effect size of AI assistance, expert qualifications, sample provenance, training sets, etc.) are not applicable or not provided in this regulatory submission.

However, I can extract information related to the performance characteristics, safety testing, and how the device's adherence to standards and safety was demonstrated.

Here's a breakdown of the available information:

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

The document doesn't explicitly state "acceptance criteria" in the format typically used for AI/imaging performance metrics (e.g., sensitivity, specificity, AUC). Instead, it demonstrates compliance with recognized medical device standards and functional tests to ensure safety and performance comparable to legally marketed predicate devices.

Acceptance Criteria (Implied from testing)	Reported Device Performance (PT1003)
Electrical Safety (AAMI ANSI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012)	Met the standard.
Electromagnetic Compatibility (IEC 60601-1-2 Edition 3: 2007-03)	Met the standard.
Home Healthcare Environment Safety (IEC 60601-1-11 Edition 2.0 2015-01)	Met the standard.
Biocompatibility - Cytotoxicity (ISO10993-5)	Met the standard.
Biocompatibility - Irritation & Skin Sensitization (ISO 10993-10)	Met the standard.
Minimum and Maximum Air Pressure	Tested as defined, result "almost same" as predicate. Max pressure 200 mmHg, Min pressure 20 mmHg.
Maximum Electric Current Value	Tested as defined, result "almost same" as predicate.
Maximum Airflow Value	Tested as defined, result "almost same" as predicate.
Noise Level	Tested as defined, result "almost same" as predicate.
Modes A and B functionality	Tested as defined, result "almost same" as predicate.
Pressure Range Comparator (compared to K182668)	Max Pressure of 200mmHg is within the safe range established by predicate K182668 (0-200mmHg).
Indications for Use Equivalence	Identical to predicate K183169 ("to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas").

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

This document does not describe a test set in the context of clinical data for AI/imaging performance. The testing performed consists of bench testing and electrical/biocompatibility safety evaluations on the device itself. Therefore, concepts like "sample size" for a data set or "data provenance" (country of origin, retrospective/prospective) are not applicable. The tests were performed on the "PT1003" device following defined procedures.

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

Not applicable. "Ground truth" for AI/imaging interpretation is not relevant for this type of device (a powered inflatable tube massager). The evaluation focuses on engineering, safety, and functional performance.

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

Not applicable. This is not a study requiring adjudication of expert 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

Not applicable. This is not an AI/imaging device.

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

Not applicable. This is not an AI/imaging device. The "standalone" performance here refers to the device's functional and safety performance in isolation, which was indeed assessed through the listed standards and function tests.

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

The "ground truth" for this device's evaluation is primarily established by regulatory standards (e.g., IEC, ISO, AAMI ANSI ES) and the functional and safety performance of legally marketed predicate devices. The device is deemed safe and effective if it meets these standards and its performance characteristics (like pressure range, cycle time) are comparable to or safely within the established parameters of already cleared devices.

8. The sample size for the training set

Not applicable. This is not an AI/imaging device, and therefore does not involve a "training set" in the machine learning sense.

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

Not applicable. As above, no training set for AI was used.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

April 23, 2020

Xiamen Senyang Co., Ltd. % Raymond Luo Technical Manager Shanghai SUNGO Management Consulting Co., Ltd. 13th F, 1500# Century Avenue Shanghai, China 200122

Re: K192358

Trade/Device Name: Pressure Therapy System PT1003 Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: September 12, 2019 Received: February 26, 2020

Dear Raymond 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Vivek J. Pinto, PhD Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K192358

Device Name Pressure Therapy System PT1003

Indications for Use (Describe)

The device is air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

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

| | Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(K) Summary

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 Shanghai SUNGO Management Consulting Co., Ltd. Name: Raymond Luo Tel: 0086-21-68828050 Mail: fda.sungo@gmail.com

B. Subject device:

Trade name:	Pressure Therapy System PT1003
Common name:	Powered inflatable Tube Massage
Classification name:	Massager, Powered Inflatable Tube
Regulation Medical Specialty	Physical Medicine
Regulation Number	890.5650
Product Code	IRP
Classification	Class II

C. Predicate device:

Pulse 2.0, Pulse Pro 2.0 of NormaTec Industries, LP, K183169
Rapid Reboot Compression Therapy System, Rapid Reboot Recovery Products, LLC, K182668

D. Reference device:

K181409, Pressure Therapy System PT1003, Rx Only

E. Indications for Use:

The device is air pressure massager intended to temporarily relieve minor muscle aches and to temporarily increase circulation to the treated areas.

F. Prescriptive

The Pressure Therapy System PT1003, and the predicate (K183169 and K182668) are OTC devices.

G. Device Description:

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H. Substantial Equivalence Table

Device	Subject Device	Predicate Device 01	Predicate Device 02
Manufacturer	XIAMEN SENYANG CO., LTD.	NormaTec Industries, LP,	Rapid Reboot Recovery Products, LLC
Model Name	Pt 1003	Pulse 2.0, Pulse Pro 2.0	Not Publicly Available
Classification	Class II Device, IRP (21 CFR890.5650)	Class II Device, IRP (21 CFR890.5650)	Class II Device, IRP (21 CFR890.5650)
Prescriptive	No. OTC	No. OTC	No. OTC
Indications foruse	The device is air pressure massagers intended totemporarily relieve minor muscle aches and/orpains, and to temporarily increase circulation tothe treated areas.	The device is air pressure massagers intended totemporarily relieve minor muscle aches and/orpains, and to temporarily increase circulation tothe treated areas.	The Rapid Reboot Compression Therapy Systemis indicated for the temporary relief of minormuscle aches and pains and for temporaryincrease in circulation to the treated areas inpeople who are in good health. The RapidReboot Compression Therapy System simulateskneading and stroking of tissues by using aninflatable garment.
Intended useEnvironment	Clinics, hospital, athlete training, andhome environments	Clinics, hospital, athlete training, andhome environments	Clinics, hospital, athlete training, and homeenvironments
Standard	AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012IEC 60601-1-11.IEC 60601-1-2ISO10993-5& ISO10993-10	AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012IEC 60601-1-11.IEC 60601-1-2ISO10993-5& ISO10993-10	IEC 60601-1:2014; IEC60601-1-2:2014; EN ISO10993-5:2009 & EN ISO10993-10:2010
SoftwareMicro-processorControl	Microprocessor	Microprocessor	Microprocessor
Mode ofCompression	Sequential Gradient, Peristaltic andPulsing	Sequential Gradient, Peristaltic andPulsing	Sequential Gradient, Peristaltic andPulsing
Power Source	110 V, 60Hz	15 VDC via an IEC 60601-1compliant power supply (100- 240 VAC	110 V, 60Hz

Therapy Time	0-30Min	input) Integrated rechargeable batteryStays on until the user turns it off or can be setup to turn off in a range of 10 minutes tocontinuous.	User determines therapy time. Choose from 10,20, or 30 minute session time, with option to addadditional 10 minutes to any therapy time.
Max PressureMin Pressure	20-200mm Hg	0-110mm Hg	0-200 mmHg
Number ofChambers	4 Chambers for each unit	5 or less	4 Chambers for each unit
CompressionApplicatorGarmentsSleeve Material	Thermoplastic Urethane	200 denier nylon with a polyurethanelaminate/extrusion	Nylon with a Polyurethanelaminate
Technology	Compressor and valve system thatsequentially inflates cells of appliance.	Compressor and valve system thatsequentially inflates cells of appliance.	Compressor and valve system whichsequentially inflates cells of appliance
Cycle time	70s	Not Publicly Available	1 min 20s
Patient Contact	Non-conductive appliances	Non-conductive appliances	Non-conductive appliances
Size	Size 285175130mm	Size: 4.4" x 3.8" x 8.1 "	Size: 10" x 6.5" x 5"
Preprogrammedmodes	Model Adjustable: The number of zones that areenabled in the attachment can be changedbetween one and five zones.	Model Adjustable: The number of zones that areenabled in the attachment can be changedbetween one and five zones.	2 modes: "A" mode inflates and deflateschambers from bottom up (distal to proximalchambers), one at a time. "B" mode also inflateschambers from bottom up, but maintainspressure in lower chambers as works its way totop. Then all chambers release pressure at sametime once all chambers have sequentiallyinflated

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Determination of Substantial Equivalence I.

The following factors of Pressure Therapy System PT1003 are substantially equivalent to currently marketed and cleared devices (K183169).

A Indications for Use: The Pressure Therapy System PT1003 indications for use are identical to the predicate, NormaTec Pulse 2.0, Pulse Pro 2.0, 510(k) K183169.
A Prescriptive: The Pressure Therapy System PT1003, and the predicate (K183169) are OTC devices.
Performance and Specifications: The Pressure Therapy System PT1003 have equivalent specifications of performance when compared to the predicate, NormaTec Pulse 2.0, Pulse Pro 2.0, 510(k) K183169.
Compliance with Standards: Both subject device and predicate device comply with the same standards expect the special standard related to the blue tooth function.
Intended Use Environment: Clinics, hospital, athlete training, and home environments, which are identical to the predicate.
Materials for patient contact are Non-conductive appliances.

The following factors of Pressure Therapy System PT1003 are different from currently marketed and cleared devices (K183169).

A Pressure range of the predicate device is 0-110mm Hg while current device is 20-200mm Hg. To ensure the pressure is safe, we identified another predicate device. K182668, which is also for OTC use and the pressure scope is 0 to 200mmHg.
A Design, Technology, and Principle of Operation: The proposed device has not got Bluetooth capability but this will not bring any new risk to the subjected device.

J. Performance characteristic

The Pt1003 pressure therapy system has been tested and met the following standards: AAMI ANSI ES 60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)

IEC 60601-1-2 Edition 3: 2007-03. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

IEC 60601-1-11 Edition 2.0 2015-01, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

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

Function test

Minimum and maximum air pressure test
Test the maximum electric current value
Test the maximum airflow value
Test the noise level
Test the modes A and B.

The test was done on PT1003 following the test procedure defined. When we compare the test data with the predicate device, we can found the test result is almost same.

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K. Conclusion

The Pt1003 Pressure Therapy System has substantially equivalent intended use as the cleared NormaTec Pulse 2.0, Pulse Pro 2.0, (K183169) and has substantially equivalent technological and performance characteristics. The pressure scope is safe by compare with the predicate device Rapid Reboot Recovery Products, LLC, K182668. After analyzing laboratory testing to applicable standards, it is concluded that Pt1003 Pressure Therapy System is as safe and effective as the predicate device, has few technological differences, but there 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).