(226 days)
Not Found
No
The device description mentions a sensor and microprocessor controlling timing and pressure, which is standard for automated medical devices and does not indicate AI/ML. There are no mentions of AI, DNN, or ML in the provided text.
Yes
The device is used for treating various medical conditions such as lymphedema and venous insufficiencies, and its function involves providing compression therapy to limbs, which directly impacts the body for therapeutic purposes.
No
The device description indicates it is a therapy system that provides compression massage, not a device used for diagnosis. Its function is to treat conditions, not to identify them.
No
The device description explicitly states the system consists of an air pump, leg sleeves, and hoses working together as one unit, indicating hardware components are integral to the device's function. While software controls the timing and pressure, it is part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a "pressure therapy system" that uses an air pump and sleeves to apply compression to limbs. This is a physical therapy or medical device that acts externally on the body.
- Intended Use: The intended use is for treating conditions like lymphedema and edema through external compression, not by analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with IVD devices.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 lymphedema, edema following trauma and sport injuries, post immobilization edema, venous insufficiencies, lymphedema.
Product codes (comma separated list FDA assigned to the subject device)
IRP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals and patient at home, who are under medical supervision
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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
1
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,
Image /page/1/Picture/8 description: The image shows the name "Michael J. Hoffmann -S" in a simple, sans-serif font. The text is horizontally aligned and appears to be the primary focus of the image. The letters are clear and legible, with consistent spacing between them.
- 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)
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.
| 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) |
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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:
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.
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 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 injures, | ||
| Post-immobilization edema, Venous | ||
| insufficiencies, Lymphedema. | 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 injures, Post-immobilization | ||
| edema, Venous insufficiencies, Lymphedema. | ||
| Description | Pt 1002 is a pneumatic pressure | |
| treatment system that repeats | ||
| expansion of sleeves to help blood | ||
| circulation and prevent blood clots or | ||
| clogs. | Power Q1000 Premium is a pneumatic pressure | |
| treatment system that repeats expansion of | ||
| sleeves to help blood circulation and prevent | ||
| blood clots or clogs. | ||
| Standard | IEC 60601-1 & IEC 60601-1-2 | |
| ISO10993-5 & ISO10993-10 | EN 60601-1 & EN 60601-1-2 | |
| Indications | Primary lymphedema, edema | |
| following trauma and sport injures, | ||
| Post-immobilization edema, Venous | ||
| insufficiencies, Lymphedema | Primary lymphedema, edema following trauma | |
| and sport injures, Post-immobilization edema, | ||
| Venous insufficiencies, Lymphedema | ||
| Mode of | ||
| Compression | 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 of | ||
| Chambers | 4 Chambers for each unit | 4 Chambers for each unit |
| Compression | ||
| Applicator | ||
| Garments | Thermoplastic Urethane | Nylon |
| Sleeve Material | ||
| Power | 30W | 30W |
| consumption | ||
| Cycle time | 30s | 0, 5, 10, 15, 20, 25, 30s selection |
| Initial is 0s | ||
| Size | Size 260170130mm | |
| Image: White device with black control panel | Size:150210210mm | |
| Image: White and purple device with two knobs | ||
| Body area | ||
| specific cuffs | Small Leg Cuff LXW:90X30cm | |
| Large Leg Cuff LXW:110X30cm | ||
| Image: Blue leg cuff | Leg: | |
| Image: Silver leg cuff | ||
| Preprogrammed | ||
| modes | Model A | |
| Image: Diagram of leg cuff model A | Model A | |
| Image: Diagram of leg cuff model A | ||
| Model B | ||
| Image: Diagram of leg cuff model B | Model C | |
| Image: Diagram of leg cuff model C | ||
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6
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:
-
- 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.
-
- 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.
-
- 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.
-
- 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.