(265 days)
Not Found
No
The description mentions a microprocessor and software controlling timing and pressure based on a sensor, which is typical for automated medical devices but does not indicate the use of AI or ML. There are no mentions of AI, DNN, ML, or any training/test sets which would be expected for an AI/ML device.
Yes
The device is indicated for treating medical conditions like primary lymphedema, post-immobilization edema, venous insufficiencies, and lymphedema, which are all therapeutic uses.
No
The device description indicates it is a therapy system that provides compression massages, and the intended use describes treating conditions such as lymphedema. There is no mention of it being used to diagnose conditions.
No
The device description explicitly states the system consists of an air pump, leg sleeves, and hoses, which are hardware components. 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:
- Intended Use: The intended use describes the device as being used for treating various conditions like edema and venous insufficiencies through compression therapy. This is a therapeutic application, not a diagnostic one.
- Device Description: The device description details a system for applying external compression to limbs using air pressure. This mechanism is for physical therapy and treatment, not for analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
In summary, the device's function and intended use clearly fall under the category of a therapeutic medical device, not an in vitro diagnostic device.
No
Explanation: The letter does not mention any information related to a "Predetermined Change Control Plan (PCCP)" or an "authorized device." PCCP is a relatively new program, and typical clearance letters like this one, especially for predicate devices, do not contain such information unless specifically authorized as a PCCP device.
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 lymph edema following trauma and sport injuries, Post immobilization edema, Venous insufficiencies, Lymph edema.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 19, 2019
Xiamen Senyang Co., Ltd. % Raymond Luo Technical Manager Shanghai SUNGO Management Consulting Co., Ltd. 13th F, 1500# Century Avenue Shanghai, 200122 Cn
Re: K181409
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: December 19, 2018 Received: December 21, 2018
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.
1
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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vivek J. Pinto -S
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) K181409
Device Name Pressure Therapy System PT1003
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 lymph edema following trauma and sport injuries, Post immobilization edema, Venous insufficiencies, Lymph edema.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ 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 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 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:
K161907 Pressure Therapy System PT1002 produced by XIAMEN SENYANG CO., LTD.
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.
| Name | Pt 1003 |
|---|---|
| Pressure (mmHg) | 0~250 mmHg |
| Mode | Mode A and Mode B selection and the initial is A |
| Interval | 50s |
F. Technical Characteristic:
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| Time(min) | Time 0-30, selection (10, 20, 30min) |
|---|---|
| Pressure Time | Pressure, 20-250mmHg, Mode A/B, 0-30Min |
G. Substantial Equivalence Table:
| Device | Subject Device | Predicate Device |
|---|---|---|
| Manufacturer | XIAMEN SENYANG CO., LTD. | XIAMEN SENYANG CO., LTD. |
| Model Name | Pt 1003 | Pt 1002 |
| Classification | Class II Device, IRP (21 CFR890.5650) | Class II Device, IRP (21 CFR890.5650) |
| Intend 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 1003 is a pneumatic pressure treatment system that repeats expansion of sleeves to help blood circulation and prevent blood clots or clogs. | Pt 1002 is a pneumatic pressure treatment system that repeats expansion of sleeves to help blood circulation and prevent blood clots or clogs. |
| Standard | AAMI ANSI ES | |
| 60601-1:2005/(R)2012 and A1:2012 | ||
| IEC 60601-1-2 | ||
| ISO10993-5& ISO10993-10 | AAMI ANSI ES | |
| 60601-1:2005/(R)2012 and A1:2012 | ||
| IEC 60601-1-2 | ||
| ISO10993-5& ISO10993-10 | ||
| Indications | Primary lymphedema, edema following trauma and sport injures, Postimmobilization edema, Venous insufficiencies, Lymphedema. | Primary lymphedema, edema following trauma and sport injures, Postimmobilization edema, Venous insufficiencies, Lymphedema. |
| Mode of | ||
| Compression | Sequential | Sequential |
| Power Source | 110 V, 60Hz | 110 V, 60Hz |
| Therapy Time | 0-30Min | 0-30Min |
| Max Pressure | 0-250mm Hg | 0-250mm Hg |
| Min Pressure | 0-250mm Hg | 0-250mm Hg |
| Number of | ||
| Chambers | 4 Chambers for each unit | 4 Chambers for each unit |
| Compression | ||
| Applicator | ||
| Garments Sleeve | ||
| Material | Thermoplastic Urethane | Thermoplastic Urethane |
| Power | 30W | 30W |
| consumption | ||
| Cycle time | 30s | 30s |
| Size | Size 260170130mm | |
| Image: White device with buttons and screen | Size: 260170130mm | |
| Image: White device with buttons | ||
| Body area | ||
| specific cuffs | Small Leg Cuff LXW:90X30cm | |
| Large Leg Cuff LXW:110X30cm | ||
| Image: Blue leg cuff | Small Leg Cuff LXW:90X30cm | |
| Large Leg Cuff LXW:110X30cm | ||
| Image: Blue leg cuff | ||
| Preprogrammed | ||
| modes | Model A | |
| Image: Model A leg compression | Model A | |
| Image: Model A leg compression | ||
| Model B | ||
| Image: Model B leg compression | Model B | |
| Image: Model B leg compression | ||
| Item | Subject Device | Predicate Device |
| Size | 260170130mm | 260170130mm |
| Appearance | Image: Subject Device | Image: Predicate Device |
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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. Also the Leg cuff material which may contact with the user is same as the predicate device. There are some factors are different.
- Appearance of the product was changed, which has not brought any new risk or concerns.
The difference of the appearance did not change any safety and performance of the device, which is just updated to meet the customer's expectation.
2) PCB of the product has been changed.
The actual change of the PCB may be found in the form below.
| Item | Predicate Device | Subject Device |
|---|---|---|
| PCB | ||
| Front | ||
| Side | ||
| Layout | Image: PCB Front Side Layout Predicate Device | Image: PCB Front Side Layout Subject Device |
| PCB | ||
| Back | ||
| Side | ||
| Layout | Image: PCB Back Side Layout Predicate Device | Image: PCB Back Side Layout Subject Device |
| Main | ||
| Micro | ||
| Processor | Type: EM78F668N | |
| Pack: 44pin-QFP | Type: BS66F350 | |
| Pack: 44 LQFP-A | ||
| Touch | ||
| Micro | ||
| Processor | Type: BS83B12A-3 | |
| Pack: 20 SOP-A | No use | |
| Touch key | Sponge | Spring |
Regarding the safety aspect, the microprocessor of subject device, EM78F668N has the same work temperature
7
and the fire-protection rating as the microprocessor of the predicate device. Regarding the performance aspect, through appropriate software, the subject device has the same air flow rate, pressure and time setting with the predicate device.
According to the analysis above, we find the difference between the subject device and the predicate device will not affect the safety or performance of the subject device.
H. Performance characteristic
The Pt1003 pressure therapy system has been tested and met the requirements of 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 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.
l. Conclusion
The Pt1003 Pressure Therapy System has substantially equivalent intended use as the cleared Pt1002 Pressure Therapy System and has substantially equivalent technological and performance characteristics. 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.