(122 days)
The Air Compression Therapy Device(model: ST-502) is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in good health. The Air Compression Therapy Device (model: ST-502) simulates kneading and stroking of tissues by using an inflatable garment.
Air Compression Therapy Device, model: ST-502 is a powered inflatable tube massager. The Air Compression Therapy Device, model: ST-502 is consists of an air pump, air pressure sensor, leg sleeves and adapter. The air pump, air pressure sensor and control components are protectively housed in a plastic case of the control unit. The control unit is connected to the dedicated leg sleeves via a series of hoses; each leg sleeve has 3 compression chambers. The Air Compression Therapy Device, model: ST-502 utilizes the pneumatically controlled leg sleeves actuated by an electronically controlled air pump unit.
The "Power" button, "Intensity" button, "Mode" button and LED indicators/displays provide for user interface. There is also a port for connecting the AC adapter plug.
The leg sleeves consist of air pipes and three airbags encased inside a soft medical fabric for increased patient comfort and biocompatibility compliance.
In operation, the user simply turns the power on via the "Power" button. And the user presses the "Intensity" button, "Mode" button to adjust the pressure intensity and working mode of the device as the needs of users.
The compression massage direction is from foot room and push up the thighs. 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 leg sleeves work under the action of sensor and microprocessor. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the sleeves to compress body.
During in the working condition, once the leg sleeves pressure of the airbags reach the proper level(240mmHg), the device is turned off, and the leg sleeves deflates to the ambient pressure through a valve inside the plastic case.
The provided text, a 510(k) Premarket Notification from the FDA, describes an "Air Compression Therapy Device, model: ST-502". This document focuses on demonstrating substantial equivalence to a legally marketed predicate device (K193354).
It does not contain information related to acceptance criteria and a study proving a device meets acceptance criteria in the context of an AI/ML-driven medical device. The device described is a physical medical device (a powered inflatable tube massager) and the evaluation is for substantial equivalence to a predicate, not performance against specific AI/ML metrics.
Therefore, I cannot provide the requested information about acceptance criteria and a study report as it pertains to an AI/ML device per your prompt, because the provided input does not describe such a device or study.
If the prompt was intended to ask about the non-AI/ML device described in the document, here's what can be inferred about its "acceptance criteria" and "proof" based on the provided FDA submission:
Interpretation for the provided Non-AI/ML Device (Air Compression Therapy Device):
For this type of device, "acceptance criteria" would primarily revolve around demonstrating performance and safety characteristics similar to the predicate device, as well as adherence to recognized consensus standards. The "study that proves the device meets the acceptance criteria" would be the collection of non-clinical tests and comparisons performed.
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a formal table of "acceptance criteria" and "reported device performance" in the way an AI/ML study would specify metrics and results. Instead, it demonstrates substantial equivalence by comparing technical characteristics and compliance with standards. The "acceptance" is implied by demonstrating equivalence to a legally marketed device and meeting safety and performance standards.
Here's an inferred table based on the comparisons made:
| Characteristic/Criterion (Inferred) | Subject Device (Air Compression Therapy Device, model: ST-502) Result | Predicate Device (Model: S9019) | Comparison/Conclusion |
|---|---|---|---|
| Indications for Use | Temporary relief of minor muscle aches and pains and for temporary increase in circulation to treated areas in good health, simulating kneading and stroking with inflatable garment. | Same | Equivalent |
| Regulation Number | 21 CFR 890.5650 | 21 CFR 890.5650 | Same |
| Product Code | IRP | IRP | Same |
| Regulatory Class | Class II | Class II | Same |
| Over-The-Counter Use | Yes | Yes | Same |
| Treatment Area | Low limbs (Foot, calf and upper leg) | Low limbs (Foot, calf and upper leg) | Same |
| Environment of Use | Clinics, hospital, athlete training, and home | Same | Same |
| Patient Population | Adult | Adult | Same |
| Power Consumption | 12W | 12W | Same |
| Therapy Time | 20 mins | 20 minutes | Same |
| Output Pressure Range | 0-240 mmHg | 0-240 mmHg | Same |
| Air Pressure Levels | 3 levels (low: 150mmHg, medium: 185mmHg, high: 215mmHg) | 3 levels (low: 150mmHg, mid: 185mmHg, high: 215mmHg) | Same |
| Pressure Error Range | ± 25mmHg | ± 25mmHg | Same |
| Inflation/Keep/Deflation Time | 3-30s / 1-5s / 1-5s | 3-30s / 1-5s / 1-5s | Same |
| Mode Types | Sequential/Peristaltic | Sequential/Peristaltic | Same |
| Number of Chambers | 3 Chambers | 3 Chambers | Same |
| Number of Treatment Modes | 3 modes (M1, M2, M3 described) | 3 modes (Mode 1, Mode 2, Mode 3 described) | Same (descriptions are identical) |
| Noise Level | ≤ 65dB | ≤ 65dB | Same |
| Electrical Safety Standard | ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:20091(R)2012, A2:2010(R)2012 | ES 60601-1 | Compliant (Stated as same or compliant to equivalent/updated standards) |
| EMC Standard | IEC 60601-1-2 Edition 4.0 2014 | IEC60601-1-2 | Compliant (Stated as same or compliant to equivalent/updated standards) |
| Biocompatibility (Cytotoxicity) | ISO 10993-5 (positive results) | Implied, but material noted as different | Subject device validated, difference does not raise new safety questions. Meets standard. |
| Biocompatibility (Irritation/Sensitization) | ISO 10993-10 (positive results) | Implied, but material noted as different | Subject device validated, difference does not raise new safety questions. Meets standard. |
| Home Healthcare Standard | ANSI AAMI HA 60601-1-11:2015 | IEC 60601-1-11 | Compliant (Stated as same or compliant to equivalent/updated standards) |
| Software Verification | IEC 62304 Edition 1.1 2015 | Not explicitly listed for predicate, but implied by regulatory requirements. | Compliant with IEC 62304 and FDA guidance for software. |
| Sleeve Material | Polyester, Nylon (Velcro) | Nylon with Polyurethane laminate | Different, but biocompatibility tested and found acceptable (D1). |
| Size and Appearance (main unit) | L215W65H51mm | 10.2x5.9×25.6 inches (different units, but functionally similar) | Different dimensions, but compliance with electrical safety and EMC standards ensures safety/effectiveness not impacted (D2). |
| Weight | ~1400g-1600g | 4.6 pounds (~2087g) | Different weight, but compliance with electrical safety and EMC standards ensures safety/effectiveness not impacted (D3). |
| Safety Features | "Power" button stops therapy | "Standby" button stops therapy | Similar functionality (D5). |
| Operating Environment Humidity | 15%-93% | 5%-90% | Similar, and compliance with ANSI/AAMI ES60601-1-11 ensures acceptability (D6). |
2. Sample size used for the test set and the data provenance:
- This is not applicable in the context of an AI/ML test set.
- For this physical device, the "test set" would implicitly refer to the physical units subjected to the non-clinical tests (e.g., electrical safety, EMC, biocompatibility). The document does not specify the number of units tested, which is typical for such submissions where testing is generally done on representative samples.
- Data provenance is not specified, but these are typically lab-based non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable for this device as it's not an AI/ML device requiring expert ground truth for classification/detection.
- The "truth" for this device is based on objective measurements against engineering and safety standards (e.g., measuring pressure output, electrical leakage, electromagnetic emissions, and biological reactions in lab tests).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as there is no human-in-the-loop assessment or subjective interpretation being adjudicated. The tests are objective measurements against specified standard limits.
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 a physical therapy device, not an AI/ML diagnostic or assistive tool. No human reader studies were conducted or are relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-only device. The core functionality is mechanical (pneumatic compression).
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For this device, the "ground truth" for its safety and performance is established through compliance with recognized consensus standards (e.g., IEC 60601-1 for electrical safety, ISO 10993 for biocompatibility) and direct physical/mechanical measurements (e.g., pressure output, timing accuracy, noise level). There is no "pathology" or "outcomes data" ground truth in the sense of a medical diagnostic AI.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device and therefore does not have a "training set" in that context.
9. How the ground truth for the training set was established:
- Not applicable. As there's no training set for an AI/ML model.
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Image /page/0/Picture/0 description: The image contains 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 31, 2022
Shenzhen Future Electronic Co., Ltd % You Yijie Manager Qimmiq Medical Consulting Service Co., Ltd. RM.1711, Building K NO.101 Science Ave International Creative Valley Guangzhou, Guangdong 510663 China
Re: K213745
Trade/Device Name: Air Compression Therapy Device, model: ST-502 Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: February 2, 2022 Received: February 2, 2022
Dear You Yijie:
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.
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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/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.
Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality 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)
Device Name
Air Compression Therapy Device, model: ST-502
Indications for Use (Describe)
The Air Compression Therapy Device(model: ST-502) is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in good health. The Air Compression Therapy Device (model: ST-502) simulates kneading and stroking of tissues by using an inflatable garment.
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 — K213745
1. Submitter's Information
Establishment Registration Information
Name: SHENZHEN FUTURE ELECTRONIC CO., LTD. Address: Bldg B. Qiangchengda Industrial Park, No. 30, Youtian Road, Longgang SHENZHEN Guangdong, CN 518116
Contact Person of applicant
Name: Zhang Benrong Address: Room 301-302, No.15 HanchengRoad, Qingdao Free Trade Zone, Shandong, China, 266555 TEL: +86-13410947296 Email: zhaoqihong@futuresz.com.cn
Contact Person of the Submission:
Name: Yijie You Address: RM.1711, Building K, NO.101 Science Ave International Creative Valley Development Zone, Guangzhou China TEL: +86 020-8224 5821 FAX: +86 020-8224 5821 Email: Jet.you@qimmiq-med.com
Date prepared: Nov. 15, 2021
2. Device Information
| Trade Name: | Air Compression Therapy Device |
|---|---|
| Model: | ST-502 |
| Classification name: | Massager, Powered Inflatable Tube |
| Review panel: | Physical Medicine |
| Product code: | IRP |
| Regulation Class: | II |
| Regulation Number: | 21CFR890.5650 |
3. Predicate Device Information
Predicate device:
510(k) submitter/holder: Shenzhen Dongjilian Electronics Co., Ltd.
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| 510(K) Number: | K193354 |
|---|---|
| Trade Name: | Air Compression Therapy Device |
| Model: | S9019 |
| Classification name: | Massager, Powered Inflatable Tube |
| Review panel: | Physical Medicine |
| Product code: | IRP |
| Regulation Class: | II |
| Regulation Number: | 21CFR890.5650 |
4. Device description
Air Compression Therapy Device, model: ST-502 is a powered inflatable tube massager. The Air Compression Therapy Device, model: ST-502 is consists of an air pump, air pressure sensor, leg sleeves and adapter. The air pump, air pressure sensor and control components are protectively housed in a plastic case of the control unit. The control unit is connected to the dedicated leg sleeves via a series of hoses; each leg sleeve has 3 compression chambers. The Air Compression Therapy Device, model: ST-502 utilizes the pneumatically controlled leg sleeves actuated by an electronically controlled air pump unit.
The "Power" button, "Intensity" button, "Mode" button and LED indicators/displays provide for user interface. There is also a port for connecting the AC adapter plug.
The leg sleeves consist of air pipes and three airbags encased inside a soft medical fabric for increased patient comfort and biocompatibility compliance.
In operation, the user simply turns the power on via the "Power" button. And the user presses the "Intensity" button, "Mode" button to adjust the pressure intensity and working mode of the device as the needs of users.
The compression massage direction is from foot room and push up the thighs. 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 leg sleeves work under the action of sensor and microprocessor. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the sleeves to compress body.
During in the working condition, once the leg sleeves pressure of the airbags reach the proper level(240mmHg), the device is turned off, and the leg sleeves deflates to the ambient pressure through a valve inside the plastic case.
Environment of use of the device: Clinics, hospital, athlete training, and home environments
Principle of operation:
The control unit is connected to the leg sleeves via hose. The control unit contains an air pump, pressing "Power" button to begin normal treatment status, the air pump will pump air into leg sleeves with stetted rhythm though air pipe, the sleeve fits on the low limbs and provide therapy.
5. Indications for Use
The Air Compression Therapy Device (model: ST-502) is indicated for the temporary relief of minor
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muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Air Compression Therapy Device (model: ST-502) simulates kneading and stroking of tissues by using an inflatable garment.
6. Summary of technological characteristics of device compared to the
| SEComparisons | Subject device(Air Compression TherapyDevice,model: ST-502) | Primary predicate device(Shenzhen DongjilianElectronics Co.,Ltd.Air Compression Therapy Device,Model: S9019) | Discussion ofdifference | |
|---|---|---|---|---|
| 510K Number | K213745 | K193354 | / | |
| Classification | 21 CFR890.5650 | 21 CFR890.5650 | Same | |
| Product Code | IRP | IRP | Same | |
| FDA Class | II | II | Same | |
| Indications for Use | The Air Compression TherapyDevice (model: ST-502) is indicatedfor the temporary relief of minormuscle aches and pains and fortemporary increase in circulation tothe treated areas in people who arein good health. The AirCompression Therapy Device(model: ST-502) simulates kneadingand stroking of tissues by using aninflatable garment. | The Air Compression TherapyDevice is indicated for thetemporary relief of minor muscleaches and pains and fortemporary increase in circulation tothe treated areas in people who arein good health. The AirCompression TherapyDevice simulates kneading andstroking of tissues by using aninflatable garment. | Same | |
| Over-The-CounterUse | Yes | Yes | Same | |
| Model | ST-502 | S9019 | / | |
| Treatmentarea/Structure ofSleeves | Low limbs (Foot, calf and upper leg) | Low limbs (Foot, calf and upper leg) | Same | |
| Environment of Use | Clinics, hospital, athlete training,and home environments | Clinics, hospital, athlete training,and home environments | Same | |
| Patient Population | Adult | Adult | Same | |
| Power source | 100-240V, 50-60Hz | 100-240V 50/60Hz | Same | |
| Power Consumption | 12w | 12W | Same | |
| SW/Firmware/MicroprocessorControl | Microprocessor | Microprocessor | Same | |
| Therapy Time | 20 mins | 20 minutes | Same | |
| Output pressurerange | 0~240 mmHg | 0~240 mmHg | Same | |
| Air pressure Level/Compression levels | 3 levels settings:low level:150mmHg;Medium level:185mmHg;High Level: 215mmHg | 3 levels settings:low level:150mmHg;Mid level:185mmHg;High Level: 215mmHg | Same | |
| Pressure errorrange | $\pm$ 25mmHg | $\pm$ 25mmHg | Same | |
| Inflation time | 3-30s | 3-30s | Same | |
| Keep time | 1-5s | 1-5s | Same | |
| Deflation time | 1-5s | 1-5s | Same | |
| Mode types | Sequential/ Peristaltic | Sequential/ Peristaltic | Same | |
| Cycle time | 25 seconds to 3 minutes and 40seconds | Range of 25 sec to 3 min 40 sec | Same | |
| Number ofchambers | 3 Chambers | 3 Chambers | Same | |
| Number oftreatment mode | 3 modes | 3 modes | Same | |
| Modes (visualdescription) | M1:Start in the foot room and pushup the thighs, the pressuregradually rises to apredetermined pressure levelwith each compression, thendepressurizes and the pressuredrops. Once the thighs aredecompressed, the circulationbegins again.Pattern 1 follow this stresssequence:Image: Pattern 1 stress sequenceM2:Starting in the foot chamber,push up the thighs, and witheach compression, the pressuregradually rises to apredetermined air pressure level,holding the air until the entiregarment is compressed. All threeparts decompress | Mode 1:Starting with the foot chamber andprogressing up the thigh chamber,each section compresses and thepressure gradually rises to the pre-determined air pressure level, thendecompresses and the air pressuredrops.Once the thigh sectiondecompresses, the cycle beginsagain.Mode 1 follows this pressuresequence:Image: Mode 1 pressure sequenceMode 2:Starting with the foot chamber andprogressing up the thigh, eachsection compresses and thepressure gradually rises to the pre-determined air pressure level, holdsthe air until the entire garment iscompressed. All three sections then | Same | |
| simultaneously, air pressuredrops, and the circulation beginsagain.Pattern 2 follow this pressuresequence:Image: Pressure sequence diagram | decompress simultaneously and theair pressure drops, then cycle beginsagain.Mode 2 follows this pressuresequenceImage: Pressure sequence diagram | |||
| M3: It consists of two phase.Phase 1: It works as a pattern 1method, and after phase 1 iscompleted, it continues to phase 2(working as a pattern 2 method)until phase 2 is completed, andthen continues to the next cyclewithout interruption.The pressure sequence of mode 3is combined with mode 1 and mode2. | Mode 3:include two stage, stage 1: it worksaccording to the method of mode 1,after the stage 1 is completed, it goto stage 2(working according to themethod of mode 2) withoutinterruption time until finish the stage2, then enter next cycle withoutinterruption .Mode1 $\rightleftharpoons$ Mode2The pressure sequence of mode 3combines mode 1 and mode 2. | |||
| Noise level | $\leq$ 65db | $\leq$ 65dB | Same | |
| Sleeve Material | Material of memory cloth: 100%polyestermaterial Velcro(loops):nylon70%, polyester 30%Velcro (hooks): 100% nylon | Nylon with a Polyurethane laminate | Different(Discussion isindicated in D1) | |
| Housing Materials | Molded ABS enclosure | Molded ABS enclosure | Same | |
| Patient contact | Non-conductive attachments | Non-conductive attachments | Same | |
| Size andappearance | L215W65H51mm | 10.2x5.9×25.6(in ) | Different(Discussion isindicated in D2) | |
| Weight | 1400g (approximately:3.08 pounds)(machine+right/left wrap)1600g (approximately:3.52 pounds)(main unit+ leg sleeves +adapter)Image: white device | 4.6 poundsImage: black device | Different(Discussion isindicated in D3) | |
| Size andappearance ofsleeves (leg part) | Leg: One size: L720*W270mmImage: leg sleeve | Leg: One size : 73*26cmImage: leg sleeves | Similar(Discussion isindicated in D4) | |
| Safety Features | The “Power” button allows user tostop therapy session at any time | Standby button allows user to stoptherapy session at any time | Similar(Discussion isindicated in D5) | |
| Operatingenvironment | Temperature: 5°C~40°CHumidity:15%-93%, non-condensingAtmospheric pressure: 70kPa-106kPa | Temperature: 5°C-40°C,Humidity:5%-90% no-condensing | Similar(Discussion isindicated in D6) | |
| Transportation &Storageenvironment | Temperature:-20°C~55°CHumidity:5%-90%, non-condensingAtmospheric pressure: 75kPa-106kPa | Temperature: -20°C~55°C;Humidity:5%-90% noncondensingAtmospheric Pressure:75kPa-106kPa | Same | |
| Standards | ANSI AAMI ES60601-1:20051/(R)2012 and A1:2012, | ES 60601-1;IEC60601-1-2;ISO 10993-5: | Same | |
| C1:20091(R)2012A2:2010(R)2012IEC 60601-1-2 Edition 4.0 2014;ANSI AAMI HA 60601-1-11:2015ISO 10993-5 Third edition 2009-06-01:ISO 10993-10 Third Edition 2010-08-01; | and | ISO 10993-10;IEC 60601-1-11 |
predicate devices (K193354)
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The discussion of differences exist between the subject and predicate devices is listed in following:
- D1: The subject device has been validated for cytotoxicity per ISO 10993- 5 and Irritation as well as Sensitization per ISO 10993-10 with positive results, the material difference of subject device with predicate device S9019 (K193354) do not raise new questions of safety and effectiveness.
- D2: The dimensions between subject device and predicate device S9019 (K193354) are the difference, but the subject device and predicate device S9019 (K193354) are both complied with ANSI/AAMI ES60601-1 and IEC 60601-1-2. so the differences do not affect the safety and effectiveness so the difference will not affect the safety and effectiveness.
- D3: The weight of subject device is difference with predicate device S9019 (K193354) but the subject device and predicate device S9019 (K193354) are both complied with ANSI/AAMI ES60601-1 and IEC 60601-1-2, so the difference will not affect the safety and effectiveness.
- D4: The size of sleeves (leg part)" of subject device is similar with the predicate device S9019 (K193354). The treatment effect of the Air Compression Therapy Device depends on the treatment pressure, treatment time, chamber number and treatment site, and the subject device and predicate device S9019 (K193354) are the same with treatment pressure, treatment time, chamber number and treatment site. So the difference will not affect the safety and effectiveness.
- D5: Just the name of button is difference, the subject device can be stopped therapy session at any time through the "Power" button by user. This difference betweet subject device predicate device S9019 (K193354) will not affect the safety and effectiveness.
- D6: Humidity of transportation & storage of subject device is similar with predicate device S9019 (K193354). But the subject device and predicate device S9019 (K193354) are both complied with ANSI/AAMI ES60601-1-11, so the differences do not affect the safety and effectiveness so the difference will not affect the safety and effectiveness.
7. Discussion of Non-Clinical Tests Performed for Safety and
effectiveness are as follows
The recognized consensus standards for safety of medical electrical equipment: ANSI AAMI ES60601-1, ANSI AAMI HA 60601-1-11 for safety, IEC 60601-1-2 for electromagnetic compatibility, ISO 10993-5 and ISO 10993-10 for biological compatibility and IEC 62304 for software verification are complied. See below table for details:10993-1
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| Standards | Standards Name |
|---|---|
| ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 | Medical Electrical Equipment - Part 1: General RequirementsFor Basic Safety And Essential Performance |
| IEC 60601-1-2 Edition 4.02014 | Medical Electrical Equipment -- Part 1-2: General RequirementsFor Basic Safety And Essential Performance -- CollateralStandard: Electromagnetic Disturbances -- Requirements AndTests |
| ANSI AAMI HA 60601-1-11:2015 | Medical Electrical Equipment - Part 1-2: General Requirementsfor Basic Safety And Essential Performance - CollateralStandard: Electromagnetic Disturbances - Requirements AndTests |
| ISO 10993-5 Third edition2009-06-01 | Biological evaluation of medical devices - Part 5: Tests for invitro cytotoxicity |
| ISO 10993-10 Third Edition2010-08-01 | Biological evaluation of medical devices - Part 10: Tests forirritation and skin sensitization |
| ISO 10993-1 Fifth edition2018-08 | Biological evaluation of medical devices - Part 1: Evaluation andtesting within a risk management process |
| IEC 62304 Edition 1.1 2015-06 CONSOLIDATEDVERSION | Medical device software - Software life cycle processes |
Software verification and validation was performed for the subject device in accordance with Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices -Guidance for Industry and FDA Staff, May 2005.
8. Discussion of Clinical Accuracy Testing Performed
There was no clinical testing performed.
9. Conclusions
Based on performance testing, comparison and analysis, the subject device Air Compression Therapy Device, model ST-502 is substantially equivalent to the predicate devices.
§ 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).