(187 days)
The Air Compression Therapy Device is indicated for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in good health. The Air Compression Therapy Device simulates kneading and stroking of tissues by using an inflatable garment.
Air Compression Therapy Device consists of an air pump, air pressure sensor, and sleeves working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses; each sleeve has 3 compression chambers. The compression massage direction is from foot to thigh. 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. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the sleeves to compress body.
This document is a 510(k) premarket notification for an "Air Compression Therapy Device," which is a powered inflatable tube massager. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices, focusing on non-clinical testing. This document does NOT describe a study involving an AI/Machine Learning device or a multi-reader multi-case (MRMC) comparative effectiveness study.
Therefore, I cannot provide a response that directly addresses the prompt's request for information on acceptance criteria and study proving an AI device's performance, including details like:
- Sample size for the test set and data provenance: The document mentions "non-clinical tests" and "safety and performance tests" but does not detail a test set of patient data.
- Number of experts and qualifications for ground truth: Not applicable for non-clinical device testing.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Explicitly stated "No clinical test data was used to support the decision of substantial equivalence."
- Standalone (algorithm-only) performance: Not applicable.
- Type of ground truth used: Not applicable for non-clinical testing.
- Sample size for the training set: Not applicable as there is no AI/ML component.
- How ground truth for the training set was established: Not applicable.
However, I can extract the acceptance criteria and performance related to the mechanical and electrical safety and manufacturing aspects of this non-AI medical device based on the provided text.
Acceptance Criteria and Device Performance for Shenzhen Dongjilian Electronics Co., Ltd.'s Air Compression Therapy Device (K193354)
The provided submission primarily relies on non-clinical testing to demonstrate substantial equivalence to predicate devices, focusing on safety, performance, and adherence to recognized standards. It does not present clinical study data or involve AI/Machine Learning technologies for diagnostic or prognostic purposes, nor does it involve human readers or ground truth established by expert consensus on clinical cases.
The "acceptance criteria" in this context refer to the device conforming to safety and performance standards for its type.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Standard Designation) | Reported Device Performance (Outcome for Device) |
|---|---|---|
| Safety | ES 60601-1:2005+A1:2012 | Conforms |
| EMC (Electromagnetic Compatibility) | IEC 60601-1-2:2014 | Conforms |
| Home healthcare environment | IEC 60601-1-11:2015 | Conforms |
| Performance | Enterprise standard | Conforms |
| Biocompatibility | ISO 10993-10:2010 (Irritation and Skin Sensitization); ISO 10993-5:2009 (Cytotoxicity) | Conforms |
| Software | IEC 62304:2006/A1:2016 | Conforms |
| Usability | IEC 60601-1-6:2010+A1:2013; IEC 62366-1:2015 | Conforms |
| Risk management | ISO 14971:2007 | Conforms |
| Product service life | (Implicitly tested to meet requirements, no specific standard listed) | Met requirements |
| Function test | (Implicitly tested to meet requirements, no specific standard listed) | Met requirements |
| Pressure accuracy | $\pm$ 25mmHg (for output pressure range 0-240mmHg) | Conforms (implied by "All the test results demonstrate Air Compression Therapy Device meets the requirements of its pre-defined acceptance criteria") |
| Noise level | $\le$ 65dB | Conforms (implied) |
| Safety Features | Standby button allows user to stop therapy session at any time | Present and functional (implied by "Same" in comparison table) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "sample size" in terms of patient data or clinical cases because no clinical testing was performed. The tests conducted were non-clinical, focusing on the device's physical, electrical, software, and material properties. The data provenance is implied to be from Shenzhen Dongjilian Electronics Co., Ltd.'s internal testing, as it's part of their 510(k) submission. No information on country of origin of patient data (retrospective or prospective) is applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. Ground truth, in the context of this submission, refers to the device's conformance to recognized engineering and safety standards, not clinical diagnostic accuracy based on expert consensus.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication was used.
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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence." Therefore, there is no information on human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical air compression therapy device, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" used for this device's acceptance is its conformance to established international and national consensus standards for medical device safety, electromagnetic compatibility, usability, software, biocompatibility, and risk management, along with internal enterprise standards for performance. This is not a clinical ground truth (e.g., pathology, outcomes data, or expert consensus on patient cases).
8. The Sample Size for the Training Set
Not applicable. This device does not involve an AI/ML model that requires a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no AI/ML model or training set.
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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 seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.
June 8, 2020
Shenzhen Dongjilian Electronics Co., Ltd. % Reanny Wang General Manager Shenzhen Reanny Medical Devices Management Consulting Co., Ltd. Room 2012#, Gebu commercial building, Hongxing community, Songgang street Shenzhen, 518105 Cn
Re: K193354
Trade/Device Name: Air Compression Therapy Device Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: May 28, 2020 Received: June 8, 2020
Dear Reanny Wang:
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 (OS) 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.
Vivek Pinto, PhD Director 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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Indications for Use
510(k) Number (if known) K193354
Device Name Air Compression Therapy Device
Indications for Use (Describe)
The Air Compression Therapy Device is indicated for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in good health. The Air Compression Therapy Device simulates kneading and stroking of tissues by using an inflatable garment.
Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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Traditional 510(k) Summary
K193354
1. Information of Submitter and Correspondent
Submitter's information:
| Company Name: | Shenzhen Dongjilian Electronics Co.,Ltd. |
|---|---|
| Street Address: | B1/1-5F, Tonglu Industrial Area, 70# Tongxin Road, Tongxin Community, Longgang District |
| City: | Shenzhen |
| State/ Province: | Guangdong |
| Country: | China |
| Telephone: | +86(755) 89964118 |
| Fax: | +86(755) 89964008 |
| Contact Person: | ZHANG HONG |
| Contact Title: | General Manager |
| Contact Email: | zh@dongjilian.com |
Date Prepared: May 27, 2020
Submission correspondent's information:
Shenzhen Reanny Medical Devices Management Consulting Co., Ltd
- Address: Room 2012#, Gebu commercial building, Hongxing community, Songgang street, Baoan district, Shenzhen 518000, China
Contact Person: Reanny Wang
E-mail: reanny@reanny.com
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Image /page/4/Picture/0 description: The image shows the word "CINCON" in a stylized, bold font. The letters are primarily white with a black outline, giving them a three-dimensional appearance. The "O" in "CINCON" has a red fill, adding a touch of color to the otherwise monochrome design. A registered trademark symbol is present to the right of the word.
Phone: +86(755) 27391220
2. Device Information
| Trade Name: | Air Compression Therapy Device |
|---|---|
| Model: | S9019 |
| Common Name: | Powered Inflatable Tube Massager |
| Classification Name: | Massager, Powered Inflatable Tube |
| Regulation: | 21 CFR § 890.5650 |
| Device Class: | Class 2 |
| Product Code: | IRP |
3. Identification of Predicate Device(s)
| Manufacturer | Rapid Reboot RecoveryProducts, LLC | Salton,INC | NormaTecIndustries, LP |
|---|---|---|---|
| Legally MarketedDevice | Rapid RebootCompression TherapySystem | Relaxor PerfectTouch Air MassagingSystem | NormaTec Pulse andNormaTec Pulse Pro |
| 510(K) Number | K182668 | K030437 | K160608 |
4. Description of Device
Air Compression Therapy Device consists of an air pump, air pressure sensor, and sleeves working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses; each sleeve has 3 compression chambers. The compression massage direction is from foot to thigh. 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. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the sleeves to compress body.
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Image /page/5/Picture/0 description: The image shows the Cincom logo. The logo is in black and white, with a red square in the middle of the "O". The logo is a stylized version of the word "CINCOM". There is a registered trademark symbol to the right of the logo.
Indications for Use 5.
The Air Compression Therapy Device is indicated for the temporary relief of minor 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 simulates kneading and stroking of tissues by using an inflatable garment.
6. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
6.1 Non-clinical testing
A series of safety and performance tests were conducted on the subject device.
- Product service life
- Software validation
- Electromagnetic compatibility and electrical safety
- Function test
All the test results demonstrate Air Compression Therapy Device meets the requirements of its pre-defined acceptance criteria and intended use, and it is substantially equivalent to the predicate devices.
6.2 Clinical Testing
No clinical test data was used to support the decision of substantial equivalence.
7. Performance Summary
The devices conform to applicable standards as follow table:
| Test Type | Standard DesignationNumber | FDA RecognitionStatus | Outcomefor Device |
|---|---|---|---|
| Safety | ES 60601-1:2005+A1:2012 | Yes | Conforms |
| EMC | IEC 60601-1-2:2014 | Yes | Conforms |
| Home healthcare environment | IEC 60601-1-11:2015 | Yes | Conforms |
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Image /page/6/Picture/0 description: The image shows the word "CINCOM" in a stylized font. The letters are outlined in white with a black fill, except for the letter "O", which has a red fill. A registered trademark symbol is located to the right of the word.
| Performance | Enterprise standard | Yes | Conforms |
|---|---|---|---|
| Biocompatibility | ISO 10993-10:2010;ISO 10993-5:2009 | Yes | Conforms |
| Software | IEC 62304:2006/A1:2016 | Yes | Conforms |
| Usability | IEC 60601-1-6:2010+A1:2013IEC 62366-1:2015 | Yes | Conforms |
| Risk management | ISO 14971:2007 | Yes | Conforms |
8. Discussion of Comparison to Predicate Devices.
The Air Compression Therapy Device submitted in this 510(k) submission is substantially equivalent in intended use, technological characteristics/ principles of operation, materials, and performance to the cleared Rapid Reboot Compression Therapy System K182668, Relaxor Perfect Touch Air Massaging System K030437, and NormaTec Pulse and NormaTec Pulse Pro K160608. Differences between the subject and predicate devices do not raise new questions of safety and effectiveness.
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Image /page/7/Picture/0 description: The image contains the word "CINCOM" in a stylized, bold font. The letter "O" in "CINCOM" has a red square in the middle. There is a horizontal line below the word, and a registered trademark symbol is located to the right of the word.
| Device | Subject device | Primary Predicate device | Secondary Predicate device | Third Predicate device | Comparison |
|---|---|---|---|---|---|
| Manufacturer | Shenzhen Dongjilian Electronics Co.,Ltd. | Rapid Reboot Recovery Products, LLC | Salton, Inc | NormaTec Industries, LP | NA |
| 510(K) number | K193354 | K182668 | K030437 | K160608 | NA |
| Model name | S9019 | Rapid Reboot Compression Therapy System | Relaxor Perfect Touch Air Massaging System | NormaTec Pulse and NormaTec Pulse Pro | NA |
| Classification | Class II Device, IRP (21 CFR890.5650) | Class II Device, IRP (21 CFR890.5650) | Class II Device, IRP (21 CFR890.5650) | Class II Device, IRP (21 CFR890.5650) | Same |
| Indications for Use (IFU) | The Air Compression Therapy Device is indicated for the temporary relief of minor 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 simulates kneading and stroking of tissues by using an inflatable garment. | The Rapid Reboot Compression Therapy System is indicated for the temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated areas in people who are in good health. The Rapid Reboot Compression Therapy System simulates kneading and stroking of tissues by using an inflatable garment. | The Perfect Touch Air Massaging System is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Perfect Touch simulates kneading and stroking of tissues by using an inflatable garment. | The NormaTec Pulse and Pulse Pro is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. | Same |
| Treatment area/Structure of Sleeves | Low limbs (Foot, calf and upper leg) | Leg (including of foot, calf, knee, upper leg);Hip (including of upper legs, glutes, hips, lower back);Arm (including of entire arm, shoulder, upper chest and back) | Leg (including of foot, calf);Back (including of lower and mid back);Arm (including of forearm, lower bicep) | Leg (including of foot, calf, knee, upper leg);Hip (including of upper legs, glutes, hips, lower back);Arm (including of entire arm, shoulder | Same |
| Device | Subject device | Primary Predicatedevice | Secondary Predicatedevice | Third Predicatedevice | Comparison |
| OTC or Rx | OTC | OTC | OTC | OTC(upper chest andback). | Same |
| Environment ofUse: | Clinics, hospital,athlete training, andhome environments | Clinics, hospital, athletetraining, and homeenvironments | Home environment | Clinics, hospital,athletetraining, and homeenvironments | Same |
| Power source | 100~240V 50/60Hz | 110V, 60HZ | 120V, 60Hz | 100- 240 VAC input | Same |
| PowerConsumption | 12W | 30W | 26W | 14W | SimilarNote 3 |
| SW/Firmware/Microprocessor Control | Microprocessor | Microprocessor | Microprocessor | Microprocessor | Same |
| Therapy Time | 20 minutes | User determinestherapy time. Choosefrom 10, 20, or 30minute session time,with option to addadditional 10 minutes toany therapy time. | 15 minutes | User controlled 10minutes to 175minutes or continuous- totaltime over 4segments | SimilarNote 1 |
| Outputpressure range | 0~240 mmHg | 0~200 mmHg | 80 to 250 mmHg | 30-110 mmHg | SimilarNote 2 |
| Air pressurelevel/Compressionlevels | 3 levels settings:low level:150mmHg;Mid level:185mmHg;High Level: 215mmHg | Not publicly available | Not publicly available | Not publicly available | Not publicly available |
| Pressure errorrange | $\pm$ 25mmHg | Not publicly available | Not publicly available | Unknown | Not publicly available |
| Inflation time | 3-30s | Not publicly available | Not publicly available | Not publicly available | Similar |
| Keep time | 1-5s | Not publicly available | Not publicly available | Not publicly available | Note 11 |
| Deflation time | 1-5s | Not publicly available | Not publicly available | Not publicly available | Same |
| Mode types | Sequential/ Peristaltic | Sequential/ Peristaltic | Sequential/ Peristaltic | Sequential/ Peristaltic | Same |
| Cycle time | Range of 25 sec to 3 | Not publicly available | Not publicly available | Not publicly available | Similar |
| Device | Subject device | Primary Predicatedevice | Secondary Predicatedevice | Third Predicatedevice | Comparison |
| min 40 sec | Note 4 | ||||
| Number ofchambers | 3 Chambers | 4 Chambers | 12 Chambers | 4 Chambers | SimilarNote 7 |
| Number oftreatmentmode | 3 modes | 2 modes | 1 mode | 2 modes | SimilarNote 6 |
| Modes (visualdescription) | Mode 1:Starting with the footchamber andprogressing up the thighchamber, each sectioncompresses and thepressure gradually risesto the pre-determinedair pressure level, thendecompresses and theair pressure drops.Once the thigh sectiondecompresses, thecycle begins again.Mode 1 follows thispressure sequence:Image: Mode 1 pressure sequenceMode 2:Starting with the footchamber andprogressing up thethigh, each section | Mode A:Starting with the distalchamber andprogressing up theproximal chamber, eachsection compresses andthe pressure graduallyrises to the pre-determined air pressurelevel, thendecompresses and theair pressure drops. Oncethe top sectiondecompresses, the cyclebegins again.Mode A follows thispressure sequence:Image: Mode A pressure sequenceMode B:Starting with the distal | Starting with the distalchamber andprogressing up theproximal chamber,each sectioncompresses and thepressure graduallyrises to the pre-determined airpressure level, thendecompresses and theair pressure drops.Operating until the topsection decompresses,the cycle begins again.Only has one mode. Followsthis sequence:Image: Secondary Predicate device pressure sequence | Sequential mode:Starting with the distalchamber andprogressing up theproximal chamber, eachsection compressesand the pressuregradually rises to thepre-determined airpressure level, thendecompresses and theair pressure drops.Once the top sectiondecompresses, thecycle begins again.Again."Sequential:"Image: Sequential mode pressure sequenceNormatec Pulse | Same |
| Device | Subject device | Primary Predicate device | Secondary Predicate device | Third Predicate device | Comparison |
| compresses and thepressure gradually risesto the pre-determinedair pressure level, holdsthe air until the entiregarment is compressed.All three sections thendecompresssimultaneously and theair pressure drops, thencycle begins again.Mode 2 follows thispressure sequence:Image: Mode 2 pressure sequence | chamber andprogressing up theproximal chamber, eachsection compresses andthe pressure graduallyrises to the pre-determined air pressurelevel, holds the air untilthe entire boot iscompressed. All foursections thendecompresssimultaneously and theair pressure drops, thencycle begins again.Mode B follows thispressure sequence:Image: Mode B pressure sequence | mode:Starting with the distalzone and progressingup the proximal zone,one zone compressesand the pressuregradually rises to thepre-determined airpressure level, holdsthe air of previoustwo zone , the otherzones do not hold, untilthe last zone finished,deflate the all last threezone then enter intonext cycle."Pulse Massage Pattern:"Image: Pulse Massage Pattern | |||
| Mode 3:include two stage, stage1: it work according tothe method of mode 1,after the stage 1 iscompleted, it go tostage 2(workingaccording to the methodof mode 2) withoutinterruption time untilfinish the stage 2, thenenter next cycle withoutinterruption .Mode1 Mode2The pressure sequence | |||||
| Device | Subject device | Primary Predicatedevice | Secondary Predicatedevice | Third Predicatedevice | Comparison |
| of mode 3 combinesmode 1 and mode 2 | |||||
| Noise level | ≤ 65dB | Not publicly available | Not publicly available | Not publicly available | SimilarNote 9 |
| SleeveMaterial | Nylon with aPolyurethane laminate | Nylon with aPolyurethane laminate | Nylon with aPolyurethanelaminate | Nylon with apolyurethanelaminate | Same |
| HousingMaterials | Molded ABS enclosure | Molded ABS enclosure | Molded ABSenclosure | Molded ABSenclosure | Same |
| Patient contact | Non-conductiveattachments | Non-conductiveattachments | Non-conductiveattachments | Non-conductiveattachments | Same |
| Size andappearance | $10.2 \times 5.9 \times 25.6$(in )Image: Subject device | 10" x 6.5" x 5"Image: Primary Predicate device | 9" x 6" x 6"Image: Secondary Predicate device | 4" x 5" x 9"Image: Third Predicate device | DifferentNote 5 |
| Weight | 4.6 pounds | 5.8 pounds | 3.2 pounds | 3.6 pounds | |
| Size andappearance ofsleeves (legpart) | Leg:Image: Subject device sleeves | Leg:Image: Primary Predicate device sleeves | Leg:One size: 10" x 22"Image: Secondary Predicate device sleeves | Leg:Short: 14" x 43"Standard: 14" x 48"Tall: 14" x 60"Image: Third Predicate device sleeves | SimilarNote 8 |
| Device | Subject device | Primary Predicatedevice | Secondary Predicatedevice | Third Predicatedevice | Comparison |
| One size: 73*26cm | X-Short: 14" x 41"Short: 14" x 43"Medium: 14" x 45"Long: 14" x 48"X-Long: 14" x 52" | ||||
| SafetyFeatures | Standby button allowsuser to stop therapysession at any time | Button on display allowsuser to stop or pausetherapy session at anytime. | Button on displayallows user to stop orpause therapysession at any time | Button on displayallows user to stop orpause therapysession at any time. | Same |
| Operatingenvironment | Temperature: 5°C-40°C, Humidity:5%-90% non-condensing | Not publicly available | Not publicly available | Not publicly available | SimilarNote 10 |
| Transportation&Storageenvironment | Temperature:20°C~55°C;Humidity:5%-90% non-condensingAtmosphericPressure:75kPa-106kPa | Not publicly available | Not publicly available | Not publicly available | |
| Standards | ES 60601-1;IEC60601-1-2;ISO 10993-5;ISO 10993-10;IEC 60601-1-11 | IEC 60601-1;IEC60601-1-2; ISO10993-5: ISO 10993-10 | Not available | IEC 60601-1;IEC 60601-1-2;ISO 10993-5;ISO 10993-10;IEC 60601-1-11 | Same |
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Similarity and Difference
The Air Compression Therapy Device S9019 has been compared with Rapid Reboot Compression Therapy System (K182668), Relaxor Perfect Touch Air Massaging System (K030437) and NormaTec Pulse and NormaTec Pulse Pro (K160608). The subject device has same intended use and principle of operation, similar technological characteristics as that of predicate devices. Although there are several specifications that are different between the subject device and predicate devices, the comparison analysis has been completed to demonstrate that the differences between these parameters would not adversely impact the safety and effectiveness of the subject device. The subject device has undergone safety and performance tests, and the results complied with the test requests. Therefore, the difference between the subject device and the predicate devices do not raise any problem of substantial equivalence. The subject devices is substantially equivalent to the predicate devices in safety and performance claims.
Note 1: Although the treatment time of subject device is different the predicate device, but the treatment time of subject device was within the range of predicated device, so the small differences do not affect the safety and effectiveness.
Note 2: Although the "Output pressure range" of the subject device is different from that of the predicate devices, but the minimum air pressure (0mmHg) of subject device is the same as the predicate device 1, the maximum air pressure of subject device (240mmHg) is within the output pressure range of the predicate device 2 (80 to 250 mmHg), in general, the output pressure range of subject device is within the range of those predicate devices. Additionally, the subject device was conforms to ANSI/AAMI ES60601-1 and ISO 14971, so the small differences do not affect the safety and effectiveness. Although the "air pressure level /compression levels" of subject device is different to the predicate devices, but they output air pressure range are similar, so the pressure level different do not affect the safety and effectiveness. Although we don't know the pressure error of predicated device, but due to their "output pressure range" are similar, so this item does not affect the safety and effectiveness.
Note 3: Although the "power consumption" of the subject device is different than the predicate devices, they both use a power adaptor and the adaptor both comply with ANSI/AAMI ES60601-1, so the difference does not affect the safety and effectiveness.
Note 4: Although the "Cycle time" of subject device is different the predicate devices, but the range of cycle time was between the predicate 3 (maximum value) and predicate device 2 (minimum value), so the small difference do not affect the safety and effectiveness.
Note 5: Although the "Size and appearance" and "Weight" between the predicate devices and subject device are different, they are both complied with ANSI/AAMI ES60601-1 and IEC 60601-1-2, so the differences do not affect the safety and effectiveness.
Note 6: Although the "Number of treatment mode" is different the predicate device, the "Indications for Use", "Principles of operations" and "Modes (visual description)" are same, so these differences do not affect the safety and effectiveness.
Note 7: Although the "Number of chambers" of subject device is different to the predicated device,
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but due to the chamber number only determines the applicable treatment site, while the "applicable treatment site" and "Indications for Use" of subject device is within the range of predicated device, so the differences do not affect the safety and effectiveness.
Note 8: The "Size and appearance of sleeves (leq part)" of subject device is different the predicate device, because their chamber and applicable treatment site is different. Based the analysis as the NOTE 7, we know: although the "Size and appearance of sleeves (leq part)" between the predicate devices and subject device is different, but the "applicable treatment site" and "Indications for Use" of subject device is within the range of predicated device, so the differences do not affect the safety and effectiveness.
Note 9: Although the "Noise level" of predicate devices are unknown, but there are both had passed the ANSI/AAMI ES60601-1 and ISO 14971 standards, so the difference do not affect safety or effectiveness issue.
Note 10: Although the "Operating environment" and "Transportation & Storage environment" of subject devices are different to the predicate devices, but they are both compliance with the ANSI/AAMI ES60601-1 and IEC 60601-1-11 standards, so the small difference will not affect the safety or effectiveness issue.
Note 11: Although the predicate device does not disclosure the inflation time, it is not possible to directly determine the substantially equivalent between the subject device and predicate device. For the safety: the subject device has compliance with IEC 60601-1 and ISO 14971 standards. And the subject device has designed the pressure sensor to protection the overpressure, so the subject device was safety. For the effectiveness: since the treatment mode, treatment pressure and cycle time of the subject device is similar to the predicate devices, so we can be considered that the subject device and predicate device had similar effectiveness. Based on the above analysis, can be considered the small difference will not affect the safety or effectiveness issue.
9. Conclusions
The subject device has same intended use, principle of operation, and technological characteristics as the predicate devices. Although there are several specifications that are different between these devices, testing and discussion been completed to demonstrate that the differences between these parameters would not adversely impact the safety and effectiveness of the subject device has undergone safety and performance tests, and the results conformed with the test requests. Therefore, the differences between the subject device and the predicate devices do not raise any concerns with respect to substantial equivalence. The subject device is substantially equivalent to the predicate devices and the differences in technological characteristics do not raise different questions of safety and effectiveness based on the testing submitted to support this submission.
§ 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).