Airpro-690 is intended for use by medical professionals and patients 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.

Device Description

Air Compression System include the host, sleeves, and the air tube to connect them together. Through a multi-chamber inflatable sleeve orderly conducting of rhythmic squeezing inflation and deflation, it cyclic pressure on limb tissue, so as to promote venous blood return, enhance arterial infusion, improve blood circulation and lymphatic circulation. Two port on the back of the controller, labeling as Channel 1/2. And four air ways on each channel. The two channels can work independently, or simultaneously. The system can identify the channel and type of wearing sleeves automatically. If two channels were connected with sleeves, the system will inflate 1/2 channel simultaneously. Treatment Time, pressure, Channel and Treatment Mode are all can be adjusted on Parameter Settings Interface of the main unit.

AI/ML Overview

This document does not describe a study that uses a test set, ground truth, or expert review for device performance related to a diagnostic or AI-driven system.

Instead, this is a 510(k) Premarket Notification from the FDA for a medical device called the "Air Compression Therapy System, Model: Airpro-690". This submission focuses on demonstrating substantial equivalence to a predicate device (LX7(V7)) through non-clinical testing for product safety and performance, rather than clinical performance based on diagnostic accuracy or AI model output.

Therefore, most of the requested information (acceptance criteria for diagnostic performance, sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, and training set information) is not applicable to this type of regulatory submission.

Here's what can be extracted and inferred based on the provided document:

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

The document lists various non-clinical tests and standards that the device met to demonstrate safety and performance, establishing substantial equivalence to the predicate device. These are not acceptance criteria in the sense of diagnostic accuracy metrics.

Characteristic / Test	Acceptance Criteria (Implied: Compliance with Standard)	Reported Device Performance
Biocompatibility	ISO 10993-1: 2009-10-15	Met (Sleeve material demonstrated biocompatibility safety by passing ISO 10993-5 and ISO 10993-10 tests)
Material (Patient Contact)	ISO 10993-5:2009 (in vitro cytotoxicity)	Passed
	ISO 10993-10:2010 (irritation and skin sensitization)	Passed
Electrical Safety	ANSI AAMI ES60601-1:2005/(R) 2012 and A1:2012	Met (Demonstrated electrical safety)
Electromagnetic Compatibility (EMC)	IEC 60601-1-2:2014	Met
Software Verification & Validation	Company's Design Control process	Met
Basic Unit Characteristics	Design specifications	Met
Output Specifications	Design specifications	Met
Power Source	Safety and effectiveness (evaluated against predicate)	Similar to predicate, but passed ANSI/AAMI ES60601-1: 2005+ A1: 2012 test.
Related Power	Safety and effectiveness (evaluated against predicate)	Similar to predicate, but passed ANSI/AAMI ES60601-1: 2005+ A1: 2012 test.
Pressure Range	Safety and effectiveness (Implied: within acceptable therapeutic range)	0~180mmHg (Smaller than predicate's maximum, but deemed not to raise additional risks)
Operating Time/Therapy Time	Safety and effectiveness (Implied: comparable to predicate)	10, 20, 30 minutes (Similar to predicate's 10~30 minutes)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This document pertains to the regulatory clearance of a physical medical device through substantial equivalence, not the clinical performance evaluation of an AI/diagnostic algorithm using a test set of data. The "tests" mentioned are non-clinical engineering and bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. See point 2.

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

Not Applicable. See point 2.

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-driven diagnostic system involving human readers.

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

Not Applicable. See point 5.

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

Not Applicable. The "ground truth" for this device's clearance is its compliance with recognized safety and performance standards (e.g., ISO, ANSI/AAMI, IEC) and its functional similarity to a legally marketed predicate device.

8. The sample size for the training set

Not Applicable. There is no AI model or "training set" in the context of this device's regulatory submission.

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

Not Applicable. See point 8.

Summary of the document's relevance to the prompt:

The provided document details a 510(k) submission for an Air Compression Therapy System. It focuses on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device by showing it meets the same safety and performance standards through non-clinical testing (electrical safety, EMC, biocompatibility, software verification, and validation, etc.). It does not contain information about studies related to diagnostic accuracy, AI performance, or human reader effectiveness with AI.

Summary

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

June 22, 2020

Shenzhen Lifotronic Technology Co., Ltd. % You Yijie Manager Oimmig Medical Consulting Service Co., Ltd RM. 1711, Building K, NO. 101 Science Ave International Creative Valley Guangzhou, Guangdong, 510663 China

Re: K192466

Trade/Device Name: Air Compression Therapy System, Model: Airpro-690 Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: January 18, 2020 Received: January 22, 2020

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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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

Sincerely,

Amber Ballard, PhD Assistant Director (Acting) THT5B4: Neurodegenerative 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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Indications for Use

510(k) Number (if known) K192466

Device Name

Air Compression Therapy System, Model: Airpro-690

Indications for Use (Describe)

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

1. Submitter's Information

Establishment Reqistration Information

Name: Shenzhen Lifotronic Technology Co., Ltd. Address: Unit A, 4th Floor, Building 15, Yijing Estate, No.1008 Songbai Road, Nanshan District, Shenzhen City, Guangdong Province, 518055, P.R.China

Contact Person of applicant

Name: Xiang Lei Address: Unit A, 4th Floor, Building 15, Yijing Estate, No.1008 Songbai Road, Nanshan District, Shenzhen City, Guangdong Province, 518055, P.R.China TEL: +86 755-29060026 FAX: +86 755-29060036 Email: ray.xiang@lifotronic.com

Contact Person of the Submission:

Name: You Yijie 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 to prepare: 8/13/2019

2. Device Information

Type of 510(K) submission: Traditional Trade Name: Air Compression Therapy System Model: Airpro-690 Common name: Compression Therapy Device Classification Name: massager, powered inflatable tube. Regulation Description: Powered inflatable tube massager. Review panel: Physical Medicine Product code: IRP Regulation Class: II Requlation Number: 21 CFR 890.5650

3. Predicate Device Information

510(k) submitter/holder: DAESING MAREF CO LTD 510(K) Number: K102320 Device: Compressible Limb Therapy System Trade name: LX7(V7) Classification Name: massager, powered inflatable tube. Regulation Description: Powered inflatable tube massager.

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Review panel: Physical Medicine Product code: IRP Requlation Class: II Regulation Number: 21 CFR 890.5650

4. Device description

5. Principle of operation:

The Air Compression Therapy System, model Airpro-690 is a pneumatic compression device and designed to apply pneumatic compression to limbs to treat conditions. It works by inflating and deflating the sleeve sequentially to develop the circulating pressure on the limbs and organization. Squeezing the proximal and distal of the limbs to promote the flow of the blood and lymphatic system, and improve the microcirculation. The System consists of the main unit, the Tubing Sets and sleeves.

6. Indications for Use

7. Summary of technological characteristics of device compared to the predicate devices (K102320)

Characteristic	Subject devicePresent application(Air CompressionTherapy System, modelAirpro-690)	Predicate device(K102320, CompressibleLimb Therapy System,Model LX7(V7))	Discussion of difference
Classification	21 CFR 890.5650	21 CFR 890.5650	Same
Product Code	IRP	IRP	Same
FDA Class	2	2	Same
Intended Use	Airpro-690 is intended foruse by medicalprofessionals and patientsat home, who are undermedical supervision, intreating many conditions,such as Primarylymphedema, Edemafollowing trauma and sportinjuries, Postimmobilization edema.	LX7(V7) is intended foruse by medicalprofessionals and patientsat home, who are undermedical supervision, intreating many conditions,such as Primarylymphedema, Edemafollowing trauma and sportinjuries, Postimmobilization edema.	Same
	Venous insufficiencies,Lymphedema.	Venous insufficiencies,Lymphedema.
Principle of operation	intermittent pneumaticcompression device	intermittent pneumaticcompression device	Same
target population	adults	adults	Same
anatomical site	Leg	Leg	Same
Material of Patient contactcomponents	Sleeve:Nylon	Sleeve:Nylon	SameSleeve was demonstratedbiocompability safety bypassing ISO 10993-5 andISO 10993-10 tests. Thedifference does not raisethe issue of product's safetyand effectiveness.
where used	home	home	Same
Design	Desk type	Desk type	Same
Power Source	a.c. 120V, 60Hz	Electricity Supply: 230V~,50/60 HzElectricity consumption:50 VA	SimilarThe proposed device wasdemonstrated electricalsafety by passing ANSI/AAMI ES60601-1: 2005+A1: 2012 test. Thedifference in power sourcedoes not raise any questionin regards to safety andeffectiveness.
ANSI AAMI ES60601-1	Yes	Yes	Same
IEC 60601-1-2	Yes	Yes	Same
Weight	3.5 Kg	2Kg(main system only)	DifferentThe Weight will not affectthe safety and effectivenessof the proposed device
Dimensions(W x H x D)	235mm(L)x185mm(W)×190mm(H)	260(W) * 160(D) *120(H)mm	DifferentThe dimensions will notaffect the safety andeffectiveness of theproposed device
Number of Chamber	4chambers, 8chambers	4chambers, 8chambers	Same
Related power	55VA	50VA	SimilarThe proposed device wasdemonstrated electricalsafety by passing ANSI/AAMI ES60601-1: 2005+A1: 2012 test. Thedifference in power doesnot raise any question inregards to safety andeffectiveness.
Mode of Compression	Sequential	Sequential	Same
Mode description	3 modes	3 modes	Same
Pressure range	0~180mmHg	0~230mmHg (Air pumppressure range)	SimilarThe pressure range forproposed device is smaller
		60~120mmHg(Recommended operatingpressure range)(unit of pressureincrement : 20mmHg)	Additional risks notconcerns for safety andeffectiveness.
Operating Time/TherapyTime	10, 20, 30minutes	10~30minutes	Similar
Compression Cycle Time	30min	30min	Same

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8. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Non-clinical verification testing of the Air Compression Therapy System, model: Airpro-690 included electrical, mechanical, and software tests to show the device meets its design specifications. Validation and performance testing validates that the device meets its user needs. Verification and validation test results established that the device meets its intended use, that it is as safe, as effective, and performs as well as the predicate devices, and that no new issues of safety and effectiveness were raised. The Air Compression Therapy System, model: Airpro-690 was designed, verified, and validated according to the company's Design Control process and has been subjected to extensive safety and performance testing as shown in the test results provided in this submission. Verification and Validation testing data demonstrate that the device meets all of its specifications including compliance with the following standards:

ISO 10993-1: 2009-10-15 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process [Including: Technical Corrigendum 1 (2010)]

ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

ISO 10993-10:2010 Biological evaluation of medical devices. Tests for irritation and skin sensitization

ANSI AAMI ES60601-1:2005/(R) 2012 and A1:2012 Medical electrical equipment. General requirements for basic safety and essential performance

IEC 60601-1-2:2014 Medical electrical equipment - part 1-2: general requirements for safety collateral standard: electromagnetic compatibility - requirements and tests

9. Conclusions

The electrical safety. EMC. biocompatibility, software verification, and validation, basic unit characteristics, and output specifications information provided is sufficient to demonstrate substantial equivalence to the predicate device. As the Air Compression Therapy System, model: Airpro-690 is nearly identical to the predicate device, differences in their characteristics do not raise any raise new questions regarding safety and effectiveness with identical indications for use and essentially identical technological characteristics, the Air Compression Therapy System, model: Airpro-690 is substantially equivalent to the predicate device Compressible Limb Therapy System, Model LX7(V7).

Regulation Number and Section

§ 890.5650 Powered inflatable tube massager.

(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).