(287 days)
Not Found
No
The description focuses on mechanical compression and automatic sleeve identification, with no mention of AI/ML terms or functionalities beyond basic automation.
Yes
The device is intended for treating various medical conditions such as lymphedema and venous insufficiencies, and it promotes physiological changes like improved blood and lymphatic circulation.
No
Explanation: The device description states its function is to provide "rhythmic squeezing inflation and deflation" to "promote venous blood return, enhance arterial infusion, improve blood circulation and lymphatic circulation." This describes a therapeutic, not a diagnostic, action.
No
The device description explicitly mentions hardware components such as the "host, sleeves, and the air tube" and describes their physical interaction and function. The performance studies also include "electrical, mechanical, and software tests," indicating the presence of hardware that was tested.
Based on the provided information, the Airpro-690 device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for treating conditions like lymphedema and edema by applying external pressure to the limbs. This is a physical therapy or medical device function, not a diagnostic test performed on samples taken from the body (in vitro).
- Device Description: The description details a system of a host, sleeves, and air tubes that apply rhythmic squeezing pressure. This mechanism is entirely external and mechanical, not involving the analysis of biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device interacts directly with the patient's limb externally.
- No Mention of Diagnostic Testing: The entire description focuses on therapeutic treatment through compression, not on diagnosing a condition.
Therefore, the Airpro-690 is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
IRP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Leg
Indicated Patient Age Range
adults
Intended User / Care Setting
medical professionals and patients 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)
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
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).
0
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
1
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
2
Indications for Use
510(k) Number (if known) K192466
Device Name
Air Compression Therapy System, Model: Airpro-690
Indications for Use (Describe)
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.
| 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
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.
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
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.
7. Summary of technological characteristics of device compared to the predicate devices (K102320)
| Characteristic | Subject device
Present application
(Air Compression
Therapy System, model
Airpro-690) | Predicate device
(K102320, Compressible
Limb 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 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. | LX7(V7) 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. | Same |
| | Venous insufficiencies,
Lymphedema. | Venous insufficiencies,
Lymphedema. | |
| Principle of operation | intermittent pneumatic
compression device | intermittent pneumatic
compression device | Same |
| target population | adults | adults | Same |
| anatomical site | Leg | Leg | Same |
| Material of Patient contact
components | Sleeve:
Nylon | Sleeve:
Nylon | Same
Sleeve was demonstrated
biocompability safety by
passing ISO 10993-5 and
ISO 10993-10 tests. The
difference does not raise
the issue of product's safety
and effectiveness. |
| where used | home | home | Same |
| Design | Desk type | Desk type | Same |
| Power Source | a.c. 120V, 60Hz | Electricity Supply: 230
V~,50/60 Hz
Electricity consumption:
50 VA | Similar
The proposed device was
demonstrated electrical
safety by passing ANSI/
AAMI ES60601-1: 2005+
A1: 2012 test. The
difference in power source
does not raise any question
in regards to safety and
effectiveness. |
| ANSI AAMI ES60601-1 | Yes | Yes | Same |
| IEC 60601-1-2 | Yes | Yes | Same |
| Weight | 3.5 Kg | 2Kg(main system only) | Different
The Weight will not affect
the safety and effectiveness
of the proposed device |
| Dimensions
(W x H x D) | 235mm(L)x185mm(W)×
190mm(H) | 260(W) * 160(D) *
120(H)mm | Different
The dimensions will not
affect the safety and
effectiveness of the
proposed device |
| Number of Chamber | 4chambers, 8chambers | 4chambers, 8chambers | Same |
| Related power | 55VA | 50VA | Similar
The proposed device was
demonstrated electrical
safety by passing ANSI/
AAMI ES60601-1: 2005+
A1: 2012 test. The
difference in power does
not raise any question in
regards to safety and
effectiveness. |
| Mode of Compression | Sequential | Sequential | Same |
| Mode description | 3 modes | 3 modes | Same |
| Pressure range | 0180mmHg | 0230mmHg (Air pump
pressure range) | Similar
The pressure range for
proposed device is smaller |
| | | 60120mmHg30minutes | Similar |
(Recommended operating
pressure range)
(unit of pressure
increment : 20mmHg) | Additional risks not
concerns for safety and
effectiveness. |
| Operating Time/Therapy
Time | 10, 20, 30minutes | 10
| Compression Cycle Time | 30min | 30min | Same |
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6
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).