(608 days)
Not Found
No
The description focuses on mechanical compression and does not mention any AI/ML components or capabilities.
Yes
The device is intended for treating various medical conditions like lymphedema and venous insufficiencies, and its description states it "improve the blood circulation of patients."
No
The device is described as a system to improve blood circulation and treat conditions like lymphedema and edema, which are therapeutic rather than diagnostic purposes.
No
The device description explicitly states it is a "system" combined with "leg and foot garments" and a "controller" that operates "air chambers." This indicates the device includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for treating conditions like lymphedema and edema by improving blood circulation through external compression. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a system that applies sequential compression to the limbs using air chambers. This is a physical therapy or medical device, not a device used to examine specimens from the human body for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information based on laboratory results.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (on the body) for therapeutic treatment.
N/A
Intended Use / Indications for Use
UAM-8100, UAM-8100N 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, Postimmobilization edema, Venous insufficiencies, Lymphedema.
Product codes
IRP
Device Description
UAM-8100, UAM-8100N is a system to improve the blood circulation of patients and User can use it personally under their doctor's indication and guidance. UAM-8100, UAM-8100N is combined with leg and foot garments. The leg garment has four air chambers operated by a controller. The leg garment is compressed sequentially in order of foot, calf, and thigh, and then fresh air is injected inside the leg garment through holes
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Leg and foot
Indicated Patient Age Range
Not Found
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
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
Biocompatibility: Testing was conducted in accordance with AAMI / ANSI / ISO 10993-5:2009/(R) 2014, Biological Evaluation of Medical Devices-- Part 5: Tests for In Vitro Cytotoxicity (1.929 Assay) and AAMI / ANSI / ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization. (Vaginal Irritation and Guinea Pig Maximization Sensitization)
Electrical Safety: Testing was conducted in accordance with AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) and IEC 60601-1-11:2015 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance -Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Electromagnetic Compatibility: Testing was conducted in accordance with IEC 60601-1-2:2007 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests
Software: Software verification and validation testing as recommended in FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005)
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). 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.
May 30, 2019
Maxstar Industrial Co., Ltd % Chris Park General Manager Med.com 1809 Holland Dr Somerset, New Jersey 08873
Re: K173158
Trade/Device Name: Air Relax/ Compressible Limb Sleeve System Model No. UAM-8100. UAM-8100N Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: April 19, 2019 Received: April 30, 2019
Dear Chris Park:
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
1
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 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,
Vivek Pinto, PhD Assistant Director. Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation 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) K173158
Device Name
Air Relax/ Compressible Limb Sleeve System Model No. UAM-8100, UAM-8100N
Indications for Use (Describe)
UAM-8100, UAM-8100N 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, Postimmobilization edema, Venous insufficiencies, Lymphedema.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date 510k summary prepared: Sep,26, 2017
I. SUBMITTER
| Submitter's Name | Maxstar Industrial Co Ltd |
|---|---|
| Submitter's Address | 152-12,Hwanggeum-ro,23 beon-gil,Yangchon- |
| eup,Gimpo-si, Gyeonggi-do,Korea | |
| Submitter's Telephone | +82 31 989 3543 |
| Contact person | Kevin Jung (speed1@maxstar.co.kr) / Sales Manager |
| Official Correspondent | J-R Kimt |
| Address | 1809 holland dr, somerset, NJ, 08873, USA |
| meddatcom@gmail.com |
II. DEVICE
Air Relax/ Compressible Limb Sleeve System Trade/proprietary Name Model No. UAM-8100, UAM-8100N Common or Usual Name Powered Inflatable Tube Massager Classification Name Massager, Powered Inflatable Tube Regulation Number 21 CFR 884.5160 Product Code IRP (21 CFR 890.5650) Regulatory Class Class II
III. PREDICATE DEVICE
| Primary Manufacturer | Maxstar Industrial Co Ltd |
|---|---|
| Device Name | Compressible Limb Sleeve System |
| 510(k) Number | K130385 |
| Regulation Name | Massager, Powered Inflatable Tube |
| Regulation Number | 21 CFR 884.5160 |
| Regulatory Class | Class II |
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IV. DEVICE DESCRIPTION
UAM-8100, UAM-8100N is a system to improve the blood circulation of patients and User can use it personally under their doctor's indication and guidance. UAM-8100, UAM-8100N is combined with leg and foot garments. The leg garment has four air chambers operated by a controller. The leg garment is compressed sequentially in order of foot, calf, and thigh, and then fresh air is injected inside the leg garment through holes
V. INDICATIONS FOR USE:
UAM-8100, UAM-8100N 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, Postimmobilization edema, Venous insufficiencies, Lymphedema.
VI. PREDICATE COMPARISON
Identification of predicate device
Predicate Device
- 510(k) number: K130385
- Name: Compressible limb Sleeve System
- Model: UAM-8100
- Company: MAXSTAR CO LTD
- Classification: 2
MAXSTAR Co., Ltd. believes that Compressible Limb Sleeve System Model: UAM-8100, UAM-8100N) is substantially equivalent in intended use, principles of operation, and technological characteristics to the predicate devices presented above and few differences between previous model as
-
- Software version
- Change of inflation and deflation timing due to software version change 2.
-
- Add the Trade name "Air Relax"
- Additional accessory (XXL size Garments Sleeve) 4.
- Additional model: New type of model UAM-8100N: Color (Navy) 5.
But do not raise new types of safety or effectiveness issues, as further discussed below.
VII. SUMMARY OF NON-CLINICAL TESTS
5
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
Biocompatibility:
Testing was conducted in accordance with AAMI / ANSI / ISO 10993-5:2009/(R) 2014, Biological Evaluation of Medical Devices-- Part 5: Tests for In Vitro Cytotoxicity (1.929 Assay) and AAMI / ANSI / ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization. (Vaginal Irritation and Guinea Pig Maximization Sensitization)
Electrical Safety:
Testing was conducted in accordance with AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) and IEC 60601-1-11:2015 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance -Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Electromagnetic Compatibility:
Testing was conducted in accordance with IEC 60601-1-2:2007 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests
Software:
Software verification and validation testing as recommended in FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005)
VIII. Product Comparison Summary
The proposed device and the predicate device have the similar intended use, mechanism of action, principle of operation, algorithm, and cuff. The proposed device is different than the predicate device in that the proposed device has different inflation and deflation times, there is a different product color for UAM-8100N, a new compression garment size has been added, a product brand name has been added, the product label K130385 has been updated, and software has been modified. The results of the software verification testing demonstrated that the differences between the proposed device and the predicate device do not raise questions regarding its safety and effectiveness.
IX. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device