(350 days)
Not Found
No
The description focuses on a mechanical pressurization system and does not mention any AI/ML components or capabilities.
Yes
The device is described as treating various medical conditions such as lymphedema and edema, and it is intended to relieve symptoms and prevent aggravation of symptoms by applying air pressure to limbs, which directly impacts the body's physiological functions for therapeutic benefit.
No.
The device description clearly states it is a "pressurization system helping to relieve the symptom of lymphedema and prevent aggravation of symptoms by applying the air pressure to limbs," which indicates a therapeutic rather than a diagnostic function.
No
The device description explicitly states that Lympha-Flow(LF1200) is a "pressurization system" that "comprises of 12-step sleeves" and applies "air pressure to limbs." This indicates the presence of physical hardware components (sleeves, pressurization system) beyond just software. Furthermore, the performance studies include "Biocompatibility testing," "Electrical safety and performance testing," and "EMC testing," which are typically associated with hardware devices. While software verification and validation were performed, this is common for devices containing software, not exclusive to software-only devices.
Based on the provided information, the Lympha-Flow(LF1200) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use describes treating conditions like lymphedema and edema by applying air pressure to limbs. This is a physical therapy or medical device intended for external application to the body.
- Device Description: The description details a pressurization system that applies air pressure to limbs to accelerate fluid circulation. This is a mechanical device, not one that analyzes samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Lympha-Flow(LF1200) does not fit this description.
N/A
Intended Use / Indications for Use
Lympha-Flow(LF1200) 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
Lympha-Flow(LF1200) is the pressurization system helping to relieve the symptom of lymphedema and prevent aggravation of symptoms by applying the air pressure to limbs.
Lympha-Flow(LF1200) comprises of 12-step sleeves and accelerates the circulation of body fluid by evenly distributing the pressure to limbs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
limbs
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
Biocompatibility testing (ISO10993-5, ISO10993-10)
Electrical safety and performance testing were conducted according to standard IEC 60601-1: 2005 + CORR.1(2006) + CORR(2007) and EMC testing were conducted in accordance with standard IEC 60601-1-2:2007.
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).
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected and appear to be emerging from a single form. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 11, 2017
Daesung Maref Co., Ltd % Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway Houston, Texas 77025
Re: K160178
Trade/Device Name: Lympha-Flow(LF1200) Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: December 16, 2016 Received: December 21, 2016
Dear Dave Kim:
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. 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 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 (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Hoffmann -S
for
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160178
Device Name Lympha-Flow(LF1200)
Indications for Use (Describe)
Lympha-Flow(LF1200) 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: December 16, 2016
I. SUBMITTER
| Submitter's Name : | DaeSung Maref Co., Ltd. |
|---|---|
| Submitter's Address: | 298-24, Gongdan-ro, Gunpo-si, Gyeonggi-do |
| Republic of Korea, 15809 | |
| Submitter's Telephone: | +82-31-459-7211 |
| Contact person: | Jae-Wha Lee / President |
| Official Correspondent: | |
| (U.S. Designated agent) | Dave Kim (davekim@mtech-inc.net) |
| Address: | 8310 Buffalo Speedway, Houston, TX 77025 |
| Telephone: | +713-467-2607 |
| Fax: | +713-583-8988 |
| II. DEVICE | |
| Trade/proprietary name: | Lympha-Flow(LF1200) |
| Common or Usual Name: | Intermittent Pneumatic Compression system |
| Regulation Name : | Powered Inflatable Tube Massager |
| Classification: | 21 CFR 890.5650 (Product Code: IRP) |
| Regulatory Class: | II |
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PREDICATE DEVICE III.
| 1) Primary Manufacturer
| Device | : DaeSung Maref Co., Ltd. |
|---|---|
| : LX7 (V7) | |
| 510(k) Number | : K102320 (Decision Date – Mar. 4, 2011) |
This predicate has not been subject to a design-related recall.
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
Lympha-Flow(LF1200) is the pressurization system helping to relieve the symptom of lymphedema and prevent aggravation of symptoms by applying the air pressure to limbs.
Lympha-Flow(LF1200) comprises of 12-step sleeves and accelerates the circulation of body fluid by evenly distributing the pressure to limbs.
| NO | Items | Specification |
|---|---|---|
| 1 | Model | Lympha-Flow(LF1200) |
| 2 | Rating Protection Type | Class II, BF-Type Device |
| 3 | Usable Place | Indoor |
| 4 | Rated Voltage | 100 - 240VAC, 50/60Hz |
| 5 | Power Consumption | 30-50VA |
| 6 | Rated Fuse | T3.15AL / 250V |
| 7 | Setting Pressure | 0~230mmHg (unit:10mmHg) |
| 8 | Setting Time | 5~100 Minutes (unit:5 Min.) |
| 9 | Mode | A, B, C |
| 10 | Dimension | 263(W) * 274(D) * 230(H)mm |
| 11 | weight | 5.2Kg(main system only) |
> Device Specification:
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V. Indications For Use:
Lympha-Flow(LF1200) 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.
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TECHNICAL COMPARISON WITH THE PREDICATE DEVICE VI.
| Model Name | Lympha-Flow(LF1200) | LX7(V7) | Difference |
|---|---|---|---|
| 510(k) Number | K160178 | K102320 | - |
| Classification | Class II Device / IRP (21 CFR 890.5650) | Class II Device / IRP (21 CFR 890.5650) | - |
| Picture | Image: Lympha-Flow(LF1200) | Image: LX7(V7) | - |
| Indications | |||
| For Use | Lympha-Flow(LF1200) 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 | 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, Venous | |||
| insufficiencies, Lymphedema. | - | ||
| Description | Lympha-Flow(LF1200) is a pneumatic pressure treatment | ||
| system that repeats expansion of sleeves to help blood | |||
| circulation and prevent blood clots or clogs. | LX7(V7) is a pneumatic pressure treatment system that | ||
| repeats expansion of sleeves to help blood circulation and | |||
| prevent blood clots or clogs. | - | ||
| Standard | EN ISO 14971 | ||
| EN 60601-1 | |||
| EN 60601-1-2 | EN ISO 14971 | ||
| EN 60601-1 | |||
| EN 60601-1-2 | - | ||
| Contraindications | Acute pulmonary edema Acute thrombophlebitis | ||
| Acute congestive cardiac failure | |||
| Acute infections | |||
| Deep Vein Thrombosis (DVT) Episodes of Pulmonary | |||
| embolism Wounds lesions or tumors at or in the vicinity of | |||
| application | |||
| Where increased venous and lymphatic return is undesirable | |||
| Bone fractures or dislocations at or in the vicinity of | |||
| application | Acute pulmonary edema Acute thrombophlebitis | ||
| Acute congestive cardiac failure | |||
| Acute infections | |||
| Deep vein thrombosis (DVT) Episodes of pulmonary | |||
| embolism Wounds, lesions, or tumors at or in the vicinity | |||
| of application Where increased venous and | |||
| lymphatic return is undesirable Bone fractures or | |||
| dislocation at or in the vicinity of application. | - | ||
| Mode of | |||
| Compression | Sequential | Sequential | - |
| Mode | |||
| description | 3 modes | 3 modes | - |
| Compression | |||
| Applicator | |||
| Garments Sleeve | |||
| Material | Nylon(oxford) | Nylon(oxford) | - |
| Power | |||
| Source | Electricity Supply:AC100-240V, 50/60Hz | ||
| Electricity consumption:30-50VA | Electricity Supply: 230 V~,50/60 Hz | ||
| Electricity consumption: 50 VA | Note 1 | ||
| Pressure range | 0~230mmHg (Air pump pressure range) | ||
| 60~120mmHg (Recommended operating pressure range) | |||
| (unit of pressure increment : 10mmHg) | 0~230mmHg (Air pump pressure range) | ||
| 60~120mmHg (Recommended operating pressure range) | |||
| (unit of pressure increment : 20mmHg) | Note 2 | ||
| Operating Time | 5~100 minutes | 10, 20, 30minutes | Note 3 |
| Number of | |||
| Chamber | 12 chambers | 4 to 8 chambers | Note 4 |
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Note 1 AC100-240V, 50/60Hz : Design was changed to fit to the voltage used in USA.
The performance is verified in accordance with IEC60601-1. The Gap analysis between IEC 60601-1 3rd Ed and ANSI/AAMI 60601-1 3rd Edition is provided separately. The subject device is not affected by the technical variations between IEC 60601-1 and ANSI/AAMI 60601-1 standards in terms of basis safety and essential performance of a medical electrical device.
Note2: The pressure limit for LF1200 is identical to the range for LX7, between 0~230mmHg. The manufacturer recommended pressure range is the same as well, between 60°120mmHg (see page 13 of LX7 Manual). For the user convenience, the pressure setting increment has changed from 20mmHg. There is no additional risk due to the change of the unit of pressure setting increments.
Note3: The operating time for Lympha-Flow (LF1200) is determined and prescribed by a physician. A time setting for LX7, the predicate device, is limited to either 10 min., or 30 min before resetting. . To improve the user convenience, a single operating time for Lympha-Flow (LF1200), the subject device, has been extended to 5~100 minutes with increments of 5 minutes before resetting. Just as LX7, the predicate device, the operating time of Lympha-Flow (LF1200) can be reset for additional treatment time as required by a physician's treatment plan.
Note 4: The sleeves for LF1200 have been redesigned and there are 12 (air) pressure cells in an arm sleeve, leg sleeve and full boy (pants) for Lympha-Flow (LF1200). The design change of the sleeve is to incorporate the customer requirements by increasing the number of chambers to make the air pressure gradient becomes much more segmented and continuous from one chamber to another. A smaller size means that the pressure point of each chamber is more focused to a treatment area. The gap between each chamber becomes smaller and more efficient in terms of overage area for LF1200 compared to LX7 for the same sleeve size. The material, sizes and operating principle remain the subject and predicate device including the recommended pressure range. The full body (pants) sleeve size is same as the LYMPHA Pant sleeve by Mego Afek (K100677). No new risk is introduced by the introduction of 12 pressure cells for each sleeve type
VI. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing (ISO10993-5, ISO10993-10)
Electrical safety and performance testing were conducted according to standard IEC 60601-1: 2005 + CORR.1(2006) + CORR(2007) and EMC testing were conducted in accordance with standard IEC 60601-1-2:2007.
9
Software Verification and Validation Testing
Software verification and validation testing were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "minor" level of concern, since a failure or latent flaw in the software would not directly result in serious injury or death to the patient or operator.
Animal Study
The animal study is not conducted. Overall Performance Conclusions All test results were satisfactory.
VII. CONCLUSIONS
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification DaeSung Maref Co., Ltd. concludes that Lympha-Flow(LF1200) Intermittent Pneumatic Compression system is substantially equivalent in comparison with LX7(V7), the predicate device as described herein.