Lympha-Flow(LF1200)

K160178 · Daesung Maref Co., Ltd. · IRP · Jan 11, 2017 · Physical Medicine

Device Facts

• Record ID: K160178
• Device Name: Lympha-Flow(LF1200)
• Applicant: Daesung Maref Co., Ltd.
• Product Code: IRP · Physical Medicine
• Decision Date: Jan 11, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Lympha-Flow(LF1200) is an intermittent pneumatic compression system; uses air pump to inflate 12-chamber sleeves; applies sequential pressure to limbs to accelerate body fluid circulation; prevents blood clots/clogs. Used in clinics or homes under medical supervision. Physician prescribes treatment parameters (pressure 60-120mmHg, time 5-100 minutes). Device consists of main system unit and inflatable sleeves (arm, leg, pants). Patient/operator connects sleeves to unit; selects mode (A, B, C) and settings. Output is mechanical compression; helps relieve lymphedema symptoms and prevents aggravation. Benefits include improved fluid drainage and symptom management.

Clinical Evidence

Bench testing only. No clinical data provided. Performance supported by biocompatibility testing (ISO 10993-5, ISO 10993-10), electrical safety (IEC 60601-1), and EMC testing (IEC 60601-1-2).

Technological Characteristics

Pneumatic compression system; 12-chamber nylon (oxford) sleeves. Power: 100-240VAC, 50/60Hz. Pressure range: 0-230mmHg (operating 60-120mmHg). Dimensions: 263x274x230mm; weight 5.2kg. Class II, BF-Type device. Standards: EN ISO 14971, EN 60601-1, EN 60601-1-2.

Indications for Use

Indicated for patients with primary lymphedema, edema following trauma/sports injuries, post-immobilization edema, venous insufficiencies, and lymphedema. Contraindicated for acute pulmonary edema, acute thrombophlebitis, acute congestive cardiac failure, acute infections, DVT, pulmonary embolism, wounds/lesions/tumors at application site, conditions where increased venous/lymphatic return is undesirable, and bone fractures/dislocations at application site.

Regulatory Classification

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.

Predicate Devices

• LX7 (V7) (K102320)

Reference Devices

• LYMPHA Pant sleeve by Mego Afek (K100677)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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) | |
|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| <span style="font-size:100%;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:100%;">☐</span> 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<br>Republic of Korea, 15809 |
| Submitter's Telephone: | [phone] |
| Contact person: | Jae-Wha Lee / President |
| Official Correspondent:<br>(U.S. Designated agent) | Dave Kim ([e-mail]) |
| Address: | 8310 Buffalo Speedway, Houston, TX 77025 |
| Telephone: | [phone] |
| Fax: | [phone] |
| 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<br>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<br>For Use | Lympha-Flow(LF1200) is intended for use by medical<br>professionals and patients at home, who are under<br>medical supervision, in treating many conditions, such<br>as : Primary lymphedema, Edema following trauma and<br>sport injuries, Post immobilization edema,<br>Venous<br>insufficiencies, Lymphedema | LX7(V7) is intended for use by medical professionals<br>and patients at home, who are under medical<br>supervision, in treating many conditions, such as<br>Primary lymphedema, Edema following trauma and<br>sport injuries, Post immobilization edema, Venous<br>insufficiencies, Lymphedema. | - |
| Description | Lympha-Flow(LF1200) is a pneumatic pressure treatment<br>system that repeats expansion of sleeves to help blood<br>circulation and prevent blood clots or clogs. | LX7(V7) is a pneumatic pressure treatment system that<br>repeats expansion of sleeves to help blood circulation and<br>prevent blood clots or clogs. | - |
| Standard | EN ISO 14971<br>EN 60601-1<br>EN 60601-1-2 | EN ISO 14971<br>EN 60601-1<br>EN 60601-1-2 | - |
| Contraindications | Acute pulmonary edema Acute thrombophlebitis<br>Acute congestive cardiac failure<br>Acute infections<br>Deep Vein Thrombosis (DVT) Episodes of Pulmonary<br>embolism Wounds lesions or tumors at or in the vicinity of<br>application<br>Where increased venous and lymphatic return is undesirable<br>Bone fractures or dislocations at or in the vicinity of<br>application | Acute pulmonary edema Acute thrombophlebitis<br>Acute congestive cardiac failure<br>Acute infections<br>Deep vein thrombosis (DVT) Episodes of pulmonary<br>embolism Wounds, lesions, or tumors at or in the vicinity<br>of application Where increased venous and<br>lymphatic return is undesirable Bone fractures or<br>dislocation at or in the vicinity of application. | - |
| Mode of<br>Compression | Sequential | Sequential | - |
| Mode<br>description | 3 modes | 3 modes | - |
| Compression<br>Applicator<br>Garments Sleeve<br>Material | Nylon(oxford) | Nylon(oxford) | - |
| Power<br>Source | Electricity Supply:AC100-240V, 50/60Hz<br>Electricity consumption:30-50VA | Electricity Supply: 230 V~,50/60 Hz<br>Electricity consumption: 50 VA | Note 1 |
| Pressure range | 0~230mmHg (Air pump pressure range)<br>60~120mmHg (Recommended operating pressure range)<br>(unit of pressure increment : 10mmHg) | 0~230mmHg (Air pump pressure range)<br>60~120mmHg (Recommended operating pressure range)<br>(unit of pressure increment : 20mmHg) | Note 2 |
| Operating Time | 5~100 minutes | 10, 20, 30minutes | Note 3 |
| Number of<br>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.

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### 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.