Air Compressible Limb Therapy System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, stacked on top of each other. The profiles are black and are connected to form a single, abstract shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the profile graphic. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 20, 2015 DaeSung Maref Co., Ltd. c/o Mr. Dave Kim 8310 Buffalo Speedway Houston, TX 77025 Re: K150033 Trade Name: LF-400 Compressible Limb Therapy System Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: March 20, 2015 Received: March 23, 2015 Dear Mr. 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-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. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours, # Felipe Aquel -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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K150033 #### Device Name LF-400 Compressible Limb Therapy System #### Indications for Use (Describe) LF-400 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) | |----------------------------------------------------------------------------------| | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # Special 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. #### Date 510k summary prepared: March 20, 2015 #### I. SUBMITTER | Submitter's Name : | DaeSung Maref Co., Ltd. | |----------------------------------------------------|--------------------------------------------------------------------------| | Submitter's Address: | 298-24, Gongdan-Ro, Gunpo-shi, Gyeonggi-Do<br>Republic of Korea, 435-862 | | Submitter's Telephone: | +82-31-459-7200 | | Contact person: | Jae-Wha Lee / President | | Official Correspondent:<br>(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: | LF-400 Compressible Limb Therapy System | |-------------------------|-----------------------------------------| | Common or Usual Name: | Air Compressible Limb Therapy System | | Regulation Name : | Powered Inflatable Tube Massager | | Classification: | 21 CFR 890.5650 (Product Code: IRP) | | Regulatory Class: | II | {4}------------------------------------------------ #### III. PREDICATE DEVICE | 1) Primary Manufacturer | : DaeSung Maref Co., Ltd. | |-------------------------|------------------------------------------| | Device | : 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 LF400 is the pressurization system helping to relieve the symptom of lymphedema and prevent aggravation of symptoms by applying the air pressure to limbs. LF400 comprises 4-step sleeves which move the body fluids through the limbs by evenly applying pressure to the limbs. | NO | Items | Specification | |----|------------------------|--------------------------------------------------------------------------------------------------------------| | 1 | Model | LF400 | | 2 | Rating Protection Type | Class II, BF-Type Device | | 3 | Usable Place | Indoor | | 4 | Rated Voltage | 100 - 127VAC, 50/60Hz | | 5 | Power Consumption | 50VA | | 6 | Rated Fuse | 3.15A/250V | | 7 | Setting Pressure | Min. Max Pressure Range:20~140mmHg<br>(unit:5mmHg)<br>Manufacturer Recommended Pressure<br>Range: 60~120mmHg | | 8 | Setting Time | 5~180 Minutes (unit:5 Min.) | | 9 | Mode | A, B, C, Pre Therapy | | 10 | Dimension | 225(W) * 225(D) * 135(H)mm | | 11 | weight | 3.5Kg(main system only) | ## > Device Specification: {5}------------------------------------------------ - ゃ Device Identification: - (1) Main Body Image /page/5/Picture/3 description: The image shows three different views of a medical device. The views are labeled as "Front", "Right", and "Left". The device is white with a light blue accent and has a screen on the front. The front view shows several ports and a handle. Top Back Image /page/5/Picture/6 description: The image shows a medical device with a white and light blue color scheme. The device features a screen, several buttons, and a knob on the front panel. The device also has a compartment on top, and power switches on the back. - (2) Garment(Cuff) Image /page/5/Figure/8 description: This image shows a leg cuff. The leg cuff is a medical device used to help prevent blood clots in the legs. The image also shows a diagram of the leg cuff, with labels indicating the thigh circumference, leg length, and ankle circumference. The leg cuff is made of a soft, flexible material and is designed to be worn around the leg. {6}------------------------------------------------ | Chamber | 4 chamber | | | | |-----------------------|----------------------------------------------------------------------------------------------------------------|---------------------|---------------------|------------| | Pressure | Min. Max Pressure Range:20~140mmHg (unit:5mmHg)<br>Manufacturer Recommended Pressure Range: 60~120mmHg | | | | | Mode | A, B, C, Pre-therapy | | | | | Cuff Material | Nylon | | | | | Size | | Thigh circumference | Ankle circumference | Leg length | | | M | 50cm | 36cm | 67cm | | | L | 62cm | 37cm | 74cm | | | XL | 74cm | 43cm | 79cm | | | XXL | 79cm | 46cm | 92cm | | | ※Tolerance: ± 2cm | | | | | Biocompatibility test | ISO10993-5 (Cytotoxicity test)<br>ISO 10993-10 (LLNA:BrdU-ELISA)<br>ISO 10993-10 (Animal Skin Irritation test) | | | | | | ARM Cuff | | |---------|-----------|--| | Image | Image | | | Chamber | 4 chamber | | {7}------------------------------------------------ | Pressure | Min. Max Pressure Range:20~140mmHg (unit:5mmHg) | | | | | | | | |-----------------------|----------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--| | | Manufacturer Recommended Pressure Range: 60~120mmHg | | | | | | | | | Mode | A, B, C, Pre-therapy | | | | | | | | | Cuff Material | Nylon | | | | | | | | | Size | Arm circumference Arm's length Arm Cuff 50cm 88cm ※Tolerance: ± 2cm | | | | | | | | | Biocompatibility test | ISO10993-5 (Cytotoxicity test)<br>ISO 10993-10 (LLNA:BrdU-ELISA)<br>ISO 10993-10 (Animal Skin Irritation test) | | | | | | | | | Hose Image | Image: Black hose | | | | | | | | | Hose Length | 256 CM | | | | | | | | | Hose Material | PVC | | | | | | | | ## > Device Characteristics ## (1) Components The basic set of Air Compression Therapy System consists of the main body, which includes the air pump that generates air pressure and control panel, air hose that transfers air pressure and cutoff sleeve (cuff) for leg and its accessories include overlapping sleeve (cuff) for leg, cutoff sleeve (cuff) for arm, overlapping sleeve (cuff) for arm, cutoff sleeve (cuff) for waist and pants sleeve (cuff). (2) Characteristics of the device (1) Operation The device consists of 4 parts-PCB, control panel, air pump (AC motor pump) and distributor (solenoid). {8}------------------------------------------------ PCB consists of user input switch, LED or LCD display and button for pressure control and controls the air pump and solenoid via micro controller. Air pump is connected to the hose and supplies air to the distributor. Air distributor supplies the air to each air chamber in order and thus, repeats the inflation of Chamber 1 → inflation of Chamber 2 → inflation of Chamber 3 → inflation of Chamber 4 in this order until the end of the set time. - (2) Electric Characteristics - a. Rated Voltage: AC100-127V~ - b. Rated Frequency: 50/60Hz - c. Power Consumption: 70VA - (3) Protection against electric shock Class II, Type BF - (4) Safety Measure - a. Fuse: 3.15A/250V b. Air pump has a fuse on the circuit to protect against over temperature. - (5) Software - a. File Name: LF400.c - b. Version: V1.0 - c. Main features: switch, display, pump, solenoid, pressure control {9}------------------------------------------------ #### V. Indications For Use: LF-400 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. ### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE | Model Name | LF400 | LX7(V7) | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | Not Assigned | K102320 | | Classification | Class II Device / IRP<br>(21 CFR 890.5650) | Class II Device / IRP<br>(21 CFR 890.5650) | | Indications for<br>Use | LF400 is intended for use by medical<br>professionals and patients at home,<br>who are under medical supervision,<br>in treating many conditions, such as :<br>Primary lymphedema, Edema<br>following trauma and sport injuries,<br>Post immobilization edema, Venous<br>insufficiencies, Lymphedema | LX7(V7) is intended for use by<br>medical professionals and patients at<br>home, who are under medical<br>supervision, in treating many<br>conditions, such as Primary<br>lymphedema, Edema following<br>trauma and sport injuries, Post<br>immobilization edema, Venous<br>insufficiencies, Lymphedema. | | Standard | EN ISO 14971<br>EN 60601-1<br>EN 60601-1-2 | EN ISO 14971<br>EN 60601-1<br>EN 60601-2-10<br>EN 60601-1-2 | | Contraindicatio<br>ns | Acute pulmonary edema<br>Acute thrombophlebitis<br>Acute congestive cardiac failure<br>Acute infections<br>Deep Vein Thrombosis (DVT)<br>Episodes of Pulmonary embolism<br>Wounds lesions or tumors at or in<br>the vicinity of application<br>Where increased venous and<br>lymphatic return is undesirable<br>Bone fractures or dislocations at or in<br>the vicinity of application | Acute pulmonary edema<br>Acute thrombophlebitis<br>Acute congestive cardiac failure<br>Acute infections<br>Deep vein thrombosis (DVT)<br>Episodes of pulmonary embolism<br>Wounds, lesions, or tumors at or in<br>the vicinity of application<br>Where increased venous and<br>lymphatic return is undesirable<br>Bone fractures or dislocation at or in<br>the vicinity of application. | | Mode of<br>Compression | Sequential | Sequential | | Mode | 3 modes (A,B,C) + Pre-therapy | 3 modes | {10}------------------------------------------------ | description | mode | | |------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------| | Power Source | For Pressure Therapy Units<br>Electricity Supply: 100-127V~,50/60Hz<br>Electricity consumption:50VA | For Pressure Therapy Units<br>Electricity Supply: 230 V~,50/60 Hz<br>Electricity consumption: 50 VA | | Therapy Time | 5~180 minutes | 10min, 20 min, 30min | | Maximum and<br>Minimum<br>Pressure | Min. Max. Pressure range:<br>20~140mmHg<br>Manufacturer recommended<br>pressure range: 60 ~ 120mmHg | Min. Max. Pressure range :<br>0-230mmHg<br>Manufacturer Recommended<br>pressure range: 60~120mmHg | | Number of<br>Chamber | 4 chamber | 4 to 8 chamber | | Compression<br>Cycle Time | 5~180 minutes | 30min | | Actual Picture | Image: blue and white medical device | Image: pink medical device | ### Differences: Note 1. Description on Mode Difference | | Description | Verification Data | Risk Assessment | |---|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------| | 1 | Pre-therapy<br>Mode is the<br>new mode.<br>It's not for<br>therapy but<br>for reducing<br>fatigue by<br>finishing<br>therapy<br>continuously massaging<br>from<br>bottom(foot)<br>to<br>top(thigh)<br>and<br>massaging<br>from top to<br>bottom. | A-Mode Time Chart<br><br>A-Mode<br><br><br>B-Mode Time Chart<br><br>B-Mode<br><br><br>C-Mode Time Chart | Additional<br>risks not<br>concerns for<br>safety and<br>effectiveness (Refer to<br>Risk<br>Management Report) | {11}------------------------------------------------ Image /page/11/Figure/1 description: The image shows two time charts, one for 'A-Mode Pressure Skip' and another for 'Pre-therapy Mode'. Both charts depict pressure variations over time for four chambers, labeled 1-Chamber through 4-Chamber. The 'A-Mode Pressure Skip' chart has a maximum time of 70 seconds, while the 'Pre-therapy Mode' chart has a maximum time of 90 seconds. Each chamber's pressure is represented by a colored shape, with the timing and duration of pressure application varying between the two modes. ## Differences: Note2. Description on Time Difference | Description | Risk<br>Assessment | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------| | 1 | | | The time setting for LX7, the predicate device, was in the unit of 10<br>min., 20 min., and 30 min. For additional treatment time, if necessary,<br>the timer had to be reset by the user in every 10, 20 or 30 min.<br><br>The time setting for LF-400, the new subject device, is available for 5 ~<br>180minutes to provide the user more flexible control over the time<br>setting, shorter or longer interval, than LX-7, the predicate device. A<br>single treatment time setting of 5~180 minutes for LF-400 is within the<br>usual treatment time range between 60 min ~ 960 minutes for treating<br>Lymphedema patients, based on the prescription of a physician. | Additional<br>risks not<br>concerns for<br>safety and<br>effectiveness<br>(Refer to Risk<br>Management<br>Report) | {12}------------------------------------------------ ## Differences: Note3. Description on Pressure Difference | | Description | Risk<br>Assessment | |---|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1 | The pressure limit for LX7 ranges between 0~230mmHg and the<br>manufacturer recommended pressure range was between 60~120mmHg<br>(see page 13 of LX7 Manual).<br><br>The air pressure setting for LF-400, the new subject device, ranges<br>between 0~140mmHg and the recommended pressure range is<br>identical to 60~120 mmHg to be aligned closely with the pressure<br>setting found in usual Lymphedema treatment cases. In few<br>Lumphedema treatment cases reported, the air pressure setting applied<br>to treat Lymphedema patients ranged between 30~160mmHg based on<br>the severity of the symptoms even though the same report indicated<br>small number of patients experienced pain or discomfort at the pressure<br>setting of 160mmHg. | The pressure<br>range for LF-<br>400 is smaller<br>than the one<br>for LX7.<br>Additional<br>risks not<br>concerns for<br>safety and<br>effectiveness<br>(Refer to Risk<br>Management<br>Report) | ## Differences: Note4. Description on Fabric Difference | | Description | Verification Data | Risk Assessment | |---|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1 | LF-400, the<br>new device,<br>uses nylon for<br>the cuffs, same<br>material used<br>for LX7(V7).<br>OXFORD is<br>the weaving<br>method of<br>fabric. It is not<br>the element of<br>fabric. | Dictionary definition on “OXFORD”<br>Noun<br><Handicraft> Two or three threads are woven in<br>parallel without being twisted. | The same<br>fabric for<br>cuffs is used<br>for the subject<br>and predicate<br>device.<br>Thus,<br>Additional<br>risks not<br>concerns for<br>safety and<br>effectiveness<br>(Refer to Risk<br>Management<br>Report) | | 2 | OXFORD<br>Composition<br>Table shows<br>that the device<br>is made 100%<br>with nylon. | OXFORD Composition Table<br>5407-41-0000     5110     N/210D SD 고 62"<br>100% NYLON F.YARN WOVEN FABRIC (OXFORD) IN GREY (SD)<br>62" (WOVEN BY SHUTTLELESS LOOM)<br>WP : N.F.Y.210D/68<br>WT : N.F.Y.210D/54<br>TOTAL WEIGHT : 170GR/YD | | {13}------------------------------------------------ #### VII. 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. ### 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 "moderate" 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. ### 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 LF-400 Compressible Limb Therapy System is safe and effective and substantially equivalent in comparison with LX7 (V7), the predicate device as described herein.