(101 days)
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.
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. 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). The device consists of 4 parts-PCB, control panel, air pump (AC motor pump) and distributor (solenoid).
The provided text describes a 510(k) premarket notification for the LF-400 Compressible Limb Therapy System, which is a medical device for treating various lymphedema and edema conditions. The document focuses on demonstrating substantial equivalence to a predicate device, the LX7 (V7), rather than presenting a study specifically designed to establish acceptance criteria and prove the device meets them in the way clinical trials or AI performance evaluations usually do.
Based on the nature of this 510(k) submission, the "acceptance criteria" discussed are primarily related to safety, electrical performance, biocompatibility, and software validation, rather than clinical efficacy metrics like sensitivity or specificity. The "reported device performance" refers to the results of these technical tests, which found the device to be satisfactory and substantially equivalent to the predicate.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria/Standard Adhered To | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO10993-5 (Cytotoxicity test)ISO 10993-10 (LLNA:BrdU-ELISA for sensitization)ISO 10993-10 (Animal Skin Irritation test) | Biocompatibility testing was conducted. No specific results are detailed, but the "Overall Performance Conclusions" state "All test results were satisfactory." |
| Electrical Safety | IEC 60601-1: 2005 + CORR.1(2006) + CORR(2007) | Electrical safety testing was conducted in accordance with the standard. The "Overall Performance Conclusions" state "All test results were satisfactory." Device is Class II, Type BF. |
| EMC (Electromagnetic Compatibility) | IEC 60601-1-2:2007 | EMC testing was conducted in accordance with the standard. The "Overall Performance Conclusions" state "All test results were satisfactory." |
| Software Validation | Followed FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software considered "moderate" level of concern (failure would not directly result in serious injury or death). | Software verification and validation testing were conducted and documented as recommended. The "Overall Performance Conclusions" state "All test results were satisfactory." Software version LF400.c V1.0. |
| Functional Equivalence | Device functionality (e.g., pressure range, modes, sequential compression) and indications for use are substantially equivalent to the predicate device (LX7). Tolerances for cuff sizes (± 2cm). Manufacturer Recommended Pressure Range: 60-120mmHg. | LF-400 pressure range: 20-140mmHg, recommended 60-120mmHg. Modes: A, B, C, Pre-Therapy (new mode described as not for therapy but for reducing fatigue). Therapy time: 5-180 minutes. Cuff material: Nylon (same as predicate). All considered satisfactory and substantially equivalent. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a "test set" in the context of clinical data (e.g., patient cases). The performance data cited are from technical tests (biocompatibility, electrical safety, EMC, software). These types of tests typically use specific numbers of samples of the device components or the device itself, rather than a "sample size" of patients or data from medical records. The text does not specify the exact number of units or materials tested for these engineering and materials assessments.
Regarding data provenance:
- The submitter, DaeSung Maref Co., Ltd., is located in the Republic of Korea.
- The standards (ISO, IEC, FDA guidance) are international and US-based.
- The tests are implied to be conducted as part of the device development and regulatory submission process, which would typically be prospective for these types of technical evaluations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to the type of performance data presented. The "ground truth" for technical standards is the standard itself, and the performance is measured against objective criteria within that standard by qualified test engineers/labs, not by a panel of medical experts establishing consensus on patient-specific data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are used for expert review of clinical results or imaging data, which are not part of this document's performance section.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The LF-400 is a physical medical device (compressible limb therapy system), not an AI/imaging diagnostic tool that involves "human readers" or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is not an AI algorithm. Its software validation ensures its control functions operate correctly, but it does not perform diagnostic interpretation or AI-driven decision-making in a "standalone" algorithmic sense.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the technical performance data, the "ground truth" is adherence to established international and national standards (ISO, IEC) for biocompatibility, electrical safety, EMC, and FDA guidance for software. These standards define the acceptable parameters and test methodologies.
8. The sample size for the training set
This is not applicable. This device does not use machine learning or AI that would require a "training set" of data. The software components are for control and user interface, verified through traditional software validation methods.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML model for this device.
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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.
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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
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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) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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-DoRepublic of Korea, 435-862 |
| Submitter's Telephone: | +82-31-459-7200 |
| 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: | 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 |
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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 |
| 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:
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- 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.
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| Chamber | 4 chamber | |||
|---|---|---|---|---|
| Pressure | Min. Max Pressure Range:20 | |||
| 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)ISO 10993-10 (LLNA:BrdU-ELISA)ISO 10993-10 (Animal Skin Irritation test) |
| ARM Cuff | ||
|---|---|---|
| Image | Image | |
| Chamber | 4 chamber |
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| 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)ISO 10993-10 (LLNA:BrdU-ELISA)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).
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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
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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(21 CFR 890.5650) | Class II Device / IRP(21 CFR 890.5650) |
| Indications forUse | LF400 is intended for use by medicalprofessionals and patients at home,who are under medical supervision,in treating many conditions, such as :Primary lymphedema, Edemafollowing trauma and sport injuries,Post immobilization edema, Venousinsufficiencies, Lymphedema | LX7(V7) is intended for use bymedical professionals and patients athome, who are under medicalsupervision, in treating manyconditions, such as Primarylymphedema, Edema followingtrauma and sport injuries, Postimmobilization edema, Venousinsufficiencies, Lymphedema. |
| Standard | EN ISO 14971EN 60601-1EN 60601-1-2 | EN ISO 14971EN 60601-1EN 60601-2-10EN 60601-1-2 |
| Contraindications | Acute pulmonary edemaAcute thrombophlebitisAcute congestive cardiac failureAcute infectionsDeep Vein Thrombosis (DVT)Episodes of Pulmonary embolismWounds lesions or tumors at or inthe vicinity of applicationWhere increased venous andlymphatic return is undesirableBone fractures or dislocations at or inthe vicinity of application | Acute pulmonary edemaAcute thrombophlebitisAcute congestive cardiac failureAcute infectionsDeep vein thrombosis (DVT)Episodes of pulmonary embolismWounds, lesions, or tumors at or inthe vicinity of applicationWhere increased venous andlymphatic return is undesirableBone fractures or dislocation at or inthe vicinity of application. |
| Mode ofCompression | Sequential | Sequential |
| Mode | 3 modes (A,B,C) + Pre-therapy | 3 modes |
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| description | mode | |
|---|---|---|
| Power Source | For Pressure Therapy UnitsElectricity Supply: 100-127V~,50/60HzElectricity consumption:50VA | For Pressure Therapy UnitsElectricity Supply: 230 V~,50/60 HzElectricity consumption: 50 VA |
| Therapy Time | 5~180 minutes | 10min, 20 min, 30min |
| Maximum andMinimumPressure | Min. Max. Pressure range:20~140mmHgManufacturer recommendedpressure range: 60 ~ 120mmHg | Min. Max. Pressure range :0-230mmHgManufacturer Recommendedpressure range: 60~120mmHg |
| Number ofChamber | 4 chamber | 4 to 8 chamber |
| CompressionCycle 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-therapyMode is thenew mode.It's not fortherapy butfor reducingfatigue byfinishingtherapycontinuously massagingfrombottom(foot)totop(thigh)andmassagingfrom top tobottom. | A-Mode Time ChartA-ModeB-Mode Time ChartB-ModeC-Mode Time Chart | Additionalrisks notconcerns forsafety andeffectiveness (Refer toRiskManagement Report) |
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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 | RiskAssessment |
|---|---|
| 1 | |
| The time setting for LX7, the predicate device, was in the unit of 10min., 20 min., and 30 min. For additional treatment time, if necessary,the timer had to be reset by the user in every 10, 20 or 30 min.The time setting for LF-400, the new subject device, is available for 5 | Additionalrisks notconcerns forsafety andeffectiveness(Refer to RiskManagementReport) |
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Differences: Note3. Description on Pressure Difference
| Description | RiskAssessment | |
|---|---|---|
| 1 | The pressure limit for LX7 ranges between 0 | The pressurerange for LF-400 is smallerthan the onefor LX7.Additionalrisks notconcerns forsafety andeffectiveness(Refer to RiskManagementReport) |
Differences: Note4. Description on Fabric Difference
| Description | Verification Data | Risk Assessment | |
|---|---|---|---|
| 1 | LF-400, thenew device,uses nylon forthe cuffs, samematerial usedfor LX7(V7).OXFORD isthe weavingmethod offabric. It is notthe element offabric. | Dictionary definition on “OXFORD”Noun Two or three threads are woven inparallel without being twisted. | The samefabric forcuffs is usedfor the subjectand predicatedevice.Thus,Additionalrisks notconcerns forsafety andeffectiveness(Refer to RiskManagementReport) |
| 2 | OXFORDCompositionTable showsthat the deviceis made 100%with nylon. | OXFORD Composition Table5407-41-0000 5110 N/210D SD 고 62"100% NYLON F.YARN WOVEN FABRIC (OXFORD) IN GREY (SD)62" (WOVEN BY SHUTTLELESS LOOM)WP : N.F.Y.210D/68WT : N.F.Y.210D/54TOTAL WEIGHT : 170GR/YD |
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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.
§ 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).