(350 days)
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.
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.
This looks like a 510(k) summary for a medical device called Lympha-Flow (LF1200), an intermittent pneumatic compression system. The document focuses on demonstrating substantial equivalence to a predicate device (LX7, K102320), rather than a standalone clinical study to prove effectiveness against explicitly stated acceptance criteria.
However, I can extract information related to performance testing and substantial equivalence, which serves a similar purpose in the regulatory context.
Acceptance Criteria and Reported Device Performance
The document doesn't present explicit "acceptance criteria" in the format of a clinical study goal (e.g., "achieve 90% sensitivity"). Instead, the acceptance criteria are implicitly defined by compliance with recognized standards and demonstration of substantial equivalence to a legally marketed predicate device. The "reported device performance" is primarily the successful completion of these tests and the determination of substantial equivalence.
Here's a table based on the provided text, outlining the performance data submitted:
| Acceptance Criteria Category (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility | Met: Testing conducted according to ISO10993-5 (Cytotoxicity) and ISO10993-10 (Irritation and Skin Sensitization). |
| Electrical Safety and Performance | Met: Testing conducted according to standard IEC 60601-1:2005 + CORR.1(2006) + CORR(2007). The subject device's basis safety and essential performance are not affected by technical variations between IEC 60601-1 and ANSI/AAMI 60601-1. |
| Electromagnetic Compatibility (EMC) | Met: Testing conducted in accordance with standard IEC 60601-1-2:2007. |
| Software Verification and Validation | Met: Testing conducted and documented as recommended by FDA's guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software deemed "minor" level of concern. |
| Substantial Equivalence to Predicate Device (LX7) | Met: The Lympha-Flow(LF1200) Intermittent Pneumatic Compression system is determined to be substantially equivalent to the LX7(V7) predicate device in terms of indications for use, fundamental operating principle, and safety/performance characteristics. Differences in power source, pressure increment, operating time, and number of chambers were evaluated and deemed not to raise new safety concerns or alter fundamental efficacy. |
Study Details (Based on available information)
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a clinical "test set" with a specific sample size. The testing described (biocompatibility, electrical safety, EMC, software V&V) is typically performed on a limited number of device units or components, not a patient sample. This is not a study with data provenance in terms of country of origin or retrospective/prospective patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. For technical standard compliance (IEC, ISO, EMC), "ground truth" is established by the successful execution of tests according to the standard's methodology and acceptance criteria. For substantial equivalence, the "ground truth" is the established safety and effectiveness of the legally marketed predicate device. There is no mention of external experts establishing ground truth for a test set.
4. Adjudication Method for the Test Set:
Not applicable. No clinical test set with human subject data requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. The document makes no mention of an MRMC comparative effectiveness study involving human readers or AI assistance. This type of study is more common for diagnostic imaging devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The device itself is a therapy device (pneumatic massager), not a diagnostic algorithm. Therefore, the concept of "standalone algorithm performance" as typically understood in AI/ML medical devices is not directly applicable. The device's performance is standalone in the sense that its mechanical and electrical functions are tested independently and against standards.
7. The Type of Ground Truth Used:
The "ground truth" here is the adherence to recognized international and national standards for medical devices (ISO, IEC, AAMI, FDA guidance) and the established safety and efficacy profile of the predicate device (LX7(V7), K102320).
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML-based device that requires a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. (See #8).
Summary of Device and Study Type:
The Lympha-Flow (LF1200) is an intermittent pneumatic compression system. The study presented here is a premarket notification (510(k)) which aims to demonstrate substantial equivalence to a previously legally marketed device (predicate device, LX7). This involves comparing the new device's technological characteristics, indications for use, and performance data (biocompatibility, electrical safety, EMC, software V&V) to those of the predicate device and relevant standards. It is not a clinical trial to establish de novo safety and effectiveness or to demonstrate improvement over human performance. The "acceptance criteria" are implicitly met through compliance with recognized standards and a successful demonstration of substantial equivalence.
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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
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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 (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-doRepublic 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 ManufacturerDevice | : 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) | - |
| IndicationsFor Use | Lympha-Flow(LF1200) is intended for use by medicalprofessionals and patients at home, who are undermedical supervision, in treating many conditions, suchas : Primary lymphedema, Edema following trauma andsport injuries, Post immobilization edema,Venousinsufficiencies, Lymphedema | LX7(V7) is intended for use by medical professionalsand patients at home, who are under medicalsupervision, in treating many conditions, such asPrimary lymphedema, Edema following trauma andsport injuries, Post immobilization edema, Venousinsufficiencies, Lymphedema. | - |
| Description | Lympha-Flow(LF1200) is a pneumatic pressure treatmentsystem that repeats expansion of sleeves to help bloodcirculation and prevent blood clots or clogs. | LX7(V7) is a pneumatic pressure treatment system thatrepeats expansion of sleeves to help blood circulation andprevent blood clots or clogs. | - |
| Standard | EN ISO 14971EN 60601-1EN 60601-1-2 | EN ISO 14971EN 60601-1EN 60601-1-2 | - |
| Contraindications | Acute pulmonary edema Acute thrombophlebitisAcute congestive cardiac failureAcute infectionsDeep Vein Thrombosis (DVT) Episodes of Pulmonaryembolism Wounds lesions or tumors at or in the vicinity ofapplicationWhere increased venous and lymphatic return is undesirableBone fractures or dislocations at or in the vicinity ofapplication | Acute pulmonary edema Acute thrombophlebitisAcute congestive cardiac failureAcute infectionsDeep vein thrombosis (DVT) Episodes of pulmonaryembolism Wounds, lesions, or tumors at or in the vicinityof application Where increased venous andlymphatic return is undesirable Bone fractures ordislocation at or in the vicinity of application. | - |
| Mode ofCompression | Sequential | Sequential | - |
| Modedescription | 3 modes | 3 modes | - |
| CompressionApplicatorGarments SleeveMaterial | Nylon(oxford) | Nylon(oxford) | - |
| PowerSource | Electricity Supply:AC100-240V, 50/60HzElectricity consumption:30-50VA | Electricity Supply: 230 V~,50/60 HzElectricity consumption: 50 VA | Note 1 |
| Pressure range | 0 | 0 | Note 2 |
| Operating Time | 5~100 minutes | 10, 20, 30minutes | Note 3 |
| Number ofChamber | 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.
§ 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).