(264 days)
Not Found
No
The device description and performance studies focus on the mechanical operation (sequential air pressurization) and standard safety/performance testing, with no mention of AI or ML.
Yes
The device is described as "treating many conditions" such as lymphedema and edema, which indicates it is used for therapeutic purposes.
No
Explanation: The device description states its purpose is to improve blood circulation by applying pressure. The "Intended Use" section also describes it as treating conditions rather than diagnosing them. There is no mention of the device providing any diagnostic information or measurements.
No
The device description explicitly states it is an "Intermittent Pneumatic Compression system" that delivers air to a "sleeve with 4 air chambers," indicating it includes hardware components beyond just software.
Based on the provided information, the LF900 device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes treating conditions like lymphedema and edema by improving blood circulation. This is a therapeutic application, not a diagnostic one.
- Device Description: The device description explains how it works by applying pressure to improve blood circulation. This mechanism is physical and external, not involving the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The LF900 does not fit this description.
N/A
Intended Use / Indications for Use
LF900 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 (comma separated list FDA assigned to the subject device)
IRP
Device Description
This product is an Intermittent Pneumatic Compression system to improve the blood circulation of the human body. The operating principle is that the air from the device will be delivered to the sleeve with 4 air chambers and the air pressurizes sequentially the chambers from 1st to 4th.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals and patients at home, who are under medical supervision / Professional healthcare environment & Home environment
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Test Summary: The LF900 complies with voluntary standards for electrical safety, electromagnetic compatibility, use in the home healthcare environment and usability.
- Electrical Safety, Electromagnetic Compatibility and Performance: The LF900 complies with the electrical safety and electromagnetic compatibility requirements established by the standards.
• IEC 60601 : 2005/A1:2012, Medical Electrical Equipment:Part 1: General Requirements for Basic Safety and Essential Performance
- IEC 60601 60601-1-2:2014, Medical Electrical Equipment Part 1 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements and Tests
- IEC 60601 60601-1-11:2015, Medical Electrical Equipment Part 1 1-11: General Requirements for Basic Safety and Essential Per formance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
- Device Performance test: The proposed device is at a safer level in terms of pressure and time compared to equivalent devices, Safety and effectiveness were confirmed by conducting verification tests for these essential performances (pressure, time, and sleeve durability).
Clinical Test Summary: Clinical testing was not required to demonstrate the substantial equivalence of the LF900 to its predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
June 22, 2021
DaeSung Maref Co., Ltd So Hyeon Assistant Researcher 298-24. Gongdan-ro Gunpo-si, 15809 Korea
Re: K203019
Trade/Device Name: LF900 Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: March 8, 2021 Received: March 29, 2021
Dear So Hyeon:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203019
Device Name LF900
Indications for Use (Describe)
LF900 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) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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1. Data Prepared [21 CFR 807.92(a)(a)]
March 8, 2021
2. Submitter's Information [21 CFR 807.92(a)(1)]
- Name of Manufacturer :
- DAESUNG MAREF CO., LTD.
- Address :
298-24, Gongdan-ro Gunpo-si, Gyeonggido Republic of Korea
- Contact Name :
- Su Hyeon, So
- Telephone No. :
- 82-31-459-7211
- Fax No. :
- 82-31-459-7215
- Email Adress :
- Registration No. : 3004116008
3. Trade Name, Regulation Name, Classification [21 CFR 807.92(a)(2)]
| Trade / Device Name | LF900 |
|---|---|
| Regulation Number | 21 CFR 890.5650 |
| Regulation Name | Massager, Powered Inflatable Tube |
| Regulation Class | II |
| Product Code | IRP |
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4
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)[
Predicate Device
- 510(k) Number :
- Applicant :
BSR KOREA Corp.(K113275)
-
Trade / Device Name :
Compressible Limb Therapy System (Power-Q1000 Premium)(K113275) -
Regulation Number :
21 CFR 890.5650 -
Regulation Name :
Massager, Powered Inflatable Tube -
Regulation Class:
II -
Product Code:
- IRP
Predicate device has not been subject to a design-related recall.
5. Description of the Device [21 CFR 807.92(a)(4)]
This product is an Intermittent Pneumatic Compression system to improve the blood circulation of the human body.
The operating principle is that the air from the device will be delivered to the sleeve with 4 air chambers and the air pressurizes sequentially the chambers from 1st to 4th.
6. Indications For Use [21 CFR 807(a)(5)]
LF900 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.
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7. Determination of Substantial Equivalence
Summary of technological characteristics of the device compared to the predicate device. [21CFR 807.92(a)(6)]
The LF900 is substantially equivalent to legally marketed predicate device (POWER-Q1000 Premium) with respect to indications for use and technology characteristics. The table below presents comparisons for device :
| Proposed Device | Predicate Device | |
|---|---|---|
| Model Name | LF900 | POWER-Q1000 Premium |
| 510(k) Number | K203019 | K113275 |
| Manufacturer | DAESUNG MAREF CO., LTD. | WONJIN MULSAN Co., Ltd. |
| Product Code | IRP | IRP |
| Device Class | II | II |
| Regulation | ||
| Number | 21 CFR 890.5650 | 21 CFR 890.5650 |
| Regulation | ||
| Name | Massager, Powered Inflatable Tube | Massager, Powered Inflatable Tube |
| Indications For | ||
| Use | LF900 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. | The device is indicated for use by | |
| medical professionals and patient at | ||
| home, who are under medical | ||
| supervision, in treating many | ||
| conditions, such as: Primary | ||
| lymphedema, edema following | ||
| trauma and sport injures, Post- | ||
| immobilization edema, Venous | ||
| insufficiencies, Lymphedema | ||
| Intended Use | ||
| environment | Professional healthcare environment | |
| & | ||
| Home environment | Professional healthcare environment | |
| & | ||
| Home environment | ||
| OTC or Rx only | Rx only | Rx only |
[Table 1. Comparison of Proposed Device to Predicate Device]
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6
| Proposed Device | Predicate Device | |
|---|---|---|
| Accessories | Leg sleeves | |
| Extension zipper | ||
| Single tubing | ||
| Double tubing | Leg Cuffs | |
| Single connectinig hose | ||
| Double connectinig hose | ||
| Extension zipper for the leg cuffs | ||
| (option) | ||
| Specifications | ||
| Power Source | 100-127V~, 50/60Hz | AC 120V, 50/60Hz |
| Time | 5-90 min | 0-99 min |
| Pressure | $10-180mmHg \pm 20 mmHg$ | $0-240mmHg \pm 20 %$ |
| Operation Mode | A,B,C,D | A,B,C,D,E |
| Number of | ||
| chamber | 4 | 4 |
The table also provides rationale for a little difference in support of substantial equivalence to the Predicate devices.
[Table 2. Little differnence with Predicate Device]
Justification to Support Substantial Equivalence
Proposed device (LF900) and Predicate device (POWER-Q1000 Premium) can be considered to be almost equivalent except for pressure range, time range, operation mode.
The time range and pressure range of the proposed device are included within the time range of the predicate device.
The operation mode simply differs in the seqeuence of pressurization, the principle of operation and usage are the same. And the pressure is also lower than that of the predicate device & Reference device.
Therefore, the differences in technological characteristics do not raise different questions of safety and effectiveness.
ব
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Non-Clinical Test Summary
The LF900 complies with voluntary standards for electrical safety, electromagnetic compatibility, use in the home healthcare environment and usability.
The following data were provided in support of the substantial equivalence determination :
-
- Electrical Safety, Electromagnetic Compatibility and Performance
The LF900 complies with the electrical safety and electromagnetic compatibility requirements established by the standards.
- Electrical Safety, Electromagnetic Compatibility and Performance
• IEC 60601 : 2005/A1:2012, Medical Electrical Equipment:Part 1: General Requirements for Basic Safety and Essential Performance
- · IEC 60601 60601-1-2:2014, Medical Electrical Equipment Part 1 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements and Tests
- IEC 60601 60601-1-11:2015, Medical Electrical Equipment Part 1 1-11: General Requirements for Basic Safety and Essential Per formance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
2) Device Performance test
The proposed device is at a safer level in terms of pressure and time compared to equivalent devices, Safety and effectiveness were confirmed by conducting verification tests for these essential performances (pressure, time, and sleeve durability).
Therefore, it can be confirmed that the proposed device (K203019) is substantially equivalent to the equivalent device (K113275).
Clinical Test Summary
Clinical testing was not required to demonstrate the substantial equivalence of the LF900 to its predicate device.
The device should only be used over full clothing and socks (because the cuffs cover the feet), never on direct skin.
The biocompatibility of the materials has not been verified by the FDA and contact of the cuffs/accessories to direct skin may lead to skin irritation, skin sensitization and/or cytotoxicity.
8. Conclusion [21 CFR 807.92(b)(3)]
The LF900 has same intended use and technical characteristics to the predicate device.
Based on that information, we conclude that the differences between the proposed device and predicate device do not introduce a new intended use and do not raise new issues of safety and effectiveness.
/ ર
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