(299 days)
No
The description focuses on mechanical principles (pressure distribution, swept volume) and battery life. There is no mention of AI, ML, or any data-driven decision-making process. The performance studies mentioned are standard software and mechanical tests, not related to AI/ML model validation.
Yes
The device is intended to treat several medical conditions such as post-thrombotic syndrome, deep vein thrombosis, lymphedema, and chronic venous insufficiency, which directly impacts the health and well-being of the patient.
No
The device description and intended use indicate that ZEROVENO is designed to treat various conditions by inducing improved vascular and lymphatic flow, not to diagnose them.
No
The device description explicitly mentions a "built-in lithium-ion battery" and "Mechanical testing was performed for Pressing pressure, Maximum pressing height, Pressing cycle duration, and Pressing range," indicating the presence of hardware components that perform a physical action (applying pressure) on the patient.
Based on the provided information, the ZEROVENO device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of the ZEROVENO device is to physically treat conditions related to vascular and lymphatic flow in the lower limbs (PTS, DVT prevention, lymphedema, swelling, varicose veins, chronic venous insufficiency). This involves applying pressure to the body.
- Device Description: The device description details a mechanical process of applying pressure to the leg to improve flow. It describes physical characteristics like wavelength, width, and depth of the wave, and battery life.
- Lack of Diagnostic Activity: There is no mention of the device analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition. IVDs are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
The ZEROVENO device appears to be a therapeutic device that uses mechanical means to treat existing conditions, rather than a diagnostic device that analyzes samples to identify or monitor a condition.
N/A
Intended Use / Indications for Use
The ZEROVENO device induces improved vascular and lymphatic flow of the lower limbs. The device is intended to treat the following:
- Management of the symptoms of post thrombotic syndrome (PTS)
- Prevention of deep vein thrombosis, (DVT)
- Treatment of lymphedema
- Treatment of leg swelling due to vascular insufficiency
- Treatment of varicose veins
- Treatment of chronic venous insufficiency
Product codes
JOW
Device Description
ZEROVENO is a product designed to distribute the pressure applied to the leg by changing the position of the contact part which supports the load of the leg alternately with the pressing pressure periodically.
The swept volume or volume of blood or lymph fluid displaced upwards for each cycle is the product of the wavelength (14cm), the width of the wave sheet (8cm) and the depth of the wave (1cm) or approximately 0.1 L/cycle.
ZEROVENO has a maximum continuous operation time of 20 hours on a low-speed basis when the built-in lithium-ion battery is fully charged.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower limbs, leg, calf
Indicated Patient Age Range
all ages except infant, Children, pregnant woman
Intended User / Care Setting
Not Found
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)
Software verification and validation testing were conducted and documentation was provided 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 failures or latent design flaws are unlikely to cause any injury to the patient or operator.
Mechanical testing:
- Pressing pressure
- Maximum pressing height
- Pressing cycle duration
- Pressing range
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).
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June 22, 2020
Dimedi Co., Ltd. % Sanglok Lee Manager Wise Company Inc. #303, 142, Gasan digital 1-ro Geumcheon-gu, 08507 Kr
Re: K192337
Trade/Device Name: Zeroveno Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: May 18, 2020 Received: May 28, 2020
Dear Sanglok Lee:
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.
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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 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 (OS) 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 Advice (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.
for Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192337
Device Name ZEROVENO
Indications for Use (Describe)
The ZEROVENO device induces improved vascular and lymphatic flow of the lower limbs. The device is intended to treat the following:
- Management of the symptoms of post thrombotic syndrome (PTS)
- Prevention of deep vein thrombosis, (DVT)
- Treatment of lymphedema
- Treatment of leg swelling due to vascular insufficiency
- Treatment of varicose veins
- Treatment of chronic venous insufficiency
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
The assigned 510(k) Number: K192337
01. Date of Submission: August 23, 2019
02. Applicant
Company name: DIMEDI Co., Ltd. Address: 209ho, Wonju Venture Plaza, 130-2, Donghwagongdan-ro, Munmak-eup, Wonju-si, Gangwon-do, Korea TEL: +82-33-744-0174 FAX: +82-33-744-0175 Email: sales@dimedi.co.kr
03. Submission Correspondent
Sanglok, Lee Wise COMPANY Inc. #303, 142, Gasan digital 1-ro, Geumcheon-gu, Seoul, Korea TEL: +82 7088123619 / +82 28313615 FAX: +82 50 4031 3619 Email: info@wisecompany.org
04. Proposed Device Identification
Proprietary Name: ZEROVENO Classification Name: Compressible limb sleeve Device Class: Class II Regulation Number:21 C.F.R.870.5800 Product Code: JOW
05. Indication for use
The ZEROVENO device induces improved vascular and lymphatic flow of the lower limbs.
The device is intended to treat the following:
- Management of the symptoms of post thrombotic syndrome (PTS)
- Prevention of deep vein thrombosis, (DVT)
- Treatment of lymphedema
- Treatment of leg swelling due to vascular insufficiency
- Treatment of varicose veins
- Treatment of chronic venous insufficiency
06. Predicate devices
- Predicate Device 510(k) Number: K073028 Device Name: Venowave VW5-10 Manufacturer: SARINGER LIFE SCIENCE TECHNOLOGIES INC.
07. Device Description
ZEROVENO is a product designed to distribute the pressure applied to the leg by changing the position of the contact part which supports the load of the leg alternately with the pressing pressure periodically.
The swept volume or volume of blood or lymph fluid displaced upwards for each cycle is the product of the wavelength (14cm), the width of the wave sheet (8cm) and the depth of the wave (1cm) or approximately 0.1 L/cycle.
4
ZEROVENO has a maximum continuous operation time of 20 hours on a low-speed basis when the built-in lithium-ion battery is fully charged. Detailed specification of ZEROVENO is as below.
| Product Name/Model Name | Sequential Compression Device/ ZEROVENO |
|---|---|
| Rated Voltage(Main Part) | DC 5 V, 1.0 A |
| Rated Voltage(Adapter) | Input: AC 100 - 240 V, 50 - 60 Hz, 0.3 A |
| Output: DC 5 V, 2.0 A) | |
| Inner Power(Battery) | DC 3.63 V, 3350 mAh |
| Power Consumption | 5 VA |
| Dimension | Main body: 186.5mm(D)×111.9mm(W)×52.7mm(H) |
| Band: 580mm(D)×200mm(W)×8mm(H) | |
| Charging adapter: 84mm(D)×47mm(W)×31mm(H) | |
| Weight | Main body: 400g |
| Dedicated Band: 70g | |
| Charging adapter: 130g | |
| Pressing pressure | ≥ 80 N, |