(281 days)
No reference devices were used in this submission.
No
The description focuses on the mechanical operation of an intermittent pneumatic compression system and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is used to prevent and mitigate medical conditions like DVT and PE, and it is also indicated for conditions such as chronic edema and leg ulcers, which are therapeutic applications.
No
The device is described as a system to prevent DVT and PE by improving blood velocity and venous blood flow, not to diagnose them. Its function is prophylactic and therapeutic (circulation enhancement, edema, pain relief), not diagnostic.
No
The device description explicitly states it consists of a controller, tubing sets, and non-woven sleeves, which are hardware components.
Based on the provided information, the DVT-4000 device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to prevent DVT by improving blood velocity and treating conditions like edema, pain, ulcers, and venous insufficiency. These are all related to the physical manipulation of the body's circulatory system, not the examination of specimens derived from the human body.
- Device Description: The device is described as an intermittent pneumatic compression system that applies pressure to the limbs. This is a physical therapy/mechanical device, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of the device analyzing blood, urine, tissue, or any other biological specimen. There is no mention of reagents, assays, or laboratory procedures.
Therefore, the DVT-4000 is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
DVT-4000 is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. DVT-4000 is Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery, Leg Ulcers, Venous Stasis / Venous Insufficiency.
Product codes (comma separated list FDA assigned to the subject device)
JOW
Device Description
DVT-4000 device is a specialized intermittent pneumatic compression (IPC) system to prevent DVT (Deep Vein Thrombosis) and PE (Pulmonary Embolism) by improving the venous blood flow in at risk patients. The system consists of the controller, the tubing sets and Non- woven, sleeves. The system offers sequential inflation promoting venous blood movement and metabolism and then has sufficient interval time to refill with blood sufficiently after deflation. The operation of the inflation and deflation is repeated until the stop button is activated. The device may be used with anti-coagulant materials or compression stocking to help prevent DVT and PE under a doctor's consultant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Leg, Foot, Calf, Thigh
Indicated Patient Age Range
Not Found
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)
Electrical safety and EMC performance testing were conducted according to standard IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 and EMC testing was conducted in accordance with standard IEC 60601-1-2:2007.
Biocompatibility testing for the sleeve material:
ISO10993-10 : Intracutaneous Reactivity (test report no. : GB16001)
ISO10993-10 : Skin sensitization (test report no. : GB16002)
ISO10993-5 : Cytoxicity (test report no. : GB16050)
Software Verification and Validation Testing: The software for this device was considered as a "moderate" level of concern. All test results were satisfactory.
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.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 03, 2016
DaeSung Maref Co., Ltd % Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway Houston, Texas 77025
Re: K160180
Trade/Device Name: DVT-4000 Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: September 28, 2016 Received: October 4, 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
1
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 vours.
M.G. Hillemann
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160180
Device Name DVT-4000
Indications for Use (Describe)
DVT-4000 is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. DVT-4000 is Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery, Leg Ulcers, Venous Stasis / Venous Insufficiency.
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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3
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: July 18, 2016
I. SUBMITTER
| Submitter's Name : | DAESUNG MAREF CO.,LTD. |
|---|---|
| Submitter's Telephone: | 298-24, Gongdan-ro, Gunpo-si, Gyeonggi-do, |
| Republic of Korea, 15809 | |
| Submitter's Telephone: | +82-31-459-7211 |
| Contact person: | Jae-Wha Lee / President |
| Official Correspondent: | Dave Kim (davekim@mtech-inc.net) |
| (U.S. Designated agent) | |
| Address: | 8310 Buffalo Speedway, Houston, TX 77025 |
| Telephone: | +713-467-2607 |
| Fax: | +713-583-8988 |
II. DEVICE
| Trade/proprietary name: | DVT-4000 |
|---|---|
| Common or Usual Name: | Intermittent Pneumatic Compression system |
| Regulation Name : | Compressible Limb Sleeve |
| Classification: | 21 CFR 870.5800 (Product Code: JOW) |
| Regulatory Class: | II |
4
III. PREDICATE DEVICE
| 1) Primary Manufacturer | : DAESUNG MAREF CO.,LTD. |
|---|---|
| 2) Device | : DVT-2600 |
| 3) 510(k) Number | : K112677 (Decision Date - Jan. 13, 2012) |
This predicate has not been subject to a design-related recall. No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
DVT-4000 device is a specialized intermittent pneumatic compression (IPC) system to prevent DVT (Deep Vein Thrombosis) and PE (Pulmonary Embolism) by improving the venous blood flow in at risk patients. The system consists of the controller, the tubing sets and Non- woven, sleeves. The system offers sequential inflation promoting venous blood movement and metabolism and then has sufficient interval time to refill with blood sufficiently after deflation. The operation of the inflation and deflation is repeated until the stop button is activated. The device may be used with anti-coagulant materials or compression stocking to help prevent DVT and PE under a doctor's consultant.
| NO | Items | Specification |
|---|---|---|
| 1 | Model | DVT-4000 |
| 2 | Rating Protection Type | Class II, BF-Type Device |
| 3 | Usable Place | Indoor |
| 4 | Rated Voltage | 100 - 240VAC, 50/60Hz |
| 5 | Power Consumption | 60-80VA |
| 6 | Safety circuit | Protection Circuit Module (PCM) equipped |
Device Specification: A
5
| 7 | Setting Pressure | Leg:2060mmHg±10mmHg140mmHg±10mmHg |
Foot: 120
|----|------------------|--------------------------------------------------|
| 8 | Setting Time | 1min~999hours (unit:1 Min.) |
| 9 | Battery Voltage | 14.4V / 2600mAh |
| 10 | Dimension | 181(W) * 214(D) * 186(H)mm |
| 11 | weight | 2Kg(main system only) |
ゃ Product Package
1. Controller Parts
| Components | Qty. | Pictures | |
|---|---|---|---|
| Main Unit | 1ea | Image: Main Unit | |
| Main System | Power Cord | 1ea | Image: Power Cord |
| Extension hose | 2ea | Image: Extension hose |
6
| Sleeve Parts & Specifications
| i | て | ||||
|---|---|---|---|---|---|
| ------------------------------------ | --- | -- | -- | -- | -- |
| No | Name | Image | Type | Description |
|---|---|---|---|---|
| 1 | Thigh sleeve | Image: Thigh sleeve | Non-woven sleeve | DS011 / Small size sleeve |
| DS012 / Medium size sleeve | ||||
| DS013 / Large size sleeve | ||||
| DS014 / X-Large size sleeve | ||||
| 2 | Calf sleeve | Image: Calf sleeve | Non-woven sleeve | DS021 / Small size sleeve |
| DS022 / Medium size sleeve | ||||
| DS023 / Large size sleeve | ||||
| DS024 / X-Large size sleeve | ||||
| 3 | Foot sleeve | Image: Foot sleeve | Non-woven sleeve | DS031 / One size sleeve |
Indications For Use: V.
DVT-4000 is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. DVT-4000 is Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema-Acute, Edema-Chroni, Extremity Pain Incident to Trauma or Surgery Leg Ulcers, Venous Stasis / Venous Insufficiency.
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| A A A A A A A A A B A B A B A A A A A A A A A A A A A A A A A A A
A COLLECT COLLED A DICON TUTUR DE DE DE DE DE DELIT
1
| I | |
|---|---|
| A VALL 18 VARD V VAILAR FAMERIC VA 1 1 | |
| T | |
| 1 |
| Model Name | 510(k) Number | Classification | Picture | Indications for Use | Standard | Difference | (k) Submission: DVT-4000 | | -Identical- | Mode of
Compression | Mode description | Power Source | Therapy Time | Maximum and
Minimum
Pressure | Number of
Chamber | Compression
Interval Time | Compression
Garments Sleeve
Material |
|------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|------------------------|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|----------------------------------------------------|-------------------------------------------------------------|------------------------------|--------------------------------------------------------------------------------------------|
| DVT-4000 | K160180 | Class II Device /JOW
(21 CFR 870.5800) | Image: DVT-4000 device | DVT-4000 is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. DVT-4000 is Circulation Enhancement, Deep Vein Thrombosis Prophylaxis Edema – Acute, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery
Leg Ulcers, Venous Stasis / Venous Insufficiency | EN ISO 14971
EN 60601-1
EN 60601-1-2 | Identical- | Contraindications | | | Sequential | DVT mode 1 | Battery Specifications
Battery Model/Type reference : HY-BP08 / 4ICR19 / 66-0
Battery Ratings : 14.4Vdc(2600mAh)
Safety circuit : PCM equipped (overcharge, overdischarge, overcurrent prevention) | Continuous | 2060mmHg(Calf, Thigh, Boot),140mmHg(Foot) | Calf, Thigh, Boots cuff : 3chamber
120
Foot cuff : 1 chamber | 28sec, 48sec, 60sec | Non-woven
consist of Polyethylene Terephthalate ≥
99.25% and Titanium Dioxide ≤0.35% |
| DVT-2600 | K112677 | Class II Device /JOW (21 CFR 870.5800) | Image: DVT-2600 device | DVT-2600 is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. DVT-2600 is Circulation Enhancement, Deep Vein Thrombosis Prophylaxis Edema – Acute, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery
Leg Ulcers, Venous Stasis / Venous Insufficiency | EN ISO 14971
EN 60601-1
EN 60601-1-2 | Identical- | - Pre-existing deep vein
thrombosis, phlebothrombosis
or pulmonary embolism
- Presumptive evidence of
Congestive Heart Failure - Inflammatory Phlebitis Process
- Severe arteriosclerosis or other
ischemic vascular disease - Decompensated cardiac
insufficiency - Carcinoma metastasis in the
affected Extremity - Lymphatic return is undesirable
Severe arteriosclerosis or active infection | DVT-2600 device is a specialized
intermittent pneumatic compression (IPC)
system to prevent DVT (Deep Vein
Thrombosis) and PE (Pulmonary
Embolism) by improving the venous blood
flow in at risk patients.
The system consists of the controller, the
tubing sets and garments.
The system offers Sequential inflation
promoting venous blood movement and
metabolism and then has sufficient
interval time to refill with blood
sufficiently after deflation.
The operation of the inflation and
deflation is repeated until the stop button
is activated.
We recommend using the device
separately or with anti-coagulant
materials or compression stocking to help
prevent DVT and PE under a doctor's
consultant. | -Identical- | Sequential | DVT mode 1
Lymph mode 1 | ①Electricity Supply: AC 100-240V~,
50/60Hz
②Power consumption: 35VA | Continuous | 2060mmHg(Calf, Thigh, Boot),140mmHg(Foot) | Calf, Thigh, Boots cuff : 3chamber
120
Foot cuff : 1chamber | 28sec, 48sec, 60sec | Non-woven
consist of Polyethylene Terephthalate ≥
99.25% and Titanium Dioxide ≤0.35% |
| | DVT-4000 device is a specialized
intermittent pneumatic compression (IPC)
system to prevent DVT (Deep Vein
Thrombosis) and PE (Pulmonary
Embolism) by improving the venous blood
flow in at risk patients.
The system consists of the controller, the
tubing sets and garments.
The system offers Sequential inflation
promoting venous blood movement and
metabolism and then has sufficient
interval time to refill with blood
sufficiently after deflation.
The operation of the inflation and
deflation is repeated until the stop button
is activated.
We recommend using the device
separately or with anti-coagulant
materials or compression stocking to help
prevent DVT and PE under a doctor's
consultant. | | Identical- | DVT-4000 is designed for the
DVT mode only
Note 1 | DVT-4000 was developed with a built-in-battery adapter and replaced SMPS
(power supply circuits) with an external
power supply for the user convenience.
The battery performance is verified in
accordance with IEC62133
Note 2 | Identical- | Identical-(Note 3) | Identical-(Note 3) | Identical- | Identical (Note 3) | | | | | | | |
| | Description | | | | | | | | | | | | | | | | |
8
510(k) Submission : DVT-4000
9
510(k) Submission : DVT-4000
10
510(k) Submission : DVT-400
Note 1. Description on Mode difference
| Description | Verification Data | Performance Testing and
Risk Assessment |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Thigh Sleeve, Calf Sleeve, Boot Sleeve
Image: [Three leg diagrams showing the inflation sequence of the sleeve] | |
| 1 | Most frequently used DVT mode:
Air pressure is applied in each chamber in sequence from the bottom to the top as shown in the Figure.
A(Inflated)B(Deflated)C(Deflated)
→A(Inflated)B(Inflated)C(Deflated)
→A(Inflated)B(Inflated)C(Inflated)
→A(Deflated)B(Deflated)C(Deflated)
Foot Sleeve
Image: [Foot sleeve diagram] | Through the performance testing, the air pressure in each chamber is properly inflated sequentially.
There is no new risk associated with the DVT mode compared to the predicate device. |
| DVT-4000 is designed to have one mode, the DVT mode.
Some devices, including DVT-2600, the predicate device, are designed to have dual modes: DVT and Lymph mode.
Through customer feedback, the DVT-4000 is designed and manufactured to function with the DVT mode exclusively instead of dual modes. Its technology, features, materials and principle of operations are identical to DVT-2600, except DVT-4000 is with a single mode only, DVT mode. | | |
| Description | Verification Data | Performance Testing and Risk
Assessment |
| DVT-4000 was developed with a built-in-
battery adapter and replaced SMPS (power
supply circuits) with an external power
supply for the user convenience. | The battery performance is verified in accordance with IEC62133. | Potential problems of having a
battery were examined in the risk
management report. Efficiency
and risk of the battery was proved
through the battery test report and
the product test report conforming
to the Medical Appliances Act |
| The battery power is not intended to be
used as the main power supply but as
auxiliary power when the main power fails
or when the patient is moving. | | Risk assessment and mitigating
measures related to the application
of a battery are described in the
risk management report. |
11
Note 2. Description on Power source difference
Note 3. Description of Sleev
| Garments | Image | Chamber | Sleeve port | Pressure | Mode | | Sleeve
Material | Size | | Location
on the body | Biocompatibility test | Hose Image | Hose Length |
|--------------|---------------------|-----------|---------------------------------------------------------------------------------------------------------------------|--------------------|----------|------------------------------|------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|--|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|-------------|
| Foot Sleeve | Image: Foot Sleeve | 1 chamber | 1 port
(Foot sleeves use different connecting
ports separately and;
incompatible with other sleeve types.) | $120140\pm10mmHg$ | DVT mode | 510(k) Submission : DVT-4000 | Non-woven sleeves60\pm10mmHg$ | | | | 500mmX310mm (Small)
consist of Polyethylene Terephthalate ≥99.25% and Titanium Dioxide ≤0.35% | 420mmX230mm (One size) | | Foot | ISO10993-10 : Intracutaneous Reactivity (test report no.: GB16001)
ISO10993-10 : Skin sensitization (test report no.: GB16002)
ISO10993-5 : Cytotoxicity (test report no.: GB16050) | Image: Hose Image. The sleeve is provided in a state that the hose has been connected. | 2 meters |
| Calf Sleeve | Image: Calf Sleeve | 3 chamber | 3 port | $20
620mmX360mm (Medium)
770mmX380mm (Large)
970mmX380mm(X-Large) | | Calf | | Image: Hose | |
| Thigh Sleeve | Image: Thigh Sleeve | 3 chamber | 3 port | $2060\pm10mmHg$ | | | | 600mmX545mm (Small)60\pm10mmHg$ | | | | 635mmX710mm (One size) | | Both foot and calf | | Image: Hose | |
750mmX640mm (Medium)
930mmX670mm (Large)
1130mmX670mm (X-Large) | | Thigh | | | |
| Boots Sleeve | Image: Boots Sleeve | 3 chamber | 3 port | $20
12
Polyvinyl chlorid (PVC)
Hose Material
13
VII. PERFORMANCE DATA
The following performance testing was performed in substantial equivalence determination.
Electrical safety and EMC performance testing
Electrical safety and performance testing were conducted according to standard IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 and EMC testing was conducted in accordance with standard IEC 60601-1-2:2007.
Biocompatibility testing (ISO10993-5, ISO10993-10)
Biocompatibility for the sleeve material is testing reports are available as follows: ISO10993-10 : Intracutaneous Reactivity (test report no. : GB16001)
ISO10993-10 : Skin sensitization (test report no. : GB16002)
ISO10993-5 : Cytoxicity (test report no. : GB16050)
Software Verification and Validation Testing
Software verification and validation testing were conducted 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 his 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.
All test results were satisfactory. The intended use of the subject device has not changed as a result of the modifications.
VIII. 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 DVT-4000 is substantially equivalent in comparison with DVT-2600, the predicate device as described herein.