(60 days)
Not Found
No
The device description and performance studies focus on mechanical function and material properties, with no mention of AI or ML.
No.
The device prevents retrograde blood flow in an extracorporeal circuit, which is a safety mechanism rather than a therapeutic action to treat a medical condition or disease.
No
The device is described as an arterial safety valve intended to prevent retrograde flow in an extracorporeal circuit during cardiopulmonary bypass procedures. Its function is mechanical (ensuring unidirectional flow) and not for diagnosing a condition or disease.
No
The device description clearly outlines physical components made of ABS, silicone rubber, and PVC, indicating it is a hardware device, not software-only.
Based on the provided information, the MiniGuard™ Arterial Safety Valve is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended for use in an Extracorporeal Circuit during cardiopulmonary bypass procedures for the prevention of retrograde flow. This is a direct interaction with the patient's blood flow outside the body, but it's a mechanical function within a medical procedure, not a diagnostic test performed on a sample in vitro.
- Device Description: The description details a mechanical valve designed to control blood flow. It doesn't mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies focus on the mechanical and biological compatibility of the device with blood flow (e.g., flow rates, pressure, hemolysis, biocompatibility). These are relevant to a medical device used in a surgical procedure, not an IVD.
- Lack of Diagnostic Metrics: There are no mentions of diagnostic metrics like sensitivity, specificity, AUC, etc., which are standard for IVD devices.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. The MiniGuard™ Arterial Safety Valve's function is purely mechanical within a surgical circuit.
N/A
Intended Use / Indications for Use
The MiniGuard™ Arterial Safety Valve is intended to be used in an Extracorporeal Circuit during cardiopulmonary bypass procedures for the prevention of retrograde flow.
Product codes
MJJ
Device Description
The MiniGuard Arterial Safety Valve ensures unidirectional flow in a blood filled line by means of a duckbill check valve located in the valve housing. If the line becomes pressurized, the check valve would automatically close and prevent flow in the reverse direction. A directional arrow as shown in Figure 12.1 below is printed on the valve to provide the user with a visual indication of blood flow. The MiniGuard Arterial Safety Valve consists of a an inlet and outlet housing made from Terlux 2802 HD ABS and a duckbill made from GLP-38L6 Off White Silicone rubber. The MiniGuard is sold with a cap made from PVC, 6811G-05. The cap is removed before use and has no patient contact. No colorants or adhesives are used on the valve.
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
Extracorporeal Circuit during cardiopulmonary bypass procedures
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
All necessary bench testing was conducted on the MiniGuard™ Arterial Safety Valve to support a determination of substantial equivalence to the predicate device. Performance testing included:
- Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, Pyrogenicity, Genotoxicity and Hemocompatibility)
- Visual Inspection
- Priming Volume
- Opening Pressure
- Minimum Flow Rate
- Maximum Flow Rate
- Retrograde Flow
- Pressure Drop
- Continuous Flow
- Leak Test
- High Pressure Leak Test
- Mechanical Hemolysis
Results of the performance testing demonstrates that the device meets all established specifications necessary for consistent performance.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4400 Cardiopulmonary bypass blood reservoir.
(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 6, 2018
Quest Medical, Inc. Tosan Onosode Regulatory Affairs Specialist One Allentown Parkway Allen, Texas 75002
Re: K182442
Trade/Device Name: MiniGuard Arterial Safety Valve Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary bypass blood reservoir Regulatory Class: Class II Product Code: MJJ Dated: September 5, 2018 Received: September 7, 2018
Dear Tosan Onosode:
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/cdrl/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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Fernando Aguel Fernando Aguel - S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
| Food and Drug Administration | |
|---|---|
| Indications for Use | Form Approved: OMB No. 0910-0120 |
| Expiration Date: 06/30/2020 | |
| See PRA Statement below. | |
| 510(k) Number (if known) | K182442 |
| Device Name | MiniGuard™ Arterial Safety Valve |
| Indications for Use (Describe) | The MiniGuard™ Arterial Safety Valve is intended to be used in an Extracorporeal Circuit during cardiopulmonary |
| bypass procedures for the prevention of retrograde flow. |
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
| FORM FDA 3881 (7/17) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 | EF |
|---|---|---|---|
| ---------------------- | ------------- | ---------------------------------------- | ---- |
1
oul പ്രാഥ്യമന ഭാഗമ
787 то 94 әреч
ាញ
【
,现
11
上
3
510(k) Summary MiniGuard™ Arterial Safety Valve
APPLICANT:
Quest Medical, Inc. One Allentown Parkway Allen, TX 75002 USA 972-390-9800/800-627-0226
Contact Person:
Tosan Onosode Regulatory Affairs Specialist Quest Medical, Inc. Phone: 972-332-6338 Fax: 972-390-2881
DATE PREPARED: SEPTEMBER 5, 2018
TRADE NAME:
MiniGuard™ Arterial Safety Valve
Generic/Common Name:
Cpb Check Valve, Retrograde Flow, In-Line
CLASSIFICATION NAME:
Cardiopulmonary Bypass Blood Reservoir
CLASSIFICATION NUMBER:
870.4400
CLASS:
Class II
Product Code:
MJJ
4
Predicate Device
K922356, RetroGuard Arterial Safety Valve
DEVICE DESCRIPTION
The MiniGuard Arterial Safety Valve ensures unidirectional flow in a blood filled line by means of a duckbill check valve located in the valve housing. If the line becomes pressurized, the check valve would automatically close and prevent flow in the reverse direction. A directional arrow as shown in Figure 12.1 below is printed on the valve to provide the user with a visual indication of blood flow. The MiniGuard Arterial Safety Valve consists of a an inlet and outlet housing made from Terlux 2802 HD ABS and a duckbill made from GLP-38L6 Off White Silicone rubber. The MiniGuard is sold with a cap made from PVC, 6811G-05. The cap is removed before use and has no patient contact. No colorants or adhesives are used on the valve.
Indications for Use
The MiniGuard™ Arterial Safety Valve is intended to be used in an Extracorporeal Circuit during cardiopulmonary bypass procedures for the prevention of retrograde flow.
TECHNOLOGICAL CHARACTERISTICS/SUBSTANTIAL EQUIVALENCE
Quest Medical's RetroGuard Arterial Safety Valve cleared under K922356 is the predicate device for this submission. At the time of clearance, the predicate device was known as Flow Control Valve, ACV-38 and the premarket application was filed by American Omni Medical, Inc. Quest Medical acquired American Omni in 1993 and the device name was thereafter changed to RetroGuard Arterial Safety Valve.
The subject device and the predicate have the same indications for use, operating principle, basic design features and are packaged and sterilized using the same materials and processes. There are minor wording differences between the indications for use of the predicate device and the subject device but these differences do not create a new intended use. The overall intended use - preventing retrograde flow remains the same for the predicate and subject device. The first difference in the indications statement is the use of the phrase "intended to be used in an Extracorporeal Circuit during cardiopulmonary bypass procedures" in the subject device's indications which seeks to clarify the phrase "indicated for use during extracorporeal procedures" used in the predicate's indication. This wording change does not introduce any change to the predicate's intended use, as the predicate device was cleared specifically for use in cardiopulmonary bypass procedures. The other difference is use of the phrase "for the prevention of retrograde flow" in the subject device's indication. This phrase, although worded differently, connotes the same meaning as the phrase "ensure that the fluid in the tubing flows in one direction only" used in the predicate's indication. These minor wording differences in the indications for use statement does not change the intended use (prevention of retrograde flow) or raise different questions of safety and effectiveness.
5
The primary differences between the subject device and the predicate are with respect to dimensions, duckbill material and shelf life. The subject device has 1/4" inlet and outlet ports and is smaller than the predicate device which has 3/8" inlet and outlet ports. The material used in the housing and caps for the predicate device and the subject device are identical. The only difference with respect to material is on the duckbill. The material used in the duckbill for the subject device and predicate are both silicone rubber but are sourced from different suppliers. The subject device duckbill is made from an off white silicone rubber which has no colorant and the predicate device duckbill uses a white silicone rubber. The predicate device shelf life is 3 years and the subject device shelf life is 1 year.
Overall, the results of functional performance and biocompatibility testing conducted on the subject device demonstrates that the differences in technological characteristics between the subject device and the predicate do not raise different questions of safety and effectiveness and the subject device is substantially equivalent to the predicate.
PERFORMANCE DATA
All necessary bench testing was conducted on the MiniGuard™ Arterial Safety Valve to support a determination of substantial equivalence to the predicate device. Performance testing included:
- Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute ● Aystemic Toxicity, Pyrogenicity, Genotoxicity and Hemocompatibility)
- . Visual Inspection
- Priming Volume .
- . Opening Pressure
- . Minimum Flow Rate
- Maximum Flow Rate
- Retrograde Flow
- Pressure Drop
- Continuous Flow
- . Leak Test
- . High Pressure Leak Test
- . Mechanical Hemolysis
Results of the performance testing demonstrates that the device meets all established specifications necessary for consistent performance.
CONCLUSIONS
The subject device, MiniGuard™ Arterial Safety Valve is substantially equivalent to the predicate device.