The MiniGuard™ Arterial Safety Valve is intended to be used in an Extracorporeal Circuit during cardiopulmonary bypass procedures for the prevention of retrograde flow.

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.

AI/ML Overview

The provided text describes the MiniGuard™ Arterial Safety Valve, outlining its intended use, technological characteristics, and performance data to support its substantial equivalence to a predicate device (RetroGuard Arterial Safety Valve, K922356). However, the document does NOT contain explicit acceptance criteria defined by specific numerical thresholds for each test, nor a detailed study that directly "proves" the device meets these criteria in the typical sense of a clinical trial or a statistically powered performance study against pre-defined metrics.

Instead, the document states: "Results of the performance testing demonstrates that the device meets all established specifications necessary for consistent performance." This implies that internal specifications were met, but these specifications are not explicitly detailed for each test.

Therefore, the following information is extracted or inferred based on the provided text. Many fields cannot be directly answered due to the nature of the available document, which is a 510(k) summary focused on substantial equivalence rather than a full study report with detailed acceptance criteria and performance data.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from testing performed)	Reported Device Performance (Inferred as 'met established specifications')
Biocompatibility:	Met established specifications for: Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, Pyrogenicity, Genotoxicity and Hemocompatibility.
Visual Inspection:	Met established specifications.
Priming Volume:	Met established specifications.
Opening Pressure:	Met established specifications.
Minimum Flow Rate:	Met established specifications.
Maximum Flow Rate:	Met established specifications.
Retrograde Flow:	Met established specifications (i.e., successfully prevented retrograde flow as intended).
Pressure Drop:	Met established specifications.
Continuous Flow:	Met established specifications.
Leak Test:	Met established specifications.
High Pressure Leak Test:	Met established specifications.
Mechanical Hemolysis:	Met established specifications.

Note: The document only states that the device "meets all established specifications necessary for consistent performance." It does not provide the specific numerical values for these specifications (e.g., "Opening pressure < X mmHg") nor the exact reported performance values (e.g., "Opening pressure was Y mmHg").

Additional Study Information:

Sample size used for the test set and the data provenance: Not specified. The document mentions "performance testing" but does not detail the number of units tested for each parameter or the origin of any data (e.g., country, retrospective/prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable / Not specified. This device is a mechanical valve, so "ground truth" as typically applied to diagnostic AI algorithms involving human expert interpretation is not relevant here. The ground truth for its performance would be determined by direct physical measurement and engineering testing.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. See point 2.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a mechanical valve; it is not an AI-based diagnostic tool that assists human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device, not an algorithm. Its performance is inherently "standalone" in the sense that it operates without human intervention once installed in the circuit.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is based on direct physical measurement and engineering testing against predefined industrial/performance specifications (e.g., flow rates, pressure, leak integrity).
The sample size for the training set: Not applicable. This is a mechanical device, not an AI model that requires a training set.
How the ground truth for the training set was established: Not applicable. See point 7.

Summary

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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

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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

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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration
Indications for Use	Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See 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 cardiopulmonarybypass 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)

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FORM FDA 3881 (7/17)	Page 1 of 1	PSC Publishing Services (301) 443-6740	EF
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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

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Predicate Device

K922356, RetroGuard Arterial Safety Valve

DEVICE DESCRIPTION

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.

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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.

Regulation Number and Section

§ 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.