MiniGuard Arterial Safety Valve

K182442 · Quest Medical, Inc. · MJJ · Nov 6, 2018 · Cardiovascular

Device Facts

• Record ID: K182442
• Device Name: MiniGuard Arterial Safety Valve
• Applicant: Quest Medical, Inc.
• Product Code: MJJ · Cardiovascular
• Decision Date: Nov 6, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4400
• Device Class: Class 2

Intended 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.

Device Story

MiniGuard Arterial Safety Valve is an in-line check valve for extracorporeal circuits; used during cardiopulmonary bypass procedures. Device utilizes a duckbill check valve mechanism within a housing; automatically closes upon line pressurization to prevent reverse blood flow. Directional arrow on housing provides visual flow guidance. Operated by perfusionists or clinical staff in surgical settings. Device ensures unidirectional flow; prevents retrograde flow; mitigates risks associated with backflow during bypass. Input is blood flow within the circuit; output is unidirectional flow maintenance. No electronic or software components.

Clinical Evidence

Bench testing only. Testing included biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, genotoxicity, hemocompatibility) and functional performance (priming volume, opening pressure, flow rates, retrograde flow, pressure drop, continuous flow, leak tests, and mechanical hemolysis). Results demonstrate the device meets all established specifications.

Technological Characteristics

Housing: Terlux 2802 HD ABS. Duckbill: GLP-38L6 off-white silicone rubber. Cap: PVC 6811G-05. Mechanical check valve; unidirectional flow via duckbill geometry. Dimensions: 1/4" inlet/outlet ports. Sterilized. No energy source. No software.

Indications for Use

Indicated for use in extracorporeal circuits during cardiopulmonary bypass procedures to prevent retrograde blood flow.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• RetroGuard Arterial Safety Valve (K922356)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 SERVICES<br>Food and Drug Administration | |
|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Form Approved: OMB No. 0910-0120<br>Expiration Date: 06/30/2020<br>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<br>bypass procedures for the prevention of retrograde flow. |

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <div> <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> </div> <div> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </div> |

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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: [phone] Fax: [phone]

### 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

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.

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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.