AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX

K193509 · Acutus Medical, Inc. · DYB · Jan 17, 2020 · Cardiovascular

Device Facts

• Record ID: K193509
• Device Name: AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX
• Applicant: Acutus Medical, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Jan 17, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The AcQGuide® Catheter Introducer Sets are indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

Device Story

AcQGuide Catheter Introducer Sets (FLEX steerable or MINI fixed-curve) facilitate vascular access and catheter positioning in the heart. Components include introducer, integrated AcQCross Qx dilator/transseptal needle, guidewire, and ECG/ES adapter cables. The AcQCross Qx features a spring-tensioned actuator for needle extension and a Luer connector for ECG monitoring or RF current delivery via an external electrosurgical generator to assist septal puncture. Used in clinical settings by physicians; the introducer handle includes a hemostasis valve and sideport for aspiration/infusion. Radiopaque markers aid fluoroscopic visualization. The device provides a pathway for cardiac catheters; RF capability offers an optional method for transseptal crossing, improving procedural efficiency.

Clinical Evidence

Bench testing only. Testing included ES generator compatibility, system connectivity, visual inspection for particulate/coring/damage, distribution cycle testing, and ISO 11070 hemostasis leak testing. Electrical safety and EMC testing performed per IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2. Biocompatibility and sterilization (EO) were leveraged from predicate/reference devices.

Technological Characteristics

Introducer sets with steerable (FLEX) or fixed-curve (MINI) shafts. Materials include platinum radiopaque markers, silicone rubber hemostasis valves, and stainless steel needles. Connectivity: ECG/ES adapter cables (1m, IEC 60601-1/2-2 compliant). Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Guidewire compliant to ISO 594-1/2.

Indications for Use

Indicated for patients requiring introduction of cardiovascular catheters into the heart, including transseptal access to the left heart.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Flextra Steerable Introducer Set (K170373)
• Guider Catheter Introducer Set (K171081)

Reference Devices

• NRG Transseptal Needle (K073326)
• AcQRef Introducer Sheath (K192016)
• AcQRef Introducer Sheath (K171557)

Submission Summary (Full Text)

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January 17, 2020

Acutus Medical, Inc. % Prithul Bom Official Correspondent Regulatory Technology Services LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K193509

Trade/Device Name: AcQGuide® FLEX and AcQGuide® MINI Introducers with AcQCros™ Qx dilator/transseptal needle Regulation Number: 21 CFR 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: December 16, 2019 Received: December 18, 2019

Dear Prithul Bom:

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 (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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for Nicole G. Ibrahim, Ph.D. 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) K193509

#### Device Name

AcQGuide® Catheter Introducer Sets: AcQGuide® FLEX and AcQGuide® MINI Introducers with AcQCross™ Qx dilator/transseptal needle

#### Indications for Use (Describe)

The AcQGuide® Catheter Introducer Sets are indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

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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Image /page/3/Picture/1 description: The image shows the logo for Acutus Medical. The logo is composed of the word "ACUTUS" in gray, with a small orange dot in the lower left corner of the "A". Below the word "ACUTUS" is the word "MEDICAL" in orange, with each letter spaced out. The logo is simple and modern, and the colors are muted and professional.

## 5.0 510(K) SUMMARY

510(k) Number: K193509 or TBD [X]

Date Prepared: December 6, 2019

## Table 1: Submitter Information

| Manufacturer: | Acutus Medical<br>2210 Faraday Ave, Suite 100<br>Carlsbad, CA 92008<br>US FDA ERN: 3012120746 | Manufacturer's Contact Person: | Greg Geissinger<br>Director of Regulatory Affairs and<br>Quality Assurance<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
|---------------|-----------------------------------------------------------------------------------------------|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------|-----------------------------------------------------------------------------------------------|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Trade Name | AcQGuide® Catheter Introducer Sets:<br>AcQGuide® FLEX and AcQGuide® MINI Introducers<br>with AcQCross™ Qx dilator/transseptal needle |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Catheter Introducer Sets |
| Classification Name | Introducer, Catheter |
| Regulation | 21 CFR 870.1340 |
| Product Code | DYB |
| Regulatory Classification: | Class II |
| Device Panel: | Cardiovascular |

#### Table 2: Device Information

The Acutus AcQGuide Catheter Introducer sets are substantially equivalent to the previously cleared predicate Flextra Steerable Introducer and Guider Catheter Introducer sets (Table 3). Neither of these have been subject to a design-related recall.

#### Table 3: Predicate Devices

| Predicate Device | Manufacturer | FDA 510(k) |
|----------------------------------|----------------|------------|
| Flextra Steerable Introducer Set | Acutus Medical | K170373 |
| Guider Catheter Introducer Set | Acutus Medical | K171081 |

In the same manner as the current ECG adapter cable is attached to the AcQCross Qx dilator/transseptal needle, a new electrosurgical (ES) adapter cable is provided in the AcQGuide Catheter Introducer sets. The ES adapter allows for the option to apply RF current from commercially marketed ES generators to facilitate the septal puncture. This is done in a similar manner as Baylis Medical's NRG Transseptal Needle (Table 4).

#### Table 4: Reference Device

| Reference Device | Manufacturer | FDA 510(k) |
|------------------------|----------------|------------|
| NRG Transseptal Needle | Baylis Medical | K073326 |

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## 5.1 Device Description

The AcQGuide Catheter Introducer Sets (Figure 1 and Figure 2) contain either a steerable introducer (AcQGuide FLEX) or fixed curve introducer (AcQGuide MINI), an integrated vessel dilator/transseptal needle (AcQCross Qx), guidewire, and electrocardiogram (ECG) and electrosurgical (ES) adapter cables. The sets are designed to facilitate vascular access to the heart and then provide variable catheter positioning within the cardiac anatomy.

Image /page/4/Picture/4 description: The image shows a medical device kit. The kit includes an AcQGuide FLEX introducer, an AcQCross Qx dilator/needle, a guidewire, and an ES & ECG adapter. The components are arranged in a white tray, and the labels point to each of the components.

Figure 1: AcQGuide FLEX Catheter Introducer Set

Image /page/4/Picture/6 description: The image shows a medical kit with various components laid out in a white tray. The kit includes an AcQGuide MINI introducer, an AcQCross Qx dilator/needle, an ES & ECG adapter, and a guidewire. The components are neatly arranged and labeled, providing a clear view of the tools included in the kit. The guidewire is coiled in a circular pattern, while the other components are positioned linearly along the tray.

Figure 2: AcQGuide MINI Catheter Introducer Set

The AcQGuide FLEX introducer (Figure 3) has an elongated shaft with central lumen capable of accepting the AcQCross Qx dilator/needle (Figure 4) as well as various cardiac catheters. The shaft has a proximal handle with a rotating actuator that allows the user to change the degree of curvature on the distal tip of the shaft (referred to as steerable tip, deflectable tip, or dynamic tip). Rotating the actuator can deflect the tip, in a planar fashion, +/- 180°. The handle is also fitted with a hemostasis valve to minimize blood loss during catheter introduction, and/or exchange, as well as a sideport with 3-way stopcock to allow blood aspiration, fluid infusion, and pressure monitoring. The introducer shaft features distal side holes to facilitate aspiration and prevent cavitation plus an embedded platinum radiopaque tip marker to facilitate fluoroscopic visualization.

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Image /page/5/Picture/1 description: The image shows the logo for Acutus Medical. The word "ACUTUS" is written in gray, block letters. Below that, the word "MEDICAL" is written in smaller, gold letters.

Image /page/5/Figure/2 description: The image shows a medical device with its dimensions labeled. The handle of the device is labeled as 22 cm long. The effective length of the device is labeled as 30 and 65 cm.

Figure 3: AcQGuide FLEX Introducer

Image /page/5/Figure/4 description: The image shows a diagram of an AcQCross Qx connected to an AcQGuide FLEX. The diagram highlights the male/female interface between the two devices. The AcQCross Qx is on the left side of the image, and the AcQGuide FLEX is on the right side.

Figure 4: AcQGuide FLEX joined to AcQCross Qx

The AcQGuide MINI introducer (Figure 5) is an elongated shaft with central lumen capable of accepting the AcQCross Qx dilator/needle (Figure 6) as well as various cardiac catheters. The shaft is attached to a proximal handle that is fitted with a hemostasis valve to minimize blood loss during catheter introduction, and/or exchange, as well as a sideport with 3-way stopcock to allow blood aspiration, fluid infusion, and pressure monitoring. The introducer shaft features distal side holes to facilitate aspiration and prevent cavitation plus an embedded platinum radiopaque tip marker to facilitate fluoroscopic visualization. The distal end of the shaft has a preformed fixed-curve shape.

Image /page/5/Figure/7 description: The image shows a medical instrument with a fixed-curve tip. The instrument has a long, thin tube with a curved tip on one end. There is a sideport with a 3-way stopcock located along the tube. The other end of the tube has a proximal handle with a hemostasis valve.

Figure 5: AcQGuide MINI Introducer

Image /page/5/Figure/9 description: The image shows a diagram of two medical devices, the AcQCross Qx and the AcQGuide MINI, connected via a male/female interface. The AcQCross Qx is a cylindrical device with a needle extending from one end. The AcQGuide MINI is a larger, cone-shaped device with a hollow opening at one end to connect to the AcQCross Qx.

Figure 6: AcQGuide MINI joined to AcQCross Qx

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Image /page/6/Picture/1 description: The image shows the logo for Acutus Medical. The logo is composed of the word "ACUTUS" in a sans-serif font, with the letters in gray. Below the word "ACUTUS" is the word "MEDICAL" in a smaller, sans-serif font, with the letters in gold. The logo is simple and modern, and it is likely used to represent the company's brand.

The AcQCross Qx integrated dilator/transseptal needle (Figure 7) combines the vessel dilator and transseptal needle of the conventional devices into a single component. The AcOCross Ox consists of an elongated shaft with a tapered tip and central lumen to track over a guidewire in a similar fashion to conventional vessel dilators. The lumen of the AcQCross Qx is fitted with a hollow stainless steel transseptal needle and both the shaft and needle are connected to the same proximal handle. The needle lumen will accept guidewire sizes up to 0.032 inches in diameter. Inside the AcQCross Ox handle, the needle is affixed to a spring-tensioned actuator that prevents needle extension until the operator purposely advances the needle via a slider button located on the outer surface of the handle. The proximal handle is fitted with a Luer connector to gain access to the central lumen of the needle. The handle is also fitted with an electrical connector that a) allows monitoring an ECG from the needle while in the heart utilizing the ECG adapter cable, and/or b) allows application of radiofrequency (RF) current from an electrosurgical generator to facilitate the septal puncture utilizing the ES adapter cable.

Image /page/6/Figure/3 description: The image shows a medical device called ACQCross QX. The device has a dilator shaft, a Luer fitting, and an electrical connector for ECG monitoring. There is also a spring-tensioned push button for needle extension and a male interlock for mating with an introducer hub.

Figure 7: AcQCross Qx Dilator/Transseptal Needle

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Image /page/7/Picture/0 description: The image shows the logo for Acutus Medical. The word "ACUTUS" is written in a sans-serif font in gray color. Below the word "ACUTUS", the word "MEDICAL" is written in a smaller sans-serif font in gold color. A registered trademark symbol is present to the right of the word "ACUTUS".

The guidewire included in the kit is manufactured by Lake Region Medical (K935170) and is supplied in a polypropylene retainer coil with a J-straightener and Luer fitting. The Luer fitting is compliant to ISO 594-1 and ISO 594-2. The ECG and ES adapter cables included are manufactured by Plastics One, are one (1) meter long, and are compliant with IEC 60601-1 and IEC 60601-2-2 safety standards.

## 5.2 Indications for Use

The AcQGuide Catheter Introducer Sets are indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

## 5.3 Comparison of Technological Characteristics with the Predicate Device

The AcQGuide Introducer Sets are identical to the predicate Flextra Steerable Introducer (K170373) and Guider Catheter Introducer (K171081) sets except they are now provided with an ES adapter cable. The design of the introducer and dilator/transseptal needle devices remains unchanged. The inclusion of the ES adapter cable in the set allows the physician the option to use RF current as an adjunct during the transseptal puncture procedure. All other feature benefits remain unchanged.

The subject and predicate devices are based on the same technological elements of creating an atrial-septal defect (puncture) in the heart to allow for introduction of various cardiovascular catheters. The following technological difference exists between the subject and predicate devices:

- Use of a commercially available ES generator to apply RF current through the AcQCross . Qx via the newly provided ES adapter cable. Although different from the predicate devices, this method is equivalent to that of the Reference Device - Baylis Medical NRG Transseptal Needle (K073326).
This difference provides convenience and efficiency over the predicate device and does not impact the intended use.

Due to supply issues, the hemostasis valve component of the AcQGuide Catheter Introducer Sets was changed from a polyisoprene valve to a silicone rubber valve. The silicone rubber valve is the same that is used in the Acutus AcQRef Introducer Sheath cleared via K192016 and originally via K171557 and whose biocompatibility has been assessed in those same filings. The performance of the new valve has been assessed to be substantially equivalent to the predicate devices through conduct of identical hemostasis leak testing specified in ISO 11070, Sterile single-use intravascular introducers, dilators and guidewires, Annex E.

#### 5.4 Performance Data

The only changes made to the AcQGuide Catheter Introducer Sets include providing an ES adapter cable to optionally apply RF current from an ES generator to facilitate the septal puncture, updating the associated Instructions for Use (IFU), and changing the hemostasis valve from polyisoprene to silicone rubber. All other aspects of the devices remain unchanged. The testing performed on the AcQGuide Catheter Introducer Sets focused on the safety and performance of the ES assistance in generating the atrial-septal puncture.

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Image /page/8/Picture/1 description: The image shows the logo for Acutus Medical. The logo is composed of the word "ACUTUS" in a stylized font, with the letters in gray. Below the word "ACUTUS" is the word "MEDICAL" in a smaller, gold font. The logo is simple and modern, and it is likely used to represent the company's brand.

The following performance data were provided in support of the substantial equivalence determination.

## 5.4.1 Biocompatibility

The AcQGuide Introducer Set devices are made of identical materials to the predicate devices with the exception of the modified hemostasis valve. The previously submitted biocompatibility testing of the predicate Flextra (K170373) and Guider (K171081) devices has been leveraged for the subject devices. The hemostasis valve in the new AcQGuide Catheter Introducer sets is of the identical material and similar design with that used in the Acutus AcQRef Introducer Sheath which has already been evaluated for biocompatibility by FDA via K192016. Therefore, no new biocompatibility testing was required for the subject devices.

#### 5.4.2 Sterilization

The AcQGuide Introducer Set devices are subjected to the identical ethylene oxide (EO) sterilization process as the predicate devices to meet a sterility assurance level (SAL) of 106 The addition of the ES adapter cable to the package has been adopted into the existing process per AAMI TIR28, Product Adoption and Process Equivalence for Ethylene Oxide Sterilization, and requires no further process validation. The shelf-life testing of the predicate devices has been leveraged for the subject devices and no additional shelf-life testing was required.

## 5.4.3 Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing were conducted on the AcQGuide Introducer Set devices with the new ES adapter cable. The testing complies with the applicable sections of ES 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance, and IEC 60601-1:2006+A12:2014, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance, IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for the basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests, and IEC 60601-2-2:2017, Medical electrical equipment – Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequencv surgical accessories. This testing is consistent with that conducted by the reference device Baylis Medical's NRG Transseptal Needle (K073326).

#### 5.4.4 Bench Testing

The AcQGuide Introducer Set devices were subject to ES Generator Compatibility testing including system connectivity, visual inspection for a) loose biological particulate, b) coring, and c) dilator damage. The packaging system is identical to the predicate and to provide added assurance the subject devices continue to meet packaging performance specifications, the devices underwent Distribution Cycle testing followed by visual inspection and electrical connectivity testing. The change in supply of the hemostasis valve was assessed to ensure the device's abilitv to maintain hemostasis was not affected. As such, the AcQGuide Catheter Introducer Sets with the new valve were tested to the same ISO 11070 Leak Test as the predicate devices.

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Image /page/9/Picture/1 description: The image shows the logo for Acutus Medical. The logo consists of the word "ACUTUS" in gray, with a small dot above the "A". Below the word "ACUTUS" is the word "MEDICAL" in a smaller, tan font. The logo is simple and modern, and it is likely used to represent the company's brand.

All other performance testing has been leveraged from the predicate devices and no additional performance testing was required.

## 5.5 Conclusions

The AcQGuide Introducer Sets are of the identical materials and design of the predicate devices and have similar technical requirements. They perform as intended and present no unacceptable risks to the intended patient population or end user. The non-clinical bench data support the safety of the device and demonstrate that the AcQGuide Introducer Sets perform as intended in the specified use conditions. The addition of the ES adapter cable for use in the optional RF method does not raise any new questions regarding safety or effectiveness of the device as compared to the reference device.

The AcQGuide Introducer Sets are substantially equivalent to the predicate Flextra Steerable Introducer set (K170373) and Guider Catheter Introducer set (K171081) devices.