(30 days)
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.
The AcQGuide Catheter Introducer Sets 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.
The provided text is a 510(k) summary for the AcQGuide® FLEX and AcQGuide® MINI Introducers with AcQCross™ Qx dilator/transseptal needle. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of acceptance criteria and device performance in the typical sense of a clinical trial for AI/software-as-a-medical-device.
Based on the document, here's an analysis of the requested information:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or a performance table for a device's diagnostic accuracy or efficacy in the way one might expect for an AI device. Instead, it describes performance data related to the safety and functionality of the device, particularly focusing on the changes made (ES adapter cable and hemostasis valve). The "performance" demonstrated is primarily about meeting existing standards and showing substantial equivalence to predicate devices.
| Area of Performance | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Materials meet biocompatibility standards for intended use (ISO 10993). | The AcQGuide Introducer Set devices are made of identical materials to predicate devices (Flextra K170373, Guider K171081), except for the hemostasis valve. The new silicone rubber valve material is identical to that evaluated in Acutus AcQRef Introducer Sheath (K192016), thus no new biocompatibility testing was required. |
| Sterilization | Achieve a Sterility Assurance Level (SAL) of 10⁻⁶. | The devices undergo the identical ethylene oxide (EO) sterilization process as predicate devices to meet SAL of 10⁻⁶. The addition of the ES adapter cable was adopted into the existing process per AAMI TIR28, requiring no further validation. Shelf-life testing leveraged from predicate devices. |
| Electrical Safety & EMC | Compliance with applicable sections of ES 60601-1, IEC 60601-1-2, IEC 60601-2-2. | Testing conducted showed compliance with applicable sections of ES 60601-1:2005, IEC 60601-1:2006+A12:2014, IEC 60601-1-2:2014, and IEC 60601-2-2:2017. This is consistent with reference device Baylis Medical's NRG Transseptal Needle (K073326). |
| ES Generator Compatibility | System connectivity, no loose biological particulate, no coring, no dilator damage. | Successfully passed ES Generator Compatibility testing, including system connectivity, visual inspection for biological particulate, coring, and dilator damage. |
| Packaging Performance | Meet packaging performance specifications after Distribution Cycle testing. | The identical packaging system to the predicate devices underwent Distribution Cycle testing, followed by visual inspection and electrical connectivity testing, with positive results implied. |
| Hemostasis Valve Performance | Maintain hemostasis as per ISO 11070 Annex E Leak Test. | The AcQGuide Catheter Introducer Sets with the new silicone rubber valve material were tested to the same ISO 11070 Leak Test as the predicate devices, demonstrating its ability to maintain hemostasis. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes bench testing for specific components and functionalities rather than a "test set" in the context of diagnostic performance evaluation for a machine learning model.
- Biocompatibility: No new testing was performed; leveraged prior biocompatibility data from predicate devices (K170373, K171081) and a similar device (K192016).
- Sterilization: Process adoption via AAMI TIR28, not new testing on a sample set.
- Electrical Safety & EMC: Testing was conducted on the AcQGuide Introducer Set devices with the new ES adapter cable. No sample size is explicitly given, but this would typically involve a small number of devices to demonstrate compliance with standards.
- Bench Testing (ES Compatibility, Packaging, Hemostasis): Testing was performed for these aspects. No specific sample sizes are mentioned, but for bench testing, these are typically conducted on a representative sample of devices, often in the range of 3-10 units, to demonstrate compliance with engineering specifications and standards.
The data provenance is not specified, but these are typically retrospective in the sense that they are engineering tests performed by the manufacturer, rather than prospective clinical trials. The country of origin for the data (testing lab location) is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable. The product described is a medical device (catheter introducer set), not an AI/diagnostic software. Therefore, there is no "ground truth" to be established by medical experts in the context of diagnostic accuracy, nor a "test set" for expert review. The testing described is engineering compliance and performance testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable for a hardware device undergoing engineering and compliance testing. Adjudication methods are relevant for interpretation of diagnostic images or clinical outcomes, typically in studies involving human readers or AI algorithms.
5. 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
This question is not applicable. The device is a physical medical instrument, not an AI system. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant to the information provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This question is not applicable. As explained in point 3, there is no "ground truth" in the context of diagnostic accuracy for this hardware device. The "truth" in these tests is compliance with engineering specifications, safety standards (e.g., biocompatibility limits, electrical safety thresholds), and functional performance parameters (e.g., hemostasis, mechanical integrity).
8. The sample size for the training set
This question is not applicable. There is no training set mentioned or relevant for this type of medical device submission.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 Medical2210 Faraday Ave, Suite 100Carlsbad, CA 92008US FDA ERN: 3012120746 | Manufacturer's Contact Person: | Greg GeissingerDirector of Regulatory Affairs andQuality AssurancePhone: (442) 232-6128Fax: (442) 232-6081Email: Greg.Geissinger@acutus.com |
|---|---|---|---|
| --------------- | ----------------------------------------------------------------------------------------------- | -------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Trade Name | AcQGuide® Catheter Introducer Sets:AcQGuide® FLEX and AcQGuide® MINI Introducerswith 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.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).