(29 days)
No
The device description focuses on mechanical and electrical components for transseptal puncture and monitoring, with no mention of AI or ML algorithms for analysis, decision-making, or image processing.
No.
A therapeutic device is one that treats or provides therapy for a medical condition. This device is used to puncture the interatrial septum to gain access to the left side of the heart, allowing other cardiovascular catheters to be introduced, but it does not directly provide therapy.
No
The device is indicated to puncture the interatrial septum to gain access for introducing various cardiovascular catheters, and it can facilitate septal puncture and monitor intracardiac electrograms. Its primary function is interventional/therapeutic access, not diagnosis. The monitoring of EGMs is secondary and supports the therapeutic procedure without diagnostically characterizing a disease state in itself.
No
The device description clearly details a physical medical device consisting of an elongated shaft, tapered tip, central lumen, stainless steel transseptal needle, proximal handle, Luer connector, and electrical connector. It is a hardware device used for a physical procedure.
Based on the provided information, the AcQCross™ Qx Integrated Transseptal DilatorNeedle is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "puncture the interatrial septum to gain access to the left side of the heart whereby various cardiovascular catheters are introduced." This describes a surgical/interventional procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a device designed for physical manipulation within the heart (dilator, needle, guidewire tracking, electrical connections for EGMs and RF). This is consistent with an invasive medical device used in a procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The AcQCross™ Qx is a tool used to facilitate a medical procedure, not to perform a diagnostic test on a sample.
N/A
Intended Use / Indications for Use
The AcQCross™ Qx Integrated Transseptal Dilator/Needle is indicated to puncture the interatrial septum to gain access to the left side of the heart whereby various cardiovascular catheters are introduced.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
AcQCross™ Qx combines the conventional vessel dilator and transseptal needle into a single device (Figure 1). AcQCross™ Ox consists of an elongated shaft with a tapered tip and central lumen to track over a guidewire. The lumen of AcQCross™ Qx is fitted with a hollow stainless steel transseptal needle (Figure 2). Both the shaft and needle are connected to the proximal handle of AcQCross™ QX. The lumen of the needle will allow for guidewires up to 0.032" in diameter. The needle is affixed to a spring-tensioned actuator in the handle of AcQCross™ QX 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 allows for monitoring intracardiac electrograms (EGMs) from the needle while in the heart utilizing the EGM adapter cable, and/or allows for the application of radiofrequency (RF) current from an electrosurgical generator to facilitate the septal puncture utilizing the ES adapter cable. AcQCross™ Qx is for single-use only and is provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
interatrial septum, left side of the heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing for AcQCross™ Qx and the predicate device, the AcQGuide Catheter Introducer Sets, were performed in accordance with the following standards.
- ISO 11070: 2014 Sterile single-use intravascular introducers, dilators and guidewires .
- . ISO 10555-1: 2013 - Sterile, single-use intravascular catheters- Part 1: General Requirements
Other than the following modifications, AcQCross™ Qx as a standalone device is identical to that of the predicate device, the AcQGuide Catheter Introducer Sets(K193509).
Biocompatibility testing was performed on AcQCross™ Qx in accordance with AAMI/ANSI/ISO 10993-1:2009 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. Testing was performed on AcQCross™ Ox as packaged with the AcOGuide Catheter Introducer Sets, which is identified in this submission as the predicate device. Biocompatibility testing for the AcQGuide Catheter Introducer Sets(K193509) was submitted with the predicate device, Flextra™ Steerable Introducer (K170373) and Guider™ Catheter Introducer (K171081), with Lancer™ Integrated Dilator/Transseptal Needle. The previously submitted biocompatibility testing in K170373 and K171081 has been leveraged for the subject device. Additional cytotoxicity and hemolysis testing was performed as a result of a new shaft supplier. The results demonstrate that AcQCross™ Qx meets the requirements of ISO 10993-1 and is biocompatible.
Sterilization validation was performed on AcOCross™ Ox in accordance with ISO 11135: 2014 -Sterilization of health-care products- Ethylene Oxide- Requirements for development, validation and routine control of a sterilization process for medical devices. AcQCross™ Ox is subjected to the identical ethylene oxide (EO) sterilization process as the predicate device, the AcQGuide Catheter Introducer Sets, to meet a sterility assurance level (SAL) of 10-6. Testing was performed on AcQCross™ Qx as packaged with the AcQGuide Catheter Introducer Sets. The previously submitted sterilization validation of K170373 and K171081 has been leveraged for the subject device. The backer card was modified to accommodate the longer device models (900301, 900303), by relocating the AcQCross™ securing feature 1.25" to 0.5" from the edge. Otherwise, packaging for AcQCross™ Qx as a standalone device is identical to that of the AcQGuide Catheter Introducer Sets, with the exclusion of the introducer. This minor change was adopted into the existing process by Acutus Medical, Inc. per AAMI TIR28, Product Adoption and Process Equivalence for Ethylene Oxide Sterilization, and requires no further process validation.
The previously submitted EMC and Electrical Safety testing of K170373 and K171081, and of the predicate device (K193509) has been leveraged for the subject device. Testing was completed in accordance with ANSI/AAMI IEC 60601-1:2005, IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, IEC 60601-1-2, 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, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories.
Design verification and validation was performed on AcQCross™ Qx as packaged with the AcQGuide Catheter Introducer Sets, identified in this submission as the predicate device. Where appropriate, the previously submitted performance testing of K170373 and K171081, and of the predicate device (K193509) has been leveraged for the subject device. Acutus Medical. Inc. performed additional performance testing to the modified, standalone AcOCross™ Ox in support of substantial equivalence with the predicate device. The following testing was performed for the standalone AcQCross™ Qx:
- Curve retention .
- . Pushability
- . Needle Actuation
- . Electrical Continuity
- . Shaft to handle tensile
Performance testing was also performed on AcQCross™ Qx with the various compatible sheaths to demonstrate that AcQCross™ performs as intended, and the addition of compatible sheath configurations do not potentially impact the safety or effectiveness of the device as compared to the predicate device. The following testing was performed:
- Needle Actuation .
- . Visual inspection
- Aspiration/Flushing .
- . Electrical Continuity
AcQCross™ Ox is a standalone version of a device that is currently cleared as a component of an introducer sheath system. AcQCross™ is made of identical materials and has minimal design modifications as referenced in Section 5.4. to that of the predicate device. AcQCross™ Qx performs as intended and presents no unacceptable risks to the intended patient population or end user. The non-clinical tests demonstrated that the device is as safe and effective as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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April 6, 2021
Acutus Medical Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services. LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K210685
Trade/Device Name: AcQCross™ Ox Integrated Transseptal Dilator/Needle Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: March 6, 2021 Received: March 8, 2021
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/cfpmr/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.
1
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 53 1 -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 mediation-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/cdrl-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-devices/device-comprehensive-regulatoryassistance/contact-us-division-ind-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,
Jaime Raben -S
for Rachel Neubrander Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
AcQCross™ Qx Integrated Transseptal Dilator/Needle
Indications for Use (Describe)
The AcQCross™ Qx Integrated Transseptal DilatorNeedle is indicated to puncture the interatrial septum to gain access to the left side of the heart whereby various cardiovascular catheters are introduced.
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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Image /page/3/Picture/0 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, orange sans-serif font. The dot above the letter "i" in Acutus is also orange.
510(K) SUMMARY
510(k) Number: K210685
Date Prepared: April 5, 2021
Table 5.1: Submitter Information
| Manufacturer: | Manufacturer's Contact Person: |
|---|---|
| Acutus Medical | |
| 2210 Faraday Ave, Suite 100 | Sarah Clay |
| Carlsbad, CA 92008 | Regulatory Affairs Associate |
| US FDA ERN: 3012120746 | Phone: (949)291-7811 |
| Fax: (442) 232-6081 | |
| Email: sarah.clay@acutus.com) |
Table 5.2: Device Information
| Trade Name | AcQCross™ Qx Integrated Transseptal Dilator/Needle |
|---|---|
| Common Name | Dilator/Transseptal Needle |
| Classification Name | Catheter Introducer |
| Regulation | 21 CFR 870.1340 |
| Product Code | DYB |
| Regulatory Classification: | Class II |
| Device Panel: | Cardiovascular |
The Acutus AcOCross™ Ox Integrated Transseptal Dilator/Needle is substantially equivalent to the previously cleared predicate, AcQGuide Catheter Introducer Sets (Table 5.3). This device has not been subject to a design-related recall.
Table 5.3: Predicate Devices
| Predicate Device | Manufacturer | FDA 510(k) |
|---|---|---|
| AcQGuide Catheter Introducer | ||
| Sets w/ AcQCross™ Qx | Acutus Medical | K193509 |
AcOCross™ Ox was cleared under K193509, as part of the AcOGuide Catheter Introducer Sets (AcQGuide Flex® and AcQGuide Mini® Introducers with AcQCross™ Ox Dilator/Transseptal Needle), which are manufactured by Acutus Medical, Inc. Acutus Medical seeks clearance for AcQCross™ Qx as a standalone device in this submission, that can be used with certain commercially available transseptal sheaths.
5.1 Device Description
AcQCross™ Qx combines the conventional vessel dilator and transseptal needle into a single device (Figure 1). AcQCross™ Ox consists of an elongated shaft with a tapered tip and central lumen to track over a guidewire. The lumen of AcQCross™ Qx is fitted with a hollow stainless steel transseptal needle (Figure 2). Both the shaft and needle are connected to the proximal handle of AcQCross™ QX. The lumen of the needle will allow for guidewires up to 0.032" in diameter. The needle is affixed to a spring-tensioned actuator in the handle of AcQCross™ QX
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Image /page/4/Picture/0 description: The image shows the logo for Acutus Medical. The logo is composed of the word "ACUTUS" in a stylized, sans-serif font, with the letters in gray. Below "ACUTUS" is the word "MEDICAL" in a smaller, sans-serif font, with the letters in orange. The logo is simple and modern, and the use of gray and orange gives it a professional look.
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 allows for monitoring intracardiac electrograms (EGMs) from the needle while in the heart utilizing the EGM adapter cable, and/or allows for the application of radiofrequency (RF) current from an electrosurgical generator to facilitate the septal puncture utilizing the ES adapter cable. AcQCross™ Qx is for single-use only and is provided sterile.
Image /page/4/Figure/2 description: The image shows two diagrams of a medical device, with labels pointing to different parts. The top diagram shows the internal components of the device, including the internal needle, Luer fitting, tension spring, electrical pin plug, and dilator shaft. The bottom diagram shows the external components of the device, including the proximal Luer fitting, spring-tensioned push button for needle extension, electrical connector for ECG monitoring, male interlock for mating with introducer hub, and dilator shaft.
Figure 1: AcQCross™ Qx Integrated Transseptal Dilator/Needle
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Image /page/5/Picture/0 description: The image shows the logo for Acutus Medical. The logo is composed of two lines of text. The top line reads "ACUTUS" in a sans-serif font, with a small orange dot above the left side of the letter A. The bottom line reads "MEDICAL" in a smaller, orange sans-serif font.
Image /page/5/Picture/1 description: The image shows a medical device, specifically a needle inside the lumen of a dilator shaft. The device has a long, thin, blue shaft with a handle on one end. A magnified view shows the needle inside the dilator shaft, with small markings along the shaft. The image provides a detailed view of the device's construction and components.
Figure 2: AcQCross™ Qx Needle inside lumen of dilator shaft
AcQCross™ Qx is designed to be compatible with certain commercially available transseptal sheaths. Table 5.4 lists the AcQCross™ Qx variants for which Acutus Medical, Inc. is seeking clearance.
| Table 5.4: AcQCross™ Qx Model Numbers | |||
|---|---|---|---|
| Product | Model | ||
| Number | Compatible Sheath | ||
| configurations | Model Number | ||
| AcQCross™ Qx – AG 61 | |||
| cm | 900300 | Abbott Agilis NxT 8.5F steerable sheath – 61cm | G408318(SMALL CURL) |
| G408319(MED CURL) | |||
| AcQCross™ Qx – AG 71 | |||
| cm | 900301 | Abbott Agilis NxT 8.5F steerable sheath – 71cm | G408320(SMALL CURL) |
| G408321(MED CURL) | |||
| G408324(LARGE CURL) | |||
| AcQCross™ Qx – SL 63 | |||
| cm | 900302 | Swartz SL1 8.5F fixed curve guiding | |
| sheath – 63cm | 407453 | ||
| AcQCross™ Qx – VZ 71 | |||
| cm | 900303 | BSW Vizigo 8.5F bi-directional guiding | |
| sheath – 71cm | D138501(SMALL CURVE) | ||
| D138502(MED CURVE) | |||
| D138503(LARGE CURVE) | |||
| AcQCross™ Qx – FC 65 | |||
| cm | 900304 | Medtronic FlexCath Advance 12F | |
| steerable sheath – 65cm | 4FC12 |
5.2 Indications for Use
The AcQCross™ Qx Integrated Transseptal Dilator/Needle is indicated to puncture the interatrial septum to gain access to the left side of the heart whereby various cardiovascular catheters are introduced.
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Image /page/6/Picture/0 description: The image shows the logo for Acutus Medical. The word "ACUTUS" is written in a sans-serif font in gray, with a small orange dot above the letter "A". Below the word "ACUTUS", the word "MEDICAL" is written in a smaller, orange sans-serif font. The logo is simple and modern, and the use of gray and orange gives it a professional look.
5.3 Comparison of Technological Characteristics with the Predicate Device
| Table 5.5: Substantial Equivalence Table- Regulatory Information | |||
|---|---|---|---|
| Feature | Proposed Device | ||
| AcQCross™ Qx Integrated Transseptal | |||
| Dilator/Needle(K210685) | Predicate Device | ||
| AcQGuide Catheter Introducer Sets (w/ | |||
| AcQCross™ Qx) (K193509) | Analysis of Differences | ||
| Classification | 21 CFR 870.1340 | 21 CFR 870.1340 | Identical to the predicate device. |
| Product Code | DYB | DYB | Identical to the predicate device. |
| Product | |||
| diagram | Image: Proposed Device Product Diagram | Image: Predicate Device Product Diagram | Identical to the predicate device. |
| Indications for | |||
| Use Statement | To puncture the interatrial septum to gain access to | ||
| the left side of the heart whereby various | |||
| cardiovascular catheters are introduced. | Indicated for introducing various cardiovascular | ||
| catheters into the heart, including the left side of the | |||
| heart through the interatrial septum. | Identical to predicate device. | ||
| Key | |||
| Components | -Elongated shaft with tapered tip and central lumen | ||
| to track over guidewire. | |||
| -Hollow stainless steel transseptal needle. Shaft and | |||
| needle connected to proximal handle. | |||
| -Needle affixed to a spring tensioned actuator which | |||
| prevents needle extension until operator advances | |||
| needle via slider button located on the outer surface | |||
| of handle. | -Elongated shaft with tapered tip and central lumen to | ||
| track over guidewire. | |||
| -Hollow stainless steel transseptal needle. Shaft and | |||
| needle connected to proximal handle. | |||
| -Needle affixed to a spring tensioned actuator which | |||
| prevents needle extension until operator advances | |||
| needle via slider button located on the outer surface of | |||
| handle. | Identical to the predicate device. | ||
| Feature | Proposed Device | ||
| AcQCross™ Qx Integrated Transseptal | |||
| Dilator/Needle(K210685) | Predicate Device | ||
| AcQGuide Catheter Introducer Sets (w/ | |||
| AcQCross™ Qx) (K193509) | Analysis of Differences | ||
| -Proximal handle fitted with luer connector to gain | |||
| access to central lumen of needle. | |||
| -Handle fitted with electrical connector to allow | |||
| ECG monitoring or RF application. | -Proximal handle fitted with luer connector to gain | ||
| access to central lumen of needle. | |||
| -Handle fitted with electrical connector to allow ECG | |||
| monitoring or RF application. | |||
| Dimensions | Needle length: Matched to Introducer | ||
| French sizes compatible: 8.5F, 12F | |||
| Guidewire sizes: up to .032" | Needle length: Matched to introducer | ||
| French sizes compatible: 8.5F | |||
| Guidewire sizes: up to .032" | Similar dimensions to predicate device. | ||
| These minor differences do not | |||
| potentially impact the safety and | |||
| effectiveness. | |||
| Material | Shaft: Polyethylene Hexene Copolymer; ethylene | ||
| homopolymer; barium sulfate with blue colorant | |||
| Needle: 304 Stainless steel Hypotube: 304 stainless | |||
| steel | |||
| Luer fitting: polycarbonate | Shaft: Polyethylene Hexene Copolymer; ethylene | ||
| homopolymer; barium sulfate with blue colorant | |||
| Needle: 304 Stainless steel Hypotube: 304 stainless | |||
| steel | |||
| Luer fitting: polycarbonate | Identical to predicate device. | ||
| Packaging | Pouch: Tyvek® 1073B Uncoated, Nylon Film | ||
| Backer card: High Density Polyethylene (HDPE) | |||
| Shelf Box: Solid bleach sulfate paperboard | |||
| Shipper: paperboard | Pouch: Tyvek® 1073B Uncoated, Nylon Film | ||
| Backer card: High Density Polyethylene (HDPE) | |||
| Shelf Box: Solid bleach sulfate paperboard | |||
| Shipper: paperboard | Identical to predicate device. | ||
| Sterilization | Ethylene Oxide (EO) | Ethylene Oxide (EO) | Identical to predicate device. |
| Shelf Life | 12 months | 12 months | Identical to predicate device. |
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Image /page/7/Picture/0 description: The image shows the logo for Acutus Medical. The logo is composed of the word "ACUTUS" in a sans-serif font, with a small orange dot above the "A". Below the word "ACUTUS" is the word "MEDICAL" in a smaller, orange sans-serif font. The logo is simple and modern, and the use of orange gives it a sense of energy and innovation.
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Image /page/8/Picture/0 description: The image shows the logo for Acutus Medical. The logo consists of the word "ACUTUS" in gray, blocky letters. Below the word "ACUTUS" is the word "MEDICAL" in smaller, orange letters. The logo is simple and modern.
5.4 Performance Data
Performance testing for AcQCross™ Qx and the predicate device, the AcQGuide Catheter Introducer Sets, were performed in accordance with the following standards.
- ISO 11070: 2014 Sterile single-use intravascular introducers, dilators and guidewires .
- . ISO 10555-1: 2013 - Sterile, single-use intravascular catheters- Part 1: General Requirements
Other than the following modifications, AcQCross™ Qx as a standalone device is identical to that of the predicate device, the AcQGuide Catheter Introducer Sets(K193509).
Table 5.6 describes the differences between the AcQGuide Catheter Introducer Sets and AcQCross™ Ox.
9
| Table 5.6: Summary of differences between Predicate Device (K193509) and AcQCross™ Qx, Subject Device | |||||
|---|---|---|---|---|---|
| AcQGuide Catheter Introducer Sets (K193509) | AcQCross™ Qx Subject Device | Analysis of Differences | |||
| Dilator shaft effective length | Model | Length: | Model | Length | Minor differences in dimensions do not potentially impact safety and effectiveness. |
| AcQGuide Mini(50cm) | $61.2cm \pm 2.0cm$ | 900302 | $67.7cm \pm 2.0cm$ | ||
| AcQGuide Mini(65cm) | $74.5cm \pm 2.0cm$ | 900300, 900304 | $83.5cm \pm 2.0cm$ | ||
| AcQGuide Flex(50cm) | $75.9cm \pm 2.0cm$ | 900301, 900303 | $93.4cm \pm 2.0cm$ | ||
| AcQGuide Flex(65cm) | $89 cm \pm 2.0cm$ | ||||
| Dilator outer diameter (in.) | $0.109" \pm .001"$ | Model | Diameter | Minor differences in dimensions do not potentially impact safety and effectiveness. | |
| 900300, 900301, 900302 | $0.111" \pm .001"$ | ||||
| 900303 | $0.114" \pm .001"$ | ||||
| 900304 | $0.154" \pm .001"$ | ||||
| Dilator distal tip outer diameter | .056" | .056" +.003/-.004 | Minor differences in dimension does not potentially impact safety and effectiveness. | ||
| Handle lock feature | Handle tip compatible with AcQGuide Mini and Flex. | ||||
| Image: Handle tip compatible with AcQGuide Mini and Flex. | Handle tip modified to be compatible with each compatible sheath. | ||||
| Image: FlexCath | |||||
| Image: Agilis, Swartz | |||||
| Image: Vizigo | Minor differences in tip do not potentially impact safety and effectiveness. | ||||
| Dilator to handle bond | Flared dilator and mechanical lock, which sit into handle to prevent axial movement. Adhesive is applied to the interface between the handle tip and the dilator to prevent rotation. | Mechanical lock is removed, and new handle tip component with a chamfered end to fully encapsulate the proximal end of the dilator (including the flare) against the handle halves, preventing axial movement. Adhesive is applied between the handle tip and dilator to prevent rotation. | Minor modification to bond do not potentially impact safety and effectiveness. |
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| Image: [Adhesive Flare mechanical lock] | Image: [Adhesive Flare Handle Tip] | ||
|---|---|---|---|
| Backer card | Modified to accommodate longer device models by relocating AcQCross™ securing feature 1.25" to 0.5" from the edge. | Packaging is otherwise identical. No change to backer card materials, thickness, or overall footprint. Minor modification does not potentially impact safety and effectiveness. | |
| Colorant; non-patient contacting component | ABS Cornflower Colorant (Pantone 284C) ABS Dove Gray Colorant (Pantone 428C) | Lustran 348 ABS, Cool Grey PMS 3C Lustran, 348-012002, Orange PMS 144C | Modified colorant does not potentially impact safety and effectiveness. |
| Material change to spring; non-patient contacting component | Steel music wire | 304 stainless steel | Minor change to material does not potentially impact safety and effectiveness. |
| Change to adhesive; indirect and non-patient contacting components | Loctite 401 & 411 (Base material: Ethyl Cyanoacrylate, Acrylic UV Curable) | Loctite 4060 (Base material: Ethyl Cyanoacrylate) Loctite 4311 (Base material: Acrylic UV Curable) | No change to base materials; minor change to adhesive formulation does not potentially impact safety and effectiveness. |
| Formulation of shaft material | 40% LDPE, 40% HDPE, 20% BaSO4 | 70% HDPE, 30% BaSO4 | Modified formulation does not potentially impact safety and effectiveness. |
| French size | 8.5F | 8.5F, 12F | French size determined by compatible sheath. Differences in dimension do not potentially impact safety and effectiveness. |
| Shaft Supplier | MET, Biomerics | MET, Biomerics, Apollo | Shaft supplier supplies identical components. Difference in supplier does not potentially impact safety and effectiveness. |
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Image /page/11/Picture/0 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 orange. The logo is simple and modern, and the use of color helps to make it stand out.
AcQCross™ Ox and the AcQGuide Catheter Introducer Sets are otherwise identical in terms of materials, dimensions, packaging, shelf-life and sterilization. Therefore, performance testing has been leveraged from the AcQGuide Catheter Introducer Sets for the subject device. The following performance testing was conducted in support of the substantial equivalence determination.
5.4.1 Biocompatibility
Biocompatibility testing was performed on AcQCross™ Qx in accordance with AAMI/ANSI/ISO 10993-1:2009 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. Testing was performed on AcQCross™ Ox as packaged with the AcOGuide Catheter Introducer Sets, which is identified in this submission as the predicate device. Biocompatibility testing for the AcQGuide Catheter Introducer Sets(K193509) was submitted with the predicate device, Flextra™ Steerable Introducer (K170373) and Guider™ Catheter Introducer (K171081), with Lancer™ Integrated Dilator/Transseptal Needle. The previously submitted biocompatibility testing in K170373 and K171081 has been leveraged for the subject device. Additional cytotoxicity and hemolysis testing was performed as a result of a new shaft supplier. The results demonstrate that AcQCross™ Qx meets the requirements of ISO 10993-1 and is biocompatible.
5.4.2 Sterilization
Sterilization validation was performed on AcOCross™ Ox in accordance with ISO 11135: 2014 -Sterilization of health-care products- Ethylene Oxide- Requirements for development, validation and routine control of a sterilization process for medical devices. AcQCross™ Ox is subjected to the identical ethylene oxide (EO) sterilization process as the predicate device, the AcQGuide Catheter Introducer Sets, to meet a sterility assurance level (SAL) of 106. Testing was performed on AcQCross™ Qx as packaged with the AcQGuide Catheter Introducer Sets. The previously submitted sterilization validation of K170373 and K171081 has been leveraged for the subject device. The backer card was modified to accommodate the longer device models (900301, 900303), by relocating the AcQCross™ securing feature 1.25" to 0.5" from the edge. Otherwise, packaging for AcQCross™ Qx as a standalone device is identical to that of the AcQGuide Catheter Introducer Sets, with the exclusion of the introducer. This minor change was adopted into the existing process by Acutus Medical, Inc. per AAMI TIR28, Product Adoption and Process Equivalence for Ethylene Oxide Sterilization, and requires no further process validation.
5.4.3 Electrical Safety and Electromagnetic Compatibility (EMC)
The previously submitted EMC and Electrical Safety testing of K170373 and K171081, and of the predicate device (K193509) has been leveraged for the subject device. Testing was completed in accordance with ANSI/AAMI IEC 60601-1:2005, IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, IEC 60601-1-2, Medical electrical equipment – Part 1-2: General requirements for the basic safety
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Image /page/12/Picture/0 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, orange sans-serif font. The dot on the "i" in Acutus is also orange.
and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests, and IEC 60601-2-2, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories.
5.4.4 Bench Testing
Design verification and validation was performed on AcQCross™ Qx as packaged with the AcQGuide Catheter Introducer Sets, identified in this submission as the predicate device. Where appropriate, the previously submitted performance testing of K170373 and K171081, and of the predicate device (K193509) has been leveraged for the subject device. Acutus Medical. Inc. performed additional performance testing to the modified, standalone AcOCross™ Ox in support of substantial equivalence with the predicate device. The following testing was performed for the standalone AcQCross™ Qx:
- Curve retention .
- . Pushability
- . Needle Actuation
- . Electrical Continuity
- . Shaft to handle tensile
Performance testing was also performed on AcQCross™ Qx with the various compatible sheaths to demonstrate that AcQCross™ performs as intended, and the addition of compatible sheath configurations do not potentially impact the safety or effectiveness of the device as compared to the predicate device. The following testing was performed:
- Needle Actuation .
- . Visual inspection
- Aspiration/Flushing .
- . Electrical Continuity
5.5 Conclusions
AcoCross™ Ox is a standalone version of a device that is currently cleared as a component of an introducer sheath system. AcQCross™ is made of identical materials and has minimal design modifications as referenced in Section 5.4. to that of the predicate device. AcQCross™ Qx performs as intended and presents no unacceptable risks to the intended patient population or end user. The non-clinical tests demonstrated that the device is as safe and effective as the predicate device.