(34 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical components for a transseptal puncture device. There is no mention of AI or ML in the provided text.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is used to access the left side of the heart, which is a procedural step rather than a therapeutic action itself.
No
The device is described as an access tool used to puncture the interatrial septum and allow for the introduction of other cardiovascular catheters. While it can monitor intracardiac electrograms, its primary indication is gaining access, not diagnosing a condition.
No
The device description clearly details a physical medical device with a shaft, needle, handle, and electrical connectors, indicating it is hardware-based.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 or interventional procedure performed directly on the patient's body.
- Device Description: The description details a physical device (dilator/needle) used for accessing a specific anatomical site within the body. It mentions features like a shaft, tip, lumen, needle, handle, and electrical connectors for monitoring and applying RF current. These are all characteristic of devices used in vivo (within a living organism).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside of a living organism) to analyze samples. This device is clearly designed for use in vivo during a medical procedure.
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, DRE
Device Description
AcQCross™ Qx combines the conventional vessel dilator and transseptal needle into a single device (Figure 1). AcQCross™ Qx consists of an elongated shaft with a tapered tip and central lumen to track over a guidewire. The lumen of AcQCross™ Ox 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™ Ox 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 AcOCross™ Ox and the predicate device. AcOCross™ Ox, was 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, the additional models of AcQCross™ Qx are identical to that of the predicate device, AcQCross™ Qx(K210685). Therefore, the testing was performed on the subject device which focused on the safety and performance related to the modifications.
These modifications are limited to dimensional changes which facilitate compatibility with different transseptal sheaths and are as follows:
- Effective dilator length .
- . Effective needle length
- Handle lock feature
AcQCross™ Qx and the predicate device are otherwise identical in terms of materials, dimensions, packaging, shelf-life and sterilization. Therefore, performance testing has been leveraged from AcQCross™ Qx(K210685) for the subject device. The following performance testing was conducted in support of the substantial equivalence determination:
- Shaft to handle tensile ●
- Length compatibility
- Snap engagement
- Kink resistance
- Needle actuation ●
- . Visual inspection
- Aspiration/flushing ●
- Electrical continuity .
Biocompatibility testing was performed on the predicate device (K210685) AcQCross™ Ox in accordance with AAMI/ANSI/ISO 10993-1:2009 - Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process. The new models of AcOCross™ Ox are made of identical materials to the predicate device. Therefore, the previously submitted biocompatibility testing in K210685 has been leveraged for the subject device. No additional biocompatibility testing was required for the subject device.
Sterilization validation was performed on AcOCross™ Ox in accordance per 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™ Qx is subjected to the identical ethylene oxide (EO) sterilization process as the predicate device to meet a sterility assurance level (SAL) of 106. The previously submitted sterilization validation of K210685 has been leveraged for the subject device. The new models have 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 modifications to the new models of AcQCross™ Qx do not impact EMC and Electrical Safety. Therefore, the previously submitted EMC and Electrical Safety testing of the predicate device, K210685, 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.
Due to the addition of new AcQCross™ Qx models compatible with certain compatible sheaths, AcOCross™ Qx was subject to the performance testing listed in Section 5.4. The subject models of AcQCross™ Qx and the predicate device are otherwise identical in terms of materials, dimensions, packaging, shelf-life and sterilization.
Therefore, the following performance testing has been leveraged from the predicate device (K210685) and no additional performance testing was required. Detailed justification is provided in Section 18.
- Dimensional Verification
- Surface Inspection ●
- Tip Curve Retention .
- System Leak- Air Leakage- Luer Fitting ●
- . Kink Resistance
- . Shaft to Handle Tensile
- Needle to Button Tensile
- . Luer to Hypotube Tensile
- Needle Actuation
- Electrical Continuity
- Pushability/Trackability in performance model ●
- Corrosion Resistance .
- Radiopacity .
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.
Not Found
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 8, 2022
Acutus Medical, Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K220047
Trade/Device Name: AcOCross Ox Integrated Transseptal Dilator/Needle Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB, DRE Dated: January 4, 2022 Received: January 5, 2022
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.
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 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,
Rachel Neubrander Assistant 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
2
Indications for Use
510(k) Number (if known)
Device Name AcQCross™ Ox Integrated Transseptal Dilator/Needle
Indications for Use (Describe)
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.
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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3
510(K) SUMMARY
510(k) Number: K220047
Date Prepared: February 8, 2022
Table 5.1: Submitter Information
| Manufacturer: | Manufacturer's Contact Person: |
|---|---|
| Acutus Medical | |
| 2210 Faraday Ave, Suite 100 | |
| Carlsbad, CA 92008 | |
| US FDA ERN: 3012120746 | Sarah Clay |
| Regulatory Affairs Specialist | |
| 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 |
| Subsequent Product Code | DRE |
| Regulatory Classification: | Class II |
| Device Panel: | Cardiovascular |
The new models of the Acutus AcQCross™ Qx Integrated Transseptal Dilator/Needle are substantially equivalent to the previously cleared predicate, AcQCross™ Qx Integrated Transseptal Dilator/Needle (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) |
|---|---|---|
| AcQCross™ Qx Integrated | ||
| Transseptal Dilator/Needle | Acutus Medical | K210685 |
The new models of AcQCross™ Ox are compatible 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™ Qx consists of an elongated shaft with a tapered tip and central lumen to track over a guidewire. The lumen of AcQCross™ Ox 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™ Ox that prevents needle extension until the operator purposely advances the needle via a slider
4
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/1 description: The image shows two diagrams of a medical device with labels pointing to its different parts. The top diagram shows a cross-section of the device, revealing the internal needle, tension spring, and electrical pin plug. The bottom diagram shows the exterior of the device, highlighting the proximal Luer fitting, electrical connector for ECG monitoring, and male interlock for mating with the introducer hub.
Figure 5.1: AcQCross™ Qx Integrated Transseptal Dilator/Needle
5
Image /page/5/Picture/0 description: The image shows a medical device, specifically a needle inside the lumen of a dilator shaft. The device is blue and has a long, thin shaft with a handle at one end. A magnified view shows the needle inside the dilator shaft, with the needle appearing as a thin, gray line within the blue shaft. The image provides a detailed view of the device's construction and components.
Figure 5.2: AcQCross™ Qx Needle inside lumen of dilator shaft
AcQCross™ Qx is designed to be compatible with certain commercially available transseptal sheaths. The new models of AcQCross™ were added to provide the physician with additional sheath selection for transseptal crossing. Table 5.4 lists the new models of AcQCross™ Qx 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 – | |||
| MH – 63cm | 900306-001 | Merit Medical ML Series (HeartSpan Transseptal) | |
| – 8.5F with 63cm working length | FCB8563ML1 | ||
| AcQCross™ Qx – | |||
| MH – 81cm | 900307-001 | Merit Medical ML Series (HeartSpan Transseptal) | |
| – 8.5F with 81cm working length | FCB8581ML1 | ||
| AcQCross™ Qx – | |||
| WT – 75cm | 900308-001 | Watchman TruSeal Access system – 12F with | |
| 75cm usable working length | M635TU70010 | ||
| M635TU70020 | |||
| M635TU70040 | |||
| AcQCross™ Qx – SL | |||
| – 81cm | 900309-001 | Abbott Braided Swartz SL Series – 8.5F with 81 | |
| usable working length | 407454 |
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.
6
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(K ) | Predicate Device | ||
| AcQCross™ Qx Integrated Transseptal | |||
| Dilator/Needle(K210685) | Analysis of Differences | ||
| Classification | 21 CFR 870.1340 | 21 CFR 870.1340 | Identical to the predicate device. |
| Product Code | |||
| Subsequent | |||
| Product Code | DYB | ||
| DRE | DYB | ||
| DRE | Identical to the predicate device. | ||
| Product | |||
| diagram | Image: Product diagram of proposed device | Image: Product diagram of predicate device | 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. | To puncture the interatrial septum to gain access to | ||
| the left side of the heart whereby various | |||
| cardiovascular catheters are introduced. | 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. | |||
| -Proximal handle fitted with luer connector to gain | |||
| access to central lumen of needle. | -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. | |||
| -Proximal handle fitted with luer connector to gain | |||
| access to central lumen of needle. | Identical to the predicate device. |
7
| Table 5.5: Substantial Equivalence Table- Regulatory Information | |||||
|---|---|---|---|---|---|
| Feature | Proposed Device | ||||
| AcQCross™ Qx Integrated Transseptal | |||||
| Dilator/Needle(K) | Predicate Device | ||||
| AcQCross™ Qx Integrated Transseptal | |||||
| Dilator/Needle(K210685) | Analysis of Differences | ||||
| -Handle fitted with electrical connector to allow ECG monitoring or RF application. | -Handle fitted with electrical connector to allow ECG monitoring or RF application. | ||||
| Dimensions | Needle effective length: | ||||
| Model | Needle effective length: | ||||
| Model | Dimensions modified for new models | ||||
| to be compatible with associated | |||||
| sheaths. These minor dimensional | |||||
| differences do not potentially impact | |||||
| the safety and effectiveness. | |||||
| Length | Length | ||||
| 900306 | 74.15cm ± .10cm | 900302 | 74.6cm ± .10cm | ||
| 900307 | 92.35cm ± .10cm | 900300, 900304 | 90.4cm ± .10cm | ||
| 900308 | 91.36cm ± .10cm | 900301. 900303 | 100.3cm ± .10cm | ||
| 900309 | 90.8cm ± .10cm | 900305 | 94.3cm ± .10cm | ||
| Dilator effective length: | |||||
| Model | Dilator effective length: | ||||
| Model | |||||
| Length | Length | ||||
| 900306 | 67.3cm ± 2.0cm | 900302 | 67.7cm ± 2.0cm | ||
| 900307 | 85.5cm ± 2.0cm | 900300, 900304 | 83.5cm ± 2.0cm | ||
| 900308 | 84.5 cm ± 2.0cm | 900301. 900303 | 93.4cm ± 2.0cm | ||
| 900309 | 85.6 cm ± 2.0cm | 900305 | 87.4cm ± 2.0cm | ||
| French sizes compatible: 8.5F, 12F | |||||
| Guidewire sizes: up to .032" | French sizes compatible: 8.5F, 12F | ||||
| Guidewire sizes: up to .032" |
8
| Table 5.5: Substantial Equivalence Table- Regulatory Information | |||
|---|---|---|---|
| Feature | Proposed Device | ||
| AcQCross™ Qx Integrated Transseptal | |||
| Dilator/Needle(K____) | Predicate Device | ||
| AcQCross™ Qx Integrated Transseptal | |||
| Dilator/Needle(K210685) | Analysis of Differences | ||
| Handle Lock | |||
| Feature | Handle tip shape modified to be compatible with | ||
| each compatible sheath. | |||
| Image: Merit device | |||
| Image: Abbott device | |||
| Image: Watchman device | Handle tip shape modified to be compatible with each | ||
| compatible sheath. | |||
| Image: FlexCath device | |||
| Image: Agilis, Swartz device | |||
| Image: Vizigo device | Handle tip shape is uniquely modified | ||
| to be compatible with each sheath's | |||
| proximal hub. Minor differences in tip | |||
| shape do not potentially impact 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. |
9
5.4 Performance Data
Performance testing for AcOCross™ Ox and the predicate device. AcOCross™ Ox, was 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, the additional models of AcQCross™ Qx are identical to that of the predicate device, AcQCross™ Qx(K210685). Therefore, the testing was performed on the subject device which focused on the safety and performance related to the modifications.
These modifications are limited to dimensional changes which facilitate compatibility with different transseptal sheaths and are as follows:
- Effective dilator length .
- . Effective needle length
- Handle lock feature
AcQCross™ Qx and the predicate device are otherwise identical in terms of materials, dimensions, packaging, shelf-life and sterilization. Therefore, performance testing has been leveraged from AcQCross™ Qx(K210685) for the subject device. The following performance testing was conducted in support of the substantial equivalence determination:
- Shaft to handle tensile ●
- Length compatibility
- Snap engagement
- Kink resistance
- Needle actuation ●
- . Visual inspection
- Aspiration/flushing ●
- Electrical continuity .
5.4.1 Biocompatibility
Biocompatibility testing was performed on the predicate device (K210685) AcQCross™ Ox in accordance with AAMI/ANSI/ISO 10993-1:2009 - Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process. The new models of AcOCross™ Ox are made of identical materials to the predicate device. Therefore, the previously submitted biocompatibility testing in K210685 has been leveraged for the subject device. No additional biocompatibility testing was required for the subject device.
10
5.4.2 Sterilization
Sterilization validation was performed on AcOCross™ Ox in accordance per 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™ Qx is subjected to the identical ethylene oxide (EO) sterilization process as the predicate device to meet a sterility assurance level (SAL) of 106. The previously submitted sterilization validation of K210685 has been leveraged for the subject device. The new models have been adopted into the existing process 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 modifications to the new models of AcQCross™ Qx do not impact EMC and Electrical Safety. Therefore, the previously submitted EMC and Electrical Safety testing of the predicate device, K210685, 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.
5.4.4 Bench Testing
Due to the addition of new AcQCross™ Ox models compatible with certain compatible sheaths, AcOCross™ Ox was subject to the performance testing listed in Section 5.4. The subject models of AcQCross™ Qx and the predicate device are otherwise identical in terms of materials, dimensions, packaging, shelf-life and sterilization.
Therefore, the following performance testing has been leveraged from the predicate device (K210685) and no additional performance testing was required. Detailed justification is provided in Section 18.
- Dimensional Verification
- Surface Inspection ●
- Tip Curve Retention .
- System Leak- Air Leakage- Luer Fitting ●
- . Kink Resistance
- . Shaft to Handle Tensile
- Needle to Button Tensile
- . Luer to Hypotube Tensile
- Needle Actuation
- Electrical Continuity
- Pushability/Trackability in performance model ●
- Corrosion Resistance .
11
- Radiopacity .
5.5 Conclusions
AcQCross™ Qx 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 nonclinical bench data support the safety of the device and demonstrate that AcQCross™ Qx performs as intended in the specified use conditions. The additional AcQCross™ Qx models does not raise any new questions regarding safety or effectiveness of the device as compared to the predicate device. The nonclinical tests demonstrated that the device is as safe and effective as the predicate device.