(31 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical aspects of a transseptal puncture device. There is no mention of AI, ML, or any data processing that would suggest the use of such technologies.
No.
The device's stated indication for use is to "puncture the interatrial septum to gain access to the left side of the heart whereby various cardiovascular catheters are introduced," which describes a procedural access tool rather than a device designed to directly treat a medical condition or restore health.
No
This device is designed for a procedural purpose—to puncture the interatrial septum and provide access to the left side of the heart. While it can monitor intracardiac electrograms (EGMs), this function appears to be for guiding the procedure rather than for diagnosing a condition. Its primary indication is not diagnostic.
No
The device description clearly details a physical medical device consisting of an elongated shaft, tapered tip, central lumen, hollow stainless steel needle, proximal handle, Luer connector, and electrical connector. It is a hardware device used for a physical procedure.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The FlexCath Cross™ is a surgical tool designed to physically puncture the interatrial septum and facilitate the introduction of other catheters into the heart. It is used within the body (in vivo).
- Intended Use: The intended use clearly states its purpose is to "puncture the interatrial septum to gain access to the left side of the heart whereby various cardiovascular catheters are introduced." This is a procedural function, not a diagnostic test performed on a specimen.
- Device Description: The description details its mechanical components (shaft, needle, handle, actuator) and its ability to monitor electrical signals or apply RF current within the heart. These are all related to the surgical procedure itself, not to analyzing a sample.
The device is a surgical instrument used for a transseptal puncture procedure, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The FlexCath Cross™ Transseptal Solution 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
FlexCath Cross™ combines the conventional vessel dilator and transseptal needle into a single device (Figure 1). FlexCath Cross™ consists of an elongated shaft with a tapered tip and central lumen to track over a guidewire. The lumen of FlexCath Cross™ is fitted with a hollow stainless steel transseptal needle (Figure 2). Both the shaft and needle are connected to the proximal handle of FlexCath Cross™. The lumen of the needle will allow for guidewires up to 0.032" in diameter. The needle is affixed to a springtensioned actuator in the handle of FlexCath Cross™ 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. FlexCath Cross™ is for single-use only and is provided sterile.
FlexCath Cross™ is designed to be compatible with certain commercially available transseptal sheaths. The new models of FlexCath Cross™ were added to provide the physician with additional sheath selection for transseptal crossing.
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, Intracardiac Structures
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)
Bench Testing:
The necessary bench testing was performed on the additional models of FlexCath Cross™ to ensure that it conforms to the design specifications and to support a determination of substantial equivalence to the predicate device.
Testing was performed on the subject device focusing on safety and performance related to modifications:
- Dilator shaft diameter
- Handle lock feature
- Colorant update to non-patient contacting handle components align with Medtronic branding
Performance testing leveraged from AcQCross™ Qx(K210685) included: - Dimensional Inspection
- Shaft to handle tensile
- Length compatibility
- Snap engagement
- Kink resistance
- Needle actuation
- Visual inspection
- Aspiration/flushing
- Electrical continuity
- Sheath compatibility: Insertion/withdrawal
Key results: The collective bench testing demonstrates that the proposed device does not raise different questions of safety or effectiveness when compared to the predicate device.
Biocompatibility:
Biocompatibility testing was performed on the predicate device K210685 in accordance with AAMI/ANSI/ISO 10993-1:2009. The subject models of FlexCath Cross™ are made of identical patient contacting materials to the predicate device.
Key results: Previously submitted biocompatibility testing in K210685 has been leveraged for the subject device, and no additional biocompatibility testing is required.
Sterilization:
Sterilization validation was performed on FlexCath Cross™ in accordance per ISO 11135: 2014. FlexCath Cross™ is subjected to the identical ethylene oxide (EO) sterilization process as the predicate device to meet a sterility assurance level (SAL) of 10°.
Key results: 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.
Electrical Safety and Electromagnetic Compatibility (EMC):
Key results: The modifications to the new models of FlexCath Cross™ 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 60601-1-2, IEC 60601-2-2.
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 contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue.
December 17, 2023
Acutus Medical, Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K233691
Trade/Device Name: FlexCath Cross™ Transseptal Solution Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: November 16, 2023 Received: November 16, 2023
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 (the 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 available 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.
1
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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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/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-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
2
by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Rachel E. Neubrander -S
Rachel Neubrander, PhD 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
3
Indications for Use
Submission Number (if known)
Device Name
FlexCath Cross™ Transseptal Solution
Indications for Use (Describe)
The FlexCath Cross™ Transseptal Solution 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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4
510(k) Summary
General Information [807.92(a)(1)]
Date Prepared: October 6, 2023
| Applicant: | Contact Person: |
|---|---|
| Acutus Medical, Inc. | |
| 2210 Faraday Ave., Suite 100 | |
| Carlsbad, CA 92008 | |
| USA | |
| Phone: 1-442-232-6080 | |
| Fax: 1-442-232-6081 | Sarah Clay |
| Senior Regulatory Affairs Specialist | |
| Acutus Medical, Inc. | |
| 2210 Faraday Ave., Suite 100 | |
| Carlsbad, CA 92008 | |
| USA | |
| Phone: 1-442-232-6080 | |
| Email: Sarah.clay@acutus.com |
Device Information [807.92(a)(2)]
| Trade Name: | FlexCath Cross™ Transseptal Solution |
|---|---|
| Generic/Common Name: | Dilator/Transseptal Needle |
| Classification: | Class II / 21 CFR § 870.1340 |
| Product Code(s): | DYB, DRE |
Predicate Device [807.92(a)(3)]
| Predicate Device | Manufacturer | FDA 510(k) |
|---|---|---|
| AcQCross™ Qx Integrated | ||
| Transseptal Dilator/Needle | Acutus Medical | K210685 |
Device Description [807.92(a)(4)]
FlexCath Cross™ combines the conventional vessel dilator and transseptal needle into a single device (Figure 1). FlexCath Cross" consists of an elongated shaft with a tapered tip and central lumen to track over a guidewire. The lumen of FlexCath Cross™ is fitted with a hollow stainless steel transseptal needle (Figure 2). Both the shaft and needle are connected to the proximal handle of FlexCath Cross™. The lumen of the needle will allow for guidewires up to 0.032" in diameter. The needle is affixed to a springtensioned actuator in the handle of FlexCath Cross™ 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. FlexCath Cross™ is for single-use only and is provided sterile.
5
Image /page/5/Figure/0 description: The image shows two diagrams of a medical device. The top diagram shows an external view of the device, with labels pointing to the dilator shaft, spring-tensioned push button for needle extension, proximal luer fitting, male interlock for mating with introducer hub, and electrical connector for EGM monitoring. The bottom diagram shows a cross-sectional view of the device, with labels pointing to the internal needle, luer fitting, dilator shaft, tension spring, and electrical pin plug.
Figure 1: FlexCath Cross™Integrated Transseptal Dilator/Needle
Image /page/5/Figure/2 description: The image shows two diagrams of a medical instrument, labeled as a needle inside the lumen of a dilator shaft. The top diagram shows a cut-away view of the instrument, revealing the needle inside the dilator shaft. The bottom diagram shows the instrument with the needle extended from the tip of the dilator shaft.
Figure 2: FlexCath Cross™ Needle inside lumen of dilator shaft
FlexCath Cross™ is designed to be compatible with certain commercially available transseptal sheaths. The new models of FlexCath Cross™ were added to provide the physician with additional sheath selection
6
for transseptal crossing. Table 1 lists the new models of FlexCath Cross™ for which Acutus Medical, Inc. is seeking clearance.
| Table 1: FlexCath Cross™ Model Numbers | |||
|---|---|---|---|
| Product (Subject Device) | Acutus Model | ||
| Number | Compatible Sheath configurations | Medtronic | |
| Model Number | |||
| FlexCath Cross™ – FCC | |||
| 10F– 65cm | 900310 | Medtronic FlexCath Contour 10F 13mmTip | 10FCC13 |
| Medtronic FlexCath Contour 10F 20mmTip | 10FCC20 | ||
| FlexCath Cross™ – FCC | |||
| 12F– 65cm | 900311 | Medtronic FlexCath Contour 12F 13mmTip | 12FCC13 |
| Medtronic FlexCath Contour 12F 20mmTip | 12FCC20 |
Indications for Use [807.92(a)(5)]
The FlexCath Cross™ Transseptal Solution is indicated to puncture the interatrial septum to gain access to the left side of the heart whereby various cardiovascular catheters are introduced.
Comparison of Technological Characteristics with the Predicate Devices [807.92(A)(6)]
Tables 2 provides a comparison of the additional models of the FlexCath Cross™ Transseptal Solution and indications for use against the predicate device.
| Table 2: Predicate Device Comparison | ||
|---|---|---|
| Characteristics | Predicate Device | |
| AcQCross Cross™ Qx Integrated Transseptal | ||
| Dilator/Needle(K210685) | Subject Device | |
| FlexCath Cross™ Transseptal Solution | ||
| Classification | Class II | Identical to K210685. |
| Regulation | 21 CFR § 870.1340, Catheter Introducer | Identical to K210685. |
| Product Code | DYB, DRE | Identical to K210685. |
| Indications for Use | To puncture the interatrial septum to gain | |
| access to the left side of the heart whereby | ||
| various cardiovascular catheters are | ||
| introduced. | Identical to K210685. | |
| Patient Anatomy | Intracardiac Structures | Identical to K210685. |
| Testing to Support | ||
| Substantial | ||
| Equivalence | Verification Testing, | |
| Validation Testing | Identical to K210685. | |
| Physical Characteristics | ||
| 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 | Identical to K210685. | |
| Table 2: Predicate Device Comparison | ||
| Predicate Device | Subject Device | |
| Characteristics | AcQCross Cross™ Qx Integrated Transseptal | |
| Dilator/Needle(K210685) | FlexCath Cross™ Transseptal Solution | |
| 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. | ||
| • Handle fitted with electrical connector to | ||
| allow EGM monitoring or RF application. | ||
| Product Diagram | Image: Panel A | Identical to K210685. |
| Dimensions | Needle effective length: $90.4cm \pm .10cm$ | |
| Dilator effective length: $83.5cm \pm 2.0cm$ | ||
| French sizes compatible: 8.5F, 12F | ||
| Guidewire sizes: up to .032" | Needle effective length: $90.4cm \pm$ | |
| .10cm | ||
| Dilator effective length: $83.5cm \pm$ | ||
| .25cm | ||
| French sizes compatible: 10F, 12F | ||
| Guidewire sizes: up to .032" | ||
| Dimensions modified for new models | ||
| to be compatible with associated | ||
| sheaths. These minor dimensional | ||
| differences are within the predicate | ||
| device ranges and do not potentially | ||
| impact the safety and effectiveness. | ||
| Handle lock feature | Handle tip shape modified to be compatible | |
| with each compatible sheath. | ||
| Image: FlexCath | ||
| Image: Agilis, Swartz | ||
| Image: Vizigo | Handle tip shape modified to be | |
| compatible with each compatible | ||
| sheath. | ||
| Image: FlexCath Contour | ||
| Handle tip shape is uniquely modified | ||
| to be compatible with each sheath's | ||
| proximal hub. Minor differences in tip | ||
| Table 2: Predicate Device Comparison | ||
| Characteristics | Predicate Device | Subject Device |
| AcQCross Cross™ Qx Integrated Transseptal | ||
| Dilator/Needle(K210685) | FlexCath Cross™ Transseptal Solution | |
| 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 | Identical to K210685. | |
| Packaging | Pouch: Tyvek® 1073B Uncoated, Nylon Film | |
| Backer card: High Density Polyethylene | ||
| (HDPE) | ||
| Shelf Box: Solid bleach sulfate paperboard | ||
| Shipper: paperboard | Identical to K210685. | |
| Sterilization | Ethylene Oxide (EO) | Identical to K210685. |
| Shelf Life | 24 months | Identical to K210685. |
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Substantial Equivalence
FlexCath Cross™ is made of identical patient contacting materials and has minimal design modifications as referenced in Table 2 to that of the predicate device. FlexCath Cross™ performs as intended and presents no unacceptable risks to the intent population or end user. The non-clinical bench data support the safety of the device and demonstrate that FlexCath Cross™ performs as intended in the specified use conditions. The additional FlexCath Cross™ models do not raise any new questions regarding safety or effectiveness of the device as compared to the predicate device. The nonclinical tests demonstrate that the device is as safe and effective as the predicate device.
Performance Data [807.92(b)]
All necessary bench testing was conducted on the additional models FlexCath Cross™ to support a determination of substantial equivalence to the predicate device.
Non-clinical Testing Summary [807.92(b)(1)]
Bench Testing
The necessary bench testing was performed on the additional models of FlexCath Cross™ to ensure that it conforms to the design specifications and to support a determination of substantial equivalence to the predicate device.
Other than the following modifications, the additional models of FlexCath Cross™ 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:
9
- Dilator shaft diameter
- Handle lock feature
- Colorant update to non-patient contacting handle components align with Medtronic branding
FlexCath Cross™ 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:
- Dimensional Inspection
- . Shaft to handle tensile
- Length compatibility .
- Snap engagement
- Kink resistance ●
- Needle actuation ●
- Visual inspection
- Aspiration/flushing
- Electrical continuity
- Sheath compatibility: Insertion/withdrawal ●
The collective bench testing demonstrates that the proposed device does not raise different questions of safety or effectiveness when compared to the predicate device.
Biocompatibility
Biocompatibility testing was performed on the predicate device K210685 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 subject models of FlexCath Cross™ are made of identical patient contacting materials to the predicate device. Therefore, the previously submitted biocompatibility testing in K210685 has been leveraged for the subject device, and no additional biocompatibility testing is required.
Sterilization
Sterilization validation was performed on FlexCath Cross™ 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. FlexCath Cross™ is subjected to the identical ethylene oxide (EO) sterilization process as the predicate device to meet a sterility assurance level (SAL) of 10°. 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.
Electrical Safety and Electromagnetic Compatibility (EMC)
The modifications to the new models of FlexCath Cross™ 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
10
compatibility - Requirements 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.
Conclusions [807.92(b)(3)]
FlexCath Cross™ is made of identical patient contacting materials and has minimal design modifications as referenced in Table 2 to that of the predicate device. FlexCath Cross™ performs as intended and presents no unacceptable risks to the intent population or end user. The non-clinical bench data support the safety of the device and demonstrate that FlexCath Cross™ performs as intended in the specified use conditions. The additional FlexCath Cross™ models do not raise any new questions regarding safety or effectiveness of the device as compared to the predicate device. The nonclinical tests demonstrate that the device is as safe and effective as the predicate device.