The CrossWise™ RF Transseptal Cannula and accessories are used to create an atrial septal defect in the heart. Secondary indications include infusing solutions including heparinized saline and mixtures of 50% contrast media and 50% saline.

Device Description

The CrossWise Multi-Use RF Adapter Cable (Model CW-1001) is used in Transseptal Puncture Procedures (TSP) to connect the CrossWise™ RF Transseptal Cannula (K241414) to a 3/32" electrosurgical (ES) pencil. The cable delivers radiofrequency (RF) energy to the CrossWise™ RF Transseptal Cannula to facilitate septal puncture. The CrossWise RF Transseptal Cannula is connected to a ValleyLabs Force2 ES Generator (K051644) via the CrossWise Multi-Use RF Adapter Cable (Model CW-1001) or CrossWise RF Adapter Cable (Model CW-1002 / K241414) and a commercially available 3/32" ES pencil. The CrossWise Multi-Use RF Adapter Cable has unique connectors on each end which cannot be connected to an improper device and/or accessory. The CrossWise Multi-Use RF Adapter Cable (Model CW-1001) and CrossWise RF Adapter Cable (Model CW-1002) are both compatible with all CrossWise RF Transseptal Access System models. The dimensions for the CrossWise Multi-Use RF Adapter Cable can be found on the package labels. Circa Scientific sterilized the CrossWise Multi-Use RF Adapter Cable via ethylene oxide (EO) for initial use and is intended for multiple patients use, following prescribed reprocessing instructions. The prescribed reprocessing includes cleaning and steam/autoclaye sterilization procedures that have been validated for up to10 uses when users follow the cleaning and sterilization methods described in the Cleaning and Sterilization Instructions sections of the CrossWise Multi-Use RF Adapter Cable IFU. The CrossWise Multi-Use RF Adapter Cable does not come into direct or indirect contact with the patient according to the definitions in Section 3.0 of ISO 10993-1, and Attachment G of the September 2023 FDA Guidance document.

AI/ML Overview

The provided document is a 510(k) Pre-Market Notification for a medical device called the "CrossWise™ Multi-Use RF Adapter Cable." This document primarily focuses on demonstrating the substantial equivalence of the new device to a previously cleared predicate device, especially regarding its reusability and materials.

The request asks for information typically found in studies validating an AI/ML medical device, specifically regarding acceptance criteria and performance data for an algorithm. However, this 510(k) submission does not describe an AI/ML device or algorithm. Instead, it describes a physical medical device (an adapter cable) and the bench testing performed to ensure its safety and effectiveness, particularly its reprocessing capabilities.

Therefore, many of the requested points, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)," "number of experts used to establish the ground truth," and "sample size for the training set," are not applicable to this type of device and submission.

However, I can extract information related to the acceptance criteria and the study that proves the device meets those criteria, reinterpreting the request for a physical device rather than an AI/ML algorithm.

Device Description:
The CrossWise™ Multi-Use RF Adapter Cable (Model CW-1001) is used in Transseptal Puncture Procedures (TSP) to connect the CrossWise™ RF Transseptal Cannula to a 3/32" electrosurgical (ES) pencil. The cable delivers radiofrequency (RF) energy to the cannula to facilitate septal puncture. The primary difference from the predicate device is its ability to be reprocessed (cleaned and re-sterilized) for up to 10 uses, and minor material modification to the connector shroud to withstand autoclave temperatures.

1. Table of Acceptance Criteria and Reported Device Performance

For this multi-use physical device, the "acceptance criteria" revolve around its ability to maintain its functionality and safety after repeated reprocessing cycles, showing substantial equivalence to the predicate device.

Acceptance Criteria Category	Specific Test/Performance Metric	Acceptance Criteria (Implicit from testing)	Reported Device Performance (Implicit from "passed testing")
Sterilization	Initial EO Sterilization SAL	SAL of $10^{-6}$	Validated to meet SAL of $10^{-6}$
	Subsequent Steam Sterilization	Validated for up to 10 cycles	Validated for up to 10 additional steam sterilization cycles.
Physical Integrity	Label Visual Inspection	Labels must be present and legible.	Devices passed visual inspection.
	Device Visual Inspection	No damage, defects, or degradation.	Devices passed visual inspection.
	Dimensional Verification	Dimensions within specified tolerances.	Devices passed dimensional verification.
Functional Performance	Impedance	Meets required electrical impedance.	Devices passed impedance testing.
	Bend Radius	Maintains structural integrity after bending.	Devices passed bend radius testing.
	Resistance	Meets required electrical resistance.	Devices passed resistance testing.
	RF Energy Delivery	Capable of delivering RF energy as intended.	Devices passed RF energy delivery testing.
	Continuity	Maintains electrical continuity.	Devices passed continuity testing.
	Tensile	Withstands specified tensile forces.	Devices passed tensile testing.
Durability	Reprocessing Durability	Maintains function after 10 reprocessing cycles and accelerated aging.	Devices passed durability testing. (Implies all tests above passed after conditioning)
Biocompatibility	Patient Contact	No direct or indirect patient contact (inherent to device type).	The device does not come into direct or indirect contact with the patient according to relevant standards.

2. Sample Size Used for the Test Set and the Data Provenance

Test Set Sample Size: The document does not explicitly state the numerical sample size for individual tests (e.g., "n=X cables tested"). It mentions "Devices" were tested and "testing was conducted on devices at 2 aging points: after manufacturing (T=0) and after 6 months of accelerated aging (T=6M AA)." It also states that devices were "subsequently conditioned to reflect the intended reusability of the devices after reprocessing."
Data Provenance: The data is from non-clinical bench testing performed by the manufacturer, Circa Scientific, Inc., to support the 510(k) submission. There is no indication of country of origin of the data beyond the manufacturer's location (Englewood, CO, USA). The testing is prospective as it's specifically designed to validate the new device's capabilities prior to market clearance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This concept is not applicable to this type of device validation. "Ground truth" established by experts (e.g., radiologists interpreting images) is relevant for AI/ML diagnostic tools. For this physical device, the "ground truth" is defined by established engineering and medical device standards for performance, sterilization, and material properties. The engineers and quality assurance personnel conducting and overseeing these tests are inherently acting as the "experts" whose work ensures compliance with these standards.

4. Adjudication Method for the Test Set

This concept is not applicable. Adjudication methods (e.g., 2+1, 3+1 consensus) are used for resolving disagreements in expert interpretations, typically in diagnostic or prognostic AI/ML studies. For bench testing of a physical device, results are typically objectively measured against pre-defined engineering specifications, not subject to subjective interpretation and adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. An MRMC study is designed to evaluate the impact of an AI diagnostic tool on human reader performance. The device here is a physical adapter cable, not an AI/ML algorithm.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. A standalone performance evaluation is performed for AI/ML algorithms. The device submitted is a physical product. Its "standalone" performance is assessed via the bench tests (e.g., electrical resistance, tensile strength) without human interaction being part of the performance metric itself, but this is a fundamentally different type of evaluation from an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this physical device is based on engineering specifications, material science properties, and established medical device performance standards (e.g., ISO 11135, ISO 17665, AAMI TIR12, ANSI/AAMI ST79, ANSI/AAMI ST98, IEC 60601-2-2). The physical and functional characteristics of the cable are objectively measured and compared against these pre-defined benchmarks to ensure safety and effectiveness for its intended use. There is no "pathology" or "outcomes data" in the sense of clinical study that establishes efficacy for this specific component; rather, component performance ensures the overall system works.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not an AI/ML device that learns from data.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no "training set."

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 26, 2024 Circa Scientific, Inc. % Jennifer Willner President JW Regulatory Consulting LLC 406 Wacouta St, Suite 417 Saint Paul, Minnesota 55101

Re: K243193

Trade/Device Name: Cross Wise™ Multi-Use RF Adapter Cable Regulation Number: 21 CFR 870.5175 Regulation Name: Septostomy catheter Regulatory Class: Class II Product Code: DXF Dated: September 30, 2024 Received: October 31, 2024

Dear Jennifer Willner:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 (QS) 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 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-regulatory

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assistance/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,

Alexandra K. Manaras -S

For Kalkidan Molla Acting 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

Enclosure

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Indications for Use

510(k) Number (if known) K243193

Device Name

CrossWise RF Transseptal Access System (Models: CW-1085A, CW-1012W, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002)

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

510(k) Number: K243193

Date Prepared: October 31, 2024

Table 1: Submitter Information

Manufacturer:	Manufacturer's Contact Person:
Circa Scientific, Inc.	Jennifer Willner, President
14 Inverness Dr E, Suite H-136	JW Regulatory Consulting LLC
Englewood, CO 80112	Phone: (612) 240 - 8904
US FDA ERN: 3009437315	Email: Jennifer@JWRegulatoryConsulting.com

Table 2: Device Information

Trade Name	CrossWise™ RF Transseptal Access System withCrossWise™ Multi-Use RF Adapter Cable
Common Name	Transseptal Access System
Classification Name	Catheter, Septostomy
Regulation	21CFR 870.5175
Product Code	DXF
Regulatory Classification:	Class II
Device Panel:	Cardiovascular

The Circa Scientific CrossWise RF Transseptal Access System with CrossWise Multi-Use RF Adapter Cable is substantially equivalent to the previously cleared predicate CrossWise RF Transseptal Access System with CrossWise RF Adapter Cable Predicate Device (Table 3).

Table 3: Predicate Devices

Predicate Device	Manufacturer	FDA 510(k)
CrossWise RF Transseptal Access System	Circa Scientific, Inc.	K241414
with CrossWise RF Adapter Cable

Device Description

The CrossWise RF Transseptal Cannula is connected to a ValleyLabs Force2 ES Generator (K051644) via the CrossWise Multi-Use RF Adapter Cable (Model CW-1001) or CrossWise RF Adapter Cable (Model CW-1002 / K241414) and a commercially available 3/32" ES pencil. The CrossWise Multi-Use RF Adapter Cable has unique connectors on each end which cannot be connected to an improper device and/or accessory.

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The CrossWise Multi-Use RF Adapter Cable (Model CW-1001) and CrossWise RF Adapter Cable (Model CW-1002) are both compatible with all CrossWise RF Transseptal Access System models. The dimensions for the CrossWise Multi-Use RF Adapter Cable can be found on the package labels.

Circa Scientific sterilized the CrossWise Multi-Use RF Adapter Cable via ethylene oxide (EO) for initial use and is intended for multiple patients use, following prescribed reprocessing instructions. The prescribed reprocessing includes cleaning and steam/autoclaye sterilization procedures that have been validated for up to10 uses when users follow the cleaning and sterilization methods described in the Cleaning and Sterilization Instructions sections of the CrossWise Multi-Use RF Adapter Cable IFU.

The CrossWise Multi-Use RF Adapter Cable does not come into direct or indirect contact with the patient according to the definitions in Section 3.0 of ISO 10993-1, and Attachment G of the September 2023 FDA Guidance document.

Indications for Use

Comparison of Technological Characteristics with the Predicate Device

The Subject and Predicate Devices have identical technological elements and are used with the identical models of CrossWise RF Transseptal Access System. The CrossWise Multi-Use RF Adapter Cable and CrossWise RF Adapter Cable are both designed to deliver radiofrequency (RF) energy to the CrossWise RF Transseptal Cannula to facilitate septal puncture and have the same overall design, function, packaging and materials of construction.

The following technological differences exist between the Subject and Predicate Device:

. Ability to reprocess (clean and re-sterilize) the Subject Device up to 10 times for use on multiple patients
. Addition of a UDI heat shrink label on the Subject Device to enable identification throughout its lifetime as a reusable device
Minor material modification to the connector shroud material (Santoprene 8281-65MED, . Black (TPE)) to withstand autoclave temperatures
. Updated labeling:
- New Pouch label and shelf carton label which do not have single use and do not o reuse symbols
- New IFU which provides validated reprocessing (cleaning and sterilization) o instructions

These differences do not raise new questions regarding safety or effectiveness and do not impact the intended use of the device.

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Feature	Subject Device	Predicate Device (K241414)	Analysis ofDifferences
Product Name	CrossWise RF TransseptalAccess System withCrossWise Multi-Use RFAdapter Cable	CrossWise RF TransseptalAccess System withCrossWise RF Adapter Cable
Manufacturer	Circa Scientific, Inc.	Circa Scientific, Inc.
Product Code /Regulation	DXF / 21CFR 870.5175	DXF / 21CFR 870.5175	Identical
Indications for Use	The CrossWise™ RFTransseptal Cannula andaccessories are used to createan atrial septal defect in theheart. Secondary indicationsinclude infusing solutionsincluding heparinized salineand mixtures of 50% contrastmedia and 50% saline.	The CrossWise™ RFTransseptal Cannula andaccessories are used to createan atrial septal defect in theheart. Secondary indicationsinclude infusing solutionsincluding heparinized salineand mixtures of 50% contrastmedia and 50% saline.	Identical
Energy Delivery	RF (monopolar mode)	RF (monopolar mode)	Identical
Device Components/ Sizes / Dimensions	Overall length: 3 meters	Overall length: 3 meters	Identical
	ES Pencil Adapter Pin OD:0.093" Pin	ES Pencil Adapter Pin OD:0.093" Pin	Identical
	Needle Connector: Staubli2mm Plug	Needle Connector: Staubli2mm Plug	Identical
	Number of conductors: 1	Number of conductors: 1	Identical
	Heat Shrink UDI Label	No label on device	Reusable devices arerequired to havepermanent labeling ondevice; difference doesnot raise new questionsof safety oreffectiveness
DeviceCompatibility	• CrossWise 8.5Fr, 71cm C1Swartz, Model CW-1085S• CrossWise 8.5Fr, 97cm C1Agilis, Model CW-1085A• CrossWise 12Fr, 88cm C1Watchman, Model CW-1012W	• CrossWise 8.5Fr, 71cm C1Swartz, Model CW-1085S• CrossWise 8.5Fr, 97cm C1Agilis, Model CW-1085A• CrossWise 12Fr, 88cm C1Watchman, Model CW-1012W	Identical
Feature	Subject Device	Predicate Device (K241414)	Analysis ofDifferences
	• CrossWise 12Fr, 88cm C1FlexCath, Model CW-1012C• ValleyLabs Force 2Electrosurgical Generator	• CrossWise 12Fr, 88cm C1FlexCath, Model CW-1012C• ValleyLabs Force 2Electrosurgical Generator
Device Materials	ES Pencil Adapter Overmold:Santoprene 8281-65MED,Black (TPE)Cable Jacket Material: TPEBovie Pin: 316 Stainless SteelNeedle Connector: TPE	ES Pencil Adapter Overmold:45D PebaxCable Jacket Material: TPEBovie Pin: 316 Stainless SteelNeedle Connector: TPE	Substantially similar;minor materialdifference does notraise new questions ofsafety or effectivenessas the device is non-patient contacting
Packaging	Sterile Pouch with IFU inShelf Carton	Sterile Pouch with IFU inShelf Carton	Identical
SterilizationMethod / SAL	As distributed: EO / 10-6By User: Steam (Autoclave) /10-6	As distributed: EO / 10-6	Identical method andcycle as initiallydistributed; PD is asingle-use device andnot sterilized by theUser
Single-Use Devices?	No	Yes	This is the main reasonfor this Special 510(k)submission
Shelf-Life	6M, however intend to extendup to 2 years upon successfulcompletion of testing toidentical protocol	6M, however intend to extendup to 2 years upon successfulcompletion of testing toidentical protocol	Identical

Table 4: Substantial Equivalence Comparison Table

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Performance Standards

The CrossWise RF Transseptal Access System with Multi-Use RF Adapter Cable has been developed in conformance with the following standards:

ISO 11135:2014, Sterilization of health-care products Ethylene oxide Requirements ● for the development validation and routine control of a sterilization process for medical devices
ISO 10993-7:2008, Biological evaluation of medical devices Part 7: Ethylene oxide ● sterilization residuals
. ISO 15223-1:2021, Medical devices – Symbols to be used with medical device labels, labeling and information to be supplied
ISO 20417:2021, Medical devices Information to be supplied by the manufacturer ●

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AAMI TIR28:2016, Product adoption and process equivalence for ethylene oxide . sterilization
ISO 17665:2024, Sterilization of health care products - Moist heat - Requirements for the development validation and routine control of a sterilization process for medical devices
AAMI TIR12:2020. Designing testing and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility ● assurance in health care facilities
ANSI/AAMI ST98:2022. Cleaning validation of health care products Requirements ● for development and validation of a cleaning process for medical devices
. IEC 60601-2-2:2023. 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

Nonclinical Performance Data

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

Sterilization

The CrossWise Multi-Use RF Adapter Cable is provided to the user in sterile condition using ethylene oxide (EO) sterilization. The Subject Device has been adopted into the identical EO sterilization cycle as the Predicate Device 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. The sterile packaged CrossWise Multi-Use RF Adapter Cable is validated to meet a sterility assurance level (SAL) of 10-9.

The modification subject to this Special 510(k) submission involves providing a multi-use device that can be reprocessed by the end user following the cleaning and sterilization instructions provided in the CrossWise Multi-Use RF Adapter IFU. As such, the CrossWise Multi-Use RF Adapter Cable has been validated to undergo up to 10 additional sterilization cycles using steam heat/autoclave sterilization methodology. This validation was conducted in accordance with ISO 17665:2024, Sterilization of health care products - Moist heat - Requirements for the development validation and routine control of a sterilization process for medical devices. The following standards were also considered during the reprocessing validation activities: AAMI TIR12:2020, Designing testing and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers, ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, and ANSI/AAMI ST98:2022, Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices.

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Bench Testing

Design verification testing was conducted to support the noted changes in the CrossWise Multi-Use RF Adapter Cable. Testing was conducted on devices at 2 aging points: after manufacturing (T=0) and after 6 months of accelerated aging (T=6M AA).

Devices were subsequently conditioned to reflect the intended reusability of the devices after reprocessing and passed the following testing:

Label visual inspection
Device visual inspection ●
Dimensional verification
Functional: ●
- Impedance O
- Bend radius o
- Resistance O
- O RF energy delivery
- Continuity O
- Tensile O
Durability

As there are no changes to the packaging system of the device, no further transportation or packaging stability testing was conducted beyond what has been reviewed under the Predicate Device K241414.

Conclusions

The CrossWise RF Transseptal Access System with CrossWise Multi-Use RF Adapter Cable is identical to the CrossWise RF Transseptal Access System with CrossWise RF Adapter Cable cleared via K241414 with minor design differences of the cable (labeling and connector resin) that enable it to be reprocessed by the end user for multiple patient use. The non-clinical bench data supports the safety of the device and demonstrates that the CrossWise RF Transseptal Access System with CrossWise Multi-Use Adapter Cable performs as intended in the specified use conditions.

The CrossWise RF Transseptal Access System with CrossWise Multi-Use RF Adapter Cable is substantially equivalent to the Predicate Device (Table 3).

Regulation Number and Section

§ 870.5175 Septostomy catheter.

(a)
Identification. A septostomy catheter is a special balloon catheter that is used to create or enlarge the atrial septal defect found in the heart of certain infants.(b)
Classification. Class II (performance standards).