(30 days)
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.
The CrossWise RF Transseptal Access System is used to puncture the Fossa Ovalis (FO) to establish transcatheter access from the right atrium to the left atrium. Monopolar radiofrequency (RF) energy is delivered between the CrossWise focal force electrode and a patient return electrode. The unique design of the focal force electrode minimizes trauma to cardiac tissue unless RF energy is applied. A colored sleeve is provided on the CrossWise RF Transseptal Cannula handle to indicate to the user when the tip of the catheter is still within the dilator.
The CrossWise RF Transseptal Cannula is supplied with a compatible dilator and a Super Stiff 0.032" PTFE-Coated Fixed Core J-Tip guidewire for vascular introduction using an over-the-wire technique. The RF Transseptal Cannula is connected to a ValleyLabs Force2 Electrosurgical Generator (Medtronic, Inc) via the CrossWise Multi-Use RF Adapter Cable (packaged separately – Model CW-1001) and a commercially available Electrosurgical Pencil.
This 510(k) clearance letter details the substantial equivalence of new models of the CrossWise RF Transseptal Access System to a previously cleared predicate device. It specifically states that the new models have minor modifications and leverage most of the performance data of the predicate device.
Therefore, the acceptance criteria and study details discussed below refer to the bench testing conducted for these minor modifications, as this is the only performance data explicitly mentioned for the subject device. The document does not contain information about clinical studies with human participants, expert ground truth adjudication, or AI performance, as it is related to a medical device's physical and functional equivalence, not an AI or diagnostic tool.
Acceptance Criteria and Study Proving Device Meets Acceptance Criteria
The provided 510(k) clearance letter details the acceptance criteria and the non-clinical performance data for the CrossWise RF Transseptal Access System line extensions (Models CW-1085C, CW-1085V, and CW-1013F). The study conducted to prove the device meets these criteria was a series of bench tests.
1. Table of Acceptance Criteria and Reported Device Performance
The letter explicitly states that the new models leverage most of the performance data of the predicate device. The following table summarizes the specific tests conducted for the minor modifications of the new models and the implied performance criteria based on the conclusion of substantial equivalence.
| Acceptance Criterion | Performance for Subject Device (CW-1085C, CW-1085V, CW-1013F) | Notes |
|---|---|---|
| Dilator Hub Snap Compatibility | Bench tested to confirm proper connection with 7 new compatible commercial introducer sheaths (CardioCurve, Vizigo, Faradrive), as well as previously compatible sheaths (Agilis, Swartz, Watchman, FlexCath). | The document states "minor dimensional changes to accommodate proper connection with other commercial introducer sheaths", and "Similar to PD; Subject Device dilator extrusions are identical with minor proximal hub modifications for compatibility with new sheaths. This does not raise new questions of safety or effectiveness." This implies successful snap compatibility. |
| Sheath Compatibility | Bench tested to confirm proper fit and function within the specified compatible commercial introducer sheaths (CardioCurve, Vizigo, Faradrive). | The document states "minor dimensional changes to accommodate proper connection with other commercial introducer sheaths", implying that compatibility was successfully demonstrated. |
| Dilator Leak Test | Bench tested. | No specific performance metrics are given, but the conclusion of safety and intended performance implies the device passed this test. This typically involves ensuring no fluid leakage under specified pressures. |
| Dilator Tensile | Bench tested. | No specific performance metrics are given, but the conclusion of safety and intended performance implies the device passed this test. This typically involves testing the strength and integrity of the dilator under tension. |
| ISO 80369-7 Luer Testing | Conformed to ISO 80369-7:2021 standard for small-bore connectors for intravascular/hypodermic applications. | The document lists ISO 80369-7:2021 under "Performance Standards" and explicitly states "ISO 80369-7 Luer Testing" was performed. Conformance to this standard means the luer connectors meet established safety and functional requirements to prevent misconnections and ensure proper fluid transfer. |
| Biological Evaluation (Biocompatibility) | Conformed to ISO 10993-1:2018. | Explicitly listed under "Performance Standards". The conclusion of substantial equivalence indicates the device's biocompatibility is acceptable. |
| Sterilization Method / SAL | Achieved Sterility Assurance Level (SAL) of 10^-6 using Ethylene Oxide (EO). | Explicitly listed in the comparison table as "Identical" to predicate device. |
| Nonpyrogenic | Yes | Explicitly listed in the comparison table as "Identical" to predicate device. |
| Shelf-Life | 2 Years | Explicitly listed in the comparison table as "Identical" to predicate device. No further stability/shelf-life testing was required for the line extension models due to no change in material, design, or processing that could lead to age-related failure. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in terms of a number of devices or units. The testing refers to "minor modifications" to the dilator hub and compatibility with new introducer sheaths. For bench tests like these, a statistically representative sample size would have been used for each test (e.g., n=3, 5, or 10 units per test configuration), but the exact numbers are not provided.
- Data Provenance: The data is non-clinical bench testing conducted by the manufacturer, Circa Scientific, Inc. The location of the testing is not specified, but it would have been conducted in a laboratory setting under controlled conditions. This is not retrospective or prospective in the clinical sense, as it does not involve patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This document describes the clearance of a medical device (a transseptal access system), not an AI or diagnostic tool that relies on expert interpretation of data to establish ground truth. The acceptance criteria are based on objective engineering and performance standards demonstrated through bench testing.
4. Adjudication Method for the Test Set
- Not applicable. As this is non-clinical bench testing of a physical medical device against engineering standards, there is no expert adjudication process in the manner of medical image interpretation or clinical outcomes. Test results would have been analyzed and verified by qualified engineering and quality personnel.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is typically conducted for diagnostic devices or AI systems where human readers interpret patient cases. This clearance is for a physical medical device used in interventional cardiology.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a physical medical device, not an algorithm, so the concept of standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
- Engineering and Performance Standards: The "ground truth" for the bench tests would have been established by predefined engineering specifications, internationally recognized standards (e.g., ISO 80369-7, ISO 10993-1, ISO 11070-1), and the performance characteristics of the predicate device. For example, the ground truth for "Dilator Leak Test" would be "no leakage observed under specified pressure," and for "ISO 80369-7 Luer Testing" would be "full compliance with all requirements of the standard."
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, this question is not relevant.
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 1, 2025
Circa Scientific, Inc.
℅ Jennifer Willner
President
JW Regulatory Consulting, LLC
406 Wacouta St, Suite 417
St. Paul, Minnesota 55101
Re: K251007
Trade/Device Name: CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)
Regulation Number: 21 CFR 870.5175
Regulation Name: Septostomy Catheter
Regulatory Class: Class II
Product Code: DXF
Dated: April 1, 2025
Received: April 1, 2025
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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K251007 - Jennifer Willner Page 2
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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K251007 - Jennifer Willner Page 3
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,
Katherine N. Trivedi
-S
Katherine Trivedi
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
Page 4
FORM FDA 3881 (6/20) Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known): K251007
Device Name: CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)
Indications for Use (Describe):
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.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Circa Scientific Inc. Page 1 of 6 April 2025
510(K) SUMMARY
510(k) Number: K251007
Date Prepared: March 31, 2025
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 |
|---|---|
| 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 line extensions are substantially equivalent to the previously cleared predicate CrossWise RF Transseptal Access System (Table 3).
Table 3: Predicate Devices
| Predicate Device | Manufacturer | FDA 510(k) |
|---|---|---|
| CrossWise RF Transseptal Access System | Circa Scientific, Inc. | K241414 |
Device Description
The CrossWise RF Transseptal Access System is used to puncture the Fossa Ovalis (FO) to establish transcatheter access from the right atrium to the left atrium. Monopolar radiofrequency (RF) energy is delivered between the CrossWise focal force electrode and a patient return electrode. The unique design of the focal force electrode minimizes trauma to cardiac tissue unless RF energy is applied. A colored sleeve is provided on the CrossWise RF Transseptal Cannula handle to indicate to the user when the tip of the catheter is still within the dilator.
The CrossWise RF Transseptal Cannula is supplied with a compatible dilator and a Super Stiff 0.032" PTFE-Coated Fixed Core J-Tip guidewire for vascular introduction using an over-the-wire technique. The RF Transseptal Cannula is connected to a ValleyLabs Force2 Electrosurgical Generator (Medtronic, Inc) via the CrossWise Multi-Use RF Adapter Cable (packaged separately – Model CW-1001) and a commercially available Electrosurgical Pencil.
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Circa Scientific Inc. Page 2 of 6 April 2025
The CrossWise RF Transseptal Cannula is designed to facilitate injection of heparinized saline and/or contrast solution. The dimensions for the CrossWise RF Transseptal Cannula can be found on the device label. The CrossWise RF Transseptal Access System offers multiple configurations compatible with various commercially available guide sheaths (Table 4). All configurations require use of a CrossWise Multi-Use RF Adapter Cable (Model CW-1001) which is packaged separately.
Table 4: Compatible Introducer Sets
| CrossWise RF Transseptal Access System | Compatible Commercial Introducer Set |
|---|---|
| Description | REF |
| CrossWise 8.5Fr, 71cm C1 Swartz | CW-1085S |
| CrossWise 8.5Fr, 97cm C1 Agilis | CW-1085A |
| CrossWise 12Fr, 88cm C1 Watchman | CW-1012W |
| CrossWise 12Fr, 88cm C1 FlexCath | CW-1012C |
| CrossWise 8.5Fr, 97cm C1 CardioCurve | CW-1085C* |
| CrossWise 8.5Fr, 97cm C1 Vizigo | CW-1085V* |
| CrossWise 13Fr, 97cm C1 Faradrive | CW-1013F* |
*These are the CrossWise line extension Models subject to this Special 510(k) application
Indications for Use
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.
Comparison of Technological Characteristics with the Predicate and Reference Device
The purpose of this submission is the addition of three new CrossWise RF Transseptal Access System line extensions: Models CW-1085C, CW-1085V, and CW-1013F. The only device affected by this change is the transseptal dilator component of the CrossWise system and only the proximal luer hub is modified. The material composition of the dilator, along with the
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Circa Scientific Inc. Page 3 of 6 April 2025
extruded shaft and distal tip design remain unchanged and are identical to the Predicate Device. The proximal luer hub has minor dimensional changes to accommodate proper connection with other commercial introducer sheaths: CardioCurve, Vizigo and Faradrive (Table 4).
These differences do not raise new questions regarding safety or effectiveness and do not impact the intended use of the device.
There is no change to the packaging of the CrossWise RF Transseptal Access System as a result of the line extensions. Labeling has been updated to include reference to the new model numbers.
Table 5: Substantial Equivalence Comparison Table
| Feature | Subject Device | Predicate Device 1 (K241414) | Analysis of Differences |
|---|---|---|---|
| Product Name | CrossWise RF Transseptal Access System | CrossWise RF Transseptal Access System | Identical |
| Manufacturer | Circa Scientific, Inc. | Circa Scientific, Inc. | Identical |
| Product Code / Regulation | DXF / 21CFR 870.5175 | DXF / 21CFR 870.5175 | Identical |
| Indications for Use | 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. | 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. | Identical |
| Energy Delivery | RF (monopolar mode) | RF (monopolar mode) | Identical |
| Key Device Components | Cannula Handle with electrical connector and luer connector | Cannula Handle with electrical connector and luer connector | Identical |
| Inner and outer polymer coated tubular stainless steel shaft | Inner and outer polymer coated tubular stainless steel shaft | Identical | |
| Radiopaque Shaft | Radiopaque Shaft | Identical | |
| RF Adapter Cable | RF Adapter Cable | Identical | |
| Dilator | Dilator | Identical | |
| Guidewire | Guidewire | Identical | |
| Sizes / Dimensions | 8.5F, 97cm, C1 Curve; 13F, 97cm, C1 Curve | 8.5F, 71cm, C1 Curve; 8.5F, 97cm, C1 Curve; 12F, 88cm, C1 Curve | Similar to PD; Subject Device adds 13F compatibility (for Faradrive sheath) with identical 12F extruded dilator. This does not raise new questions of safety or effectiveness |
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Circa Scientific Inc. Page 4 of 6 April 2025
| Feature | Subject Device | Predicate Device 1 (K241414) | Analysis of Differences |
|---|---|---|---|
| Guidewire Compatibility | 0.032" | 0.032" | Identical |
| Introducer Compatibility | CardioCurve, Vizigo, Faradrive | Agilis, Swartz, Watchman, FlexCath | Similar; Subject Device dilator extrusions are identical with minor proximal hub modifications for compatibility with new sheaths. This does not raise new questions of safety or effectiveness |
| Device Materials (Patient Contacting) | Handle: Polypropylene, White colorant; Shaft: Stainless Steel, Adcoat 41-3500, White colorant; Distal Tip: Stainless Steel; Guidewire: Stainless Steel, PTFE; Dilator Shaft: High Density Polyethylene, Barium Sulfate, Blue Colorant | Handle: Polypropylene, White colorant; Shaft: Stainless Steel, Adcoat 41-3500, White colorant; Distal Tip: Stainless Steel; Guidewire: Stainless Steel, PTFE; Dilator Shaft: High Density Polyethylene, Barium Sulfate, Blue Colorant | Identical |
| Packaging | Sterile Pouch with IFU in Shelf Carton | Sterile Pouch with IFU in Shelf Carton | Identical |
| Sterilization Method / SAL | EO / 10-6 | EO / 10-6 | Identical |
| Single-Use Devices? | Yes | Yes | Identical |
| Inserted Over a Guidewire? | Yes | Yes | Identical |
| Shelf-Life | 2 Years | 2 Years | Identical |
| Nonpyrogenic? | Yes | Yes | Identical |
| Connection Cable? | Yes | Yes | Identical |
| Single Use or Multi-Use Connection Cable? | Multi-Use (K243193) | Multi-Use (K243193) | Identical |
| Compatible RF Generator | ValleyLabs Force 2 Electrosurgical Generator | ValleyLabs Force 2 Electrosurgical Generator | Identical |
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Performance Standards
The CrossWise RF Transseptal Access System line extension models have been developed in conformance with the following standards:
- ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- FDA Guidance: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", September 2023
- 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
- ISO 11070-1:2014, Sterile single-use intravascular introducers, dilators and guidewires
- ISO 80369-7:2021, Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
Nonclinical Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Bench Testing
The minor modifications for the CrossWise RF Transseptal Access System line extension models leveraged most of the performance data of the Predicate Device with the following exceptions:
- Dilator Hub Snap Compatibility
- Sheath Compatibility
- Dilator Leak Test
- Dilator Tensile
- ISO 80369-7 Luer Testing
As there was no change in material, design or processing that could lead to age related failure, no further stability/shelf-life testing was required. 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 Transseptal Access System line extensions are identical to the Predicate Device cleared via K241414 with minor luer hub differences in the dilator component that enable compatibility with other commercial introducer sheaths. The non-clinical bench data supports the
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safety of the device and demonstrates that the CrossWise Transseptal Access System line extensions perform as intended in the specified use conditions.
The CrossWise RF Transseptal Access System line extensions (Table 4) are substantially equivalent to the Predicate Device (Table 3).
§ 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).