(132 days)
K220047 AcQCross Qx Integrated Transseptal Dilator/Needle
No
The description focuses on the mechanical and electrical components of the device and does not mention any AI or ML capabilities.
No
The device is used to create an atrial septal defect, which is a procedure rather than a therapeutic treatment for a disease or condition. It is an access tool to facilitate other procedures.
No
The device is described as creating an atrial septal defect by puncturing the Fossa Ovalis and delivering radiofrequency energy. This is a therapeutic, interventional procedure, not a diagnostic one. While it can infuse solutions like contrast media, this is secondary to its primary therapeutic function.
No
The device description clearly details hardware components such as a cannula, dilator, guidewire, and adapter cable, and mentions electrical safety and mechanical testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "create an atrial septal defect in the heart" and "infusing solutions". This is a surgical/interventional procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The description details a system used to puncture tissue and deliver energy, which is consistent with a surgical/interventional device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device is used for a therapeutic/interventional purpose.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
DXF
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-thewire technique. The RF Transseptal Cannula is connected to a ValleyLabs Force2 Electrosurgical Generator (Medtronic, Inc) via the CrossWise RF Adapter Cable (packaged separately - Model CW-1002) and a commercially available Electrosurgical Pencil.
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 four configurations compatible with various commercially available guide sheaths (Table 5). All four configurations require use of a single model (CW-1002) CrossWise RF Adapter Cable Model which is packaged separately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart, atrial septal defect, Fossa Ovalis (FO) from the right atrium to the left atrium
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:
Design verification testing was performed on the CrossWise RF Transseptal Access System with CrossWise RF Adapter Cable at two time points: immediately after manufacturing (T=0) and after six months of accelerated aging (T=6M AA). Devices were subjected to 2X sterilization and distribution simulation before testing.
CrossWise RF Transseptal Access System testing included:
- Packaging Integrity
- Label Integrity
- Visual & Dimensional
- Introducer Set Compatibility
- Electrical Functionality/Compatibility
- Electrical Safety
- Mechanical Functionality
- Mechanical Durability
- Puncture Performance
- Particulate Generation
- Radiopacity
- Corrosion Resistance
CrossWise RF Adapter Cable testing included:
- Packaging Integrity
- Label Integrity
- Visual & Dimensional
- Electrical Functionality and Compatibility
- Electrical Safety
- Mechanical Functionality
- Mechanical Durability
Key results: The nonclinical bench data support the safety of the device and demonstrate that the CrossWise RF Transseptal System performs as intended in the specified use conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K232852 Cross Vascular RF Transseptal Needle
Reference Device(s)
K220047 AcQCross Qx Integrated Transseptal Dilator/Needle
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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 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.
September 26, 2024
Circa Scientific, Inc. % Jennifer Willner President JW Regulatory Consulting, LLC 406 Wacouta St. Suite 417 Saint Paul, Minnesota 55101
Re: K241414
Trade/Device Name: CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) Regulation Number: 21 CFR 870.5175 Regulation Name: Septostomy Catheter Regulatory Class: Class II Product Code: DXF Dated: May 17, 2024 Received: May 17, 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.
1
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
2
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
3
Indications for Use
510(k) Number (if known) K241414
Device Name
CrossWise RF Transseptal Access System (Models: CW-1085A, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002)
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) |
|---|---|
| ------------------------------------------------------------------------------------ | ------------------------------------------------------------------------- |
| X | 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
510(k) Number: K241414
Date Prepared: September 26, 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
CrossWise™ 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 RF Adapter Cable is substantially equivalent to the previously cleared predicate Cross Vascular RF Transseptal Needle with Connection Cable Predicate Device (Table 3) and has aspects similar to those in the AcQCross Qx Integrated Transseptal Dilator/Needle Reference Device (Table 4).
Table 3: Predicate Devices
| Predicate Device | Manufacturer | FDA 510(k) |
|---|---|---|
| Cross Vascular RF Transseptal Needle | Cross Vascular, Inc. | K232852 |
Table 4: Reference Device
| Reference Device | Manufacturer | FDA 510(k) |
|---|---|---|
| AcQCross Qx Transseptal Dilator/Needle | Acutus Medical | K220047 |
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-thewire technique. The RF Transseptal Cannula is connected to a ValleyLabs Force2
5
Electrosurgical Generator (Medtronic, Inc) via the CrossWise RF Adapter Cable (packaged separately - Model CW-1002) and a commercially available Electrosurgical Pencil.
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 four configurations compatible with various commercially available guide sheaths (Table 5). All four configurations require use of a single model (CW-1002) CrossWise RF Adapter Cable Model which is packaged separately.
| CrossWise Transseptal Access System | Compatible Commercial Introducer Set | ||
|---|---|---|---|
| Description | REF | Description | REF |
| CrossWise 8.5Fr, 71cm | |||
| C1 Swartz | CW-1085S | Swartz Braided Transseptal Guiding | |
| Introducer 8.5Fr, 63cm, SL0 and SL1 | |||
| [St Jude Medical / Abbott] | 407451 | ||
| 407453 | |||
| CrossWise 8.5Fr, 97cm | |||
| C1 Agilis | CW-1085A | Agilis NxT Steerable Introducer 8.5Fr, | |
| 71cm, Small, Medium, Large Curl | |||
| [St Jude Medical / Abbott] | 408309 | ||
| 408310 | |||
| G408324 | |||
| CrossWise 12Fr, 88cm C1 | |||
| Watchman | CW- | ||
| 1012W | Watchman | ||
| [Boston Scientific] | M635TU70010 | ||
| CrossWise 12Fr, 88cm C1 | |||
| FlexCath | CW-1012C | FlexCath Advance Steerable Sheath 12F | |
| [Medtronic] | 4FC12 |
Table 5: Compatible Introducer Sets
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 Subject and Predicate (PD) and Reference (RD) Devices are based on the same technological elements of delivering RF power in a monopolar mode between their distal tip electrode and commercially available Patient Return Electrode. Both devices are also loaded through commercially available transseptal introducer sets and have connections at their proximal end to a RF generator. The Subject and PD/RD devices both contain holes at the distal end to facilitate injection of contrast solution.
The following technological differences exist between the Subject and PD/RD device(s):
- Materials of construction
- Inner lumen dielectric coating .
- Tip electrode geometry
- . Tip protrusion indicator sleeve
These differences do not raise new questions regarding safety or effectiveness and do not impact the intended use of the device.
6
| Feature | Subject Device | Predicate Device 1 (K232852) | Reference Device 2 (K220047) | Analysis of Differences |
|---|---|---|---|---|
| Product | ||||
| Name | CrossWise RF Transseptal | |||
| Access System | Cross Vascular RF Transseptal | |||
| Needle | AcQCross Qx Integrated | |||
| Transseptal Dilator/Needle | ||||
| Manufacturer | Circa Scientific, Inc. | Cross Vascular, Inc. | Acutus Medical, Inc. | |
| Product Code | ||||
| / Regulation | DXF / 21CFR 870.5175 | DXF / 21CFR 870.5175 | DYB, DRE / 21CFR 870.1340 | Identical to PD |
| Indications | ||||
| for Use | The CrossWise RF Transseptal | |||
| System is 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 Cross Vascular RF | |||
| Transseptal Needle is 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 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. | Identical to PD; Same as RD with | |||
| addition of infusing solutions | ||||
| Energy | ||||
| Delivery | RF (monopolar mode) | RF (monopolar mode) | RF (monopolar mode) | Identical to PD & RD |
| Key Device | ||||
| Components | Cannula Handle with electrical | |||
| connector and luer connector | Needle Handle with electrical | |||
| connector and luer connector | Integrated Dilator/Needle Handle | |||
| with electrical connector and luer | ||||
| connector | Equivalent to PD & RD | |||
| Inner and outer polymer coated | ||||
| tubular stainless steel shaft | Outer polymer coated SST Shaft | Elongated shaft with tapered tip | ||
| and central lumen to track over | ||||
| guidewire. | ||||
| Hollow stainless steel transseptal | ||||
| needle. Shaft and needle connected | ||||
| to proximal handle. | Similar to PD & RD; minor design | |||
| differences do not raise new | ||||
| questions of safety or effectiveness | ||||
| Radiopaque Shaft | Radiopaque Shaft/Tip | Radiopaque Shaft/Tip | Identical to PD & RD | |
| RF Adapter Cable | Connection Cable | Adapter Cables – EGM & ES | Identical to PD & RD | |
| Dilator | Integrated dilator/needle | Similar – PD relies on dilator from | ||
| Introducer Set while RD has | ||||
| Feature | Subject Device | Predicate Device 1 (K232852) | Reference Device 2 (K220047) | Analysis of Differences |
| integrated dilator/needle; Minor | ||||
| design differences do not raise new | ||||
| questions of safety or effectiveness | ||||
| Guidewire | Guidewire | Identical to RD | ||
| Sizes / | ||||
| Dimensions | 8.5F, 71cm, C1 Curve | |||
| 8.5F, 97cm, C1 Curve | ||||
| 12F, 88cm, C1 Curve | 8.5F, 71cm, C0 Curve | |||
| 8.5F, 71cm, C1 Curve | ||||
| 8.5F, 98cm, C0 Curve | ||||
| 8.5F, 98cm, C1 Curve | 8.5F, 61cm | |||
| 8.5F, 71cm | ||||
| 8.5F, 63cm | ||||
| 12F, 65cm | ||||
| 12F, 70cm | Similar to PD & RD; Subject Device | |||
| not available in 61-65cm lengths but | ||||
| does not raise new questions of | ||||
| safety or effectiveness | ||||
| Guidewire | ||||
| Compatibility | 0.032" | 0.032" | 0.032" | Identical to PD & RD |
| Introducer | ||||
| Compatibility | Agilis, Swartz | |||
| Watchman | ||||
| FlexCath | Agilis, Swartz | Heartspan | ||
| Watchman | ||||
| FlexCath | ||||
| Agilis, Swartz | ||||
| Vizigo | Similar; Subject Device not | |||
| compatible with all of RD | ||||
| compatible devices but 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, blue | |||
| colorant | ||||
| Shaft: 304 Stainless Steel, | ||||
| Adcoat 41-3500, blue colorant | ||||
| Distal Tip: Gold | Shaft: Polyethylene Hexene | |||
| Copolymer; ethylene | ||||
| homopolymer; barium sulfate with | ||||
| blue colorant | ||||
| Needle: 304 Stainless steel | ||||
| Hypotube: 304 stainless steel | ||||
| Luer fitting: polycarbonate | Similar; minor design differences do | |||
| not raise new questions of safety or | ||||
| effectiveness | ||||
| Packaging | Sterile Pouch with IFU in Shelf | |||
| Carton | Sterile Pouch with IFU in Shelf | |||
| Carton | Sterile Pouch with IFU in Shelf | |||
| Carton | Identical to PD & RD | |||
| Feature | Subject Device | Predicate Device 1 (K232852) | Reference Device 2 (K220047) | Analysis of Differences |
| Sterilization | ||||
| Method / | ||||
| SAL | EO / 10-6 | EO / 10-6 | EO / 10-6 | Identical to PD & RD |
| Single-Use | ||||
| Devices? | Yes | Yes | Yes | Identical to PD & RD |
| Inserted Over | ||||
| a Guidewire? | Yes | No | Yes | Identical to RD |
| Shelf-Life | 6M, however intend to extend | |||
| up to 2 years upon successful | ||||
| completion of testing to | ||||
| identical protocol | 6M, however intend to extend up | |||
| to 2 years upon successful | ||||
| completion of testing to identical | ||||
| protocol | 12 Months | Identical to PD | ||
| Non- | ||||
| pyrogenic? | Yes | Yes | Yes | Identical to PD & RD |
| Connection | ||||
| Cable? | Yes | Yes | Yes | Identical to PD & RD |
| Single Use or | ||||
| Multi-Use | ||||
| Connection | ||||
| Cable? | Single Use | Single Use | Single Use | Identical to PD & RD |
| Compatible | ||||
| RF Generator | ValleyLabs Force 2 | |||
| Electrosurgical Generator | Cross Vascular RF Generator | |||
| RFG-01-00 | Valleylabs Force 2 Electrosurgical | |||
| Generator | Identical to RD |
Table 6: Substantial Equivalence Comparison Table
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Performance Standards
The CrossWise RF Transseptal Access System has 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
- . IEC 60601-1:2020, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
- . IEC 60601-1-2:2014+A1:2020, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
- 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
- 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
- AAMI TIR42:2021 Evaluation of Particulate Associated with Vascular Medical Devices
- ISO 11607-1:2019, Packaging for terminally sterilized medical devices Part 1: . Requirements for materials, sterile barrier systems and packaging systems
- ASTM D4169:2022, Standard Practice for Performance Testing of Shipping Containers . and Systems
- 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
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Nonclinical Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility
Biocompatibility testing was performed on the CrossWise RF Transseptal Access System in accordance with ISO 10993-1, Biological evaluation of medical devices - Part I: Evaluation and testing within a risk management process. The panel of biocompatibility testing included the following recommended tests:
- Cytotoxicity ●
- Irritation/Intracutaneous Reactivity ●
- Acute Systemic Toxicity ●
- Sensitization ●
- Hemocompatibility: ●
- o Hemolysis, Direct and Indirect Methods
- Complement Activation o
- o Partial Thromboplastin Time (PTT)
- Heparinized Platelet and Leukocyte (PL&L) Count Assay with Comparison Article O
- In Vivo Thrombogenicity in Canine o
- Material Mediated Pyrogenicity ●
The results demonstrate that the CrossWise RF Transseptal Access System meets the requirements of ISO 10993-1 and is biocompatible for its intended use.
Sterilization
Sterilization validation adoption was performed on the CrossWise RF Transseptal Access System with CrossWise RF Adapter Cable 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 CrossWise RF Transseptal Access System with CrossWise RF Adapter Cable is subjected to a similar ethylene oxide (EO) sterilization process as the Predicate Devices to meet a sterility assurance level (SAL) of 10°.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted on the CrossWise RF Transseptal Access System with CrossWise RF Adapter Cable. The testing complies with the applicable sections of IEC 60601-1:2020, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance, IEC 60601-1-2: 2014 +A1: 2020, Medical electrical equipment -Part 1-2: General requirements for the basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests, and IEC 60601-2-2:2023, Medical electrical equipment – Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical
Circa Scientific Inc.
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accessories.
This testing is consistent with that conducted by the Predicate Devices.
Bench Testing
Design verification testing was performed on the CrossWise RF Transseptal Access System with CrossWise RF Adapter Cable at two time points: immediately after manufacturing (T=0) and after six months of accelerated aging (T=6M AA). Devices were subjected to 2X sterilization and distribution simulation before the following types of testing was conducted:
CrossWise RF Transseptal Access System:
- Packaging Integrity
- Label Integrity ●
- . Visual & Dimensional
- Introducer Set Compatibility
- Electrical Functionality/Compatibility ●
- Electrical Safety
- Mechanical Functionality
- Mechanical Durability ●
- Puncture Performance
- Particulate Generation
- Radiopacity ●
- . Corrosion Resistance
CrossWise RF Adapter Cable:
- Packaging Integrity ●
- Label Integrity ●
- Visual & Dimensional ●
- Electrical Functionality and Compatibility ●
- Electrical Safety ●
- Mechanical Functionality ●
- Mechanical Durability
Conclusions
The CrossWise RF Transseptal Access System with CrossWise RF Adapter Cable is of similar materials and design of the PD/RD devices and has similar technical requirements. The nonclinical bench data support the safety of the device and demonstrate that the CrossWise RF Transseptal System performs as intended in the specified use conditions.
The CrossWise RF Transseptal Access System with CrossWise RF Adapter Cable is substantially equivalent to the Predicate (Table 3) and Reference (Table 4) Devices.