(57 days)
No
The description focuses on the physical components and function of an RF adapter cable for delivering energy, with no mention of AI or ML capabilities.
Yes
The device is used to create an atrial septal defect in the heart, which is a therapeutic intervention. It also delivers radiofrequency (RF) energy to facilitate septal puncture.
No
The device is described as being used to create an atrial septal defect and deliver RF energy to facilitate septal puncture, which are therapeutic actions, not diagnostic.
No
The device description clearly details physical components (cannula, adapter cable) and their interaction with other hardware (electrosurgical pencil, ES generator) to deliver RF energy. There is no mention of software as the primary or sole component.
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 directly on the patient's body.
- Device Description: The device is a cannula and adapter cable used to deliver RF energy for a surgical procedure (transseptal puncture). It is used in conjunction with an electrosurgical generator.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on samples.
The device is clearly intended for use in vivo (within the living body) for a therapeutic/interventional purpose, not in vitro (in glass/outside the body) for diagnostic testing.
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart (atrial septal)
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)
Study Type: Nonclinical Performance Data - Sterilization and Bench Testing
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. The sterile packaged CrossWise Multi-Use RF Adapter Cable is validated to meet a sterility assurance level (SAL) of 10-6. The device has been validated to undergo up to 10 additional sterilization cycles using steam heat/autoclave sterilization methodology in accordance with ISO 17665:2024.
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
- Bend radius
- Resistance
- RF energy delivery
- Continuity
- Tensile
- Durability
Key Results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 & 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.
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) 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)
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.
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: 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 with
CrossWise™ 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 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.
5
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
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 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.
6
| Feature | Subject Device | Predicate Device (K241414) | Analysis of
Differences |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | CrossWise RF Transseptal
Access System with
CrossWise Multi-Use RF
Adapter Cable | CrossWise RF Transseptal
Access System with
CrossWise 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™ 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 |
| 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: Staubli
2mm Plug | Needle Connector: Staubli
2mm Plug | Identical |
| | Number of conductors: 1 | Number of conductors: 1 | Identical |
| | Heat Shrink UDI Label | No label on device | Reusable devices are
required to have
permanent labeling on
device; difference does
not raise new questions
of safety or
effectiveness |
| Device
Compatibility | • CrossWise 8.5Fr, 71cm C1
Swartz, Model CW-1085S
• CrossWise 8.5Fr, 97cm C1
Agilis, Model CW-1085A
• CrossWise 12Fr, 88cm C1
Watchman, Model CW-
1012W | • CrossWise 8.5Fr, 71cm C1
Swartz, Model CW-1085S
• CrossWise 8.5Fr, 97cm C1
Agilis, Model CW-1085A
• CrossWise 12Fr, 88cm C1
Watchman, Model CW-
1012W | Identical |
| Feature | Subject Device | Predicate Device (K241414) | Analysis of
Differences |
| | • CrossWise 12Fr, 88cm C1
FlexCath, Model CW-1012C
• ValleyLabs Force 2
Electrosurgical Generator | • CrossWise 12Fr, 88cm C1
FlexCath, Model CW-1012C
• ValleyLabs Force 2
Electrosurgical Generator | |
| Device Materials | ES Pencil Adapter Overmold:
Santoprene 8281-65MED,
Black (TPE)
Cable Jacket Material: TPE
Bovie Pin: 316 Stainless Steel
Needle Connector: TPE | ES Pencil Adapter Overmold:
45D Pebax
Cable Jacket Material: TPE
Bovie Pin: 316 Stainless Steel
Needle Connector: TPE | Substantially similar;
minor material
difference does not
raise new questions of
safety or effectiveness
as the device is non-
patient contacting |
| Packaging | Sterile Pouch with IFU in
Shelf Carton | Sterile Pouch with IFU in
Shelf Carton | Identical |
| Sterilization
Method / SAL | As distributed: EO / 10-6
By User: Steam (Autoclave) /
10-6 | As distributed: EO / 10-6 | Identical method and
cycle as initially
distributed; PD is a
single-use device and
not sterilized by the
User |
| Single-Use Devices? | No | Yes | This is the main reason
for this Special 510(k)
submission |
| 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 | Identical |
Table 4: Substantial Equivalence Comparison Table
7
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 ●
8
- 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.
9
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).