(28 days)
No
The summary describes a physical medical device (needle and cable) used for a surgical procedure with RF energy. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on physical and electrical properties, not algorithmic performance.
Yes
The device is used to create an atrial septal defect in the heart, which is a therapeutic intervention for a medical condition.
No
Explanation: The device is used to create an atrial septal defect in the heart and infuse solutions. It is designed for surgical procedures to puncture the fossa ovalis and gain access to the left atrium, which are therapeutic actions, not diagnostic ones.
No
The device description clearly details physical components (needle, cable) and their interaction with other hardware (introducer set, RF generator, patient return electrode). It is a hardware device with electrical and mechanical functionalities.
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 procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The description details a needle used to puncture tissue and deliver RF energy and solutions directly into the heart. This is an invasive medical device used for treatment/intervention, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
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 Cross Vascular RF Transseptal Needle and Connection Cable 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 Cross Vascular RF Transseptal Needle is used in transseptal surgical procedures to puncture the fossa ovalis and gain access from the right side of the left atrium. The RF Transseptal Needle within a compatible transseptal introducer set (Table 4) along with radiofrequency (RF) energy from the RF Generator is used to facilitate the septal puncture.
The RF Transseptal Needle delivers RF power in a monopolar mode between the device's distal electrode and a commercially available external Patient Return Electrode (PRE) which is in compliance with IEC 60601-2-2. The RF Transseptal Needle is loaded through a compatible transseptal sheath and dilator (Table 4) and is connected at its proximal end to the Cross Vascular RF Generator via the Cross Vascular Connection Cable.
The RF Transseptal needle and Connection Cable are packaged individually in a single use, sterile package. All other components required for the transseptal procedure are NOT included in the package with the RF Transseptal Needle or in the package with the Connection Cable.
The distal end of the needle contains a small through hole to facilitate injection of contrast solution. The active tip is specially shaped to be atraumatic to the cardiac tissue until RF energy is applied.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart
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)
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility: Biocompatibility testing was performed on the Cross Vascular RF Transseptal Needle in accordance with ISO 10993-1:2018. The results demonstrate that the Cross Vascular RF Transseptal Needle meets the requirements of ISO 10993-1 and is biocompatible for its intended use.
Sterilization: Sterilization validation was performed on the Cross Vascular RF Transseptal Needle in accordance with ISO 11135:2014. The Cross Vascular RF Transseptal Needle is subjected to a similar ethylene oxide (EO) sterilization process as the Predicate Device to meet a sterility assurance level (SAL) of 10-6.
Electrical Safety and Electromagnetic Compatibility (EMC): Electrical safety and EMC testing were conducted on the Cross Vascular RF Transseptal Needle. The testing complies with the applicable sections of IEC 60601-1:2005+A1:2012, IEC 60601-1-2:2014, and IEC 60601-2-2:2017. This testing is consistent with that conducted by the Predicate Device, NRG Transseptal Needle (K073326).
Bench Testing: Design verification testing was performed on the Cross Vascular RF Transseptal Needle and Connection 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: Visual & Dimensional, Introducer Set Compatibility, Electrical Functionality, Mechanical Functionality, Mechanical Durability, Particulate, Radiopacity, Corrosion Resistance, Packaging Integrity, Label Integrity.
The non-clinical bench data support the safety of the device and demonstrate that the Cross Vascular RF Transseptal Needle 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).
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 12, 2023
Cross Vascular Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K232852
Trade/Device Name: Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable Regulation Number: 21 CFR 870.5175 Regulation Name: Septostomy catheter Regulatory Class: Class II Product Code: DXF Dated: September 14, 2023 Received: September 14, 2023
Dear Prithul Bom:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
1
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
2
by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Rachel E. Neubrander -S
Rachel Neubrander 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) TBD
Device Name
Cross Vascular RF Transseptal Needle Cross Vascular Connection Cable
Indications for Use (Describe)
The Cross Vascular RF Transseptal Needle and Connection Cable 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) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
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Image /page/4/Picture/1 description: The image shows the logo for CrossVascular. The logo consists of a stylized "V" shape inside of concentric circles on the left, and the text "CrossVascular" on the right. The "V" shape and circles are in shades of blue and gray, while the text is in gray.
5.0 510(K) SUMMARY
510(k) Number: K232852
Date Prepared: July 14, 2023
Table 1: Submitter Information
| Manufacturer: | Manufacturer's Contact Person: |
|---|---|
| Cross Vascular Inc. | Jennifer Willner, President |
| 535 Stevens Ave West | JW Regulatory Consulting LLC |
| Solana Beach, CA 92075 | Phone: (612) 240 - 8904 |
| US FDA ERN: Pending | Email: Jennifer@JWRegulatoryConsulting.com |
Table 2: Device Information
| Trade Name | Cross Vascular RF Transseptal Needle |
|---|---|
| Cross Vascular Connection Cable | |
| Common Name | RF Transseptal Needle |
| Connection Cable | |
| Classification Name | Catheter, Septostomy |
| Regulation | 21CFR 870.5175 |
| Product Code | DXF |
| Regulatory Classification: | Class II |
| Device Panel: | Cardiovascular |
The Cross Vascular Transseptal Needle device is substantially equivalent to the previously cleared predicate NRG Transseptal Needle (Table 3) which has not been subject to a designrelated recall.
Table 3: Predicate Devices
| Predicate Device | Manufacturer | FDA 510(k) |
|---|---|---|
| NRG Transseptal Needle | Boston Scientific (formerly Baylis Medical) | K073326 |
5.1 Device Description
The Cross Vascular RF Transseptal Needle is used in transseptal surgical procedures to puncture the fossa ovalis and gain access from the right side of the left atrium. The RF Transseptal Needle within a compatible transseptal introducer set (Table 4) along with radiofrequency (RF) energy from the RF Generator is used to facilitate the septal puncture.
The RF Transseptal Needle delivers RF power in a monopolar mode between the device's distal electrode and a commercially available external Patient Return Electrode (PRE) which is in compliance with IEC 60601-2-2. The RF Transseptal Needle is loaded through a compatible transseptal sheath and dilator (Table 4) and is connected at its proximal end to the Cross Vascular RF Generator via the Cross Vascular Connection Cable.
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Image /page/5/Picture/1 description: The image shows the logo for CrossVascular. The logo consists of a stylized "V" shape formed by three blue lines, enclosed within three concentric blue circles. A fourth gray circle is partially visible behind the "V". To the right of the circular design, the word "CrossVascular" is written in gray, with "Cross" in a darker shade than "Vascular".
The RF Transseptal needle and Connection Cable are packaged individually in a single use, sterile package. All other components required for the transseptal procedure are NOT included in the package with the RF Transseptal Needle or in the package with the Connection Cable.
The distal end of the needle contains a small through hole to facilitate injection of contrast solution. The active tip is specially shaped to be atraumatic to the cardiac tissue until RF energy is applied.
Table 4 provides a list of introducer sets that have been determined to be compatible with the Cross Vascular RF Transseptal Needles. These introducer sets include an 8.5 Fr dilator whose ID is compatible with an 0.032" guidewire. Therefore, the RF Transseptal Needle has an OD compatible to meet this 0.032" dilator ID requirement.
| Cross Vascular RF Transseptal Needle | Compatible Commercial Introducer Set | ||
|---|---|---|---|
| Description | REF | Description | REF |
| Sterile, RF needle, 71cm, | |||
| C0, Standard Curve | RFN-71-CO | Swartz Braided Transseptal Guiding | 407451 |
| Sterile, RF needle, 71cm, | |||
| C1, Large Curve | RFN-71-C1 | Introducer, 8.5Fr x 63, SL0 and SL1 | 407453 |
| Sterile, RF needle, 98cm, | |||
| C0, Standard Curve | RFN-98-CO | Agilis NxT Steerable Introducer, | G408320 |
| Sterile, RF needle, 98cm, | |||
| C1, Large Curve | RFN-98-C1 | 8.5Fr x 71cm | G408321 |
| G408324 |
Table 4: Compatible Introducer Sets
5.2 Indications for Use
The Cross Vascular RF Transseptal Needle with Connection Cable 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.
5.3 Comparison of Technological Characteristics with the Predicate Device
The Subject and Predicate 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. The Subject Device has been validated with Covidien's Valleylab Model E7507 Patient Return Electrode. Both devices are also loaded through commercially available transseptal introducer sets and attach a Connection Cable to their proximal end which is connected to an RF generator. The Subject and Predicate Devices both contain holes at the distal end to facilitate injection of contrast solution.
The following technological differences exist between the Subject and Predicate Device:
- . Materials of construction
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Image /page/6/Picture/1 description: The image shows the logo for CrossVascular. The logo consists of a stylized "V" shape formed by three concentric circles in blue and gray. To the right of the symbol is the company name, "CrossVascular," in gray sans-serif font. The logo is clean and modern in appearance.
- . Predicate Device can optionally be connected to an external pressure monitoring system to monitor cardiac pressures
- Predicate Device provides a reusable connector cable .
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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Image /page/7/Picture/0 description: The image shows the logo for CrossVascular. The logo consists of a stylized "V" shape formed by three parallel lines, enclosed within three concentric circles, also formed by parallel lines. To the right of the emblem, the text "CrossVascular" is written in a simple, sans-serif font.
RF Transseptal Needle 510(k)
| Feature | Subject Device | Predicate Device (K073326) | Conclusion |
|---|---|---|---|
| Product Name | Cross Vascular RF Transseptal Needle | NRG Transseptal Needle | |
| Manufacturer | Cross Vascular, Inc. | Boston Scientific (formerly Baylis Medical) | |
| Product Code / | |||
| Regulation | DXF / 21CFR 870.5175 | DXF / 21CFR 870.5175 | Identical |
| Indications for Use | 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. | Creation of an atrial septal defect in the | ||
| heart. Secondary applications include | |||
| transseptal heart access, monitoring | |||
| intracardiac pressures, sampling blood, and | |||
| infusing solutions | Similar; Subject Device | ||
| is not designed to | |||
| monitor intracardiac | |||
| pressures or sampling of | |||
| blood but does not raise | |||
| new questions of safety | |||
| or effectiveness | |||
| Energy Delivery | RF (monopolar mode) | RF (monopolar mode) | Identical |
| Key Device | |||
| Components | Handle with Connector | Handle with Connector | Identical |
| Polymer Coated SST Shaft | Polymer Coated SST Shaft | Identical | |
| Radiopaque Distal Tip | Radiopaque Distal Tip | Identical | |
| Connection Cable | Connection Cable | Identical | |
| Length & Curve | 71cm, Standard Curve (C0) | ||
| 71cm, Large Curve (C1) | |||
| 98cm, Standard Curve (C0) | |||
| 98cm, Large Curve (C1) | 56cm, Curve C0 | ||
| 71cm, Curve C0 | |||
| 71cm, Curve C1 | |||
| 89cm, Curve C0 | |||
| 89cm, Curve C1 | |||
| 98cm, Curve C0 | |||
| 98cm, Curve C1 | Similar; Subject Device | ||
| not available in 56cm | |||
| and 89cm lengths but | |||
| does not raise new | |||
| questions of safety or | |||
| effectiveness | |||
| OD | Proximal: 0.047" (1.2 mm) | ||
| Distal: 0.032" (0.8 mm) | Proximal: 1.2 mm | ||
| Distal: 0.74mm | Nearly Identical |
Table 5: Substantial Equivalence Comparison Table
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Image /page/8/Picture/0 description: The image contains the logo for CrossVascular. The logo consists of a stylized letter V enclosed within concentric circles on the left, and the text "CrossVascular" on the right. The letter V and the circles are in blue, while the text is in gray.
RF Transseptal Needle 510(k)
| Feature | Subject Device | Predicate Device (K073326) | Conclusion |
|---|---|---|---|
| Dilator ID | |||
| Compatibility | 0.032" | 0.032" | Identical |
| Device Materials | |||
| (Patient Contacting) | Handle: Polypropylene | ||
| Shaft: 304 Stainless Steel, Adcoat | |||
| 41-3500 | |||
| Distal Tip: Gold | Handle: Unknown polymer (ABS suspected) | ||
| Shaft: 304 Stainless Steel; unknown polymer | |||
| jacket (Pebax suspected) | |||
| Distal Tip: Platinum/Iridium | Similar; minor design | ||
| differences do not raise | |||
| new questions of safety | |||
| or effectiveness | |||
| Packaging | Sterile Pouch with IFU in Shelf Carton | Rigid Tray in Sterile Pouch with IFU in | |
| Shelf Carton | Similar; minor design | ||
| differences do not raise | |||
| new questions of safety | |||
| or effectiveness | |||
| Sterilization | |||
| Method / SAL | EO / 10-6 | EO / Not disclosed | Identical |
| Single-Use Devices? | Yes | Yes | Identical |
| Radiopaque? | Yes | Yes | Identical |
| Inserted Over a | |||
| Guidewire? | No | No | Identical |
| Shelf-Life | 6M, however intend to extend up to 2 | ||
| years upon successful completion of | |||
| testing to identical protocol | Unknown, suspect 3 years | Similar; minor | |
| difference in shelf-life | |||
| does not raise new | |||
| questions of safety or | |||
| effectiveness | |||
| Non-pyrogenic? | Yes | Yes | Identical |
| Connection Cable? | Yes | Yes | Identical |
| Single Use or | |||
| Multi-Use | |||
| Connection Cable? | Single Use | Multi-Use | Similar; minor design |
| difference does not raise | |||
| new questions of safety | |||
| or effectiveness |
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Image /page/9/Picture/0 description: The image shows the logo for CrossVascular. The logo consists of a stylized letter V made of concentric circles on the left, and the word "CrossVascular" in gray on the right. The letter V is made of three blue circles and one gray circle.
RF Transseptal Needle 510(k)
| Feature | Subject Device | Predicate Device (K073326) | Conclusion |
|---|---|---|---|
| Compatible RF | |||
| Generator | Cross Vascular RF Generator | ||
| RFG-01-00 | BMC RF Puncture Generator | ||
| RFP-100A and RFP-100 | Similar; design | ||
| difference does not raise | |||
| new questions of safety | |||
| or effectiveness |
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Image /page/10/Picture/0 description: The image shows the logo for CrossVascular. The logo consists of a stylized "V" shape inside of three concentric circles on the left, and the text "CrossVascular" on the right. The "V" shape and two of the circles are blue, while the outermost circle and the word "Cross" are gray. The word "Vascular" is a lighter shade of gray.
5.4 Performance Standards
The Cross Vascular RF Transseptal Needle has been developed in conformance with the following standards and FDA guidance, as applicable:
- 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 2020
- . IEC 60601-1:2005+A1:2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
- IEC 60601-1-2:2014, Medical Electrical Equipment Part 1-2: General Requirements ● for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests
- IEC 60601-2-2:2017, 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 11135-1:2014, 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 10555-1:2013, Intravascular catheters Sterile and single-use catheters Part 1: . General requirements
- . 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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Image /page/11/Picture/0 description: The image shows the logo for CrossVascular. The logo consists of a stylized "V" shape formed by three blue lines, with three concentric circles behind it. The text "CrossVascular" is written in gray to the right of the symbol.
5.5 Nonclinical Performance Data
The following performance data were provided in support of the substantial equivalence determination.
5.5.1 Biocompatibility
Biocompatibility testing was performed on the Cross Vascular RF Transseptal Needle in accordance with ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: 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 o
- Complement Activation o
- Partial Thromboplastin Time (PTT) о
- Heparinized Platelet and Leukocyte (PL&L) Count Assay with Comparison Article O
- In Vivo Thrombogenicity in Canine .
- Material Mediated Pyrogenicity ●
The results demonstrate that the Cross Vascular RF Transseptal Needle meets the requirements of ISO 10993-1 and is biocompatible for its intended use.
5.5.2 Sterilization
Sterilization validation was performed on the Cross Vascular RF Transseptal Needle 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 Cross Vascular RF Transseptal Needle is subjected to a similar ethylene oxide (EO) sterilization process as the Predicate Device to meet a sterility assurance level (SAL) of 10-6.
5.5.3 Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted on the Cross Vascular RF Transseptal Needle. The testing complies with the applicable sections of IEC 60601-1:2005+A1:2012, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance, IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for the basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests, and IEC 60601-2-2:2017, 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. This testing is consistent with that conducted by the Predicate Device, NRG Transseptal Needle (K073326).
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Image /page/12/Picture/1 description: The image shows the logo for CrossVascular. The logo consists of a stylized "V" shape formed by three lines, enclosed within three concentric circles. The "V" and circles are in shades of blue and gray. To the right of the emblem, the word "CrossVascular" is written in a sans-serif font, with the "Cross" portion in a darker gray and the "Vascular" portion in a lighter gray.
5.5.4 Bench Testing
Design verification testing was performed on the Cross Vascular RF Transseptal Needle and Connection 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:
- Visual & Dimensional ●
- Introducer Set Compatibility
- Electrical Functionality ●
- Mechanical Functionality ●
- Mechanical Durability
- Particulate
- Radiopacity
- Corrosion Resistance
- Packaging Integrity
- Label Integrity ●
5.6 Conclusions
The Cross Vascular RF Transseptal Needle is of similar materials and design of the Predicate Devices and has similar technical requirements. The devices perform as intended and present no unacceptable risks to the intended patient population or end user. The non-clinical bench data support the safety of the device and demonstrate that the Cross Vascular RF Transseptal Needle performs as intended in the specified use conditions.
The Cross Vascular RF Transseptal Needle with Connection Cable is substantially equivalent to the Predicate Device, NRG Transseptal Needle (K073326).