The Boss Crossing Support Catheter (Boss CSC) is indicated to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents.

Device Description

The Boss Crossing Support Catheter (Boss CSC) is intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or other diagnostic contrast agents. The proposed device is intended for single use and is provided sterile using Ethylene Oxide gas. The device consists of two low profile catheters, 2.4F and 3.9F, which are compatible with 0.018" and 0.035" guidewires, respectively. Both catheter shafts are composed of a high modulus thermoplastic material in a monolithic single layer construction. The proximal end of each catheter includes a standard catheter hub with Luer fitting and a strain relief. Like the predicate, Terumo NaviCross Support catheters, the distal end of the Boss CSC catheter is equipped with an RO marker band to enable visibility under fluoroscopy. There is a hydrophilic coating on the distal portion of each catheter shaft to enhance lubricity.

The 2.4Fand 3.9F catheters are packaged together in individual spiral HDPE hoops that are secured to a HDPE card and placed inside a Tyvek Mylar pouch. There are two versions of the device offered:

3.9F/90cm length catheter packaged with a 2.4F/135cm length catheter
3.9F/90cm length catheter packaged with a 2.4F /150cm length catheter

As stated, the 2.4F and 3.9F catheters are packaged together. Each catheter is individually inserted into a spiral HDPE protective hoop which is then secured to an HDPE backer card. The two catheter hoops and backer card are inserted into a Tyvek/Mylar pouch that is then placed into a cardboard outer shelf box. Five (5) individual pouches are then placed in a cardboard shelf box.

AI/ML Overview

The provided text describes a medical device, the Boss Crossing Support Catheter (Boss CSC), and the testing conducted to support its substantial equivalence to predicate devices. However, it does not include the specific details you've requested regarding acceptance criteria and a study that proves the device meets those criteria in the context of AI/ML performance.

The document discusses various bench tests and biocompatibility tests to demonstrate the device's physical performance, material safety, and sterility. These tests are conducted to ensure the device performs as intended and is safe for use, but they are not related to the performance of an AI/ML diagnostic or assistive device that would have metrics like sensitivity, specificity, or reader improvement.

Below is a breakdown of why this document cannot provide the information you're looking for, and where such information would typically be found for an AI/ML device:

Reason for lack of requested information:

This 510(k) submission is for a physical medical device (a catheter), not an AI/ML-driven diagnostic or assistive technology. Therefore, the concepts of "acceptance criteria" as you've defined them (e.g., sensitivity, specificity, human reader improvement), "test set sample size," "ground truth establishment," or "multi-reader multi-case studies" are not applicable to this particular submission.

What is included (and would be equivalent for a physical device):

Acceptance Criteria & Reported Performance: The document lists various performance tests (e.g., Kink Resistance, Tensile Strength, Flow Rate, Leak Test, Hydrophilic Coating Integrity, etc.). For each of these, the "acceptance criteria" would be defined in the test protocols (e.g., "no kinks observed under X force," "tensile strength > Y N," "flow rate within Z ml/min"). The "reported device performance" would be the actual measured values from these bench tests. The document states "The Boss CSC catheters submitted in this 510(k) have demonstrated similar performance characteristics to the predicate devices" and "The performance of the Boss CSC Catheters demonstrates substantial equivalence to the performance of the predicate devices," implying these criteria were met.
Sample Size for Test Set: For physical devices, this would refer to the number of catheters tested for each performance characteristic. The document doesn't specify the exact number of devices tested for each bench test, but it notes "Testing was performed on aged and non-aged Boss CSC catheters."
Data Provenance: Not applicable in the AI/ML sense. Data comes from bench testing of the manufactured device.
Experts / Ground Truth: Not applicable for physical device performance. The "ground truth" is the physical measurement itself. For example, a "kink" is a directly observable physical event.
Adjudication Method: Not applicable.
MRMC Study: Not applicable.
Standalone Performance: The "standalone" performance for a physical device refers to its ability to meet its functional specifications directly, which is what the bench tests evaluate.
Type of Ground Truth: Direct physical measurements and observations from bench testing.
Sample Size for Training Set: Not applicable (no AI/ML model to train).
How Ground Truth for Training Set was Established: Not applicable.

Hypothetical Example (if this were an AI/ML device):

If the Boss Crossing Support Catheter were, for instance, an AI-powered system designed to detect potential anatomical blockages during catheter insertion by analyzing real-time imaging, the requested information would look something like this:

1. A table of acceptance criteria and the reported device performance

Performance Metric	Acceptance Criterion	Reported Device Performance
Sensitivity	≥ 90%	92.5% (95% CI: 90.1, 94.4)
Specificity	≥ 80%	84.1% (95% CI: 81.3, 86.6)
F1 Score	≥ 85%	88.3%
Reader AUC (with AI) - (without AI)	≥ 0.05 increase	0.07 increase in ROC AUC

2. Sample sized used for the test set and the data provenance

Sample Size: 500 patient cases (250 with blockages, 250 without), comprising 1500 image frames.
Data Provenance: A multi-center retrospective dataset collected from hospitals in the United States (70%), Germany (20%), and Japan (10%).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: 3
Qualifications:
- Expert 1: Interventional Radiologist, 15 years experience in peripheral vascular interventions, board certified.
- Expert 2: Vascular Surgeon, 12 years experience, specializes in complex peripheral revascularization.
- Expert 3: Interventional Cardiologist, 10 years experience, with a focus on peripheral artery disease.

4. Adjudication method for the test set

Adjudication Method: 2+1 (Two experts independently reviewed each case. If they agreed, that was the ground truth. If they disagreed, a third senior expert was brought in to make the final decision).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study Done: Yes
Effect Size: Average increase of 0.07 in ROC AUC (from 0.81 without AI to 0.88 with AI assistance) across all readers for detecting blockages, and a 15% reduction in reading time without compromising accuracy.

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

Standalone Performance Done: Yes, as reported in the table above (Sensitivity 92.5%, Specificity 84.1%).

7. The type of ground truth used

Type of Ground Truth: Expert Consensus (adjudicated by 3 experts based on angiographic images and clinical reports).

8. The sample size for the training set

Training Set Sample Size: 10,000 patient cases (approximately 30,000 image frames).

9. How the ground truth for the training set was established

Ground Truth for Training Set: Established by a team of 5 clinical residents and 2 junior interventional radiologists, with periodic audits and quality checks performed by a senior interventional radiologist. Cases flagged for ambiguity were escalated for consensus review by senior staff. Pathology reports and outcomes data were sometimes used as secondary confirmation where available for specific types of blockages.

Summary

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June 2, 2022

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Marvao Medical Devices Ltd Mary Legraw Regulatory Consultant to Marvao Medical Avania Ltd 100 Crowley Drive, Suite 216 Marlborough, Massachusetts 01752

Re: K220632

Trade/Device Name: Boss Crossing Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: March 2, 2022 Received: March 4, 2022

Dear Mary Legraw:

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 (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 located 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.

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

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801 and Part 809 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-regulatoryassistance/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,

for Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220632

Device Name Boss Crossing Support Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
" " " "

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Traditional Premarket Notification Submission Boss Crossing Support Catheter Date Prepared: March 2, 2022

Submitter

Name:	Marvao Medical Devices Ltd.
Address:	Unit 1 Galway Business Park,Dangan, Galway H91 A3EFIrelandChris.davey@marvaomedical.com+353 (0)91-759301
Contact Person:	Mary P. LeGrawAvania100 Crowley Drive, Suite 216Marlborough, MA 01752mary.legraw@avaniaclinical.comPhone: (617) 820-0387

Device

Name of Device:	Boss Crossing Support Catheter
Common Name:	Support Catheter
Classification Name:	Percutaneous Catheter
Regulatory Class:	Class II
Product Code:	DQY
Device Panel:	Division of Cardiovascular Devices
Predicate Device
Primary Predicate Name and 510(k) Number:	Terumo NaviCross Support Catheter K173779 (0.018”)
Reference Device:	Terumo NaviCross Support Catheter K110540 (0.035”)

Device Description

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profile catheters, 2.4F and 3.9F, which are compatible with 0.018" and 0.035" guidewires, respectively. Both catheter shafts are composed of a high modulus thermoplastic material in a monolithic single layer construction. The proximal end of each catheter includes a standard catheter hub with Luer fitting and a strain relief. Like the predicate, Terumo NaviCross Support catheters, the distal end of the Boss CSC catheter is equipped with an RO marker band to enable visibility under fluoroscopy. There is a hydrophilic coating on the distal portion of each catheter shaft to enhance lubricity.

The 2.4Fand 3.9F catheters are packaged together in individual spiral HDPE hoops that are secured to a HDPE card and placed inside a Tyvek Mylar pouch. There are two versions of the device offered:

1. 3.9F/90cm length catheter packaged with a 2.4F/135cm length catheter
1. 3.9F/90cm length catheter packaged with a 2.4F /150cm length catheter

Principle of Operation

The subject device and predicate devices share the same principle of operation. The physician first establishes access to the vasculature with an introducer sheath and guidewire using standard endovascular procedures and techniques. Like the Terumo NaviCross Support catheters, the BOSS catheter is advanced over a guidewire toward the target vessel. The BOSS catheter is then used to provide support for the guidewire, as needed, while the physician advances the guidewire deeper into the target vessel. As is the case with Terumo's NaviCross catheter, the physician can use the BOSS catheter to exchange the guidewire if needed, and the catheter itself can also be exchanged over the guidewire as needed, or the 0.018" wire compatible catheter can be advanced through the 0.035" wire compatible catheter. Like the Terumo NaviCross catheter, the BOSS catheter can also be used for injection of saline or contrast media.

Indications for Use

Substantial Equivalence Summary

The proposed device is substantially equivalent in regard to design and materials to the predicate Terumo NaviCross Support catheters 510(k) K110540 (0.035") and 510(k) K173799 (0.018") device.

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Performance Testing

Bench testing was completed to assure the device performed as intended in accordance with design and functional specifications. The Boss CSC catheters submitted in this 510(k) have demonstrated similar performance characteristics to the predicate devices. Testing was performed on aged and non-aged Boss CSC catheters. The following performance tests were conducted on these catheters.

Visual and Dimensional Verification ●
. Simulated Use
Kink Resistance ●
Catheter Shaft Tensile Strength .
Luer to Shaft Joint Tensile Strength ●
Distal Catheter Shaft Tensile Strength ●
Luer Hub Physical Performance ●
Torque Test ●
. Leak Test
Catheter Burst Test ●
Flow Rate Test ●
Hydrophilic Coating Integrity Test ●
Package Integrity Test (Seal Strength, Bubble Leak, Visual and Dimensional)
Simulated Distribution Test

The performance of the Boss CSC Catheters demonstrates substantial equivalence to the performance of the predicate devices.

Biocompatibility Test Summary

Biocompatibility testing per ISO 10993-1 demonstrates the device is biocompatible. The following testing was performed:

Cytotoxicity. .
Maximization Sensitization, .
Intracutaneous Reactivity ●
Systemic Toxicity ●
Pyrogenicity
ASTM Hemolysis (Direct and Indirect) ●
SC5b-9 Complement Activation Assay ●
Hemocompatibility .

Sterilization and Shelf Life Summary

The Boss CSC catheters are single-use devices sterilized using EO gas. Sterilization is conducted in accordance with ANSI/AAMI/ISO 11135-1, Sterilization of health care products -

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Ethylene Oxide-Part 1: Requirements for development, validation and routine control of sterilization process for medical devices. The device is sterilized to a SAL of 10°.

Accelerated aging testing was performed post device sterilization that supports a shelf life of 12 months from the date of sterilization.

Conclusions

Marvao Medical Devices believes the proposed Boss Crossing Support Catheter is substantially equivalent to the legally marketed predicate devices. The indications for use, methods of operation, design and materials used are either identical or substantially equivalent to existing legally marketed predicate products. In addition, performance testing supports substantial equivalence of the proposed and predicate devices.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).