The Trellis™-8 Peripheral Infusion System is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

Device Description

The Trellis-8 Peripheral Infusion System enables the physician to isolate a treatment region, infuse a physician-specified fluid, and disperse the fluid by means of oscillation of a Dispersion Wire. The Isolation/Infusion component is a multi-lumen catheter with two compliant balloons at the distal end and infusion holes located between these balloons. The device also has a central through-lumen that is compatible with a 0.035" guidewire. The Dispersion Wire provides oscillation when activated. The Dispersion Wire is connected to an integral Oscillation Drive Unit that oscillates the Dispersion Wire within the isolated region to further disperse the infused fluid. If desired by the physician, post procedure aspiration of the isolated area between the occluding balloons may be accomplished through the catheter by using the guidewire lumen.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA regarding the Trellis-8 Peripheral Infusion System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through clinical trials or performance studies in the way a pharmaceutical or novel high-risk device might.

Therefore, the document does not contain the detailed information typically found in a study report designed to rigorously quantify device performance against pre-defined acceptance criteria, especially not for AI/ML-driven diagnostics.

Based on the information provided in the 510(k) Summary (page 4), here's what can be extracted and why other requested information is not available:

1. Table of acceptance criteria and reported device performance:

The document states: "The Trellis-8 Peripheral Infusion System was tested in the same manner as the Trellis Reserve. All components, subassemblies, and/or full devices met the required specifications for the completed tests."

Acceptance Criteria (Implicit): That "all components, subassemblies, and/or full devices met the required specifications" as established for the predicate device, Trellis Reserve Infusion System (K032261), and as designed under Bacchus Vascular's Quality System, which complies with 21 CFR. Specific numerical or qualitative acceptance criteria (e.g., burst pressure, flow rate deviation limits, etc.) are not detailed in this summary.
Reported Device Performance: The summary states that the device "met the required specifications for the completed tests." No specific performance metrics or values are reported.

Summary of available information for Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implicit)	Reported Device Performance
All components, subassemblies, and/or full devices meet the required specifications as established for the predicate device (Trellis Reserve Infusion System K032261) and as designed under Bacchus Vascular's Quality System (21 CFR compliant).	"All components, subassemblies, and/or full devices met the required specifications for the completed tests."

Regarding the other requested information:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

This information is not provided. The 510(k) summary mentions "Testing Summary" but does not detail sample sizes, test types (e.g., in-vitro, in-vivo, clinical), or data provenance. Since this is a device for fluid infusion, testing would likely involve bench testing (e.g., material compatibility, structural integrity, flow rates) rather than human clinical data for this type of submission.

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

This information is not applicable/provided. For a device like the Trellis-8 Peripheral Infusion System, "ground truth" in the diagnostic or AI sense (e.g., confirmed diagnosis by experts) is not relevant. Performance is typically measured against physical and engineering specifications.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable/provided. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, which are not detailed in this 510(k) summary.

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:

This information is not applicable/provided. MRMC studies are specific to diagnostic tools, especially those involving AI/ML interpretation. The Trellis-8 Peripheral Infusion System is an infusion system, not a diagnostic imaging device.

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

This information is not applicable/provided. This device does not feature an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" (or basis for evaluation) for this device would be established engineering specifications derived from relevant standards, risk analysis, and performance of the predicate device. It would not involve expert consensus, pathology, or outcomes data in the sense of diagnostic accuracy.

8. The sample size for the training set:

This information is not applicable/provided. This device does not involve AI or machine learning, so there is no "training set."

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

This information is not applicable/provided. As above, there is no AI or associated training set.

In summary, the provided document is a 510(k) clearance letter for a medical device (Trellis-8 Peripheral Infusion System), indicating its substantial equivalence to a predicate device. It does not include detailed study results, acceptance criteria, or ground truth methodologies that would be typical for an AI/ML-enabled diagnostic device or a study designed to rigorously quantify performance against explicit criteria in a clinical setting. The "study" mentioned is a general statement that the device was tested to meet "required specifications" similar to its predicate.

Summary

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November 22, 2021

Bacchus Vascular, Inc. Maureen Bensing Manager, RA & QA 3110 Coronado Dr. Santa Clara, California 95054

Re: K050147

Trade/Device Name: Trellis-8 Peripheral Infusion System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEY, KRA

Dear Maureen Bensing:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 3. 2005. Specifically, FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075, Gregory.Oconnell(@FDA.HHS.gov.

Sincerely,

Gregory W Digitally signed by Gregory W. O'connell -S O'connell -S Pate: 2021.11.22

Gregory O'Connell 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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 3 2005

Ms. Maureen Bensing Manager, Regulatory Affairs and Quality Assurance Bacchus Vascular, Inc. 3110 Coronado Drive Santa Clara, CA 95054

K050147 Re:

Trade/Device Name: Trellis-8 Peripheral Infusion System Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II (two) Product Code: KRA Dated: January 21, 2005 Received: January 24, 2005

Dear Ms. Bensing:

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. The I ou mayy arons provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); good manufacturing practice requirements as set

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Page 2 - Ms. Maureen Bensing

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFF 1000-1050.
product radiation control provisions (Sections 531-542 of the Actil; ad in rever Section S product radiation control provisions (Decisions on device as described in your Section 510(k) I his letter will anow you to begin manxoning your antial equivalence of your device to a legally premarket notification. The PDA miding of basification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your act 101) 594-4648. Also, please note the regulation entitled, contact the Office of Compulation at (501) 597 - 10 - (21CFR Part 807.97). You may obtain "Misbranding by reference to premation inclinear notifical viring the Act from the Division of Small other general Information on your responsible and its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free number (800) 67 Manufacturers, International and Octobern 11/2018 11:52 PM www.fda.gov/cdrh/dsmamain.html

Sincerely yours,

Duina P. Vichener

(A Bram D. Zuckerman, M.D. Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name:

Indications for Use:

This application Ko50i47

Trellis-8 Peripheral Infusion System

The Trellis™-8 Peripheral Infusion System is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

Prescription Use X

(Per 21 CFR 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)

PLEASE DO NOT WRITE BELOW THIS LINE -(CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Diana R. Victurner

Division Sign-Off) Civision of Cardiovascular Devices

510(k) Number K050147

Confidential

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510(k) Summary

FEB - 3 2005

Date Prepared

January 21, 2005

General Information

Class	Class II
Trade Name	TrellisTM-8 Peripheral Infusion System
Submitter	Bacchus Vascular, Inc3110 Coronado DriveSanta Clara, CA 95054Tel: 408-980-8300Fax: 408-980-8383
Contact	Maureen BensingManager, Regulatory Affairs and Quality Assurance

Intended Use

The Trellis™-8 Peripheral Infusion System is intended for controlled and selective infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature.

Predicate Device

Trellis Reserve Infusion System K032261 - -Bacchus Vascular, Inc

Device Description

Materials

All materials used in the manufacture of the Trellis-8 Peripheral Infusion System are suitable for this use and have been used in numerous previously cleared products.

Testing Summary

The Trellis-8 Peripheral Infusion System was tested in the same manner as the Trellis Reserve. All components, subassemblies, and/or full devices met the required specifications for the completed tests. The Trellis-8 Peripheral Infusion System was designed under Bacchus Vascular Quality System which is in compliance with 21CFR.

Summary of Substantial Equivalence

The Trellis-8 Peripheral Infusion System is equivalent to the predicate product, the Trellis Reserve Infusion System. The indications for use, function, methods of manufacturing, and materials used are substantially equivalent. Bacchus Vascular, Inc believes the Trellis-8 Peripheral Infusion System is substantially equivalent to existing legally marketed devices.

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).