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

Device Description

The Trellis Reserve Infusion Catheter 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. When inflated, the compliant balloons isolate a treatment zone to maintain concentration of the infused fluid. The device also has a central through-lumen that is compatible with a 0.035" guidewire. The Dispersion Wire component is a sheathed, shape-set Nitinol cable that 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

This FDA document is a 510(k) premarket notification for the "Trellis Reserve Infusion System." It outlines the device's technical specifications and asserts its substantial equivalence to a previously marketed predicate device.

However, this document does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving the device meets those criteria.

Here's why and what information is missing:

Acceptance Criteria and Reported Device Performance: This document states that the device "met the required specifications for the completed tests" (page 5), but it does not list specific quantitative acceptance criteria for performance metrics (e.g., infusion rate, balloon inflation pressure, dispersion efficiency, safety parameters) nor does it provide the numerical results or reported device performance against those criteria.
Study Details (Sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone): The document mentions "Testing Summary" and that the device "was tested in the same manner as the original Trellis Reserve Infusion System (K023514)" (page 5). However, it does not provide any specifics about the studies conducted, such as:
- The sample size used for any test sets.
- The provenance of the data (country, retrospective/prospective).
- The number or qualifications of experts.
- Any adjudication methods.
- Whether comparative effectiveness studies (MRMC) or standalone algorithm performance studies were done.
- The type of ground truth used.
- The sample size or ground truth establishment for a training set (if applicable to this type of device, which is a physical medical device, not an AI/software device).

Therefore, based on the provided text, I cannot complete the table or answer the specific questions about the study design and results.

The document is a regulatory submission focused on establishing substantial equivalence, primarily by demonstrating that the device's design, materials, and intended use are similar to a predicate device, and that it has passed internal verification testing. It does not go into the level of detail regarding clinical trial design, ground truth establishment, or performance metrics typically found for AI/software as a medical device (SaMD) clearances or more extensive clinical studies.

Summary

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November 22, 2021

Bacchus Vascular, Inc. Gregory Mathison Vice President 3110 Coronado Dr. Santa Clara, California 95054

Re: K032261

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

Dear Gregory Mathison:

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 August 22, 2003. 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,

Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2021.11.22 13:31:19 -05'00'

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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Public Health Service

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AUG 2 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bacchus Vascular, Inc. c/o Mr. Gregory J. Mathison Vice President ---Clinical Affairs, Regulatory Affairs, Quality Assurance 3110 Coronado Drive Santa Clara, CA 95054

Re: K032261

Trade Name: Trellis Reserve Infusion Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous flush catheter Regulatory Class: II (two) Product Code: KRA Dated: July 21, 2003 Received: July 28, 2003

Dear Mr. Mathison:

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 general controls 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.

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Page 2 - Mr. Gregory J. Mathison

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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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

Enclosure

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Bacchus Vascular, Inc.

Indications for Use

510(k) Number (if known):

Device Name:

Indications for Use:

This application

Trellis Reserve Infusion System

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Used

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Veer

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Ni

Confidential

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K03226/

AUG 2 2 2003

510(k) Summary

General Information

Classification	Class II
Trade Name	Trellis™ Reserve Infusion System
Submitter	Bacchus Vascular, Inc.3110 Coronado DriveSanta Clara, CA 95054
	408-980-8300
Contact	Gregory J. MathisonVice President, Regulatory & Clinical Affairs

Intended Use

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

Predicate Devices

Trellis Reserve Infusion System	K023514	Bacchus Vascular, Inc.
---------------------------------	---------	------------------------

Device Description

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Materials

All materials used in the manufacture of the Trellis Reserve are suitable for this use and have been used in numerous previously cleared products.

Testing Summary

The Trellis Reserve Infusion System was tested in the same manner as the original Trellis Reserve Infusion System (K023514). All components, subassemblies, and/or full devices met the required specifications for the completed tests. The Trellis Reserve was designed under the Bacchus Quality System that is in compliance with 21CFR§820.30.

Summary of Substantial Equivalence

The Trellis Reserve Infusion System is equivalent to the predicate product, the original Trellis Reserve Infusion System. The indications for use, function, methods of manufacturing, and materials used are substantially equivalent. Bacchus Vascular, Inc. believes the Trellis Reserve 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).