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 which oscillates the Dispersion Wire up to 25 Hertz 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 document is a 510(k) summary for the Trellis Reserve Infusion System. It describes the device, its intended use, and claims substantial equivalence to previously cleared devices. However, it does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the way requested.

The document states: "The Trellis Reserve Infusion System was tested in the same manner as the Trellis and Trellis Plus Infusion Systems (K013635 & K021958). All components, subassemblies, and/or full devices met the required specifications for the completed tests." This is a general statement that internal testing was conducted and met "required specifications," but it doesn't provide the details needed to answer your questions.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's what can be extracted based on the instruction to "describe the acceptance criteria and the study that proves the device meets the acceptance criteria" using the provided text:

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

Acceptance Criteria (Implied)	Reported Device Performance
Meet "required specifications" as per testing for predicate devices (K013635 & K021958)	"All components, subassemblies, and/or full devices met the required specifications for the completed tests."

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

Sample size used for the test set: Not specified. The document only states "All components, subassemblies, and/or full devices."
Data provenance: Not specified. This would typically be internal testing by the manufacturer (Bacchus Vascular, Inc.), likely in the USA where the company is based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This type of information is usually relevant for studies involving human interpretation or clinical endpoints, not for performance testing of a medical device's physical and functional specifications. The "ground truth" for device specifications is typically defined by engineering standards and design requirements.

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

Not applicable for performance testing of engineering specifications.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done, as this document pertains to a medical device for infusing fluids, not an AI software.

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

Not applicable, as this is a physical medical device, not an algorithm.

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

The "ground truth" for this device's performance testing would be defined by the engineering specifications and design requirements set by Bacchus Vascular, Inc. and presumably validated against industry standards or regulatory guidance for similar devices.

8. The sample size for the training set

Not applicable, as this is a physical medical device, not a machine learning model requiring a training set.

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

Not applicable, as this is a physical medical device, not a machine learning model.

In summary: The provided FDA 510(k) summary is a regulatory filing for a medical device (Trellis Reserve Infusion System). It confirms that the device was tested and met required specifications, drawing equivalence to previously cleared predicate devices. However, it does not provide detailed information about the specific "acceptance criteria" (e.g., specific quantitative performance metrics) or the methodology of the "study that proves the device meets the acceptance criteria" in the format of a clinical trial or AI performance study. The testing mentioned refers to standard engineering and performance verification for medical devices.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the agency's name, "U.S. Food & Drug Administration."

November 22, 2021

Bacchus Vascular, Inc. Gregory Mathison VP, Clinical & Regulatory Affairs, OA 3110 Coronado Dr. Santa Clara, California 95054

Re: K023514

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 December 2, 2002. 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 13:29:43 -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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract design of an eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 2 2002

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: K023514

Trade Name: Trellis Reserve Infusion System Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II (two) Product Code: KRA Dated: November 21, 2002 Received: November 22, 2002

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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.

Deat Telle
Bram D. Zuckerman, M.D.
Director

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):	This application
Device Name:	Trellis Reserve Infusion System
Indications for Use:	The Trellis TM 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 Use __

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Division of Cardiovascular & Respiratory Devices
510(k) Number K023514

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16023514

DEC 0 2 2002

ATTACHMENT E

510(k) SUMMARY

Confidential

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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 & Quality Assurance

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 Infusion System	K013635	Manufactured by Bacchus Vascular, Inc.
Trellis Plus Infusion System	K021958	Manufactured by Bacchus Vascular, Inc.

Device Description

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.

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Testing Summary

The Trellis Reserve Infusion System was tested in the same manner as the Trellis and Trellis Plus Infusion Systems (K013635 & K021958). 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 which is in compliance with 21CFR§820.30.

Summary of Substantial Equivalence

The Trellis Reserve Infusion System is equivalent to the product, the Trellis Plus 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.

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