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

Device Description

The Trellis 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.

AI/ML Overview

The provided text is related to a 510(k) premarket notification for the Trellis Infusion System. It describes the device, its intended use, and the testing conducted to demonstrate substantial equivalence to predicate devices. However, it does not contain specific acceptance criteria or detailed results of a study that prove the device meets precise acceptance criteria in the format required for a typical AI/ML device submission.

The document pre-dates many of the modern requirements for AI/ML device submissions, which typically involve detailed performance metrics like sensitivity, specificity, AUC, and their associated confidence intervals against established ground truth.

Given the information available, I can extract and infer some aspects, but I cannot fulfill all parts of your request as the document doesn't provide the level of detail seen in a modern AI/ML device submission.

Here's an attempt to structure the information based on your request, highlighting what is present and what is missing:

Device Name: Trellis Infusion System

Acceptance Criteria and Device Performance (Based on provided text):

The document lists various tests conducted to ensure the Trellis met "all specifications" and reports a general conclusion of safety and effectiveness without numerical performance metrics or explicit acceptance thresholds.

Acceptance Criteria (Implied/General from Text)	Reported Device Performance
Tensile Strength	"All components, subassemblies, and/or full devices met the required specifications for the above tests."
Torque-to-Fail	"All components, subassemblies, and/or full devices met the required specifications for the above tests."
Catheter Trackability and Dispersion Wire Insertion	"All components, subassemblies, and/or full devices met the required specifications for the above tests."
Guidewire Compatibility	"All components, subassemblies, and/or full devices met the required specifications for the above tests."
Balloon Compliance and Burst	"All components, subassemblies, and/or full devices met the required specifications for the above tests."
Device and Battery Life	"All components, subassemblies, and/or full devices met the required specifications for the above tests."
Catheter Leakage	"All components, subassemblies, and/or full devices met the required specifications for the above tests."
Infusion Flow Rates	"All components, subassemblies, and/or full devices met the required specifications for the above tests."
Catheter Corrosion	"All components, subassemblies, and/or full devices met the required specifications for the above tests."
Electrical Safety and EMC	"All components, subassemblies, and/or full devices met the required specifications for the above tests."
Acute Safety (in vivo)	"Testing of the Trellis and the predicate was conducted in animal arteries to assess acute safety... Histological examination of treated vessels demonstrated that neither device caused serious injury to the vessel wall. Endothelial cell removal was greater in the predicate device than with the Trellis Infusion System." (This implies the Trellis performed at least as well, and potentially better, in terms of minimizing endothelial cell removal compared to the predicate.)

Study Details:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for each test. For the pre-clinical in vivo testing, it mentions "animal arteries" but doesn't quantify the number of animals or vessels.
- Data Provenance: Not specified (e.g., country of origin). The in vivo testing was "pre-clinical," implying animal studies rather than human clinical data. The description of testing does not specify retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The testing described primarily involves engineering performance tests and anatomical/histological assessments in animal models, not human expert interpretation in the way AI/ML ground truth is established.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as the tests described are primarily objective engineering and in vivo animal studies, not human interpretation-based assessments requiring adjudication.
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. This is a traditional medical device submission for an infusion system, not an AI/ML device. Therefore, no MRMC study or AI assistance evaluation was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical catheter system, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the engineering tests, the ground truth would be the defined specifications for each test (e.g., a specific tensile strength value).
- For the in vivo testing, the "ground truth" was established by direct observation during the procedure (e.g., visualization under fluoroscopy) and subsequent "histological examination of treated vessels" by presumably qualified pathologists/veterinary pathologists, though their details are not provided.
The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of human services. To the right of the symbol is a blue square containing the acronym "FDA" in white letters. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

November 22, 2021

Bacchus Vascular, Inc. Marybeth Gamber Regulatory Specialist 3110 Coronado Dr. Santa Clara, California 95054

Re: K013635

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

Dear Marybeth Gamber:

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 11, 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,

Gregory W. Digitally signed by
Gregory W.
O'connell - O'connell -S
S Date: 2021.11.22
13:26:47 -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

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, symbolizing protection and care.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2002

Ms. Marybeth Gamber Regulatory Specialist Bacchus Vascular, Incorporated 3110 Coronado Drive Santa Clara, CA 95054

Re: K013635

Trade Name: Trellis Infusion System Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II (two) Product Code: KRA Dated: February 1, 2001 Received: February 4, 2002

Dear Ms. Gamber:

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 for are barred or 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, do noos mat hat o one 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.

{2}------------------------------------------------

Page 2 - Ms. Marybeth Gamber

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 or any 1 with all the Act's requirements, including, but not limited to: registration and listing (21 comply with an the 110 - 11 CFR Part 801); good manufacturing practice requirements as set Of R rat 007), accesses (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) This lotter will and w your e FDA finding of substantial equivalence of your device to a legally prematicated predicated on. The 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 and 11 you desire specific art 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 OF X 1 at 3646. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-1010. 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 Ource general information on you 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,

Dolores Huerta

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

Enclosure

{3}------------------------------------------------

Bacchus Vascular, Inc.

Indications for Use

510(k) Number (if known):	This application
Device Name:	Trellis Infusion System
Indications for Use:	The Trellis™ Infusion System is intended for controlled andselective infusion of physician-specified fluids, includingthrombolytics, 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)
Division of Cardiovascular & Respiratory Devices

510(k) Number	K013635
---------------	---------

Prescription Use X	OR	Over-The-Counter Use ______
--------------------------------------------------------------------	----	-----------------------------

(Per 21 CFR 801.109) (Optional Format 1-2-96).

{4}------------------------------------------------

K013635

FEB 1 1 2002

510(k) Summary

General Information

Classification	Class II
Trade Name	Trellis Infusion System
Submitter	Bacchus Vascular, Inc.3110 Coronado DriveSanta Clara, CA 95054408-980-8300
Contact	Greg MathisonVice President, Clinical and Regulatory Affairs
Date Summary Prepared	February 1, 2002

Intended Use

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

Predicate Devices
Dispatch Coronary Infusion CatheterManufactured by SCIMED Life Systems, Inc.	K932616
Pulse*Spray Infusion SystemManufactured by AngioDynamics	K950907
ISOLATE Infusion SystemManufactured by Lake Region, Inc.	K913517
SquirtTM Fluid Delivery SystemManufactured by Merit Medical	K981417

Device Description

{5}------------------------------------------------

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.

Materials

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

Testing

The following testing was conducted to ensure the Trellis met all specifications:

Tensile Testing .
Torque-to-Fail Testing .
Catheter Trackability and Dispersion Wire Insertion ●
Guidewire Compatibility ●
Balloon Compliance and Burst Testing ●
t Device and Battery Life Testing
Catheter Leak Testing
Infusion Flow Rates
Catheter Corrosion Testing .
Electrical Safety and Electromagnetic Compatibility Testing .

The results of the above tests demonstrated that the device is as safe & effective as the legally marketed predicate device. All components, subassemblies, and/or full devices met the required specifications for the above tests.

Pre-clinical in vivo Testing

Testing of the Trellis and the predicate was conducted in animal arteries to assess acute safety, feasibility of introduction into the vascular system, the ability to visualize the devices under fluoroscopy, adverse reactions and/or device failures, and to examine acute histologic effects or injury to a normal vessel wall. Histological examination of treated vessels demonstrated that neither device caused serious injury to the vessel wall. Endothelial cell removal was greater in the predicate device than with the Trellis Infusion System.

Summary of Substantial Equivalence

The Trellis is equivalent to the predicate products from SciMed, Merit Medical, AngioDynamics, and Lake Region. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent. Bacchus Vascular, Inc. believes the Trellis 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).