TRELLIS PLUS INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH 20CM (100CM CATHETER LENGTH 10CM INFUSION H

K021958 · Bacchus Vascular, Inc. · QEY · Jul 3, 2002 · Cardiovascular

Device Facts

• Record ID: K021958
• Device Name: TRELLIS PLUS INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH 20CM (100CM CATHETER LENGTH 10CM INFUSION H
• Applicant: Bacchus Vascular, Inc.
• Product Code: QEY · Cardiovascular
• Decision Date: Jul 3, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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

Device Story

Trellis Plus Infusion System is a multi-lumen catheter designed for peripheral vasculature treatment. Device features two distal compliant balloons to isolate a treatment zone and infusion holes located between them to deliver physician-specified fluids (e.g., thrombolytics). A sheathed, shape-set Nitinol Dispersion Wire, connected to an integral Oscillation Drive Unit, oscillates at up to 25 Hertz within the isolated region to disperse the infused fluid. The catheter includes a central through-lumen compatible with 0.035" guidewires. Used by physicians in clinical settings to maintain fluid concentration within a targeted vessel segment, potentially improving therapeutic efficacy of infused agents.

Clinical Evidence

Bench testing only. The device was tested in the same manner as the predicate Trellis Infusion System (K013635). All components, subassemblies, and full devices met required specifications. Design conducted under Bacchus Quality System in compliance with 21 CFR 820.30.

Technological Characteristics

Multi-lumen catheter with two compliant balloons and central 0.035" guidewire lumen. Dispersion component consists of a sheathed, shape-set Nitinol cable. Energy source: integral Oscillation Drive Unit providing mechanical oscillation up to 25 Hz. Materials are biocompatible and consistent with previously cleared products. Device is a mechanical infusion and dispersion system.

Indications for Use

Indicated for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

Regulatory Classification

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.

Predicate Devices

• Trellis Infusion System (K013635)

Submission Summary (Full Text)

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November 22, 2021

Bacchus Vascular, Inc. Greg Mathinson Vice President 3110 Coronado Dr. Santa Clara, California 95054

Re: K021958

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

Dear Greg Mathinson:

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 July 3, 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, [phone], Gregory.Oconnell(@FDA.HHS.gov.

Sincerely,

Digitally signed by Gredorv W. Gregory W. O'connell -O'connell -Spate: 2021.11.22 13:28:34 -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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 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: K021958

> Device Name: Trellis Plus Infusion System Regulation Number: 21 CFR 870.1210 Regulation Name: Catheter, Continuous Flush Regulatory Class: Class II (two) Product Code: 74 KRA Dated: June 13, 2002 Received: June 14, 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.

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 - Mr. Gregory J. Mathison

forth in the quality systems (OS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Vanderwell

Donna-Bea Tillman, Ph.D. Acting Director 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

Trellis Plus Infusion System

The Trellis™ Plus 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 | <span style="text-decoration: overline;">X</span> | OR | Over-The-Counter Use <span style="text-decoration: overline;"></span> |
|----------------------|---------------------------------------------------|----|-----------------------------------------------------------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) |

(Division Sign-Off)
Division of Cardiovascular and Respiratory Device

| 510(k) Number | K021958 |
|---------------|---------|
|---------------|---------|

Confidential

000011

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3 2002 . De gr

Bacchus Vascular, Inc.

510(k) Summary

### General Information

| Classification | Class II |
|----------------|-------------------------------------------------------------------------------------------|
| Trade Name | Trellis™ Plus Infusion System |
| Submitter | Bacchus Vascular, Inc.<br>3110 Coronado Drive<br>Santa Clara, CA 95054 |
| | 408-980-8300 |
| Contact | Gregory J. Mathison<br>Vice President, Clinical and Regulatory Affairs, Quality Assurance |

#### Intended Use

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

#### Predicate Devices

| Trellis Infusion System | K013635 |
|----------------------------------------|---------|
| Manufactured by Bacchus Vascular, Inc. | |

#### Device Description

The Trellis Plus 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.

#### Materials

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

#### Testing Summary

The Trellis Plus Infusion System was tested in the same manner as the Trellis Infusion System (K013635). All components, subassemblies, and/or full devices met the required specifications for the completed tests. The Trellis Plus was designed under the Bacchus Quality System which is in compliance with 21CFR 820.30.

#### Summary of Substantial Equivalence

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

Confidential

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