(19 days)
No
The device description focuses on mechanical components (catheter, balloons, wire, oscillation unit) and fluid delivery, with no mention of AI/ML terms or functions. The performance studies compare it to a predicate device without indicating any AI/ML-driven analysis or decision-making.
Yes
The device is intended for the infusion of physician-specified fluids like thrombolytics into the peripheral vasculature to treat medical conditions, which aligns with the definition of a therapeutic device.
No
The device is described as an "Infusion System" and its purpose is for "controlled and selective infusion of physician-specified fluids" and to "disperse the fluid by means of oscillation". This indicates a therapeutic function, not a diagnostic one.
No
The device description clearly details physical components such as a catheter, balloons, a dispersion wire, and an oscillation drive unit, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for controlled and selective infusion of fluids into the peripheral vasculature. This is an in-vivo (within the living body) application, not an in-vitro (outside the living body) diagnostic test.
- Device Description: The device is a catheter system designed to be inserted into blood vessels to deliver fluids and disperse them. This is a therapeutic or interventional device, not a diagnostic one that analyzes samples outside the body.
- No mention of analyzing samples: The description focuses on the mechanical action of isolating a region, infusing fluid, and dispersing it. There is no mention of collecting or analyzing biological samples (blood, urine, tissue, etc.) to diagnose a condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
QEY, KRA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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. 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, (301) 796-6075, 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
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, arranged in a way that suggests movement or flow. The profiles are enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper and left portions of the circle.
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 (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.
Vanderwell
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
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 | X | OR | Over-The-Counter Use |
|---|---|---|---|
| (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
4
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. |
| 3110 Coronado Drive | |
| Santa Clara, CA 95054 | |
| 408-980-8300 | |
| Contact | Gregory J. Mathison |
| 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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