(42 days)
No
The device description focuses on mechanical components (catheter, balloons, wire, oscillation drive unit) and fluid infusion, with no mention of AI or ML technologies. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, to treat conditions in the peripheral vasculature. The goal of the device is to treat and improve the patient's condition, 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 rather than a diagnostic one.
No
The device description clearly outlines physical components like a multi-lumen catheter, balloons, a dispersion wire, and an oscillation drive unit, indicating it is a hardware-based medical device.
Based on the provided information, the Trellis ™ Reserve Infusion System 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 body) procedure, not an in-vitro (outside the body) diagnostic test.
- Device Description: The device is a catheter system designed for delivering fluids and mechanically dispersing them within a blood vessel. It does not involve analyzing samples of bodily fluids or tissues to provide diagnostic information.
- Lack of IVD characteristics: There is no mention of analyzing samples, using reagents, or providing diagnostic results based on laboratory testing.
The device is clearly intended for therapeutic intervention within the patient's body.
N/A
Intended Use / 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.
Product codes
QEY, KRA
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.
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 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.
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).
0
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
1
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.
2
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
3
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 __
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number K023514
4
16023514
DEC 0 2 2002
:
ATTACHMENT E
510(k) SUMMARY
Confidential
5
510(k) Summary
General Information
| Classification | Class II |
|---|---|
| Trade Name | Trellis™ Reserve Infusion System |
| Submitter | Bacchus Vascular, Inc. |
| 3110 Coronado Drive | |
| Santa Clara, CA 95054 | |
| 408-980-8300 | |
| Contact | Gregory J. Mathison |
| Vice 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
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.
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.
6
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.
7
Bacchus Vascular, Inc.
. . .
:
Indications for Use
| 510(k) Number (if known): | This application |
|---|---|
| Device Name: | Trellis Reserve Infusion System |
| Indications for Use: | . 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 Use __
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number K023514