(98 days)
Not Found
No
The device description focuses on mechanical components (catheter, balloons, wire, oscillation unit) and does not mention any computational or algorithmic functions that would suggest AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is described as an "Infusion System" used for the "controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature." This process of delivering therapeutic agents directly into the body to treat a condition qualifies it as a therapeutic device.
No
The device is intended for the infusion and dispersion of fluids, not for identifying a medical condition or disease.
No
The device description clearly details physical components like a catheter, balloons, a guidewire, a dispersion wire, and an oscillation drive unit, indicating it is a hardware-based medical device.
Based on the provided information, the Trellis™ Infusion System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature." This describes a therapeutic intervention performed within the patient's body (in vivo), not a test performed on samples outside the body (in vitro) to diagnose a condition.
- Device Description: The description details a catheter system designed for delivering fluids and mechanically dispersing them within blood vessels. This is consistent with a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples, detect biomarkers, or provide diagnostic information about a patient's condition.
IVD devices are typically used to examine specimens such as blood, urine, or tissue to provide information for diagnosis, monitoring, or screening. The Trellis™ Infusion System's function is to deliver treatment directly to a specific site within the body.
N/A
Intended Use / Indications for Use
The Trellis™ 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 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing:
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K932616, K950907, K913517, K981417
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. 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 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)
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
FEB 1 1 2002
510(k) Summary
General Information
| Classification | Class II |
|---|---|
| Trade Name | Trellis Infusion System |
| Submitter | Bacchus Vascular, Inc. |
| 3110 Coronado Drive | |
| Santa Clara, CA 95054 | |
| 408-980-8300 | |
| Contact | Greg Mathison |
| Vice 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 Catheter | |
| Manufactured by SCIMED Life Systems, Inc. | K932616 |
| Pulse*Spray Infusion System | |
| Manufactured by AngioDynamics | K950907 |
| ISOLATE Infusion System | |
| Manufactured by Lake Region, Inc. | K913517 |
| SquirtTM Fluid Delivery System | |
| Manufactured by Merit Medical | K981417 |
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,
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.