(19 days)
The Trellis™ Plus Infusion System is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
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.
The provided documents describe a 510(k) premarket notification for the Trellis Plus Infusion System, a medical device for infusing fluids into the peripheral vasculature. The submission focuses on demonstrating substantial equivalence to a predicate device (the Trellis Infusion System, K013635). As such, it does not include a study or acceptance criteria in the typical sense of a novel device performance study. Instead, the "acceptance criteria" are implied by the demonstration of equivalence to the predicate device, meaning the new device performs at least as well as the predicate for its intended use, and the "study" is the battery of tests performed to demonstrate this equivalence.
Here's an analysis based on the provided text, addressing the requested points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The documents do not present a formal table of specific acceptance criteria (e.g., specific quantitative performance metrics like accuracy, sensitivity, specificity, or error rates) for the Trellis Plus Infusion System, nor does it report detailed quantitative device performance data against such metrics. Instead, the "acceptance criteria" are implicitly met by demonstrating that the device functions as intended and is substantially equivalent to its predicate.
| Acceptance Criteria (Implied by Equivalence) | Reported (Demonstrated) Device Performance |
|---|---|
| Functional Equivalence: The device should perform its intended function (controlled and selective infusion, isolation of treatment region, fluid dispersion) similarly to the predicate device. | The Trellis Plus Infusion System "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," aligning with the description of its intended use. It was "tested in the same manner as the Trellis Infusion System" and "All components, subassemblies, and/or full devices met the required specifications for the completed tests." |
| Material Compatibility: Materials used should be suitable for use and equivalent to those in previously cleared products. | "All materials used in the manufacture of the Trellis Plus are suitable for this use and have been used in numerous previously cleared products." |
| Manufacturing Standards: Device should be designed and manufactured under appropriate quality systems. | "The Trellis Plus was designed under the Bacchus Quality System which is in compliance with 21CFR 820.30." |
| Safety and Effectiveness: Implied to be similar to the predicate device, meaning it should not introduce new questions of safety or effectiveness. | The FDA’s substantial equivalence determination implies that the device is as safe and effective as the predicate for its indicated use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for any "test set" in terms of patient data. The "Testing Summary" indicates that "All components, subassemblies, and/or full devices met the required specifications," implying in-vitro or bench testing rather than in-vivo human studies for this 510(k).
- Data Provenance: Not applicable as no human patient data is described. The testing described appears to be laboratory-based (bench testing).
- Retrospective/Prospective: Not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this type of 510(k) submission, particularly for a mechanical device demonstrating substantial equivalence, is generally based on engineering specifications, regulatory standards, and performance of the predicate device, not on expert consensus from clinical image interpretation or diagnosis.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of adjudication for a test set, as the evaluation type is focused on engineering and functional testing rather than clinical interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document makes no mention of an MRMC comparative effectiveness study. This type of study is typically performed for AI or diagnostic imaging devices where human interpretation is a key component, which is not the case for an infusion system.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. This concept is not relevant to the Trellis Plus Infusion System, which is a physical medical device (catheter system) with mechanical functions, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the substantial equivalence claim is effectively:
- Engineering specifications and regulatory requirements: The device's components and overall system performance meeting predefined technical requirements.
- Performance of the predicate device: The Trellis Plus Infusion System is considered substantially equivalent if its performance characteristics (function, materials, manufacturing) are similar to the legally marketed Trellis Infusion System (K013635).
8. The Sample Size for the Training Set
Not applicable. The Trellis Plus Infusion System is a mechanical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is used for this type of device.
In summary, for the Trellis Plus Infusion System, the "acceptance criteria" and "study" are framed within the context of a 510(k) submission demonstrating substantial equivalence to a predicate device. This involves rigorous engineering and functional testing against established specifications, rather than clinical trials with patient-specific ground truth data or AI model performance metrics.
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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, (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
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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 (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
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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 | 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
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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.3110 Coronado DriveSanta Clara, CA 95054 |
| 408-980-8300 | |
| Contact | Gregory J. MathisonVice 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
Image /page/4/Picture/18 description: The image shows the number 000012. The number is written in a simple, sans-serif font. The digits are evenly spaced and the number is centered in the image. The image is a simple representation of the number 12 with leading zeros.
§ 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).