(25 days)
The Trellis™-6 Peripheral Infusion System is intended for controlled and selective infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature.
The Trellis-6 Peripheral 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. The Isolation/Infusion component is a multi-lumen catheter with two compliant balloons at the distal end and infusion holes located between these balloons. The device also has a central through-lumen that is compatible with a 0.035" guidewire. The Dispersion Wire provides oscillation when activated. The Dispersion Wire is connected to an integral Oscillation Drive Unit that oscillates the Dispersion Wire 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.
The provided documentation is a 510(k) premarket notification for the Trellis-6 Peripheral Infusion System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through a standalone study. The document explicitly states: "The Trellis-6 Peripheral Infusion System was tested in the same manner as the Trellis-8. All components, subassemblies, and/or full devices met the required specifications for the completed tests."
Therefore, the acceptance criteria and study proving the device meets them would have been established for the predicate device, the Trellis-8 Infusion System (K050147), and the K071664 submission leverages that prior work by demonstrating the Trellis-6 system is equivalent.
Based on the provided text for K071664, I can infer the following about what would have been implicitly accepted based on the predicate device, but the document does not contain the detailed study results for the Trellis-6 itself.
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria (Inferred from function) | Reported Device Performance (Implied by Substantial Equivalence to Trellis-8) |
|---|---|
| Mechanical Performance: | |
| Balloon inflation/deflation | Functions as intended, enabling isolation of treatment region. (Equivalent to Trellis-8) |
| Infusion capability | Allows controlled and selective infusion of physician-specified fluids (including thrombolytics) into the peripheral vasculature. (Equivalent to Trellis-8) |
| Dispersion Wire oscillation | Provides oscillation when activated, dispersing infused fluid within the isolated region. (Equivalent to Trellis-8) |
| Guidewire compatibility | Compatible with a 0.035" guidewire through its central lumen. (Equivalent to Trellis-8) |
| Aspiration capability | Allows post-procedure aspiration of the isolated area between occluding balloons through the catheter using the guidewire lumen. (Equivalent to Trellis-8) |
| Biocompatibility: | |
| Material safety | All materials are suitable for use and have been used in numerous previously cleared products, implying acceptable biocompatibility. (Equivalent to Trellis-8) |
| Functional Equivalence: | |
| Indications for Use | Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature, matching the predicate. (Explicitly stated as substantially equivalent in indications for use) |
| Manufacturing Methods | Utilizes manufacturing methods substantially equivalent to the predicate, ensuring consistent quality and performance. (Explicitly stated as substantially equivalent in manufacturing methods) |
2. Sample size used for the test set and the data provenance:
- The document for K071664 does not specify the sample size for any test set or the data provenance. It only states that the Trellis-6 was "tested in the same manner as the Trellis-8" and "All components, subassemblies, and/or full devices met the required specifications for the completed tests." The details of these tests would be in the K050147 submission for the Trellis-8.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of information is not applicable or provided in a 510(k) submission focused on substantial equivalence for a device like the Trellis-6 Peripheral Infusion System, which is a mechanical delivery system rather than an diagnostic AI/imaging tool requiring expert interpretations for ground truth.
4. Adjudication method for the test set:
- Not applicable or provided for the same reasons as above.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. The Trellis-6 is an infusion system, not an AI or imaging device that would involve human readers or comparative effectiveness studies of AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The Trellis-6 is a physical medical device, not an algorithm.
7. The type of ground truth used:
- For mechanical devices like this, "ground truth" typically refers to engineering specifications, physical measurements, and performance benchmarks (e.g., flow rates, balloon integrity, material strength, oscillation frequency). The document implies these were assessed against "required specifications," but does not detail them.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This device is not an AI/ML algorithm.
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November 22, 2021
Bacchus Vascular, Inc. Anthony Sowunmi Director, Quality Assurance And Regulatory Affairs 3110 Coronado Dr. Santa Clara, California 95054
Re: K071664
Trade/Device Name: Trellis-6 Peripheral Infusion System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEY, KRA
Dear Anthony Sowunmi:
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 13, 2007. 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 O'connell -S Date: 2021.11.22 13:35:00 -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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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 13 2007
Bacchus Vascular, Inc. c/o Mr. Anthony Sowunmi 3110 Coronado Drive Santa Clara, CA 95054
Re: K071664
Trade/Device Name: Trellis-6 Peripheral Infusion System Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II, Product Code: KRA Dated: June 15, 2007 Received: June 18, 2007
Dear Mr. Sowunmi:
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.
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Page 2 - Mr. Anthony Sowunmi
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Duma R. Volmer
C Bram D. Zuckerman, M.D. 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 Uso:
This application K071664
Trellis-6 Peripheral Infusion System
The Trellis™-6 Peripheral Infusion System is intended for THC Tromb
controlled and selective infusion of physician-specified controlled aning thrombolytics, into the peripheral vasculature.
Prescription Use X
(Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
SEDO NOT WRITE BELOW THIS I CONTENUE ON ANOTHER PAGE IF NEEDED)
Total CDRH, Office of Device Evaluation (ODE)
Donna R. Holmes
Division Sign-Off
Division of Cardiovascular Devices
510(k) Number K071664
C0161610621
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510(k) Summary
Date Prepared June 15, 2007
JUL 1 3 2007
General Information
| Class | Class II |
|---|---|
| Trade Name | Trellis™-6 Peripheral Infusion System |
| Submitter | Bacchus Vascular, Inc |
| 3110 Coronado Drive | |
| Santa Clara, CA 95054 | |
| Tel: 408-980-8300 | |
| Fax: 408-980-8383 | |
| Contact | Anthony Sowunmi |
| Director, Quality Assurance and Regulatory Affairs |
Intended Use
The Trellis™-6 Peripheral Infusion System is intended for controlled and selective infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature.
Predicate Device
Trellis-8 Infusion System K050147 Bacchus Vascular, Inc
Device Description
The Trellis-6 Peripheral 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. The Isolation/Infusion component is a multi-lumen catheter with two compliant balloons at the distal end and infusion holes located between these balloons. The device also has a central through-lumen that is compatible with a 0.035" guidewire. The Dispersion Wire provides oscillation when activated. The Dispersion Wire is connected to an integral Oscillation Drive Unit that oscillates the Dispersion Wire 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-6 Peripheral Infusion System are suitable for this use and have been used in numerous previously cleared products.
Testing Summary
The Trellis-6 Peripheral Infusion System was tested in the same manner as the Trellis-8. All components, subassemblies, and/or full devices met the required specifications for the completed tests.
Summary of Substantial Equivalence
The Trellis-6 Peripheral Infusion System is equivalent to the predicate product, the Trellis-8 Infusion System. The indications for use, function, methods of manufacturing, and materials used are substantially equivalent.
§ 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).