TRELLIS-8 PERIPHERAL INFUSION SYSTEM

K130904 · Covidien · QEY · Oct 25, 2013 · Cardiovascular

Device Facts

• Record ID: K130904
• Device Name: TRELLIS-8 PERIPHERAL INFUSION SYSTEM
• Applicant: Covidien
• Product Code: QEY · Cardiovascular
• Decision Date: Oct 25, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Trellis-8 Peripheral Infusion System is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

Device Story

Trellis-8 Peripheral Infusion System is a multi-lumen catheter designed for peripheral vasculature procedures. Device features two compliant balloons at the distal end to isolate a treatment region; infusion holes located between balloons allow delivery of physician-specified fluids (e.g., thrombolytics). An integral Oscillation Drive Unit (ODU) connects to a Dispersion Wire, which oscillates within the isolated region to disperse infused fluids. Device includes a central lumen compatible with 0.035" guidewires. Post-procedure, contents in the treatment area can be aspirated via the guidewire lumen and infusion/aspiration window. Used by physicians in clinical settings to treat peripheral vascular conditions. Benefits include localized drug delivery and enhanced fluid dispersion within an isolated vessel segment.

Clinical Evidence

No clinical data provided. Evidence consists of bench-top functional testing (mechanical integrity, balloon burst/seal, ODU/wire performance), animal testing (vessel trauma comparison), and biocompatibility testing (ISO 10993). Results demonstrate the modified device meets specifications and causes no more vessel trauma than the predicate.

Technological Characteristics

Multi-lumen catheter with two compliant balloons and central 0.035" guidewire lumen. Features an integral Oscillation Drive Unit (ODU) for mechanical dispersion. Biocompatibility per ISO 10993. Modifications include combined infusion/aspiration lumens and circumferential infusion technology. Energy source for ODU not specified.

Indications for Use

Indicated for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

Regulatory Classification

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.

Predicate Devices

• Trellis-8 Peripheral Infusion System (K050147)

Submission Summary (Full Text)

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July 27, 2020

Covidien Jennifer Sullivan Regulatory Affairs Manager 15 Hampshire Street Mansfield, Massachusetts 02048

Re: K130904

Trade/Device Name: Trellis-8 Peripheral Infusion System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEY, KRA

Dear Jennifer Sullivan:

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 October 25, 2013. Specifically, FDA is updating this SE Letter 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, [phone], [e-mail].

Sincerely.

Gregory W.
O'connell -S
Digitally signed by Gregory W.
O'connell -S
Date: 2020.07.27 08:16:20
-04'00'

Gregory O'Connell Assistant Director Plaque Modification Devices Team 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 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 25, 2013

Covidien Ms. Jennifer Sullivan Regulatory Affairs Manager 15 Hampshire Street Mansfield, MA 02048

Re: K130904

Trade/Device Name: Trellis-8 Peripheral Infusion System Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous flush catheter Regulatory Class: Class II Product Code: KRA Dated: October 4, 2013 Received: October 7, 2013

Dear Ms. Sullivan:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Kenneth J. Cavanaugh -

# S

for 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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# Section 4 Indications for Use Statement

510(k) Number (if known):

Device Name: Trellis-8 Peripheral Infusion System

Indications for Use:

The Trellis-8 Peripheral Infusion System is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Kenneth J. Cavanaugh -S

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Image /page/4/Picture/0 description: The image contains the logo for Covidien. The logo consists of a blue square with a white square inside, and a light blue vertical line running through the center. To the right of the square is the word "COVIDIEN" in blue, sans-serif font.

#### 510(K) SUMMARY

#### 1. 510(k) Owner:

Covidien 15 Hampshire Street Mansfield, MA 02048 (508) 452—1659 Telephone: Fax: (508) 452—1659

Contact: Jennifer Sullivan Title: Regulatory Affairs Manager Date Prepared: March 21, 2013

#### 2. Device:

Trade Names: Trellis-8 Peripheral Infusion System Classification Name: Continuous Flush Catheter Regulation Number: 21 CFR 870.1210 Product Code(s): KRA Classification: Class II

#### 3. Predicate Device:

Trellis-8 Peripheral Infusion System K050147

#### 4. Device Description:

The Trellis-8 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 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 (ODU) that oscillates the Dispersion Wire within the isolated region to further disperse the infused fluid. Once the procedure is complete, the contents in the treatment area can be aspirated via the guide wire lumen and the infusion/aspiration (IA) window if desired.

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## 5. Intended Use:

The Trellis-8 Peripheral Infusion System is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

# 6. Technological Characteristics:

The primary differences between the proposed device and the predicate device are the combination of the infusion and aspiration lumens, addition of circumferential infusion technology, and increased catheter amplitude. The modified device has the same fundamental technological characteristics as compared to its predicate device.

# 7. Performance Data:

Bench top functional testing was completed to support substantial equivalence between the modified device and the current device. The test regimen evaluated the following:

- . Mechanical integrity through tensile, kink, catheter trackability, and compliance with sheath and guidewire testing
- Balloon integrity through balloon seal, burst and tensile testing
- ODU and Dispersion Wire integrity through speed, torque and hemostatic valve seal ● testing

The results of the functional testing show that the modified device continues to meet the product specifications.

Animal testing was conducted to assess vessel trauma between the proposed and predicate devices. The results of animal testing show that the modified device causes no more vessel trauma than the predicate.

Biocompatibility testing per ISO 10993: Biological Evaluation of Medical Devices was completed to support biocompatibility between the modified device and the predicate device. The results of the biocompatibility testing show that the modified devices continue to be biocompatible for its intended use.

The results of functional testing, animal and biocompatibility testing demonstrate substantial equivalence.

## 8. Conclusion:

Based on bench, animal and biocompatibility testing results, Covidien has demonstrated that the modified Trellis-8 Peripheral Infusion System is substantially equivalent to the existing Trellis-8 Peripheral Infusion System.