TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P)

K012747 · Medtronic Perfusion Systems · DPT · Sep 14, 2001 · Cardiovascular

Device Facts

• Record ID: K012747
• Device Name: TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P)
• Applicant: Medtronic Perfusion Systems
• Product Code: DPT · Cardiovascular
• Decision Date: Sep 14, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2120
• Device Class: Class 2

Intended Use

The Trillium™ Bio-Probe Disposable Blood Flow Probe is a single-use insert designed to be used in the Bio-Probe Blood Flow Monitoring System. The Bio-Probe Blood Flow Monitoring System is to be used with an appropriate model Bio-Console to measure directly the blood flow in the extracorporeal perfusion circuit.

Device Story

Trillium™ Bio-Probe is a single-use insert for Bio-Probe Blood Flow Monitoring System; used with Bio-Console to measure blood flow in extracorporeal perfusion circuits. Device features Trillium™ biopassive surface coating on blood-contacting surfaces. Operates as part of extracorporeal cardiopulmonary bypass setup; provides real-time flow measurement to perfusionists/clinicians. Output allows monitoring of perfusion circuit flow rates to ensure adequate patient support during procedures. Benefits include biocompatible surface coating to reduce blood-material interaction.

Clinical Evidence

Bench testing only. In vitro analysis included coating characteristics, physical characteristics, and performance characteristics to demonstrate substantial equivalence to predicate devices.

Technological Characteristics

Single-use blood flow probe insert. Primary technological modification is the application of Trillium™ biopassive surface coating to blood-contacting surfaces. Device is intended for use with Bio-Console extracorporeal blood pumping consoles. Class II device (21 CFR 870.2120).

Indications for Use

Indicated for use with Bio-Console extracorporeal blood pumping consoles to measure blood flow in extracorporeal perfusion circuits. Prescription use only.

Regulatory Classification

Identification

An extravascular blood flow probe is an extravascular ultrasonic or electromagnetic probe used in conjunction with a blood flowmeter to measure blood flow in a chamber or vessel.

Predicate Devices

• Bio-Probe Disposable Blood Flow Probe (K830858)
• AFFINITY® Hollow Fiber Oxygenator with Trillium™ Biopassive Surface (K973760)

Submission Summary (Full Text)

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K012747

# SEP 1 4 2001

### SUMMARY OF SAFETY AND EFFECTIVENESS

### COMPANY AND CONTACT PERSON

Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 Tel: [phone] FAX: [phone]

Marie L. Holm, Associate Product Regulations Manager, Regulatory Affairs

#### DEVICE NAME

Trillium™ Bio-Probe Disposable Blood Flow Probe

# NAME OF PREDICATED OR LEGALLY MARKETED DEVICE

Bio-Probe Disposable Blood Flow Probe (K830858) ലിറ്റ് Tribe Biopodable Diosa provith Trillium™ Biopassive Surface (K973760)

#### DESCRIPTION OF DEVICE

The Trillium™ Bio-Probe Disposable Blood Flow Probe is a single-use insert designed to be used in the Bio-Probe Blood Flow Monitoring System.

#### STATEMENT OF INTENDED USE

The Trillium™ Bio-Probe Disposable Blood Flow Probe is a single-use insert designed to be used in the Bio-Probe Blood Flow Monitoring System.

The Bio-Probe Blood Flow Monitoring System is to be used with an appropriate model Bio-Console to measure directly the blood flow in the extracorporeal perfusion circuit.

### STATEMENT OF INTENDED USE OF PREDICATED/MARKETED DEVICE

The Bio-Probe Disposable Blood Flow Probe is a single use insert designed to be used in the Bio-Probe Blood Flow Monitoring System.

The Bio-Probe Blood Flow Monitoring System is to be used with an appropriate model Bio-Console to measure directly the blood flow in the extracorporeal perfusion circuit.

### STATEMENT OF TECHNOLOGICAL CHARACTERISTICS COMPARISON

Information regarding technological characteristics comparison is provided in the following section, "Determination of Substantial Equivalence".

Special 510(k) Notification Medtronic, Inc.

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# DETERMINATION OF SUBSTANTIAL EQUIVALENCE

This "SPECIAL 510(k)" is being submitted for a modification to the Bio-Probe Disposable Blood Flow Probe. The modification to the current Bio-Probe Disposable Blood Flow Probe is to coat the blood contact surfaces with Trillium™.

The Trillium™ Bio-Probe Disposable Blood Flow Probe is being compared to the following Marketed Devices:

- Bio-Probe Disposable Blood Flow Probe (K830858) ●
- AFFINITY® Hollow Fiber Oxygenator with Trillium™ Biopassive Surface . (K973760)

The Trillium"" Bio-Probe Disposable Blood Flow Probe has the same indications statement and intended uses as the:

- Bio-Probe Disposable Blood Flow Probe (K830858) .
The Trillium™ Bio-Probe Disposable Blood Flow Probe has "no new technological characteristics (e.g., materials and manufacturing processes)" from the Bio-Probe Disposable Blood Flow Probe. The technological characteristic is solely the coating material of the blood pathway:

- Trillium™ .
The technological characteristic of the Trillium™ Biopassive Surface is common to other medical devices (hollow fiber oxygenators) currently in commercial distribution as follows:

- AFFINITY® Hollow Fiber Oxygenator with Trillium™ Biopassive Surface . (K973760)
This technological characteristic "could affect the safety and effectiveness of the device". However, these "technological characteristics do not raise new types of safety or effectiveness questions". In addition, "there are acceptable scientific methods which exist for assessing effects of these new technological characteristics".

"Performance data to assess the effects of these new technological characteristics" has been performed. These "performance data demonstrate" that the Trillium" Bio-Probe Disposable Blood Flow Probe is substantially equivalent to other marketed extracorporeal cardiopulmonary devices.

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The biocompatibility and in vitro bench testing demonstrated that when compared to the The bloompatibility and in Willie benon tool Disposable Blood Flow Probe does not predioute donooo, the wand effectiveness and are substantially equivalent to other Significally direct career and or oreal cardiopulmonary devices. The in vitro bench testing included analysis of:

- Coating Characteristics .
- Physical Characteristics .
- Performance Characteristics .

Special 510(k) Notification Medtronic, Inc.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle faces right and appears to be in flight. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

SEP 1 4 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Marie L. Holm Medtronic Perfusion Systems 7611 Northland Drive N Minneapolis, MN 55428-1088

Re: K012747

Trade Name: Trillium™ Bio-Probe Disposable Blood Flow Probe (DP38T and DP38PT) Regulation Number: 21 CFR 870.2120 Regulation Name: Extravascular Blood Flow Probe Regulatory Class: Class II (two) Product Code: DPT Dated: August 15, 2001 Received: August 16, 2001

Dear Ms. Holm:

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 - Ms. Marie L. Holm

Please be advised that FDA's issuance of a substantial equivalence determination does not mean i loast of advisou that I Drivision that your device complies with other requirements of the Act that I Dr Has Intact a and regulations administered by other Federal agencies. You must or any I colorated and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic ford in and quality by overns (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) I mis letter with and h your e FDA finding of substantial equivalence of your device to a legally promated predicated 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 additionally 21 Of 1 1 1 1 1 1 1 - 4646. Additionally, for questions on the promotion and advertising of Compliance please contact the Office of Compliance at [phone]. 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 Oivision of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

**Sincerely yours,**

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510 (k) Number if known: K012747 -

Device Name: Trillium™ Bio-Probe Disposable Blood Flow Probe

The Trillium™ Bio-Probe Disposable Blood Flow Probe is designed for use in the Bio-Probe Blood Flow Monitoring System.

### Indications for Use:

The Bio-Probe blood flow monitoring system is to be used with an appropriate model Bio-Console® extracorporeal blood pumping console to measure directly the blood flow in the extracorporeal perfusion circuit.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number k012747

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter use **_**