24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524

K012143 · Medtronic Cardiac Surgical Products · DRA · Oct 24, 2001 · Cardiovascular

Device Facts

• Record ID: K012143
• Device Name: 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524
• Applicant: Medtronic Cardiac Surgical Products
• Product Code: DRA · Cardiovascular
• Decision Date: Oct 24, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1280
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is intended for use in venting the left heart during cardiopulmonary bypass surgery.

Device Story

24 Fr. Left Heart Vent Catheter with integrated pressure monitoring line; used during cardiopulmonary bypass surgery to vent left heart and monitor left ventricular pressure. Device inserted by cardiac surgeon; provides continuous pressure data to external monitoring equipment. Enables management of left heart venting and pressure monitoring via single catheter. Benefits patient by facilitating safe venting and real-time pressure assessment during bypass.

Clinical Evidence

Bench testing only. Testing included kink, clamp, flexibility, burst, leak, and pull testing, and verification of pressure monitoring capability. No clinical data provided.

Technological Characteristics

24 Fr. catheter; includes integrated pressure monitoring line. Materials include Polyvinyl Chloride (PVC). Mechanical design for venting and pressure sensing. No software or electronic components.

Indications for Use

Indicated for venting the left heart during cardiopulmonary bypass surgery in patients undergoing such procedures.

Regulatory Classification

Identification

A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.

Predicate Devices

• Adult Vent Catheter (K834352)
• Aortic Root Cannula with Pressure Monitoring Line (K831591)

Reference Devices

• Infant Vent Catheter (K834039)

Submission Summary (Full Text)

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OCT 2 4 2001

K012143

#### APPENDIX III

## SUMMARY OF SAFETY AND EFFECTIVENESS TRUTHFUL AND ACCURATE STATEMENT DECLARATION OF CONFORMITY

Special 510(k) Notification 24 Fr. Left Heart Vent w/ Pressure Monitoring Line Confidential Medtronic, Inc. Medtronic Cardiac Surgical Products 7/6/01 18

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# SUMMARY OF SAFETY AND EFFECTIVENESS

#### COMPANY

Medtronic, Inc. Medtronic Cardiac Surgical Products 620 Watson Street S.W. Grand Rapids, MI 49504

# CONTACT PERSON

Melissa Harriger Associate Product Requiations Manager Medtronic Cardiac Surgical Products 620 Watson Street SW Tel: [phone] FAX: [phone]

#### DEVICE NAME

24 Fr. Left Heart Vent Catheter w/ Pressure Monitoring Line (12524)

## NAME OF PREDICATED OR LEGALLY MARKETED DEVICE

Adult Vent Catheter (K834352) Aortic Root Cannula with Pressure Monitoring Line (K831591)

#### DESCRIPTION OF DEVICE

The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is designed for use in venting the left heart during cardiopulmonary bypass surgery.

The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is equipped with a pressure monitoring line, which allows measurement of left ventricular pressure.

#### STATEMENT OF INTENDED USE

The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is intended for use in venting the left heart during cardiopulmonary bypass surgery.

# STATEMENT OF INTENDED USE OF PREDICATED/MARKETED DEVICE

The Adult Vent Catheter is intended for use in venting the left heart during cardiopulmonary bypass surgery.

| Special 510(k) Notification | 24 Fr. Left Heart Vent w/ Pressure Monitoring Line Confidential |
|-------------------------------------|-----------------------------------------------------------------|
| Medtronic, Inc. | |
| Medtronic Cardiac Surgical Products | 7/6/01 |
| | 19 |

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# STATEMENT OF TECHNOLOGICAL CHARACTERISTICS COMPARISON

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

# DETERMINATION OF SUBSTANTIAL EQUIVALENCE

This "SPECIAL 510(k)" is being submitted for a modification to the Adult Vent Catheter. The modification to the current Adult Vent Catheter is to include a pressure monitoring line and material change

The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is being compared to the following Marketed Devices:

- Adult Vent Catheter (K834352) ●
- . Infant Vent Catheter (K834039)
- Aortic Root cannula(s) with Integral Pressure Monitoring Line (K831591) .

The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line has the same indications statement and intended uses as the:

- Adult Vent Catheter (K834352) .
- . Infant Vent Catheter (K834039)

The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line has no new technological characteristics (e.g. materials and manufacturing processes). The technological characteristic of the pressure monitoring line is common to other products in commercial distribution as follows. Additionally, using Polyvinyl Chloride (PVC) is common to other catheter products in distribution, as indicated below in the Infant Vent Catheter.

- Aortic Root Cannula with Integral Pressure Monitoring Line (K831591)
- . Infant Vent Catheter (K834039)

This technological characteristic "could affect the safety and effectiveness of the device". However, this technological characteristic does not raise new types of safety or effectiveness questions. In addition, "there are acceptable scientific methods which exist for assessing effects of this technological characteristic".

"Performance data to assess the effects of this technological characteristic" has been performed. These "performance data demonstrate" that the 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is substantially equivalent to other Medtronic marketed cannula.

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The biocompatibility rationale and in vitro bench testing demonstrated that when compared to the predicate devices, the 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line does not significantly affect safety and effectiveness and are substantially equivalent to other commercially distributed devices. The in vitro bench testing included analysis of: kink testing, clamp testing, flexibility testing, burst, leak testing, pull testing and pressure monitoring capability.

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Image /page/4/Picture/2 description: The image is a black and white circular logo. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is facing to the right. Encircling the eagle is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 4 2001

Ms. Melissa Harriger Associate Product Regulation Manager Medronic Cardiac Surgery 620 Watson SW Grand Rapids, MI 49504

Re: K012143

Trade Name: 24 Fr. Left Heart Vent Catheter w/ Pressure Monitoring Line Regulation Number: 21 CFR 870.4210 Regulation Name: Catheter, Steerable Regulatory Class: Class II (two) Product Code: DRA Dated: September 24, 2001 Received: September 25, 2001

Dear Ms. Harriger:

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. Melissa Harriger

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 promated 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 [phone]. Additionally, for questions on the promotion and advertising of your device, 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 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/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: K012143 -

Device Name: 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line

#### Indications for Use:

The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is intended for venting the left heart during cardiopulmonary bypass surgery.

Concurrence of CDRH, Office of Device Evaluation (ODE)

ﺎ Prescription Use

OR

Over-The-Counter use

(Per 21 CFR 801.109)

Division of Cardiovascular & Respiratory Devices
510(k) Number K012443