HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS

K091268 · Hospira, Inc. · DQE · Sep 18, 2009 · Cardiovascular

Device Facts

• Record ID: K091268
• Device Name: HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS
• Applicant: Hospira, Inc.
• Product Code: DQE · Cardiovascular
• Decision Date: Sep 18, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1230
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Hospira Advanced Sensor Catheters: Indicated for the assessment of the hemodynamic status of a patient, including but not restricted to the following: Venous Pressures, Cardiac Output. Oxyhemoglobin Saturation, and Venous Blood Sampling. A secondary indication is for the therapeutic infusion of solutions. Hospira Critical Care Catheters: Indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients including the following : acute heart failure; differentiating ruptured ventricular septum form mitral regurgitation; diagnosis of tamponate; severe hypovolemia; complex circulatory situations (e.g., fluid management with acute burn patients); medical emergencies; adult respiratory distress syndrome; gram negative sepsis; drug intoxication; acute renal failure; hemorrhagic pancreatitis; intra- and postoperative management of high risk patients; history of pulmonary or cardiac disease; fluid shifts (such as extensive intra-abdominal operations); management of high risk obstetrical patients; known cardiac disease; toxemia; premature separation of the placenta; cardiac output determination by thermodilution method; and blood sampling. Additional indication for Hospira Critical Care Pacing Lead Catheters: Indicated for temporary transluminal ventricular pacing using a temporary ventricular lead.

Device Story

Multi-lumen catheters for pulmonary artery placement; distal balloon for flow-directed positioning; thermistor for core temperature/cardiac output; fiber optics for mixed venous oxygen saturation (SvO2); access ports for drug delivery/blood sampling; pacing lead port on specific models. Used in clinical settings (OR, ICU) by physicians for hemodynamic assessment. Provides real-time physiological data to guide fluid management, drug therapy, and cardiac support. Benefits include improved diagnostic accuracy in complex circulatory states and critical care management.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biocompatibility, expansion symmetry, over-inflation, multiple inflations, deflation time, and burst strength; all passed acceptance criteria.

Technological Characteristics

Multi-lumen catheter; distal balloon; thermistor; fiber optics; heater coil. Materials: resin-based balloon, extrusion tubing. Connectivity: standalone. Sterilization: standard method. No software/algorithm described.

Indications for Use

Indicated for patients requiring hemodynamic monitoring (e.g., acute heart failure, hypovolemia, sepsis, post-op management, cardiac/pulmonary disease) or temporary transluminal ventricular pacing. Applicable to patients needing venous pressure, cardiac output, SvO2 monitoring, or therapeutic infusion.

Regulatory Classification

Identification

A fiberoptic oximeter catheter is a device used to estimate the oxygen saturation of the blood. It consists of two fiberoptic bundles that conduct light at a desired wavelength through blood and detect the reflected and scattered light at the distal end of the catheter.

Predicate Devices

• Hospira Critical Care and Advanced Sensor Catheter (K061450)

Submission Summary (Full Text)

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K0911268

April 2009

Hospira, Inc. Confidential

Special 510(k) Hospira Critical Care and Advanced Sensor Catheters

# SEP 1 8 2009

#### 1 510(k) SUMMARY

#### 1. Submitted by:

Hospira, Inc. D-389 Bldg. H2 275 N. Field Drive Lake Forest, IL 60045 Phone: [phone] Fax: [phone]

Contact: Daniela Weksler

#### Manufacturer and Establishment Registration Number: 2.

#### Manufacturer:

ICU Medical (UTAH), Inc. 4455 Atherton Dr. Salt Lake City, UT 84123

Establishment Registration #: 1713468

| 3. Date Prepared: | April 24, 2009 |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 4. Name/Classification<br>of Device: | Class II<br>74 DYG - 21 CFR 870.1240 - Flow-Directed Catheter<br>74 KRB - 21 CFR 870.1915 - Thermodilution Probe<br>74 DQE - 21 CFR 870.1230 - Fiberoptic Oximeter<br>Catheter |
| 5. Trade Name of<br>Proposed Device: | Hospira Critical Care and<br>Advanced Sensor Catheter |

- 6. Predicate Devices: Hospira Critical Care and Advanced Sensor Catheter (K061450)
### 7. Proposed Device Description:

The Hospira Critical Care and Advanced Sensor Catheters have multi-lumens that incorporate some or all of the following components and features: a distal balloon for positioning the catheter tip via blood flow within the pulmonary artery, a heater coil for determining continuous cardiac output, a thermistor for monitoring core temperature and cardiac output, fiber optics for monitoring mixed venous oxygen saturation (SvQ2), and access ports for drug delivery or blood sampling. In addition, the Hospira Critical Care Pacing Lead Catheters include an access port for use with Transluminal Right Ventricular Pacing Leads. The catheters also incorporate insertion distance markings and are provided with a syringe for inflating the balloon.

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#### 8. Statement of Intended Use:

#### Hospira Advanced Sensor Catheters:

Indicated for the assessment of the hemodynamic status of a patient, including but not restricted to the following: Venous Pressures, Cardiac Output, Oxyhemoglobin Saturation, and Venous Blood Sampling. A secondary indication is for the therapeutic infusion of solutions.

#### Hospira Critical Care Catheters:

Indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients including the following : acute heart failure; differentiating ruptured ventricular septum form mitral regurgitation; diagnosis of tamponate; severe hypovolemia; complex circulatory situations (e.g., fluid management with acute burn patients); medical emergencies; adult respiratory distress syndrome; gram negative sepsis; drug intoxication; acute renal failure; hemorrhagic pancreatitis; intra- and postoperative management of high risk patients; history of pulmonary or cardiac disease; fluid shifts (such as extensive intra-abdominal operations); management of high risk obstetrical patients; known cardiac disease; toxemia; premature separation of the placenta; cardiac output determination by thermodilution method; and blood sampling.

Additional indication for Hospira Critical Care Pacing Lead Catheters:

Indicated for temporary transluminal ventricular pacing using a temporary ventricular lead.

#### 9. Summary of Substantial Equivalence

The Hospira Critical Care and Advanced Sensor Catheters as described in this submission are substantially equivalent to the predicate Hospira Critical Care and Advanced Sensor Catheters (K061450) with respect to manufacturing methods and materials with respect to the following characteristics:

#### Similarities:

- 1) The catheters have the same intended use and indications for use.
- 2) The catheters contain the same type of components.
- 3) The method of sterilization is the same.
- 4) The manufacturing process is the same.
- 5) The resin blend used for the balloon is the same.
- 6) The resin used for the bump and extrusion tubing of the Advanced Sensor Catheters is the same.

76

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#### Differences:

- 1) The material used to manufacture the balloon in both the Critical Care and Advance Sensor Catheters will be a slightly different formulation.
- 2) The resin dye and stiffness specification for the extrusion used in the Advance Sensor Catheters.
- 3) The bond coat insulation on the heater lead wire for the Advance Sensor Catheters

### 10. Statement of Safety and Effectiveness

The Hospira Critical Care and Advanced Sensor Catheters have been tested for biocompatibility and for expansion symmetry, over inflation, multiple inflations, deflation time, and burst strength and have passed all of the acceptance criteria. The Hospira Critical Care and Advanced Sensor Catheters meet the functional claims and intended use as described in the product labeling, and are as safe and effective in terms of substantial equivalence as the predicate catheters described in this document.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles a stylized eagle or bird with three wing-like shapes. The symbol is black, and the text is also black.

#### Public Health Service

SEP 1 8 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Hospira, Inc. c/o Mr. Keith R. Dunn-Manager, Global Regulatory Affairs 275 N. Field Dr. Lake Forest, IL 60045

Re: K091268

Trade/Device Name: Hospira Critical Care and Advanced Sensor Catheters (see enclosure for listing of 29 models) Regulatory Number: 21 CFR 870.1230 Regulation Name: Fiberoptic Oximeter Catheter Regulatory Class: Class II (Two) Product Code: DQE, DYG and KRB

Dated: August 17, 2009

Received: August 18, 2009

### Dear Mr. Dunn:

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 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. Keith R. Dunn

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. 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,
W.M.S.T.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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# Indications for Use

510(k) Number: K091268

Device Name:

Hospira Critical Care and Advanced Sensor Catheters

### Indications for Use:

Hospira Advanced Sensor Catheters:

Indicated for the assessment of the hemodynamic status of a patient, including but not restricted to the following: Venous Pressures, Cardiac Output. Oxyhemoglobin Saturation, and Venous Blood Sampling. A secondary indication is for the therapeutic infusion of solutions.

#### Hospira Critical Care Catheters;

Indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients including the following : acute heart failure; differentiating ruptured ventricular septum form mitral regurgitation; diagnosis of tamponate; severe hypovolemia; complex circulatory situations (e.g., fluid management with acute burn patients); medical emergencies; adult respiratory distress syndrome; gram negative sepsis; drug intoxication; acute renal failure; hemorrhagic pancreatitis; intra- and postoperative management of high risk patients; history of pulmonary or cardiac disease; fluid shifts (such as extensive intra-abdominal operations); management of high risk obstetrical patients; known cardiac disease; toxemia; premature separation of the placenta; cardiac output determination by thermodilution method; and blood sampling.

W.M.P.

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_

Page 1 of 2

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Additional indication for Hospira Critical Care Pacing Lead Catheters:

Indicated for temporary transluminal ventricular pacing using a temporary ventricular lead.

Prescription Use __ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

1.

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K081268

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K091268 Hospira Critical Care and Advanced Sensor Cathters (29 models)

and the same of the same

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| Model # | Model Title |
|-----------|------------------------------------------------------------|
| 412400406 | Pentalumen™ Torque-Line® Catheter with Extra Infusion Port |
| 412370406 | Pentalumen™ Torque-Line® Catheter with Extra Infusion Port |
| 412390406 | Multiflex Torque-Line™ Catheter |
| 412480406 | Torque-Line® Catheter |
| 412500406 | Torque-Line® Catheter |
| 412510406 | Multiflex Torque-Line® S-Tip Catheter |
| 412520406 | Pentalumen™ Torque-Line® Catheter with RV Pacing Port |
| 413000402 | Pentalumen™ Catheter with RV Pacing Port |
| 412160402 | Pentalumen™ Catheter with Extra Infusion Port |
| 412170402 | Pentalumen™ Catheter with Extra Infusion Port |
| 412230402 | Multiflex Cather |
| 412270402 | Multiflex S-Tip Catheter |
| 412290402 | Multiflex Cather |
| 412310406 | Multiflex Torque-Line™ Catheter |
| 412320402 | Pentalumen™ Catheter with Extra Infusion Port |
| 412330406 | Pentalumen™ Catheter with Extra Infusion Port |
| 503240406 | Opticath® PA Catheter |
| 503280406 | Opticath ® PA Catheter with Extra Port |
| 503370406 | Opticath® PA Catheter with Extra Port |
| 503270406 | Opticath ® PA Catheter with Extra Port |
| 503250406 | Opticath ® PA Catheter |
| 503440406 | Opticath® PA Catheter with RV Pacing Port |
| 525090413 | Opti Q® SvO2/CCO Fiberoptic Catheter (with Q-Tip) |
| 525100413 | Opti Q® SvO2/CCO Fiberoptic Catheter (with J-Tip) |
| 525110413 | Opti Q® SvO2/CCO Fiberoptic Catheter (with Q-Tip) |
| 525160413 | TDQ™ CCO Catheter |
| 525150413 | TDQ™ CCO Catheter |
| 503540406 | Opticath ® PA Catheter |
| 503550406 | Opticath ® PA Catheter |