3M CDI H/S CUVETTES WITH HEPARON TREATMENT

K973472 · 3M Healthcare · DRY · Dec 8, 1997 · Cardiovascular

Device Facts

• Record ID: K973472
• Device Name: 3M CDI H/S CUVETTES WITH HEPARON TREATMENT
• Applicant: 3M Healthcare
• Product Code: DRY · Cardiovascular
• Decision Date: Dec 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4330
• Device Class: Class 2

Intended Use

The CDI 100 Extracorporeal Hematocrit/Oxygen Saturation Monitoring System is intended for use during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit, hemoglobin, and oxygen saturation is desired.

Device Story

3M CDI H/S Cuvettes with Heparon Treatment are sterile, single-use components for the CDI 100 Extracorporeal Hematocrit/Oxygen Saturation Monitoring System. Cuvettes are integrated into the extracorporeal circuit during cardiopulmonary bypass. The primary modification is the addition of a covalently bound heparin coating to the fluid path to improve hemocompatibility. The system provides continuous, real-time monitoring of hematocrit, hemoglobin, and oxygen saturation levels. Data is used by clinicians to manage patient blood parameters during bypass. The device does not involve complex software or AI algorithms; it functions as a physical sensor interface within the bypass circuit.

Clinical Evidence

No clinical data was performed. Substantial equivalence was established through nonclinical bench testing comparing the performance characteristics of the heparin-coated cuvettes to the currently marketed non-coated cuvettes.

Technological Characteristics

Sterile, single-use cuvettes available in 1/4", 1/8", and 1/2" diameters. Features a covalently bound heparin coating on the fluid path. No dimensional changes compared to the predicate. Operates as part of the CDI 100 extracorporeal monitoring system.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass procedures requiring continuous monitoring of blood hematocrit, hemoglobin, and oxygen saturation.

Regulatory Classification

Identification

A cardiopulmonary bypass on-line blood gas monitor is a device used in conjunction with a blood gas sensor to measure the level of gases in the blood.

Predicate Devices

• CDI 100 Extracorporeal Hematocrit/Oxygen Saturation Monitoring System (K902654)
• PDR Thoracic Catheter, Atrium Medical (K912645)

Submission Summary (Full Text)

{0}------------------------------------------------

K973472

## 510(k) SUMMARY

DEC - 8 1997

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is

Submitter's Name: Submitter's Address: Contact Person: Phone-Number: FAX Number: Summary Date:

3M Health Care 1311 Valencia Avenue, Tustin, CA 92780 Diana Rhea [phone] X233 [phone]

Device Trade Name: CDI 100 Extracorporeal Hematocrit/ Oxygen Saturation Monitoring System

Device Classification Name:

Cardiopulmonary bypass on-line blood gas monitor and cardiopulmonary bypass in line blood gas sensor (21 CFR 870.4330)

Predicate Devices:

| Product | 510(k) Number | Clearance Date |
|-----------------------------------------------------------------------------|---------------|----------------|
| CDI 100 Extracorporeal<br>Hematocrit/Oxygen Saturation Monitoring<br>System | K902654 | 11/5/90 |
| PDR Thoracic Catheter, Atrium Medical<br>(heparin coating only) | K912645 | 9/13/91 |

Device Description:

The 3M CDI H/S Cuvettes with Heparon Treatment are sterile, single-use medical devices. They are available in 1/4", 1/8", and 1/2" diameter sizes. Additionally, the 3M CDI H/S Cuvettes with Heparon Treatment have a covalently bound heparin coating.

## Indications for Use:

The CDI 100 Extracorporeal Hematocrit/Oxygen Saturation Monitoring System is intended for use during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit, hemoglobin, and oxygen saturation is desired.

{1}------------------------------------------------

#### Technological Characteristics:

The only difference between the 3M CDI H/S Cuvettes with Heparon Treatment and the currently marketed 3M CDI H/S Cuvettes is the application of a covalently bound heparin coating to the fluid path of the devices. There are no dimensional changes to the cells and cuvettes due to the addition of the Heparon treatment.

## Nonclinical Performance:

The performance characteristics of the 3M CDI H/S Cuvettes with Heparon Treatment were exhaustively tested and compared with the performance characteristics of the currently marketed 3M CDI H/S Cuvettes. All new and existing performance characteristics of the 3M CDI Heparin Coated H/S Cuvettes have been validated.

#### Clinical Performance:

Clinical testing was not performed on these devices.

#### Conclusions from Nonclinical Tests:

The 3M CDI H/S Cuvettes with Heparon Treatment perform as intended according to their performance specifications. The 3M CDI H/S Cuvettes with Heparon Treatment are substantially equivalent to their predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Rockville MD 20857

Ms. Diana M. Rhea Advanced Regulatory Affairs Coordinator 3M Health Care, Cardiovascular Systems CDI Products 1311 Valencia Avenue Tustin, California 92680

DEC - 8 1997

Re: K973472 CDI™ 100 Extracorporeal Hematocrit/Oxygen Saturation Monitoring System Regulatory Class: II (Two) Product Code: DRY Dated: September 11, 1997 September 12, 1997 Received:

Dear Ms. Rhea:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{3}------------------------------------------------

Page 2 - Ms. Diana Rhea

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Page 1 of 1

510(k) Number (if known): K973472

Device Name: CDI H/S Cuvettes with Heparon Treatment

Indications For Use: These cuvettes are to be used with the CDI 100 Extracorporeal Hematocrit/Oxygen Saturation Monitoring System, which is intended for use during cardiopulmonary bypass procedures when continuous monitoring og blood hematocrit, hemoglobin, and oxygen saturation is desired.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sete is Campere

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K973472

Prescription Use
(Per 21 CFR 801.109)
✓

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)