The CDI 400 Extracorporeal Blod Gas Monitoring System is intended for use during cardiopulmonary bypass procedures when continuous monitoring of blood gases is desired.

Device Description

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

AI/ML Overview

The provided document is a 510(k) summary for the 3M CDI QUIK-CELLS with Heparin Treatment, which are components of the CDI 400 Extracorporeal Blood Gas Monitoring System. The device is a modification of previously cleared devices, specifically the application of a heparin coating.

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "The performance characteristics of the 3M CDI OUIK-CELLS with Heparin Treatment were exhaustively tested and compared with the performance characteristics of the currently marketed 3M CDI OUIK-CELLS. All new and existing performance characteristics of the 3M CDI Heparin Coated QUIK-CELLS have been validated."

However, specific numerical acceptance criteria (e.g., minimum accuracy, precision, or specific thresholds for chemical or physical properties) and the corresponding reported performance values are not detailed in this summary. The "Nonclinical Performance" section provides a general statement of validation without quantifiable results.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not specified. The document states "exhaustively tested" but provides no numbers for the test set.
Data Provenance: Not specified. Given the nature of the device (a component for blood gas monitoring during cardiopulmonary bypass) and the "Nonclinical Performance" section, the testing was likely conducted in a laboratory setting (in vitro or ex vivo), rather than involving human subjects. The country of origin is not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. The study described is a non-clinical performance evaluation comparing the modified device to a predicate device, not one requiring expert interpretation of medical images or patient data to establish ground truth.

4. Adjudication Method for the Test Set:

Not applicable. The study is a non-clinical performance evaluation, not a human reader study requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

Not applicable. This is a 510(k) submission for a medical device component (blood gas sensor) involving non-clinical performance testing. It does not involve AI or human readers for diagnostic interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The "Nonclinical Performance" section describes the testing of the device's characteristics in a standalone manner, comparing it to the predicate device. The device itself is a measurement component, not an algorithm, so "standalone algorithm performance" is not the correct terminology, but the device's inherent performance was evaluated independently.

7. The Type of Ground Truth Used:

The ground truth for the non-clinical performance study would have been established by accepted laboratory measurement standards and validated methods for assessing the performance of blood gas monitoring components (e.g., accuracy against known blood gas compositions, stability, biocompatibility). The document implies that the predicate device's established performance served as a benchmark for the modified device's equivalence.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI algorithm that requires a training set. It's a physical medical device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. This device is not an AI algorithm that requires a training set.

Summary

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510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in Firs summer 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 Thorson (714) 258-8001 X233 (714)258-0810

Device Trade Name: CDI 400 Extracorporeal Blood Gas 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 400 ExtracorporealHematocrit/Oxygen Saturation MonitoringSystem	K890113	5/23/89
CDI 100 ExtracorporealHematocrit/Oxygen Saturation MonitoringSystem	K902654	11/5/90

Device Description:

Indications for Use:

The CDI 400 Extracorporeal Blod Gas Monitoring System is intended for use during cardiopulmonary bypass procedures when continuous monitoring of blood gases is desired.

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Technological Characteristics:

This modification to the 3M CDI QUIK-CELLS includes the application of a covalently bound heparin coating to the fluid path of the device. In addition, the 3M CDI QUIK-CELLS with Heparin Treatment have a slightly thicker membrane. There are no other dimensional changes to the cells due to the addition of the Heparin Treatment.

Nonclinical Performance:

The performance characteristics of the 3M CDI OUIK-CELLS with Heparin Treatment were exhaustively tested and compared with the performance characteristics of the currently marketed 3M CDI OUIK-CELLS. All new and existing performance characteristics of the 3M CDI Heparin Coated QUIK-CELLS have been validated.

Clinical Performance:

Clinical testing was not performed on these devices.

Conclusions from Nonclinical Tests:

The 3M CDI OUIK-CELLS with Heparin Treatment perform as intended according to their performance specifications. The 3M CDI QUIK-CELLS with Heparin Treatment are substantially equivalent to their predicate devices.

Page 2-3

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2.2 Safety Literature Search

Although a safety literature search is not required for class II devices, one has been included below.

I certify that I have conducted a reasonable search of all information known or otherwise available to me about the types and causes of safety and/or effectiveness problems that have been reported with cardiopulmonary bypass on-line blood gas monitors and cardiopulmonary bypass in line blood gas sensors within the past five years. I further certify that I am aware of the types of problems to which cardiopulmonary bypass on-line blood gas monitors and cardiopulmonary bypass in line blood gas sensors are susceptible and that the following list of safety and/or effectiveness problems about these devices is complete and accurate:

1.) Occlusion of the cell
Leakage of fluid from the cell, or ingress of air emboli into the 2.) cell
Loss of sterility 3.)

Below is a bibliography of the materials upon which the above summary is based:

1.) Customer Complaint File, various dates, 3M Health Care, CDI Products.
U.S. Food and Drug Administration Recall Number Z 1084/1085-1. 2.) Initiated by CDI, 3M Health Care on May 20, 1991.
U.S. Food and Drug Administration Recall Number Z 2628-2 through 3.) Z2633-2. Initiated by CDI, 3M Health Care On December 18, 1991.
U.S. Food and Drug Administration Recall Numbers Z-635-2 through 4.) Z-645-2. Initiated by CDI, 3M Health Care on February 2, 1992.
Medical Device Report M174488, filed 1/30/92 by CDI, 3M Health 5.) Care.
Medical Device Report M174493, filed 2/4/92 by CDI, 3M Health 6.) Care.
Medical Device Report M268836, filed 2/17/92 by CDI, 3M Health 7.) Care.
Medical Device Report M268956, filed 2/19/92 by CDI, 3M Health 8.) Care.
9.) Medical Device Report M268957, filed 2/19/92 by CDI, 3M Health Care.
10.) Medical Device Report M255427, filed 2/13/92 by CDI, 3M Health Care.
Medical Device Report M255429, filed 2/13/92 by CDI, 3M Health 11.) Care.

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Medical Device Report M174556, filed 2/12/92 by CDI, 3M Health 12.) Care.
Medical Device Report M174629, filed 2/2/92 by CDI, 3M Health 13.) Care.
Medical Device Report M174966, filed 4/16/92 by CDI, 3M Health 14.) Care.
Medical Device Report M174942, filed 4/16/92 by CDI, 3M Health 15.) Care.
16.) Medical Device Report M174941, filed 4/16/92 by CDI, 3M Health Care.
17.) Medical Device Report M174943, filed 4/16/92 by CDI, 3M Health Care.
Medical Device Report M174964, filed 4/16/92 by CDI, 3M Health 18.) Care.
19.) Medical Device Report M320347, filed 3/14/93 by CDI, 3M Health Care.
Medical Device Report M377386, filed 3/26/93 by CDI, 3M Health 20.) Care.
Medical Device Report M377387, filed 3/26/93 by CDI, 3M Health 21.) Care.
22.) Medical Device Report M377388, filed 3/26/93 by CDI, 3M Health Care.
23.) Medical Device Report M544290, filed 8/5/94 by CDI, 3M Health Care.
24.) Medical Device Report M800711, filed 4/17/95 by 3M Health Care.
Medical Device Report M820946, filed 7/31/95 by 3M Health Care. 25.)
26.) Medical Device Report 2023117-1997-00001, filed 3/14/97 bv 3M Health Care.

Printed name of person required to submit 510(k): Diana M. Thorson Signature of person required to submit 510(k): Machines M) theresto Title of person submitting 510(k): Advanced Regulatory Affairs Coordinator Name of Company: 3M Health Care Date: 2/24/98

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Image /page/4/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

MAY 1 5 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Diana M. Thorson Advanced Requlatory Affairs Coordinator 3M Health Care, Cardiovascular Systems CDI Products 1311 Valencia Avenue Tustin, CA 92780

Re : K980732 3M CDI Quick-Cell with Heparin Treatment Regulatory Class: II (Two) Product Code: DRY Dated: February 24, 1998 Received: February 25, 1998

Dear Ms. Thorson:

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 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). 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 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set-forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlations.

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Page 2 - Ms. Diane Thorson

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/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

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Page 1 of 1

510(k) Number (if known): K980732-

3M CDI QUIK-CELLS With Heparin Treatment Device Name:__________________________________________________________________________________________________________________________________________________________________

These cells are to be used with the CDI System Indications For Use: Indications for 6000 Gas Monitoring System, which is intended for 400 Extractporcal brood our heartering by sound.
use during cardiopulmonary bypass procedures when continous monitoring of blood gases is desired.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sette a. Cooper le

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K-98073. 510(k) Number_

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.4330 Cardiopulmonary bypass on-line blood gas monitor.

(a)
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.(b)
Classification. Class II (performance standards).