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.

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.

AI/ML Overview

The provided 510(k) summary for the K973472 device, the 3M CDI H/S Cuvettes with Heparon Treatment, does not contain explicit acceptance criteria and a detailed study report demonstrating the device meets these criteria in the format typically used for AI/ML device submissions. Instead, this submission focuses on demonstrating substantial equivalence to a predicate device through nonclinical performance testing.

Here's an attempt to extract and infer the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria in a table. However, it indicates the overarching performance expectation and reported outcome:

Acceptance Criteria (Inferred from Predicate Equivalence)	Reported Device Performance
Perform as intended according to performance specifications (i.e., equivalent to predicate)	The 3M CDI H/S Cuvettes with Heparon Treatment perform as intended according to their performance specifications. All new and existing performance characteristics have been validated.
Functionality and safety equivalent to the predicate device, especially regarding hematocrit, hemoglobin, and oxygen saturation monitoring during cardiopulmonary bypass.	"Substantially equivalent to their predicate devices."
No significant difference in technological characteristics (beyond the heparin coating).	"The only difference... is the application of a covalently bound heparin coating... There are no dimensional changes."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for test set: Not explicitly stated. The "Nonclinical Performance" section describes "exhaustively tested" and "compared with the performance characteristics of the currently marketed 3M CDI H/S Cuvettes." This implies laboratory or bench testing rather than a clinical human data test set.
Data Provenance: Not applicable in the context of human data. The testing was nonclinical, likely performed in an engineering or laboratory setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is not an AI/ML diagnostic device requiring expert interpretation of results to establish ground truth. Its performance relates to physical characteristics and measurement accuracy, likely validated against calibrated standards or established laboratory methods.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As this involves nonclinical performance testing of a physical device component, adjudication by experts for a test set is not relevant.

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

No. This device is an in-line monitoring system component, not an AI/ML diagnostic or assistive technology that would involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to the performance of the device itself (the cuvettes with heparin treatment) rather than an algorithm. The "Nonclinical Performance" section describes standalone testing of the cuvettes to validate their performance characteristics against the predicate. The device operates automatically without a human-in-the-loop for its core measurement function.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the nonclinical testing would refer to:

Established laboratory standards: For parameters like dimensions, material properties, and potentially coating efficacy.
Performance of the predicate device: The primary comparison was against the "currently marketed 3M CDI H/S Cuvettes," implying the predicate's established performance served as a benchmark for equivalence.
Internal performance specifications: The device was tested to perform "according to their performance specifications," suggesting predefined criteria based on engineering and physiological requirements.

8. The sample size for the training set

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

9. How the ground truth for the training set was established

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

Summary of Device-Specific Information:

The 510(k) K973472 for the 3M CDI H/S Cuvettes with Heparon Treatment is a predicate-based submission focusing on demonstrating substantial equivalence. The key difference from the predicate device is the addition of a covalently bound heparin coating. No clinical testing was performed, and the evaluation rested entirely on nonclinical performance tests proving that the heparin-coated cuvettes performed "as intended" and were "substantially equivalent" to the previously cleared, non-heparin-coated cuvettes.

Summary

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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 (714) 258-8001 X233 (714)258-0810

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 ExtracorporealHematocrit/Oxygen Saturation MonitoringSystem	K902654	11/5/90
PDR Thoracic Catheter, Atrium Medical(heparin coating only)	K912645	9/13/91

Device Description:

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.

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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.

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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.

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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 (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/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

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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)
✓

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).