The COBE® SMAR, T™ Tubing and Connectors are sterile devices with non-pyrogenic fluid pathways, for single use only, and are not to be resterilized by the user. The devices are used in connecting oxygenators, reservoirs, filters, and other cardiopulmonary bypass components into circuits used in surgical procedures requiring extracorporeal support. The tubing may also be used in roller-type cardiopulmonary bypass blood pumps. In particular, tubing sizes with a 3/32 inch wall thickness are used in the pump head of a roller-type cardiopulmonary bypass blood pump, where the tubing is cyclically compressed by the pump to cause blood to flow through the cardiopulmonary bypass circuit.

COBE® SMAR.T™ Tubing is polyvinyl chloride (PVC) tubing ranging in size from 0.075" ID x 0.020" wall to 5/8" ID x 1/8" wall. COBE® SMAR, T™ Connectors are of the following generic types: straight with or without luer port, reducer with or without luer port, Y with or without luer port, male or female luer locks, and saturation/hematocrit monitor connectors.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a study proving that the device meets specific performance thresholds in a clinical or analytical setting. Instead, it describes a 510(k) submission for a medical device (COBE® SMARxT™ Tubing and Connectors) and outlines the testing performed to demonstrate substantial equivalence to a predicate device.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific quantitative acceptance criteria or reported device performance values against those criteria. It lists the types of performance tests conducted but does not specify the pass/fail thresholds or the measured outcomes.

Acceptance Criteria	Reported Device Performance
(Not specified quantitatively in the provided text)	Performance testing consisted of:- Bond Strength- Static Leak Test- Rated Pressure- Kink Resistance- Tubing Pump Life- Tubing Spallation- Saturation/Hematocrit Connector TestingIn-vitro testing was performed to demonstrate:- Improved blood compatibility of the materials containing the surface modifying additive.

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

The document does not specify the sample sizes used for any of the performance or biocompatibility tests. It also does not mention the data provenance (e.g., country of origin, retrospective/prospective). The tests described appear to be in vitro and potentially laboratory-based rather than clinical studies with human subjects.

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

This information is not applicable and not provided. The testing described is technical performance and biocompatibility testing of a medical device, not a diagnostic or AI-driven system that requires expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This is not applicable as the tests described are objective engineering and material property assessments, not subjective assessments 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

This is not applicable. The device is tubing and connectors for cardiopulmonary bypass circuits, not an AI-assisted diagnostic or decision-support system.

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

This is not applicable. The device is a physical medical component, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests would be the established engineering specifications and material properties for similar medical-grade tubing and connectors, along with standards for biocompatibility. For example:

Bond Strength: Meeting a minimum force required to separate bonded components.
Static Leak Test: No leakage observed under a specified pressure.
Rated Pressure: Withstanding a maximum specified pressure without failure.
Kink Resistance: Maintaining patency under specified bending conditions.
Tubing Pump Life: Enduring a minimum number of pump cycles without failure or significant degradation.
Tubing Spallation: Exhibiting an acceptable level of particulate generation during pumping.
Biocompatibility: Meeting ISO 10993 standards and showing no adverse biological reactions in vitro.

The predicate device (COBE® Tubing and Connectors) likely served as the benchmark against which the new device demonstrated "substantial equivalence."

8. The Sample Size for the Training Set

This is not applicable as the device is not an AI/ML algorithm requiring a training set.

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

This is not applicable.

Summary of the Study:

The study performed was a series of in-vitro performance and biocompatibility tests designed to demonstrate that the COBE® SMARxT™ Tubing and Connectors are substantially equivalent to the legally marketed predicate device (COBE® Tubing and Connectors). The primary difference in the new device is the addition of a non-leaching, surface-modifying additive to improve blood compatibility. The tests aimed to prove that this additive does not negatively impact the safety and effectiveness of the device's core mechanical and fluid-handling functions, and in fact, provides an improved characteristic (blood compatibility). The specific quantitative results and acceptance criteria for these tests are not provided in the summary.

Summary

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OCT 26 1998

510(k) Summary

SUBMITTER:	COBE Cardiovascular, Inc.14401 W. 65th WayArvada, CO 80004
CONTACT PERSON:	Lynne LeonardPhone: (303) 467-6586Fax: (303) 467-6429
DATE PREPARED:	August 6, 1998
DEVICE TRADE NAME:	COBE® SMARxT™ Tubing and Connectors
COMMON/USUAL NAME:	Cardiopulmonary Bypass Tubing and Connectors
CLASSIFICATION NAMES:	Cardiopulmonary Bypass Pump TubingCardiopulmonary Bypass Vascular Catheter, Cannula, or TubingCardiopulmonary Bypass Adaptor, Stopcock, Manifold, or Fitting
PREDICATE DEVICE:	COBE® Tubing and Connectors

DEVICE DESCRIPTION:

INDICATIONS FOR USE

The COBE® SMAR,T™ Tubing and Connectors are intended to be used in surgical procedures requiring extracorporeal support for periods of up to six hours.

STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON

The COBE® SMAR, T™ Tubing and Connectors have the same intended use as currently marketed COBE® Tubing and Connectors. The primary difference is that the COBE® SMAR, T™ Tubing and Connectors contain a non-leaching, surface modifying additive that is added to the formulation prior to fabrication to improve blood compatibility.

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Biocompatibility and performance tests were performed to demonstrate that the COBE® SMAR,T™ Tubing and Connectors are substantially equivalent to the currently marketed COBE® Tubing and Connectors.

Performance testing consisted of:

Bond Strength Static Leak Test Rated Pressure Kink Resistance Tubing Pump Life Tubing Spallation Saturation/Hematocrit Connector Testing
In-vitro testing was performed to demonstrate improved blood compatibility of the materials containing the surface modifying additive.

These data support that the COBE® SMAR, T™ Tubing and Connectors are substantially equivalent to the currently marketed COBE® Tubing and Connectors, and that the addition of the surface-modifying material does not affect safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 26 1998

Ms. Lynne Leonard Manager, Regualtory Submissions COBE Cardiovascular, Inc. 14401 W. 65th Way Arvada, CO 80004

K981613 Re : COBE® SMARXT™ Tubing and Connectors Regulatory Class: II (Two) Product Code: DWE Dated: Auqust 7, 1998 Received: August 11, 1998

Dear Ms. Leonard:

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 atvice 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 provisions 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 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 Reqister. 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. Lynne Leonard

This letter will allow you to begin marketing your device as Inis fecter will arow you one on the motification. The FDA finding described in Your 518(A) promise of your device to a legally marketed of substantial equivalence or flassification for your device and predicate actiour device to proceed to the market.

If you desire specific advice for your device on our labeling II you desire specific advanced additionally 809.10 for in vitro regulacion (er ces), please contact the Office of Compliance at (1agnoscic devices), promally, for questions on the promotion and (Jor) Joing of your device, please contact the Office of advertising on (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your (aronsibilities under the Act may be obtained from the Division responsibilities 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, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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Indications For Use

Ic 98 510(k) Number (If known): ____________________________________________________________________________________________________________________________________________________

Device Names: COBE® SMAR TTM Tubing and Connectors

Indications For Use:

COBE® SMAR T™ Tubing and Connectors are intended to be used in surgical procedures requiring extracorporeal support for periods of up to six hours.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Litte R. Loemperse
(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K981613

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use __

Regulation Number and Section

§ 870.4390 Cardiopulmonary bypass pump tubing.

(a)
Identification. A cardiopulmonary bypass pump tubing is polymeric tubing which is used in the blood pump head and which is cyclically compressed by the pump to cause the blood to flow through the cardiopulmonary bypass circuit.(b)
Classification. Class II (performance standards).