COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD by COBE CARDIOVASCULAR, INC.

The COBE® Sentry® SMAR T™ 43 Micron Arterial Filter with PrimeGard® is indicated for use in the arterial line of an extracorporeal circuit during cardiopulmonary bypass procedures, for periods of up to six hours.

Device Description

The COBE® Sentry® SMAR T™ 43 Micron Arterial Filter with PrimeGard® is a sterile device with a nonpvrogenic fluid pathway. It is for single use only and is not to be resterlized by the user. The device is indicated for use in the arterial line of an extracorporeal circuit during cardiopulmonary bypass procedures, for periods of up to six hours. It is designed to filter out micro-particles intrough the arterial line of a cardiopulmonary bypass circuit.

The Sentry® SMAR,T™ Arterial Filter consists of a transparent cap and casing with 3/8" barbed inlet and outlet ports. The cap has an integral luer lock vent/purge port. The filter cartridge consists of a 43 micron screen filter media, fan-folded with support netting. The filter cartridge is attached to an internal support which minimizes the blood volume within the device and directs blood flow. Blood coming into the device contacts the flow director plate of the support, which slows the blood flow to facilitate removal of air. The PrimeGard® heparin coating enhances air removal during priming. The Sentry® SMAR,T™ Arterial Filter contains surface-modifying additives that improve the blood compatibility of the device.

AI/ML Overview

The provided text describes a 510(k) pre-market notification for a medical device, the COBE® Sentry® SMART™ 43 Micron Arterial Filter with PrimeGard®. This submission is for a new version of an existing device, primarily adding surface-modifying additives to improve blood compatibility.

Based on the information provided, here's an analysis of the acceptance criteria and study as requested, with a significant caveat that specific acceptance thresholds are not explicitly stated in this document. The document focuses on demonstrating substantial equivalence to a predicate device rather than meeting specific performance targets against a predefined standard.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, the document does not provide a table with explicit numerical acceptance criteria. Instead, the "acceptance criteria" are implied to be that the new device performs similarly or better than the predicate device across various performance aspects, and that the addition of new materials does not negatively affect safety and effectiveness. The reported performance is a statement of substantial equivalence across these performance areas.

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Integrity	Demonstrated similar or better mechanical integrity than predicate.	Performance tests were performed to demonstrate substantial equivalence to the currently marketed COBE® Sentry® 43 Micron Arterial Filter with PrimeGard®. (Implies satisfactory mechanical integrity).
Air Challenge	Demonstrated similar or better air removal capability than predicate.	Performance tests were performed to demonstrate substantial equivalence... (Implies satisfactory air challenge performance).
Pressure Drop	Demonstrated similar or acceptable pressure drop compared to predicate.	Performance tests were performed to demonstrate substantial equivalence... (Implies acceptable pressure drop).
Blood Trauma	Demonstrated similar or less blood trauma (platelet reduction, WBC reduction, plasma free hemoglobin) than predicate.	Performance tests were performed to demonstrate substantial equivalence... (Implies acceptable levels of blood trauma, or an improvement). In-vitro testing also performed to demonstrate improved blood compatibility.
Filtration Efficiency	Demonstrated similar or better filtration efficiency than predicate.	Performance tests were performed to demonstrate substantial equivalence... (Implies satisfactory filtration efficiency).
Ease of Prime	Demonstrated similar or improved ease of priming compared to predicate.	Performance tests were performed to demonstrate substantial equivalence... (Implies satisfactory ease of prime, potentially enhanced by PrimeGard®).
Priming Volume	Demonstrated similar or acceptable priming volume compared to predicate.	Performance tests were performed to demonstrate substantial equivalence... (Implies acceptable priming volume compared to predicate, and that the new material did not adversely impact it).
Biocompatibility	Demonstrated equivalent or improved biocompatibility.	Biocompatibility tests were performed to demonstrate substantial equivalence. In-vitro testing was also performed to demonstrate improved blood compatibility of the materials containing the surface modifying additives. (This is a key improvement over the predicate device).

2. Sample Size for Test Set and Data Provenance

The document does not specify the sample sizes used for any of the performance or biocompatibility tests. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective). This level of detail is typically found in the full study reports, which are not included in this 510(k) summary.

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

This information is not provided. The assessment appears to be based on objective performance measurements rather than subjective expert ratings.

4. Adjudication Method

This information is not provided. Given the nature of the performance tests (e.g., mechanical integrity, blood trauma), an adjudication method as typically described for diagnostic imaging studies (e.g., 2+1 radiologist consensus) would not be applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices where human readers interpret outputs, not for a filtering device like this arterial filter.

6. Standalone Performance Study

The document describes performance tests for the device itself (e.g., mechanical integrity, filtration efficiency, blood trauma). This can be considered a form of standalone performance study as it evaluates the algorithm/device's performance without a human-in-the-loop for interpretation. The "algorithm" in this case is the physical design and material properties of the filter.

7. Type of Ground Truth Used

The "ground truth" for the tests described would be based on objective measurements and laboratory standards. For example:

Mechanical Integrity: Measured against engineering specifications and industry standards for filter strength and durability.
Air Challenge: Measured air removal efficiency.
Pressure Drop: Measured pressure differential across the filter at specified flow rates.
Blood Trauma: Measured reductions in platelet and white blood cell counts, and quantification of plasma free hemoglobin using laboratory assays.
Filtration Efficiency: Measured particle removal efficiency.
Biocompatibility: Assessed using standardized in-vitro tests for compatibility with blood and tissues (e.g., cytotoxicity, hemolysis, complement activation, thrombogenicity).

8. Sample Size for the Training Set

The concept of a "training set" is not applicable to this device. This is a physical medical device, not an AI or machine learning algorithm that requires a training set of data.

9. How Ground Truth for the Training Set Was Established

As the concept of a training set is not applicable, this information is not relevant.

Summary

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SEP 1 0 1998

510(k) Pre-Market Notification: COBE®Sentry® SMART™ 43 Micron Arterial Filter with PrimeGard® 18

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:	June 25, 1998
DEVICE TRADE NAME:	COBE® Sentry® SMART TM 43 Micron Arterial Filter with PrimeGard®
COMMON/USUAL NAME:	Arterial Filter
CLASSIFICATION NAMES:	Cardiopulmonary Bypass Arterial Line Blood Filter
PREDICATE DEVICE:	COBE® Sentry® 43 Micron Arterial Filter with PrimeGard®

DEVICE DESCRIPTION:

INDICATIONS FOR USE

The COBE® Sentry® SMAR,T™ 43 Micron Arterial Filter with PrimeGard® is indicated for use in the arterial line of an extracorporeal circuit during cardiopulmonary bypass procedures, for periods of up to six hours.

STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON

The COBE® Sentry® SMAR, TM 43 Micron Arterial Filter with PrimeGard® has the same intended use as currently marketed COBE® Sentry® 43 Micron Arterial Filter with PrimeGard®. The primary difference is that the COBE® Sentry® SMAR, T™ 43 Micron Arterial Filter with PrimeGard® contains non-leaching, surface modifying additives that are added to the device to improve blood compatibility.

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Biocompatibility and performance tests were performed to demonstrate that the COBE® Sentry® SMAR TT™ 43 Micron Arterial Filter with PrimeGard® is substantially equivalent to the currently marketed COBE® Sentry® SMAR T™ 43 Micron Arterial Filter with PrimeGard®

Performance testing consisted of:

1. Mechanical Integrity
1. Air Challenge
Pressure Drop 3.
Blood Trauma (including platelet reduction, white blood cell reduction, and plasma free ধ: hemoglobin generation)
1. Filtration Efficiency
1. Ease of Prime
1. Priming Volume

In-vitro testing was also performed to demonstrate improved blood compatibility of the materials containing the surface modifying additives.

These data support that the COBE® Sentry® SMAR JT™ 43 Micron Arterial Filter with PrimeGard® is substantially equivalent to the currently marketed COBE® Sentry® 43 Micron Arterial Filter with PrimeGard®, and that the addition of the surface-modifying materials does not affect safety and effectiveness.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 1998

Ms. Lynne Leonard Manager, Requlatory Submissions COBE Cardiovascular, Inc. 14401 West 65th Way Arvada, CO 80004-3599

Re : K982254 COBE® Sentry® SMAR,T™ 43 Micron Arterial Filter with PrimeGuard® Requlatory Class: III (three) Product Code: DTM Dated: June 25, 1998 Received: June 26, 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 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 requlations 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 Register. Please note: this

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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.

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, 2Misbranding by reference to premarket notification? (21CFR 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. Callahon

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

Enclosure

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Indications For Use

K 98 225 510(k) Number (If known): __

COBE® Sentry® SMAR TTM 43 Micron Arterial Filter with PrimeGard® Device Name:

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Berta O. Lemperle

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices ್ರಿ ಇತ್ತಿ ಮ 510(k) Number _

Prescription Use
(Per 21 CFR 801.109) ✗

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 870.4260 Cardiopulmonary bypass arterial line blood filter.

(a)
Identification. A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions.”