Dade Behring BFTII is a semi-automated opto-mechanical coagulation analyzer. The BFTII is used in conjunction with coagulation reagents for measurement of various coagulometric tests.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Dade Behring BFTII, based on the provided 510(k) notification:

This document focuses on a medical device, not an AI algorithm. Therefore, many of the requested fields pertinent to AI studies (like MRMC effectiveness, training set details, or ground truth establishment for a training set) are not applicable or directly derivable from this type of submission. The study described is a performance comparison of a new medical device against legally marketed predicate devices, not an AI efficacy study.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly list "acceptance criteria" in the traditional sense of a specified threshold for performance metrics. Instead, it claims substantial equivalence to existing legally marketed devices (Dade Behring BCT and CA-6000) based on similar intended use and results obtained through quantitative measurement of coagulometric tests via optical clot detection.

The comparison information provided is summarized conceptually as:

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance (BFTII)
Intended Use	Substantially equivalent to BCT & CA-6000	Intended for use to determine PT, aPTT, and Fibrinogen (Same as predicates)
Measurement Method	Substantially equivalent to BCT & CA-6000	Performs quantitative measurement of coagulometric tests by optical clot detection (Same as predicates)
Results Obtained	Substantially equivalent to BCT & CA-6000	(Implied to be comparable, specific data not provided in summary)

Note: The 510(k) summary is a high-level overview. Detailed performance data (e.g., precision, accuracy, correlation with predicate devices) would be found in the full 510(k) submission, which is not fully provided here. The summary focuses on stating the basis for substantial equivalence rather than presenting raw performance numbers against pre-defined thresholds.

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

The provided 510(k) summary does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This information would typically be in the detailed performance data submitted to the FDA, but it's not included in this summary.

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

This information is not applicable in the context of this device and submission. The BFTII is an automated laboratory analyzer. Its "ground truth" for PT, aPTT, and Fibrinogen measurements would be established through comparison with reference methods or existing validated devices, often involving statistical analysis of quantitative results, not expert consensus on image interpretation or clinical diagnoses.

4. Adjudication Method for the Test Set

This is not applicable as the device performs quantitative measurements, not subjective interpretation requiring human adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

This is not applicable. The BFTII is a semi-automated coagulation analyzer and does not involve human readers for interpretation in the way an imaging AI algorithm would. Therefore, an MRMC study is not relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device itself is a "standalone" instrument in that it performs the measurements automatically. The performance study would have focused on the accuracy, precision, and comparability of its quantitative output to predicate devices or reference methods. It's a device, not an AI algorithm, so the term "standalone algorithm performance" doesn't directly apply in the AI sense. Its performance is intrinsically "standalone" in its operation.

7. The Type of Ground Truth Used

For a coagulation analyzer, the "ground truth" would typically be established through:

Comparison to a gold standard or reference method: Highly accurate laboratory assays known for their reliability.
Comparison to legally marketed predicate devices: As implied by the substantial equivalence claim. This involves running the same patient samples on both the new device and the predicate(s) and comparing the quantitative results statistically (e.g., correlation, bias, agreement).

The summary implies the ground truth for comparison was established via results obtained from legally marketed predicate devices (Dade Behring BCT and CA-6000) for coagulometric tests.

8. The Sample Size for the Training Set

This is not applicable. The BFTII is a hardware and software system for performing specific laboratory tests, not a machine learning model that undergoes a "training phase" with a labeled dataset in the AI sense. Its design and calibration would follow engineering, chemistry, and metrology principles, not AI training paradigms.

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

This is not applicable for the same reasons as point 8. The device is not an AI algorithm that learns from data.

Summary

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Dade Behring Inc. Dade Behring BFTII 510(k) Notification

84501

JUL 28 1999

510(k) Summary For Dade Behring BFTII

Manufactures Name, Address, Telephone, and Contact Person, Date of 1. Preparation:

Manufacturer:

Contact Information:

Dade Behring Marburg GmbH Emil-von-Behring Str. 76 Marburg/Germany

Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Rebecca S. Ayash Tel: 302-631-6276

Preparation date:

June 29, 1999

2. Device Name/ Classification:

Dade Behring Fibrintimer II (BFTII): Classification Number:

Multipurpose system for in vitro coagulation studies Class II (864.5425)

3. Identification of the Legally Marketed Device:

Behring Coagulation Timer & CA-6000

4. Device Description:

Dade Behring BFTII is a semi-automated opto-mechanical coagulation analyzer. The BFTII is used in conjunction with coagulation reagents for measurement of various coagulometric tests.

5. Device Intended Use:

The Dade Behring Fibrintimer II (BFTII) is a semi-automated device intended for use to determine PT, aPTT, and Fibrinogen.

6. Medical device to which equivalence is claimed and comparison information:

There are a number of multipurpose systems for in vitro coagulation studies. Two such products are the Dade Behring BCT, K955278 and CA-6000, K964139. The BFTII is substantially equivalent in intended use and results obtained to both the BCT and CA-6000. The BFTII, like the BCT and CA-6000, performs quantitative measurement of coagulometric tests by optical clot detection.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. Above the caduceus, the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern. The text is in all caps and appears to be in a sans-serif font.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 28 1999

Ms. Rebecca S. Ayash Manager, Regulatory and Biology Dade Behring, Inc. Glasgow Building 500, Mailbox 514 P.O. Box 6101 Newark, Delaware 19714-6101

Re: K984501 Trade Name: Dade Behring BFTII Regulatory Class: II Product Code: JPA Dated: May 12, 1998 Received: May 13, 1998

Dear Ms. Ayash:

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 Regulations, 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 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

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) 594-4588. 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,

Steven Sutman

Steven I. Gutman, M.D. M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Dade Behring Inc. Dade Behring BFTII 510(k) Notification

Indications Statement

Device Name:

Dade Behring BFTII

Indications for Use:

The Dade Behring BFTII is a semi-automated device intended for use to determine PT, a
nd and will to aPTT, and Fibrinogen.

Peter E. Machin

(Dion S.
Di of ratory Devices K984501
510(k) Number

(Please do not WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter-Use_ (Optional Format 1-2-96)

000018

Regulation Number and Section

§ 864.5425 Multipurpose system for in vitro coagulation studies.

(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.