The Dade® PFA-100® Platelet Function Analyzer and associated reagents are in vitro diagnostic devices intended to aid in the detection of platelet dysfunction in citrated human whole blood.

To aid in the detection of platelet dysfunction in citrated human whole blood.

Device Description

The PFA-100® system provides a tool for clinicians to use in the detection of platelet dysfunction induced by intrinsic platelet defects, von Willebrand factor (vWF) functional deficiencies, or exposure to platelet inhibiting agents. The PFA-100® system simulates, under high shear stress, the interaction of platelets with an injured blood vessel. These conditions allow the PFA-100® system to measure in vitro platelet function as related to primary hemostasis.

AI/ML Overview

This 510(k) summary (K060489) for the Dade® PFA-100® Platelet Function Analyzer and Reagents primarily references existing literature to demonstrate performance, rather than presenting a single, dedicated device performance study with specific acceptance criteria. This is common for submissions claiming substantial equivalence to an already marketed device (K970505 and K002885).

Therefore, the acceptance criteria are not explicitly stated in a quantitative form with pass/fail thresholds for the new device itself. Instead, the submission uses existing studies to show that the device performs similarly to or confirms known clinical observations related to platelet function.

Here's an attempt to extract the requested information based on the provided text, acknowledging that some details are inferred or not explicitly stated for a "new device" performance study but rather for established device performance:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the acceptance criteria are not explicitly defined for a new device study. Instead, the performance is demonstrated through studies showing the PFA-100's ability to detect platelet dysfunction and assess DDAVP treatment, with specific sensitivity, specificity, and efficiency values reported for various conditions. These values, derived from previously published studies, implicitly serve as the "performance" against which the device's utility is being demonstrated.

Criterion Type (Implicit)	Acceptance Criteria (Implicit)	Reported Device Performance (from cited studies)
Detection of Platelet Defects (Cariappa et al.)	PFA-100 should show good sensitivity and specificity in detecting platelet defects.	CEPI: Sensitivity = 100%, Specificity = 97%, Efficiency = 98%CADP: Sensitivity = 87%, Specificity = 80%, Efficiency = 83%
Detection of VWD (Cariappa et al.)	PFA-100 should show good sensitivity and efficiency in detecting von Willebrand Disease (VWD).	CEPI: Sensitivity = 100%, Efficiency = 98%CADP: Sensitivity = 80%, Efficiency = 80%
Pediatric Patient Performance (Lippi et al.)	PFA CT for CEPI and CADP in pediatric patients should not be significantly different from normal adults.	PFA CT for CEPI and CADP not different in pediatric patients and normal adults.
DDAVP Treatment Assessment (Fressinaud et al., Koscielny et al.)	PFA CT should normalize in VWD Type I patients after DDAVP infusion. PFA should indicate improved hemostasis post-DDAVP.	PFA CT normalized in 23 Type I patients after DDAVP infusion.PFA CTs normalized in 229 patients after DDAVP.
General Impaired Hemostasis Detection (Koscielny et al.)	PFA Col/EPI CTs should be prolonged in a high percentage of patients with impaired hemostasis.	PFA Col/EPI CTs were prolonged in 250 of 256 (97.7%) patients with impaired hemostasis.

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

The submission references multiple studies, each with its own sample size and provenance:

Cariappa et al.: 52 patients. Data provenance not specified (retrospective/prospective, country).
Lippi et al.: 52 patients. Data provenance not specified (retrospective/prospective, country).
Fressinaud et al.: 41 patients (23 VWD Type I). Data provenance not specified (retrospective/prospective, country).
Koscielny et al. (First Entry): 5649 patients. Data provenance not specified (retrospective/prospective, country).
Koscielny et al. (Second Entry):
- 256 impaired hemostasis in prospective study.
- 5102 (317 impaired hemostasis) in retrospective study.
- Combined total of 5649 patients in the overarching study.
- Data provenance not specified for country of origin, but study design (prospective/retrospective) is mentioned for parts of it.

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

The provided text does not contain any information regarding the number of experts or their qualifications used to establish ground truth for the cited studies. The "ground truth" was established using a combination of other diagnostic assays and clinical outcomes (e.g., bleeding history, aggregometry, bleeding time, VWF assays, PT, aPTT, FVIII activity, RIPA, VWF multimers, pathology for VWD/platelet defects, and observation of DDAVP treatment response).

4. Adjudication Method for the Test Set

The provided text does not contain any information on adjudication methods for establishing ground truth in the cited studies. Given the nature of the studies (often using multiple clinical and laboratory assessments to reach a diagnosis), it's likely a form of comprehensive clinical diagnosis rather than a single adjudication process for an AI model.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on human readers improving with AI vs. without AI assistance was not done or reported in this submission. The PFA-100 is an automated diagnostic device, not an AI-assisted interpretation tool for human readers in the context of what an MRMC study typically assesses for AI.

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

Yes, the performance reported for the PFA-100 system is standalone performance. The PFA-100 is an automated instrument that directly measures platelet function and provides quantitative results (Closure Times). The "device performance characteristics" section describes the output solely based on the device's measurements in various clinical scenarios, without human-in-the-loop interaction in generating the primary analytical results.

7. The Type of Ground Truth Used

The ground truth for the cited studies was established using a combination of clinical diagnoses, other laboratory assays, and observed patient outcomes/responses to treatment.

Examples include:

Clinical diagnosis of platelet defects or VWD: Based on bleeding history and a battery of tests (bleeding time, aggregometry, platelet count, PT, aPTT, VWF assays, VWF:Ag, VWF:RCo, FVIII activity, RIPA, VWF multimers, flow cytometry).
Response to DDAVP treatment: Normalization of PFA CTs and assessment of blood usage.
Impaired hemostasis: Based on clinical picture and a range of diagnostic tests.

8. The Sample Size for the Training Set

The device is a PFA-100 instrument and reagents, which functions based on physical principles (simulating shear stress and platelet-collagen interaction), not a machine learning or AI algorithm that typically requires a "training set" in the presented context. Therefore, the concept of a "training set sample size" as used for AI/ML development does not apply here. The device's operational parameters and reagents are developed through R&D and calibration rather than typical machine learning training.

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

As explained above, since this is not an AI/ML device, the concept of a "training set" and establishing "ground truth for a training set" in that specific context is not applicable. The device's design and calibration would have been based on established hematological principles and empirical testing to ensure accurate and reproducible measurement of platelet function.

Summary

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Kα60489

JUL 2 1 2006

510(k) Summary Dade® PFA-100® Platelet Function Analyzer Dade® PFA-100® Reagents

Manufacturer's Name, Address, Telephone, and Contact Person, 1. Date of Preparation:

Manufacturer:	Dade Behring Marburg GmbHEmil-von-Behring Str. 7635041 Marburg, Germany
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Contact Information:	Dade Behring Inc.P.O. Box 6101Newark, Delaware 19714Attn: Radames RiesgoTel: 305.480.7558
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Preparation date: July 11. 2006

2. Device Name/ Classification:

Dade® PFA-100® Platelet Function Analyzer and Dade® PFA-100® Reagents / Automated platelet aggregation systems, Class II (21 CFR § 864.5700)

3. ldentification of the Legally Marketed Device:

Dade® PFA-100® Platelet Function Analyzer (K970505 and K002885)

4. Device Description:

5. Device Intended Use:

The Dade® PFA-100® Platelet Function Analyzer and associated reagents are in vitro diagnostic devices intended to aid in the detection of platelet dysfunction in citrated human whole blood.

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

The modified Dade® PFA-100® system is substantially equivalent in intended use and performance to the currently marketed Dade® PFA-1008 system.

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7. Device Performance Characteristics:

Different studies conducted by independent organizations have shown results that suggest good performance of the system when testing pediatric populations and good assessment of DDAVP treatment.

A summary of the different studies used in support of this submission is included in this section.

Summary of New Literature Demonstrating PFA-100 System Performance in Pediatric Populations

Attachment	Reference	Assay Used	Diagnosis	Results	No. ofpatients instudy
4	Cariappa etal.	• Bleeding history• Bleeding time• Aggregometry• Platelet count• PT• aPTT• VWF assays• Repeat testingafter drugdiscontinuation• PFA-100	• Plateletdefects	PFA:• Sensitivityo CEPI = 100%o CADP = 87%• Specificityo CEPI = 97%o CADP = 80%• Efficiencyo CEPI = 98%o CADP = 83%	52
			• VWD	• Sensitivityo CEPI = 100%o CADP = 80%• Efficiencyo CEPI = 98%o CADP = 80%
5	Lippi et al.	• VWF:Ag• PFA-100	• Normalplateletfunction	PFA CT for CEPIand CADP notdifferent inpediatric patientsand normal adults	52
Attachment	Reference	Assay Used	Therapy	Diagnosis	Results	No. ofpatients instudy
6	Fressinaudet al.	• Bleedinghistory• Bleeding time• Platelet count• VWF:Ag• VWF:RCo• FVIII activity• RIPA• VWFmultimers• PFA-100	• DDAVP• VWFconcent.	CongenitalVWD	PFA CTnormalized in 23Type I patientsafter DDAVPinfusion	41(23 VWDType I)
7	Koscielnyet al.	• Platelet count• PT• APTT• PFA-100• Bleeding time• VWF:Ag• Aggregometry• Flow cytometry	None	• VWD• Aspirin-inducedplateletdefect• Otherplateletdefects	PFA Col/EPICTs wereprolonged in 250of 256 (97.7%)patients withimpairedhemostasis	5649
8	Koscielnyet al.	• Platelet count• PT• APTT• PFA-100• Bleeding time• VWF:Ag• Aggregometry• Flow cytometry	• DDAVP	• VWD• Aspirin-inducedplateletdefect• Otherplateletdefects	• PFA CTsnormalized in229 patientsafter DDAVP• Blood usagesame inpatients afterDDAVP andthose withnormalhemostasis	5649 (256impairedhemostasisinprospectivestudy)
			• None		• Blood usage8X higher inpatients withuntreatedabnormalhemostasisthan in thosewith normalhemostasis	5102 (317impairedhemostasisinretrospectivestudy)

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Summary of Literature Demonstrating PFA-100 System

Performance in Management of Bleeding Disorders

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Food and Druq Administration 2098 Gaither Road Rockville MD 20850

JUL 2 1 2006

Dade Behring, Inc c/o Radames Riesgo Regulatory Affairs & Compliance Manager Bldg 500, Mail Box 514 P.O. Box 6101 Newark, DE 19714-6101

Re: K060489

Trade/Device Name: Dade® PFA-100® Platelet Function Analyzer Dade® PFA-100® Reagents Regulation Number: 21 CFR 864.5700 Regulation Name: Automated Platelet Aggregation System Regulatory Class: Class II Product Code: JOZ Dated: 23 February 2006 Received: 24 February 2006

Dear Mr. Riesgo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter

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will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Robert H. Roffey

Robert L. Becker, Jr., MD, PhD Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K060489

Dade® PFA-100® Platelet Function Analyzer Device Name: Dade® PFA-100® Reagents

Indications for Use:

To aid in the detection of platelet dysfunction in citrated human whole blood.

V Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Peter H. Ractery

Session Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

660487

Regulation Number and Section

§ 864.5700 Automated platelet aggregation system.

(a)
Identification. An automated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet-rich plasma.(b)
Classification. Class II (performance standards).