MDA® Simplastin® HTF is a tissue thromboplastin reagent derived from cultured human cells for use in determination of the prothrombin time (PT) in human plasma.

Device Description

Tissue Thromboplastin reagent for use in determination of the prothrombin (PT) in human plasma.

AI/ML Overview

This document does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically found for AI/ML medical devices. This is a 510(k) summary from 1998 for a laboratory reagent (MDA® Simplastin® HTF), which is a device type significantly different from modern AI/ML devices. Therefore, many of the requested categories are not applicable.

However, I can extract the information provided regarding the device's performance and the studies conducted to demonstrate substantial equivalence to a predicate device, as required for a traditional 510(k).

Here's a breakdown based on the provided text, indicating where information is not applicable (N/A) for this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for a laboratory reagent and not an AI/ML device, explicit numerically defined "acceptance criteria" and "reported device performance" in the typical sense of metrics like sensitivity, specificity, or AUC are not presented in this summary. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device through various performance characteristics.

The table below summarizes the key performance characteristics and comparisons mentioned:

Performance Characteristic	MDA® Simplastin® HTF (New Device)	Ortho RecombiPlasTin® (Predicate Device)	Study to Demonstrate Equivalence
Normal Patient Mean	12.1 seconds	11.7 seconds	Prothrombin Time method comparison with clinical specimens
Precision	Demonstrated	N/A (implied acceptable for predicate)	Precision studies on three levels of plasma controls; normal, borderline abnormal, and coumadin plasma pools
INR Values	Demonstrated equivalence to predicate	N/A (implied acceptable for predicate)	INR method comparisons with clinical specimens
Factor II, V, VII, X	Demonstrated equivalence to predicate	N/A (implied acceptable for predicate)	Factor II,V,VII and X method comparison with clinical specimens
Interference	Demonstrated acceptable performance	N/A (implied acceptable for predicate)	Interference studies on lipemic, icteric and hemolyzed samples
Reference Ranges	Established for normal plasma pool	N/A (implied acceptable for predicate)	Reference ranges on normal plasma pool
Heparin Tolerance	Evaluated	N/A (implied acceptable for predicate)	Heparin tolerance evaluation utilizing heparin spiked plasma samples
Open Vial Stability	Demonstrated	N/A (implied acceptable for predicate)	Open vial stability studies
Safety and Efficacy	Supported by precision, interference, normal donor, and stability data	N/A (implied acceptable for predicate)	Nonclinical and clinical tests
Substantial Equivalence	Demonstrated to predicate device	N/A	All comparison studies (PT, INR, Factor comparisons)

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

Sample Size: The document does not specify exact sample sizes for the "test set" (clinical specimens). It mentions "clinical specimens" were used for method comparisons (PT, INR, Factor comparisons), precision studies (on plasma pools), and interference studies (on lipemic, icteric, hemolyzed samples). Without specific numbers, it's impossible to quantify.
Data Provenance: Not explicitly stated (e.g., country of origin). The studies involved "clinical specimens," suggesting real-world human plasma samples. Given the submitter's address in North Carolina, USA, it's highly probable the data originated from the USA.
Retrospective or Prospective: Not explicitly stated. The nature of the "method comparison" and "precision studies" could allow for either retrospective analysis of banked samples or prospective collection. However, for a device of this type and era, prospective studies involving fresh samples would be common for some elements like reference range determination.

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

Number of Experts: N/A. For a laboratory reagent determining prothrombin time (PT), the "ground truth" is typically established by measurements from an established, reference method or the predicate device itself, not by expert interpretation of images or clinical data. There is no mention of experts establishing a ground truth in this context.
Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

Adjudication Method: N/A. This concept is not applicable to a laboratory reagent that provides a quantitative measurement. The "ground truth" (or reference standard) would be the result from another lab method.

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

MRMC Study: No. This type of study is specific to AI/ML devices that assist human interpretation (e.g., radiologists reading images). This device is a laboratory reagent.
Effect Size of Human Readers with/without AI: N/A.

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

Standalone Performance: Not applicable in the context of an AI/ML algorithm. The "performance" of this device is its standalone ability to accurately measure prothrombin time, which was demonstrated through precision, accuracy (vs predicate), and interference studies.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for this device would be the results obtained from a legally marketed predicate device (Ortho RecombiPlasTin® Reagent) or other established, reference prothrombin time methods, against which the new device's measurements were compared (e.g., "Prothrombin Time method comparison," "INR method comparisons," "Factor II,V,VII and X method comparison").

8. The Sample Size for the Training Set

Training Set Sample Size: N/A. This device is not an AI/ML algorithm that requires a "training set" in the computational sense. Its performance is based on the chemical and enzymatic reactions of the reagent itself.

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

Ground Truth for Training Set: N/A, as there is no training set for this type of device.

Summary

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K974566

510(k) Premarket Notification Organon Teknika Corporation MDA® Simplastin® HTF

FEB 24 1908

510(k) Summary MDA@Simplastin® HTF

The submitter's name, address, telephone number, a contact person, and the date the (a)(1) summary was prepared;

Submitter's Name: Organon Teknika Corporation

Submitter's Address: 100 Akzo Avenue, Durham, North Carolina, 27712 USA

Submitter's Telephone: (919) 620-2288

Submitter's Contact: Rebecca Rivas

Date 510(k) Summary Prepared: 12/4/97

The name of the device, including the trade or proprietary name if applicable, the (a)(2) common or usual name, and the classification name, if known;

Trade or Proprietary Name: MDA®Simplastin® HTF

Common or Usual Name: Thromboplastin reagent

Classification Name: Prothrombin time test

An identification of the legally marketed device to which the submitter claims (a)(3) substantial equivalence;

Device Equivalent to: Ortho RecombiPlasTin® Reagent

A description of the device. (a)(4)

Device Description: Tissue Thromboplastin reagent for use in determination of the prothrombin (PT) in human plasma.

(a)(5) A statement of the intended use of the device.

Device Intended Use: Determination of the prothrombin time (PT) in human plasma.

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510(k) Premarket Notification Organon Teknika Corporation MDA® Simplastin® HTF

A summary of the technological characteristics of the new device in comparison to (a)(6) those of the predicate device.

Assay Feature	MDA®Simplastin® HTF	OrthoRecombiPlasTin®
Thromboplastin Source	Cultured Human Cells	Recombinant HumanTissue Factor
Intended Use	Determination ofProthrombin time inhuman plasma	Determination ofProthrombin time in humanplasma
Samples	Anticoagulated Plasma	AnticoagulatedPlasma
Technology	Clot formation	Clot formation
Normal Patient Mean(sec.)	12.1 seconds	11.7 second
Preservative	Nitrobromodioxide	Sodium Azide
Controls	Routine Coagulation	Routine Coagulation

A brief discussion of the nonclinical tests submitted, referenced, or relied on in the (b)1) premarket notification submission for a determination of substantial equivalency.

Testing was performed to establish the performance characteristics of the new device including: Precision studies on three levels of plasma controls, and open vial stability studies.

A brief discussion of the clinical tests submitted, referenced, or relied on in the (b)(2) premarket notification submission for a determination of substantial equivalency.

Testing was performed to establish the performance characteristics and substantial equivalence of the new device including: Prothrombin Time method comparison; INR method comparisons; Factor II,V,VII and X method comparison; precision studies on normal plasma pool, borderline abnormal plasma pool and coumadin plasma pool; interference studies on lipemic, icteric and hemolyzed samples; reference ranges on normal plasma pool; and heparin tolerance evaluation utilizing heparin spiked plasma samples.

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510(k) Premarket Notification Organon Teknika Corporation MDA® Simplastin® HTF

The conclusions drawn from the nonclinical and clinical tests that demonstrate that the (b)3) device is as safe, as effective, and performed as well or better than the legally marketed device identified in (a)(3).

The data shown in this submission supports:

The safety and efficacy of MDA® Simplastin® HTF through the following studies: 1. precision studies on controls and clinical specimens, interference studies utilizing clinical specimens, normal donor reference range and open vial stability data.
Substantial equivalence to the predicate device Ortho RecombiPlasTin® through the 2. following studies: method comparisons for Prothrombin times, INR values; Factor II; Factor V; Factor VII; and Factor X all utilizing clinical specimens.

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Image /page/3/Picture/10 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle's head and neck, formed by three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 2 4 1998

Rebecca A. Rivas Requlatory Affairs Organon Teknika Corporation 100 Akzo Avenue Durham, North Carolina 27712

Re : K974566 MDA® Simplastin® HTF Requlatory Class: II Product Code : ... GJS ... ... Dated: December 4, 1997 December 5, 1997 Received:

Dear Ms. Rivas:

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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 In addition, FDA may publish further announcements action. 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/dsmamain.html".

Sincerely yours,
Steven Sitman

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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510(k) Premarket Notification Organon Teknika Corporation MDA® Simplastin® HT

510(k) Number (If known): <994566

Device Name: MDA®SinplastiN® HTF

Indications For Use:

MDA® Simplastin® HTF is a tissue thromboplastin reagent derived from cultured human cells for use in determination of the prothrombin time (PT) in human plasma.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Clinical Lab 510(k) Number Over-The-Counter OR Prescription Use v Use (Per 21 CFR 801.109) (Optional Format 1-2-96)

018

Regulation Number and Section

§ 864.7750 Prothrombin time test.

(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).