POTENS+ is an in vitro medical device to determine the coagulation profile of citrated human plasma specimens to be used by a medical professional in a laboratory setting. This profile includes Prothrombin Time (PT) derived Fibrinogen (FBG), and the International Normalization Ratio (INR).

Prothrombin Time is used to determine the status of the extrinsic clotting pathway for Clotting Factors I, II, V, VII and X, and to assist in monitoring oral anticoagulants.

Fibrinogen is used to diagnose disseminated intravascular coagulation (DIC), as a representation of acute disease - part of the "acute phase response," and it is an independent risk variable in heart attack and stroke prediction.

INR is used to monitor the patients receiving anticoagulation therapy.

Device Description

Semi-automated system for in vitro coagulation studies, clot based and photo-optical.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the POTENS+ device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a tabular format. Instead, it describes performance characteristics that demonstrated substantial equivalence to predicate devices. The key performance metrics are correlation coefficients (r-values) and precision (Coefficient of Variation - CVs).

Performance Metric	Acceptance Criteria (from predicate equivalence)	Reported Device Performance (POTENS+)
Correlation Coefficients (r-values)
Fibrinogen	Not explicitly stated as acceptance criteria, but predicate equivalence was shown for values ≥ 0.973 (based on reported range)	0.973 to 0.980
PT	Not explicitly stated, but predicate equivalence was shown for values ≥ 0.95 (based on reported range)	0.95 to 0.974
INR	Not explicitly stated, but predicate equivalence was shown for values ≥ 0.919 (based on reported range)	0.919 to 0.963
Precision (Coefficient of Variation - CV)
Fibrinogen	NCCLS recommendations (CVs < 6%)	< 6%
PT	NCCLS recommendations (CVs < 5%)	< 5%
INR	NCCLS recommendations (CVs < 8%)	< 8%

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

Sample Size for Test Set: The document states that a "comparison study was conducted using patient specimens over the normal, diagnostic, and therapeutic range." It does not specify the exact number of patient specimens used.
Data Provenance: The data comes from "patient specimens," implying clinical samples. The country of origin is not specified, but the submission is to the FDA (USA), suggesting it could be US-based, although not explicitly stated. The study was prospective in the sense that it was conducted specifically for this submission, comparing the new device to predicate devices.

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

The document does not mention the use of experts to establish ground truth for the test set. The ground truth appears to be established by the predicate devices (Organon Tecknika Coag-A-Mate MTX for Fibrinogen and Organon Tecknika MDA-180 for PT & INR) and "commercially available methods/products."

4. Adjudication Method for the Test Set:

No adjudication method is mentioned. The comparison was directly between the POTENS+ device results and those from the predicate devices using patient specimens.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) system for laboratory analysis, not an imaging device or system that requires human interpretation in the same way. Therefore, the concept of "human readers" and "AI assistance" in the context of an MRMC study is not applicable here.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop):

Yes, a standalone performance study was done. The entire submission focuses on the performance of the POTENS+ device itself (the "algorithm only") in comparison to predicate devices, without human-in-the-loop performance considerations for its core function.

7. Type of Ground Truth Used:

The ground truth used was primarily:

Predicate device results: The results obtained from the legally marketed predicate devices (Organon Tecknika Coag-A-Mate MTX for Fibrinogen and MDA-180 for PT & INR) were used as the reference standard for comparison.
Commercially available methods/products: The text also states that equivalence was demonstrated using "commercially available methods/product along with patient specimens."

8. Sample Size for the Training Set:

The document does not mention a "training set" or "training data" as it typically would for machine learning algorithms. The POTENS+ device is described as a semi-automated system for in-vitro coagulation studies using clot-based and photo-optical methodologies, not an AI/ML-driven device in the modern sense that requires a separate training phase with a distinct dataset. The "training" in this context would likely refer to internal calibration and factory settings, not data-driven learning.

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

As no specific "training set" is described for an AI/ML model, the concept of establishing ground truth for it is not applicable directly from this document. The device's operation is based on established scientific principles of coagulation assays, and its accuracy is validated against existing, proven methods and devices.

Summary

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DEC - 8 2003

K033137

510(k) SUMMARY Section D. Section D.

POTENS+

This summary of safety and effectiveness information is being submitted in accordance with the requirement of SMDA 1990 and the final rule under 21 CFR 807.92 published December 14, 1994.

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

Submitter's Name: WADA, Inc

Submitter's Address: 1556 San Leandro Lane, Montecito, CA 93108

Submitter's Telephone: 805-969-2758

Submitter's Contact: Gail Rodrick-Highberg (510-792-1527)

Date 510(k) Summary Prepared: September 19, 2003

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

Trade or Proprietary Name: POTENS+

Common or usual Name: Multipurpose System for In Vitro Coagulation Studies:

Classification Name: Multipurpose System for In Vitro Coagulation Studies.

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

Device equivalent to:

Organon Tecknika Coag-A-Mate MTX (K962857) for Fibrinogen Organon Tecknika MDA-180 (K924453) for PT & INR

(a)(4) A description of the device

Device description: Semi-automated system for in vitro coagulation studies, clot based and photo-optical.

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

Device Intended Use: POTENS+ is a multipurpose system for use in performing clot based, photo-optical in-vitro coagulation studies including Prothrombin Time (PT) derived Fibrinogen (FBG), and the International Normalization Ratio (INR).

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

POTENS+. MTX and MDA-180 are multipurpose systems capable of performing in-vitro coagulation studies; all three perform clot-based assays.

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Table 1 below outlines the similarities/differences between the POTENS+, MTX and MDA-180.

Table 1

	POTENS+(Test Device)	CAM-MTX(Predicate Device)	MDA-180(Predicate Device)
Analytes	PT, FBG and INR	FBG	PT, FBG and INR
Methodology	Fibrin Clot based assay;optical measurement ofdirect light transmissionduring clot formation.	Clauss method: Fibrin Clotbased assay; opticalmeasurement of relativelight transmission to thetime of clot formation.	Clauss method: Fibrin Clotbased assay; opticalmeasurement of relativelight transmission to thetime of clot formation.
Instrumentsystem	Potentiophotometer ,Reagent Dispenser,Pipettor, Heating block,computer and printer	Analyzer (measuring rotorand photometer), computerand printer	Multi-Channel DiscreteAnalyzer
Principles ofoperation	Detects change in lighttransmittance at 660nm	Detects change in lighttransmittance at 405 nm	Detects change in lighttransmittance in thespectral range 405 to 710nm.FBG @ 425 nmPT @ 580 nm
Method ofDetection	Optical (LED with siliconphotovoltaic cell)	Optical using a photometerand detectors	Optical (tungsten lamp)using photodiode detectors
SignalProcessing	Linear handling of lighttransmission using digitalelectronics	Logarithmic conversion oflight transmission usinganalog electronics	Logarithmic handling oflight transmission usinganalog electronics
Reagents/Accessories	Calibration Standards (2)Controls (3)Reagent WaterTest CuvettesCuvette rackNormal salineThromboplastin (Dade®Thromboplastin C Plus)	Reference Plasma (forcalibration)Verify Controls:Veronal BufferSample cupsCuvette RotorFibriquik (Thrombin)	VeriCal Calibrator SetVerify ControlsReagent WaterProbe CleanerBufferTest CuvettesClauss Reagents(Thrombin, Imidiazolebuffer)
OperatingTemp	37 ± 0.3°C	37°C	37 ± 1°C
Test Sample	Citrated plasma	Citrated plasma	Citrated plasma
Test SampleDilution	Not required	Required	Required

Similaritics and Difference Between POTENS+, MTX and the MDA-180

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

Testing was performed to determine correlation and bias, precision and interfering substances. Interfering substances, and specimen collection and preparation are well documented for these type of assays are in accordance with NCCLS standards and recommendations of the International Society of Thrombosis and Hemostasis.

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

A comparison study was conducted using patent specimens over the normal, diagnostic and therapeutic range. Correlation coefficients (r-values) ranged from for 0.973 to 0.980 for Fibrinogen, 0.95 to 0.974 for PT and 0.919 to 0.963 for INR results. Total precision for Fibrinogen was well within NCCLS recommendations using human based and bovine based control plasmas. Total precision for PT and INR using human based control plasmas were also well within NCCLS recommendations.

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

The performance characteristics of the POTENS+ are comparable to those of the predicate devices. The data presented in the premarket notification demonstrate that the POTENS+ performs substantially equivalent to the predicate devices. Comparison studies were performed to demonstrate that POTENS+ is equivalent to the MTX for determining Fibrinogen concentration and to the MDA-180 for determining PT and INR results.

Equivalence was demonstrated using commercially available methods/product along with patient specimens covering the normal, therapeutic and diagnostic range. Correlation coefficients (r-values) ranged from for 0.973 to 0.980 for Fibrinogen, 0.95 to 0.974 for PT and 0.919 to 0.963 for INR results.

Precision studies were performed following the guidelines in NCCL EP5A "Evaluation of Precision Performance of Clinical Chemistry Devices". Total precision coefficient of variations (CVs) were less than 6% for fibrinogen using normal and abnormal control plasma, less than 5% for PT using normal and abnormal human control plasma and less than 8% for INR using normal and abnormal human control plasma.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a stylized lower portion representing the body.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Wada Inc.

DEC - 8 2003

c/o Ms. Gail Rodrick-Highberg Regulatory Consultant Highberg Associates 35949 Nicolet Court Fremont, California 94536

Re: K033137

Trade/Device Name: POTENS+ Regulation Number: 21 CFR § 864.5425 Regulation Name: Multipurpose System for in vitro Coagulation Studies Regulatory Class: II Product Code: JPA Dated: September 29, 2003 Received: September 30, 2003

Dear Ms. Rodrick-Highberg:

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 either 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 (QS) regulation (21 CFR Part 820). This letter 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.

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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 (301) 594-3084. 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 (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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS FOR USE Section C. ...

Page 1 of 1

510(k) Number (if known) _K 033137

Device Name: POTENS+

Indications for Use:

Prothrombin Time is used to determine the status of the extrinsic clotting pathway for Clotting Factors I, II, V, VII and X, and to assist in monitoring oral anticoagulants.

INR is used to monitor the patients receiving anticoagulation therapy.

Josephine Bautista

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) KU33137

Rx
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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.