Indications for Use: Physiological purpose: To aid the clinician deciding whether to administer thrombolytic therapy or to provide another avenue of treatment; Condition: Patient is a potential candidate for thrombolytic therapy; Patient Population: adult (35 to 75 years) patients diagnosed as having symptoms of Acute Myocardial Infaction: Body or type of tissue interacted with: No body or tissue contact; Prescription versus over-the-counter: HP TPI is a prescription device.

Device Description

HP TPI is an accessory software device that provides probability indices to aid the clinician deciding whether to administer thrombolytic therapy or to provide another avenue of treatment. HP TPI can only be installed in prescription host devices that meet the HP TPI interface and computing platform requirements.

AI/ML Overview

The provided document does not contain explicit acceptance criteria or a detailed study proving the device meets specific performance criteria in the format requested. The document is primarily a 510(k) submission summary for "HP TPI Application" (Thrombolytic Predictive Instrument), outlining its purpose, regulatory information, and general claims of safety and effectiveness.

Here's an analysis based on the information available:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or present a table of reported device performance metrics against such criteria. It generally states: "Documented test results obtained from extensive testing coupled with detailed user documentation of HP TPI and host devices produces a very high confidence level that the device is safe and effective when used as intended."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the given text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the given text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the given text.

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

The document refers to the device as an "accessory software device that provides probability indices to aid the clinician deciding whether to administer thrombolytic therapy or to provide another avenue of treatment." This implies human-in-the-loop use. However, no details about an MRMC study or effect size of human improvement with AI assistance are provided.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document describes the device as providing "probability indices to aid the clinician," indicating it's not intended for standalone use. No standalone performance study details are provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided in the given text. The device's purpose revolves around aiding decisions for "Acute Myocardial Infarction," which would typically involve clinical diagnosis and outcomes, but the specific ground truth methodology is not detailed.

8. The sample size for the training set

This information is not provided in the given text.

9. How the ground truth for the training set was established

This information is not provided in the given text.

Summary of what is available:

Device Name: Model M1792A Thrombolytic Predictive Instrument (HP TPI Application)
Intended Use: To aid clinicians in deciding on thrombolytic therapy or alternative treatments for adult patients (35-75 years) with symptoms of Acute Myocardial Infarction.
Algorithm: Uses ECG measurement information from the host cardiograph and patient data input by the operator to calculate risk indices.
Verification and Validation: States that "HP TPI software operates properly with no known safety related defects," "the algorithm embodied in the software performs the same as the algorithm used during clinical testing," "identified hazards have been mitigated," and "host cardiograph performance has not been compromised." This is a high-level verification statement without specifics on the "clinical testing."

Summary

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JUN 1 5 1998

K974087

Chapter 25: Summary of Safety and EFFECTIVENESS

1.0 Manufacturer/Submitter

1.1 Name and Address

Hewlett-Packard Cardiology Products Division Medical Products Group 3000 Minuteman Road Andover, MA 01810

1.2 Establishment Registration Number 1218950

Hewlott-Packard Manufacturing Site 1.3 Address

Hewlett-Packard Medical Products (Quindao) LTD 188 Zhuzhou Rd., Laoshan District Qingdao 266101 China

Manufacturing Site Establishment Registration 1.3.1 Number

9680888

1.4 Sterilization Site

Does not apply.

1.5 Contact Persons

You may contact Ray Stelting at (978) 659-3445 or Rick Petersen at (978) 659-2213, or Chas Burr at (978) 659-2529

1.6 Date

10/28/97

2.0 Regulatory Information

2.1 References

510(k) Notifications:

· K951978, M1791A Acute Cardiac Ischemia-Time Insensitive Predictive Instrument (ACI-TIPI)
· K895520, PageWriter XLi M1700A and Page-Writer XL M1701A
· K954980, PageWriter 200i M1770A and Page-Writer 200 M1771A

2.2 Device Name. Trade Name

Proprietary: Model M1792A Thrombolytic Predictive Instrument

Trade: HP TPI Application

2.3 Products (Components) Included As Part Of This Device:

accessories or additional components No are included as part of the Model M1792A Thrombolytic Predictive Instrument device.

2.4 Device Classification

We are not aware of a classification for this device.

2.5 Performance Standard:

None established under section 514.

3.0 Description

What it is and intended use 3.1

HP TPI is intended to be used by clinicians treating patients diagnosed as having experienced a recent acute myocardial infarction.

In the USA, Federal law restricts HP TPI to sale by or on the order of a physician.

It is intended to be used in a professional health care facility.

It is not intended for home use.

3.2 How the Algorithm Works

The algorithm uses ECG measurement information from the host cardiograph machine along with patient data input by the operator as factors in the equation used to calculate risk indices. The computed indices and the input data are printed on each ECG report.

HP TPI 510(k)

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3.3 Indications for Use

The indications for use of the HP TPI software device are:

Physiological purpose: To aid the clinician deciding whether to administer thrombolytic therapy or to provide another avenue of treatment;

Condition: Patient is a potential candidate for thrombolytic therapy;

Patient Population: adult (35 to 75 years) patients diagnosed as having symptoms of Acute Myocardial Infarction;

Body or type of tissue interacted with: No body or tissue contact;

Prescription versus over-the-counter: HP TPI is a prescription device.

4.0 Verification and Validation

Verification and validation shows that (1) HP TPI software operates properly with no known safety related defects when executing on qualified computing platforms, (2) the algorithm embodied in the software performs the same as the algorithm used during clinical testing, (3) identified hazards have been mitigated, and (4) that the host cardiograph performance has not been compromised by the installation of the HP TPI application software.

5.0 Safe and Effective When Used as Labeled

Documented test results obtained from extensive testing coupled with detailed user documentation of HP TPI and host devices produces a very high confidence level that the device is safe and effective when used as intended.

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Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 5 1998

Mr. Ray Stelting Hewlett-Packing Company Medical Products Group 3000 Minuteman Road Andover, MA 01810

K974087 Re: Model M1792A Thrombolytic Predictive Instrument Requlatory Class: III (three) Product Code: 74 LOS Dated: October 28, 1997 Received: October 29, 1997

Dear Mr. Stelting:

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 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 Requlation (QS) for Medical Deviees:-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 requlations.

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Page 2 - Mr. Ray Stelting

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 requlation (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, "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,
Thomas J. Callehan

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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Page Lof

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:________________ Thromboly Fic_Predictive

Indications For Use:

Contraindications: "NOTE: The Thrombolytic Predictive Instrument (TPI) is contraindicated for patients with conditions that mimic acute myocardial infaction. Some of these conditions are: Prinzmetal variant angina, acute pericarditis, acute myocarditis, cardiomyopathy, and primary and secondary cardiac neoplasms.

The Thrombolytic Predictive Instrument (TPI) is also contraindicated for patients with conditions for whom the administration of thrombolytics is contraindicated. Some of these conditions are: aortic dissection, acute myocardial infarction due to bacterial endocarditis, intracardiac thrombi, and acute nonsuppurative and suppurative pericarditis mimicking acute myocardial infarction.

These situations, as well as Posterior Acute Myocardial Infarction, were not considered or covered in the development of the predictive instrument calculations."

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Concurha N modoo 6-9-98

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use_

(Division Sign-Off)
(Optional Format 1-2-96)
Division of Cardiovascular, Respiratory,
and Neurological Devices

510(k) Number_

Regulation Number and Section

N/A