The HP ORVue Intra-Op [M2510A] Intraoperative Recording System is indicated for use in healthcare facilities by healthcare professionals whenever there is a need for a anesthesia record. This product is indicated for all patients requiring a anesthesia record. The specific medical indication for use of this device is:

This device is a prescription device.
This device is not intended to contact the patient.
This device is used continuously in Operating Theatres during Anesthesia
The Recording of calculations (Fluid, Hemodynamic, Renal, Oxygenation and Ventilation) indicated for any patient who will have medication administered and which requires dose computation.
The physiological purpose is indirect. The device is intended to gather and store patient information during Anesthesia, and to document computed calculations as needed by care providers.

Device Description

The HP ORVue Intra-Op [M2510A] Intraoperative Recording System is a product that provides documentation of all anesthesiarelevant information, replacing parts (or all) of the paperchart of the anesthesia protocol in the operating theatre. ORVue Intra-Op [M2510A] is easily adaptable to different types of anesthesia by means of multiple anesthesia-specific configurations designed to automate the charting process and address the needs of health care providers. It is capable of providing the following six reports: Anesthesia Report One Time, Anesthesia Report Continuous, Billing Report, QA Report, Graphics Report, Notes Report, whereas the anesthesia report contains the following information : Medication trends (Drugs/Gases and Infusions/Transfusions), Parameter trends, List of entries, IV/IA lines, Surgical information, Anesthesia information, Equipment used, Transfusions administered, Anesthesia times, Personnel involved, Discharge location. Summary of anesthesia, Post-op orders, Space for additional notes. It is also capable of accessing data automatically from other HP and Non-HP devices/systems (such as Infusion pumps, computer systems (Database) and medical devices).

AI/ML Overview

The provided text describes the HP ORVue Intra-Op [M2510A] Intraoperative Recording System, a device for documenting anesthesia-related information. However, it does not contain the specific details required to complete all sections of your request regarding acceptance criteria and a study proving device performance.

Specifically, the document is a 510(k) premarket notification letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific performance metrics and acceptance criteria.

Here's what can be inferred and what information is missing based on your request:

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

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document. The submission focuses on substantial equivalence to predicate devices and software validation.	The device provides "Recording of Calculations" functionality for Fluid Balance, Hemodynamic, Renal, Oxygenation, and Ventilation. These calculations are "identical to those of the market cleared devices Component Monitoring System Model HP M1175/76A [K922058] and Patient Monitor Model HP 78534C [K870380]."

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

Sample size for test set: Not mentioned.
Data provenance: Not mentioned.

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)

Not mentioned.

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

Not mentioned. The document primarily discusses software validation and substantial equivalence, not a performance study with a test set.

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: Not mentioned. This device is an intraoperative recording system, not an AI diagnostic tool that would typically involve human readers. Its primary function is documentation and calculation.
Effect size of human improvement with AI: Not applicable for this device as described.

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

The document states, "All of the processes for safe software development that were used to develop original device were followed and the software was fully validated." This implies internal software testing, but details on standalone performance (e.g., specific metrics for calculation accuracy) are not provided in this excerpt. The calculations themselves are stated to be "identical" to previously cleared devices, suggesting reliance on the established performance of those predicate devices.

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

For the "Recording of Calculations" functionality, the ground truth for the calculations would likely be the mathematical algorithms and formulas themselves, validated against established medical science or engineering principles, similar to the predicate devices. The document explicitly states the calculations are "identical" to already cleared devices, suggesting their accuracy was established through comparison with these existing, validated systems.

8. The sample size for the training set

Not applicable. This device is not described as an AI/ML device that requires a training set in the typical sense for learning patterns from data. Its functionality involves executing predefined calculations and recording. "Software validation" refers to ensuring the software performs its intended functions correctly, not training a model.

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

Not applicable, as there is no mention of a training set for an AI/ML model. The "ground truth" for the software validation would be the specifications and requirements for the calculations and recording functions, which are verified through testing to ensure the software performs as designed.

Summary

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SEP 1 1 1997

K965160

page 13

A -- Executive Summary

Reason for Submission

The reason for this submission is to notify FDA that Hewlett-Packard plans to bring a new device , HP ORVue Intra-Op [M2510A] Intraoperative Recording System , to market.

This submission is to have Calculations of

. Fluid Balance
Hemodynamic .
Renal
Oxygenation .
Ventilation .

as a Recording functionality in the HP ORVue Intra-Op [M2510A] software as one of the applications to support and enhance the clinical Intraoperative Recording (Anesthesia Protocol).

Until now Hewlett-Packard has determined the functionality of the HP OR Vue Intra-Op [M2510A] to be exempt from reporting (based on exemptions described in FDA's guidance for computer controlled devices, see also Chapter "D. Description of the Device " part "Overview").

As a result this submission will primarily focus on the 'Recording of Calculations' functionality.

In terms of being a computerized system capable of accessing and displaying data coupled with Recording of the above described Calculations, this device is similar to the previously submitted CareVue 5000 system cleared to market under 510(k) number K922210 while the Calculations are identical to those of the market cleared devices Component Monitoring System Model HP M1175/76A [K922058] and Patient Monitor Model HP 78534C [K870380].

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Description

ORVue Intra-Op [M2510A] is easily adaptable to different types of anesthesia by means of multiple anesthesia-specific configurations designed to automate the charting process and address the needs of health care providers.

It is capable of providing the following six reports:

- Anesthesia Report One Time
- Anesthesia Report Continuous
- Billing Report
- QA Report
- Graphics Report
- Notes Report

whereas the anesthesia report contains the following information : Medication trends (Drugs/Gases and Infusions/Transfusions), Parameter trends, List of entries, IV/IA lines, Surgical information, Anesthesia information, Equipment used, Transfusions administered, Anesthesia times, Personnel involved, Discharge location. Summary of anesthesia, Post-op orders, Space for additional notes.

It is also capable of accessing data automatically from other HP and Non-HP devices/systems (such as Infusion pumps, computer systems (Database) and medical devices).

Validation

All of the processes for safe software development that were used to develop original device were followed and the software was fully validated.

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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 features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

SEP 1 1 1997

Mr. Herbert van Dyk Regulatory Affairs Medical Products Group-Boeblingen Hewlett-Packard GmbH Schickardstrasse 4 D-71034 Boeblingen GERMANY

Re: K965160 ORVue Intra-Op Intraoperative Recording System (M2510A) Regulatory Class: II (two) Product Code: 73 BSZ Dated: June 13, 1997 Received: June 16, 1997

Dear Mr. Dyk:

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 requlations 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 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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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) 594-4648. 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. Callahan

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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Indications for Use

· This device is a prescription device.
· This device is not intended to contact the patient.
· This device is used continuously in Operating Theatres during Anesthesia
· The Recording of calculations (Fluid, Hemodynamic, Renal, Oxygenation and Ventilation) indicated for any patient who will have medication administered and which requires dose computation.
· The physiological purpose is indirect. The device is intended to gather and store patient information during Anesthesia, and to document computed calculations as needed by care providers.

r, t

M. Perry fa AAC

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number

Regulation Number and Section

§ 868.5160 Gas machine for anesthesia or analgesia.

(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).