The Model 6000 is intended to provide continuous noninvasive monitoring of SpO2 and EtCO2 indications. The parameters are derived from both the measurements of arterial oxygen hemoglobin saturation and pulse rates as well as relative expired and inspired CO2 levels. The recorded data may be displayed locally and also transmitted wirelessly to any device supporting the 802.11 communication protocol.

This device is intended for use on adult, geriatric, and neonatal patients in bedside or mobile applications within health care institutions and/or health care environments only under the direction of a physician or qualified clinician.

Device Description

The device is a two parameter patient monitor. Both EtCO2 and SpO2 parameters are derived from commercially available modules that are incorporated internally. The device displays the waveforms and numerical values associated with each parameter on a color LCD display, and transmits the information to a network based computing device over the 802.11a - g IEEE wireless protocol. The device is intended for use on adult, geriatric, pediatric, and neonatal patients only under the direction of a physician or qualified clinician.

AI/ML Overview

The provided text describes a 510(k) summary for the Ivy Biomedical Systems Model 6000 Two Parameter Bedside Monitor. It details the device's characteristics, intended use, and substantial equivalence to a predicate device. However, it does not include specific information about acceptance criteria for performance metrics (e.g., accuracy, precision for SpO2 or EtCO2) nor a dedicated study section with the detailed information requested in the prompt (sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, etc.).

The document states: "The device was verified and validated according to the product specifications. The test criteria consist of standardized levels and internal product requirements. Tests performed on the device include environmental and mechanical stress testing, electromagnetic immunity and emissions testing, and medical device safety testing. Software on the device was verified and validated according to the functionality of the operations of the device. The test results confirm that the device is in accordance with its specifications."

This summary indicates that performance and safety testing were conducted internally, aligning with various industrial and medical device standards (UL 60601-1, IEC 60601-1-2, etc.). However, it does not explicitly state the quantitative acceptance criteria for SpO2 and EtCO2 accuracy, nor does it present the results of such performance tests in a format that allows for the construction of the requested table or detailed study description.

Therefore, for many of the requested points, the information is not available in the provided text.

Here is a summary of what can and cannot be extracted from the provided text based on your prompt:

Acceptance Criteria and Study for Model 6000 Two Parameter Bedside Monitor

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Metric	Acceptance Criteria	Reported Device Performance
SpO2 Accuracy	Not specified	Not specified
EtCO2 Accuracy	Not specified	Not specified
Pulse Rate Accuracy	Not specified	Not specified
Respiratory Rate Accuracy	Not specified	Not specified
Environmental & Mechanical Stress Testing	Standardized levels and internal product requirements	Confirmed compliance with specifications
Electromagnetic Immunity & Emissions Testing	Standardized levels and internal product requirements	Confirmed compliance with specifications
Medical Device Safety Testing	Standardized levels and internal product requirements	Confirmed compliance with specifications
Software Verification & Validation	Functionality of operations	Confirmed compliance with specifications

Explanation: The document broadly states that "The device was verified and validated according to the product specifications. The test criteria consist of standardized levels and internal product requirements. The test results confirm that the device is in accordance with its specifications." However, it does not provide specific numerical acceptance criteria or reported performance values for parameters like SpO2 or EtCO2 accuracy which would typically be included in a detailed performance study for such a device.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document implies internal testing and compliance with various international standards (UL, IEC, ISO, CAN/CSA, CISPR), but no details on clinical data collection are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not specified. This device is a monitor measuring physiological parameters, not an diagnostic imaging or interpretation device that would typically rely on human expert consensus for ground truth on a test set. The ground truth for such devices usually involves highly accurate reference measurement equipment. However, the document does not detail how the ground truth for its performance validation (e.g., SpO2 or EtCO2 accuracy) was established.

4. Adjudication method for the test set:

Not applicable/Not specified. Given the nature of the device (physiological monitor), an adjudication method in the context of expert review is not typically relevant as it would be for AI-driven interpretation tasks.

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:

Not applicable/Not specified. The Model 6000 is a patient monitor, not an AI-assisted diagnostic tool that interprets data for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this type of device.

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

The device is a standalone monitor. Its performance would inherently be evaluated in a standalone manner, measuring its accuracy against reference standards. However, the details of such standalone performance testing (e.g., specific accuracy metrics, methodologies) are not provided in this 510(k) summary beyond the general statement of "verification and validation."

7. The type of ground truth used:

Not specified. For physiological monitors, ground truth typically involves highly accurate, gold-standard reference devices (e.g., a CO-oximeter for SpO2, a calibrated gas analyzer for EtCO2). The document mentions that "EtCO2 and SpO2 parameters are derived from commercially available modules that are incorporated internally," implying these modules themselves may have established accuracy, but it doesn't detail the validation of the integrated system against an independent ground truth.

8. The sample size for the training set:

Not applicable/Not specified. This device is a physiological monitor, not a machine learning model that requires a "training set." Its functionality is based on established engineering principles and commercially available modules, rather than learned patterns from a large dataset.

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

Not applicable. As there's no mention of a training set for a machine learning model, this question is not relevant to the described device.

Summary

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K091787

510(k) Summary

June 8, 2009

Name and Address of Applicant

Ivy Biomedical Systems, Inc. 11 Business Park Drive Branford, CT, 06405

(203) 481-4183 Phone: (203) 481-8734 Fax :

Primary Contact

Jennifer Laine Electrical Engineer (203) 481-4183 x185

Proprietary Name of Device

Model 6000 Two Parameter Bedside Monitor

Common Names of the Device

SpO2 and EtCO2 Monitor

Device Classification

The device is classified as a Class II device by the both the Cardiovascular and Anesthesiology Panels under 21 CFR Part 870.2700 "Oximeter" per DQA and 21 CFR Part 868.1400 "Carbon Dioxide Gas Analyzer" per CCK respectively.

Establishment Registration Number of Manufacturer

1221108

Legally Marketed Predicate

Oridion Capnography, Inc. Capnostream20 Two Parameter Bedside Monitor, cleared under 510(k), K060065

OCT - 9 2009

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Summary of Technological Characteristics of Device Compared to Predicate

The device has similar indications for use and intended use as the predicate device. Both systems monitor EtCO2 or the relative level of carbon dioxide in exhaled breath, respiratory rate, oxygen saturation in arterial hemoglobin (SpO2), and pulse rate. In both devices, the measurements are collected noninvasively and displayed on a VGA color TFT LCD display. The trend of each measured indication may be stored and represented at multiple resolutions. They are both non-ambulatory devices and applicable to patients of all ages. Unlike the predicate, the Model 6000 device is not intended to be used in home environments.

Both devices deliver alarms meeting the voluntary harmonized standard IEC 60601-1-8.

The energy source for both the device and predicate is equivalent. They receive power and ground either through AC Mains or a battery pack. Neither device makes physical contact with the patient; the patient-side electronics of both are electrically isolated from Mains power.

Description

Intended Use

The Model 6000 is intended to provide continuous nonitoring of SpO2 and EtCO2 indications. The parameters are derived from both the measurements of arterial oxygen hemoglobin saturation and pulse rates as well as relative expired and inspired CO2 levels. The recorded data may be displayed locally and also transmitted wirelessly to any device supporting the 802.11 communication protocol. This device is intended for use on adult, geriatric, pediatric, and neonatal patients in bedside or mobile applications within health care institutions and/or health care environments.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

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Performance and Safety Testing

The device complies voluntarily with the following industrial standards:

UL 60601-1. 2nd Edition IEC 60601-1-2:2001 IEC 60601-1-4:2004 IEC 60601-1-6, 2nd Edition IEC 60601-1-8, 2nd Edition IEC 60601-2-49:2001 ISO 13485:2003 CAN/CSA 22.2 No 601.1 M90 CAN/CSA-ISO13485:2003 21 CFR Part 870 MDD: 93/42/EEC Annex II, IIa (per manufacturer) CISPR11 Group 1, Class B

These standards guarantee that the device was designed by a company possessing a full quality system and meets the safety and performance criteria required for an Electrical Medical Device in markets within the European Union. The device was verified and validated according to the product specifications. The test criteria consist of standardized levels and internal product requirements. Tests performed on the device include environmental and mechanical stress testing, electromagnetic immunity and emissions testing, and medical device safety testing. Software on the device was verified and validated according to the functionality of the operations of the device. The test results confirm that the device is in accordance with its specifications.

Classification Criteria

The device provides Class II protection against electric shock. .
The device does not contact the patient directly but plugs into a pulse oximetry sensor . and/or EtCO2 cable with nasal cannula which do contact the skin of the patient. These accessories are legally marketed and sold in the United States.
The degree of protection against the ingress of water is IPX1. .
. The device is not sterile.
. The use of the device is not suitable in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.
During normal operating conditions, the device is in a continuous mode of operation. .
The device is externally supplied by AC Mains power, but may also be powered by an . internal Li-polymer battery pack.
The device is portable. It may be moved between uses. .

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an eagle with its wings spread, clutching a staff with a snake wrapped around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is in black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

Ms. Jennifer Laine Electrical Engineer Ivy Biomedical Systems. Incorporated 11 Business Park Drive Branford, Connecticut 06405

OCT - 9 2009

Re: K091787

Trade/Device Name: Model 6000 Two Parameter Bedside Monitor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DOA, CCK Dated: October 6, 2009 Received: October 7, 2009

Dear Ms. Laine:

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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Laine

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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.goy/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/industry/support/index.html.

Sincerely yours,

for

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K091787

Device Name: Model 6000 Two Parameter Bedside Monitor

Indications for Use:

Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

and the same of the same of the same of the same of the same of

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K091787

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).