PM-2000XL Pro: The monitor monitors parameters such as ECG (3-lead, 5-lead, 12-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (Sp02), lovasive or noninvasive blood pressure (2/4 channels IBP NIBP), Cardiac Output (CO), Temperature (dual-TEMP), Expired C02 and Anesthetic gas (AG). The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.

PM-2000XL: The monitor monitors parameters such as EGG (3-lead, 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (dual-IBP, NIBP), Temperature (dual-TEMP), Expired C02 and Quick Temperature (Quick TEMP. The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both. The arrhythmia detection and ST Segment analysis are not intended for neonatal patients.

Device Description

The PM-2000XL & PM-2000XL Pro Patient Monitors provide the following primary features:

PM-2000XL & PM-2000XL Pro Patient Monitor can perform long-time continuous monitoring of multiple physiological parameters. Also, they are capable of storing, disnlaying, analyzing and controlling measurements, and they will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time.

PM-2000XL Patient Monitor can monitor parameters including SpO2, NIBP, EGG RESP, TEMP, C02, IBP

PM-2000XL Pro Patient Monitor can monitor parameters including SpO2, NIBP, ECG RESP, TEMP, C02, IBP, C.O. and AG

PM-2000XL is outfitted with a 8.4-inch display screen, PM-2000XL Pro is 15-inch, as well as an equal large touch screen, which enables the operation by touching the screen, thus offering convenience for doctors and nurses.

PM-2000XL Patient Monitor has parameter modules including SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, EGG RESP, C02, IBP and Quick Temp.

PM-2000XL Pro Patient Monitor has parameter modules including SpO2 with EDAN-Sp02 module or Nellcor SPO2 module, NIBP with EDAN NIBP module or Omron M3600. TEMP, EGG, RESP, C02, CO, IBP, AG.

The EDAN SpO2 module used in PM-2000XL Pro and PM-2000XL is also used by H1 100B Pulse Oximeter which has been cleared by FDA under K110922. The C02 module and Nellcor SpO2 module used in PM-2000XL Pro are the same to those used in M3B3, which has been cleared by K083821 in May 14, 2009.

PM-2000XL Pro could be configured with two different NIBP modules, one is EDAN NIBP module, the other one is Omron M3600 NIBP module; M3600 module used in PM-2000XL Pro is the same to that used in BX-10, which has been cleared by K032857 in April.21.2003.

The C02 module and Nellcor SpO2 module used in PM-2000XL are the same to those used in M3B, which has been cleared by K083821 in May 14, 2009.

Arrhythmia and ST Analysis used in PM-2000XL Pro is the same to that in PC EGG which has been cleared by FDA under K102854 and K092010.

AI/ML Overview

This is a 510(k) summary for a patient monitor and, as such, typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed studies for device performance against specific acceptance criteria. The document explicitly states:

"This premarket notification submission demonstrates that PM-2000XL & PM-2000XL Pro Patient Monitor is substantially equivalent to the predicate device."

Therefore, the information you've requested regarding acceptance criteria, specific device performance studies, and ground truth establishment for a new device's algorithms (which would be necessary for AI/software-as-a-medical-device submissions) is not present in this document. This submission is for a patient monitor, which is a hardware device that incorporates various modules for physiological parameter monitoring. The performance of these modules is either cleared through previous 510(k)s (as explicitly stated for components like the EDAN SpO2 module, Nellcor SpO2 module, and Omron NIBP module) or is expected to meet established performance standards for such physiological monitors, without requiring a novel performance study to prove it for this specific integration.

Here's an analysis based on the provided text, explaining why much of the requested information is not available and what is stated:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not provide a table of acceptance criteria and reported device performance for the PM-2000XL & PM-2000XL Pro as a whole using new data. Instead, it relies on the substantial equivalence to a predicate device (M50 & M80 Patient Monitor K110922) and the prior clearance of its individual components/modules.

Implied Acceptance Criteria: The implied acceptance criteria are that the device performs equivalently to the predicate device and that its individual modules meet their previously established performance standards.

The document mentions that:

The EDAN SpO2 module is also used by H1 100B Pulse Oximeter cleared under K110922.
The C02 module and Nellcor SpO2 module are the same as those used in M3B3 (cleared under K083821) and M3B (cleared under K083821).
The Omron M3600 NIBP module is the same as that used in BX-10 (cleared under K032857).
Arrhythmia and ST Analysis used in PM-2000XL Pro are the same as that in PC EGG (cleared under K102854 and K092010).

This signifies that the performance of these individual components has already been evaluated and deemed acceptable in their preceding 510(k) clearances.

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

Not applicable in this submission. The document relies on the existing clearances of its components and the substantial equivalence to the predicate device. New clinical performance data for the integrated system is not presented.

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

Not applicable. Ground truth establishment for a novel algorithm's test set performance is not part of this 510(k) submission, as it's not demonstrating the performance of a new algorithm.

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

Not applicable.

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. This is not an AI-assisted diagnostic or interpretative device requiring MRMC studies. It is a physiological monitoring device.

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

Not applicable in the context of a new, standalone algorithm. The "algorithms" present are for the interpretation of physiological signals (e.g., arrhythmia detection, ST segment analysis), which are noted to be the "same to that in PC EGG which has been cleared by FDA under K102854 and K092010." This implies their standalone performance was assessed in those prior submissions, not in this one.

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

Not applicable to this 510(k). The ground truth for the performance of the various physiological monitoring parameters (SpO2 accuracy, NIBP accuracy, ECG arrhythmia detection accuracy, etc.) would have been established during the development and clearance of the individual modules or the predicate device, likely using recognized clinical standards and reference methods for each physiological parameter.

8. The sample size for the training set:

Not applicable. This submission is not for a new machine learning algorithm that requires a training set.

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

Not applicable.

Summary

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510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________ MAY 2 5 2012

Submitter

Advanced Instrumentations, Inc. 6800 N.W. 77th Court Miami, Fl 33166 Telephone: 305-477-6331 305-477-5351 Fax:

Registration # 1066270

Official correspondent :

Jorge Millan, PhD Email: jmillan@hiatec.org 601 West 20 St Hialeah, FL 33010 Phone : (305) 925-1260

Date Prepared:

February 29, 2012

Device name and classification:

. Device Name: Patient Monitor models PM-2000XL & PM-2000XL Pro
Classification Name: Patient Physiological Monitor (with arrhythmia . detection or alarms)
Product code: MHX, DRT, DXN, DSK, FLL, DQA, CCK, CBQ, CBS, CBR, . CCL, DSA, DRT, DSF, and MLD
Regulatory Class: Class II .

Predicate Device:

M50 & M80 Patient Monitor K110922 Manufacturer: EDAN Instruments

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Device Description:

The PM-2000XL & PM-2000XL Pro Patient Monitors provide the following primary features:

PM-2000XL Patient Monitor can monitor parameters including SpO2, NIBP, EGG RESP, TEMP, C02, IBP

PM-2000XL Pro Patient Monitor can monitor parameters including SpO2, NIBP, ECG RESP, TEMP, C02, IBP, C.O. and AG

PM-2000XL Pro Patient Monitor has parameter modules including SpO2 with EDAN-Sp02 module or Nellcor SPO2 module, NIBP with EDAN NIBP module or Omron M3600. TEMP, EGG, RESP, C02, CO, IBP, AG.

The C02 module and Nellcor SpO2 module used in PM-2000XL are the same to those used in M3B, which has been cleared by K083821 in May 14, 2009.

Arrhythmia and ST Analysis used in PM-2000XL Pro is the same to that in PC EGG which has been cleared by FDA under K102854 and K092010.

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Intended Use:

PM-2000XL Pro:

The monitors parameters such as ECG (3-lead, 5-lead, 12-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (Sp02), lovasive or noninvasive blood pressure (2/4 channels IBP NIBP), Cardiac Output (CO), Temperature (dual-TEMP), Expired C02 and Anesthetic gas (AG). The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.

PM-2000XL:

The monitor monitors parameters such as EGG (3-lead, 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (dual-IBP, NIBP), Temperature (dual-TEMP), Expired C02 and Quick Temperature (Quick TEMP. The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both. The arrhythmia detection and ST Segment analysis are not intended for neonatal patients.

Effectiveness and Safety Contraindications:

Comparison to the predicate device:

The subject device has similar technology characteristics and has the same intended use as the predicate device. The PM-2000XL & PM-2000XL Pro Patient Monitor has the same characteristics as the predicate device cleared under K110922. Both models use the same technology and manufacturing processes.

Substantially Equivalent Determination:

This premarket notification submission demonstrates that PM-2000XL & PM-2000XL Pro Patient Monitor is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAY 2 5 2012

Advanced Instruments, Inc. c/o Jorge Millan, PhD. Executive Director Hialeah Technology Center, Inc. 601 West 20 Street Hialeah, FL 33010

Re: K120631

Trade/Device Name: Patient Monitor, PM-2000XL & PM-2000XL Pro Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: Class II (two) Product Code: MHX, CBQ, CBR, CBS, CCK, CCL, DQA, DRT, DSA, DSF, DSK, DXN, FLL, MLD Dated: February 28, 2012 Received: March 2, 2012

Dear Dr. Millan:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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Page 2 - Jorge Millan, PhD

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.

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.gov/AboutFDA/CentersOffices/CDRH0ffices/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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

M.A. Hilleben

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

KI2063 510(k) Number (if known):

Device Name:

Patient Monitor models PM-2000XL & PM-2000XL Pro

Indications for Use:

PM-2000XL Pro:

The monitor monitors parameters such as ECG (3-lead, 5-lead, 12-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (Sp02), Invasive or noninvasive blood pressure (2/4 channels IBP NIBP), Cardiac Output (CO), Temperature (dual-TEMP), Expired C02 and Anesthetic gas (AG). The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.

PM-2000XL:

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)

(Division Sign-Off)
Division of Cardiovascular Devices

K 120631 510(k) Number

Page 1 of __ 1________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.