The noninvasive oscillometric blood pressure parameter is intended for measurement of systolic, and mean arterial blood pressure, as well as pulse rate, for adult, pediatric and neonatal patients.

The optional GE TruSignal pulse oximetry and accessories are indicated for continuous nonitoring of functional oxygen saturation (SpO2) and pulse rate, including monitoring conditions of clinical patient motion or low perfusion, with adult, pediatric and neonatal patients.

The optional Masimo Rainbow SET® Pulse CO-oximetry and accessories are indicated for the continuous noninvasive monitoring of:

· functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, during both no motion and motion

conditions, and for patients who are well or poorly perfusion) for adult, pediatric and neonatal patients,

· carboxyhemoglobin saturation (SpCO) for adult and pediatric patients,

· methemoglobin saturation (SpMet) for adult, pediatric and neonatal patients,
· total hemoglobin concentration (SpHb) for adult and pediatric patients, and/or

· respiratory rate (RRa) for adult and pediatric patients.

The optional Nellcor™ oximetry and accessories are indicated for the continuous, noninyasive monitoring of arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients during both motion and non-motion conditions, and for patients who are well or poorly perfused. The optional Oximax SPD™ Alert (SPD) feature is intended only for facility-use care of adults to desaturation indicative of repetitive reductions in airflow through the upper airway and into the lungs.

The optional Nellcor™ Respiration Rate parameter is intended for the continuous noninvasive monitoring of respiration rate in adult patients who are well perfused during non-motion conditions.

The optional Welch Allyn SureTemp Plus electronic thermometer is intended to measure oral, axillary, and rectal temperature of adult and pediatric pational Exergen TemporalScanner thermometer is intended for the intermittent measurement of human body temperature of patients of all ages.

A wireless network connection is provided to transmit clinical data into various hospital information systems. An optional remote alarm cable connection is intended to complement visual and audible alarms and not replace the need for the presence of a caregiver.

The portable device is designed for use in hospital-type facilities. The VC150 can also be used in satellite areas or alternate care settings.

"Portable" refers to the ability of the VC150 to be easily moved by the caregiver, such as on a roll stand. The VC150 is not intended to be used for continuous monitoring during patient transport.

Device Description

The VC150 is a portable vital signs monitor for use in hospitals and hospital-type facilities. It can be used also in satellite areas or alternate care settings. The monitor is used for adult, pediatric, and neonatal patients, one at a time. The battery-operated monitor offers non-invasive determination of blood pressure (systolic, diastolic, and mean arterial blood pressure), pulse rate, temperature, oxygen saturation, total hemoglobin, carboxyhemoglobin, methemoglobin, and respiration rate. The VC150 monitor includes features and measurement modules that are optional or configurable. The monitors can be equipped with the following parameters and technologies:

NIBP and pulse rate: GE SuperSTAT or Classic (auscultatory) algorithms
SpO2 and pulse rate: GE TruSignal, Nellcor OxiMax, or ● Masimo Rainbow SET
Respiration rate: Nellcor OxiMax or Masimo Rainbow SET
Hemoglobin (SpHb), Methemoglobin (SpMet), Oxygen Content (SpOC), and Carboxyhemoglobin (SpCO): Masimo Rainbow SET
. Temperature: Welch Allyn SureTemp Thermometer or Exergen Temporal Arterial Thermometer

The VC150 monitors include a wireless network connection. An integrated printer is optional. The VC150 has an 8.4-inch LCD panel with a touch screen and an alarm light integrated in the front bezel on top of the display. An optional cable connection is available to interface with a traditional nurse-call system for triggering remote alarms. A computer can be connected to the VC150 via a cable to retrieve electronic patient records stored on the device in PDF format.

AI/ML Overview

This document, a 510(k) summary for the VC150 Vital Signs Monitor, does not contain specific acceptance criteria or details of a study proving the device meets those criteria in the way a performance study for an AI-powered diagnostic device would.

The VC150 is a vital signs monitor, and the 510(k) submission primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance metrics through a clinical study with detailed acceptance criteria for an AI algorithm.

However, based on the information provided, here's what can be extracted and inferred, along with what is explicitly stated as not applicable or not available:

Acceptance Criteria and Device Performance

The document does not explicitly present a table of acceptance criteria and reported device performance in terms of diagnostic metrics (e.g., sensitivity, specificity, AUC) because it's a vital signs monitoring device subject to substantial equivalence, not an AI-driven diagnostic.

Instead, acceptance is implied by compliance with voluntary standards and successful non-clinical testing. The "reported device performance" is essentially that it functions comparably to predicate devices for its intended physiological measurements.

Feature/Parameter Tested	Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Blood Pressure (NIBP), Pulse Rate, Temperature, SpO2, SpCO, SpMet, SpHb, Respiration Rate	Demonstrates functionality and accuracy comparable to established predicate devices and relevant voluntary standards (e.g., ISO, AAMI for NIBP, SpO2).	Device is able to perform these measurements using approved modules (GE SuperSTAT/Classic, GE TruSignal, Nellcor OxiMax, Masimo Rainbow SET, Welch Allyn SureTemp, Exergen TemporalScanner) and functions as intended for its specified patient populations (adult, pediatric, neonatal). The document states the device is "as safe and effective and performs substantially equivalent as the following predicate devices."
System Functionality	Meets established requirements, risk management activities, and passes design verification, system integration, system verification/validation, performance, safety, and usability testing.	All listed testing activities were successfully completed, demonstrating the device works as specified and is safe for its intended use.
Compliance with Standards	Adherence to relevant voluntary standards (e.g., electrical safety, EMC, performance standards for vital signs monitoring).	The VC150 and its applications comply with voluntary standards as detailed in this premarket submission.

Study Details (Based on available information)

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a single "test set" in the context of a clinical performance study. The 510(k) relies on non-clinical testing and substantial equivalence. Device performance would have been verified through various technical and bench tests, likely using specific test fixtures, simulated conditions, and potentially a small number of human subjects for usability or specific sensor validation, but this is not detailed.
- Data Provenance: Not applicable in the context of a large-scale clinical dataset. The evaluation method is non-clinical.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for physiological measurements in non-clinical testing is typically established by reference measurement devices or validated simulators, not human experts in the sense of a diagnostic consensus.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No multi-reader adjudication method would be used for non-clinical verification of a vital signs monitor.
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:
- No. This is a vital signs monitor, not an AI-assisted diagnostic imaging device. An MRMC study is not relevant to this device type.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in a way. The performance of the various measurement algorithms (NIBP, SpO2, etc.) intrinsic to the device would have been evaluated in a "standalone" fashion (i.e., the device performing the measurement and displaying the result) during non-clinical verification. This is inherent to testing any medical device's core functionality.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the physical measurements (BP, SpO2, temp): Ground truth would be established through calibrated reference devices, validated physiological simulators, or direct comparison with accepted clinical gold standards in controlled, often bench-top or limited human subject, testing environments. For example, a non-invasive blood pressure module would be tested against an invasive arterial line or a highly accurate reference oscillometric device. Oxygen saturation would be tested against co-oximetry in blood samples.
The sample size for the training set:
- Not applicable. This device is not described as having an AI algorithm that requires a "training set" in the machine learning sense. The underlying physiological measurement algorithms (e.g., oscillometric NIBP algorithms, pulse oximetry algorithms) are well-established, rule-based, or traditionally coded algorithms, not typically "trained" on large datasets in the modern AI paradigm.
How the ground truth for the training set was established:
- Not applicable, as there is no stated AI "training set." The ground truth for the development of the predicates' algorithms (which are then incorporated or used as benchmarks) would have been established historically through clinical studies specific to those technologies.

In summary: The provided document is a 510(k) clearance letter and summary for a vital signs monitor, not a performance study for an AI-powered diagnostic device. The evaluation pathway for this device type focuses on substantial equivalence to existing predicate devices and compliance with recognized performance standards, primarily through non-clinical testing. Therefore, many of the requested details regarding acceptance criteria and performance studies in the context of AI are not present in this type of submission.

Summary

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

October 30, 2014

lnnokas Yhtyma Oy Ms. Tiina Kotipalo Director of Quality and Regulatory Affairs Vihikari 10 90440 Kempele Finland

Re: K133810

Trade/Device Name: Vital Signs Monitor VC150 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II Product Code: MWI Dated: October 23, 2014 Received: October 27, 2014

Dear Ms. Kotipalo:

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.

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. Tiina Kotipalo

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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Melissa A. Torres -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K133810

Device Name VC150

Indications for Use (Describe)

The VC150 is intended to monitor a single patient's vital signs at the site of care or during intra-hospital transport.

The noninvasive oscillometric blood pressure parameter is intended for measurement of systolic, and mean arterial blood pressure, as well as pulse rate, for adult, pediatric and neonatal patients.

The optional Masimo Rainbow SET® Pulse CO-oximetry and accessories are indicated for the continuous noninvasive monitoring of:

· functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, during both no motion and motion

conditions, and for patients who are well or poorly perfusion) for adult, pediatric and neonatal patients,

· carboxyhemoglobin saturation (SpCO) for adult and pediatric patients,

· methemoglobin saturation (SpMet) for adult, pediatric and neonatal patients,
· total hemoglobin concentration (SpHb) for adult and pediatric patients, and/or

· respiratory rate (RRa) for adult and pediatric patients.

The optional Nellcor™ Respiration Rate parameter is intended for the continuous noninvasive monitoring of respiration rate in adult patients who are well perfused during non-motion conditions.

The portable device is designed for use in hospital-type facilities. The VC150 can also be used in satellite areas or alternate care settings.

"Portable" refers to the ability of the VC150 to be easily moved by the caregiver, such as on a roll stand. The VC150 is not intended to be used for continuous monitoring during patient transport.

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510(k) Summary

510(k) number: K133810 Device Trade Name: VC150

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:	Oct 30th, 2014
Submitter:	Innokas Yhtymä Oy
	Vihikari 10
	90440 Kempele
	Finland
Primary ContactPerson:	Tiina KotipaloDirector of Quality and Regulatory Affairs
	Innokas Yhtymä Oy
	Vihikari 10
	90440 Kempele, Finland
	Phone: +358 44 5623 131
	Fax: +358 8 562 3151
	Email: tiina.kotipalo@innokasmedical.fi
Secondary ContactPerson:	Risto SalmioProgram Manager
	Innokas Medical Engineering Oy
	Elimäenkatu 20 A
	00510 Helsinki, Finland
	Phone: +358 40 5520 878
	Fax: +358 9 730 535
	Email: risto.salmio@innokasmedical.fi
Device TradeName:	VC150
Common/UsualName:	Physiological or Vital Signs Monitor; Patient Monitor
ClassificationNames:	21 CFR 870.2300
Product Code:	MWI
PredicateDevice(s):	K102426 CARESCAPE V100 Vital Signs Monitor
	K101680 Welch Allyn Spot Ultra Vital Signs and Welch Allyn
	Spot Vital Signs LXi

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K110028 Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and Accessories

K121806 Bedside Respiratory Patient Monitoring System

Device Description: The VC150 is a portable vital signs monitor for use in hospitals and hospital-type facilities. It can be used also in satellite areas or alternate care settings. The monitor is used for adult, pediatric, and neonatal patients, one at a time. The battery-operated monitor offers non-invasive determination of blood pressure (systolic, diastolic, and mean arterial blood pressure), pulse rate, temperature, oxygen saturation, total hemoglobin, carboxyhemoglobin, methemoglobin, and respiration rate. The VC150 monitor includes features and measurement modules that are optional or configurable. The monitors can be equipped with the following parameters and technologies:

NIBP and pulse rate: GE SuperSTAT or Classic (auscultatory) algorithms
SpO2 and pulse rate: GE TruSignal, Nellcor OxiMax, or ● Masimo Rainbow SET
Respiration rate: Nellcor OxiMax or Masimo Rainbow SET
Hemoglobin (SpHb), Methemoglobin (SpMet), Oxygen Content (SpOC), and Carboxyhemoglobin (SpCO): Masimo Rainbow SET
. Temperature: Welch Allyn SureTemp Thermometer or Exergen Temporal Arterial Thermometer

The VC150 is intended to monitor a single patient's vital signs at Intended use: the site of care or during intra-hospital transport.

The noninvasive oscillometric blood pressure parameter is intended for measurement of systolic, diastolic, and mean arterial blood pressure, as well as pulse rate, for adult, pediatric and

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Image /page/6/Picture/0 description: The image contains the logo for Innokas Medical. The logo consists of a circular icon with a stylized letter "m" inside, accompanied by the text "Innokas" in a dark green, sans-serif font, with the word "Medical" underneath in a lighter gray color. The icon is positioned to the left of the text, creating a balanced and professional visual identity.

neonatal patients.

The optional GE TruSignal pulse oximetry and accessories are indicated for continuous noninvasive monitoring of functional oxygen saturation (SpO₂) and pulse rate, including monitoring during conditions of clinical patient motion or low perfusion, with adult, pediatric and neonatal patients.

The optional Masimo Rainbow SET® Pulse CO-oximetry and accessories are indicated for the continuous noninvasive monitoring of:

. functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, during both no motion and motion conditions, and for patients who are well or poorly perfused (low perfusion) for adult, pediatric and neonatal patients,
. carboxyhemoglobin saturation (SpCO) for adult and pediatric patients,
methemoglobin saturation (SpMet) for adult, pediatric and neonatal patients,
total hemoglobin concentration (SpHb) for adult and ● pediatric patients, and/or
. respiratory rate (RRa) for adult and pediatric patients.

The optional Nellcor™ oximetry and accessories are indicated for the continuous, noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients during both motion and non-motion conditions, and for patients who are well or poorly perfused. The optional Oximax SPD™ Alert (SPD) feature is intended only for facility-use care of adults to detect patterns of desaturation indicative of repetitive reductions in airflow through the upper airway and into the lungs.

The optional Nellcor™ Respiration Rate parameter is intended for the continuous, noninvasive monitoring of respiration rate in adult patients who are well perfused during non-motion conditions.

The optional Welch Allyn SureTemp Plus electronic thermometer

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Image /page/7/Picture/0 description: The image shows the logo for Innokas Medical. The logo consists of a circular icon with the letter "m" inside, and the words "Innokas Medical" to the right of the icon. The word "Innokas" is in a darker green color, while the word "Medical" is in a lighter gray color.

is intended to measure oral, axillary, and rectal temperature of adult and pediatric patients. The optional Exergen TemporalScanner thermometer is intended for the intermittent measurement of human body temperature of patients of all ages.

The portable device is designed for use in hospitals and hospitaltype facilities. The VC150 can also be used in satellite areas or alternate care settings.

"Portable" refers to the ability of the VC150 to be easily moved by the caregiver, such as on a roll stand. The VC150 is not intended to be used for continuous monitoring during patient transport.

The VC150 employs the same fundamental scientific Technology: technology as its predicate devices. Conclusion from the substantial equivalence comparison submitted with this 510(k) demonstrate that VC150 monitor is as safe and effective and performs substantially equivalent as the following predicate devices:
- CARESCAPE V100 Vital Signs Monitor (K102426) ●
- Welch Allyn Spot Ultra Vital Signs and Welch Allyn ● Spot Vital Signs LXi (K101680)
- Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter ● and Accessories (K110028)
- Bedside Respiratory Patient Monitoring System (K121806)

Determination of Summary of Non-Clinical Tests:

Substantial Equivalence:

The VC150 and its applications comply with voluntary standards as detailed in this premarket submission. The following quality assurance measures have been applied to the development of the system:

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Establishment of requirements
Risk management activities
Design reviews .
Design verification testing
System integration testing
System verification and validation testing ●
Performance testing
Safety testing
Usability testing .

Summary of Clinical Tests:

The subject of this premarket submission, VC150, did not require clinical studies to support substantial equivalence.

The results of these activities demonstrate that the VC150 Conclusion: monitor is as safe, as effective, and performs as well as or better than the predicate devices.

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).