The Neo-Servo i Atom Infant Incubator Model 102 is a closed-type incubator for newborns and premature neonates. It is mainly intended for temperature control in neonatal hypothermia, observation and examination in newborn nurseries, prevention of body temperature drop shortly after delivery, and pre-operative and post-operative intensive care in neonatal surgery. The incubator is provided with a function to control the infant's skin temperature.

Device Description

The Neo-Servo i Atom Infant incubator Model 102 consists of a hood, a main body, a control panel and is offered with or without a stand with casters. The Model 102 incorporates two (2) modes of control: air (manual control) and baby (servo control).

The Model 102 incorporates the sensors (humidity and temperature) inside the hood monitor the air conditions inside the hood. These are connected to the Sensor module. It is equipped with an incubator air temperature control function to circulate air containing the heat generated b the heater attached to the conditioning chamber inside the hood by means of a fan in order to maintain the incubator air temperature at a fixed level. It is equipped with a skim temperature control function o maintain the infant's skin temperature at a fixed level in response to the patient's temperature as measured by the skin probe. There are optional humidity chamber and x-ray cassette tray.

There are 2 functional modes:

Skin temperature control mode referred to as "Servo Control Mode" 1.
Air temperature control mode referred to as "Manual Control Mode" 2.

AI/ML Overview

The provided text describes the Neo-Servo i Atom Infant Incubator Model 102 and its substantial equivalence to a predicate device (Atom Model V-2200 – K061856). The information focuses on design, indications for use, and adherence to performance standards rather than a study proving the device meets specific acceptance criteria through a clinical trial or AI model evaluation.

Therefore, many of the requested categories related to AI performance, sample sizes, expert ground truth, and adjudication methods are not applicable to this document. The document primarily demonstrates substantial equivalence by comparing the device's features and compliance with recognized safety and performance standards.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a comparison to a predicate device, which implicitly defines "acceptance criteria" as meeting or exceeding the predicate's performance and complying with relevant standards.

Feature / Criterion	Acceptance Criteria (Implicit from Predicate & Standards)	Reported Device Performance (Neo-Servo i Atom Infant Incubator Model 102)
Indications for Use	Intended for temperature control, observation, and critical care for newborns/premature neonates, with skin temperature control.	Identical to predicate: temperature control in neonatal hypothermia, observation/examination, prevention of body temperature drop, pre/post-operative intensive care; skin temperature control.
Environment of Use	Hospital, delivery suites, NICU.	Identical to predicate: Hospital, delivery suites, NICU.
Patient Population	Infants and neonates ≤ 10 kg.	Identical to predicate: Infants and neonates ≤ 10 kg.
Technology and Design	Similar to predicate (Atom V-2200).	Identical technology and design to Atom V-2200.
Materials (patient contact)	Similar to predicate.	Identical to predicate K061856.
Skin Temperature Setting Range (Servo)	34 - 37.5 °C (override 37.6 - 38.0 °C).	Identical: 34 - 37.5 °C (override mode 37.6 - 38.0 °C).
Incubator Air Temperature	23 - 39 °C (including override).	Identical: 23 - 39 °C (including override).
Display Range (Skin)	30.0 - 42 °C, Accuracy ± 0.3 °C.	Identical: 30.0 - 42 °C, Accuracy ± 0.3 °C.
Display Range (Air)	20.0 - 42.0 °C, Accuracy ± 0.3 °C.	Identical: 20.0 - 42.0 °C, Accuracy ± 0.3 °C.
Heater Output	0 - 100% in 10 increments.	Identical: 0 - 100% in 10 increments.
Warm-up Time	≤ 60 min @ 25°C.	Identical: ≤ 60 min @ 25°C.
Humidity Setting Range	40 - 95% RH.	Identical: 40 - 95% RH.
Humidity Display	15 - 99% RH.	Identical: 15 - 99% RH.
Continuous Humidity	~ 8 hours.	Identical: ~ 8 hours.
Oxygen Supply (Max Concentration)	≥ 65% @ 10 Lpm.	Identical: ≥ 65% @ 10 Lpm.
Environment CO2 Concentration	< 0.4% at center of mattress at 750 ml/min.	Identical: < 0.4% at center of mattress at 750 ml/min.
Safety and Performance Standards Compliance	Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60061-2-19.	"Performance testing has been performed according to recognized standards and the proposed device met and passed all testing criteria." (Specific results not detailed in this summary).

2. Sample Sizes Used for the Test Set and Data Provenance

This information is not provided in the document. The submission relies on performance testing against standards, not a test set of data in the context of an AI/algorithm evaluation.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable as this is a medical device (incubator) submission based on engineering performance testing and substantial equivalence, not an AI/algorithmic device requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

Not applicable for the same reasons as #3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This document does not mention any MRMC study or AI assistance.

6. If a Standalone (Algorithm Only) Performance Study Was Done

No. This device is a physical incubator, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the defined performance specifications within recognized standards (IEC 60601 series) and the performance characteristics of the predicate device. The device's performance was measured against these established engineering and safety benchmarks.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the same reasons as #8.

Summary of the Study Proving Acceptance Criteria:

The "study" demonstrating the Neo-Servo i Atom Infant Incubator Model 102 meets acceptance criteria is primarily a series of engineering performance tests and assessments against recognized international standards (IEC 60601-1, IEC 60601-1-2, IEC 60061-2-19) and a direct comparison to a legally marketed predicate device (Atom Model V-2200, K061856) to establish substantial equivalence.

The document states: "Performance testing has been performed according to recognized standards and the proposed device met and passed all testing criteria." This indicates that the device underwent rigorous bench testing to ensure it conforms to the safety and performance requirements outlined in these standards, and that its functional specifications match or are acceptably similar to the predicate device. The detailed results of these tests are not included in this summary but would have been part of the full 510(k) submission.

Summary

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Premarket Notification 510(k) Section 5 - 510(k) Summary

Neo-Servo i

DEC 2 2 2010

510(k) Summary Page 1 of 4 17-Sept-10

Atom Medical Corporation 3-18-15, Hongo, Bunkyo-ku Tel - 011-81-3-3815-3632

Tokyo, Japan 113-0033

Tokyo, Japan 113-0033	Fax – 011-81-3-3812-3199
Official Contact:	Tsuyoshi Sugino – Regulatory Affairs Manager
Proprietary or Trade Name:	Neo-Servo i Atom Infant Incubator Model 102
Common/Usual Name:	Neonatal Incubator
Classification Name/Code:	FMZ – neonatal incubatorCFR 880.5400
Device:	Neo-Servo i Atom Infant Incubator Model 102
Predicate Devices:	Atom Model V-2200 – K061856

Device Description:

There are 2 functional modes:

Skin temperature control mode referred to as "Servo Control Mode" 1.
Air temperature control mode referred to as "Manual Control Mode" 2.

Indications for Use:

Environment of Use: Hospitals, delivery suites, NICU

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510(k) Summary Page 2 of 4

17-Sept-10

Summary of substantial equivalence

	Proposed	Predicate
	Neo-Servo i	K061856
	Atom Infant Incubator Model 102	Atom V-2200 Infant Incubator
Indications for Use	The Neo-Servo i Incubator Model 102is a closed-type incubator for newbornsand premature neonates. It is mainlyintended for temperature control inneonatal hypothermia, observation andexamination in newborn nurseries,prevention of body temperature dropshortly after delivery, and pre-operativeand post-operative intensive care inneonatal surgery. The incubator isprovided with a function to control theinfant's skin temperature.	The V-2200 infant incubator is intendedto keep premature neonates or infants ina warm environment which is coveredby a hood and isolated from ambient airand of which internal air temperatureand humidity, are controlled.
Environment of use	Hospital, delivery suites, NICUNot for transport	Hospital, delivery suites, NICUNot for transport
Patient Population	Infant and neonates ≤ 10 kg	Infant and neonates ≤ 10 kg
Features and Performance Characteristics
Overall dimensions	With HL stand100(D) x 60(W) x 138-158(H) cmMattress - 65(W) x 36.5(D) x 2(T) cmAdjustable height of 86 - 106 cm fromthe floor to the mattress top	With HL stand109 (D) x 61(W) x 133-153(H) cmMattress - 74(W) x 36(D) x 2(T) cm
Weight	90 kg	107.5 kg
Major components	HoodMain bodyControl unit	HoodMain bodyControl unit
Power	AC 120V	AC 120 V
Operating conditions	Ambient - 20-30 °CRH - 30-75%	Ambient - 20-30 °CRH - 30-75%
Storing conditions	Ambient - 0-50 °CRH - 30-75%	Ambient - 0-50 °CRH - 30-75%
Maximum load capacity	IV Pole ~ 10 kgDrawer ~ 3kg	IV Pole ~ 5kgDrawer ~ 5kgMF Rail ~ 10kg
	Proposed	Predicate
	Neo-Servo i	K061856
	Atom Infant Incubator Model 102	Atom V-2200 Infant Incubator
Features and Performance Characteristics (continued)
Accessories / optionalcomponents	Skin Temperature ProbeElectrostatic Air filterAccess port coversX-ray cassette tray (optional)Humidifier chamber (optional)	Skin Temperature ProbeElectrostatic Air filterAccess port coversX-ray cassette tray (optional)Humidifier chamber (optional)Optional only on V-2200Pulse oximeterOxygen sensor
Control modes	Manual and Servo	Manual and Servo
Skin Temperature SettingRange	Servo34 - 37.5 °C(override mode 37.6 - 38.0 °C)	Servo34 - 37.5 °C(override mode 37.6 - 38.0 °C)
Incubator air temperature	23 - 39 °C (including override)	23 - 39 °C (including override)
Display range	Skin - 30.0 - 42 °CAccuracy - ± 0.3 °CAir - 20.0 - 42.0°CAccuracy - ± 0.3 °C	Skin - 30.0 - 42 °CAccuracy - ± 0.3 °CAir - 20.0 - 42.0°CAccuracy - ± 0.3 °C
Heater output	0 - 100% in 10 increments	0 - 100% in 10 increments
Warm-up time	≤ 60 min @ 25°C	≤ 60 min @ 25°C
Alarms	High temperatureSet temperatureSkin temperature	High temperatureSet temperatureSkin temperature
Humidity	In Servo mode	In Servo mode
Humidity setting range	40 - 95% RH	40 - 95% RH
Humidity display	15 - 99% RH	15 - 99% RH
Continuous humidity	~ 8 hours	~ 8 hrs
Alarms	Humidity sensorLow water levelNo waterHumidity chamber offSet humidity	Humidity sensorNo waterHumidity chamber offSet humidity
Oxygen supply	Maximum concentration ≥ 65% @ 10Lpm	Maximum concentration ≥ 65% @ 10Lpm
Environment CO2concentration in the hood	< 0.4% at center of mattress at 750ml/min	< 0.4% at center of mattress at 750ml/min
Oxygen supply	Maximum concentration ≥ 65% @ 10Lpm	Maximum concentration ≥ 65% @ 10Lpm
Other alarms	FanSystem failure	FanSystem failurePower failure
Other functions	Not offeredNot offered	SpO2 monitoring (optional)Oxygen (FiO2) control (optional)
Mattress	Tilting	Titling
X-ray cassette	Optional	Optional
Performance testing
Performance testing has beenperformed per the followingstandards	IEC 60601-1 (1995) – MedicalElectrical Equipment - Part 1: GeneralRequirements for Safety, 1988;Amendment 2IEC 60601-1-2 : 2001- MedicalElectrical Equipment - Part 1-2: Generalrequirements for Safety-Collateralstandard: Electromagnetic compatibilityRequirements and tests (Edition 3)IEC 60061-2-19 (1996) - Amendment 1- Medical Electrical Equipment - Part 2:Particular Requirements for Safety ofBaby Incubators.	IEC 60601-1 (1995) – MedicalElectrical Equipment - Part 1: GeneralRequirements for Safety, 1988;Amendment 2IEC 60601-1-2 : 2001-- MedicalElectrical Equipment - Part 1-2: Generalrequirements for Safety-Collateralstandard: Electromagnetic compatibilityRequirements and tests (Edition 3)IEC 60061-2-19 (1996) - Amendment 1- Medical Electrical Equipment - Part 2:Particular Requirements for Safety ofBaby Incubators.

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Premarket Notification 510(k)
Section 5 – 510(k) Summary

510(k) Summary

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Premarket Notification 510(k) Section 5 – 510(k) Summary

510(k) Summary Page 4 of 4 17-Sept-10

Substantial Equivalence Rationale

The Neo-Servo i Atom Infant Incubator Model 102 is viewed as substantially equivalent to the predicate device because:

Indications -

Identical to predicate Atom V-2200 Infant incubator K061856 .

Technology -

Identical technology and design Atom V-2200 Infant incubator K061856 .

Materials -

The materials in patient contact are identical to the predicate K061856 .

Environment of Use -

Identical to predicate Atom V-2200 Infant incubator K061856 .

Performance Testing -

Performance testing has been performed according to recognized standards and the proposed device met and passed all testing criteria.

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

Atom Medical Corporation C/O Mr. Paul Dryden Promedic. Incorporated 24301 Woodstage Drive Bonita Springs, Florida 34134

DEC 2 2 2000

Re: K102710

Trade/Device Name: Neo-Servo I Atom Infant Incubator Model 102 Regulation Number: 21 CFR 880.5400 Regulation Name: Neonatal Incubator Regulatory Class: II Product Code: FMZ Dated: November 22, 2010 Received: November 23, 2010

Dear Mr. Dryden:

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- Mr. Dryden

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 (OS) 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/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/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,

Anthony D. Watson, B.S., M.S., M.B.A. 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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K102710 DEC 2 2 2010

Indications for Use Statement

Page 1 of 1

510(k) Number:

(To be assigned)

Device Name:

Neo-Servo i Atom Infant Incubator Model 102

Indications for Use:

Environment of use - Hospitals, delivery suites, NICU

Prescription Use XX (Part 21 CFR 801 Subpart D) or

Over-the-counter use (21 CFR 807 Subpart C)

Red C. 12/20/10

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital
Division of Anest Devises Division of Anool, Dental Devices

510(k) Number:

Regulation Number and Section

§ 880.5400 Neonatal incubator.

(a)
Identification. A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.(b)
Classification. Class II (performance standards).