The V-2100G Advanced Infant Incubator is a hooded container that is intended to provide a controlled thermal environment and isolation from ambient air for premature and neonatal infants. The V-2100G is not intended for the transport of infants.

Device Description

The V-2100G Infant Incubator provides standard functions to control the incubator temperature, either by manual (air) or servo (baby) control, and air humidity. The incubator also provides an external communication function that allows data to be exported to the user's PC for evaluation and storage. In addition, the incubator provides the following optional functions: oxygen controller, pulse oximeter, and weight monitor.

The temperature in the incubator can be controlled using one of two modes: manual control mode or servo control mode. In manual control mode, the incubator air temperature is controlled to maintain the desired infant temperature. The air temperature is initially set based on the user's training and experience and is then adjusted based on the infant's needs and clinical status. In the servo control mode, a skin temperature probe is attached to the infant and is monitored by the incubator controller. The heater output is controlled to maintain the infant's skin temperature at a set value. Changes to the heater output are made gradually, so as to minimize temperature overshoot and infant stress.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called the "V-2100G Advanced Infant Incubator." This document is used for regulatory submission to the FDA and primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results typical for novel devices or AI/software-as-a-medical-device (SaMD) clearances.

Therefore, many of the requested categories related to clinical studies, AI performance, ground truth, and expert adjudication are not applicable or extractable from this specific document. The performance testing mentioned is for functional and design verification against recognized consensus standards for medical electrical equipment and infant incubators, not for evaluating accuracy or effectiveness in an AI context.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard Compliance)	Reported Device Performance (Compliance Statement)
IEC 60601-1 (1988-12) Medical Electrical Equipment, Part 1: General Requirements for Safety	"demonstrates that the V-2100G Infant Incubator is in compliance with... IEC 60601-1"
EN 60601-1-2 (1993) Medical Electrical Equipment, Part 1: General Requirements for Safety, Electromagnetic Compatibility – Requirements and Tests	"demonstrates that the V-2100G Infant Incubator is in compliance with... EN 60601-1-2"
IEC 60601-2-19 (1990-12) Medical Electrical Equipment, Part 2: Particular Requirements for Safety of Baby Incubators	"demonstrates that the V-2100G Infant Incubator is in compliance with... IEC 60601-2-19"
ISO 7767 (1997) Oxygen Monitors for Monitoring Patient Breathing Mixtures – Safety Requirements	"demonstrates that the V-2100G Infant Incubator is in compliance with... ISO 7767" (if optional oxygen controller is included and subject to this standard for monitoring)

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is described as "Performance testing for the V-2100G Infant Incubator has been conducted for functional and design verification." The summary states this testing "demonstrates that the V-2100G Infant Incubator is in compliance with the following recognized consensus standards."

Summary of Device Performance:

The device is reported to be in compliance with the listed IEC, EN, and ISO standards for medical electrical equipment safety, electromagnetic compatibility, and particular requirements for baby incubators. This indicates that the incubator meets the established safety and performance benchmarks defined by these standards for its designated function of providing a controlled thermal environment.

Further Requested Information (Not Applicable or Extractable):

Sample size used for the test set and the data provenance: Not applicable. This document describes performance testing against safety and design standards, not a clinical study with a "test set" of patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical "ground truth" or expert review is mentioned for this type of device and submission.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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-powered device nor is it a diagnostic device that involves "human readers."
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not a software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device's performance would be the specifications and requirements of the engineering and safety standards it complies with.
The sample size for the training set: Not applicable. This device does not use AI or machine learning that requires a "training set."
How the ground truth for the training set was established: Not applicable.

Conclusion:

The 510(k) summary for the V-2100G Advanced Infant Incubator demonstrates substantial equivalence through comparisons with predicate devices and compliance with recognized consensus standards for functional and design verification. It does not contain information related to clinical trials, AI performance, or expert-adjudicated ground truth, as it is a traditional medical device, not an AI/SaMD product.

Summary

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Ko21809

510(k) Summary

for

V-2100G Advanced Infant Incubator

1. SPONSOR

Atom Medical Corporation 3-18-15, Hongo Bunkyo-Ku Tokyo, 113-0033 Japan

Contact Person: Hiroshi Tanaka, Manager, Quality Regulatory Department Telephone: 03-3815-2311

Date Prepared: May 31, 2002

DEVICE NAME 2.

Proprietary Name:	V-2100G Advanced Infant Incubator
Common/Usual Name:	Infant Incubator
Classification Name:	Neonatal Incubator

నే. PREDICATE DEVICES

The V-2100G Advanced Infant Incubator is substantially equivalent to the following devices:

Air Shields Isolette® Infant Incubators and Accessories .
. Ohmeda Ohio Care Plus Infant Incubators and Accessories

4. INTENDED USE

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5. DEVICE DESCRIPTION

6. SUBSTANTIAL EQUIVALENCE

Atom Medical Corporation makes the claim of substantial equivalence based on intended use, design, operational and technological characteristics, and principles of operation. Atom Medical Corporation believes that the descriptive information, performance test summaries, and certificates of compliance provided in this premarket notification are precise enough to demonstrate the substantial equivalence of the V-2100G Infant Incubator to the identified predicate devices. The V-2100G and the predicate devices are all intended to provide a controlled environment for neonates. The V-2100G and the predicate devices all operate in both manual and servo modes for temperature control. All devices also offer humidity control as a standard function and a variety of optional functions including oxygen supply and control, a weight monitor, and an RS-232 communications module. All devices have similar displays, alarms, and user controls.

7. PERFORMANCE TESTING

Performance testing for the V-2100G Infant Incubator has been conducted for functional and design verification. This testing demonstrates that the V-2100G Infant Incubator is in compliance with the following recognized consensus standards;

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IEC 60601-1 (1988-12) Medical Electrical Equipment, Part 1: General Requirements for Safety, Amendment 1 (1991-11), Amendment 2 (1995-03)

. EN 60601-1-2 (1993) Medical Electrical Equipment, Part 1: General Requirements for Safety, Electromagnetic Compatibility-Requirements and Tests
IEC 60601-2-19 (1990-12) Medical Electrical Equipment, Part 2: Particular Requirements for Safety o f Baby Incubators, Amendment 1 (1996-10)
ISO 7767 (1997) Oxygen Monitors for Monitoring Patient Breathing Mixtures -. Safety Requirements

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with the profiles overlapping each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 8 2002

Atom Medical Corporation C/O Ms. Sheila Hemeon-Heyer, Esq. Senior Staff Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

Re: K021809

Trade/Device Name: V-2100G Advanced Infant Incubator Regulation Number: 880.5400 Regulation Name: Neonatal Incubator Regulatory Class: II Product Code: FMZ Dated: May 31, 2002 Received: June 03, 2002

Dear Ms. Hemeon-Hever:

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 such 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. Sheila Hemeon-Heyer

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); 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.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Time 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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510(k) Number (if known):

Device Name: V-2100G Advanced Infant Incubator

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Cirincione

(Division Sign-Off) (Division of Dental, Infection Control, and General Hospital Devices 510(k) Number -

Prescription Use	✓
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Atom Medical Corporation May 31, 2002 V-2100G Infant Incubator - Abbreviated 510(k)

Page viii

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).