ISOLETTE INFANT INCUBATOR, MODEL C2000E

K031387 · Hill-Rom Manufacturing, Inc. · FMZ · Aug 1, 2003 · General Hospital

Device Facts

• Record ID: K031387
• Device Name: ISOLETTE INFANT INCUBATOR, MODEL C2000E
• Applicant: Hill-Rom Manufacturing, Inc.
• Product Code: FMZ · General Hospital
• Decision Date: Aug 1, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5400
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Air Shields ISOLETTE® Infant Incubator is designed to care for the smaller premature baby as well as the healthier full term baby. It does this by providing a controlled environment, one in which the baby can be provided with the necessary care as well as being left undisturbed in the security of the incubator. It is to this end that the product can be used in any department of the hospital that provides neonatal and infant care. One would typically expect the ISOLETTE® to be used in the NICU/SCBU (Neonatal Intensive Care Unit and/or the Special Baby Care Unit). The design lends itself to all levels of care in the NICU making it suitable for use in level I, II, III, and IV where applicable. Other departments would include the Step Down Nursery, Newborn Nursery and Pediatrics. This device, when fitted with the battery backup feature, may be used to move the infant from one area of the hospital to another while maintaining the controlled environment. This device is not intended for home use. This is a prescription device.

Device Story

C2000e Isolette is an enhancement of the C2000 Infant Incubator; provides controlled thermal/environmental support for neonates. Enhancements include a horizontal rail system for accessory attachment and a battery backup system for intra-hospital transport during power failure or movement. Operated by clinical staff in hospital settings (NICU, SCBU, nurseries, pediatrics). Device maintains stable environment; battery backup ensures continuity of care during transit. Benefits include undisturbed care and environmental stability for premature and full-term infants.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Neonatal incubator with horizontal accessory rail and battery backup system. Maintains controlled thermal environment. No specific materials or software algorithms described.

Indications for Use

Indicated for premature and full-term infants requiring a controlled environment for care. Suitable for use in NICU/SCBU (levels I-IV), step-down nurseries, newborn nurseries, and pediatrics. Not for home use; prescription only.

Regulatory Classification

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.

Predicate Devices

• C2000 Isolette® Infant Incubator (K960980)

Submission Summary (Full Text)

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# AUG = 1 2003

K031387

#### Section I 510(k) Summary of Safety and Effectiveness

Applicant:

Hill-Rom Air Shields 330 Jacksonville Road Hatboro, Pa. 19040 Registration No: 2510954

Contact Person:

Monica Ferrante Ph 215-682-8691 Fax [phone]

Device trade/proprietary name:

C2000e Isolette® Infant Incubator

Device common/usual/classification name:

Neonatal Incubator

Classification:

General Hospital 21 CFR 862.113 Neonatal Incubator, ???, Class II

Performance Standards:

None applicable

Predicate Device:

K960980 C2000 Isolette® Infant Incubator

Device Description

The C2000e is an enhancement to the currently marketed C2000 Isolette Infant Incubator originally cleared under 510(k) K960980. The features, functions, and performance of the C2000 incubator remain the same. The C2000e enhancements are additions to the C2000 product features. These additions are a horizontal rail system for attachment of accessories and a battery back up for the unit to maintain the controlled environment in

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the event of a power failure or to move the infant within the hospital environment.

## Intended Use

The Air Shields ISOLETTE® Infant Incubator is designed to care for the smaller premature baby as well as the healthier full term baby. It does this by providing a controlled environment, one in which the baby can be provided with the necessary care as well as being left undisturbed in the security of the incubator.

It is to this end that the product can be used in any department of the hospital that provides neonatal and infant care. One would typically expect the ISOLETTE® to be used in the NICU/SCBU (Neonatal Intensive Care Unit and/or the Special Baby Care Unit). The design lends itself to all levels of care in the NICU making it suitable for use in level I, II, III, and IV where applicable. Other departments would include the Step Down Nursery, Newborn Nursery and Pediatrics.

This device, when fitted with the battery backup feature, may be used to move the infant from one area of the hospital to another while maintaining the controlled environment.

Description of Modifications

The modifications to the device include a horizontal rail system for attachment of accessories and a battery back up for the unit to maintain the controlled environment in the event of a power failure or to move the infant within the hospital environment.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 1 2003

Ms. Monica Ferrante Regulatory Affairs Hill-Room Manufacturing, Incorporated 330 Jacksonville Road Hatboro, Pennsylvania 19040

Re: K031387

Trade/Device Name: C2000e Isolette® Infant Incubator Regulation Number: 880.5400 Regulation Name: Neonatal Incubator Regulatory Class: II Product Code: FMZ, FPL Dated: June 26, 2003 Received: June 27, 2003

Dear Ms. Ferrante:

We have reviewed your Section 510(k) premarket notification of intent to market the device reterenced 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. Iisting 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. Ferrante

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Patricia Cucurullo

Susan Runner, DDS, MA Interim Direct 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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#### SMDA Requirements Section A

### Indication for Use Statement

510(k) Number:

Device Name: C2000e Isolette® Infant Incubator

Indications for Use:

The Air Shields ISOLETTE® Infant Incubator is designed to care for the smaller premature baby as well as the healthier full term baby. It does this by providing a controlled environment, one in which the baby can be provided with the necessary care as well as being left undisturbed in the security of the incubator.

It is to this end that the product can be used in any department of the hospital that provides neonatal and infant care. One would typically expect the ISOLETTE® to be used in the NICU/SCBU (Neonatal Intensive Care Unit and/or the Special Baby Care Unit). The design lends itself to all levels of care in the NICU making it suitable for use in level I, III, III, and IV where applicable. Other departments would include the Step Down Nursery, Newborn Nursery and Pediatrics.

This device, when fitted with the battery backup feature, may be used to move the infant from one area of the hospital to another while maintaining the controlled environment.

This device is not intended for home use.

This is a prescription device.

(Please do not write below this line continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use

Patricia Cusciente

(Optional Format 1/2/96)

sthesiology. General Hosni

510(k) Number: K031387