VERSALET 7700 CARE CENTER

K053399 · Draeger Medical Infant Care, Inc. · FMZ · Aug 4, 2006 · General Hospital

Device Facts

• Record ID: K053399
• Device Name: VERSALET 7700 CARE CENTER
• Applicant: Draeger Medical Infant Care, Inc.
• Product Code: FMZ · General Hospital
• Decision Date: Aug 4, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5400
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Versalet 7700 Care Center is a mobile, caster mounted, neonatal device, which is used to assist in maintaining an infant's skin temperature and thermal environment. The device accomplishes this using radiant or convective heat. Accessories and options to the device permit environmental control and monitoring and may include optional features such as humidification and in-bed scale. It is intended for inpatient use in maternity nurseries, and neonatal care environments of hospitals or other healthcare facilities. This device is not intended for home use.

Device Story

Mobile, caster-mounted neonatal warming device; provides thermal isolation via convective air system (incubator mode) or radiant heat via overhead infrared heaters (radiant warmer mode). Transitions between modes by opening canopies and raising overhead arm; maintains convective heat during transition to minimize heat loss. Used in hospital maternity nurseries and neonatal care units; operated by clinicians. Provides thermal stability; allows caregiver access via port holes, side panels, or full canopy opening. Includes optional humidification and in-bed scale. Output consists of controlled thermal environment; assists clinicians in maintaining infant skin temperature.

Clinical Evidence

No clinical data. Bench testing and hardware/software verification and validation performed to satisfy Quality System Regulation Design Controls.

Technological Characteristics

Mobile, caster-mounted warming system. Dual-mode: convective air (incubator) and infrared radiant heating. Includes optional humidification and in-bed scale. Not intended for sterilization; cleaning/disinfection per manual. Software verification and validation performed.

Indications for Use

Indicated for neonates requiring thermal support in hospital maternity nurseries or neonatal care environments. Not for home use.

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

• Versalet 7700 Care Center (K993051)
• Giraffe OmniBed (K993407)

Submission Summary (Full Text)

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KOS3399

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

Applicant:

Draeger Medical Infant Care Inc 330 Jacksonville Road Hatboro, Pa. 19040 Registration No: 2510954

Contact Person:

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

Device trade/proprietary name:

Versalet 7700 Care Center

Device common/usual/classification name:

Infant Incubator / Infant Radiant Warmer

Classification:

General Hospital 21 CFR 880.5400, and 21 CFR 880.5130

Performance Standards:

None applicable

Predicate Device:

K993051 Versalet 7700 Care Center K993407 Giraffe OmniBed

Device Description

The Versalet™ 7700 Care Center is a warming device that combines the heating technologies of both incubators and radiant warmers into one product. The Versalet™ 7700 Care Center provides thermal isolation through a convective air system with canopies and side panels forming an enclosure that isolates the air surrounding the infant from the room air, much the same as a traditional infant incubator. The Versalet™ 7700 Care Center offers access to the infant in the incubator mode by allowing the caregiver to open port holes or side panels. If

AUG - 4 2006

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K0533 99

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more access is needed, the device can then be transitioned into a radiant warmer device by opening the canopies and raising the over head arm. This allows full access to the infant. The over head arm contains two infrared heaters that provide radiant heat only when the canopies are opened and the over head arm is fully raised. Thus the Versalet™ 7700 Care Center offers the caregiver excellent access while providing good thermal stability. While the device is in the transition mode from incubator to warmer there is a continued supply of convective heat to minimize the heat loss during this period.

### Intended Use

The Versalet 7700 Care Center is a mobile, caster mounted, neonatal device, which is used to assist in maintaining an infant's skin temperature and thermal environment. The device accomplishes this using radiant or convective heat. Accessories and options to the device permit environmental control and monitoring and may include optional features such as humidification and in-bed scale. It is intended for inpatient use in maternity nurseries, and neonatal care environments of hospitals or other healthcare facilities.

### Technological Characteristics

The new device is equivalent to currently marketed devices with regards to materials, construction and basic design. There are no new questions of safety or effectiveness with regards to the new device. The new device and currently marketed devices are considered substantially equivalent. All issues concerning safety and effectiveness of the Versalet 7700 Care Center are addressed in the design, labeling and manufacture of the device.

## Performance Data

The Versalet 7700 Care Center technology is well established in clinical practice, therefore, pre-clinical and clinical testing are not required to establish the performance of the device. Testing to the relevant international standards and product specifications to include hardware and software verification and validation satisfies the requirements of the Quality System Requlation Design Controls.

#### Sterilization Information

The Versalet 7700 Care Center, nor any of its components are intended for sterilization. The User Manual provides information for cleaning and disinfection of the system.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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AUG - 4 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Monica Ferrante Director of Regulatory Affairs Draeger Medical Infant Care, Incorporated 330 Jacksonville Road Hatboro, Pennsylvania 19040

Re: K053399

Trade/Device Name: Versalet 7700 Care Center Regulation Number: 880.5400 Regulation Name: Neonatal Incubator Regulatory Class: II Product Code: FMZ, FMZ, FMT Dated: July 14, 2006 Received: July 17, 2006

Dear Ms. Ferrante:

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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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 liederal 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 (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.

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/industry/support/index.html.

Sincerely yours.

Susan Buntne

Chiu Lin, Ph.D. 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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# Indications for Use

510(k) Number (if known): K053399

Device Name: Versalet 7700 Care Center

Indications For Use:

The Versalet 7700 Care Center is a mobile, caster mounted, neonatal device, which is used to assist in maintaining an infant's skin temperature and thermal environment. The device accomplishes this using radiant or convective heat. Accessories and options to the device permit environmental control and monitoring and may include optional features such as humidification and in-bed scale. It is intended for inpatient use in maternity nurseries, and neonatal care environments of hospitals or other healthcare facilities.

This device is not intended for home use.

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)

Rid C. Chapman for ADW 8/4/2006

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vision of Anesthesiology, General Hospital
fection Control, Dental Devices

K052299

Number: 165277