MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX

K070291 · Medix I.C.S.A. · FMZ · Sep 21, 2007 · General Hospital

Device Facts

• Record ID: K070291
• Device Name: MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX
• Applicant: Medix I.C.S.A.
• Product Code: FMZ · General Hospital
• Decision Date: Sep 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5400
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Medix Natal Care ST-MX/LX/BX Intensive Care Incubator provides a controlled thermal environment for neonates who are unable to provide their own thermoregulation. The Medix Natal Care ST-MX/LX/BX Intensive Care Incubator can be used in two operating model: Air Control Mode and Skin Control Mode with two probes that can be used with twins or for a follow up of central/peripheral temperature variations in a patient as a tool for the early detection of thermal stress-effect on the newborn.

Device Story

Neonatal intensive care incubator providing controlled thermal environment; utilizes microprocessor-based temperature control. Inputs include skin and air temperature via two probes; optional inputs include pulse oximetry, humidity, oxygen, and weight. Operates in Air Control or Skin Control modes. Features include double-wall hood, Trendelenburg/Fowler positioning, and access ports. Used in clinical settings by healthcare providers. Displays temperature data, alarms, and trends on LCD or electroluminescent screens. Assists clinicians in maintaining patient thermoregulation and detecting thermal stress. Benefits include stable environment for neonates unable to regulate body temperature.

Clinical Evidence

Bench testing only. Included functional performance and electrical safety testing per FDA guidance documents and regulations.

Technological Characteristics

Microprocessor-controlled neonatal incubator. Features double-wall construction, mobile panel, and dual skin temperature probes. Displays: LCD (LX model) or electroluminescent (MX model). Connectivity: optional modular accessories for pulse oximetry, humidity, oxygen, and weighing. Dimensions: H 53 in x W 41.3 in x D 23.5 in. Includes Trendelenburg/Fowler positioning and multiple access ports.

Indications for Use

Indicated for neonates unable to provide their own thermoregulation. Used for controlled thermal environment, including twin monitoring or central/peripheral temperature variation tracking for early detection of thermal stress.

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

• Medix PC-305 (K920049)
• Isolette Infant Incubator, Model C2HS, Hill-Rom Air Shields (K001242)

Submission Summary (Full Text)

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K06291 15 5

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Image /page/0/Picture/2 description: The image shows the logo for "medix i.c.s.a.". The word "medix" is in a stylized font, with each letter made up of thick, parallel lines. The word is enclosed in a rectangular box with rounded corners. Below and to the right of "medix" is the text "i.c.s.a.", written in a smaller, simpler font. The overall design is clean and professional.

Image /page/0/Figure/3 description: The image contains three logos. The first logo has the letters DNV stacked vertically with two anchors above the letters. Below the letters is the text "ISO 9001 ISO 13485 CERTIFIED COMPANY". The second logo has a symbol above the text "NORWEGIAN ACCREDITATION 2005". The third logo is the same as the first logo, but the text below the letters DNV is "ISO-9001 REGISTERED FIRM".

# Summarv

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92 for the Medix, NATAL CARE ST-MX/LX/BX incubator.

### Company making the submission:

| | This summary is submitted by: | or | Correspondent/US Agent: |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------|----|-------------------------------------------------------------------------------------------------------|
| Name<br>Address | Medix i.c.s.a<br>Calle 89 Jose Arias 293<br>(B1672ACA) Villa Lynch<br>San Martin Buenos Aires<br>Argentina | | Delphi Consulting Group<br>11874 South Evelyn Circle<br>Houston, Texas 77071-3404<br>USA |
| Telephone<br>Fax<br>Toll Free<br>Contact<br>E-mail | (54-11) 4754-5555<br>(54-11) 4754-1713<br><br>Juan Carlos Guerra<br>[e-mail] | | [phone]<br>[phone]<br>[phone]<br>J. Harvey Knauss<br>[e-mail] |

#### ﻟﺴﻴﻨﻴ Device Name:

| Trade/Proprietary Name: | NATAL CARE ST-MX/LX/BX incubator |
|-------------------------|--------------------------------------|
| Common/Usual Name: | Neonatal Incubator |
| Classification Name: | Incubator, Neonatal, 21 CFR 880.5400 |

#### 2. Predicate Devices:

The NATAL CARE ST-MX/LX/BX incubator is substantially equivalent to other neonatal incubators on the market such as: Medix PC-305, K920049, Medix i. s.a. and Isolette Infant Incubator, Model C2HS, Hill-Rom Air Shields, K001242.

#### Intended Use Statement: 3.

Indications for Use: The Medix Natal Care ST-MX/LX/BX Intensive Care Incubator provides a controlled thermal environment for neonates who are unable to provide their own thermoregulation. The Medix Natal Care ST-MX/LX/BX Intensive Care Incubator can be used in two operating model: Air Control Mode and Skin Control Mode with two probes that can be used with twins or for a follow up of central/peripheral temperature variations in a patient as a tool for the early detection of thermal stress-effect on the newborn.

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## 4 . Description of Device:

The NATAL CARE ST-MX/LX/BX incubator is a new updated line of intensive care incubators with skin and air microprocessor temperature control. incorporating the latest technical and design advances for neonatal care.

The distinctive features of an intensive care incubator are offered: together with large displays showing skin and air temperature, with their respective control temperatures. A graphic display (electroluminescent or LCD) allows the selection of a conflagration options menu, and checks modular accessories that are optionally incorporated (pulse oximetry, humidity servo control, oxygen servo control, weighing scales).

NATAL CARE ST-MX/LX/BX incubator is comprised of three main elements: the clear hood, shell and stand. Together they measure H 53 in X W 41.3 in X D 23.5 in.

Two skin temperature probes are incorporated, allowing its use with twins or for a follow up of central/peripheral temperature variations in a patient as a tool for the early detection of thermal stress- effect on the newborn.

### Basic Models:

| NATAL CARE<br>ST-BX | INTENSIVE CARE UNIT INCUBATOR includes a mobile panel<br>with displays for Air and Skin temperature, alarm indicators,<br>Trendelemburg and Flowler continuous movement, double wall,<br>4 access doors with 180° swinging (two therapy and two lateral<br>auxiliary ones), 4 oval hand ports, tow on each therapy door and<br>one iris diaphragm port on one of the auxiliary doors, 8 IV ports,<br>X-Ray tray. Additional accessories may be added. |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| NATAL CARE ST-<br>LX | INTENSIVE CARE UNIT INCUBATOR includes a mobile panel<br>with a LCD liquid crystal graphic display. Air and Skin<br>temperature, alarms, curves, comfort zone, patient identification,<br>electric Trendelemburg and Fowler, double wall with 180°<br>swinging (two therapy and two lateral auxiliary ones), 4 oval hand<br>ports, tow on each therapy door and one iris diaphragm port on<br>one of the auxiliary doors, 8 IV ports, X-Ray tray. Additional<br>accessories may be added. |
| NATAL CARE ST-<br>MX | INTENSIVE CARE UNIT INCUBATOR includes a mobile panel<br>with an electroluminescent display. Air and Skin temperature,<br>alarms, curves, comfort zone, patient identification, electric<br>Trendelemburg and Fowler, double wall with 180° swinging (two<br>therapy and two lateral auxiliary ones), 4 oval hand ports, tow on<br>each therapy door and one iris diaphragm port on one of the<br>auxiliary doors, 8 IV ports, X-Ray tray. Additional accessories<br>may be added. |

CALLE 89 JOSE ARIAS 293 - (B1672ACA) VILLA LYNCH - SAN MARTIN BUENOS AIRES - REP. ARGENTINA - TEL. [phone] - FAX: [phone] e - mail: medix . com . ar - http://www.medix.com/ar

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#### 5. Summary of the technological characteristics of the device compared to predicate devices:

The modifications from the Medix PC-305 K920049 are:

- . Redesign of system controller and display
- Redesign of airflow system, double walls .
- Ability to use two body temperature sensors .

The modifications from the Hill-Rom Air-Shields Isolette K001242 are: None.

Method of construction and materials are very similar. Method of operation and Indications for Use are the same as the predicate devices.

- 6. Testing:
Testing of the Medix NATAL CARE ST-MX/LX/BX incubator included functional performance and electrical safety testing as outlined in FDA Guidance Documents and regulations.

- 7. Rx or OTC
The Medix NATAL CARE ST-MX/LX/BX incubator is a Rx device. Prescription device per 21 CFR Subpart D.

- 8. Conclusions:
Based upon the testing and comparison to the predicate devices the Medix NATAL CARE ST-MX/LX/BX incubator has the same intended use, with similar technological characteristics. The system performs as intended and does not raise any new safety or effectiveness issues.

Medix i.c.s.a.

J. Lull

Eng. Juan Carlos Guerra Vice President & CEO

SHIPPED JAN 17 2007 Date:

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure embracing a globe. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 1 2007

Medix i.c.s.a C/O Mr. James Harvey Knauss Consultant Delphi Consulting Group 11874 South Evelyn Circle Houston, Texas 77071

Re: K070291

Trade/Device Name: MEDIX Natal Care Intensive Care Incubator, Models – Natal Care ST-MX/LX/BX Regulation Number: 21 CFR 880.5400 Regulation Name: Neonatal Incubator Regulatory Class: II Product Code: FMZ Dated: September 11, 2007 Received: September 12, 2007

Dear Mr. Knauss:

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 tar898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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### Page 2 - Mr. Knauss

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 (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 Runser

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 Statement

K 070291 510(k) Number

Device Name:

MEDIX Natal Care Intensive Care Incubator, Models - Natal Care ST-MX/LX/BX

Indications for Use: The Medix Natal Care ST-MX/LX/BX Intensive Care Incubator provides a controlled thermal environment for neonates who are unable to provide their own thermoregulation. The Medix Natal Care ST-MX/LX/BX Intensive Care Incubator can be used in two operating modes: Air Control Mode and Skin Control Mode with two probes that can be used with twins or for a follow up of central/peripheral temperature variations in a patient as a tool for the early detection of thermal stress-effect on the newborn.

Prescription Use YES (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Arin On

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K474291

Indications for use statement.do DCG