(234 days)
Not Found
No
The description mentions "microprocessor temperature control" and "graphic display" for configuration and checking accessories, but there is no mention of AI, ML, or any learning or adaptive algorithms. The control appears to be based on pre-programmed logic and sensor feedback.
Yes
The device is an intensive care incubator that provides a controlled thermal environment for neonates, which is a form of medical treatment to maintain their health.
No
The device is an intensive care incubator that provides a controlled thermal environment for neonates. While it uses probes for temperature monitoring and mentions "early detection of thermal stress-effect," its primary function is therapeutic (providing a controlled environment), not diagnostic. The temperature readings are for control and monitoring, not for diagnosing a disease.
No
The device description clearly outlines physical components like a clear hood, shell, stand, and temperature probes, indicating it is a hardware device with integrated software for control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Medix Natal Care ST-MX/LX/BX Intensive Care Incubator is a device that provides a controlled thermal environment for neonates. It monitors and regulates temperature using probes placed on the patient's skin.
- Lack of Sample Analysis: The device does not analyze any samples taken from the body. It directly interacts with the patient to maintain their body temperature.
Therefore, the function and intended use of this incubator clearly fall outside the scope of in vitro diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FMZ
Device Description
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 ST-BX: INTENSIVE CARE UNIT INCUBATOR includes a mobile panel with displays for Air and Skin temperature, alarm indicators, Trendelemburg and Flowler continuous movement, double wall, 4 access doors with 180° swinging (two therapy and two lateral auxiliary ones), 4 oval hand ports, tow on each therapy door and one iris diaphragm port on one of the auxiliary doors, 8 IV ports, X-Ray tray. Additional accessories may be added.
NATAL CARE ST-LX: INTENSIVE CARE UNIT INCUBATOR includes a mobile panel with a LCD liquid crystal graphic display. Air and Skin temperature, alarms, curves, comfort zone, patient identification, electric Trendelemburg and Fowler, double wall with 180° swinging (two therapy and two lateral auxiliary ones), 4 oval hand ports, tow on each therapy door and one iris diaphragm port on one of the auxiliary doors, 8 IV ports, X-Ray tray. Additional accessories may be added.
NATAL CARE ST-MX: INTENSIVE CARE UNIT INCUBATOR includes a mobile panel with an electroluminescent display. Air and Skin temperature, alarms, curves, comfort zone, patient identification, electric Trendelemburg and Fowler, double wall with 180° swinging (two therapy and two lateral auxiliary ones), 4 oval hand ports, tow on each therapy door and one iris diaphragm port on one of the auxiliary doors, 8 IV ports, X-Ray tray. Additional accessories may be added.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
neonates / newborn
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
K06291 15 5
Image /page/0/Picture/1 description: The image shows a date, "SEP 21 2007". The month is September, the day is the 21st, and the year is 2007. The text is in a simple, sans-serif font and is left-aligned.
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 | |||
| Address | Medix i.c.s.a | ||
| Calle 89 Jose Arias 293 | |||
| (B1672ACA) Villa Lynch | |||
| San Martin Buenos Aires | |||
| Argentina | Delphi Consulting Group | ||
| 11874 South Evelyn Circle | |||
| Houston, Texas 77071-3404 | |||
| USA | |||
| Telephone | |||
| Fax | |||
| Toll Free | |||
| Contact | |||
| (54-11) 4754-5555 | |||
| (54-11) 4754-1713 |
Juan Carlos Guerra
jcguerra@medix.com.ar | | (832) 285-9423
(832) 615-3550
(888) 216-6521
J. Harvey Knauss
Harvey@delphiconsulting.com |
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.
1
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
ST-BX | INTENSIVE CARE UNIT INCUBATOR includes a mobile panel
with displays for Air and Skin temperature, alarm indicators,
Trendelemburg and Flowler continuous movement, double wall,
4 access doors with 180° swinging (two therapy and two lateral
auxiliary ones), 4 oval hand ports, tow on each therapy door and
one iris diaphragm port on one of the auxiliary doors, 8 IV ports,
X-Ray tray. Additional accessories may be added. |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| NATAL CARE ST-
LX | INTENSIVE CARE UNIT INCUBATOR includes a mobile panel
with a LCD liquid crystal graphic display. Air and Skin
temperature, alarms, curves, comfort zone, patient identification,
electric Trendelemburg and Fowler, double wall with 180°
swinging (two therapy and two lateral auxiliary ones), 4 oval hand
ports, tow on each therapy door and one iris diaphragm port on
one of the auxiliary doors, 8 IV ports, X-Ray tray. Additional
accessories may be added. |
| NATAL CARE ST-
MX | INTENSIVE CARE UNIT INCUBATOR includes a mobile panel
with an electroluminescent display. Air and Skin temperature,
alarms, curves, comfort zone, patient identification, electric
Trendelemburg and Fowler, double wall with 180° swinging (two
therapy and two lateral auxiliary ones), 4 oval hand ports, tow on
each therapy door and one iris diaphragm port on one of the
auxiliary doors, 8 IV ports, X-Ray tray. Additional accessories
may be added. |
CALLE 89 JOSE ARIAS 293 - (B1672ACA) VILLA LYNCH - SAN MARTIN BUENOS AIRES - REP. ARGENTINA - TEL. (54-11) 4754-5555 - FAX: (54-11) 4764-1713 e - mail: medix . com . ar - http://www.medix.com/ar
2
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.
-
- 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.
- Testing:
-
- Rx or OTC
The Medix NATAL CARE ST-MX/LX/BX incubator is a Rx device. Prescription device per 21 CFR Subpart D.
- Rx or OTC
-
- 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.
- Conclusions:
Medix i.c.s.a.
J. Lull
Eng. Juan Carlos Guerra Vice President & CEO
SHIPPED JAN 17 2007 Date:
3
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.
4
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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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
5
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