(13 days)
Not Found
No
The summary describes a standard infant incubator with temperature and humidity control, alarms, and basic mechanical features. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies.
Yes
The device is an infant incubator designed to provide a controlled thermal environment for neonates who are unable to regulate their own temperature, facilitating their transition to the external environment. This directly addresses and mitigates a physiological problem, which is a therapeutic function.
No
The device is an infant incubator designed to provide a controlled thermal environment for neonates. Its function is to support physiological regulation (thermoregulation) rather than to diagnose medical conditions. While it has alarms for monitored conditions, these are for safety and operational awareness, not for making a diagnosis.
No
The device description clearly outlines physical components like a hood, base, cabinet, controller, and mattress, indicating it is a hardware device with integrated software for control and monitoring.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The CHS-i1000 Infant Incubator provides a controlled thermal environment for neonates. It directly interacts with the patient (the neonate) to regulate their body temperature.
- Lack of Specimen Analysis: The description does not mention any analysis of biological specimens. The device's function is entirely focused on providing external support and monitoring of the neonate's environment and temperature.
Therefore, the CHS-i1000 Infant Incubator falls under the category of a medical device that provides direct patient care, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CHS-i1000 Infant Incubator provides a controlled thermal environment for neonates who are unable to provide their own thermoregulation. They may be used for short periods of time to facilitate the neonate's transition from the uterus to the external environment. The CHS-i1000 Infant Incubators can be used in two operating modes, such as Air Control Mode and Skin Control Mode. The CHS-i1000 incubator is not for the transport of the patient.
The CHS-i1000 Infant Incubator has alarms to alert clinicians when certain patient or equipment conditions occur, such as a malfunction, or an excessive departure of the patient's temperature from the set value.
The CHS-i1000 Infant Incubator incorporates other features, such as humidification of the infant environment and tilting of the bed.
Product codes
FMZ
Device Description
The CHS-i1000 incubator provides a controlled temperature and humidity for infants. It is designed to minimize the effect of external heat loss on infants.
The incubator is composed of 4 main elements namely, the hood, base, cabinet and controller. Together they measure W1000 x H1367 x D634mm. The foam based mattress that measures W690 x D370mm positions centrally within the confines of the hood. The mattress can also be raised at the head and foot end to a maximum incline of 12°. This is achieved by turning the handles that are located on each end of the base.
The hood is made of a clear acrylic to permit clear visibility of the baby yet provide isolation for the baby. The hood comprised of access ports gives access to the baby without compromising the thermal environment. Four of the access ports (two on the front and two on the rear) allow for regular access by the caregiver. The other two access ports are in the form of iris ports with are used primarily for ventilator tubes and monitoring cables to be channeled into the hood to the baby. Pulling the mattress towards the caregiver can enhance access even further.
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
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)
Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1 and EN/IEC 60601-2-19 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(1993), and Biocompatibility testing was conducted in accordance with standard ISO 10993-1. All test results were satisfactory.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
APR 2 1 2004
510(k) Submission – CHS-i1000
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: February 2, 2004
-
- Company and Correspondent making the submission:
Name - Choong Wae Medical Corp. Address – 698, Shindaebang-Dong, Dongjack-Gu, Seoul, Korea 156-010 Telephone - +82-2-840-6806 Fax - +82-2-841-1213 Contact - Mr. Myung Hak Cha Internet - http://www.cwm.co.kr
- Company and Correspondent making the submission:
-
- Device :
Proprietary Name – CHS-i1000 Neonatal Incubator Common Name - Infant Incubator Classification Name - Incubator, Neonatal
- Device :
3. Predicate Device :
Manufacturer : OHMEDA Medical Model : 4000 CARE-PLUS 510(k) No. : K974349(Decision Date - February. 12. 1998)
-
- Classifications Names & Citations :
21CFR 880.5400, FMZ, Incubator, Neonatal, Class2 Guidance document for the preparation of premarket notifications [510(k)'s] for Neonatal and Neonatal Transport Incubators.
- Classifications Names & Citations :
- Description :
The CHS-i1000 incubator provides a controlled temperature and humidity for infants. It is designed to minimize the effect of external heat loss on infants.
1
Image /page/1/Picture/0 description: The image shows a sequence of handwritten characters, which appear to be "K040910". The characters are written in a cursive style, with some connections between the letters and numbers. The writing is clear and legible, although the style is informal.
000030
510(k) Submission - CHS-i1000
The incubator is composed of 4 main elements namely, the hood, base, cabinet and controller. Together they measure W1000 x H1367 x D634mm. The foam based mattress that measures W690 x D370mm positions centrally within the confines of the hood. The mattress can also be raised at the head and foot end to a maximum incline of 12°. This is achieved by turning the handles that are located on each end of the base.
The hood is made of a clear acrylic to permit clear visibility of the baby yet provide isolation for the baby. The hood comprised of access ports gives access to the baby without compromising the thermal environment. Four of the access ports(two on the front and two on the rear) allow for regular access by the caregiver. The other two access ports are in the form of iris ports with are used primarily for ventilator tubes and monitoring cables to be channeled into the hood to the baby. Pulling the mattress towards the caregiver can enhance access even further.
6. Indication for use :
The CHS-i1000 Infant Incubator provides a controlled thermal environment for neonates who are unable to provide their own thermoregulation. They may be used for short periods of time to facilitate the neonate's transition from the uterus to the external environment. The CHS-i1000 Infant Incubators can be used in two operating modes, such as Air Control Mode and Skin Control Mode. The CHSi1000 incubator is not for the transport of the patient.
The CHS-i1000 Infant Incubator has alarms to alert clinicians when certain patient or equipment conditions occur, such as a malfunction, or an excessive departure of the patient's temperature from the set value.
The CHS-i1000 Infant Incubator incorporates other features, such as humidification of the infant environment and tilting of the bed.
- Comparison with predicate device :
Choong Wae Medical Corp., believes that the CHS-i1000 Infant Incubator is substantially equivalent to the 4000 CARE-PLUS of OHMEDA Medical.
2
-
- Safety, EMC and Performance Data :
Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1 and EN/IEC 60601-2-19 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(1993), and Biocompatibility testing was conducted in accordance with standard ISO 10993-1. All test results were satisfactory.
- Safety, EMC and Performance Data :
-
- Conclusions :
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Choong Wae Medical Corp. concludes that CHS-i1000 is safe and effective and substantially equivalent to predicate devices as described herein.
- Conclusions :
-
- Choong Wae Medical Corp. will update and include in this summary any other information deemed seasonably necessary by the FDA.
END
- Choong Wae Medical Corp. will update and include in this summary any other information deemed seasonably necessary by the FDA.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three wing-like shapes, representing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1 2004
Choongwae Medical Corporation C/O Mr. Chan Yo Won Responsible Third Party Official Underwriters Laboratories, Incorporation 2600 N.W. Lake Road Camas, Washington 98607-8542
Re: K040910
Trade/Device Name: CHS-i1000 Neonatal Incubator Regulation Number: 880.5400 Regulation Name: Neonatal Incubator Regulatory Class: II Product Code: FMZ Dated: March 9, 2004 Received: April 8, 2004
Dear Mr. Won:
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.
4
Page 2 - Mr. Won
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 (301) 594-4618. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Kein Mulvey
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
K0409/0
Indications for Use
Cim
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number(if known):
204113410 510(k) Number:
Device Name: CHS-i1000 Neonatal Incubator
Indications for Use:
CHS-i1000 Infant Incubator provides a controlled thermal The environment for neonates who are unable to provide their own thermoregulation. They may be used for short periods of time to facilitate the neonate's transition from the uterus to the external environment. The CHS-i1000 Infant Incubators can be used in two operating modes, such as Air Control Mode and Skin Control Mode. The CHS-i1000 incubator is not for the transport of the patient.
The CHS-i1000 Infant Incubator has alarms to alert clinicians when certain patient or equipment conditions occur, such as a malfunction, or an excessive departure of the patient's temperature from the set value.
The CHS-i1000 Infant Incubator incorporates other features, such as humidification of the infant environment and tilting of the bed.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 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)
000033