(143 days)
Not Found
No
The description focuses on thermal regulation and environmental control using traditional heating and humidification technologies. There is no mention of AI or ML terms, image processing, or data sets for training/testing.
Yes
The device is described as assisting in maintaining an infant's skin temperature and thermal environment using radiant and convective heat, which is a therapeutic intervention for neonates.
No
This device is described as a "warming device" that provides "thermal support" and environmental control (humidification) for infants, focusing on maintaining skin temperature and thermal environment. There is no mention of it being used for diagnosis or detection of any medical condition.
No
The device description clearly outlines a physical medical device with hardware components such as heaters, canopies, side panels, and a mobile, caster-mounted structure. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The Versalet 7700 Care Center is a warming device designed to maintain an infant's skin temperature and thermal environment. It uses radiant and convective heat and can include humidification.
- Intended Use: Its intended use is for providing thermal support and environmental control for infants in a clinical setting.
The device's function and intended use are focused on providing external support and environmental control to the infant, not on analyzing biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Versalet™ 7700 Care Center is a mobile, caster mounted, neonatal device that is used to assist in maintaining an infant's skin temperature and thermal environment. The device accomplishes this through the use of radiant and convective heat. Accessories to the device permit environmental control and monitoring including humidification. It is intended for in-patient use in maternity nurseries, and neonatal care environments of hospitals or other healthcare facilities.
Product codes (comma separated list FDA assigned to the subject device)
FMZ
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 primarily through a convective air system with canopies and side panels to form an enclosure that isolates the air surrounding the infant from the room air. The Versalet™ 7700 Care Center offers access to the infant by allowing the caregiver to open port holes, side panels, canopies, and, if more access is needed, raising up of the over head arm. The over head arm is the upper half of the infant enclosure containing the canopies. The over head arm can be is raised to obtain full access to the infant. The over head arm contains two Calrod (Magnesium oxide encased in Incoloy sheath) heaters that provide heat when the canopies are opened or the over head arm is raised.
In addition to providing thermal support, the Versalet™ 7700 Care Center is capable of controlling options and accessories to aid the caregiver in rendering care to the infant. A humidification accessory is designed to operate with the Versalet™ 7700 Care Center.
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
neonatal
Intended User / Care Setting
in-patient use in maternity nurseries, and neonatal care environments of hospitals or other healthcare facilities.
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)
Not Found
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.
K940951, K960980, K971366, K971198
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
3 2000 FEB
510(k) Summary
September 09, 1999
Applicant:
Hill-Rom Air-Shields 330 Jacksonville Road Hatboro, PA 19040 Reg. No: 2510954
Contact Person:
James G. Carpenter Ph: (215) 675-5200 Fx: (215) 682-8689
Device trade/proprietary name:
Versalet™ 7700 Care Center
Device common/usual/classification name:
Infant Incubator
Classification:
General Hospital 21 CFR 880.5400 Incubator Neonatal, FMZ, Class II
Performance Standards:
None applicable.
Predicate (Current) Device:
| Hill-Rom Air-Shields Resuscitaire® Radiant Warmer, | K940951 |
|---|---|
| Hill-Rom Air-Shields ISOLETTE® Infant Incubator, | K960980 |
| Hill-Rom Incuwarmer | K971366 |
| Dräger Babytherm 8004 Babytherm 8010 | K971198 |
б
1
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 primarily through a convective air system with canopies and side panels to form an enclosure that isolates the air surrounding the infant from the room air. The Versalet™ 7700 Care Center offers access to the infant by allowing the caregiver to open port holes, side panels, canopies, and, if more access is needed, raising up of the over head arm. The over head arm is the upper half of the infant enclosure containing the canopies. The over head arm can be is raised to obtain full access to the infant. The over head arm contains two Calrod (Magnesium oxide encased in Incoloy sheath) heaters that provide heat when the canopies are opened or the over head arm is raised.
In addition to providing thermal support, the Versalet™ 7700 Care Center is capable of controlling options and accessories to aid the caregiver in rendering care to the infant. A humidification accessory is designed to operate with the Versalet™ 7700 Care Center.
Intended Use:
The Versalet™ 7700 Care Center is a mobile, caster mounted, neonatal device that is used to assist in maintaining an infant's skin temperature and thermal environment. The device accomplishes this through the use of radiant and convective heat. Accessories to the device permit environmental control and monitoring including humidification. It is intended for in-patient use in maternity nurseries, and neonatal care environments of hospitals or other healthcare facilities.
Design and Construction:
Both the new and predicate device(s) utilize the same materials and methods of construction. They are fabricated from steel, aluminum, and plastic. The new device's most highly stressed areas utilize only steel and aluminum. Plastics are used in less stressed areas. Steel and aluminum components are welded or assembled with commercially available fasteners. Plastics used in less stressed areas are assembled with fasteners.
The new device electronics are controlled by a microprocessor, as are the predicate devices.
2
The subject device and predicate device(s) in this submission are substantially equivalent. All issues concerning the safety and effectiveness of the Versalet™ 7700 Care Center are addressed in the design, labeling, and manufacture of the device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a representation of the human form.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 2000 FEB
Mr. Larryl W. Krasley Regulatory Affairs Specialist Hill-Rom Air-Shields 330 Jacksonville Road Hatboro, Pennsylvania 19040
Re : K993051 Versalet 7700 Care Center Model 7700 Trade Name: Regulatory Class: II Product Code: FMZ Dated: January 6, 2000 Received: January 7, 2000
Dear Mr. Krasley:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Page 2 - Mr. Krasley
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
1993051 510(k) Number: Unknown
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 and convective heat. Accessories and options to the device permit environmental control and monitoring including humidification. It is intended for inpatient use in maternity nurseries, and neonatal care environments of hospitals or other healthcare facilities.
(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
(Optional Format 1/2/96)
Beate Balke
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_19 JOS
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