(241 days)
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.
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 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.
The provided text for K053399 states that "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."
This means that a detailed study proving the device meets specific acceptance criteria, as usually understood in terms of new device performance evaluation, was not performed, nor was it deemed necessary for this 510(k) submission.
Therefore, many of the requested elements about acceptance criteria and study details cannot be directly extracted from this document, as they were not part of the submission's requirements for this particular device.
Here's an attempt to answer based on the provided information, indicating when information is explicitly stated as not applicable or not provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Premarket Testing | Pre-clinical testing to establish performance | Not required (technology well-established) |
| Clinical testing to establish performance | Not required (technology well-established) | |
| Regulatory Compliance | Satisfy requirements of Quality System Regulation Design Controls, including hardware and software verification and validation | Satisfied |
| Safety and Effectiveness | No new questions of safety or effectiveness compared to predicate devices | Deemed substantially equivalent |
| Performance Standards | Compliance with applicable performance standards | None applicable |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not applicable/Not provided. Clinical testing was not required.
- Data provenance: Not applicable/Not provided. Pre-clinical and clinical data were not required.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided, as formal pre-clinical or clinical testing requiring expert ground truth establishment was not performed.
4. Adjudication method for the test set
- Not applicable/Not provided, as formal pre-clinical or clinical testing requiring adjudication was not performed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is an infant warming device, not an AI-assisted diagnostic tool. No MRMC study was mentioned or performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an infant warming device, not an algorithm. No standalone algorithm performance study was mentioned or performed.
7. The type of ground truth used
- Not applicable/Not provided, as formal pre-clinical or clinical testing requiring ground truth was not performed. The basis for safety and effectiveness primarily relies on substantial equivalence to predicate devices and established technology.
8. The sample size for the training set
- Not applicable/Not provided, as this is not an AI/machine learning device that would typically involve a training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided, as this is not an AI/machine learning device.
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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 215-682-8689
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
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
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 (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 (301) 443-6597 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
Number: 165277
§ 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).