(91 days)
The Air Shields ISOLETTE® Infant Incubator is designed to care for the smaller premature baby as well as the healthier full term baby. It does this by providing a controlled environment, one in which the baby can be provided with the necessary care as well as being left undisturbed in the security of the incubator.
It is to this end that the product can be used in any department of the hospital that provides neonatal and infant care. One would typically expect the ISOLETTE® to be used in the NICU/SCBU (Neonatal Intensive Care Unit and/or the Special Baby Care Unit). The design lends itself to all levels of care in the NICU making it suitable for use in level I, II, III, and IV where applicable. Other departments would include the Step Down Nursery, Newborn Nursery and Pediatrics.
This device, when fitted with the battery backup feature, may be used to move the infant from one area of the hospital to another while maintaining the controlled environment.
This device is not intended for home use.
This is a prescription device.
The C2000e is an enhancement to the currently marketed C2000 Isolette Infant Incubator originally cleared under 510(k) K960980. The features, functions, and performance of the C2000 incubator remain the same. The C2000e enhancements are additions to the C2000 product features. These additions are a horizontal rail system for attachment of accessories and a battery back up for the unit to maintain the controlled environment in the event of a power failure or to move the infant within the hospital environment.
The provided text describes a 510(k) submission for the C2000e Isolette® Infant Incubator, an enhancement to an already marketed device. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through clinical studies in the same way a new, high-risk device might.
Therefore, the document does not contain the kind of information requested in the prompt (acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, training sets, etc.). The focus is on the modifications made and how they relate to the predicate device.
Here's why the requested information is absent and what the document does provide:
- No Acceptance Criteria or Reported Device Performance Table: The document doesn't define specific performance metrics or acceptance criteria for the C2000e beyond the general statement that "The features, functions, and performance of the C2000 incubator remain the same." The enhancements are merely additions (horizontal rail and battery backup).
- No Clinical Study Details: There is no mention of a formal clinical study to prove the device meets acceptance criteria. The 510(k) process for device enhancements often relies on engineering testing and comparison to the predicate, not clinical trials with human subjects to establish diagnostic performance.
- No Sample Sizes, Data Provenance, Expert Ground Truth, Adjudication, MRMC, or Standalone Performance: These are all concepts related to clinical performance studies, typically for diagnostic or predictive AI/ML devices. An infant incubator, particularly an enhanced version of an existing one, would not undergo such evaluation in a 510(k) submission.
- No Training Set Information: As there's no AI/ML component described, there's no training set.
- No Ground Truth Type: Similarly, ground truth is a concept for evaluating diagnostic accuracy, which is not applicable here.
What the document does provide in relation to regulatory approval:
- Predicate Device: K960980 C2000 Isolette® Infant Incubator. The C2000e is an enhancement, meaning its substantial equivalence hinges on the original C2000's proven safety and effectiveness.
- Modifications: Addition of a horizontal rail system and a battery backup.
- Intended Use Statement: Describes the incubator's purpose (controlled environment for infants) and where it can be used (NICU, SCBU, Step Down Nursery, Newborn Nursery, Pediatrics). It also clarifies that the battery backup allows for safe transport within the hospital.
- Regulatory Classification: Class II device, specifically a Neonatal Incubator (21 CFR 880.5400).
- Performance Standards: "None applicable" (referring to specific mandatory standards for the device's original submission, though general requirements like GMP still apply).
In summary: The nature of this 510(k) submission for an enhanced infant incubator does not require or include the detailed performance study information requested in your prompt. The regulatory approval is based on demonstrating that the new features do not raise new questions of safety or effectiveness and that the device as a whole is substantially equivalent to a legally marketed predicate.
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AUG = 1 2003
Section I 510(k) Summary of Safety and Effectiveness
Applicant:
Hill-Rom Air Shields 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:
C2000e Isolette® Infant Incubator
Device common/usual/classification name:
Neonatal Incubator
Classification:
General Hospital 21 CFR 862.113 Neonatal Incubator, ???, Class II
Performance Standards:
None applicable
Predicate Device:
K960980 C2000 Isolette® Infant Incubator
Device Description
The C2000e is an enhancement to the currently marketed C2000 Isolette Infant Incubator originally cleared under 510(k) K960980. The features, functions, and performance of the C2000 incubator remain the same. The C2000e enhancements are additions to the C2000 product features. These additions are a horizontal rail system for attachment of accessories and a battery back up for the unit to maintain the controlled environment in
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the event of a power failure or to move the infant within the hospital environment.
Intended Use
The Air Shields ISOLETTE® Infant Incubator is designed to care for the smaller premature baby as well as the healthier full term baby. It does this by providing a controlled environment, one in which the baby can be provided with the necessary care as well as being left undisturbed in the security of the incubator.
It is to this end that the product can be used in any department of the hospital that provides neonatal and infant care. One would typically expect the ISOLETTE® to be used in the NICU/SCBU (Neonatal Intensive Care Unit and/or the Special Baby Care Unit). The design lends itself to all levels of care in the NICU making it suitable for use in level I, II, III, and IV where applicable. Other departments would include the Step Down Nursery, Newborn Nursery and Pediatrics.
This device, when fitted with the battery backup feature, may be used to move the infant from one area of the hospital to another while maintaining the controlled environment.
Description of Modifications
The modifications to the device include a horizontal rail system for attachment of accessories and a battery back up for the unit to maintain the controlled environment in the event of a power failure or to move the infant within the hospital environment.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 1 2003
Ms. Monica Ferrante Regulatory Affairs Hill-Room Manufacturing, Incorporated 330 Jacksonville Road Hatboro, Pennsylvania 19040
Re: K031387
Trade/Device Name: C2000e Isolette® Infant Incubator Regulation Number: 880.5400 Regulation Name: Neonatal Incubator Regulatory Class: II Product Code: FMZ, FPL Dated: June 26, 2003 Received: June 27, 2003
Dear Ms. Ferrante:
We have reviewed your Section 510(k) premarket notification of intent to market the device reterenced 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. Iisting 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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Page 2 -- Ms. Ferrante
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 (OS) 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 vours.
Patricia Cucurullo
Susan Runner, DDS, MA Interim Direct 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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SMDA Requirements Section A
Indication for Use Statement
510(k) Number:
Device Name: C2000e Isolette® Infant Incubator
Indications for Use:
The Air Shields ISOLETTE® Infant Incubator is designed to care for the smaller premature baby as well as the healthier full term baby. It does this by providing a controlled environment, one in which the baby can be provided with the necessary care as well as being left undisturbed in the security of the incubator.
It is to this end that the product can be used in any department of the hospital that provides neonatal and infant care. One would typically expect the ISOLETTE® to be used in the NICU/SCBU (Neonatal Intensive Care Unit and/or the Special Baby Care Unit). The design lends itself to all levels of care in the NICU making it suitable for use in level I, III, III, and IV where applicable. Other departments would include the Step Down Nursery, Newborn Nursery and Pediatrics.
This device, when fitted with the battery backup feature, may be used to move the infant from one area of the hospital to another while maintaining the controlled environment.
This device is not intended for home use.
This is a prescription device.
(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
Patricia Cusciente
(Optional Format 1/2/96)
sthesiology. General Hosni
510(k) Number: K031387
§ 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).