(243 days)
The Infant Resuscitation System provides the basic equipment required for pulmonary resuscitation during infancy. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen and/or manual ventilation to the infant. These practices are well-described in collaborative guidelines established by the American Heart Association (AHA) and the American Academy of Pediatrics (AAP).
Resuscitation may be required whenever an infant fails to establish effective, adequate breathing patterns necessary to meet tissue oxygen demands and/or to rid the body of carbon dioxide.
The Infant Resuscitation System incorporates the following features for the practice of infant resuscitation: a suction device for routine clearance of the trachea and nasal passages; an oxygen flowmeter to deliver 100% oxygen to the infant requiring such therapy; and an airway pressure manometer with an adjustable pressure relief valve (12-55 cm H2O). The airway pressure manometer may be attached to a resuscitation bag (not included) and is used to measure the pressure belivered to the infant in order to facilitate adequate pressurization of the lungs. An adjustable pressure relief valve is a safety feature which helps prevent the user from over-inflating the infant's lungs, which could result in rupture of the alve may be adjusted to release excess gas at a user selected pressure point. The ability to adjust the pressure relief valve facilitates optimal oxygen delivery as lung compliance changes dynamically after birth during the trauterine life. The operative range (12-55 cm H2O) of this feature meets the recommendations by the AHA and AAP. The Infant Resuscitation System is outfitted with unregulated air and oxygen outlet connection which may be attached to an optional gas blender for the purposes of delivering air and oxygen mixes in the user selected percentages. The Resuscitation System may be equipped with optional hoses to connect the system to wall or cylinder outlets and/or yoke assemblies.
The Infant Resuscitation System does not include the resuscitation bag for manual ventilation.
The Ohmeda Infant Resuscitation System (IRS) is a combination of existing medical devices and is intended for pulmonary resuscitation of infants. The performance data section of the submission states that "Pulmonary resuscitation of infants includes well established clinical practices. These practices are well-described in collaborative guidelines established by the American Heart Association and the American Academy of Pediatrics. The IRS provide clinicians with the means to implement these practices. Consequently, clinical testing to demonstrate safety and effectiveness is not required. Bench testing will be conducted to ensure that the device meets its specifications."
Based on the provided text, the submission does not contain specific acceptance criteria or a detailed study report that would typically be expected for a novel device. Instead, the FDA's decision for substantial equivalence is based on the device being a combination of already cleared predicate devices and adherence to established clinical guidelines.
For the purpose of your request, I will extract relevant information about the device's functional description and how its specifications align with clinical guidelines, which serve as a de-facto acceptance criteria in the absence of explicit quantitative benchmarks.
Here's the information structured as requested, based strictly on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from functional description & guidelines) | Reported Device Performance |
|---|---|
| Suction Device: Routine clearance of mucous and debris from trachea and nasal passages. | Incorporates a suction device for routine clearance of mucous and debris from the trachea and nasal passages. |
| Oxygen Flowmeter: Delivery of oxygen to the infant. | Includes one oxygen flowmeter for delivery of oxygen to the infant requiring such therapy. |
| Airway Pressure Manometer: Measures pressure delivered to the infant to facilitate adequate pressurization of the lungs. | Attached to a resuscitation bag (not included) and measures the pressure delivered to the infant. |
| Airway Pressure Manometer Adjustable Pressure Relief Valve: Safety feature to prevent over-inflation; operative range 12-55 cm H2O, meeting AHA and AAP recommendations. | Has an adjustable pressure relief valve (12-55 cm H2O). Operative range (12-55 cm H2O) meets AHA and AAP recommendations. |
| Optional Gas Blender: Mixes air and oxygen in user-selected percentages. | An optional gas blender mixes air and oxygen in percentages selected by the user. |
| Hoses/Connections: To connect to wall/cylinder outlets and/or assemblies. | Includes hoses to connect the system to wall or cylinder outlets and/or assemblies. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Consequently, clinical testing to demonstrate safety and effectiveness is not required. Bench testing will be conducted to ensure that the device meets its specifications."
- Sample size for the test set: Not applicable (no clinical testing was performed; bench testing details are not provided).
- Data provenance: Not applicable (no clinical test data is mentioned).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. No clinical testing was done to establish ground truth with experts. The device's design is stated to align with "collaborative guidelines established by the American Heart Association and the American Academy of Pediatrics."
4. Adjudication Method for the Test Set
Not applicable. No clinical testing or adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document states that clinical testing was not required.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a physical medical device, not an AI algorithm. The performance evaluation was based on the device conforming to its "specifications" via "bench testing" and alignment with established clinical practices.
7. The Type of Ground Truth Used
The "ground truth" for the device's design and functionality is implicitly based on:
- Expert Consensus / Clinical Guidelines: "collaborative guidelines established by the American Heart Association and the American Academy of Pediatrics."
- Predicate Device Equivalence: The device is a combination of legally marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model; therefore, there is no "training set" in the computational sense.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set mentioned for this device.
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Ohmeda Infant Resuscitation System 510(k) Summary .
DEC - 2 1997
1. Predicate Device Information
The IRS is a combination of the following stand-alone medical devices:
- Ohio Pressure Compensated Flowmeter 510(k) No. K760102 .
- Ohio Continuous Suction Regulator (wall vacuum powered) 510(k) No. K883229 .
- Ohio Continuous Suction Regulator (venturi powered) Substantially equivalent to the . wall vacuum powered configuration
- Ohmeda Oxygen Blender 510(k) No. K853905 ●
- Airway Manometer Substantially equivalent to the Airway Manometer included in the ● resuscitation section of the Air Shields Resuscitaire™ (a Class II Infant Radiant Warmer)
In addition, the IRS is substantially equivalent to the resuscitation sections of the Hill Rom Stabilet 2000C Infant Warmer and to the Air Shields Resuscitaire™ Radiant Warmer.
2. Intended Use Statement
The Infant Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen and/or manual ventilation to the infant. These practices are well-described in collaborative guidelines established by the American Heart Association and the American Academy of Pediatrics.
Resuscitation may be required whenever an infant fails to establish effective, adequate breathing patterns necessary to meet tissue oxygen demands and/or to rid the body of carbon dioxide.
3. Functional Description
The Infant Resuscitation System incorporates a suction device for routine clearance of mucous and debris from the trachea and nasal passages, as well as one oxygen flowmeter for delivery of oxygen to the infant requiring such therapy. The airway pressure manometer is attached to a resuscitation bag (not included) and measures the pressure delivered to the infant in order to facilitate adequate pressurization of the lungs. An optional gas blender mixes air and oxygen in percentages selected by the user. The Infant Resuscitation System includes hoses to connect the system to wall or cylinder outlets and/or assemblies. It does not include the resuscitation bag for manual ventilation.
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4. Assessment of Technological Characteristics
The technological characteristics of the IRS are similar to those of the predicate devices to which the IRS is substantially equivalent. The IRS is a combination of devices which are either preamendment devices or have been cleared for commercial distribution via Premarket Notification.
5. Performance Data
Pulmonary resuscitation of infants includes well established clinical practices. These practices are well-described in collaborative guidelines established by the American Heart Association and the American Academy of Pediatrics. The IRS provide clinicians with the means to implement these practices. Consequently, clinical testing to demonstrate safety and effectiveness is not required. Bench testing will be conducted to ensure that the device meets its specifications.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 2 1997
Mr. Alberto F. Profumo Ohmeda, Inc. 9065 Guilford Road Columbia, Maryland 21046-1801
Re : K971243 Ohmeda Infant Resuscitation System ("IRS") Requlatory Class: II (two) Product Code: 73 BTM September 4, 1997 Dated: September 8, 1997 Received:
Dear Mr. Profumo:
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 requlations 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 current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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 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.
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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) 594-4648. 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,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known):
Device Name: Infant Resuscitation System
Indications For Use:
Clinical Use Description Infant Resuscitation System
The Infant Resuscitation System provides the basic equipment required for pulmonary resuscitation during infancy. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen and/or manual ventilation to the infant. These practices are well-described in collaborative guidelines established by the American Heart Association (AHA) and the American Academy of Pediatrics (AAP).
Resuscitation may be required whenever an infant fails to establish effective, adequate breathing patterns necessary to meet tissue oxygen demands and/or to rid the body of carbon dioxide.
The Infant Resuscitation System incorporates the following features for the practice of infant resuscitation: a suction device for routine clearance of the trachea and nasal passages; an oxygen flowmeter to deliver 100% oxygen to the infant requiring such therapy; and an airway pressure manometer with an adjustable pressure relief valve (12-55 cm H2O). The airway pressure manometer may be attached to a resuscitation bag (not included) and is used to measure the pressure belivered to the infant in order to facilitate adequate pressurization of the lungs. An adjustable pressure relief valve is a safety feature which helps prevent the user from over-inflating the infant's lungs, which could result in rupture of the alve may be adjusted to release excess gas at a user selected pressure point. The ability to adjust the pressure relief valve facilitates optimal oxygen delivery as lung compliance changes dynamically after birth during the trauterine life. The operative range (12-55 cm H2O) of this feature meets the recommendations by the AHA and AAP. The Infant Resuscitation System is outfitted with unregulated air and oxygen outlet connection which may be attached to an optional gas blender for the purposes of delivering air and oxygen mixes in the user selected percentages. The Resuscitation System may be equipped with optional hoses to connect the system to wall or cylinder outlets and/or yoke assemblies.
The Infant Resuscitation System does not include the resuscitation bag for manual ventilation.
(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)
Over- The Counter Use
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
(Optional Format 1-2-96)
510(k) Number _
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).