(106 days)
The NeoPEEP Neonatal Resuscitation Circuit with PEEP valve is indicated as an accessory to add positive end expiratory pressure breathing capability to a Manual Resuscitator. This valve is designed into the breathing circuit T-Piece with a standard fitting for face mask, laryngeal mask or endotracheal tube attachment.
This is a prescription device.
The NeoPEEP Neonatal Resuscitation Circuit with PEEP control valve is a breathing circuit intended for use with manual resuscitation devices for emergency neonatal resuscitation.
This document is a 510(k) summary for the NeoPEEP Neonatal Resuscitation Circuit with PEEP. It focuses on establishing substantial equivalence to a predicate device, rather than presenting a detailed study with acceptance criteria and performance metrics for a novel AI device. Therefore, much of the requested information regarding AI device evaluation is not explicitly available in this document.
However, based on the provided text, we can infer some information relevant to the device's functional performance:
- Device Description: The NeoPEEP Neonatal Resuscitation Circuit with PEEP control valve is a breathing circuit intended for use with manual resuscitation devices for emergency neonatal resuscitation.
- Intended Use: The NeoPEEP Neonatal Resuscitation Circuit with PEEP valve is indicated as an accessory to add positive end expiratory pressure breathing capability to a Manual Resuscitator.
- Predicate Device: The substantial equivalence claim is based on comparison to the Fisher & Paykel NEOPUFF Infant Resuscitator patient circuit with PEEP. This suggests that the performance characteristics of the NeoPEEP would be expected to be similar to this predicate device.
Given that this is a 510(k) submission for a non-AI medical device, the typical "study" proving acceptance criteria involves demonstrating that the device meets established safety and performance standards for its class and is substantially equivalent to a legally marketed predicate device. This usually involves engineering testing, biocompatibility assessments, and performance verification to ensure it functions as intended and safely. The document does not describe a clinical trial or a study with a test set, ground truth, or expert review in the manner one would for an AI diagnostic device.
Here's an attempt to answer the questions based on the available information, noting where the information is not provided:
1. A table of acceptance criteria and the reported device performance
No explicit table of acceptance criteria and reported device performance is present in the provided text. The document's primary purpose is to establish substantial equivalence to a predicate device based on "intended use, design, operational and technological characteristics, and principles of operation." This implies that the device is expected to perform comparably to the predicate device in delivering positive end expiratory pressure during neonatal resuscitation.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document pertains to a hardware medical device (resuscitation circuit) and does not describe a clinical study with a test set of data (e.g., images, patient records) or data provenance in the context of an AI algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth and expert review in this context would typically refer to the validation of a diagnostic AI device, which is not what this submission is about.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a test set requiring adjudication in this document.
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 is not an AI-assisted device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this type of device, "ground truth" might refer to engineering specifications or regulatory standards for pressure delivery and safety, but it's not discussed in terms of clinical outcomes or expert review in the text.
8. The sample size for the training set
Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI device.
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510(k) Summary of Safety and Effectiveness Section I
Applicant:
Marshall Products Ltd 13 Ferry Court, Ferry Lane Bath, United Kingdom BA2 4JW Owner/Operator number: 9095220 Registration No: In process
MAY 2 9 2007
Contact Person:
Neoforce Group, Inc. 35 Commerce Drive lvyland, Pa. 18974
Mary Staniewicz Ph 215-672-6800 Fax 215-672-1123
Device trade/proprietary name:
NeoPeep Neonatal Resuscitation Circuit with PEEP
Device common/usual/classification name:
Attachment, Breathing, Positive End Expiratory Pressure
Classification:
Anesthesiology 21 CFR 868.5965 Attachment, Breathing, Positive End Expiratory Pressure, BYE, Class II
Performance Standards:
None applicable
Predicate Device:
.
K892885 NEOPUFF Infant Resuscitator K981415 0-20 cm H2O PEEP Valve
Device Description
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The NeoPEEP Neonatal Resuscitation Circuit with PEEP control valve is a breathing circuit intended for use with manual resuscitation devices for emergency neonatal resuscitation.
Intended Use
The NeoPEEP Neonatal Resuscitation Circuit with PEEP valve is indicated as an accessory to add positive end expiratory pressure breathing capability to a Manual Resuscitator. This valve is designed into the breathing circuit T-Piece with a standard fitting for face mask or endotracheal tube attachment.
Substantial Equivalence
The Marshall Products NeoPeep Neonatal Resuscitation Circuit with PEEP is believed to be substantially equivalent, based on intended use, design, operational and technological characteristics, and principles of operation, to the Fisher & Paykel NEOPUFF Infant Resuscitator patient circuit with PEEP.
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Public Health Service
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Monica Ferrante Vice President Regulatory NeoForce Group, Incorporated 35 Commerce Drive Ivyland, PA 18974
MAY 2 9 2007
Re: K070416
Trade/Device Name: NeoPEEP Neonatal Resuscitation Circuit with PEEP Regulation Number: 21 CFR 868.5965 Regulation Name: Positive End Expiratory Pressure Breathing Attachment Regulatory Class: II Product Code: BYE Dated: May 16, 2007 Received: May 21, 2007
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 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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sylette Y. Michel O. M.D.
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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Attachment B
Indication for Use Statement
510(k) Number: K 070 4/ 6
Device Name: NeoPEEP Neonatal Resuscitation Circuit with PEEP
Indications for Use:
The NeoPEEP Neonatal Resuscitation Circuit with PEEP valve is indicated as an accessory to add positive end expiratory pressure breathing capability to a Manual Resuscitator. This valve is designed into the breathing circuit T-Piece with a standard fitting for face mask, laryngeal mask or endotracheal tube attachment.
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
Qld
(Optional Format 1/2/96)
an angn-Off) Claim of Anesthesiology, General Hospital, action Control, Dental Devices
2.3(K) Number: Kd70y1l
Page 14 of 48
§ 868.5965 Positive end expiratory pressure breathing attachment.
(a)
Identification. A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation.(b)
Classification. Class II (performance standards).