Ambu® Mark IV Baby Resuscitator is intended for manual pulmonary resuscitation and emergency respiratory support. Ambu® Mark IV Baby Resuscitator is intended for infants and children with a body weight up to 44 lbs (20 kg), approx. 4-5 years of age. Ambu® Mark IV Baby Resuscitator is a reusable resuscitator.

Device Description

Ambu® Mark IV Baby Resuscitator should only be used by persons trained in resuscitation. Ambu Mark IV Baby Resuscitator is used for manual pulmonary resuscitation and emergency respiratory support of neonates, infants and children up to 44 lbs (20 kg), approx. 4-5 years of age. Ambu® Mark IV Baby Resuscitator is a reusable device. The product can be cleaned after use according to the description in the direction for use. The product consists of a self inflating double walled resuscitator bag, with a self expanding inner bag and a non inflating walled outer cover. The outer cover has an airtight connection with the neck of the inner bag supported by the connector in one end. At the opposite end of the bag the outer cover has an airtight connection with the inlet valve housing. The Inlet Valve allows ambient air or supplementary oxygen to flow into the bag and prevents air flowing backwards from the bag through the inlet valve. An oxygen tube reservoir can be mounted to the Ambu® Mark IV Baby Resuscitator. The patient valve is attached to the bag by a turn able airtight patient connection. The patient valve directs the ventilation air through the patient airway and directs the patient expiration air through the expiration connector. A pressure-limiting valve (40 cm H₂O) with an override mechanism is placed in the patient valve housing. The manometer port in patient valve housing enables connection to a manometer. If a manometer is not attached the manometer port is closed with a cap. The patient- and expiration connectors are standard connectors to avoid unsuitable connections with other devices. The patient connector, patient valve housing and inlet valve housing is made of hard plastic. The self inflating bag is made of silicone rubber that can be squeezed by hand and returns to normal state when the hand is released. Ambu® Mark IV Baby Resuscitator has a 300 ml stroke volume.

AI/ML Overview

The Ambu® Mark IV Baby Resuscitator is a manual emergency ventilator intended for manual pulmonary resuscitation and emergency respiratory support for neonates, infants, and children up to 20 kg (approximately 4-5 years of age). It is a reusable device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list specific numerical acceptance criteria (e.g., specific force, flow rates, or pressure ranges) for the device's performance. Instead, it states that the non-clinical tests were performed to ensure the product "meets the recognized consensus standards for manual product resuscitation" and has "equivalent functionality as the predicate devices."

Therefore, the acceptance criteria are implicitly tied to meeting the performance characteristics of the predicate devices and relevant consensus standards.

Acceptance Criteria (Implicit)	Reported Device Performance
Meets recognized consensus standards for manual resuscitation products.	Non-clinical laboratory tests were performed to ensure the product meets these standards.
Provides equivalent functionality to predicate devices (Ambu® Silicone Resuscitator, Infant/Child; Ambu® Baby R, Resuscitator model R; Ambu® SPUR® II Infant).	Comparison tests to predicate devices have been performed, and "the characteristics of the Ambu® Mark IV Baby Resuscitator are identical to one or more of the predicate devices in all of the products technological characteristics." The conclusion is that it has "equivalent functionality."
Operates with a pressure-limiting valve at 40 cm H₂O.	The device is described as having "A pressure-limiting valve (40 cm H₂O) with an override mechanism is placed in patient valve housing."
Delivers a 300 ml stroke volume.	The device "has a 300 ml stroke volume."
Material Biocompatibility	Biocompatibility of the resuscitator was tested. The inflating bag is made of silicone rubber.
Reusability and Cleaning Effectiveness	The device is reusable and intended to be cleaned after use according to directions. Tests performed ensure this capability.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of clinical data for performance assessment. The studies conducted were non-clinical laboratory tests. Therefore, information regarding sample size for a test set of human subjects or patient data provenance is not applicable as no clinical tests were performed.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Since no clinical studies were performed and the evaluation was based on non-clinical laboratory tests and comparison to predicate devices, there were no experts used to establish ground truth in the typical sense of interpreting clinical data or images. The "ground truth" for compliance was defined by engineering specifications, recognized consensus standards for medical devices, and the established performance of legally marketed predicate devices.

4. Adjudication Method

There was no adjudication method described as there were no clinical studies or human-interpreted data that would require such a process. The evaluation was based on objective laboratory measurements and comparison to established device characteristics and standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical medical device (manual ventilator), not an AI algorithm or diagnostic tool that would typically be evaluated with MRMC studies involving human readers. The regulatory submission explicitly states, "No clinical tests are performed."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

This question is not applicable as the device is a mechanical medical device, not an algorithm or software. The "standalone" performance refers to the device's inherent mechanical and functional performance as assessed through laboratory testing, rather than an algorithm's performance.

7. The Type of Ground Truth Used

The ground truth used for evaluating the Ambu® Mark IV Baby Resuscitator was based on:

Engineering Specifications and Design Requirements: The device was designed to meet specific technical parameters (e.g., 300 ml stroke volume, 40 cm H₂O pressure-limiting valve).
Recognized Consensus Standards: Non-clinical laboratory tests ensured the product met these established safety and performance standards for manual resuscitation devices.
Predicate Device Performance: The primary "ground truth" for equivalence was the established functional and technological characteristics of the legally marketed predicate devices. The new device's characteristics were shown to be "identical" to these predicates.

8. The Sample Size for the Training Set

There is no training set in the context of machine learning or AI as the device is a mechanical medical device. The term "training set" is not applicable here.

9. How the Ground Truth for the Training Set Was Established

As there is no training set, this question is not applicable.

Summary

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DEL 2 0 2005

$\qquad k053/42$

510(k) Summary

510(k) owner: Ambu A/S Baltorpbakken 13 2750 Ballerup Denmark Tel.: +45 72252000 Fax.: +45 72252050

Contact person: Laila Strange Lundtoft Regulatory Affairs Manager

October 2005 Preparation date of the 510(k) summary:

1. Name of device:

Device Common name:	Manual Emergency Ventilator (Reusable)
Device Trade name:	Ambu® Mark IV Baby Resuscitator
Classification Name:	Ventilator, Emergency, Manual (Resuscitator)21 CFR 868.5915
Product Code:	BTM

1. Identifies the legally marketed device to which equivalence is claimed

Manufacturer	Trade Name	Productcode
Ambu A/S	Ambu® SiliconeResuscitator, Infant/Child	BTM
Ambu A/S	Ambu® Baby R,Resuscitator model R	BTM
Ambu A/S	Ambu® SPUR® II Infant	BTM

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4. Description of device

Description of device
Ambu® Mark IV Baby Resuscitator should only be used by persons trained Ambu "Mark II Baby Result is well known to trained users. in resuscition Raby Resuscitator is used for manual pulmonary Ambu Mark IV Duby Resultatory support of neonates, infants and resuscitation and emergency rouptrated (bs (20 kg), approx. 4-5 years of age.

age.
Ambu® Mark IV Baby Resuscitator is a reusable device. The product can be Ambu Flark IV Buby Robation to the description in the direction for use. Cleaned uiter use accoraing to «flating double walled resuscitator bag, with rne product consists of a sell minating walled outer cover. The outer cover a scir expanding inner bag o the neck of the inner bag supported by the has an all tight connection we end. At the opposite end of the bag the connector in as an airtight connection with the inlet valve housing. outer cover has an all air or supplementary oxygen to flow into The Iniet Valve diows ambiening backwards from the bag through the inlet the bag and prevents an nowligen tube reservoir can be mounted to the

Ambu® Mark IV Baby Resuscitator.

Amba - Flantes - Babing is attached to the bag by a turn able airtight rne patient valve directs the ventilation air through patient connection: The patient airway and directs the patient expiration air through the expiration connector.

chrough the expiration confress.
A pressure-limiting valve (40 cm H₂O) with an override mechanism is placed in patient valve housing.

placed in patient valve housing enables connection to a rne manometer por in panometer is not attached the manometer port is closed with a cap.

Closed with a copy.
The patient- and expiration connectors are standard connectors to avoid unsuitable connections with other devices.

unsuluble connector, patient valve housing and inlet valve housing is me putlent connector, patient inflating bag is made of silicone rubber that made of hand and returns to normal state when the hand is can De Squobed By, Mark IV Baby Resuscitator has a 300 ml stroke volume.

5. The intended use

The Intended ass Ambu "Hark IV Baby Despiratory support. Ambu® Mark IV Baby resuscitation is intended for infants and children with a body weight up to 44 lbs (20 kg), approx. 4-5 years of age.

6. Summary of the technological Characteristics

The resuscitator bag has a double walled resuscitator bag. The patient rne resubertator bag to and from the patient. The inlet valve directs vare air into the bag. An oxygen tube reservoir can be mounted to the product. The device has a pressurelimiting valve (40 cm H₂O). The producer The action the patient valve housing enables connection to a manometer. The device is a reusable resuscitator.

manometers The arracteristics of the Ambu® Mark IV Baby Resuscitator

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are identical to one or more of the predicate devices in all of the products technological characteristics.

1. Brief discussion of the non-clinical tests submitted The non-clinical tests performed are laboratory tests to ensure that the product meets the recognized consensus standards for manual product the rests the rests has been performed, the biocompatibility of the resultaters on a more of the marison tests to predicate devices have been performed.
1. Brief discussion of the clinical tests submitted No clinical tests are performed
1. Conclusions drawn from the non-clinical and clinical tests From the results of the non-clinical tests performed it has been concluded that Ambu® Mark IV Baby Resuscitator has equivalent functionality as the predicate devices. pressurelyded that Ambu® Mark IV Baby Resuscitator is a safe and

effective resuscitator and comparable to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human figures connected by flowing lines, representing health and well-being. The caduceus is positioned to the right of a circular inscription that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA". The text is arranged around the upper half of the circle, framing the caduceus symbol.

DEC 2 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ambu A/S C/O Ms. Sanjay Parikh Technical and Regulatory Affairs Ambu, Incorporated 6740 Baymeadow Drive Glen Burnie, Maryland 21060

Re: K053142

Trade/Device Name: Ambu® Mark IV Baby Resuscitator Regulation Number: 21 CFR 868.5915 Regulation Name: Manual Emergency Ventilator Regulatory Class: II Product Code: BTM Dated: November 8, 2005 Received: November 9, 2005

Dear Ms. Parikh:

We have reviewed your Section 510(k) premarket notification of intent to market the device we may of 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 mendie comments, 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 appt of a "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 your device ear be roublish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Parikh

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 moun that I Dr may Federal statutes and regulations administered by other Federal agencies. of the Flet of ally I vatin all the Act's requirements, including, but not limited to: registration 1 ou intest compry with and 807); labeling (21 CFR Part 801); good manufacturing practice and fisting (21 OF R Part 807), adality systems (QS) regulation (21 CFR Part 820); and if requirements as betrent nroduct 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) rms reter notification. The FDA finding of substantial equivalence of your device to a promative nettired 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), rl 35th acentact the Office of Compliance at (240) 276-0120. Also, please note the regulation i 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 maj overn 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,

Sayite Y. Michie Davis.

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):

KOS3142

Ambu® Mark IV Baby Resuscitator Device Name:

Indications For Use:

mulcations i or or ooo.
Ambu® Mark IV Baby Resuscitator is intended for manual pulmonary resuscitation Ambur Malk IV Baby Resultator is Internate, infants and children with a body and Chiorgono) 100p.i0 kg), approx. 4-5 years of age. weight up 10 14 12 14 12 14 12 1 reusable resuscitator.

x Prescription Use __ (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)

Page 1 of 1 __

Cee Silurn

(won Sign-Osf)
Anesthesiology, General Hospital, School Control. Dental Devices

K057142

Regulation Number and Section

§ 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).