AMBU MARK IV RESUSCITATOR by AMBU A/S

Ambu® Mark IV Resuscitator is intended for manual pulmonary resuscitation and emergency respiratory support. Ambu® Mark IV Resuscitator is intended for use on patients with a body weight of more than 33 lbs (15 kg), approx. 3 years of age.

Ambu Mark IV Resuscitator is a reusable resuscitator.

Device Description

Mark IV Resuscitator should only be used by persons trained in resuscitation. The use of the Ambu Mark IV Resuscitator product is well known to trained users. The product is intended for manual pulmonary resuscitation of patients with a body weight of more than 33 lbs (15 kg), approx. 3 years of age.

Ambu - Hark II - Resubertano is a reusable device. The product can be Cleaned areer use according to the description in the direction for use. rne produce consists of a bon inflating double walled resuscitator bag, with a sell expanding inner bag and in a thin-walled outer cover. The outer cover nds an all tight connections in the neck of the inner bag supported by the valve end. At the opposite end of the bag the outer cover has an all air airtight connection with the inlet valve housing. rne intervalve anows ambient air or supplementary oxygen to flow into the bug and prevents an a backwards from the bag through the inlet the bug and prevents an An oxygen reservoir bag can be mounted to the Ambu® Mark IV Resuscitator.

Amba - Flank IV Resubliation
The patient valve housing is attached to the bag by a turn able airtight The patient valve neasing the ventilation air through patient connector into the patient t nirway and directs the patient expiration air through the expiration connector.

the patient- and expiration connectors are standard connectors to avoid unsuitable connections with other devices.

dhisultuble connector, patient valve housing and inlet valve housing is rne patient connector, patient inflating bag is made of silicone rubber that made of hard plastic. Ind and returns to normal state when the hand is removed.

The Ambu® Mark IV Resuscitator has an oxygen reservoir bag volume of 1500 ml. The stroke volume with one hand is > 600 ml and max. 1300 ml.

AI/ML Overview

This document describes the Ambu® Mark IV Resuscitator, a manual emergency ventilator. The information provided is primarily focused on its substantial equivalence to previously marketed devices and does not detail a study with specific acceptance criteria and performance metrics for the device itself. Instead, it relies on demonstrating that the new device has "equivalent functionality" to predicate devices.

Therefore, many of the requested elements for a study proving device performance or acceptance criteria are not directly applicable or available in the provided text.

Here is a summary based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, no specific quantitative acceptance criteria or detailed performance metrics are given for the Ambu® Mark IV Resuscitator as a new device. The submission relies on demonstrating substantial equivalence to predicate devices. The "performance" is implicitly tied to meeting recognized consensus standards for manual resuscitators and having "equivalent functionality" to the predicate devices.

Acceptance Criteria Category	Specific Criteria (Implicit/Explicit)	Reported Device Performance (Implicit/Explicit)
Safety	No adverse events; complies with applicable standards.	Concluded to be a safe device.
Effectiveness	Equivalent functionality to predicate devices.	Concluded to be an effective device with equivalent functionality to predicate devices.
Material Properties	Silicone rubber for inflating bag, hard plastic for connectors.	Device made of specified materials.
Dimensions/Capacity	Oxygen reservoir bag: 1500 ml; Stroke volume (one hand): > 600 ml and max. 1300 ml.	Device meets these specifications.
Intended Use	For manual pulmonary resuscitation and emergency respiratory support for patients > 33 lbs (15 kg), approx. 3 years of age.	Device meets this intended use.
Cleaning/Reuse	Reusable; can be cleaned according to instructions for use.	Device is reusable and can be cleaned as directed.
Compatibility	Patient and expiration connectors are standard.	Connectors are standard to avoid unsuitable connections.
Biocompatibility	Established.	Biocompatibility established.
Consensus Standards	Product meets recognized consensus standards for manual resuscitators.	Product meets recognized consensus standards.

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

Sample Size for Test Set: Not applicable. No dedicated "test set" in the sense of patient data or clinical samples was used as no clinical tests were performed. The "tests" were laboratory tests comparing to predicate devices.
Data Provenance: Not applicable. No human data (clinical or retrospective) used.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Number of Experts: Not applicable. No human test set requiring expert ground truth was utilized.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. No human test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

Was an MRMC study done? No. The submission explicitly states "No clinical tests are performed." This product is a physical medical device, not an AI or imaging diagnostic tool that would typically undergo an MRMC study.
Effect Size of AI vs. without AI assistance: Not applicable. This is not an AI-assisted device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Was a standalone study done? No. This product is a physical manual resuscitator, not an algorithm.

7. The type of ground truth used:

Type of Ground Truth: For the non-clinical tests (laboratory and comparison tests), the "ground truth" would be objective measurements and established standards for manual resuscitators, as well as the known specifications and performance of the legally marketed predicate devices (Ambu® SIR 2, Ambu® Mark III, Ambu® SPUR® II Adult). The comparison tests to predicate devices implicitly used the predicate devices' established performance as a benchmark.

8. The Sample Size for the Training Set:

Sample Size for Training Set: Not applicable. This device is not an AI algorithm that requires a "training set." The development process likely involved engineering and design iterations, but not a data-driven training set in the AI sense.

9. How the Ground Truth for the Training Set was Established:

How Ground Truth for Training Set was Established: Not applicable. As it's not an AI device, there's no "training set" or corresponding ground truth to establish in that context.

Summary

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K053/40

DEC 2 3 2005 510(k) Summary

1. 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 31. October 2005 Preparation date of the 510(k) summary: 2. Name of device: Manual Emergency Ventilator (Reusable) Device Common name: Ambu® Mark IV Resuscitator Device Trade name: Ventilator, Emergency, Manual (Resuscitator) Classification Name: 21 CFR 868.5915 BTM Product Code:
1. Identifies the legally marketed device to which equivalence is claimed

Manufacturer	Trade Name	Productcode
Ambu A/S	Ambu® SIR 2 (SiliconeResuscitator), Adult	BTM
Ambu A/S	Ambu® Mark IIIResuscitator	BTM
Ambu A/S	Ambu® SPUR® II Adult	BTM

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1. Description of device
  Description of device
  Mark IV Resuscitator should only be used by persons trained in Ambu Thank IV Resusentator product is well known to trained users. resuscitation: The ase of the proced for manual pulmonary resuscitation Allibu Mark IV Resuseted in our of patients with a body weight of more than 33 lbs (15 kg), approx. 3 years of age.

chan 55 ibs (15 kg) approx is a reusable device. The product can be Ambu - Hark II - Resubertano to the description in the direction for use. Cleaned areer use according to tiflating double walled resuscitator bag, with rne produce consists of a bon in a thin-walled outer cover. The outer cover a sell expanding inner bag and in the neck of the inner bag supported by the nds an all tight connections valve end. At the opposite end of the bag the connector in the pa airtight connection with the inlet valve housing. outer cover has an all air air or supplementary oxygen to flow into rne intervalve anows ambient a backwards from the bag through the inlet the bug and prevents an An oxygen reservoir bag can be mounted to the Ambu® Mark IV Resuscitator.

the patient- and expiration connectors are standard connectors to avoid unsuitable connections with other devices.

The Ambu® Mark IV Resuscitator has an oxygen reservoir bag volume of 1500 ml. The stroke volume with one hand is > 600 ml and max. 1300 ml.

1. The intended use
  Ambu® Mark IV Resuscitator is intended for manual pulmonary Ambu "Hilling and emergency respiratory support. Ambu® Mark IV resuscitation and emergene) respits with a body weight of more than 33 Ibs (15 kg), approx. 3 years of age.
1. Summary of the technological Characteristics
  The resuscitator bag has a double walled resuscitator bag. The patient valve directing the airflow to and from the patient. The inlet valve directs the air into the bag. An oxygen reservoir bag can be mounted to the product. The device is a reusable resuscitator. product. The device is a reastics of the Ambu® Mark IV Resuscitator 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 meets the rests has been performed, the biocompatibility of the resultures been established and comparison tests to predicate devices

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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 Conclusions arawn nom the non-clinical tests performed it has been concluded for rrom the results of the nor. Sation has equivalent functionality as the predicate devices. predicate devices:
  It is concluded that Ambu® Mark IV Resuscitator is a safe and effective It is concided that him in the predicate devices.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 3 2005

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

Re: K053140

Trade/Device Name: Ambu® Mark IV Resuscitator Regulation Number: 21 CFR 868.5915 Regulation Name: Manual Emergency Ventilator Regulatory Class: II Product Code: BTM Dated: November 8, 2005 Received: November 10, 2005

Dear Ms. Parikh:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your end have determined the device is substantially equivalent (for the relerenced above and have attermclosure) to legally marketed predicate devices marketed in murcations for ass stated in May 28, 1976, the enactment date of the Medical Device Interstate commerce prior to rray as a reclassified in accordance with the provisions of Amendinents, or to act roos 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 approvin uppression (the Act. The general controls provisions of the Act include controls provisions of a 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 (IPMA), it may be subject to such additional controls. Existing major regulations affecting (I MA), it may of subject to tach adatof Federal Regulations, Title 21, Parts 800 to 898. In your device can be fourther 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 mean that i DA mas made a autes and regulations administered by other Federal agencies. of the Act of ally I oderal battless and equirements, including, but not limited to: registration 1 out indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and ifsing (21 CF R Part 807), lability systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality 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) This letter will anow you to begin mading of substantial equivalence of your device to a premarket nothleation. The FDF milling or 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), If you desire specific authorite 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 may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Drimber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sygitte yf. Michan Oins

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):

Ambu® Mark IV Resuscitator Device Name:

Indications For Use:

Ambu® Mark IV Resuscitator is intended for manual pulmonary resuscitation and Ambur Man 1 v 1 toodookater to inteatients with a body weight of more than 33 Ibs (15 kg), approx. 3 years of age.

Ambu Mark IV Resuscitator is a reusable resuscitator.

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)

Page 1 of रू

Lise Sullivan

mon dan-Or) / rsion of Anestheswiogy, General Hospital, m sollon Control, Dental Devices

Number K033149

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).