The Resusci Flow series (Resusci Flow and Resusci Flow with blender) is a manually operated ventilator intended to assist a doctor in resuscitating an infant who has spontaneous breathing by providing the positive end-expiratory pressure (PEEP) and the peak inspiratory pressure (PIP).

The Resusci Flow series (Resusci Flow 104 PV and Resusci Flow 104EV) is intended for resuscitation of neonates in a delivery room and a NICU. It is used to remove secretions from the neonatal mouth and nostrils or to ventilate or assist in ventilating neonates suffering from apnea or other respiratory failure.

All are intended for neonates and infants (≤ 10kg or 22 lbs) in a delivery room and a NICU.

Device Description

There are four (4) models of the Resusci Flow resuscitator.

Resusci Flow ●
Resusci Flow with blender ●
Resusci Flow 104PV .
Resusci Flow 104EV .

They all have the same basic design. Table 1 outlines the basic features and differences of each model.

AI/ML Overview

The Atom Medical Corporation's Resusci Flow series resuscitator (models: Resusci Flow, Resusci Flow with blender, Resusci Flow 104 PV, and Resusci Flow 104 EV) underwent performance testing to demonstrate substantial equivalence to predicate devices and adherence to relevant standards.

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists several performance tests conducted, referencing ISO standards and internal criteria. The reported device performance for all listed criteria was that the Resusci Flow series "met all pass/fail criteria, cited standards requirements or were found to be equivalent in comparison to the predicates."

Acceptance Criteria / Test	Reported Device Performance
ISO 10651-5 clause 5.1.10 Display accuracy of the airway pressure gauge	Met pass/fail criteria and standards requirements
Gas discharge flow rate from the patient circuit	Met pass/fail criteria and standards requirements
ISO 10651-5 Clause 7.7.1 Delivered concentration accuracy of oxygen	Met pass/fail criteria and standards requirements
ISO 10651-5 clause 7.1.2.2 Inspiratory resistance	Met pass/fail criteria and standards requirements
ISO 10651-5 clause 7.2.4 pressure limitation	Met pass/fail criteria and standards requirements
ISO 10651-5 clause 7.2.4 and 5.1.10 Pressure characteristics of peak inspiratory pressure (PIP inspiratory resistance)	Met pass/fail criteria and standards requirements
Confirm the maximum open pressure (Pmax)	Met pass/fail criteria and standards requirements
ISO 10651-5 clause 7.2.4 and 5.1.10 positive end-expiratory pressure (PEEP)	Met pass/fail criteria and standards requirements
Environment Performance	Met pass/fail criteria and standards requirements
Vibration Testing	Met pass/fail criteria and standards requirements
Drop Testing	Met pass/fail criteria and standards requirements
Test pressure loss alarm	Met pass/fail criteria and standards requirements
ISO 11195 Gas mixers alarm for loss of pressure	Met pass/fail criteria and standards requirements
ISO 10079-3 for suction equipment	Met pass/fail criteria and standards requirements
Safety requirements	Met pass/fail criteria and standards requirements
Vomitus Resistance	Met pass/fail criteria and standards requirements
Expiratory Resistance	Met pass/fail criteria and standards requirements

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

The document states that "bench tests" were performed. However, it does not specify the sample size (number of devices, number of tests run for each criterion) used for these tests. The data provenance is internal to Atom Medical Corporation ("We have performed bench tests"), implying the tests were conducted by the manufacturer. The document does not specify the country of origin of the data beyond the manufacturer's location (Tokyo, Japan). The tests are described as performance testing, implying a prospective evaluation of the device's capabilities against established standards and predicates, rather than retrospective analysis of existing data.

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

The provided text details bench testing against international standards and comparison to predicate devices, rather than a clinical study requiring expert assessment of ground truth in a clinical context. Therefore, this information is not applicable. The "ground truth" for the bench tests would be the specifications and requirements outlined in the cited ISO standards.

4. Adjudication Method for the Test Set:

Not applicable, as this describes bench testing against established standards and specifications, not a clinical study requiring expert adjudication of clinical outcomes or images.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on substantial equivalence through bench testing and comparison to predicate device specifications. There is no mention of human readers or AI assistance.

6. Standalone Performance Study:

Yes, a standalone performance study in the form of "bench tests" was done. The performance of the Resusci Flow series was evaluated against a list of ISO standards and internal criteria. The conclusion was that the devices "met all pass/fail criteria, cited standards requirements or were found to be equivalent in comparison to the predicates." This constitutes an evaluation of the algorithm (or device in this case) alone without human-in-the-loop performance.

7. Type of Ground Truth Used:

The ground truth used for the performance testing was based on:

International Standards: Specifically, ISO 10651-5 for powered resuscitators, ISO 10079-3 for suction equipment, and ISO 11195 for gas mixers. These standards define the acceptable performance parameters and test methods.
Predicate Device Specifications: The applicant claims the device has "equivalent specifications of performance as the predicate" devices (Fisher & Paykel NeoPuff and GE Giraffe/Panda T-piece resuscitator). This implies that the performance parameters of the predicate devices served as a benchmark for equivalence.
Internal Pass/Fail Criteria: The document mentions "all pass/fail criteria," which would typically be internal, pre-defined thresholds for acceptable performance for each test.

8. Sample Size for the Training Set:

Not applicable. This is a medical device submission based on substantial equivalence through bench testing, not an artificial intelligence/machine learning algorithm requiring a training set.

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

Not applicable, as there is no training set for an AI/ML algorithm in this submission.

Summary

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K102542

510(k) Summary Page 1 of 5 27-Mar-11

APR -- 6 2011

Atom Medical Corporation 3-18-15, Hongo, Bunkyo-ku

3-18-15, Hongo, Bunkyo-kuTokyo, Japan 113-0033	Tel - 011-81-3-3815-3632Fax - 011-81-3-3812-3199
Official Contact:	Tsuyoshi Sugino - Regulatory Affairs Manager
Proprietary or Trade Name:	Resusci Flow series resuscitator
Common/Usual Name:	Infant Resuscitator
Classification Name/Code:	BTL - powered emergency ventilatorCFR 868.5925
Device:	Resusci FlowResusci Flow and blenderResusci Flow 104 EVResusci Flow 104 PV
Predicate Devices:	GE - Giraffe and Panda – K070210Fisher & Paykel - NeoPuff – K892885

Device Description:

There are four (4) models of the Resusci Flow resuscitator.

Resusci Flow ●
Resusci Flow with blender ●
Resusci Flow 104PV .
Resusci Flow 104EV .

They all have the same basic design. Table 1 outlines the basic features and differences of each model.

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510(k) Summary Page 2 of 5 27-Mar-11

Table 1 Resusci Flow Series

Feature	Resusci Flow	Resusci Flowwith Blender	Resusci Flow104PV	Resusci Flow104EV
PIP (Peak Inspiratory.Pressure)	Yes	Yes	Yes	Yes
Suction(Piping Type)	No	No	Yes	No
Suction(Venturi Type)	No	No	No	Yes
Oxygen / Air Mixture	No	Yes	Yes	Yes
Inlet Gas Sources	Mixture of oxygenand air	OxygencompressiongasAircompressiongas	Oxygen compressiongasAir compression gasSuction compressiongas	Oxygencompression gasAir compressiongas
Pressure Relief Valve	Yes	Yes	Yes	Yes
Pressure Gauge	Yes	Yes	Yes	Yes
Suction Pressure Gauge	No	No	Yes	Yes
Outlet	Single outlet	Single outlet	Double outlets(Outlet A/B)	Double outlets(Outlet A/B)
	This outlet is for resuscitation usingaerosol tube and "T" Flow Valve.It may be connected a face mask ortracheal tube.		Outlet A is for resuscitation usingaerosol tube and "T" Flow Valve.It may be connected a face mask ortracheal tube.Outlet B can be connected to oxygentent, oxygen mask, oxygen cannula andhumidifier jar etc.
Predicates	Fisher & PaykelRD1000 NEOPUFFINFANTRESUSCITATOR	Giraffe and Panda T-piece Resuscitation System(K070210)

Indications for Use:

All are intended for neonates and infants (< 10kg or 22 lbs) in a delivery room and a NICU.

Environment of Use: Hospitals, delivery suites, NICU

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510(k) Summary Page 3 of 5 27-Mar-11

Summary of substantial equivalence

Resusci Flow

The Resusci Flow model was compared to the predicate Fisher & Paykel NeoPuff (K892885) and found to be substantially equivalent based upon:

Indications for Use - The Resusci Flow has equivalent indications for use to the predicate.

The details of the NeoPuff indications are not available, except in their labeling due to the age of the clearance, 1989. Nonetheless the indications for use are equivalent.

Patient Population - The Resusci Flow has the equivalent patient population neonates and infants. We have been more specific than the predicate NeoPuff and included a limitation of patient weight.

Environment for use - The Resusci Flow has the identical environments for use as the predicate.

Prescriptive - The Resusci Flow is identical to the predicate.

Design and Technology - The Resusci Flow has an equivalent design and features as the predicate and has the identical technology as the predicate.

Performance and Specifications - The Resusci Flow has equivalent specifications of performance as the predicate.

Compliance with standards - Both devices declare compliance with the internal standard ISO 10651-5 for powered resuscitators.

Conclusion

The Resusci Flow is substantially equivalent to the predicate NeoPuff (K892885) in indications for use, patient population, and environment for use, technology characteristics, specifications / performance and compliance with international standards

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510(k) Summary Page 4 of 5 27-Mar-11

Resusci Flow with Blender, Resusci Flow 104 PV and Resusci Flow 104 EV

The Resusci Flow with Blender, Resusci Flow 104PV, and Resusci Flow 104EV were compared to the predicate GE Giraffe and Panda T-piece resuscitator (K070210). As well as the Resusci Flow with Blender, Resusci Flow 104PV, and Resusci Flow 104EV were compared to the predicate GE Giraffe and Panda (K070210) for equivalence.

Indications for Use - The Resusci Flow with Blender, Resusci Flow 104PV, and Resusci Flow 104EV have equivalent indications for use to the predicate.

Patient Population - The Resusci Flow with Blender, Resusci Flow 104PV, and Resusci Flow 104EV have the equivalent patient population neonates and infants.

Environment for use - The Resusci Flow with Blender, Resusci Flow 104PV, and Resusci Flow 104EV have the identical environments for use as the predicate.

Prescriptive - The Resusci Flow with Blender, Resusci Flow 104PV, and Resusci Flow 104EV are identical to the predicate.

Design and Technology - The Resusci Flow with Blender, Resusci Flow 104PV, and Resusci Flow 104EV have an equivalent design and features as the predicate and has the identical technology as the predicate.

Performance and Specifications - The Resusci Flow with Blender, Resusci Flow 104PV, and Resusci Flow 104EV have equivalent specifications of performance as the predicate.

Compliance with standards - Both devices declare compliance with the internal standard ISO 10651-5 for gas powered resuscitators and ISO 10079-3 for suction equipment.

Conclusion

The Resusci Flow with Blender. Resusci Flow 104PV, and Resusci Flow 104EV is substantially equivalent to the predicate GE Giraffe and Panda (K070210) in indications for use, patient population, and environment for use, technology characteristics, specifications / performance and compliance with international standards.

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510(k) Summary Page 5 of 5 27-Mar-11

Performance Testing

We have performed bench tests which included the list below and found that the Resusci Flow series (Resusci Flow, Resusci Flow with blender, Resusci Flow 104 PV, and Resusci Flow 104 EV) resuscitators met all pass /fail criteria, cited standards requirements or were found to be equivalent in comparison to the predicates.

ISO 10651-5 clause 5.1.10 Display accuracy of the airway pressure gauge .
. Gas discharge flow rate from the patient circuit
ISO 10651-5 Clause 7.7.1 Delivered concentration accuracy of oxygen .
ISO 10651-5 clause 7.1.2.2 Inspiratory resistance .
ISO 10651-5 clause 7.2.4 pressure limitation .
ISO 10651-5 clause 7.2.4 and 5.1.10 Pressure characteristics of peak . inspiratory pressure (PIP inspiratory resistance)
. Confirm the maximum open pressure (Pmax)
ISO 10651-5 clause 7.2.4 and 5.1.10 positive end-expiratory pressure (PEEP) .
. Environment Performance
. Vibration Testing
. Drop Testing
Test pressure loss alarm .
ISO 11195 Gas mixers alarm for loss of pressure .
. ISO 10079-3 for suction equipment
. Safety requirements
Vomitus Resistance .
Expiratory Resistance .

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Image /page/5/Picture/1 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 symbol resembling an eagle or bird in flight, with three stylized wing segments and a flowing tail.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Atom Medical Corporation C/O Mr. Paul Dryden ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134

APR -- 6 2011

Re: K102542

Trade/Device Name: Resusci Flow Series, Resusci Flow, Resusci Flow with Blender, Resusci Flow 104 PV and Resusci Flow 104 EV Regulation Number: 21 CFR 868.5925 Regulation Name: Powered Emergency Ventilator Regulatory Class: II Product Code: BTL Dated: March 27, 2011 Received: March 29, 2011

Dear Mr. Dryden:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Mr. Dryden

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 requirem. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its offective number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

in fer

Anthony Watson, B.S., M.S., M.B.A. 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 Statement

510(k) Number:

K102542

Device Name:

Resusci Flow series Resusci Flow Resusci Flow with blender Resusci Flow 104 PV Resusci Flow 104 EV

Indications for Use:

All are intended for neonates and infants (≤ 10kg or 22 lbs) in a delivery room and a NICU.

Prescription Use XX (Part 21 CFR 801 Subpart D) or '

Over-the-counter use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

f. Schulthess

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control and Dental Devices
510(k) Number: K.V. 542

Regulation Number and Section

§ 868.5925 Powered emergency ventilator.

(a)
Identification. A powered emergency ventilator is a demand valve or inhalator 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).