Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of:
Infant: <= 10 Kg, Child: <= 23 Kg, Adult: > 23 Kg

This manual resuscitator is supplied with a single patient use positive end expiratory pressure (PEEP) valve for use hospital, transport, emergency, and post hospital care to evaluate end lung pressure above atmospheric at the end of exhalation in constant and intermittent gas flow conditions.

Single patient use device for use hospital, transport, emergency, and post hospital care for the elevation of lung pressure above atmospheric pressure at the end of exhalation.

Device Description

GaleMed DISPO-BAG Manual Resuscitation Bags are disposable, medical devices which temporarily augment ventilation in patients during ventilatory insufficiency or ventilatory failure. GaleMed DISPO-BAG Manual Resuscitation Bags use a duck-bill valve in the non-rebreathing valve assembly, attaches the non-rebreathing valve directly onto the ventilation bag and includes an oxygen enrichment (reservoir) system.

GaleMed Disposable PEEP Valves are disposable medical devices which elevate the pressure in a patient's lungs above atmospheric pressure at the end of exhalation. The GaleMed Disposable PEEP Valve is a, spring actuated valve, which when placed into a circuit provides positive end expiratory pressure for the patient. The valve is provided in two pressure ranges (5-20 cmH2O and 2.5 - 10 cm H2O) and several connector sizes which comply to ISO 5356- I "Anesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets". Likewise the GaleMed single patient use fixed value PEEP valve is a, spring actuated valve, which when placed into a circuit provides positive end expiratory pressure for the patient. The valve is provided in two pressure settings of 2.4, 5.0, 7.5 and 10.0 cmHzO) also offered in several connector sizes which comply to ISO 5356- I "Anesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets".

AI/ML Overview

The provided text describes a 510(k) premarket notification for the GaleMed DISPO-BAG Manual Resuscitator, the DISPO-BAG Manual Resuscitator with Disposable PEEP Valve, and the Disposable PEEP Valve. This document primarily focuses on establishing substantial equivalence to predicate devices, rather than detailing a specific study to prove the device meets acceptance criteria in the typical AI/CAD sense.

The "study" referenced here is the bench testing conducted to confirm the accuracy and compliance of the devices with relevant international standards.

Here's an analysis based on the provided text, structured to answer your questions where applicable. However, many of your specific questions related to AI/CAD system studies (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) are not relevant or applicable to this type of medical device submission. This submission is for a physical medical device (resuscitator/PEEP valve), not an AI/CAD diagnostic software.

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are primarily defined by compliance with established international standards for resuscitators and connectors. The reported device performance is that the devices meet these requirements.

Acceptance Criteria (Standards Met)	Reported Device Performance
ISO 10651-4:2002 ("Lung ventilators - Part 4: Particular requirements for operator powered resuscitators")	GaleMed DISPO-BAG Manual Resuscitation Bags and the predicate device meet these requirements.
ISO 5356-1:2004 ("Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets")	GaleMed DISPO-BAG Manual Resuscitation Bags and the predicate device meet these requirements. GaleMed Disposable PEEP Valves and the predicate device meet these requirements.
Accuracy of PEEP Valve pressure ranges	Bench testing confirmed the accuracy of the devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified in the document. This would typically involve testing a statistically representative sample of physical devices according to the test protocols outlined in the relevant ISO standards.
Data Provenance: The bench testing would have been conducted by the manufacturer, GaleMed Corporation, based in I-Lan, Taiwan. The data is prospective in the sense that the devices were manufactured and then tested to confirm their performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable for this type of device. Ground truth for a physical device like a resuscitator or PEEP valve is established by meeting engineering specifications and performance metrics defined by international standards, not by expert interpretation of data or images. The "ground truth" is whether the device physically performs as required by the standards (e.g., delivers the correct pressure, fits correctly, etc.).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of medical images where expert consensus is needed to establish ground truth for a diagnostic task. This document details bench testing of a physical device.

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 for a physical medical device, not an AI/CAD system. There are no "human readers" or "AI assistance" involved in its primary function.

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

Not applicable. This is not an AI algorithm. The device, when used by a healthcare professional, performs its function directly.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth used for this device is compliance with international performance standards (ISO 10651-4:2002 and ISO 5356-1:2004) and bench testing confirmed accuracy for stated pressure ranges. This is an engineering/performance-based ground truth, not a clinical diagnostic ground truth.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this device.

Summary

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KOS2019

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510(k) Summary

OCT 1 5 2008

Owner:	GaleMed Corporation97, Li-gong 2nd Road, Wu-jiaI-Lan, Taiwan 268Tel: + 866 3 990 8618Fax: + 866 3 990 8245
Owner/Operator Number:	8043316
Official Contact:	Thomas LoescherTel: (760) 930-4025Fax: (760) 930-0040
Trade Names:	Resuscitators:1. DISPO-BAG Manual Resuscitation2. Bag DISPO-BAG Manual Resuscitation Bag with Disposable PEEP ValveP.E.E.P. Valve: Disposable PEEP Valve
Common/Usual Name:	Resuscitators:1. Manual Resuscitation2. Manual Resuscitation Bag with PEEP ValveP.E.E.P. Valve: PEEP Valve
Classification Name:	Dispo - Bag Manual Resuscitator:Device Name: Ventilator, Emergency, Manual (Resuscitator)Product Code: BTMRegulation: 868.5915Device Class: 2Disposable PEEP Valve:Device Name: Attachment, Breathing, Positive End Expiratory PressureProduct Code: BYERegulation: 868.5965Device Class: 2
Device:	Dispo-Bag Manual ResuscitatorDispo-Bag Manual Resuscitator with Disposable PEEP ValveDisposable PEEP Valve

Predicate Devices:
Ventilator, Emergency, Manual (Resuscitator):

K944301:	Hudson RCI, Temecula, CA (Teleflex Medical, Research Triangle Park, NC);LIFESAVER® Single patient use Manual Resuscitators; Cat. Nos. 5360, 5361, 5362, 5364, 5365, 5366, 5367, 5369, 5370, 5371, 5372, 5373, 5377, 5380, 5387, and 5389.
----------	-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Attachment, Breathing, Positive End Expiratory:

K902062:	Hudson RCI, Temecula, CA (Teleflex Medical, Research Triangle Park, NC);LIFESAVER® PEEP Valve; Cat. Nos. 5383 and 5385.
----------	-----------------------------------------------------------------------------------------------------------------------------

Device Description:

DISPO-BAG Manual Resuscitation Bags with and without Disposable PEEP Valve:
GaleMed DISPO-BAG Manual Resuscitation Bags are disposable, medical devices which temporarily augment ventilation in patients during ventilatory insufficiency or ventilatory failure.

87 Li-gong 200 Road, Wu-jia, I-Lan 268

율. +866-(0)3-990-8618 Fax: +866-(0)3-990-8245

Page 1 of 3

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Image /page/1/Picture/1 description: The image shows a logo with the word "galer" in a bold, sans-serif font. Below the word "galer" are two lines of smaller text. The first line is a series of dots, and the second line appears to say "caring for life". The logo also includes a dark, abstract shape to the left of the word "galer".

GaleMed DISPO-BAG Manual Resuscitation Bags use a duck-bill valve in the non-rebreathing valve assembly, attaches the non-rebreathing valve directly onto the ventilation bag and includes an oxygen enrichment (reservoir) system.

GaleMed DISPO-BAG Manual Resuscitation Bags may be used in the hospital, in physician office, outpatient care facilities, extended care facility, home, emergency medical services and patient transport.

GaleMed DISPO-BAG Manual Resuscitation Bags incorporate a number of features, which are designed to allow flexibility in product configuration:

Adult, child and infant models with and without face mask �
Adult, child and infant models with open and closed oxygen reservoir systems .
Adult, child and infant models with and without a Positive End Expiratory Pressure . (P.E.E.P.) device on the expiratory port

Disposable PEEP Valve:

GaleMed Disposable PEEP Valves are disposable medical devices which elevate the pressure in a patient's lungs above atmospheric pressure at the end of exhalation. The GaleMed Disposable PEEP Valve is a, spring actuated valve, which when placed into a circuit provides positive end expiratory pressure for the patient. The valve is provided in two pressure ranges (5-20 cmH2O and 2.5 - 10 cm H2O) and several connector sizes which comply to ISO 5356- I "Anesthetic and respiratory equipment -Conical connectors - Part 1: Cones and sockets". Likewise the GaleMed single patient use fixed value PEEP valve is a, spring actuated valve, which when placed into a circuit provides positive end expiratory pressure for the patient. The valve is provided in two pressure settings of 2.4, 5.0, 7.5 and 10.0 cmHzO) also offered in several connector sizes which comply to ISO 5356- I "Anesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets".

GaleMed Disposable PEEP Valves may be used in the hospital, extended care facility, emergency medical services and patient transport. They may be used in a constant or intermittent flow system such as resuscitation bags or continuous gas flow systems.

GaleMed Disposable PEEP Valve configurations include:

. 2.5 - 10.0 cm H2O Adjustable Valve
5.0 20.0 cm H2O Adjustable Valve .
Fixed Valves at 2.5, 5.0, 7.5 and 10 cm H2O .

Indications for Use:

DISPO-BAG Manual Resuscitation Bag:

Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of:

Infant: ≤ 10 Kq, Child: ≤ 23 Kg, Adult: >> 23 Kg

DISPO-BAG Manual Resuscitation Bag with Disposable PEEP Valve:

Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of:

Infant: ≤ ≤ 10 Kg, Child: ≤ ≤ 23 Kg, Adult: > > 23 Kg

Disposable PEEP Valve:

Single patient use device for use hospital, transport, emergency, and post hospital care for the elevation of lung pressure above atmospheric pressure at the end of exhalation.

Image /page/1/Figure/25 description: The image contains an address. The address is "87 Li-gong 2nd Road, Wu-jia, I-Lan 268, Taiwan". The address is located in the bottom center of the image. The rest of the image is blank.

+866-(0)3-990-8618 Fax: +866-(0)3-990-8245

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K082092

Contraindications:

DISPO-BAG Manual Resuscitation Bag:

Contraindicated in individuals with a body mass of:

Infant: > > 10 Kg, Child: > > 23 Kg, Adult: < < 23 Kg

DISPO-BAG Manual Resuscitation Bag with Disposable PEEP Valve:

Contraindicated in individuals with a body mass of:

Infant: > > 10 Kg, Child: > > 23 Kg, Adult: < < 23 Kg

Contraindicated in individuals not requiring elevation of lung pressure above atmospheric at the end of exhalation.

Disposable PEEP Valve:

Contraindicated in individuals not requiring elevation of lung pressure above atmospheric at the end of exhalation.

Patient Population:

DISPO-BAG Manual Resuscitation Bag:

Patient populations from infant (neonate) to adult.

DISPO-BAG Manual Resuscitation Bag with Disposable PEEP Valve:

Patient populations from infant (neonate) to adult.

Disposable PEEP Valve:

Patient populations from infant (neonate) to adult.

Environment of Use:

DISPO-BAG Manual Resuscitation Bag:

Hospital, transport, emergency, and post hospital care environments.

DISPO-BAG Manual Resuscitation Bag with Disposable PEEP Valve:

Hospital, transport, emergency, and post hospital care environments.

Disposable PEEP Valve:

Hospital, transport, emergency, and post hospital care environments.

Comparative of Technological Characteristics:

DISPO-BAG Manual Resuscitation Bags with and without Disposable PEEP Valve:

GaleMed DISPO-BAG Manual Resuscitation Bags are substantially equivalent in indication for use, environment of use, patient population, design, material and function to the identified predicates.

GaleMed DISPO-BAG Manual Resuscitation Bags and the predicate device use a duck-bill valve in the non-rebreathing valve assembly attach the non-rebreathing valve directly onto the ventilation bag and include an oxygen enrichment (reservoir) system.

GaleMed DISPO-BAG Manual Resuscitation Bags and the predicate device meet the requirements setforth ISO 10651-4:2002 entitled "Lung ventilators - Part 4: Particular requirements for operator powered resuscitators" and ISO 5356-1:2004 entitled "Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets".

Disposable PEEP Valves:

GaleMed Disposable PEEP Valves are substantially equivalent in indication for use, environment of use, patient population, design, material and function to the identified predicates.

GaleMed Disposable PEEP Valves and the predicate device meet the requirements settorth ISO 5356-1:2004 entitled "Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets". Bench testing confirmed the accuracy of the devices.

Conclusion:

The GaleMed DISPO-BAG Manual Resuscitation Bag, DISPO-BAG Manual Resuscitation Bag with Disposable PEEP Valve and Disposable PEEP Valve are substantially equivalent to the predicate device. Both have similar design characteristics, ventilate in the same manner and have substantially equivalent performance. GaleMed and the predicate devices are made from identical material, have the same intended use and are used in identical environments.

87 Li-gong 20d Road, Wu-jia, I-Lan 268 Taiwan

+866-(0)3-990-8618 Fax: +866-(0)3-990-8245

Page 3 of 3

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, rendered in black. The bird is facing right and has a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 2008

GaleMed Corporation C/O Mr. Thomas C. Loescher President A Plus Medical 5431 Avenida Encinas, Suite G Carlsbad, California 92008-4411

Re: K082092

Trade/Device Name: DISPO-BAG Manual Resuscitation Bag Disposable PEEP Valve DISPO-BAG Manual Resuscitation Bag with Disposable PEEP Valve Regulation Number: 21 CFR 868.5915 Regulation Name: Manual Emergency Ventilator Regulatory Class: II Product Code: BTM, BYE Dated: October 1, 2008 Received: October 2, 2008

Dear Mr. Loescher:

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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Page 2 - Mr. Loescher

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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Chiu-Lien, Ph.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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Indications for Use Statement

510(k) Number:	KO82092
Device Name:	DISPO- BAG Manual Resuscitation Bag
Indications for Use:	Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of:Infant: $\leq$ 10 Kg, Child: $\leq$ 23 Kg, Adult: > 23 Kg

Prescription Use Prescription Use

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)

L. Ahmed

(Divísion Sign-Øff) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K082092

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Indications for Use Statement

510(k) Number:	KO82092
Device Name:	DISPO- BAG Manual Resuscitation Bag with Disposable PEEPValve
Indications for Use:	Single patient use manual resuscitator for use hospital, transport,emergency, and post hospital care to temporary ventilate a patientfor the given body mass ranges of:Infant: ≤ 10 Kg, Child: ≤ 23 Kg, Adult: > 23 KgThis manual resuscitator is supplied with a single patient use positiveend expiratory pressure (PEEP) valve for use hospital, transport,emergency, and post hospital care to evaluate end lung pressureabove atmospheric at the end of exhalation in constant andintermittent gas flow conditions.
Prescription Use X(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)

Ahmad

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K082092

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Indications for Use Statement

510(k) Number: KO82092
Device Name: Disposable PEEP Valve
Indications for Use: Single patient use positive end expiratory pressure (PEEP) valve for use hospital, transport, emergency, and post hospital care to evaluate end lung pressure above atmospheric at the end of exhalation in constant and intermittent gas flow conditions.

Prescription Use (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)

signature

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K68

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).