The BAG manual resuscitator and accessories

K251631 · Laerdal Medical AS · BTM · Nov 24, 2025 · Anesthesiology

Device Facts

• Record ID: K251631
• Device Name: The BAG manual resuscitator and accessories
• Applicant: Laerdal Medical AS
• Product Code: BTM · Anesthesiology
• Decision Date: Nov 24, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5915
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The BAG is indicated for patients requiring total or intermittent ventilatory support. Ventilation is possible with or without supplemental oxygen. The BAG is intended to be used in both pre-hospital and healthcare facility environments. The sizes versions also include indications for the patient population: Adult: The Adult model is intended for patients over 20 kg (44 lbs). Pediatric: The Pediatric model is intended for patients 2.5 - 20 kg (5.5 - 44 lbs). Newborn: The Newborn model is intended for patients 2.5 - 5 kg (5.5 -11 lbs). The BAG PEEP Valve is indicated for patients in need of ventilatory support with positive end-expiratory pressure (PEEP). The BAG PEEP valves can be used for all patient sizes indicated for The BAG manual resuscitator. The BAG PEEP valve is intended to be used in both pre-hospital and healthcare facility environments. The BAG Manometer is indicated for measuring the gas pressure provided to a patient requiring total or intermittent ventilatory support. The BAG Manometer can be used for all patient sizes indicated for The BAG manual resuscitator. The BAG Manometer is intended to be used in both pre-hospital and healthcare facility environments.

Device Story

The BAG is a non-sterile, self-inflating manual resuscitator for short-term (<24 hours) ventilatory support. It operates by manual compression of a ventilation bag to inflate the patient's lungs, utilizing valves to manage oxygen intake and prevent rebreathing. Accessories include a spring-actuated PEEP valve to maintain end-expiratory pressure and a mechanical manometer to provide visual airway pressure feedback (0-60 cmH2O). Used in pre-hospital and healthcare settings by CPR-trained professionals. The device provides manual respiratory support via face mask or airway tube. Benefits include portable, immediate ventilatory assistance. Healthcare providers monitor the manometer output to ensure appropriate pressure delivery and adjust ventilation accordingly.

Clinical Evidence

Bench testing only. Testing included compliance with ISO 10651-4 (resuscitator performance), ISO 5356-1 (connectors), ISO 10993-1 (biocompatibility), and ISO 18562 series (gas pathway biocompatibility). Human factors/usability engineering performed per FDA guidance and IEC 62366-1. Magnetic resonance compatibility tested per ASTM F2052-21 and ASTM F2213-17. Packaging tested per ISTA 3A.

Technological Characteristics

Manual resuscitator with TPE bag, polycarbonate/HDPE connectors, silicone valves, PVC tubing, LDPE reservoir, stainless steel springs. PEEP valve: polycarbonate housing, silicone valve, stainless steel spring. Manometer: polycarbonate housing/piston, stainless steel spring, silicone exhaust port. Mechanical operation; no software or energy source. Complies with ISO 10651-4, ISO 5356-1, ISO 18562, ISO 10993.

Indications for Use

Indicated for patients requiring total or intermittent ventilatory support. Adult model: >20 kg. Pediatric model: 2.5-20 kg. Newborn model: 2.5-5 kg. PEEP valve indicated for patients needing PEEP. Manometer indicated for measuring gas pressure during ventilation. Used in pre-hospital and healthcare facilities.

Regulatory Classification

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.

Predicate Devices

• Flexicare Single Use Resuscitator Bag (K181583)
• Hsiner Resuscitator and PEEP Valve (K053466)
• Intersurgical 7160030 Manometer (K122077)

Reference Devices

• Foremount Disposable PVC Resuscitator Model A1, A2, B1, B2 and Accessories (K170663)

Submission Summary (Full Text)

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FDA U.S. FOOD &amp; DRUG ADMINISTRATION

November 24, 2025

Laerdal Medical AS
% Daniel Dillon
Senior Regulatory Scientist
MED Institute
1330 Win Hentschel Boulevard
Suite 100
West Lafayette, Indiana 47906

Re: K251631
Trade/Device Name: The BAG manual resuscitator and accessories
Regulation Number: 21 CFR 868.5915
Regulation Name: Manual Emergency Ventilator
Regulatory Class: Class II
Product Code: BTM, BYE, CAP
Dated: May 27, 2025
Received: May 28, 2025

Dear Daniel Dillon:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

U.S. Food &amp; Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K251631 - Daniel Dillon
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K251631 - Daniel Dillon
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

John S. Bender -S

for Ethan Nyberg, Ph.D.
Assistant Director
DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known)
K251631

Device Name
The BAG manual resuscitator and accessories

Indications for Use (Describe)
The BAG is indicated for patients requiring total or intermittent ventilatory support. Ventilation is possible with or without supplemental oxygen. The BAG is intended to be used in both pre-hospital and healthcare facility environments.

The sizes versions also include indications for the patient population:

Adult: The Adult model is intended for patients over 20 kg (44 lbs).
Pediatric: The Pediatric model is intended for patients 2.5 - 20 kg (5.5 - 44 lbs).
Newborn: The Newborn model is intended for patients 2.5 - 5 kg (5.5 -11 lbs).

The BAG PEEP Valve is indicated for patients in need of ventilatory support with positive end-expiratory pressure (PEEP). The BAG PEEP valves can be used for all patient sizes indicated for The BAG manual resuscitator. The BAG PEEP valve is intended to be used in both pre-hospital and healthcare facility environments.

The BAG Manometer is indicated for measuring the gas pressure provided to a patient requiring total or intermittent ventilatory support. The BAG Manometer can be used for all patient sizes indicated for The BAG manual resuscitator. The BAG Manometer is intended to be used in both pre-hospital and healthcare facility environments.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Laerdal helping save lives

# 510(k) Summary

The BAG manual resuscitator

21 CFR 868.5915

Date Prepared: November 20, 2025

## Submitted By

Claudia Pajares Ibanez, Manager, Regulatory Affairs

Laerdal Medical AS

Tanke Svilandsgate 30

P.O. Box 377

4002 Stavanger

Norway

T: [phone]-1892

[e-mail]

## Device Information

The BAG manual resuscitator and accessories have the following names and classifications:

| Trade Name | Common Name | Classification Name | Regulation | Class | Product Code |
| --- | --- | --- | --- | --- | --- |
| The BAG | manual resuscitator | Manual emergency ventilator | 868.5915 | II | BTM |
| The BAG | PEEP valve | Positive end expiratory pressure breathing attachment | 868.5965 | II | BYE |
| The BAG | Manometer | Airway pressure monitor | 868.2600 | II | CAP |

## Indications for Use

The BAG is indicated for patients requiring total or intermittent ventilatory support. Ventilation is possible with or without supplemental oxygen. The BAG is intended to be used in both pre-hospital and healthcare facility environments.

The sizes versions also include indications for the patient population:

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Traditional
510(\mathrm{k})
; The BAG manual resuscitator, Laerdal Medical AS 510(k) Summary

Adult: The Adult model is intended for patients over 20 kg (44 lbs).

Pediatric: The Pediatric model is intended for patients 2.5 - 20 kg (5.5 - 44 lbs).

Newborn: The Newborn model is intended for patients 2.5 - 5 kg (5.5 -11 lbs).

The BAG PEEP Valve is indicated for patients in need of ventilatory support with positive end-expiratory pressure (PEEP). The BAG PEEP valves can be used for all patient sizes indicated for The BAG manual resuscitator. The BAG PEEP valve is intended to be used in both pre-hospital and healthcare facility environments.

The BAG Manometer is indicated for measuring the gas pressure provided to the patient requiring total or intermittent ventilatory support. The BAG Manometer can be used for all patient sizes indicated for The BAG manual resuscitator. The BAG Manometer is intended to be used in both pre-hospital and healthcare facility environments.

## Predicate Devices

The BAG manual resuscitator is substantially equivalent to the Flexicare Single Use Resuscitator Bag (510(k) No. K181583, cleared December 7, 2018).

The BAG PEEP Valve is substantially equivalent to the PEEP valve described in the 510(k) for the Hsiner Resuscitator and PEEP Valve (510(k) No. K053466, cleared March 22, 2006).

The BAG Manometer is substantially equivalent to the Intersurgical 7160030 Manometer (510(k) No. K122077, cleared January 10, 2013).

## Device Description

The BAG is a non-sterile self-inflating manual resuscitator. It is indicated for patients requiring ventilatory support. Ventilation is possible with or without supplemental oxygen. The BAG manual resuscitator is intended for short-term use (&lt; 24 hours per patient) and may be used multiple times on a single patient when kept free from contamination. It is available in three sizes: adult (for patients &gt; 20 kg (44 lbs.), pediatric (for patients 2.5-20 kg (5.5-44 lbs.), and newborn (for patients 2.5-5 kg (5.5-11 lbs.)).

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Traditional 510(k); The BAG manual resuscitator, Laerdal Medical AS 510(k) Summary

The BAG PEEP Valve is a non-sterile single patient use PEEP Valve, for use with The BAG manual resuscitator to maintain positive end expiratory pressure (PEEP). It is indicated for patients in need of ventilatory support with PEEP. It may be used multiple times on a single patient when kept free from contamination. The device has four parts: a main body, an adjustable screw cap, inner valve, and one or two springs (one for the 2-10 cmH₂O version and two for the 5-20 cmH₂O version). It attaches to the expiratory port of The BAG manual resuscitator. The BAG PEEP valve comes in two versions, one with a range of 2-10 cmH₂O and one with a range of 5-20 cmH₂O. The 2-10 cmH₂O version has a stated accuracy of +1/-2 cmH₂O at 2 cmH₂O and a stated accuracy of +1/-3 cmH₂O at 5-10 cmH₂O. The 5-20 cmH₂O version has a stated accuracy of ±3 cmH₂O throughout its range.

The BAG Manometer is a non-sterile single patient use airway pressure manometer, for use with The BAG manual resuscitator. The BAG Manometer is indicated for measuring the gas pressure provided to the patient. It provides a visual indication of gas pressure provided to the patient. It is intended for short-term use (&lt; 24 hours per patient) and may be used multiple times on a single patient when kept free from contamination. The device has a range of 0-60 cmH₂O and is accurate to ±10% of the reading in the range of 20-60 cmH₂O.

The use of either of the two accessories is optional, i.e., they are used at the discretion of the healthcare professional.

## Substantial Equivalence

The three tables below present the similarities and differences between the submitted devices and the predicate devices for substantial equivalence purposes. The differences between the submitted devices and the predicate devices do not raise any new issues of safety and effectiveness. Performance data are available to support substantial equivalence and were developed using acceptable scientific methods for evaluation.

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Traditional 510(k); The BAG manual resuscitator, Laerdal Medical AS 510(k) Summary

Table 1 Comparison of The BAG manual resuscitator to the Flexicare Single Use Resuscitator Bag

| The BAG manual resuscitator
(Subject of this submission) | | Flexicare Single Use Resuscitator Bag
(K181583) | | | Comparison |
| --- | --- | --- | --- | --- | --- |
| General | | | | | |
| Intended use | Provides emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. | Provides emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. | | | Same |
| Indications for use | Device is available in three sizes, each having slightly different indications for use statements, that follows this template:
“The BAG is indicated for patients requiring total or intermittent ventilatory support. Ventilation is possible with or without supplemental oxygen. The [X] model is intended for patients [Y]. The BAG is intended to be used in both pre-hospital and healthcare facility environments.”
The variable text is as follows:
[X] [Z]
Adult over 20 kg (44 lbs)
Pediatric 2.5 - 20 kg (5.5 - 44 lbs)
Newborn 2.5 - 5 kg (5.5 -11 lbs) | Device is available in three sizes, each having slightly different indications for use statements, that follows this template:
“Flexicare’s [X] Single Use Resuscitator Bag is intended for manual pulmonary resuscitation and emergency respiratory support of [Y] with a body weight of [Z]. For use with ambient air and supplemental oxygen if required. For use by CPR-trained personnel only within hospital and pre-hospital environments.”
The variable text is as follows:
[X] [Y] [Z]
Adult adult patients 22 lbs. to 66 lbs. (10-30 kg)
Infant neonates and infants up to 22 lbs. (10 kg) | | | Equivalent. Indications for use can vary, yet substantial equivalence is supported, because the two devices have the same intended use.
Based on the range of sizes, the devices have nearly identical patient populations. Size version of the resuscitators cover the ventilatory performance patient body mass ranges of ISO 10651-4:2002. The lower end for The BAG manual resuscitator is 2.5 kg (5.5 lbs), while the predicate device indicates no lower weight range. Thus, The BAG manual resuscitator’s patient population is within the range of the predicate’s patient population. |
| Prescription status | Prescription use only | Prescription use only | | | Same |

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Traditional 510(k); The BAG manual resuscitator, Laerdal Medical AS 510(k) Summary

| | The BAG manual resuscitator
(Subject of this submission) | Flexicare Single Use Resuscitator Bag
(K181583) | Comparison |
| --- | --- | --- | --- |
| Environment of use | Healthcare facilities, pre-hospital | Hospital, pre-hospital | Equivalent. “Healthcare facilities” is slightly broader than “hospital”, but is not a significant change with respect to substantial equivalence because, regardless of the environment of use, both devices are intended to be used by healthcare professionals trained in resuscitation, delivering ventilatory support and in the use of manual resuscitators. |
| Intended users | Healthcare professionals trained in resuscitation, delivering ventilatory support and in the use of manual resuscitators. | CPR-trained personnel only | Same. The term “health care professionals trained in resuscitation” refers to individuals certified in CPR. Thus, although the wording is different, the intended users are the same. |
| Design | | | |
| Principle of operation | Manual inflation of lungs via bag with valves to allow addition of oxygen and prevention of rebreathing expired air. | Manual inflation of lungs via bag with valves to allow addition of oxygen and prevention of rebreathing expired air. | Same |
| Ventilation Adult bag sizes | 1800 ml | Equivalent. Ventilation bag size is a design choice. The substantial equivalence of the sizes is demonstrated by performance testing to FDA-recognized consensus standards, most especially to ISO 10651-4. | Equivalent. Ventilation bag size is a design choice. The substantial equivalence of the sizes is demonstrated by performance testing to FDA-recognized consensus standards, most especially to ISO 10651-4. |
| Pediatric | 588 ml | 635 ml | |
| Newborn | 318 ml | 370 ml | |
| Key components | • Ventilation bag
• Patient, inlet and pressure-relief valves
• Oxygen reservoir
• PEEP valve option
• Manometer option | • Ventilation bag
• Patient, inlet and pressure-relief valves
• Oxygen reservoir
• PEEP valve option
• Manometer option
• Medication port
• CO2 monitoring port
• Face mask | Equivalent. The predicate device includes the same components as The BAG manual resuscitator, plus a few components that are optional, i.e., not critical to the safe and effective performance of the device. A medication port is not necessary because drag delivery can be performed (and is preferably performed) without passing through a resuscitator. A CO2 monitoring port is not necessary because a T-adapter with gas sampling port can be attached to the device at the user's discretion. Note also that neither ISO 10651-4:2002 nor ISO 10651-4:2023 require manual resuscitators to include these two functions. Face masks are outside the scope of the submission. Thus, the differences do not impact substantial equivalence. |

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Traditional 510(k); The BAG manual resuscitator, Laerdal Medical AS 510(k) Summary

| | The BAG manual resuscitator
(Subject of this submission) | Flexicare Single Use Resuscitator Bag
(K181583) | Comparison |
| --- | --- | --- | --- |
| Key materials | • Ventilation bag – TPE
• Connectors – Polycarbonate and HDPE
• Valves – Silicone
• O₂ tubing – PVC
• Reservoir bag – LDPE
• Valve spring – Stainless steel | • Ventilation bag – TPE
• Connectors – ABS
• Valves – Silicone
• O₂ Tubing – PVC
• Reservoir bag – PVC
• Valve spring – Stainless steel | Equivalent. The substantial equivalence of the devices with respect to material is supported by performance testing and biocompatibility evaluation using FDA-recognized consensus standards. |
| Compliance to FDA recognized standards | • ISO 10651-4:2002
• ISO 18562-1:2017
• ISO 18562-2:2017
• ISO 18562-3:2017
• ISO 18562-4:2017
• ISO 5356-1:2015 | • EN ISO 10651-4:2009
(ISO 10651-4:2002)
• BS ISO 18562-2 2017
• ISO 5356-1:2004 | Equivalent. The BAG manual resuscitator uses the current versions of two FDA-recognized standards (ISO 10651-4 and ISO 5356-1) and additional FDA-recognized standards in the ISO 18562-series of standards. Thus, The BAG manual resuscitator supplies the same or a higher assurance of safety and effectiveness with respect to the scope of the standards, supporting substantial equivalence. |
| Reuse status | Single patient use, < 24 hours | Single use | Same, with clarification of length of use, which does not affect substantial equivalence. |
| Sterility status | Nonsterile | Nonsterile | Same. |
| Performance | | | |
| Inspiratory resistance | Adult 4.2 cmH₂O @ 50 L/min | 1.5 cmH₂O @ 50 L/min | Equivalent. The ISO 10651-4:2002 requirement for inspiratory and expiratory resistance is < 5 cmH₂O, for (a) body mass ≤ 10 kg @ 5 l/min, and (b) body mass > 10 kg @ 50 l/min. Both devices meet this requirement, supporting substantial equivalence. |
| | Pediatric 4.0 cmH₂O @ 50 L/min and 0.5 cmH₂O @ 5 L/min | 1.5 cmH₂O @ 50 L/min | |
| | Newborn 0.4 cmH₂O @ 5 L/min | 0.4 cmH₂O @ 5 L/min | |
| Expiratory resistance | Adult 2.6 cmH₂O @ 50 L/min | 1.7 cmH₂O @ 50 L/min | |
| | Pediatric 2.8 cmH₂O @ 50 L/min and 0.3 cmH₂O @ 5 L/min | 1.7 cmH₂O @ 50 L/min | |
| | Newborn 0.4 cmH₂O @ 5 L/min | 0.9 cmH₂O @ 5 L/min | |
| Deadspace volume | Adult 6.90 ml | 4.27 ml | Equivalent. Although The BAG resuscitator exhibits a slightly higher deadspace volume compared to the predicate device, the values are within the requirements |
| | Pediatric | 5.01 ml | |

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Traditional 510(k); The BAG manual resuscitator, Laerdal Medical AS 510(k) Summary

| | | The BAG manual resuscitator
(Subject of this submission) | Flexicare Single Use Resuscitator Bag
(K181583) | Comparison |
| --- | --- | --- | --- | --- |
| | Newborn | 6.90 ml | 4.46 ml | of ISO 10651-4:2002 (specifically, < 7 ml based on the minimum delivered volume). Thus, deadspace volume remains within clinically acceptable limits, does not raise new questions of safety or effectiveness this difference, and supports substantial equivalence. |
| Maximum limited pressure of pressure relief valve | Adult | 60 ± 5 cmH2O @ 60 L/min | Three versions: (1) 60 cmH2O, (2) 40 cmH2O, or (3) no pressure relief valve | Equivalent |
| | Pediatric | 60 ± 5 cmH2O @ 60 L/min;
41 ± 4 cmH2O @ 15 L/min | 40 cmH2O | |
| | Newborn | 41 ± 4 cmH2O @ 15 L/min | 40 cmH2O | |

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Traditional 510(k); The BAG manual resuscitator, Laerdal Medical AS

510(k) Summary

Table 2 Comparison of The BAG PEEP Valve to the Hsiner PEEP valve

| | The BAG PEEP Valve (Subject of this submission) | Hsiner PEEP Valve (K053466) | Comparison |
| --- | --- | --- | --- |
| General | | | |
| Intended use | Elevates pressure in a patient's lungs above atmospheric pressure at the end of exhalation. | Elevates pressure in a patient's lungs above atmospheric pressure at the end of exhalation. | Same |
| Indications for use | The BAG PEEP Valve is indicated for patients in need of ventilatory support with positive end-expiratory pressure (PEEP). The BAG PEEP valves can be used for all patient sizes indicated for The BAG manual resuscitator. The BAG PEEP valve is intended to be used in both pre-hospital and healthcare facility environments. | Used in conjunction with manual resuscitators and other ventilatory support equipment to provide positive end expiratory pressure. | Same (editorial differences only) |
| Prescription status | Prescription use only | Prescription use only | Same |
| Environment of use | Healthcare facilities, pre-hospital | Not stated | Equivalent. Based on the predicate device's indications for use, the environment of use is likely the same. |
| Intended users | Healthcare professionals trained in resuscitation, delivering ventilatory support with PEEP and in the use of manual resuscitators. | Not stated | Equivalent. Based on the predicate device's indications for use, the environment of use is likely the same. |
| Design | | | |
| Principle of operation | Adjustable spring-actuated valve | Adjustable spring-actuated valve | Same |
| Key components | • Valve
• Spring
• Housing | • Valve
• Spring
• Housing | Same key components |
| Key materials | • Valve – Silicone
• Spring – Stainless steel
• Housing – Polycarbonate | Not stated | Equivalent. Even though the materials of the predicate device are unknown, the substantial equivalence of the devices with respect to material is demonstrated by performance testing and biocompatibility evaluation using FDA-recognized consensus standards. |
| Reuse status | Single patient use, < 24 hours | Single use | Same, with clarification of length of use, which does not affect substantial equivalence. |

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Traditional 510(k); The BAG manual resuscitator, Laerdal Medical AS 510(k) Summary

| The BAG PEEP Valve
(Subject of this submission) | | Hsiner PEEP Valve
(K053466) | Comparison |
| --- | --- | --- | --- |
| Sterility status | Nonsterile | Nonsterile | Same |
| Standards compliance | ISO 5356-1:2015 | ISO 5356-1:2004 | Equivalent. The BAG manual resuscitator uses the later version of the standard. |
| Performance | | | |
| PEEP pressure range | 5-20 cmH2O or
2-10 cmH2O | 5-20 cmH2O or
2-10 cmH2O | Same |
| | Accuracy ± 3 cmH2O | Not stated | Equivalent. The 510(k) Summary of another device (Foremount Disposable PVC Resuscitator Model A1, A2, B1, B2 and Accessories, 510(k) K170663) has a similar pressure ranges (5-20 cmH2O and 0-10 cmH2O) and similar accuracy (± 2 cmH2O). The differences in accuracy (in some cases 1 cmH2O better, in other cases 1 cmH2O worse) and not considered clinically significant and thus support substantial equivalence. |
| 2-10 cmH2O | +1/-2 cmH2O @ 2 cmH2O;
+1/-3 cmH2O @ 5-10 cmH2O | | |

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Traditional 510(k); The BAG manual resuscitator, Laerdal Medical AS 510(k) Summary

Table 3 Comparison of The BAG Manometer to the Intersurgical 7160030 Manometer

| The BAG Manometer (Subject of this submission) | | Intersurgical 7160030 Manometer (K122077) | Comparison |
| --- | --- | --- | --- |
| General | | | |
| Intended use | Measures the pressure in a patient's upper airway. | Measures the pressure in a patient's upper airway. | Same |
| Indications for use | The BAG Manometer is indicated for measuring the gas pressure provided to the patient. The BAG Manometer can be used for all patient sizes indicated for The BAG manual resuscitator. The BAG Manometer is intended to be used in both pre-hospital and healthcare facility environments. | The Intersurgical In-line single patient use manometer is intended to be used for monitoring the patients airway pressure during ventilation. The manometer is to be used with resuscitation systems and Mapleson C breathing circuits. | Equivalent. Indications for use can vary, yet substantial equivalence is supported, because the two devices have the same intended use. The predicate device has a wider range of the use ("resuscitation systems"), but the fact that The BAG Manometer is used only with The BAG manual resuscitator does not create a new or different intended use. |
| Prescription status | Prescription use only | Prescription use only | Same |
| Environment of use | Healthcare facilities, pre-hospital | Hospital, ambulance, and all other environments | Equivalent. "Healthcare facilities" is slightly broader than "hospital", and The BAG Manometer is not intended for "all other environments" as was stated for the predicate device. These differences are not significant with respect to substantial equivalence because, regardless of the environment of use, both devices are intended to be used by healthcare professionals trained in resuscitation, delivering ventilatory support and in the use of manual resuscitators. |
| Intended users | Healthcare professionals trained in resuscitation, delivering ventilatory support and in the use of manual resuscitators. | Must only be used by personnel trained in resuscitation and/or airway resuscitation. | Equivalent. Although the predicate device uses different wording to describe intended users, the intended users are substantially the same. |
| Design | | | |
| Principle of operation | A balance of the force exerted by the air in the system and the force exerted by a calibrated spring defines the indicator position. The display on each manometer is a similar size and the pressure is specified where the indicator lines up with number marked on the outside of the transparent cylinder. | A balance of the force exerted by the air in the system and the force exerted by a calibrated spring defines the indicator position. The display on each manometer is a similar size and the pressure is specified where the indicator lines up with number marked on the outside of the transparent cylinder. | Same |

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Traditional 510(k); The BAG manual resuscitator, Laerdal Medical AS

510(k) Summary

The BAG Manometer (Subject of this submission) Intersurgical 7160030 Manometer (K122077) Comparison

| Key components | • Spring
• Housing (i.e., cylinder)
• Piston (i.e., indicator) | • Spring
• Cylinder
• Indicator | Same |
| --- | --- | --- | --- |
| Key materials | • Spring – Stainless steel
• Housing – Polycarbonate
• Exhaust port on housing - Silicone
• Piston – Polycarbonate | • Steel
• Polypropylene
• Silicone
• TPE
• Styrene acrylonitrile resin | Equivalent. The substantial equivalence of the devices with respect to material is supported by performance testing and biocompatibility evaluation using FDA-recognized consensus standards. |
| Reuse status | Single patient use, <24 hours | Single patient use | Same, with clarification of length of use, which does not affect substantial equivalence. |
| Sterility status | Nonsterile | Nonsterile | Same |
| Performance | | | |
| Pressure range | 0-60 cmH2O | 0-60 cmH2O | Same |
| Gradations | 0-60 cmH2O, in 10 cmH2O increments | 0-60 cmH2O, in 10 cmH2O increments | Same |
| Deadspace volume | <7 ml (when combined with the resuscitator) | Unknown | The deadspace volume meets the requirements of ISO 10651-4:2002 for the operating environmental range, supporting substantial equivalence. The predicate does not provide this information in its labeling. |
| Measured Accuracy | ±1 cmH2O @ 10 cmH2O
±2 cmH2O @ 20 cmH2O
±3 cmH2O @ 30 cmH2O
±4 cmH2O @ 40 cmH2O
±5 cmH2O @ 50 cmH2O
±6 cmH2O @ 60 cmH2O | ±2 mbar (2 cmH2O) @ 10 cmH2O
±4 mbar (4 cmH2O) @ 20 cmH2O
±5 mbar (5 cmH2O) @ 30 cmH2O
±5 mbar (5 cmH2O) @ 40 cmH2O
±7 mbar (7 cmH2O) @ 50 cmH2O
±7 mbar (7 cmH2O) @ 60 cmH2O | Equivalent. The BAG Manometer is more accurate than the predicate device, supporting substantial equivalence. Note: Accuracy at 10 cmH2O is not clinically significant. In the critical range of 40-60 cmH2O, The BAG Manometer demonstrates better performance, supporting substantial equivalence. |

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Traditional 510(k); The BAG manual resuscitator, Laerdal Medical AS 510(k) Summary
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# Discussion of Tests and Test Results

Design verification and design validation testing demonstrates that The BAG manual resuscitator and accessories meet their functional requirements and performance specifications. In particular, testing was conducted on:

- The BAG manual resuscitator, in accordance with:

- ISO 10651-4:2002, Lung ventilators – Part 4: Particular requirements for operator-powered resuscitators, using the resuscitator alone and with all accessories,
- ISO 5356-1:2015, Anesthetic and respiratory equipment – Conical connectors – Part 1: Cones and sockets.

- The BAG manual resuscitator, for maximum deliverable tidal volume, dead space, and operation for 24 hours, in accordance with ISO 10651-4:2023, Lung ventilators – Part 4: Particular requirements for operator-powered resuscitators.

- The BAG PEEP Valve, for accuracy, using the operation and storage conditions and simulated ventilations from ISO 10651-4:2002.

- The BAG Manometer, for accuracy, using the operation and storage conditions from ISO 10651-4:2002.

- All accessories, for label durability and ability to withstand drops.

- All devices (separate and combined), for magnetic resonance compatibility in accordance with:

- ASTM F2052-21, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment, and
- ASTM F2213-17, Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment.

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Traditional 510(k); The BAG manual resuscitator, Laerdal Medical AS 510(k) Summary
13

- All devices combined, for biocompatibility in accordance with:
- ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process,
- ISO 18562-1:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process,
- ISO 18562-2:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter,
- ISO 18562-3:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds, and
- ISO 18562-4:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate.

- All devices combined, for human factors in accordance with:
- FDA’s guidance, Applying Human Factors and Usability Engineering to Medical Devices (2016)
- FDA’s guidance, Content of Human Factors Information in Medical Device Marketing Submissions (2022)
- IEC 62366-1, Edition 1.1 2020-06 Consolidated Version, Medical devices - Part 1: Application of usability engineering to medical device

- The packaging of all devices, for ability to withstand expected shipping conditions, in accordance with ISTA 3A:2008, Packaged-products for parcel delivery system shipment 70 kg (150 lb) or less.

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Traditional 510(k); The BAG manual resuscitator, Laerdal Medical AS 510(k) Summary
14

- All devices, at the end of their shelf life, for continued compliance with performance requirements.

## Conclusion

The results of these tests support the conclusion that The BAG manual resuscitator and accessories perform acceptably and do not raise any different questions regarding safety or effectiveness compared to the predicate devices, thus supporting a determination of substantial equivalence.