Predicate Devices

K051964 - PowerNeb® CoMedica, K895485 - IPV - Percussionaire Corp

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a mechanical therapeutic device with different modes of operation (Aerosol, CHFO, CPEP) and mentions bench testing for performance and equivalence, but there is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies.

Therapeutic

Yes

The device description explicitly states, "The MetaNeb® System is a therapeutic device."

Diagnostic

No
The MetaNeb® System is described as a "therapeutic device" indicated for mobilization of secretions, lung expansion therapy, and treatment/prevention of pulmonary atelectasis. Its function is to enhance mucus clearance and resolve/prevent atelectasis, not to diagnose conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components (Circuit, Controller, and Stand) and the performance studies include bench testing of these physical components.

IVD (In Vitro Diagnostic)

Based on the provided information, the MetaNeb® System is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use clearly describes a therapeutic device used for mobilizing secretions, lung expansion, treating/preventing atelectasis, and providing supplemental oxygen. These are all direct treatments and therapies applied to the patient, not tests performed on samples taken from the patient.
Device Description: The description details a therapeutic device with different modes (Aerosol, CHFO, CPEP) and components (Circuit, Controller, Stand). This aligns with a device used for respiratory therapy, not for analyzing biological samples.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The MetaNeb® System's function is to directly treat respiratory conditions.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The MetaNeb® System is indicated for mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and also has the ability to provide supplemental oxygen when used with compressed oxygen.

Product codes (comma separated list FDA assigned to the subject device)

NHJ

Device Description

The MetaNeb® System is a therapeutic device that uses a systematic approach to enhance normal mucus clearance and resolve or prevent patchy atelectasis.

The system has three modes: ·

. Aerosol-for the delivery of aerosol only. In this mode CHFO and CPEP are not available.
CHFO (Continuous High Frequency Oscillation)-a pneumatic form of chest physiotherapy that delivers . medicated aerosol while oscillating the airways with continuous pulses of positive pressure.
CPEP (Continuous Positive Expiratory Pressure)-supplies medicated aerosol combined with continuous . positive pressure to help hold open and expand the airways.

There are three maior components to The MetaNeb® System:

Circuit includes a mouthpiece, handset, nebulizer, tubing, and filter/tri-connector. It is a single patient . use, disposable that is intended for multiple treatment sessions.
Controller contains the controls to select the three different modes. It also has a manometer to monitor . pressure. Power is supplied by a hose connected to a 50 psi oxygen source.
Stand lets The MetaNeb® System be easily moved from room to room. .

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Adult and Child > 2 years old

Intended User / Care Setting

Hospitals, sub-acute facilities, physician offices, and clinics.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical bench testing was performed to demonstrate that the MetaNeb® is equivalent to the predicates. These tests included:

Comparative Particle Characterization testing via Cascade Impactor
- Adult flow rates
- Pediatric flow rates
- In various controller modes (Aerosol, CHFO, CPEP)
Cleaning validation
Simulated Life Cycle testing
Environmental and Mechanical testing
Comparative Performance Testing as compared to the predicate in simulated breathing and ventilator condition

Key results for performance testing:
CPEP Mode @ Max Flow:
Peak Pressure (cmH2O): 27.8 to 29.9
Total Respirable Dose (0.5-5 um)
Albuterol: 735.5 - 890.6
Ipratrompium: 149.2 - 187
Cromolyn: 2567.6 - 3046.6

CHFO Mode @ MetaNeb "High":
Peak Pressure (cmH2O): 21.1 to 25.4
Frequency (BPM): 226
Total Respirable Dose (0.5-5 um)
Albuterol: 139.2 - 200.2
Ipratrompium: 27- 54.6
Cromolyn: 673.1 - 948.1
Albuterol: 421.6 - 572.4
Ipratrompium: 124.5 - 204.6
Cromolyn: 1367.9 - 1903.9

CHFO Mode @ MetaNeb "High" with Ventilator Connection:
Peak Pressure (cmH2O): 20.5 to 44.1
Frequency (BPM): 226 to 231
Total Respirable Dose (0.5-5 um)
Albuterol: 95.8 + 13.1
Ipratrompium: 110.8 + 8.6
Cromolyn: 73.4 + 15.4

Biocompatibility of Materials:
The MetaNeb® system has been evaluated for biocompatibility. The system has 3 levels of biocompatibility:

Controller, which is a pneumatic system: Addressed via VOC, CO, Ozone and PM25 testing.
Patient circuit before the nebulizer (Group 2 reference): Indirect, external communicating, tissue / mucosal, prolonged duration (> 24 hr 30 days) per FDA internal memo and historical guidance. Tested for Cytotoxicity, Sensitization, Genotoxicity, Implantation.
All materials were tested according to ISO 10993-1 for the appropriate level of patient contact and duration and found to pass the applicable ISO 10993-1 test requirements.

The comparative testing demonstrates that the proposed device is substantially equivalent to the predicate devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K051964 - PowerNeb® CoMedica, K895485 - IPV - Percussionaire Corp

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).

Summary

0

K124032

510(k) Summary Page 1 of 8

Date Prepared	26-Mar-13	APR 2 5 2013
Hill-Rom Services Pte Ltd
1 Yishun Ave 7
Singapore, 768923, Singapore	Tel - 011 - 65 65945215
Fax - 011 - 65 65945201
Official Contact:	Hejie Wang - RA / QA Specialist
Proprietary or Trade Name:	MetaNeb® or MetaNeb® 4
Common/Usual Name:	Noncontinuous ventilator (IPPB)
Classification Code/Name:	NHJ - non-continuous ventilator (IPPB)
21 CFR 868.5905
Class 2
Predicate Devices:	K051964 - PowerNeb® CoMedica
K895485 - IPV - Percussionaire Corp

Device Description:

The MetaNeb® System is a therapeutic device that uses a systematic approach to enhance normal mucus clearance and resolve or prevent patchy atelectasis.

The system has three modes: ·

. Aerosol-for the delivery of aerosol only. In this mode CHFO and CPEP are not available.
CHFO (Continuous High Frequency Oscillation)-a pneumatic form of chest physiotherapy that delivers . medicated aerosol while oscillating the airways with continuous pulses of positive pressure.
CPEP (Continuous Positive Expiratory Pressure)-supplies medicated aerosol combined with continuous . positive pressure to help hold open and expand the airways.

There are three maior components to The MetaNeb® System:

Circuit includes a mouthpiece, handset, nebulizer, tubing, and filter/tri-connector. It is a single patient . use, disposable that is intended for multiple treatment sessions.
Controller contains the controls to select the three different modes. It also has a manometer to monitor . pressure. Power is supplied by a hose connected to a 50 psi oxygen source.
Stand lets The MetaNeb® System be easily moved from room to room. .

Indications for Use:

The MetaNeb® System is indicated for mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and also has the ability to provide supplemental oxygen when used with compressed oxygen.

Patient Population:

Adult and Child > 2 years old

1

510(k) Summary Page 2 of 8 26-Mar-13

Environment of Use:

Hospitals, sub-acute facilities, physician offices, and clinics.

Predicate Device Comparison:

The MetaNeb® system is viewed as substantially equivalent to the predicate devices because:

Indications -

The proposed indications for use for mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and also has the ability to provide supplemental oxygen when used with compressed oxygen are identical to the predicates

Discussion: The indications for use are identical to the predicates CoMedica PowerNeb (K51964) and Bird IPV (K895485).

Technology -

The design of the MetaNeb® system as a pneumatically operated system with different modes of operation: CPEP. CHFO, and aerosol only are identical to the predicates in design and basic function and performance. Discussion: The design of MetaNeb® is substantially equivalent to the predicates CoMedica PowerNeb (K51964) and Bird IPV (K895485).

The MetaNeb® offers some convenient features for the user that are different than the predicates. These are Aerosol Only mode vs. the Comedica PowerNeb (K051964) which requires the user to set the CPEP to minimum flow to deliver aerosol only. While the predicate IPV (K895485) has use an in-line nebulizer but does not have an aerosol only setting. These differences do not raise any new safety or efficacy concerns relative to the predicates.

Materials -

The materials in the gas and fluid pathway are considered external communicating, tissue contacting, prolonged duration have been tested per ISO 10993-1.

Discussion: All associated materials in the gas or fluid pathway have been tested per ISO 10993-1 and where applicable VOC and PM2 & testing was performed. The results demonstrate the materials to be safe for the intended use.

Environment of Use -

The proposed environments of use are hospital and sub-acute facilities which are identical to the predicates, noting that the Bird IPV is also intended for the home environment.

Discussion: The intended environments of use are identical to the predicates CoMedica PowerNeb (K.51964) and Bird IPV (K895485).

2

510(k) Summary Page 3 of 8 26-Mar-13

Patient Population -

The MetaNeb® is intended for patients that require therapy mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis.

Discussion: It is noted that the Bird IPV indicates that it is used with neonates to adults and the patient population for the MetaNeb® system could be > 2 years old. This is considered equivalent to the predicates CoMedica PowerNeb (K51964) and Bird IPV (K895485).

Differences -

There are no differences between the proposed device which would raise any new safety or risks and thus can be found to be substantially equivalent.

| | MetaNeb® | PowerNeb
CoMedica - K051964 | IPV
Bird - K895485 |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CFR
Classification | 868.5905 | 868.5905 | 868.5905 |
| Classification name | NHJ | NHJ | NHJ |
| | Device, positive
pressure breathing,
intermittent (IPPB) | Device, positive pressure
breathing, intermittent
(IPPB) | Device, positive
pressure breathing,
intermittent (IPPB) |
| Indications for Use | Indicated for
mobilization of
secretions,

lung expansion therapy,

treatment and
prevention of pulmonary
atelectasis,

ability to provide
supplemental oxygen
when used with
compressed oxygen. | Indicated for mobilization
of secretions,

lung expansion therapy,

treatment and prevention of
pulmonary atelectasis,

ability to provide
supplemental oxygen when
used with compressed
oxygen. | Indicated for the
mobilization and raising
of endobronchial
secretions,
bronchodilation,
reducing mucosal
edema, resolution of
diffuse patchy
atelectasis in all patient
populations. |
| Environments of Use | Hospital, sub-acute
facilities | Hospital, sub-acute facilities | Hospital, sub-acute
facilities, homecare |
| Patient Population | Adult
Child > 2 years old | All patients that require
therapy mobilization of
secretions, lung expansion
therapy, the treatment and
prevention of pulmonary
atelectasis | All patient populations |

Table 1 - Substantial Equivalence Comparative Table

3

510(k) Summary

	MetaNeb®	PowerNeb	IPV
		CoMedica - K051964	Bird - K895485
Contraindications	-Untreated tension
pneumothorax
-Untrained or unskilled
operator
-History of pneumothorax
-Pulmonary air leak
-Recent pneumonectomy
-Pulmonary hemorrhage
-Myocardial infarction
-Vomiting	-Untreated tension
pneumothorax
-Untrained or unskilled
operator
-History of pneumothorax
-Pulmonary air leak
-Recent pneumonectomy
-Pulmonary hemorrhage
-Myocardial infarction
-Vomiting	-Untreated tension
pneumothorax
-Lack of adequate,
skilled supervision
Mode of Operation	Pneumatic system using a
fixed venturi patient circuit
combined with medicated
aerosol to deliver continuous
high frequency oscillation
therapy at 2 pre-set
frequencies and amplitude.	Pneumatic system using a
fixed venturi patient circuit
combined with medicated
aerosol to deliver
continuous high frequency
oscillation therapy at 1
pre-set frequency and
amplitude	Pneumatic system using
a variable (sliding)
venturi patient circuit
combined with
medicated aerosol to
deliver continuous high
frequency oscillation
therapy at multiple user
settable frequencies and
amplitudes.
	Can deliver continuous
expiratory pressure (CPEP)
combined with medicated
aerosol.	Can deliver continuous
expiratory pressure (CPEP)
combined with medicated
aerosol.	Equivalent CPEP
function not available.
Modes	CPEP
CHFO
Aerosol Only	CPEP
CHFO
Can allow in-line aerosol
treatments	CHFO
Can allow in-line
aerosol treatments
CPEP
Continuous Positive
Expiratory Pressure	Controlled static flow with
positive pressures ≤ 30 cm
H2O	Controlled static flow with
positive pressures ≤ 20 cm
H2O	No static flow mode

·

4

510(k) Summary Page 5 of 8 26-Mar-13

| | MetaNeb® | PowerNeb
CoMedica - K051964 | IPV
Bird - K895485 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CHFO
Continuous High
Frequency Oscillations | Controlled continuous flow
with frequencies up to 300
beats per minute and peak
positive pressures $\le$ 30 cmH2O | Controlled continuous flow
with frequencies up to 300
beats per minute and peak
positive pressures $\le$ 30 cmH2O | Controlled
Intrapulmonary
Percussive Ventilation
(IPV) frequencies up to
300 beats per minute
and peak positive
pressures $\le$ 80 cmH2O |
| Aerosol Only | Controlled continuous
constant flow to in-line
nebulizer delivering
medicated aerosol only. | Equivalent Aerosol Only
function by setting CPEP to
minimum flow with in-line
nebulizer | Can use in-line
nebulizer |
| Patient Circuit | Disposable circuit referred to
as "hand-set" includes
connection for in-line
nebulizer | Disposable circuit referred to
as "hand-set" includes
connection for in-line
nebulizer | Reusable circuit
includes connection for
in-line nebulizer |
| | Draw in room air mix with
medicated aerosol and gas
from controller | Draw in room air mix with
medicated aerosol and gas
from controller | Draw in room air mix
with medicated aerosol
and gas from controller |
| Patient Circuit settings | Expiratory resistance
adjustment | Expiratory resistance
adjustment | Not available |
| Patient Interface | Mouthpiece
Face mask
Insert into ventilator circuit | Mouthpiece
Face mask | Mouthpiece
Insert into ventilator
circuit |
| Controller | Pneumatic and air or oxygen | Pneumatic and air or oxygen | Pneumatic and air or
oxygen |
| Controller settings | On/off
Mode selection
Frequency selection for
CHFO mode
Pressure adjustment for CPEP
mode
Pressure manometer
Connection for patient circuit | On/off
Mode selection
Pressure adjustment for CPEP
mode
Connection for patient circuit | On/off
Pressure and frequency
adjustment for CHFO
mode
Pressure manometer
Connection for patient
circuit |
| | MetaNeb® | PowerNeb
CoMedica - K051964 | IPV
Bird - K895485 |
| Ventilator connection | Placed in-line in the
inspiratory limb of the
ventilator circuit with a
standard "T" adapter.

Ventilator set to pressure
mode only | Not available | Placed in-line in the
ventilator circuit with a
IPV cone adapter

Ventilator set to
pressure mode only |
| Performance Testing | | | |
| CPEP Mode @ Max
Flow
Peak Pressure (cmH2O):
Total Respirable Dose
(0.5-5 um)
(Report 12-0058) | 27.8 to 29.9
Albuterol
735.5 - 890.6
Ipratrompium
149.2 - 187
Cromolyn
2567.6 - 3046.6 | 32.6 to 35.1
Albuterol
631.5 - 818.8
Ipratrompium
137.1 - 155.1
Cromolyn
2362.1 - 2695.2 | This mode is not
available on IPV |
| CHFO Mode @
MetaNeb "High"
Peak Pressure (cmH2O):
Frequency (BPM)
Total Respirable Dose
(0.5-5 um)
(Report 12-0058) | 21.1 to 25.4
226
Albuterol
139.2 - 200.2
Ipratrompium
27- 54.6
Cromolyn
673.1 - 948.1
Albuterol
421.6 - 572.4
Ipratrompium
124.5 - 204.6
Cromolyn
1367.9 - 1903.9 | 9.7 to 10.3
222 to 235
Albuterol
171.3 - 202.1
Ipratrompium
30.5 - 48.3
Cromolyn
805.4 - 1002.7 | 25.3 to 27.0
214 to 235
Albuterol
243.7 - 349.5
Ipratrompium
90 - 112.7
Cromolyn
900.1 - 1196.1 |
| CHFO Mode @
MetaNeb "High" with
Ventilator Connection
Peak Pressure (cmH2O):
Frequency (BPM)
Total Respirable Dose
(0.5-5 um)
(Report 12-0061) | 20.5 to 44.1
226 to 231
Albuterol
95.8 + 13.1
Ipratrompium
110.8 + 8.6
Cromolyn
73.4 + 15.4 | | 19.8 to 44.4
226 to 235
Albuterol
91.1 + 10.6
Ipratrompium
97.1 ± 3.4
Cromolyn
88 + 9.2 |
| | MetaNeb® | PowerNeb
Comedica - K051964 | IPV
Bird - K895485 |
| Materials | Materials have been
evaluated under the
following
Direct contact
Indirect contact gas
pathway
VOC
PM2.5
CO
Ozone | Many materials are identical
to the MetaNeb®
Cleared under K051964 | No data -
Cleared under K895485 |

:

.

r

.

・

·

:

·

:

5

510(k) Summary

· .

.

·

6

510(k) Summary Page 7 of 8 26-Mar-13

Non-clinical Testing Summary -

We performed comparative a series of non-clinical bench testing to demonstrate that the MetaNeb® is equivalent to the predicates. These tests included:

Comparative Particle Characterization testing via Cascade Impactor .
- o Adult flow rates
- Pediatric flow rates o
- o In various controller modes (Aerosol, CHFO, CPEP)
. Cleaning validation
Simulated Life Cycle testing ' .
Environmental and Mechanical testing ●
. Comparative Performance Testing as compared to the predicate in simulated breathing and ventilator condition

The other tests can be found in the identified Sections of this submission.

. Cleaning validation
. Environmental and Mechanical testing

The comparative testing demonstrates that the proposed device is substantially equivalent to the predicate devices.

Biocompatibility of Materials -

· The MetaNeb® system has been evaluated for biocompatibility. There are several levels of patient contact and methods of testing that had to be utilized. The following is a summary of the system and our approach to evaluating biocompatibility.

The system can be viewed as having 3 levels of biocompatibility:

7

Controller, which is a pneumatic system .
- Address via VOC, CO, Ozone and PM25 testing . O
. Patient circuit before the nebulizer (Group 2 reference)
- Indirect, external communicating, tissue / mucosal, prolonged duration (> 24 hr 30 days) per FDA o internal memo and historical guidance
- Cytotoxicity, Sensitization, Genotoxicity, Implantation o

Discussion -

All materials were tested according to ISO 10993-1 for the appropriate level of patient contact and duration and found to pass the applicable ISO 10993-1 test requirements.

Substantial Equivalence Conclusion -

The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to substantially equivalent.

8

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The caduceus is depicted with three wavy lines, representing the snakes, and the text is in a simple, sans-serif font.

Public Health Service

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

April 25, 2013

Mr. Paul Dryden Consultant Hill-Rom Services Pte, Limited 1-Yishun-Avenue-7 Singapore 768923

Re: K124032

Trade/Device Name: MetaNeb® Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: NHJ Dated: March 26, 2013 Received: March 27, 2013

Dear Ms. Wang:

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.

9

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 devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Kwame O. Ulmer-S for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Respiratory, Infection Control and

Dental Devices

Office of Device Evaluation

Center for Devices and

Radiological Health

Enclosure

10

Indications for Use Statement

.

. . . .

Page 1 of 1

510(k) Number:	K124032
Device Name:	MetaNeb®
Indications for Use:

The MetaNeb® System is indicated for mobilization of secretions, lung expansion therapy, the treatment
and prevention of pulmonary atelectasis, and also has the ability to provide supplemental oxygen when
used with compressed oxygen.

Patient population - Adult and Children > 2 years old

Environments of use - Hospitals, sub-acute facilities, physician offices, and clinics.

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)

Amy K-Levelle, S
2013.04.25 10:34:25 for L.S.
-04'00'

(Division Sign-Off)

Division of Anesthesiology, General Hospital

eneral Hospital Division of Anesthestology, Gental Devices

510(k) Number: K124032

Page 28 of 311