(118 days)
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.
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, CHFO (Continuous High Frequency Oscillation), and CPEP (Continuous Positive Expiratory Pressure). There are three major components: Circuit, Controller, and Stand.
Here's an analysis of the MetaNeb® System (K124032) based on the provided 510(k) summary, structured to address your specific points:
Since this is a 510(k) submission for a non-continuous ventilator, the "acceptance criteria" are primarily established by demonstrating substantial equivalence to predicate devices, rather than meeting specific quantifiable performance targets like sensitivity or specificity for an AI device. The study performed is a "comparative effectiveness study" in the sense of comparing the new device's performance to the predicate devices through various bench tests.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the MetaNeb® System are implicitly derived from demonstrating substantial equivalence to its predicate devices (PowerNeb® CoMedica K051964 and IPV - Percussionaire Corp K895485). This means the device must perform comparably in its intended use, safety, and effectiveness.
Table 1: Acceptance Criteria (as demonstrated by substantial equivalence to predicates) and Reported Device Performance
| Category / Performance Metric | Acceptance Criteria (Implied by Predicate Performance) | MetaNeb® Reported Performance (Range or Value) |
|---|---|---|
| Indications for Use | Mobilization of secretions, lung expansion therapy, prevention of pulmonary atelectasis, ability to provide supplemental oxygen (identical to predicates). | Identical: Mobilization of secretions, lung expansion therapy, treatment and prevention of pulmonary atelectasis, ability to provide supplemental oxygen when used with compressed oxygen. |
| Technology | Pneumatically operated system with CPEP, CHFO, and aerosol only modes (identical to predicates in design and basic function). | Pneumatic system with CPEP, CHFO, and Aerosol Only modes. (Compared to predicates, MetaNeb® has a dedicated Aerosol Only mode, unlike PowerNeb which requires setting CPEP to minimum flow, and IPV which uses an in-line nebulizer without a specific aerosol-only setting). |
| Materials Biocompatibility | Materials in gas/fluid pathway are safe for intended use, as per ISO 10993-1. (Predicates were cleared with their respective materials). | All associated materials in the gas or fluid pathway tested per ISO 10993-1 (Cytotoxicity, Sensitization, Irritation/Intracutaneous reactivity, Genotoxicity, Implantation as applicable). VOC, PM2.5, CO, Ozone testing performed for controller. All found to pass applicable ISO 10993-1 test requirements. |
| Environment of Use | Hospital, sub-acute facilities (identical to predicates). | Identical: Hospitals, sub-acute facilities, physician offices, and clinics (Bird IPV also includes homecare, but MetaNeb®'s scope aligns with the common environment for both). |
| Patient Population | Broad patient population, including adults and children (PowerNeb for "all patients", Bird IPV for "neonates to adults"). | Adult and Child > 2 years old (considered equivalent to predicates, aligning more closely with PowerNeb's general indication). |
| CPEP Mode @ Max Flow | ||
| - Peak Pressure (cmH2O) | Comparable to PowerNeb (32.6 to 35.1) | 27.8 to 29.9 (Lower range than PowerNeb, but within clinically acceptable ranges and demonstrating therapeutic pressure delivery). |
| - Total Respirable Dose (0.5-5um) | Comparable to PowerNeb (Albuterol: 631.5-818.8; Ipratropium: 137.1-155.1; Cromolyn: 2362.1-2695.2) | Albuterol: 735.5 - 890.6Ipratropium: 149.2 - 187Cromolyn: 2567.6 - 3046.6 (Comparable or slightly higher doses, indicating effective aerosol delivery). |
| CHFO Mode @ MetaNeb "High" | ||
| - Peak Pressure (cmH2O) | Comparable to PowerNeb (9.7 to 10.3) and IPV (25.3 to 27.0). | 21.1 to 25.4 (Closer to IPV's pressure range, demonstrating effective oscillation mechanics). |
| - Frequency (BPM) | Comparable to PowerNeb (222 to 235) and IPV (214 to 235). | 226 (Consistent with predicates). |
| - Total Respirable Dose (0.5-5um) | Comparable to PowerNeb (Albuterol: 171.3-202.1; Ipratropium: 30.5-48.3; Cromolyn: 805.4-1002.7) and IPV (Albuterol: 243.7-349.5; Ipratropium: 90-112.7; Cromolyn: 900.1-1196.1). | Albuterol: 139.2 - 200.2Ipratropium: 27 - 54.6Cromolyn: 673.1 - 948.1 (Lower for PowerNeb comparison, but this is reported under CHFO "MetaNeb High", there is another set of higher values under MetaNeb for albuterol, ipratrompium and cromolyn which are 421.6-572.4, 124.5-204.6, and 1367.9-1903.9 respectively. This indicates a different setting or test condition leads to higher doses, which are comparable to or exceed predicates, showing effective aerosol delivery during CHFO). |
| CHFO Mode w/ Ventilator Conn. | ||
| - Peak Pressure (cmH2O) | Comparable to IPV (19.8 to 44.4). | 20.5 to 44.1 (Consistent with IPV). |
| - Frequency (BPM) | Comparable to IPV (226 to 235). | 226 to 231 (Consistent with IPV). |
| - Total Respirable Dose (0.5-5um) | Comparable to IPV (Albuterol: 91.1 ± 10.6; Ipratropium: 97.1 ± 3.4; Cromolyn: 88 ± 9.2). | Albuterol: 95.8 + 13.1Ipratropium: 110.8 + 8.6Cromolyn: 73.4 + 15.4 (Comparable, showing effective aerosol delivery during CHFO while connected to a ventilator). |
| Safety - Contraindications | Similar contraindications to predicates (e.g., untreated tension pneumothorax, pulmonary air leak, recent pneumonectomy, pulmonary hemorrhage, myocardial infarction, vomiting, untrained operator). | Largely identical list of contraindications to PowerNeb, and similar to IPV. |
| Patient Circuit | Disposable or reusable (predicates vary), connection for in-line nebulizer, draw in room air mix, expiratory resistance adjustment. | Disposable "hand-set" with connection for in-line nebulizer, draws in room air mix, expiratory resistance adjustment (similar to PowerNeb). |
| Controller Features | On/off, mode selection, pressure / frequency adjustment, manometer, connection for patient circuit (features vary slightly among predicates). | On/off, mode selection, frequency selection for CHFO mode, pressure adjustment for CPEP mode, pressure manometer, connection for patient circuit (similar and offers convenience features like dedicated Aerosol Only mode compared to predicates). |
Study Details Proving Acceptance Criteria:
The submission relies on a series of non-clinical bench tests to demonstrate substantial equivalence, rather than human clinical trials.
-
Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a "sample size" in the context of patients. The "test set" consists of mechanical/bench testing of the device and its components. The specific number of devices or components tested for each experiment (e.g., how many circuits were tested for particulate characterization, or how many full systems for life cycle testing) is not detailed.
- Data Provenance: Retrospective, as it involves laboratory testing conducted by the manufacturer to support the 510(k) submission. Country of origin for the data is assumed to be Singapore where Hill-Rom Services Pte Ltd is located, or at a contracted testing facility.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a device performance bench test comparing against predicate devices, "ground truth" is established by validated testing methodologies and standards (e.g., aerosol particle sizing, pressure measurements) and comparison against the specifications/performance of legally marketed predicate devices. It doesn't involve expert consensus on medical images or clinical outcomes. The experts involved would be engineers and technical specialists conducting and analyzing the tests.
-
Adjudication method for the test set:
- Not Applicable. As this is bench testing for substantial equivalence, clinical adjudication by medical experts isn't part of the process. Test results are compared directly against established engineering parameters, predicate device specifications, and relevant standards (e.g., ISO 10993-1).
-
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:
- No. This is not an AI-powered diagnostic device, so a MRMC study is not relevant or applicable.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The "standalone performance" is represented by the non-clinical bench testing where the device's technical specifications and performance characteristics (e.g., pressure output, aerosol particle size, frequency of oscillation) are measured directly and compared against the established performance ranges of the predicate devices under controlled laboratory conditions, without human interaction beyond initiating the test.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Technical Specifications and Predicate Device Performance. The "ground truth" for this submission is based on:
- Validated engineering and physics principles (e.g., how pressure is measured, how aerosol particles are characterized).
- Internationally recognized standards (e.g., ISO 10993-1 for biocompatibility).
- The established and cleared performance characteristics of the legally marketed predicate devices.
- Technical Specifications and Predicate Device Performance. The "ground truth" for this submission is based on:
-
The sample size for the training set:
- Not Applicable. This is a hardware medical device, not an AI/machine learning algorithm requiring a "training set."
-
How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI algorithm. The device's design and engineering are based on established pneumatic principles and medical needs for respiratory therapy.
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510(k) Summary Page 1 of 8
| Date Prepared | 26-Mar-13 | APR 2 5 2013 |
|---|---|---|
| Hill-Rom Services Pte Ltd1 Yishun Ave 7Singapore, 768923, Singapore | Tel - 011 - 65 65945215Fax - 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 868.5905Class 2 | |
| Predicate Devices: | K051964 - PowerNeb® CoMedicaK895485 - 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
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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).
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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® | PowerNebCoMedica - K051964 | IPVBird - K895485 | |
|---|---|---|---|
| CFRClassification | 868.5905 | 868.5905 | 868.5905 |
| Classification name | NHJ | NHJ | NHJ |
| Device, positivepressure breathing,intermittent (IPPB) | Device, positive pressurebreathing, intermittent(IPPB) | Device, positivepressure breathing,intermittent (IPPB) | |
| Indications for Use | Indicated formobilization ofsecretions,lung expansion therapy,treatment andprevention of pulmonaryatelectasis,ability to providesupplemental oxygenwhen used withcompressed oxygen. | Indicated for mobilizationof secretions,lung expansion therapy,treatment and prevention ofpulmonary atelectasis,ability to providesupplemental oxygen whenused with compressedoxygen. | Indicated for themobilization and raisingof endobronchialsecretions,bronchodilation,reducing mucosaledema, resolution ofdiffuse patchyatelectasis in all patientpopulations. |
| Environments of Use | Hospital, sub-acutefacilities | Hospital, sub-acute facilities | Hospital, sub-acutefacilities, homecare |
| Patient Population | AdultChild > 2 years old | All patients that requiretherapy mobilization ofsecretions, lung expansiontherapy, the treatment andprevention of pulmonaryatelectasis | All patient populations |
Table 1 - Substantial Equivalence Comparative Table
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510(k) Summary
| MetaNeb® | PowerNeb | IPV | |
|---|---|---|---|
| CoMedica - K051964 | Bird - K895485 | ||
| Contraindications | -Untreated tensionpneumothorax-Untrained or unskilledoperator-History of pneumothorax-Pulmonary air leak-Recent pneumonectomy-Pulmonary hemorrhage-Myocardial infarction-Vomiting | -Untreated tensionpneumothorax-Untrained or unskilledoperator-History of pneumothorax-Pulmonary air leak-Recent pneumonectomy-Pulmonary hemorrhage-Myocardial infarction-Vomiting | -Untreated tensionpneumothorax-Lack of adequate,skilled supervision |
| Mode of Operation | Pneumatic system using afixed venturi patient circuitcombined with medicatedaerosol to deliver continuoushigh frequency oscillationtherapy at 2 pre-setfrequencies and amplitude. | Pneumatic system using afixed venturi patient circuitcombined with medicatedaerosol to delivercontinuous high frequencyoscillation therapy at 1pre-set frequency andamplitude | Pneumatic system usinga variable (sliding)venturi patient circuitcombined withmedicated aerosol todeliver continuous highfrequency oscillationtherapy at multiple usersettable frequencies andamplitudes. |
| Can deliver continuousexpiratory pressure (CPEP)combined with medicatedaerosol. | Can deliver continuousexpiratory pressure (CPEP)combined with medicatedaerosol. | Equivalent CPEPfunction not available. | |
| Modes | CPEPCHFOAerosol Only | CPEPCHFOCan allow in-line aerosoltreatments | CHFOCan allow in-lineaerosol treatments |
| CPEPContinuous PositiveExpiratory Pressure | Controlled static flow withpositive pressures ≤ 30 cmH2O | Controlled static flow withpositive pressures ≤ 20 cmH2O | No static flow mode |
·
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510(k) Summary Page 5 of 8 26-Mar-13
| MetaNeb® | PowerNebCoMedica - K051964 | IPVBird - K895485 | |
|---|---|---|---|
| CHFOContinuous HighFrequency Oscillations | Controlled continuous flowwith frequencies up to 300beats per minute and peakpositive pressures $\le$ 30 cmH2O | Controlled continuous flowwith frequencies up to 300beats per minute and peakpositive pressures $\le$ 30 cmH2O | ControlledIntrapulmonaryPercussive Ventilation(IPV) frequencies up to300 beats per minuteand peak positivepressures $\le$ 80 cmH2O |
| Aerosol Only | Controlled continuousconstant flow to in-linenebulizer deliveringmedicated aerosol only. | Equivalent Aerosol Onlyfunction by setting CPEP tominimum flow with in-linenebulizer | Can use in-linenebulizer |
| Patient Circuit | Disposable circuit referred toas "hand-set" includesconnection for in-linenebulizer | Disposable circuit referred toas "hand-set" includesconnection for in-linenebulizer | Reusable circuitincludes connection forin-line nebulizer |
| Draw in room air mix withmedicated aerosol and gasfrom controller | Draw in room air mix withmedicated aerosol and gasfrom controller | Draw in room air mixwith medicated aerosoland gas from controller | |
| Patient Circuit settings | Expiratory resistanceadjustment | Expiratory resistanceadjustment | Not available |
| Patient Interface | MouthpieceFace maskInsert into ventilator circuit | MouthpieceFace mask | MouthpieceInsert into ventilatorcircuit |
| Controller | Pneumatic and air or oxygen | Pneumatic and air or oxygen | Pneumatic and air oroxygen |
| Controller settings | On/offMode selectionFrequency selection forCHFO modePressure adjustment for CPEPmodePressure manometerConnection for patient circuit | On/offMode selectionPressure adjustment for CPEPmodeConnection for patient circuit | On/offPressure and frequencyadjustment for CHFOmodePressure manometerConnection for patientcircuit |
| MetaNeb® | PowerNebCoMedica - K051964 | IPVBird - K895485 | |
| Ventilator connection | Placed in-line in theinspiratory limb of theventilator circuit with astandard "T" adapter.Ventilator set to pressuremode only | Not available | Placed in-line in theventilator circuit with aIPV cone adapterVentilator set topressure mode only |
| Performance Testing | |||
| CPEP Mode @ MaxFlowPeak Pressure (cmH2O):Total Respirable Dose(0.5-5 um)(Report 12-0058) | 27.8 to 29.9Albuterol735.5 - 890.6Ipratrompium149.2 - 187Cromolyn2567.6 - 3046.6 | 32.6 to 35.1Albuterol631.5 - 818.8Ipratrompium137.1 - 155.1Cromolyn2362.1 - 2695.2 | This mode is notavailable on IPV |
| CHFO Mode @MetaNeb "High"Peak Pressure (cmH2O):Frequency (BPM)Total Respirable Dose(0.5-5 um)(Report 12-0058) | 21.1 to 25.4226Albuterol139.2 - 200.2Ipratrompium27- 54.6Cromolyn673.1 - 948.1Albuterol421.6 - 572.4Ipratrompium124.5 - 204.6Cromolyn1367.9 - 1903.9 | 9.7 to 10.3222 to 235Albuterol171.3 - 202.1Ipratrompium30.5 - 48.3Cromolyn805.4 - 1002.7 | 25.3 to 27.0214 to 235Albuterol243.7 - 349.5Ipratrompium90 - 112.7Cromolyn900.1 - 1196.1 |
| CHFO Mode @MetaNeb "High" withVentilator ConnectionPeak Pressure (cmH2O):Frequency (BPM)Total Respirable Dose(0.5-5 um)(Report 12-0061) | 20.5 to 44.1226 to 231Albuterol95.8 + 13.1Ipratrompium110.8 + 8.6Cromolyn73.4 + 15.4 | 19.8 to 44.4226 to 235Albuterol91.1 + 10.6Ipratrompium97.1 ± 3.4Cromolyn88 + 9.2 | |
| MetaNeb® | PowerNebComedica - K051964 | IPVBird - K895485 | |
| Materials | Materials have beenevaluated under thefollowingDirect contactIndirect contact gaspathwayVOCPM2.5COOzone | Many materials are identicalto the MetaNeb®Cleared under K051964 | No data -Cleared under K895485 |
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510(k) Summary
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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:
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- 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) o
- Cytotoxicity, Sensitization, Irritation / Intracutaneous reactivity o
- Patient circuit components and materials after the nebulizer (Group 1) .
- Indirect, external communicating, tissue / mucosal, permanent duration (> 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.
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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
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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
§ 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).