(232 days)
The eRapid NCP Nebulizer System is to be used with patients for whom doctors have prescribed medicine for nebulization. It is intended for adult and pediatric patients age 4 and older who can coordinate breathing through a mouthpiece, and may be used in hospitals, hospital-type facilities, nursing homes, sub-acute institutions and home environments.
Both the eRapid NCP and the predicate eRapid device are identical in purpose, function, core technology and method of operation. They are single-patient use, reusable electronic nebulizers, using micro-perforated vibrating membrane technology to aerosolize liquid medications. They are for adult and pediatric inhalation therapy in a home care, nursing home, sub-acute institution, or hospital environment. The devices are hand-held and portable, consisting of a controller and a nebulizer handset, connected with a connection cord. Power input for both devices is provided by either AA batteries, or a DC or AC adapter. Alternate power cords, plugs and adapters allow their use in any country.
The provided text is a 510(k) Premarket Notification from the FDA, specifically concerning the eRapid NCP Nebulizer System. It outlines the device's technical specifications, intended use, and comparison to a predicate device. However, it does not contain information about the acceptance criteria and the study that proves the device meets those criteria in the context of an AI/ML powered medical device.
The document primarily focuses on demonstrating substantial equivalence to a previously cleared nebulizer, relying on the fact that the core aerosol generation technology (the handset) remains identical, and the changes are limited to the controller, connection cord, and power supply. The performance data provided are related to:
- Biocompatibility and Airpath Testing: Ensures materials are safe.
- Electromagnetic Compatibility (EMC) and Electrical Safety: Confirms the device meets relevant safety standards.
- Software Verification and Validation Testing: Addresses the moderate level of concern for the software, confirming it meets IEC 62304 standards.
- Aerosol Performance: Demonstrates that the new controller does not negatively impact the aerosol generation, which is solely determined by the unchanged nebulizer handset.
- Simulated Use Testing: Shows the device performs within specifications throughout its useful life.
- Validation of Cleaning and Disinfection Methods: Confirms the effectiveness of cleaning procedures.
Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria and study details because the provided document does not describe an AI/ML powered medical device or studies related to its performance in classification/prediction tasks.
The document states: "There is no other mechanism in place that changes the aerosol particle size, whether through software and/or user interface. This micro-perforated membrane vibrates at a high frequency against a body of fluid. The vibration source is the piezoelectric actuator that is activated by an electronic drive circuit of the Controller. The actuator and the perforated membrane are the main components of the aerosol head that is in contact with the liquid medication to be aerosolized. Liquid jets are created as an inertial response to the vibration of the membrane. Surface tension and hydrodynamic effects then cause these jets to disperse to produce a stream of precisely controlled droplets." This description clearly indicates a mechanical process for aerosol generation, not one driven or significantly influenced by AI/ML.
To answer your request, I would need a document detailing the validation of an AI/ML powered medical device.
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August 11, 2023
PARI Respiratory Equipment, Inc. Michael Judge VP, Operations and Regulatory Affairs 2412 Pari Way Midlothian, Virginia 23112
Re: K223840
Trade/Device Name: eRapid Nebulizer System Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: July 5, 2023 Received: July 10, 2023
Dear Michael Judge:
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. 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 located 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.
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
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ethan L. Nyberg -S
Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia 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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Indications for Use
510(k) Number (if known) K223840
Device Name eRapid NCP Nebulizer System
Indications for Use (Describe)
The eRapid NCP Nebulizer System is to be used with patients for whom doctors have prescribed medicine for nebulization. It is intended for adult and pediatric patients age 4 and older who can coordinate breathing through a mouthpiece, and may be used in hospitals, hospital-type facilities, nursing homes, sub-acute institutions and home 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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1. Submitter Information
| Name: | PARI Respiratory Equipment, Inc. |
|---|---|
| Address: | 2412 Pari WayMidlothian, VA 23112 |
| Phone: | (804) 253-7274, ext. 269 |
| Fax: | (804) 253-0260 |
| Contact Name: | Michael Judge |
| Email: | mike.judge@pari.com |
| Device Name | |
| Name of Device: | eRapid NCP Nebulizer System |
| Common Name: | Nebulizer |
| Classification Name: | Nebulizer (21 CFR 868.5630) |
| Regulatory Class: | II |
| Product Code: | CAF |
3. Legally Marketed Predicate Device
eRapid Nebulizer System, K112859
The following predicate device has not been subject to a design-related recall.
4. Device Description
Both the eRapid NCP and the predicate eRapid device are identical in purpose, function, core technology and method of operation. They are single-patient use, reusable electronic nebulizers, using micro-perforated vibrating membrane technology to aerosolize liquid medications. They are for adult and pediatric inhalation therapy in a home care, nursing home, sub-acute institution, or hospital environment. The devices are hand-held and portable, consisting of a controller and a nebulizer handset, connected with a connection cord. Power input for both devices is provided by either AA batteries, or a DC or AC adapter. Alternate power cords, plugs and adapters allow their use in any country.
5. Mechanism of Action
The medication is filled into the medication reservoir of the nebulizer handset for presenting its liquid content to the vibrating membrane of the nebulizer to generate aerosol for inhalation. There is only the On/Off button on the controller to turn on the device, and start the treatment. When the treatment is done the device automatically shuts off.
This eFlow technology uses a wafer-thin plate or membrane of stainless steel, which is perforated with numerous laser-drilled holes (Figure 3). The size of the membrane holes determines the aerosol particle size. There is no other mechanism in place that changes the aerosol particle size, whether through software and/or user interface. This micro-perforated membrane vibrates at a high frequency against a body of fluid. The vibration source is the piezoelectric actuator that is activated by an electronic drive circuit of the Controller. The actuator and the perforated membrane are the main components of the aerosol head that is in contact
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with the liquid medication to be aerosolized. Liquid jets are created as an inertial response to the vibration of the membrane. Surface tension and hydrodynamic effects then cause these jets to disperse to produce a stream of precisely controlled droplets.
Image /page/4/Figure/1 description: This image shows a diagram of a drug delivery system. The system consists of a reservoir containing the drug, electronics, a membrane with laser-drilled holes, a piezo actuator, and batteries. The drug is released as an aerosol through the laser-drilled holes.
Figure 3: Principle of function of the vibrating membrane technology for aerosol generation
6. Indication for Use
The eRapid NCP Nebulizer System is to be used with patients for whom doctors have prescribed medicine for nebulization. It is intended for adult and pediatric patients age 4 and older who can coordinate breathing through a mouthpiece, and may be used in hospitals, hospital-type facilities, nursing homes, sub-acute institutions and home environments.
| PRODUCT | FDA-Cleared eRapidNebulizer System | eRapid NCP Nebulizer System |
|---|---|---|
| Device Classification | Nebulizer 21 CFR 868.5630 | Nebulizer 21 CFR 868.5630 |
| 510k No. | K112859 | K223840 |
| Manufacturer (Reg.No.) | PARI Respiratory Equipment, Inc.(2954963) | PARI Respiratory Equipment, Inc.(2954963) |
| Regulatory Class | II | II |
| Product Code | CAF | CAF |
| Intended Use / | The eRapid Nebulizer is a handheld | The eRapid NCP Nebulizer System |
| Indications for Use | nebulizer designed to aerosolize anymedications prescribed by a physi-cian. The eRapid Nebulizer Systemis intended for adult and pediatricpatients, and may be used in hospi-tals, hospital-type facilities, nursinghomes, sub-acute institutions, andhome environments. | is to be used with patients for whomdoctors have prescribed medicinefor nebulization. It is intended foradult and pediatric patients age 4and older who can coordinatebreathing through a mouthpiece,and may be used in hospitals, hospi-tal-type facilities, nursing homes,sub-acute institutions and home en-vironments. |
| Prescription Use | Rx Only | Rx Only |
| METHOD OF OPERATION | ||
| Technology Used | Micro-perforated vibrating mem-brane technology to aerosolize liq-uid medications | Micro-perforated vibrating mem-brane technology to aerosolize liq-uid medications |
| Aerosol Direction/Output | Sprayed into aerosol chamber,cleared by inspiratory flow | Sprayed into aerosol chamber,cleared by inspiratory flow |
| Breath Enhanced/Controlled/ Triggered | Breath enhanced two-way valvesystem. | Breath enhanced two-way valvesystem. |
| Fluid Delivery –Generator | Direct contact between aerosol headand fluid in sealed chamber (medi-cation reservoir). | Direct contact between aerosol headand fluid in sealed chamber (medi-cation reservoir). |
| Configuration | Remote (tethered) only. | Remote (tethered) only. |
| Automatic Shut-off | Yes. Automatic shut-off when:(1) medication reservoir is empty;(2) out-of-range parameters are de-tected; or (3) programmed maxi-mum operating time) is reached. | Yes. Automatic shut-off when:(1) medication reservoir is empty;(2) out-of-range parameters are de-tected; or (3) programmed maxi-mum operating time) is reached. |
| DESIGN CAPACITIES | ||
| Medication Reservoir | ||
| Min. Fill | 2.0 mL | 2.0 mL |
| Max. Fill | 6.0 mL | 6.0 mL |
| Residue | Approx. 1.0 ml residue (dependingon filled volume) | Approx. 1.0 ml residue (dependingon filled volume) |
| AEROSOL PERFORMANCE | ||
| Total Output Rate(mg/min) | 619 (AVG) SD=72 | 663 (AVG) SD=60 |
| Mass Median Diameter( $\mu$ m) | 4.35 (AVG) SD=0.09 | 4.37 (AVG SD=0.10 |
| GeometricalStandard Deviation | 1.53 | 1.53 |
| Fine Particle Fraction<5 (%) | 63.56 | 63.15 |
| ELECTRICAL COMPARISON (eBase Controller) | ||
| eBase (Round) 1st Generation | eBase (NCP) 2nd Generation | |
| Mean Frequency (Hz) | 117040 | 117650 |
| Mean Power (Watts) | 1.255 | 1.253 |
| SOFTWARE | ||
| Level of Concern | Moderate | Moderate |
| Device-Specific | Yes | Yes |
| Dependent on ExternalDevices | No | No |
| Function | By continuous loop: (1) conductspower pre-processing; (2) supervis-es the nebulizer's aerosol genera-tion; and (3) communicates to theuser on the operational status of thedevice and out-of-range parameters.These functions are performed con-tinuously until the medication res-ervoir is empty, out-of-range pa-rameters are detected, or pro-grammed maximum operating time(Tmax) is reached. | By continuous loop: (1) conductspower pre-processing; (2) supervis-es the nebulizer's aerosol genera-tion; and (3) communicates to theuser on the operational status of thedevice and out-of-range parameters.These functions are performed con-tinuously until the medication res-ervoir is empty, out-of-range pa-rameters are detected, or pro-grammed maximum operating time(Tmax) is reached. |
| Audio-Visual Signals | LED, tone sounds, and illuminateddisplay showing graphical symbolsconcerning battery level, operation- | Tone sounds, and illuminated dis-play showing graphical symbolsconcerning battery level, operation- |
| al status and failure mode. | al status and failure mode. | |
| ELECTRICAL CONECTION | ||
| CISPR 11 Group | II | II |
| CISPR 11 Class | B | B |
| Protection Class | B-with power supply. Internallypowered - with batteries | B-with power supply. Internallypowered - with batteries |
| Liquid Protection Rating(controller) | IPX0 (No Protection) | IP22 |
| Rated Supply Voltage(controller) | 12V | 5V |
| Rated Input Current(controller) | 300 mA | 750 mA |
| Rated Input Power(Controller) | 3.6 W | 3.75 W |
| Electrical Requirement(power supply) | 100V - 240V, 50 Hz/60 Hz | 100V - 240V, 50 Hz/60 Hz |
| Battery Operation | Four AA disposable or rechargeablebatteries | Three NiMH AA rechargeable bat-tery pack |
| Frequency power forvibrating mesh mem-brane | 1.8w, 117 kHz | 1.8w, 117 kHz |
| NEBULIZER MATERIALS | ||
| Mouthpiece | Polypropylene | Polypropylene |
| Valve(s) | Silicone rubber | Silicone rubber |
| Aerosol chamber | Polypropylene | Polypropylene |
| Fluid feed | Polypropylene, Thermoplastic elas-tomer | Polypropylene, Thermoplastic elas-tomer |
| Aerosol Head | Stainless steel, ceramics, adhesive | Stainless steel, ceramics, adhesive |
| Medication Reservoir | Polypropylene, Thermoplastic elastomer | Polypropylene, Thermoplastic elastomer |
| Medication Cover | Polypropylene, POM, Thermo-plastic elastomer | Polypropylene, POM, Thermo-plastic elastomer |
| MECHANICAL | ||
| WeightController, NebulizerHandset, w/Batteries | Approx. 9.5 oz. (269g) | Approx. 9.3 oz. (264g) |
| DimensionsController | H 43.5 mm Ø 117 mm | L 157mm x W 66mm x H 22mm |
| Handset | L 145 x W 50 x H 63 mm | L 145 x W 50 x H 63 mm |
| Temperature Range | 59° to 95°F (15° – 35°C) | 59° to 95°F (15° – 35°C) |
| Humidity | 30% to 95% | 30% to 95% |
| Ambient Temperature | - 4° to 140°F (-25° – 70°C) | - 4° to 140°F (-25° – 70°C) |
| Ambient Humidity | 10% to 95% | 10% to 95% |
| CLEANING / DISINFECTION | ||
| Cleaning | Cleaning with detergent and water. | Cleaning with detergent and water. |
| Disinfection | Disinfection with chemical (Control III) or thermal means (boiling) | Disinfection with chemical (Control III) or thermal means (boiling) |
| Cleaning Aid | PP/TPE accessory to mechanicallyrinse the aerosol head membranepores by means of backwashing(back flushing). | PP/TPE accessory to mechanicallyrinse the aerosol head membranepores by means of backwashing(back flushing). |
- Comparison of eRapid NCP Nebulizer system to the Predicate Device
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eRapid NCP Nebulizer System and Predicate eRapid Nebulizer system a.
Similarities are that both the eRapid NCP and the predicate eRapid device are identical in purpose, function, core technology and energy sources. That is, they are portable, reusable, single-patient use, handheld electronic nebulizers that use a piezo-driven, microperforated vibrating membrane technology to aerosolize liquid medications for the treatment or prophylaxis of respiratory diseases. They are to be used with adult and pediatric patients for whom doctors have prescribed medication, i.e. they are for prescription use only. They may be used in hospitals, hospital-type facilities, nursing homes, sub-acute institutions and home environments. Energy sources for the devices are provided by: (1) connection to a mains power source, via an AC Power Supply; or, batteries.
Both the eRapid NCP and the predicate eRapid employ breath enhanced, two-way valve systems. Further, both devices have permanent modes of action, i.e., once the on/off switch on the controller is pressed, continuous nebulization occurs until the medication is nebulized. Neither has any breath trigger or interrupter. Fluid delivery / generation for both devices is by direct contact between the aerosol head and the fluid in sealed medication reservoir.
The difference between the two devices are a 2nd generation eBase controller. The redesigned eBase Controller features: (1) Different housing design with a more modern user interface, (2) Integrated rechargeable battery pack, (3) Higher resolution LCD display, (4)
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Adjustable settings for audio and visual features. In addition, The eBase NCP Controller will require a new Connection Cord and Power Supply.
Only the part of the Connection Cord that plugs into the eBase NCP Controller was modified. The other end of the Connection Cord, which is already part of the FDA-cleared device, has not been changed.
Differences from FDA-cleared device are thus confined to the new control unit, connection cord, and power supply.
8. Performance Data
The following performance data were provided in support of a substantial equivalence determination.
Biocompatibility and Airpath Testing a.
The eRapid NCP Nebulizer System uses the identical eRapid Nebulizer Handset that was previously cleared in the predicate eRapid Nebulizer System. All materials used are identical in both formulation and processing, and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents, etc.).
The three new components proposed in the eRapid NCP Nebulizer System, eBase Controller (1), Connection Cord (2), and AC Power Supply (3), have been evaluated for biocompatibility.
The following common materials were used. Controller (Housing): ABS, TPE, Connection Cord: PP, TPE, and AC Power Supply (Housing): PC.
b. Electromagnetic Compatibility (EMC) and Electrical Safety
EMC testing and Electrical Safety testing were conducted regarding the 2nd generation eBase controller, connection cord and AC power supply. These components were evaluated as a complete eRapid NCP Nebulizer System:
- ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/ (R)2012 and -A2:2010/(R)2012
- -IEC 60601-1-2:2014 (+AMD1:2020)
- IEC 60601-1-6:2010, AMD1:2013, AMD2:2020 -
- IEC 60601-1-11:2015/AMD1:2020 -
C. Software Verification and Validation Testing
The software for this device is of a "moderate level of concern" and validation testing was conducted in accordance with FDA's guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued May 2005" Software safety classification is Class B, according to recognized standard IEC 62304.
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d. Aerosol Performance
When considering aerosol performance, the eRapid NCP Nebulizer is substantially equivalent to the predicate eRapid Nebulizer. The handset, including the aerosol head, is solely responsible for aerosol performance and is the same handset as used in the predicate eRapid Nebulizer System.
The only variable in the eFlow technology that allows for a change to the aerosol performance is the Nebulizer Handset, and specifically the dimension of the laser drilled holes in the vibrating mesh contained in the Aerosol Head. By increasing the size of these laser drilled holes, the aerosol particle size is increased or decreased, respectively. The aerosol particle size is not controlled or changed electronically or with software.
The difference between the predicate and subject nebulizer system is the 2nd generation eBase controller. As stated above the controller does not affect the aerosol performance and only provides a fixed power and frequency to the Nebulizer Handset. Both controllers have been electrically tested to demonstrate they produce the same frequency and power, within the accepted tolerance.
To further substantiate that the two controllers produce the same result, aerosol performance testing was done, and the results compared with the predicate device. The results were similar within the acceptable tolerance limits.
Simulated Use Testing e.
Testing was conducted to determine if the eRapid NCP Nebulizer System performed within specifications stated in the IFU, throughout its useful lifecycle. The testing concluded that the device remained within those specifications
f. Validation of Cleaning and Disinfection Methods
Microbiological efficiency control tests were conducted in order to validate the nebulizer cleaning and disinfection methods in the IFU. Testing involved validation of: (1) a manual cleaning method; (2) a chemical disinfection method; and (3) two thermal disinfection methods. All testing concluded that the nebulizer could be cleaned and disinfected effectively by use of the methods stated in the IFU.
9. Conclusion
Based on the FDA guidelines, we believe that the eRapid NCP Nebulizer System is substantially equivalent to the previously cleared predicate device.
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).