(147 days)
The eFlow is a handheld nebulizer that will be used with patients for whom doctors have prescribed medication for nebulization. The eFlow is intended for adult and pediatric patients.
The PARI eFlow™ is a small, single patient use, reusable electronic nebulizer for the inhalation treatment of aerosol medications. It is a hand-held device containing a capped medication cup that can be filled by the user. Power input is provided by cither 4 AA batteries, a DC adapter or an AC adapter. Alternate power cords/plugs/adapters allow use in any country.
This 510(k) submission for the eFlow™ Electronic Nebulizer does not contain a study proving the device meets specific acceptance criteria in the way described in your request.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical testing. It explicitly states that clinical testing was not completed/is not required to show substantial equivalence.
Therefore, I cannot fill out the requested table for acceptance criteria and reported device performance, nor can I provide information on sample sizes for test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance. These types of studies are not part of this 510(k) submission for this particular device.
Here's a breakdown of what is provided, addressing your points where possible, and clearly indicating when information is absent based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not applicable. The submission does not define specific acceptance criteria (e.g., a "target accuracy of 90%") or report performance against such criteria. It makes comparative statements against predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No clinical test set details are provided as no clinical testing was performed for substantial equivalence demonstration. The "test set" described relates to non-clinical engineering performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No expert ground truth establishment method is described for this submission's non-clinical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method is described for this submission's non-clinical testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a medical device (nebulizer), not an AI-powered diagnostic or decision support system. Therefore, an MRMC study related to human reader improvement with AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. For the non-clinical tests (MMAD, RF, TOR), the "ground truth" would be the measured physical properties of the aerosol generated by the device, as determined by standard laboratory methods. There is no mention of expert consensus, pathology, or outcomes data.
8. The sample size for the training set
- Not applicable. No training set for an algorithm is relevant or provided.
9. How the ground truth for the training set was established
- Not applicable. No training set for an algorithm is relevant or provided.
Summary of Non-Clinical Test Findings (as provided):
The submission states: "EFlow was tested to compare performance to the predicate devices, including:"
- MMAD (Mass Median Aerodynamic Diameter): "eFlow MMAD is comparable to or lower than prodicate devices."
- RF (Respirable Fraction): "eFlow RF is comparable to or greater than predicate devices."
- TOR (Total Output Rate): "eFlow TOR is comparable to or greater than predicate devices."
- Safety/EMC (Electromagnetic Compatibility): "eFlow meets the requirements of EN/IEC 60601-1, DIN EN 60601-2 and UL 1431."
The conclusion from these tests is: "eFlow meets performance requirements and raises no new issues of safety or effectiveness." This demonstrates "substantial equivalence" as required for a 510(k) submission, rather than meeting acceptance criteria for a specific clinical performance claim.
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KO33833
eFlow™ Electronic Nebulizer 510(k) Submission 510(k) Summary
MAY - 5 2004
Submitter Information
| Name: | PARI Innovative Manufacturers, Inc. |
|---|---|
| Address: | 2943 Oaklake Blvd.Midlothian, Virginia 23112 |
| Phone Number: | 804-639-7235 x235 |
| FAX Number: | 804-639-7244 |
| Contact Name: | Lawrence Weinstein |
| Date Prepared: | August 14, 2003 |
Device Name
| Common Name: | Electronic Nebulizer |
|---|---|
| Proprietary Name: | eFlow™ |
| Classification Name: | Nebulizer (Direct Patient Interface) |
Legally Marketed Predicate Device
| Manufacturer | Device | 510(k) Number |
|---|---|---|
| AeroGen Inc | AeroNeb IITM Portable Nebulizer | K992381 |
| AeroGen Inc | AcroNebTM Portable Nebulizer | K003022/970010 |
| PARI Innovative Manufacturers, Inc. | PARI LC Star® nebulizer | K963924 |
Device Description
The PARI eFlow™ is a small, single patient use, reusable electronic nebulizer for the inhalation treatment of aerosol medications. It is a hand-held device containing a capped medication cup that can be filled by the user. Power input is provided by cither 4 AA batteries, a DC adapter or an AC adapter. Alternate power cords/plugs/adapters allow use in any country.
Intended Use
The eFlow™ is a handheld nebulizer that will be used with patients for whom doctors have prescribed medication for nebulization. The eFlow is intended for adult and pediatric patients.
Technological Characteristics Compared to Predicate Device
eFlow, LC Star and Aeroneb are all nebulizers used to aerosolize medication for inhalation. I.C Star is a compressor driven jet nebulizer while elilow and Aeroneb use ultrasonic/piezoelectric vibration to generate the aerosol.
eFlow makes use of similar/identical materials for the nebulizer, as compared to the LC Star and also uses a similar two valve system to provide breath enhanced aerosol delivery.
Non-clinical Test Summary
EFlow was tested to compare performance to the predicate devices, including:
- MMAD: eFlow MMAD is comparable to or lower than prodicate devices. ●
- RI: eFlow RF is comparable to or greater than predicate devices. ●
- TOR: eFlow TOR is comparable to or greater than predicate devices. .
- Safety/EMC: eFlow meets the requirements of EN/IEC 60601-1, DIN EN 60601-2 and U'L 1431. .
Clinical Performance Summary
Clinical testing was not completed/is not required to show substantial equivalence.
Conclusions from Testing
eFlow meets performance requirements and raises no new issues of safety or effectiveness.
PARI Confidential por and the Market Millian Market Mark Mark Mark Page 42719 Market Page
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 5 2004
Pari Innovative Manufacturers C/O Mr. Robert Mosenkis CITECH 5200 Butler Pike Plymouth Meeting, PA 19462
Re: K033833
Trade/Device Name: eFlow Electronic Inhaler/Nebulizer Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: April 20, 2004 Received: April 21, 2004
Dear Mr. Mosenkis:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Mosenkis
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-5613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
Chris
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K033833
Device Name: _eFlowTM Electronic Nebulizer
Indications for Use:
The cFlow is a handheld nebulizer that will be used with patients for whom doctors have prescribed medication for nebulization. The cFlow is intended for adult and pediatric patients.
Prescription Usc XXX (Part 21 CFR 801 Subpart D)
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AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Page of
Aulialion
(Division Slan-Off) Division of Assethesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K0538
§ 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).