(66 days)
To provide a portable compressed air source for the nebulization of drugs to be delivered to a patient via a hand-held nebulizer in the home, nursing home or hospital environments.
The Medic-Aid Porta-Neb is an electrically powered compressor which provides 6-8 Lpm of air flow under a back pressure of 12 psi. It is designed to be connected to a hand-held nebulizer to provide the air source to nebulize drugs to be inhaled by a patient.
The provided document is a 510(k) Non-Confidential Summary of Safety and Effectiveness for the Medic-Aid Porta-Neb Nebulizer Compressor. This type of submission is a premarket notification to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device).
Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical or performance study with defined thresholds for sensitivity, specificity, accuracy, etc. Instead, it demonstrates substantial equivalence to a predicate device by comparing various attributes. The 'acceptance criteria' in this context are implicitly that the Porta-Neb device's attributes are equivalent to or better than the predicate device, or meet recognized standards, without introducing new questions of safety or effectiveness.
| Attribute | Acceptance Criteria (Implicit: Equivalence to Predicate or Standard) | Reported Device Performance (Porta-Neb) | Predicate Device (DeVilbiss Pulmo-Aide K854520) Performance |
|---|---|---|---|
| Use | |||
| Intended to nebulize drugs | Yes | Yes | Yes |
| Utilized with different nebulizers | Yes | Yes | Yes |
| Serves as an air source to drive nebulizers | Yes | Yes | Yes |
| Portable | Yes | Yes | Yes |
| Used in hospital, nursing home, or home | Yes | Yes | Yes |
| Design | |||
| Small, compact, portable | Yes | Yes | Yes |
| Operates on 110 Volt | Yes | Yes | Yes |
| Nebulizer flow rates | Comparable to predicate | 6-8 Lpm | 5-7 Lpm |
| Has air outlet to connect to air delivery tubing | Yes | Yes | Yes |
| Is used with nebulizer, mask, or mouthpiece | Yes | Yes | Yes |
| Materials | |||
| No materials related to this device are in contact with the patient | Yes | Yes | Yes |
| Packaging | |||
| Provided clean | Yes | Yes | Yes |
| Performance Standards / Specifications | |||
| None applicable under Section 514 | Yes | Yes | Yes |
| Meets design, safety and performance requirements of EN 60601, UL 2601, IEC 601-1, CAN / CSA C22.2 No.60 1.1 | Yes (Meeting these standards is the implicit criterion) | Yes | Not known, but assumed Yes (for predicate) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes a submission for substantial equivalence to a predicate device, not a clinical study involving a test set of patient data or specific samples for performance evaluation in the usual sense. Therefore, there is no traditional "test set" sample size as would be used for evaluating diagnostic accuracy or clinical outcomes. The evaluation is based on comparing the device's technical specifications and intended use against a known predicate device and recognized standards.
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)
Since there is no traditional "test set" or clinical study described in the document, no experts were used to establish ground truth in the context of a clinical validation study. The ground truth for this submission is based on established engineering and safety standards, and the known characteristics of the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As there is no clinical "test set" and no human interpretation of data being evaluated, no adjudication method was used. The comparison is based on objective device specifications and regulatory standards.
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
No MRMC comparative effectiveness study was done. This document pertains to a medical device (nebulizer compressor) that is not an AI/software device requiring such studies to evaluate a human reader's performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The Medic-Aid Porta-Neb is a hardware device (nebulizer compressor), not an algorithm or software requiring standalone performance testing in the context of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the established performance and safety characteristics of the predicate device (DeVilbiss Pulmo-Aide K854520) and compliance with recognized electrical/medical device safety standards (e.g., EN 60601, UL 2601, IEC 601-1, CAN / CSA C22.2 No.60 1.1).
8. The sample size for the training set
Not applicable. This is a hardware device submission, not an AI/ML model needing a training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth established for one.
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Image /page/0/Picture/1 description: The image shows the logo for Medic-Aid. The logo consists of a stylized mountain range above the text "MEDIC-AID". The mountain range is made up of three black triangles, and the text is also in black. There is a registered trademark symbol to the right of the word "AID".
Non-Confidential Summary of Safety and Effectiveness
page 1 of 3 May 27, 1997
AUG - 1 1997
Medic-Aid Ltd. Heath Place Bognor Regis, West Sussex PO22 9SL United Kingdom
| Tel - 011-44-1243-840888 | Fax - 011-44-1243-846100 |
|---|---|
| Official Contact: | Ed Walters, Quality Manager |
| Proprietary or Trade Name: | Medic-Aid - Porta-Neb Nebulizer Compressor |
| Common/Usual Name: | Nebulizer compressor |
| Classification Name: | Non-ventilatory, medicinal nebulizer (atomizer) |
| Device: | Medic-Aid Porta-Neb |
| Predicate Devices: | DeVilbiss - Pulmo-Aide K85520 |
Device Description:
The Medic-Aid Porta-Neb is an electrically powered compressor which provides 6-8 Lpm of air flow under a back pressure of 12 psi. It is designed to be connected to a hand-held nebulizer to provide the air source to nebulize drugs to be inhaled by a patient.
| Indicated Use -- | To provide a portable compressed air source for the nebulization of drugs to be delivered to a patient via a hand-held nebulizer. |
|---|---|
| Environment of Use -- | Hospitals, nursing home and homes. |
| Patient population -- | Patients requiring nebulized drug delivery. |
Comparison to Predicate Devices:
Page 3 of 22
Image /page/0/Picture/12 description: The image contains two logos. The first logo on the left is the ISO 9001 quality assured firm logo. The second logo on the right has a crown on top of a check mark with the word "UKAS" below the check mark.
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Non-Confidential Summary of Safety and Effectiveness
(continued)
page 2 of 3
May 27, 1997
| Attribute | ||
|---|---|---|
| Porta-Neb | DeVilbiss Pulmo-Aide | |
| K854520 | ||
| Use | ||
| Intended to nebulize drugs | Yes | Yes |
| Utilized with different nebulizers | Yes | Yes |
| Serves as a air source to drive nebulizers | Yes | Yes |
| Portable | Yes | Yes |
| Used in hospital, nursing home, or home | Yes | Yes |
| Design | ||
| Small, compact, portable | Yes | Yes |
| Operates on 110 Volt | Yes | Yes |
| Nebulizer flow rates - | 6-8 Lpm | 5-7 Lpm |
| Has air outlet to connect to air delivery tubing which connects to nebulizer | Yes | Yes |
| Is used with nebulizer, mask or mouthpiece | Yes | Yes |
| Materials | ||
| No materials related to this device are in contact with the patient | Yes | Yes |
| Packaging | ||
| Provided clean | Yes | Yes |
| Performance Standards / Specifications | ||
| None applicable under Section 514 | Yes | Yes |
| Page 4 of 22 |
.
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Non-Confidential Summary of Safety and Effectiveness
(continued)
page 3 of 3
May 27, 1997
| Attribute | Porta-Neb | DeVilbiss Pulmo-AideK854520 |
|---|---|---|
| Meets design, safety and performancerequirements of EN 60601, UL 2601,IEC 601-1, CAN / CSA C22.2 No.60 1.1 | Yes | Not known, but assumed |
| Yes |
Differences between Other Legally Marketed Predicate Devices
There is no differences between the intended device and the predicate devices which would be significant to patient safety or effectiveness.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mr. Ed Walters Medic-Aid, Ltd. c/a ProMedic, Inc. 6329 W. Waterview Court McCordsvile, Indiana 46055-4501
AUG - 1 1997
Re : K971933 Porta-Neb Nebulizer Compressor Regulatory Class: II (two) Product Code: 73 CAF Dated: May 27, 1997 May 27, 1997 Received:
Dear Mr. Walters:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 reqistration, 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Ed Walters
This letter will allow you to begin marketing your device as described in your 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 your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan', Ph.D Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 3
INDICATIONS FOR USE
Page 1 of 1
Pursuant to the Notice of February 6, 1996 regarding listing of Indications for Use on a separate sheet, the following is per that request.
| 510(k) Number: | K971933 (To be assigned) |
|---|---|
| Device Name: | Medic-Aid, Ltd. Porta-Neb, nebulizer compressor system |
| Intended Use : | To provide a portable compressed air source forthe nebulization of drugs to be delivered to a patient via ahand-held nebulizer in the home, nursing home or hospitalenvironments. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per CFR 801.109)
or
Over-the-counter use _________________________________________________________________________________________________________________________________________________________
Page 9 of 22
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number_
§ 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).