(62 days)
The Omron Compressor Nebulizer Systems include a compressor and nebulizer, Model NE-C28 uses a DC powered compressor and Model NE-C30 can operate with AC/DC power. The electrically powered compressor provides compressed air to the supplied pneumatic nebulizer to aerosolize drugs for inhalation by the patient.
The nebulizer is driven by the integral air compressor. The device may be used with pediatric and adult patients in the home, hospital, and sub-acute care settings.
Not intended for use with Pentamidine.
The Oniron Compressor Systems, model NE-C28 and NE-C30, consist of a nebulizer and AC powered piston-type compressor that's generates compressed air. The Model NE-C30 also includes a rechargeable battery pack and can be connected to DC voltage.
Both units utilize the same handheld nebulizer, which is a venturi type which converts the liquid medication into a fine aerosol which is inhaled by the patient via a mouthpiece of mask. The nebulizers can be cleaned and reused.
The provided document is a 510(k) premarket notification for Omron Compressor Systems, Models NE-C28 and NE-C30. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies or establishing detailed acceptance criteria based on performance studies.
Therefore, the document does not contain the information requested regarding acceptance criteria studies for a device with embedded AI or similar technologies that would require a detailed performance evaluation against a specific ground truth.
Specifically, the following information is not present in the document:
- A table of acceptance criteria and the reported device performance: The document lists device attributes (like drug delivery rate, reservoir size) and operating conditions, but these are specifications, not performance acceptance criteria against a clinical outcome or diagnostic accuracy.
- Sample size used for the test set and the data provenance: No test sets, clinical studies, or data provenance information is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment is irrelevant in this type of submission.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is a compressor nebulizer system, which does not involve human readers or AI assistance in the way, for example, an AI diagnostic tool would.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document primarily focuses on:
- Device Description: What the device is and how it works.
- Intended Use/Indications for Use: What the device is for and for whom.
- Predicate Device Comparison: Demonstrating substantial equivalence to a previously cleared device (Omron NE-C09 - K914836) by comparing features and specifications.
- Safety Standards: Listing compliance with relevant electrical safety and risk management standards (IEC 60601-1, IEC 60601-1-2, UL 60601-1, FCC Part 15, ISO 14971).
The core of a 510(k) submission for this type of device is to show that it is "as safe and effective as, or substantially equivalent to, a legally marketed device" and does not typically involve the kind of performance studies with acceptance criteria, ground truth, and expert evaluation that would be required for a novel diagnostic device or an AI-powered system.
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MAY 2 5 2006
Image /page/0/Picture/1 description: The image shows the text "Kob0811" in a handwritten style. The text appears to be written with a thick marker or pen, giving it a bold and somewhat uneven appearance. The characters are spaced closely together, and the overall impression is that of a quick, informal note.
Premarket Notification 510(k) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Omron
510(k) Summary
Non-Confidential Summary of Safety and Effectiveness Page 1 of 2 19-May-06
| Omron Healthcare, Inc. | Tel - 847-247-5713 |
|---|---|
| 1200 Lakeside Dr. | Fax - 847-680-6269 |
| Bannockburn, IL 60015 | |
| Official Contact: | Donna Djinovich - Regulatory Affairs Manager |
| Proprietary or Trade Name: | Omron Compressor Systems |
| Common/Usual Name: | Nebulizer Compressor Systems |
| Classification Name: | Nebulizer (Direct Patient Interface) |
| Device: | Models NE-C28 and NE-C30 |
| Predicate Devices: | Omron - NE-C09 - K914836 |
| Device Description: |
The Oniron Compressor Systems, model NE-C28 and NE-C30, consist of a nebulizer and AC powered piston-type compressor that's generates compressed air. The Model NE-C30 also includes a rechargeable battery pack and can be connected to DC voltage.
Both units utilize the same handheld nebulizer, which is a venturi type which converts the liquid medication into a fine aerosol which is inhaled by the patient via a mouthpiece of mask. The nebulizers can be cleaned and reused.
| Indications for Use: | |
|---|---|
| Indicated Use -- | The Omron Compressor Nebulizer Systems include a compressorand nebulizer, Model NE-C28 uses a DC powered compressorand Model NE-C30 can operate with AC/DC power. Theelectrically powered compressor provides compressed air to thesupplied pneumatic nebulizer to aerosolize drugs for inhalationby the patient. |
| The nebulizer is driven by the integral air compressor. Thedevice may be used with pediatric and adult patients in the home,hospital, and sub-acute care settings. | |
| Not intended for use with Pentamidine. | |
| Patient Population -- | Pediatric and adult |
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Non-Confidential Summary of Safety and Effectiveness
Page 2 of 2 19-May-06
| Environment of Use -- | Home, hospital, and sub-acute care settings. |
|---|---|
| Contraindications -- | None |
Device Attributes:
| Features | NE-C28 | NE-C30 |
|---|---|---|
| Indications for use | The electrically powered compressor provides compressedair to the supplied pneumatic nebulizer to aerosolize drugsfor inhalation by the patient.The nebulizer is driven by the integral air compressor. | Same |
| Environment of Use | Home, Hospital, Sub-acute Institutions | Same |
| Patient Population | Pediatric and adult | Same |
| Contraindications | None | Same |
| Pneumatic compressor | Yes | Yes |
| Pneumatic nebulizer | Yes | Yes |
| Software driven | No | No |
| Materials in patientcontact | Polypropylene | Identical |
| Standard met | IEC 60601-1, IEC 60601-1-2, UL 60601-1, FCC Part 15ISO 14971 | Same |
| Drug delivery rate | 0.35 ml/min | 0.4 ml/min |
| Reservoir size | 7 ml | 7 ml |
| Nebulizer componentscleanable | Yes | Yes |
| Operating conditions | 10°C to 40°C 30% to 85% RH | Same |
| Storage conditions | -20°C to 60°C 10% to 90% RH | Same |
| Dimensions (mm) | 168(W) x 175(D) x 100(H) | 124(W) x 98(D) x51(H) |
| Weight (kg) withoutbattery | 1.7 kg | 0.4 kg |
Differences Between Other Legally Marketed Predicate Devices
The Models NE-C28 and NE-C30 are viewed as substantially equivalent to the following predicate device – Omron NE-C09 – K914836.
There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 5 2006
Omron Healthcare, Incorporated C/O Mr. Paul Dryden President ProMedic, Incorporated 6329 West Waterview Court Mccordsville, Indiana 46055-9501
Re: K060811
Trade/Device Name: Omron Compressor Systems, Models NE-C28 and NE-C30 Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: March 23, 2006 Received: March 24 2006
Dear Mr. Dryden:
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. Dryden
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 (240) 276-0120. 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/industry/support/index.html.
Sincerely yours,
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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Premarket Notification 510(k) - Response to e-mail of 5-May-06
Indications for Use Statement
K060811 510(k) Number:
Models NE-C28 and NE-C30 Device Name:
The Omron Compressor Nebulizer Systems include a Indications for Use: compressor and nebulizer, Model NE-C28 uses a DC powered compressor and Model NE-C30 can operate with AC/DC power. The electrically powered compressor provides compressed air to the supplied pneumatic nebulizer to aerosolize drugs for inhalation by the patient.
The nebulizer is driven by the integral air compressor. The device may be used with pediatric and adult patients in the home, hospital, and sub-acute care settings.
It is not intended for use with Pentamidine.
Prescription Use XX (Part 21 CFR 801 Subpart D) or
Over-the-counter use (21 CFR 807 Subpart C)
ﺒﺪﺃ
Omron
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Auy Sulson
ology, General Hospital,
Contact, Lerial Devices
K060811
§ 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).