(189 days)
The system is used on the order of a physician for the treatment of asthma, bronchitis and other respiratory diseases. The nebulizer converts the liquid medication into a fine aerosol mist which can be inhaled for home respiratory therapy. This allows the medication to be deposited at the affected areas of the patients airway.
The Sunrise Medical Model 800 Series jet nebulizer is a reusable hand held, small volume jet nebulizer. The nebulizer is designed for use in conjunction with a compressed gas source such as the Sunrise Medical Pulmo-Aide Model 5650 Compressor (FDA 510(k) Registration # K923888), Sunrise Medical Pulmo-Mate Model 4650 Compressor (FDA 510(k) Registration # K931015) or Sunrise Medical Pulmo-Aide LT Model 3650 Compressor (FDA 510(k) Registration # K970289). The nebulizer & compressor system is used on the order of a physician to treat various respiratory problems. The nebulizer converts the liquid medication into a fine aerosol mist, which can be inhaled for home respiratory therapy. This allows the medication to be deposited at the affected areas of the patient's airway. The Sunrise Medical Model 800 Series iet nebulizer is designed to offer high respirable aerosol output for the patient. The nebulizer is intended as a long term usage nebulizer (approximately 1 year) similar to other reusable nebulizers that are currently being marketed by competitors of Sunrise Medical such as the Pari LC Plus and Pari Jet permanent nebulizers manufactured by Pari of Germany and distributed here in the U.S. Accessories include a triggering system to shut off airflow to the nebulizer to conserve medication between breaths.
Here's an analysis of the provided text regarding the acceptance criteria and study for the KG93492 medical device submission:
Based on the provided 510(k) summary for the Sunrise Medical Model 800 Nebulizer (KG93492), the information is very limited regarding specific acceptance criteria and detailed study performance data. This document is a summary provided for FDA clearance of a Class II device, which often focuses on substantial equivalence to predicate devices rather than extensive clinical trials with detailed performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of acceptance criteria with corresponding performance results in a structured format often seen for software or AI-based devices. Instead, it relies on demonstrating substantial equivalence to existing predicate devices (Sunrise Medical Model 700, Pari LC Plus, Pari Jet).
The key performance claims are related to:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Respirable Aerosol Output (Qualitative) | The Sunrise Medical Model 800 Series jet nebulizer is designed to offer high respirable aerosol output for the patient. |
| Longevity/Usage Duration (Qualitative) | The nebulizer is intended as a long term usage nebulizer (approximately 1 year) similar to other reusable nebulizers that are currently being marketed by competitors... |
| Aerosol Output & Particle Size (Substantial Equivalence) | "Testing performed on the aerosol output and particle size show that the new Sunrise Medical Model 800 Nebulizer is substantially equivalent to the existing legally marketed predicate devices and that all of these devices will produce a similar aerosol treatment." (This is the most direct statement of performance relative to a benchmark/predicate) |
| Functional Characteristics (Substantial Equivalence) | "The Sunrise Medical Model 800 Nebulizer is equivalent in functional characteristics to the existing legally marketed predicate devices. The devices all utilize a compressed air source for operation." (This implies it meets the functional expectations of predicate devices, such as the ability to convert liquid medication to mist when connected to a compressor.) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a sample size for a "test set" in the context of clinical or performance testing. The statement "Testing performed on the aerosol output and particle size..." indicates that some form of testing was done, but details regarding the number of devices tested, number of measurement cycles, or the specific methodology are not provided in this summary.
Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided. Given that this is a 510(k) for a medical device (nebulizer) and not an AI/software device, the concept of "ground truth" and expert adjudication in the manner typically discussed for diagnostic algorithms is generally not applicable here. Performance is measured against physical metrics (aerosol output, particle size) rather than expert interpretation of data.
4. Adjudication Method for the Test Set:
An adjudication method (e.g., 2+1, 3+1) is not relevant or described for this type of device submission. Performance is measured objectively rather than through expert consensus on qualitative outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging or AI-assisted diagnostic tools to assess how human readers' performance (e.g., accuracy, speed) is affected by AI assistance. A nebulizer is a therapeutic device, not a diagnostic one.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. This device is a physical, mechanical nebulizer, not an algorithm or software. Its performance is inherent to its design and function, not an "algorithm only" performance.
7. The Type of Ground Truth Used:
The "ground truth" for evaluating the nebulizer's performance would be objective, quantitative measurements of physical properties like:
- Aerosol Output Rate: The amount of medication delivered per unit of time.
- Particle Size Distribution: The range and average size of the aerosolized particles (specifically, the respirable fraction).
These are empirical measurements, not expert consensus, pathology, or outcomes data in the usual sense. The document states "Testing performed on the aerosol output and particle size," implying these direct measurements were the basis for comparison.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/machine learning model, so there is no "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 needed for it.
Summary of Limitations from the Provided Text:
The provided 510(k) summary is very high-level and characteristic of device submissions from 1999 for physical medical products. It focuses heavily on establishing substantial equivalence to predicate devices based on functional characteristics, intended use, and general performance claims (high respirable output, similar aerosol treatment, long-term use). It lacks the detailed quantitative performance metrics, study designs, sample sizes, and ground truth methodologies that would be expected for more modern AI/software-as-a-medical-device (SaMD) submissions or even detailed clinical studies for novel physical devices. The FDA clearance is based on the premise that the new device is "substantially equivalent" to already marketed devices, implying that if the predicates were safe and effective, so too would be the new device given similar performance characteristics.
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KG93492
510(k) Summary
| Submitter's Name: | Sunrise Medical HHG, Inc.100 DeVilbiss DriveSomerset PA 15501Frank Clementi814-443-7474 |
|---|---|
| Date Prepared: | October 7, 1999 |
| Device Name: | Nebulizer FDA Classification CAF |
| Common or Usual Name: | Jet Nebulizer |
| DeVilbiss Model Number: | Nebulizer Model 800 |
| Trade Proprietary Name: | N/A Model number only. |
| Established RegistrationNumber: | 2515872 |
| FDA Classification: | Class II |
| Equivalent Legally Marketed Predicate Devices: | |
| Legally Marketed Predicate Device 510(k) Registration # | |
| Sunrise Medical Model 700 | K952249 |
| Pari LC Plus | K894555 |
Pari PariJet
Description of Device:
The Sunrise Medical Model 800 Series jet nebulizer is a reusable hand held, small volume jet nebulizer. The nebulizer is designed for use in conjunction with a compressed gas source such as the Sunrise Medical Pulmo-Aide Model 5650 Compressor (FDA 510(k) Registration # K923888), Sunrise Medical Pulmo-Mate Model 4650 Compressor (FDA 510(k) Registration # K931015) or Sunrise Medical Pulmo-Aide LT Model 3650 Compressor (FDA 510(k) Registration # K970289). The nebulizer & compressor system is used on the order of a physician to treat various respiratory problems. The nebulizer converts the liquid medication into a fine aerosol mist, which can be inhaled for home respiratory therapy. This allows the medication to be deposited at the affected areas of the patient's airway.
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The Sunrise Medical Model 800 Series iet nebulizer is designed to offer high respirable aerosol output for the patient. The nebulizer is intended as a long term usage nebulizer (approximately 1 year) similar to other reusable nebulizers that are currently being marketed by competitors of Sunrise Medical such as the Pari LC Plus and Pari Jet permanent nebulizers manufactured by Pari of Germany and distributed here in the U.S.
Accessories include a triggering system to shut off airflow to the nebulizer to conserve medication between breaths.
Statement of Intended Use:
The Sunrise Medical Model 800 Series iet nebulizer is designed for use in conjunction with a compressed gas source such as the Sunrise Medical Pulmo-Aide Model 5650 Compressor (FDA 510(k) Registration # K923888), Sunrise Medical Pulmo-Mate Model 4650 Compressor (FDA 510(k) Registration # K931015) or Sunrise Medical Pulmo-Aide LT Model 3650 Compressor (FDA 510(k) Registration # K970289). The system is used on the order of a physician to treat various respiratory problems. The nebulizer converts the liquid medication into a fine aerosol mist, which can be inhaled for home respiratory therapy. This allows the medication to be deposited at the affected areas of the patient's airway.
The Sunrise Medical Model 800 Series jet nebulizer is designed to offer high respirable aerosol output for the patient. The nebulizer is intended as a long term usage nebulizer (approximately 1 year) similar to other reusable nebulizers that are currently being marketed by competitors of DeVilbiss such as the Pari LC Plus and Pari Jet permanent nebulizers manufactured by Pari of Germany and distributed here in the U.S.
The target patient population for this device is comprised of both children and adults suffering from asthma, bronchitis, emphysema, and other respiratory disorders. The device is to be used by the patient only on the order of a physician in conjunction with prescribed medication(s).
The intended environment of use is in the home with AC powered compressors or for portable use with DC/battery powered compressors.
Technological Characteristics:
The Sunrise Medical Model 800 Nebulizer is equivalent in functional characteristics to the existing legally marketed predicate devices. The devices all utilize a compressed air source for operation.
Testing performed on the aerosol output and particle size show that the new Sunrise Medical Model 800 Nebulizer is substantially equivalent to the existing legally marketed predicate devices and that all of these devices will produce a similar aerosol treatment.
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Public Health Service
APR 2 1 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Frank Clementi Sunrise Medical HHG Inc. Respiratory Products Division Dba DeVilbiss Health Care 100 DeVilbiss Drive P.O. Box 635 Somerset, PA 15501-0635
K993492 Re: Sunrise Medical Model 800 Nebulizer Regulatory Class: II (two) Product Code: CAF Dated: January 21, 2000 Received: January 24, 2000
Dear Mr. Clementi:
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 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). 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 (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 requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. 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
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Page 2 - Mr. Frank Clementi
for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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/dsma/dsmamain.html".
Sincerely yours,
Joanna Westerhausen for
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: (if known):
Sunrise Medical Model 800 Nebulizer Device Name:
Indications For Use:
The system is used on the order of a physician for the treatment of asthma, bronchitis and other respiratory diseases. The nebulizer converts the liquid medication into a fine aerosol mist which can be inhaled for home respiratory therapy. This allows the medication to be deposited at the affected areas of the patients airway.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaulation (ODE)
f. Allertson
§ 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).