(157 days)
The Koo SVN is a handheld, pneumatic nebulizer designed to aerosolize prescription drugs for inhalation by a patient. Its use is indicated whenever a healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer.
The Koo SVN is intended for use with pediatric (defined by the prescribed medication) and adult patients consistent with the indications for the aerosol medication. This includes hospital/institutional settings, home care use, schools and long term care facilities.
The Koo SVN is a simple handheld small volume nebulizer powered by compressed air to nebulize the I ne Noo S V It is a simple handler shall vith a mouthpiece or standard aerosol / oxygen face mask. The SVN can be packaged with optional accessories, i.e., oxygen tubing, mouthpiece and hose, and face mask. The nebulizer and its accessories are single patient, multi-use devices.
The provided submission describes the Koo Small Volume Nebulizer (SVN). The device is a handheld, pneumatic nebulizer designed to aerosolize prescription drugs for inhalation. The study presented is a comparative performance study against a predicate device, the Miller (VixOne) nebulizer (K926055). The acceptance criteria are essentially defined by the performance of this predicate device, demonstrating substantial equivalence.
Here's the detailed breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Koo SVN are implicitly defined by performing "equivalently" to the predicate device, Miller (VixOne) K926055, across various particle characterization metrics. The study aims to show that the Koo SVN's performance falls within a similar range as the predicate.
| Metric (Drug) | Acceptance Criteria (Predicate: Miller (VixOne) K926055) | Reported Device Performance (Koo SVN) |
|---|---|---|
| Total Output (ug) | ||
| Albuterol | $1160 \pm 96$ | $1005 \pm 21$ |
| Ipratropium | $196 \pm 7$ | $184 \pm 10$ |
| Cromolyn | $4344 \pm 353$ | $4156 \pm 113$ |
| Particle Size (MMAD) (Microns) | ||
| Albuterol | $2.10 \pm 0.17$ | $1.80 \pm 0.2$ |
| Ipratropium | $1.93 \pm 0.06$ | $1.90 \pm 0.1$ |
| Cromolyn | $1.57 \pm 0.21$ | $1.53 \pm 0.06$ |
| Geometric Std. Dev. (GSD) | ||
| Albuterol | $3.00 \pm 0.25$ | $2.84 \pm 0.14$ |
| Ipratropium | $3.11 \pm 0.48$ | $2.71 \pm 0.1$ |
| Cromolyn | $2.83 \pm 0.05$ | $2.63 \pm 0.2$ |
| Respirable Fraction (% Mass 0.5-5 microns) | ||
| Albuterol | $67.3% \pm 3.2%$ | $69.0% \pm 2.0%$ |
| Ipratropium | $66.7% \pm 5.8%$ | $70.3% \pm 0.6%$ |
| Cromolyn | $68.0% \pm 2.0%$ | $71.0% \pm 3.6%$ |
| Respirable Mass (ug 0.5 - 5.0 microns) | ||
| Albuterol | $781 \pm 71$ | $693 \pm 17$ |
| Ipratropium | $131 \pm 13$ | $129 \pm 6$ |
| Cromolyn | $2949 \pm 155$ | $2953 \pm 232$ |
| Treatment Time (min) | ||
| Albuterol | $4.33 \pm 0.38$ | $4.00 \pm 0$ |
| Ipratropium | $2.92 \pm 0.38$ | $2.67 \pm 0.29$ |
| Cromolyn | $1.58 \pm 0.38$ | $1.50 \pm 0$ |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that the testing provided a "95% confidence level." While the exact number of samples for each specific measurement (e.g., total output, particle size for each drug) is not explicitly stated as a single number, the statistical confidence level (95%) implies a sufficient sample size was used for each test to achieve this confidence.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It is implied that the testing was conducted by the manufacturer, KOO (Shanghai) Industries Co., Ltd., as part of the 510(k) submission process, making it prospective testing for the purpose of demonstrating substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study (comparative performance of a nebulizer using physical measurements) does not involve human experts establishing "ground truth" in the way a diagnostic AI study would. The ground truth here is the measurable physical properties of aerosolized drugs, determined through standardized laboratory techniques (Cascade Impactor). Therefore, this question is not applicable to this submission.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this study does not involve expert review or adjudication of results. The results are physical measurements.
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 study comparing the physical performance characteristics of a medical device (nebulizer) to a predicate device, not an AI-powered diagnostic tool involving human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. The Koo SVN is a physical medical device, not an algorithm or software-driven device. The submission explicitly states "Software driven: No."
7. The Type of Ground Truth Used
The "ground truth" for this study is derived from objective physical measurements obtained through standardized laboratory testing, specifically "Particle Characterization per Cascade Impactor." This method directly measures key aerosol performance parameters such as Total Output, Particle Size (MMAD), Geometric Standard Deviation (GSD), Respirable Fraction, and Respirable Mass.
8. The Sample Size for the Training Set
Not applicable. As a physical medical device and not an AI or machine learning algorithm, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
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Koo SVN
K 112041
510(k) Summary Page 1 of 4 1 5-Jul-201 1
DEC 222 2011
| KOO (Shanghai) Industries Co., Ltd.100 Zhongde Road, Dakun Industrial ParkSongjiang Shanghai 201614 China | T - 011 86 21 57858410F - 011 86 21 57858410 x.107 |
|---|---|
| Official Contact: | Chris Koo - President |
| Proprietary or Trade Name: | Koo Small Volume Nebulizer (SVN) |
| Common/Usual Name: | Small Volume Nebulizer |
| Classification Name: | Nebulizers (direct patient interface)Procode - CAF - CFR 868.5630 |
| Predicate Devices: | K926055 - Miller (Vixone) Westmed |
Device Description:
Device Deserription.
The Koo SVN is a simple handheld small volume nebulizer powered by compressed air to nebulize the I ne Noo S V It is a simple handler shall vith a mouthpiece or standard aerosol / oxygen face mask. The SVN can be packaged with optional accessories, i.e., oxygen tubing, mouthpiece and hose, and face mask. The nebulizer and its accessories are single patient, multi-use devices.
Indications for Use:
The Koo SVN is a handheld, pneumatic nebulizer designed to aerosolize prescription drugs for inhe reo b r r louinent. Its use is indicated whenever a healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer.
The Koo SVN is intended for use with pediatric (defined by the prescribed medication) and adult patients consistent with the indications for the aerosol medication. This includes hospital/institutional settings, home care use, schools and long term care facilities.
| Patient Population: | Pediatric (defined by the prescribed medication) and adult patients consistent with the indications for the aerosol medication |
|---|---|
| Environment of Use: | Hospital/institutional settings, home care use, schools and long term care facilities |
| Contraindications: | None |
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Premarket Notification 510(k) Section 5 – 510(k) Summary
510(k) Summary
| Features | Proposed SVN | Predicate Miller (VixOne) K926055 |
|---|---|---|
| Indications for use | The Koo SVN nebulizer is a handheld, pneumatic nebulizer designed to aerosolize prescription drugs for inhalation by a patient. Its use is indicated whenever a healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer. | A handheld, pneumatic nebulizer designed to aerosolize prescription drugs for inhalation by a patient. Its use is indicated whenever a healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer |
| Environment of Use | Hospital/institutional settings, home care use, schools and long term care facilities. | Hospital/institutional settings, home care use, schools and long term care facilities. |
| Patient Population | Pediatric (defined by the prescribed medication) and adult patients consistent with the indications for the aerosol medication | Pediatric and AdultPediatric population not defined |
| Contraindications | None | None |
| Principle of Operation | Pneumatic (gas powered) jet nebulizer | Pneumatic (gas powered) jet nebulizer |
| Aerosolization | Continuous during inhalation and exhalation | Continuous during inhalation and exhalation |
| Compressed gas source | Nebulizer compressorWall air / oxygen with flow rate control | Nebulizer compressorWall air / oxygen with flow rate control |
| Typical flow rate | 6-8 lpm | 6-8 lpm |
| Components available in kit with nebulizer | Mouthpiece / HoseFace MaskOxygen / Delivery tubingAerosol tee | Mouthpiece / HoseFace MaskOxygen / Delivery tubingAcrosol tee |
| Component / Accessories intended use | All are single patient, multi-use | All are single patient, multi-use |
| Software driven | No | No |
| Performance | ||
| Materials tested per ISO 10993 or identical to another device | CytotoxicitySensitizationIrritation | Identical tests to K091272For the tests required |
| DEHP | PVC based components certified DEHP Free | Not labeled |
Comparison to Predicates
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. .
510(k) Summary Page 3 of 4 15-Jul-2011
| Features | ProposedSVN | PredicateMiller (VixOne)K926055 |
|---|---|---|
| Particle Characterization per Cascade Impactor | ||
| Total Output (ug) | Albuterol -$1005 \pm 21$ | Albuterol -$1160 \pm 96$ |
| Ipratropium -$184 \pm 10$ | Ipratropium -$196 \pm 7$ | |
| Cromolyn -$4156 \pm 113$ | Cromolyn -$4344 \pm 353$ | |
| Particle size (MMAD)(Microns) | Albuterol -$1.80 \pm 0.2$ | Albuterol -$2.10 \pm 0.17$ |
| Ipratropium -$1.90 \pm 0.1$ | Ipratropium -$1.93 \pm 0.06$ | |
| Cromolyn -$1.53 \pm 0.06$ | Cromolyn -$1.57 \pm 0.21$ | |
| Geometric Std. Dev.(GSD) | Albuterol -$2.84 \pm 0.14$ | Albuterol -$3.00 \pm 0.25$ |
| Ipratropium -$2.71 \pm 0.1$ | Ipratropium -$3.11 \pm 0.48$ | |
| Cromolyn -$2.63 \pm 0.2$ | Cromolyn -$2.83 \pm 0.05$ | |
| Respirable Fraction(% Mass 0.5-5microns) | Albuterol -$69.0% \pm 2.0%$ | Albuterol -$67.3% \pm 3.2%$ |
| Ipratropium -$70.3% \pm 0.6%$ | Ipratropium -$66.7% \pm 5.8%$ | |
| Cromolyn -$71.0% \pm 3.6%$ | Cromolyn -$68.0% \pm 2.0%$ | |
| Respirable Mass (ug0.5 -5.0 microns) | Albuterol -$693 \pm 17$ | Albuterol -$781 \pm 71$ |
| Ipratropium -$129 \pm 6$ | Ipratropium -$131 \pm 13$ | |
| Cromolyn -$2953 \pm 232$ | Cromolyn -$2949 \pm 155$ | |
| Treatment time (min) | Albuterol -$4.00 \pm 0$ | Albuterol -$4.33 \pm 0.38$ |
| Ipratropium -$2.67 \pm 0.29$ | Ipratropium -$2.92 \pm 0.38$ | |
| Cromolyn -$1.50 \pm 0$ | Cromolyn -$1.58 \pm 0.38$ | |
| Confidence level oftesting | The test and number of samplestested provided a 95% confidencelevel | The test and number of samples testedprovided a 95% confidence level |
| Simulated Life / Mechanical and Environmental testing | ||
| Nebulizer | Cleaned and tested after 30 cycles | Single patient, multi-use |
| Environmental testingall components | Hot / Cold cycles | |
| Mechanical testing | Dimensional changesDrop test |
Substantial Equivalence Discussion
The above table compares the key features of the proposed Koo SVN nebulizer with the identified predicate and demonstrates that the device can be found to be substantially equivalent.
In summary one can conclude that substantial equivalence is met based upon the following:
The SVN small volume, handheld nebulizer is viewed as substantially equivalent to the predicate device because:
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510(k) Summary Page 3 of 4 15-Jul-2011
Indications -
The proposed indications for use are to aerosolize commonly prescribed medications is identical to predicate - K926055 - Miller - Vixone, now owned by Westmed.
Technology -
The design as a jet (gas powered) nebulizer powered by an external compressed gas source is the identical principle of operation as the predicate - K926055 - Miller - Vixone.
Materials -
The materials in the gas and fluid pathway have been tested per ISO 10993 and found to be nonreactive.
In addition evidence to support DEHP free for accessories made of PVC is provided.
、
Environment of Use -
The proposed environments of use are common and usual for handheld nebulizers and identical to predicate - K926055 - Miller - Vixone.
Patient Population -
The patient population of adult and pediatric (defined by the prescribed medication) patients consistent with the indications for the aerosol medication. With the typical gas flow of 6-8 lpm, this is sufficient to satisfy the expected tidal volume of pediatric population as well as an adult. This is identical to predicate - K926055 - Miller - Vixone.
Comparative Performance -
We performed comparative particle characterization testing via Cascade Impactor and the results demonstrated fequivalent performance to the predicate K926055.
In addition, ye performed testing related to intra- and inter-sample dose and particle variability. simulation life / cleaning validation, environmental and mechanical testing. The results demonstrated that the proposed device either passed or met its performance specifications after each test
All testing gemonstrated that the proposed device is substantially equivalent to the predicate devices.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
KOO (Shanghai) Industries Company, Limited C/O Mr. Paul Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134
DEC 2 2 2011
Re: K112041
Trade/Device Name: Koo Small Volume Nebulizer (SVN) Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: December 14, 2011 Received: December 15, 2011
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. 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 Eederal 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely, yours,
hh for
Arthur D. Weston R.S.M.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use Statement
Page 1 of 1
510(k) Number:
(To be assigned)
Device Name:
Koo Small Volume Nebulizer (SVN)
Indications for Use:
The Koo SVN is a handheld, pneumatic nebulizer designed to aerosolize prescription drugs for inhalation by a patient. Its use is indicated whenever a healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer.
The Koo SVN is intended for use with pediatric (defined by the prescribed medication) and adult patients consistent with the indications for the aerosol medication. This includes hospital/institutional settings, home care use, schools and long term care facilities.
Prescription Use XX (Part 21 CFR 801 Subpart D) or
Over-the-counter use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L Schultheis
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
K 11204 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).