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510(k) Data Aggregation
(236 days)
Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor
Nebulizer (NB-1103)
The Compressor Nebulizer system is intended to provide air to the pneumatic nebulizer in order to aerosolize medications for inhalation by the patient for respiratory disorders. The nebulizer is driven by the integral air compressor.
The system is designed for use with pediatric (ages 2 years and above) and adult patients in the home, hospital, and sub-acute settings.
The compressor Nebulizer is mainly composed of the compressor and nebulizer kit(Optional). The compressor is mainly composed of shell, compressed motor, pump, fuse wire, air filter, power cord and plug (NB-1100,NB-1101,NB-1102,NB-1103 applicable), PCB (only model NB-1102,NB-1103applicable). The device is equipped with a nebulizer kit including Nebulizer Cup, Air Tube, Mouthpiece(Optional), Adult Mask(Optional), Child Mask(Optional) to easily delivery the medical aerosol. The Nebulizer kit is available in three models/configurations as below.
- NK-101: Nebulizer Cup, Air Tube, Adult Mask and/or Child Mask, Mouthpiece;
- NK-301: Nebulizer Cup, Air Tube, Adult Mask and/or Child Mask;
- NK-501: Nebulizer Cup, Air Tube, Mouthpiece
This device operates on the Venturi principle. According to the principle of Venturi, the compressed air of the motor is used to form a high-speed air flow through the small pipe mouth. The negative pressure generated drives the liquid or other fluid to spray together on the barrier, and under the high-speed impact makes the droplets turn into mist particles to spray from the outlet trachea.
The provided FDA 510(k) clearance letter and summary for JOYTECH Healthcare Co., Ltd.'s Compressor Nebulizer (K243468) primarily details the substantial equivalence of the new device to a predicate device, focusing on non-clinical performance testing, specifically particle size characterization.
It's important to note that this document does not describe a study involving human subjects or artificial intelligence (AI). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the engineering and performance specifications for a nebulizer, evaluated through laboratory testing against a predicate device and relevant standards. Therefore, many of the requested points related to AI/MRMC studies, expert ground truth, adjudication methods, and training sets for algorithms are not applicable to this specific device clearance.
Below is an interpretation of the provided information within the framework of your request, focusing on the relevant parts and explicitly stating where information is not available or not applicable.
Acceptance Criteria and Device Performance for JOYTECH Compressor Nebulizer (K243468)
The acceptance criteria for this device are established by demonstrating substantial equivalence to a legally marketed predicate device (Omron Compressor Nebulizer Systems NE-C801, K110860) and by meeting relevant performance standards, particularly regarding aerosol particle characterization. The 'study' proving this is primarily the "Particle Size characterization testing" detailed in the submission.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by performing "comparative particle test comparison" against the predicate device. The goal is to show that the proposed device performs similarly or equivalently to the predicate across key aerosolization parameters. The performance data provided is the direct result of this testing.
Table: Comparative Particle Test Comparison (Summary of Select Parameters)
| Test Item | Endpoint (Acceptance Criteria Implicitly Compared to Predicate) | Subject Device (JOYTECH NB-1103) Performance (Range across drugs/interfaces) | Predicate Device (OMRON NEC801) Performance (Range across drugs/interfaces) | Comparison Result (as per Submitter) |
|---|---|---|---|---|
| MMAD ($\mu$m) | Particle size distribution suitable for inhalation therapy, comparable to predicate. | 3.413 - 5.757 | 3.7 - 6.248 | Equivalent / Similar |
| GSD | Particle size distribution uniformity, comparable to predicate. | 1.764 - 2.381 | 1.605 - 2.141 | Equivalent / Similar |
| Respirable Dose ($\mu$g) | Amount of drug delivered in respirable range, comparable to predicate. | 51.307 - 1628.633 | 50.723 - 1239.14 | Equivalent / Similar |
| Respirable Fraction (%) | Proportion of aerosolized drug in respirable range, comparable to predicate. | 39.103 - 67.958 | 31.781 - 63.741 | Equivalent / Similar |
| Total Delivered Dose ($\mu$g) | Total amount of drug delivered, comparable to predicate. | 112.976 - 2562.202 | 146.303 - 2131.073 | Equivalent / Similar |
| Total Delivered Dose Fraction (%) | Proportion of initial drug dose delivered, comparable to predicate. | 21.305 - 49.063 | 27.55 - 40.801 | Equivalent / Similar |
| Fine Particle Fraction (%) (4.7$\mu$m) | Percentage of particles greater than 4.7 $\mu$m, comparable to predicate. | 35.232 - 64.547 | 39.467 - 72.054 | Equivalent / Similar |
| **Ultra-Fine Particle Fraction (%) ( |
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(221 days)
GUS831 Compressor Nebulizer
GUS831 compressor nebulizer is designed for the production of compressed air to operate a nebulizer kit for the production of medical aerosol for respiratory disorders. The nebulizer kit is intended for multiple use by single patient for single medication. GUS831 compressor nebulizer is intended for domestic use with children from 5 years old, adolescent and adult patients and requires the order of a physician for medical use.
GUS831 Compressor Nebulizer is a portable aerosol nebulizer electronically powered by an external power adapter and by an internal rechargeable lithium polymer battery. The compressed air, created by the membrane pump of the device, flows into the nebulizer container kit. The air pressure forced the liquid through the nozzle where it is atomized against a plate within the container. The device is equipped with a mouthpiece to easily delivery the medical aerosol.
Here's a breakdown of the acceptance criteria and study information for the GUS831 Compressor Nebulizer, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on demonstrating substantial equivalence to a predicate device (U-RIGHT Compressor Nebulizer, K121969) rather than explicitly stating pre-defined acceptance criteria with pass/fail thresholds against a specific standard for all performance parameters. However, the aerosol characterization section presents quantitative data for both the subject and predicate devices, implying those values serve as comparative criteria.
Note: The "acceptance criteria" here are implicitly defined by the predicate device's performance, with the goal being "statistically identical" or "substantially equivalent" performance.
| Performance Parameter | Test Condition | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (GUS831) | Conclusion on Meeting Acceptance Criteria |
|---|---|---|---|---|
| Aerosol Characterization (Adult Conditions @ 28 LPM) | ||||
| Particle Size (MMAD) Albuterol Sulfate (2.5 mg/3 ml) | Adult @ 28 LPM | 3.87±0.31 µm | 2.64±0.35 µm | Substantially Equivalent (implicitly) |
| Particle Size (MMAD) Ipratropium Bromide (0.5 mg/2.5 ml) | Adult @ 28 LPM | 3.37±0.46 µm | 2.51±0.36 µm | Substantially Equivalent (implicitly) |
| Particle Size (MMAD) Cromolyn Sodium (20 mg/2.0 ml) | Adult @ 28 LPM | 2.87±0.15 µm | 2.64±0.34 µm | Substantially Equivalent (implicitly) |
| Geometric Standard Deviation Albuterol Sulfate (2.5 mg/3 ml) | Adult @ 28 LPM | 3.77±0.48 | 3.32±0.57 | Substantially Equivalent (implicitly) |
| Geometric Standard Deviation Ipratropium Bromide (0.5 mg/2.5 ml) | Adult @ 28 LPM | 4.14±0.25 | 3.59±0.48 | Substantially Equivalent (implicitly) |
| Geometric Standard Deviation Cromolyn Sodium (20 mg/2.0 ml) | Adult @ 28 LPM | 3.70±0.55 | 3.37±0.70 | Substantially Equivalent (implicitly) |
| Total Dose Delivered Albuterol Sulfate (2.5 mg/3 ml) | Adult @ 28 LPM | 514±55 µg | 471±45 µg | Substantially Equivalent (implicitly) |
| Total Dose Delivered Ipratropium Bromide (0.5 mg/2.5 ml) | Adult @ 28 LPM | 89±12 µg | 91±9 µg | Substantially Equivalent (implicitly) |
| Total Dose Delivered Cromolyn Sodium (20 mg/2.0 ml) | Adult @ 28 LPM | 2772±441 µg | 3286±383 µg | Substantially Equivalent (implicitly) |
| Total Respirable Dose (0.5-5 um) Albuterol Sulfate | Adult @ 28 LPM | 259±37 µg | 263±38 µg | Substantially Equivalent (implicitly) |
| Total Respirable Dose (0.5-5 um) Ipratropium Bromide | Adult @ 28 LPM | 42±5 µg | 50±8 µg | Substantially Equivalent (implicitly) |
| Total Respirable Dose (0.5-5 um) Cromolyn Sodium | Adult @ 28 LPM | 1448±312 µg | 1913±328 µg | Substantially Equivalent (implicitly) |
| Coarse Particle Dose (>4.7 um) Albuterol Sulfate | Adult @ 28 LPM | 253±38 µg | 178±23 µg | Substantially Equivalent (implicitly) |
| Coarse Particle Dose (>4.7 um) Ipratropium Bromide | Adult @ 28 LPM | 41±8 µg | 35±6 µg | Substantially Equivalent (implicitly) |
| Coarse Particle Dose (>4.7 um) Cromolyn Sodium | Adult @ 28 LPM | 1143±106 µg | 1268±316 µg | Substantially Equivalent (implicitly) |
| Fine Particle Dose (4.7 um) Albuterol Sulfate | Pediatric @ 12 LPM | 701±107 µg | 576±36 µg | Substantially Equivalent (implicitly) |
| Coarse Particle Dose (>4.7 um) Ipratropium Bromide | Pediatric @ 12 LPM | 152±8 µg | 113±27 µg | Substantially Equivalent (implicitly) |
| Coarse Particle Dose (>4.7 um) Cromolyn Sodium | Pediatric @ 12 LPM | 4343±426 µg | 2920±113 µg | Substantially Equivalent (implicitly) |
| Fine Particle Dose ( |
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(447 days)
COMPRESSOR NEBULIZER MODEL MCN-S600XX
Stronghealth Compressor Nebulizer MCN-S600XX is used to administer various aerosol treatments of all Subgream Compressor Nebulizer MCN-30007X is 350 a idinister or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.
The intended environment for use of the product is in the patient's home on the order of a physician.
Not Found
This document is a 510(k) premarket notification letter from the FDA regarding the "Stronghealth Compressor Nebulizer MCN-S600XX." It primarily addresses the device's substantial equivalence to a predicate device and its regulatory classification. It does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.
Therefore, I cannot provide the requested information, as it is not present in the provided text. The document is a regulatory approval letter, not a performance study report.
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(238 days)
U-RIGHT COMPRESSOR NEBULIZER
U-RIGHT Compressor Nebulizer, model TD-7013/ TD-7012, is designed to provide a compressed air source to aerosolize physician-prescribed liquid medication when used in combination with the packaged Nebulizer kit, except for Pentamidine. The packaged Nebulizer kit is intended for single use by single patient. U-RIGHT Compressor Nebulizer, model TD-7013/ TD-7012, is intended for use with children, adolescents ( 2 years to 18 years old), and adult patients in the homecare settings.
U-RIGHT Compressor Nebulizer is a light weight portable aerosol nebulizer, which uses a pneumatic piston that compresses air, forcing it to flow into the nebulizer container. And the force of the air flowing into the nebulizer container disperses the liquid medicine into aerosol particles for inhalation treatment of a physician's prescription medicine.
The only difference between model TD-7012 and TD-7013 is the outer casing design. The operating principle, the compressor type, working mechanism, and the accessories Nebulizer kit are all the same in these two models.
The submission describes the acceptance criteria and study for the U-RIGHT Compressor Nebulizer (model TD-7013/TD-7012).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Aerosol Characterization | Particle Size Distribution via Cascade Impactor | Equivalent performance to predicate device (K990435) with no significant difference (p>0.05) in particle distributions for Ipratropium bromide, Ventolin, and Cromolyn sodium. Consistent repeatability across drug classes. | Shown to be consistent in repeatability tests for three classes of drugs and demonstrated equivalent performance to the predicate device K990435 with no significant difference (p>0.05) in particle distributions. Meets product specifications. |
| Airpath Testing | Gas Sample Analysis | Device does not emit potential toxic gases (carbon monoxide, carbon dioxide, ozone, VOCs). Output of particulate matter conforms to EPA PM2.5 standard. | Device does not emit potential toxic gases. Output of particulate matter conformed to EPA requirements of the PM2.5 standard. |
| Biocompatibility | Cytotoxicity (ISO 10993-5) | Bio-compatible | Tests conducted and results are assumed to have met standards, classified as "Biocompatibility evaluations... have been conducted for the gas path contact materials." |
| Irritation (ISO 10993-10) | Bio-compatible | Tests conducted and results are assumed to have met standards. | |
| Sensitization (ISO 10993-10) | Bio-compatible | Tests conducted and results are assumed to have met standards. | |
| Implantation (ISO 10993-6) | Bio-compatible | Tests conducted and results are assumed to have met standards. | |
| Genotoxicity (ISO 10993-3) | Bio-compatible | Tests conducted and results are assumed to have met standards. | |
| Safety and EMC | Electrical Safety (EN 60601-1:2006) | Compliance with standard | Tested to meet the standard. |
| Electromagnetic Compatibility (EN 60601-1-1-2:2007, CISPR 11:2009+A1:2010) | Compliance with standards | Tested to meet the standards. |
2. Sample Size Used for the Test Set and the Data Provenance
The provided text describes performance testing comparing the U-RIGHT Compressor Nebulizer to a predicate device. For the Aerosol Characterization Testing, the test involved comparing aerosol particle distributions with three specific drugs (Ipratropium bromide, Ventolin, and Cromolyn sodium) to the predicate device. The sample size for this comparative testing is not explicitly stated as a number of devices or number of tests per device, but the comparison was made across these three drugs.
Data provenance: The testing was conducted by TaiDoc Technology Corporation as part of their 510(k) submission. The location of the testing facility is not specified, but the applicant is based in Taiwan. The study appears to be prospective as it involves performance testing of the newly developed device against an existing predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" in this context is referring to measurable physical properties and compliance with engineering standards, not expert interpretations of medical images or conditions. The "ground truth" for the aerosol characterization would be the measured particle size distribution from the predicate device and the specified statistical equivalence, while for other tests it's compliance with safety and environmental standards.
4. Adjudication Method for the Test Set
This information is not applicable as the studies are focused on objective performance measurements and compliance with technical standards, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The study described is a technical performance comparison between a new device and a predicate device (device-to-device comparison), not a reader study involving human interpretation of data/images.
6. Standalone Performance Study
Yes, a standalone performance study was done for the device. The "Aerosol Characterization Testing" assessed the particle size distribution of the U-RIGHT Compressor Nebulizer with different drugs and demonstrated its performance characteristics and repeatability. The "Airpath Testing" and "Materials" testing (biocompatibility) also assessed the device's standalone performance regarding air quality output and material safety. The "Safety and EMC" testing specifically evaluated the device's adherence to relevant electrical safety and electromagnetic compatibility standards. While these tests had a comparative element to a predicate where applicable, they fundamentally assessed the device's inherent performance and compliance.
7. Type of Ground Truth Used
The ground truth used in these studies is primarily based on:
- Predicate Device Performance: For aerosol characterization, the performance of the legally marketed predicate device (Bestneb Portable Aerosol Therapy Unit, Model AP-10010, K990435) served as the reference point for equivalence (statistical significance p>0.05).
- Regulatory and Engineering Standards: For airpath testing, biocompatibility, electrical safety, and EMC, the ground truth is defined by compliance with established international standards (e.g., ISO 10993 series, EN 60601 series, CISPR 11) and EPA requirements (PM2.5 standard).
- Product Specifications: The device's own product specifications were also used as a benchmark for performance.
8. Sample Size for the Training Set
This information is not applicable. This device is a medical nebulizer, not an AI/machine learning algorithm, and therefore does not have a "training set" in the computational sense. The product development likely involved design iterations and internal testing, but not a formal 'training set' as used in AI validation.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reason stated in point 8.
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(267 days)
QUALITY LIFE TECHNOLOGIES COMPRESSOR NEBULIZER
The Quality Life Technologies Compressor Nebulizer is an AC powered air compressor that provides a source of compressed air for home health care use. The product is used in conjunction with a jet (pneumatic) nebulizer to convert liquid medication into an aerosol form with particles smaller than 5 microns diameter for inhalation into the patient's respiratory tract for the treatment of respiratory disorders.
The target population for this device consists of adult patients suffering from, but not limited to asthma, cystic fibrosis, and chronic obstructive pulmonary disease. Further, additional applications for aerosolized medication are constantly under investigation and this device may be deemed suitable for such applications as prescribed.
The intended environment for use of the product is in the patient's home on the order of a physician.
Our Quality Life Technologies Compressor Nebulizer works to convert the medication to a high-quality mist of fine particles and spray liquid medications in aerosol form into gases that are directly delivered to the patient.
The provided text describes a 510(k) summary for the Quality Life Technologies Compressor Nebulizer, comparing it to predicate devices. The submission focuses on demonstrating substantial equivalence rather than presenting an exhaustive study of acceptance criteria and performance against those criteria as would be done for a novel device.
However, based on the non-clinical tests mentioned, we can infer some "acceptance criteria" and the reported performance.
Here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission, the "acceptance criteria" are implied by the performance of the predicate devices and general medical device safety and efficacy standards. The "reported device performance" is largely presented as meeting these standards or being substantially equivalent to the predicates.
| Acceptance Criterion (Implied) | Reported Device Performance (Quality Life Technologies Compressor Nebulizer) |
|---|---|
| Biocompatibility: Meet requirements of ISO 10993 Part-1. | Biocompatible: "The patient contact components of the Quality Life Technologies Compressor Nebulizer met the requirements of ISO 10993 Part-1, Biological Evaluation of Medical Devices." |
| Electrical Safety: Meet requirements of IEC 60601-1. | Met Electrical Safety Standards: "Quality Life Technologies Compressor Nebulizer met the requirements of IEC 60601-1." |
| Electromagnetic Compatibility (EMC): Meet requirements of IEC 60601-1-2. | Met EMC Standards: "Quality Life Technologies Compressor Nebulizer met the requirements of IEC 60601-1-2." |
| Functional Performance (Substantial Equivalence to Predicate K870027 - SALTER LABS): | |
| - MMAD (Mean Mass Aerodynamic Diameter) for Albuterol Sulfate ( |
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(58 days)
COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321
K-jump Health Co, Ltd. Compressor Nebulizer System includes a DC powered air compressor that provides a source of compressed air for home health care use. The compressor is used with a pneumatic nebulizer to convert certain inhaled drugs into an aerosol form for inhalation by a patient. The device can be used with adult or pediatric patients.
K-jump Health Co. Ltd. Compressor Nebulizer System. Model KN -9321. is a pneumatic nebulizer which, when driven by its built-in air compressor, nebulizes specific inhalable drugs for inhalation by a patient for treatment of respiratory disorders such as allergies, asthma, cystic fibrosis, COPD, etc. It can used with adult or pediatric patients.
The K-jump Health Co, Ltd. Compressor Nebulizer System, Model KN -9321, consists of a nebulizer and a DC powered piston-type compressor that generates compressed air. Small, light-weight and designed for convenience, the The Kjump Health Co, Ltd. Portable Nebulizer System, Model KN -9321 offers the user a choice of running off of AC power via a universal adapter or DC power via an optional 12 volt auto adapter, or an optional rechargeable battery pack. The device consists mainly of a motor drive piston compressor, a printed circuit board and a switch. The circuit board does not incorporate a microprocessor but serves as a means to prevent double feed of power. The circuit board is not a part of the charging circuit for the battery pack.
Specifically, the device is made up of a DC pump assembly, a plastic body (including a top cover, a mina body, a rear cover, an inlet filter, a filter cover, an outlet filter and a cushion), a drug ampoule assembly (including a drug ampoule, a cap and a micronization cone), a printed circuit board with electronic components, a DC socket, an AC adapter power source (or a rechargeable battery assembly as an optional power source), and a key for ON/OFF operation. The DC pump assembly consists of a motor, a motor housing, a cam, a bearing, a crank, a cylinder, two valves and a base for ampoule.
The nebulizer, which employs a venturi effect to convert the medication into a fine aerosol mist, is used either snapped directly onto the compressor outlet barb or with an optional extension tube. Providing a connection between the compressor outlet barb and the nebulizer bottom, the optional extension tube allows the user to place the compressor on a sturdy surface and to simply hold onto the nebulizer. The nebulizer is designed for single patient use and is reusable. The nebulizer with or without its tubing adapter is designed specifically for use only with the The K-jump Health Co, Ltd. Portable Nebulizer System, Model KN -9321. Use of the nebulizer, tubing or compressor with other compressors, nebulizer or tubing may product incorrect flow resulting in improper treatment.
The K-iump Health Co. Ltd. Compressor Nebulizer System, Model KN -9321 will be sold with a carrying bag, AC adapter (power supply) with power cord, the optional tubing with connectors, 5 packs of filters, one mouth-piece, one set of drug ampoule assembly and a user manual. Optional accessories which will be offered with this device are the car connection cable and re-chargeable battery pack.
Here is an analysis of the provided text regarding the acceptance criteria and study for the K-jump Health Co., Ltd. Compressor Nebulizer System, Model KN-9321:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state "acceptance criteria" in a pass/fail quantifiable manner, but rather presents a comparative table to a predicate device and lists various tests performed. The implicit acceptance criteria are that the device performs equivalently or comparably to the predicate device and meets relevant performance and safety standards.
| Characteristic / Test | Predicate Device Performance (Med2000 Model P1) | K-jump Device (Model KN-9321) Performance | Implicit Acceptance Criteria (based on comparison to predicate) |
|---|---|---|---|
| Compressor Characteristics | |||
| Max Compressor Pressure | 29 psig | 30 psig | Similar or better than predicate |
| Average Flow Rate | 6.0 lpm @ 14.7 psi | 4.5 lpm @ 12 psi | Similar to predicate (though noted difference, deemed acceptable via overall equivalence) |
| Mode of Operation | 20 min ON/40 min OFF | 20 min ON/40 min OFF | Same as predicate |
| Nebulizer Characteristics | |||
| Particle Size Range | 0.5 to 5 microns | 0.5 to 5 microns | Same as predicate |
| Capacity | 6 ml. | 7 ml. | Similar to predicate |
| Mean Flow Rates | 3.07 L/min | 3.05 L/min | Similar to predicate |
| Performance Testing | |||
| Aerosol Dose & Particle Size | Performed with 3 drugs | Study performed using Cascade Impactor Method with Albuterol Sulfate, Ipratropium Bromide, and Cromolyn Sodium. | Deemed comparable to predicate. |
| Emitted Particulate & VOC | Not explicitly stated for predicate in summary | Conformed to EPA requirements of PM 10 and PM 2.5 Standard | Meets EPA standards. |
| Simulated Lifetime Performance | Not explicitly stated for predicate in summary | Performed with Albuterol Sulfate | Demonstrates durability/performance over time. |
| Flow Rate Characterization | Not explicitly stated for predicate in summary | Performed | Characterized flow rate. |
| Biocompatibility Testing | Not explicitly stated for predicate in summary | Performed on Nebulizer Adult & Pediatric Masks, Ampoule, Micronization Cone, Ampoule Cap, Mouthpiece and Mask Adapter. Includes: Cytotoxicity, Maximization Test for Delayed Hypersensitivity, Subacute Repeated Dose Toxicity Study, Salmonella Typhimurium Reverse Mutation Assay (Ames Test), Intramuscular Implant Test, Cell Growth Analysis, Irritation Test. | No adverse biocompatibility issues found. |
| EMC, Electrical, Mechanical, Environmental Testing | Not explicitly stated for predicate in summary | Performed | Meets required standards. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical performance testing rather than a "test set" in the context of AI/ML evaluation.
- Sample Size for Performance Testing: Not explicitly stated for each test (e.g., how many nebulizers were tested for particle size, how many cycles for lifetime performance). The tests appear to be conducted on a sufficient number of units to demonstrate performance and safety.
- Data Provenance: The tests are "bench testing" performed by the manufacturer (K-jump Health Co., Ltd.) or contracted labs. The provenance is internal to the manufacturer's testing and compliance processes. No specific country of origin for the data itself (beyond the manufacturer's location) is mentioned, nor is it categorized as retrospective or prospective in the medical study sense, as it's device testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable. The submission describes a traditional medical device (nebulizer) that is evaluated through physical and chemical performance tests, and biocompatibility assessments, not through image interpretation or diagnostic tasks that would require expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not applicable, as there is no "test set" requiring expert adjudication in the context of human interpretation of medical data. The evaluation is based on objective measurements and laboratory results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, what was the effect size of how much human readers improve with AI vs without AI assistance?
This information is not applicable. The device is a compressor nebulizer, which is a physical device for drug delivery, not an AI/ML algorithm used to assist human readers (e.g., radiologists) in diagnostic tasks. Therefore, no MRMC study or AI-related effectiveness measure is relevant or provided.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical medical device, not a standalone AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is established by:
- Performance Standards: Compliance with industry standards for nebulizer performance (e.g., particle size distribution, flow rates, output).
- Safety Standards: Compliance with biocompatibility standards (e.g., ISO testing for cytotoxicity, irritation, sensitization), electrical safety (EMC, electrical testing), and material safety (VOC analysis).
- Predicate Device Comparison: The performance of the predicate device (Med2000 SpA Nebulizer Compressor) serves as a benchmark for "ground truth" for substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable. There is no AI/ML component described, and thus no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set mentioned or implied by the nature of the device.
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(226 days)
COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES
The EMG NBA02-XXX Series Compressor Nebulizer is a compact medical nebulizing device intended for professional use containing a compressor and medical nebulizer used as prescribed by a physician for medication in the home or health care facility.
The EMG NBA02-XXX Series Compressor Nebulizer is a compact medical nebulizing device intended for professional use containing a compressor and medical nebulizer.
This document is a 510(k) premarket notification letter from the FDA to EMG Technology Company Limited regarding their EMG NBA02-XXX Compressor Nebulizer. It states that the device has been found substantially equivalent to legally marketed predicate devices and can be marketed.
This document does not contain information about acceptance criteria or a study proving that the device meets those criteria. It is a regulatory approval document, not a scientific study or performance report. Therefore, I cannot extract the requested information from the provided text.
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(155 days)
VIGORMIST COMPRESSOR NEBULIZER
The VigorMist Compressor is intended to be used with a compatible pneumatic nebulizer (specifically the W estMed V ixOne) t o c onvert c ertain inhalable drugs into an aerosol form for inhalation by a patient for the treatment of asthma, COPD, and other respiratory ailments. The device is intended for the home care market. It is intended for use with a single adult, pediatric, or infant patient.
The VigorMist™ Compressor is a small air compressor designed to provide sufficient air pressure and flow to power a hand held nebulizer. It measures 11 7/8" x 7 1/8" x 4 1/2" and weights 4.6 lbs.
The device has a thermal protector that will automatically shut off the device when overheated. The operating components are located internally. The compressor, some minor wiring and exhaust/intake tubing are located inside .. External components include a switch, filter with housing, AC cord and cover or accessories compartment. The accessories coming with the compressor include a nebulizer, Air tube and mouthpiece.
The provided information for the VigorMist Compressor Nebulizer (K031413) primarily focuses on its intended use, description, and regulatory details for a 510(k) submission. It does not include detailed studies or data proving specific acceptance criteria in the way a modern AI/software device submission would.
Based on the provided text, I can infer some general acceptance criteria for a medical device like this (e.g., performance specifications, biocompatibility, standards conformity), but the document does not present quantitative metrics or specific study designs to demonstrate these.
Here's an attempt to structure the information based on your request, highlighting what is present and what is conspicuously absent:
Acceptance Criteria and Device Performance for VigorMist Compressor Nebulizer (K031413)
The provided 510(k) summary for the VigorMist Compressor Nebulizer (K031413) indicates that the device underwent testing to ensure it met performance specifications and regulatory requirements. However, the document does not present specific quantitative acceptance criteria or detailed results of a study designed to demonstrate performance against those criteria in a format typical for complex AI or diagnostic devices.
Instead, the submission states that "The VigorMist™ successfully completed testing and demonstrates that the product fulfills performance specifications." This indicates that some form of internal validation was conducted, likely against engineering and safety standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance Specifications (e.g., air pressure, flow rate, aerosol conversion efficiency) | "The VigorMist™ successfully completed testing and demonstrates that the product fulfills performance specifications." (No specific numerical values or ranges are provided in this document.) |
| Biocompatibility | Successfully completed. (No details on tests or results.) |
| Standards Conformity | Successfully completed. (No specific standards listed as evidence within this document, though general conformity to medical device regulations is implied by the 510(k) clearance.) |
| Safety (Thermal Protection) | "The device has a thermal protector that will automatically shut off the device when overheated." (This is a design feature, not a direct performance metric with acceptance criteria.) |
Regarding the Study That Proves the Device Meets Acceptance Criteria:
The document refers to "Performance Testing" but does not describe a clinical study or a detailed technical study with the characteristics requested (sample size, ground truth, expert adjudication, etc.). This submission is for a Compressor Nebulizer, a relatively simple electro-mechanical device, and the regulatory pathway in 2003 for such devices generally relied on demonstrating substantial equivalence to predicates through engineering testing and adherence to recognized standards, rather than large-scale clinical trials or AI-specific validation studies.
Here's what can be inferred or explicitly stated from the document in response to your specific questions:
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of what is provided. The document refers to "testing," but it's likely referring to bench testing, engineering validation, and standards conformity for the device hardware itself, not a test set of data like one would use for an AI algorithm.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. Ground truth, in the sense of expert consensus on medical images or patient outcomes, is not relevant to the type of testing described for this device.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Assistance
- MRMC Study: No. This type of study is not relevant for a compressor nebulizer.
- Effect Size of AI Improvement: Not applicable, as there is no AI component mentioned.
6. If a Standalone (Algorithm Only) Performance Study Was Done
- Standalone Study: No. This device is a hardware compressor; it does not contain an algorithm in the sense of a software-based diagnostic or analytical tool.
7. The Type of Ground Truth Used
- Type of Ground Truth: For a compressor nebulizer, "ground truth" would relate to engineering specifications (e.g., precise measurements of air pressure, flow rate, aerosol particle size distribution determined by calibrated instruments, and compliance with safety standards). The document states testing was completed for "biocompatibility, standards conformity," and "performance specifications," indicating these were the basis for demonstrating quality and safety.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable.
Conclusion:
The provided 510(k) summary for the VigorMist Compressor Nebulizer (K031413) serves as a regulatory document demonstrating substantial equivalence to predicate devices, focusing on the device's design, intended use, and a general statement of successful completion of performance, biocompatibility, and standards conformity testing. It does not contain the detailed study descriptions, quantitative acceptance criteria, or ground truth methodologies that would be expected for a modern AI-powered diagnostic device submission, as it is a mechanical device.
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(81 days)
COMPRESSOR/NEBULIZER #3650
The DeVilbiss Model 3650 Compressor / Nebulizer is designed for use on the order of a physician for the treatment of respiratory diseases such as asthma, cystic fibrosis and chronic obstructive pulmonary disease.
The DeVilbiss Model 3650 Compressor / Nebulizer is designed for use on the order of a physician for the treatment of respiratory diseases such as asthma, cystic fibrosis and chronic obstructive pulmonary disease. In terms of function, safety and effectiveness this device is substantially equivalent to other legally marketed compressor / nebulizers commonly used for the treatment of respiratory diseases. The compressor is constructed of materials, both metal and plastic, that are similar or identical to legally marketed devices. The unit is designed and manufactured to comply with electrical and mechanical safety standards applicable to this type of device (Underwriter's Laboratory Standard UL1431, Attachment D).
Used in conjunction with a jet (pneumatic) nebulizer, the system converts liquid medication into an aerosol form that can be inhaled by the patient for the treatment of a variety of respiratory disorders. The DeVilbiss Model 3650 compressor / nebulizer system produces an aerosol output with the majority of the aerosol by mass contained in particles less than 5 microns in diameter (per the requirements of the BSI standard, Attachment E). This aerosol particle size performance is comparable to other legally marketed devices as noted in the Table of Comparison and the Discussion of Similarities and Performance Data (Sections 6.0 & 7.0).
Given the provided text, it is not possible to provide a detailed response to the requested information regarding acceptance criteria and a study proving device conformance. The document is a 510(k) summary from 1997 for the DeVilbiss Model 3650 Compressor/Nebulizer, which pre-dates many of the modern requirements and practices for AI/ML device evaluations implicit in your questions.
Here's why and what can be extracted:
The document explicitly states: "The DeVilbiss Model 3650 Compressor / Nebulizer is substantially equivalent to other legally marketed compressor / nebulizers commonly used for the treatment of respiratory diseases." This indicates a predicate device comparison rather than a standalone clinical study with the kind of modern metrics you're requesting.
Here's what can be gathered, and what cannot:
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A table of acceptance criteria and the reported device performance
- Acceptance Criteria Mentioned (Implicit/Explicit):
- "majority of the aerosol by mass contained in particles less than 5 microns in diameter (per the requirements of the BSI standard, Attachment E)."
- Compliance with electrical and mechanical safety standards (Underwriter's Laboratory Standard UL1431, Attachment D).
- Functional and safety equivalence to legally marketed predicate devices.
- Reported Device Performance:
- "This aerosol particle size performance is comparable to other legally marketed devices." No specific numerical value for "majority" is given within this summary, only that it meets the BSI standard requirement.
- Functionally, converts liquid medication into aerosol.
- Electrically and mechanically safe per UL1431.
Acceptance Criteria Reported Device Performance Majority of aerosol by mass - Acceptance Criteria Mentioned (Implicit/Explicit):
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