(58 days)
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.
§ 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).