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510(k) Data Aggregation
(15 days)
The S-SCORT...Jr® Quickdraw, Model 2400 portable battery powered suction pump is a nonsterile reusable device, with a non-sterile single use disposable canister and integrated suction tip, that is to be used by professional personnel trained in Emergency Care techniques of constant suctioning to clear the airway by removing bodily fluids and particulate matter.
The S-SCORT ...Jr® Quickdraw device is a design with added Subject Device Desertifications: a battery power level indicator, a custom non-sterile single use Uchents of user Inchary voltaons, a suction tip, an equally effective suction pump. The S-SCORT ... Jr® Quickdraw performance is significantly equivalent as the legally marketed devices.
Components: The subject S-SCORT...Jr® Quickdraw consists of a high-specd diaphragm pump Componently "The bagger ed electric motor, an internal 12 VDC sealed lead acid rechargeable powered by an integrative circuit board with controls and signaling light-emitting diodes. All battery, and enoticolno of can o a molded plastic custom chassis. The 12 V battery and 12 V components are assemble to both operate and charge the device from any 12 VDC source. Charging may also take it possible to toing an external 110 VAC to 9 VDC power converter.
Collection Canister: The S-SCORT ... Jr® Quickdraw uses a non-sterile single use disposable Concection Camster . The o OCON 11 is blow molded in a transparent plastic of Rigid Polyvinyl Chloride (RPVC) material that has been determined biocompatible (the RPVC does not contain Childride (11) VC) material that the canister sidewall has graduation marks that indicate the the plastioner DEFF you in canister has an integrated hydrophobic filter, which votune of content in oached in one capable of bacterial filtration to 99.98% with pore size of 20 microns and .200" in thickness.
Here's a breakdown of the acceptance criteria and study information for the S-SCORT...Jr® Quickdraw, Model 2400, based on the provided document:
Acceptance Criteria and Device Performance
The document describes the tests performed but does not explicitly state "acceptance criteria" as pass/fail thresholds with specific numerical ranges for each criterion. Instead, it describes general performance expectations and what the tests will measure. However, based on the context, we can infer the intended acceptance for these key performance indicators. The device performance is implied to meet these expectations for substantial equivalence.
Table of Acceptance Criteria (Inferred) and Reported Device Performance (Implied)
| Performance Criterion (Inferred Acceptance) | Reported Device Performance (Implied) |
|---|---|
| Vacuum Levels | |
| (Expected: 300 - 500 mmHg) | Assumed to meet this range, as it's a "principle performance criterion." |
| Time to suction 200cc of vomitus | |
| (Expected: Adequate/Clinically acceptable) | Assumed to be adequate, as it's a "principle performance criterion." |
| Continuous operation from internal battery | |
| (Expected: Minimum of 20 minutes) | Assumed to meet or exceed 20 continuous minutes. |
Note: The document states "Tests will be performed using industry standard protocols* to challenge the performance criteria that are typical for this type of medical product," and concludes that the device "will be substantially equivalent." This implies that the device did meet or is expected to meet these criteria, but specific numerical results are not provided in this summary.
Study Details
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study with human subjects. The "study" described herein is primarily a set of performance and safety tests.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of devices. The tests are described as being performed "using industry standard protocols." It's standard for medical device testing to involve a representative number of devices to demonstrate consistency, but a specific "sample size" like in a clinical trial isn't detailed here.
- Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. Given it's a 510(k) submission, the performance testing would have been conducted prospectively in a lab environment.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable and not provided. The "ground truth" for these performance tests is defined by established engineering and medical device standards (e.g., specific vacuum levels, suction speed, battery life). The "experts" would be the engineers and technicians conducting the tests and interpreting the results against the defined standards.
4. Adjudication Method for the Test Set
- This information is not applicable and not provided. Performance testing typically involves objective measurements against predefined specifications, rather than subjective adjudication by multiple experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The document is a 510(k) summary for a portable aspiration pump, focusing on demonstrating substantial equivalence through technical performance and safety testing, not on comparing human reader performance with or without AI assistance. AI is not mentioned as part of this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a hardware product (a portable suction pump), not an algorithm or software-only device. Performance tests described are for the physical device itself.
7. The Type of Ground Truth Used
- The "ground truth" for the performance tests (vacuum levels, suction time, battery life) is based on engineering specifications and established industry standards (ISO 10079-1, ISO 10993-1, IEC 60601-1, IEC 60601-1-2). For biocompatibility, it refers to material properties meeting ISO 10993-1.
8. The Sample Size for the Training Set
- Not applicable. This device is a medical device, not an AI/machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, there is no training set for this type of medical device.
Ask a specific question about this device
(71 days)
Replacement battery for R & D Battery part number(s) 5025 (K#K951281 AND K942018).
This battery is a replacement battery for Laerdal Medical Corp. 79-12-05 7050 Series Suction Cup, 510(k) 14 Number K840110.
This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.
Replacement Battery Part Number STR5
The provided text is a 510(k) premarket notification letter from the FDA regarding a replacement battery. It confirms substantial equivalence but does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.
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