(114 days)
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No
The summary describes a mechanical device for fluid drainage with safety features, and there is no mention of AI, ML, image processing, or data-driven algorithms.
Yes
The device is intended for the "drainage of fluid from a patient" and disruption of "intrapleural pressure mechanism," which are therapeutic interventions.
No
The device is described as allowing the safe and effective drainage of fluid from a patient, focusing on therapeutic intervention rather than diagnosis.
No
The description clearly details a physical device designed for fluid drainage, incorporating mechanical safety features. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to drain fluid and air from a patient's chest. This is a therapeutic procedure performed directly on the patient, not a test performed on a sample taken from the patient.
- Device Description: The description focuses on the mechanical function of the device for drainage and preventing backflow, not on analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely mechanical and therapeutic.
N/A
Intended Use / Indications for Use
This device has been designed to allow the safe and effective drainage of fluid from a patient following disruption in the normal anatomical arrangement of the chest or a disturbance of the intrapleural pressure mechanism causing the entry and accumulation of air and or fluid.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
This is achieved by a design incorporating safety features to maintain a constant suction pressure, prevent the ingress of air and fluid back into the chest cavity, whilst maintaining an unobstructed drain from the patient.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
chest
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device is safe and effective for the application for which it is intended and has been tested to confirm its safety and effectiveness for over 1 year, without incident in the UK.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 880.6740 Vacuum-powered body fluid suction apparatus.
(a)
Identification. A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
0
Image /page/0/Picture/2 description: The image shows the logo for Rocketmedical. The logo consists of a black circle with a white "R" inside, along with a white cross and two white lines. Below the logo, the word "Rocketmedical" is written in black font.
JUL 26 1996
Summary of Safety and Effectiveness
Pleuraseal III Chest Drainage System
This device has been designed to allow the safe and effective drainage of fluid from a patient following disruption in the normal anatomical arrangement of the chest or a disturbance of the intrapleural pressure mechanism causing the entry and accumulation of air and or fluid.
This is achieved by a design incorporating safety features to maintain a constant suction pressure, prevent the ingress of air and fluid back into the chest cavity, whilst maintaining an unobstructed drain from the patient.
This is a class II device, registered by Rocket Medical (Establishment number: 8010022/9610632). This device is substantially equivalent to a medical device which is currently in commerce and has been submitted to the FDA, marketed by Atrium.
The device is safe and effective for the application for which it is intended and has been tested to confirm its safety and effectiveness for over 1 year, without incident in the UK.
Rocket Medical continues to search all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting system to identify adverse safety and effectiveness information and as such, applicable data is recorded for this product.
CERTIFICATION
I hereby certify that this Summary of Safety and Effectiveness applies for the above indicated device.
27th March 1996
Date
Signature
Signed by Leslie Todd Quality Assurance Manager Rocket Medical Wear Industrial Estate, Washington Tyne & Wear, England. NE37 1NE
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