(37 days)
The Models S-1100, S-1200, S-2100, and S-2200 covered by this submission are sterile, single use devices, that are intended for postoperative chest drainage.
The Pleur-evac Sahara Model S-100 Autotransfusion Bag is a sterile, non-pyrogenic, single-use device, intended for post-surgical collection and reinfusion of autologous blood from the thoracic cavity when attached to a Pleur-evac Sahara Chest Drainage,
Pleur-evac Sahara Adult/Pediatric Chest Drainage System Models S-1100, S-1200, S-2100, and S-2200
Deknatel DSP Worldwide, Inc. has recently acquired the Thora-Klex® Chest Drainage System product lines from Davol Inc., C.R. Bard, Inc. Deknatel DSP Worldwide, Inc. has incorporated certain features of the currently marketed Model 0077000 Thora-Klex Chest Drainage System with the features of the currently marketed Model A-6000 Pleur-evac Chest Drainage System into a new chest drainage system, the Pleur-evac Sahara Adult/Pediatric Chest Drainage System. Combining the proven technologies from the Thora-Klex and the Pleur-evac into one unit, creates a new, completely dry Pleur-evac Chest Drainage Unit. Features from the Thora-Klex and the Pleur-evac were transferred to the Pleur-evac Sahara unit without design changes.
There are two basic Pleur-evac Sahara Chest Drainage models: the S-1100 Chest Drainage Unit which is shorter, wider and deeper than the standard Pleur-evac unit but more like the Thora-Klex Model 0077000 shape: and the S-2100 Chest Drainage Unit which carries the standard dimensions of the Pleur-evac Model A-6000 Chest Drainage unit. The S-1100 and S-2100 Chest Drainage Units are capable of autotransfusion option, by attaching a Pleur-evac Sahara Model S-100 Autotransfusion Bag. The Models S-1200 and the S-2200 are identical to the Models S-1100 and S-2100, but are provided with a Model S-100 Autotransfusion Bag attached. The Pleur-evac Sahara Chest Drainage are three bottle systems that include a means for integral suction control, a one way seal via a check valve, and a chamber for collecting fluids,
Hangers are located on the right and left sides of the chest drainage unit to provide support for the chest drainage unit when it is suspended from a hospital bed rail.
The Pleur-evac Sahara Models S-2100 and S-2200 are provided with an integral rotating floorstand. These units free stand when placed on a leveled surface with the floorstand in the open position. The floorstand rotates freely from the closed position to the open position. Once open, the floorstand requires the actuation of a lever to return to the closed position. The design of the Pleur-evac Sahara Models S-1100 and S-1200 does not require a rotating floorstand, since the base of the unit acts as a floorstand.
Pleur-evac Sahara Model S-100 Autotransfusion Bag
The Pleur-evac Sahara Autotransfusion Bag, includes an Autotransfusion Bag that contains a rigid top plate assembled onto a flexible vinyl bag. The Autotransfusion Bag is mounted over a wire support frame. The wire frame maintains the bag in an open position during the collection phase of operation. The frame is removed from the bag during the reinfusion phase to allow the bag to collapse and the reinfusion of the collected blood to occur.
The Pleur-evac Sahara Autotransfusion Bag operates with either suction drainage or gravity drainage. During operation with suction drainage, the Autotransfusion Bag is connected to an appropriate Pleur-evac Sahara Chest Drainage unit that is connected to a vacuum source. The patient vacuum is controlled by the Pleur-evac Sahara Chest Drainage System. During operation with gravity drainage, the Autotransfusion Bag is connected to an appropriate Pleur-evac Sahara Chest Drainage unit that is not attached to a suction source.
The Pleur-evac Sahara Autotransfusion Bag is connected to the Pleur-evac Sahara S-1100 Chest Drainage Unit by means of the Easy-Link Adaptor. The adaptor, which is attached to the Autotransfusion Bag, locks into the Easy-Link receptor on the Pleurevac Sahara Chest Drainage unit. For the Pleur-evac Sahara Model S-2100 Chest Drainage Unit, the Easy-Link Adaptor is removed from the Model S-100 Autotransfusion Bag by the clinician, and the Autotransfusion Bag is attached directly to the side of the Pleur-evac Chest Drainage Unit, using the metal frame on the bag and the hooks provided on the chest drainage unit. This means of attachment is employed by the currently marketed Pleur-evac Model A-6000 Chest Drainage System. Tubing connectors are provided for attaching the Pleur-evac Sahara Autotransfusion Bag to the appropriate Pleur-evac Sahara Chest Drainage Unit. The connectors are color coded for ease of proper connection.
Tubing clamps are located on each of the tubing ports on the Autotransfusion Bag. The tubing clamps must be closed in order to occlude the patient drainage tube prior to disconnecting the connectors. An injection site is located on one set of connectors through which anti-coagulants may be added to the Autotransfusion Bag or from which samples of the drainage fluid mav be taken.
A hanger strap located on the top of the unit provides a means for suspending the Autotransfusion Bag from an I.V. pole during reinfusion.
The Models S-100 and the A-1500 Autotransfusion Bags have similar face graphics, j box graphics, and instructions for use. The labeling for the Model S-100 Autotransfusion Bag also includes reference and use of the Easy-Link Adaptor.
This is a 510(k) summary for a medical device cleared in 1996. The provided text describes the device, its intended use, and argues for substantial equivalence to previously cleared predicate devices. It does not contain information about the performance or acceptance criteria in the format requested for AI/ML device studies. The "performance equivalence" section discusses engineering and functional comparisons to predicate devices, not clinical efficacy or diagnostic accuracy as would be expected for modern AI/ML submissions.
Therefore, many of the requested fields cannot be filled as the information is not present in the provided document.
Here's an attempt to extract what is available, with explanations for what is missing:
Acceptance Criteria and Device Performance Study
This submission describes the Pleur-evac Sahara Adult/Pediatric Chest Drainage System and the Model S-100 Autotransfusion Bag. The device is a traditional medical device (a chest drainage system), not an AI/ML device. Therefore, the acceptance criteria and study details discussed in the document relate to engineering performance and substantial equivalence to predicate devices, rather than diagnostic accuracy or clinical effectiveness typically evaluated in AI/ML products.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Functional Aspect) | Reported Device Performance (Comparison) |
|---|---|
| Suction control accuracy | Met performance specifications and found comparable to Pleur-evac Model A-6000 and Thora-Klex Model 0077000 Chest Drainage Systems. |
| Airflow capacity | Met performance specifications and found comparable to Pleur-evac Model A-6000 and Thora-Klex Model 0077000 Chest Drainage Systems. |
| Response to patient air leak | Met performance specifications and found comparable to Pleur-evac Model A-6000 and Thora-Klex Model 0077000 Chest Drainage Systems. |
| System cracking pressure | Met performance specifications and found comparable to Pleur-evac Model A-6000 and Thora-Klex Model 0077000 Chest Drainage Systems. |
| High negative pressure relief valve performance | Met performance specifications and found comparable to Pleur-evac Model A-6000 and Thora-Klex Model 0077000 Chest Drainage Systems. |
| Negative pressure indicator performance | Met performance specifications and found comparable to Pleur-evac Model A-6000 and Thora-Klex Model 0077000 Chest Drainage Systems. |
| Autotransfusion Bag performance | Tested the effect of the S-100 Autotransfusion bag when subjected to simulated patient pressure, implied to meet specifications (comparable to predicate). |
| Biocompatibility (Autotransfusion Bag internal components) | Materials identical to Pleur-evac Model A-1500 Autotransfusion Bag, leveraging prior 510(k) clearance (#K854301). |
| Biocompatibility (Patient Drainage Tube & Injection Site) | Met requirements of ISO 10993 Part-1. Materials found suitable for use. |
Information Not Found in the Document (Relevant to AI/ML Device Submissions)
The document does not provide the following information as it pertains to a traditional, non-AI medical device:
- Sample size used for the test set and the data provenance: Not applicable. This was a physical device engineering performance test, not a clinical data-driven study in the context of AI/ML.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML algorithm (e.g., diagnostic labels) is not relevant here.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: No. This is not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the engineering tests, the "ground truth" would be established engineering standards and measurements, compared against the predicate devices. For biocompatibility, it's compliance with ISO standards.
- The sample size for the training set: Not applicable. This device does not have a "training set" in the AI/ML context.
- How the ground truth for the training set was established: Not applicable.
§ 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.