The Pleur-evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion System, is a sterile, non-pyrogenic, single use, three chamber collection/reinfusion device that is intended for collection and continuous reinfusion of autologous blood.

The Pleur-evac Sahara Model S-100 Autotransfusion Bag is a sterile, non-pyrogenic, single-use device, used for post-surgical collection and reinfusion of autologous blood from the thoracic cavity when attached to a Pleur-evac Sahara Plus Continuous Reinfusion Autotransfusion System.

Device Description

The Pleur-evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion System is a chest drainage system that incorporates features from the Thora-Klex Model 0077000, the Pleur-evac Model A-6000, and the Pleur-evac Plus Model A-9150 systems. It includes a dry one-way seal, negative pressure indicator, automatic high negative pressure relief valve, dry suction regulator, air leak meter, positive pressure relief valve, manual high negative pressure relief valve, floorstand, hangers, and a patient drainage tube configuration. It also has a reinfusion port, reinfusion tube, and spike port for continuous reinfusion. The collection/reinfusion chamber is shorter and deeper than the Pleur-evac Plus Model A-9150 to increase capacity. The patient drainage tube components are latex-free. The system can be used with a Pleur-evac Sahara Model S-100 Autotransfusion Bag or a blood transfer bag for reinfusion. The Model S-100 Autotransfusion Bag is a flexible vinyl bag with a rigid top plate and a wire support frame, designed for collection and reinfusion of blood. It includes an Easy-Link Adaptor and tubing clamps.

AI/ML Overview

This 510(k) submission (K963850) is for a medical device seeking clearance through substantial equivalence to previously cleared devices, rather than establishing de novo safety and effectiveness through clinical trials with defined acceptance criteria and statistical performance metrics. Therefore, the information typically requested in your prompt regarding acceptance criteria, study design for proving performance against those criteria, and AI-specific details is not applicable in this context.

Here's why and what information can be extracted based on the provided text:

Key Takeaways from a 510(k) of this Nature:

Substantial Equivalence: The primary goal of this submission is to demonstrate that the new device (Pleur-evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion System and Pleur-evac Sahara Model S-100 Autotransfusion Bag) is as safe and effective as already legally marketed predicate devices. This typically involves showing similar design, materials, intended use, and functioning, often supported by bench testing, rather than extensive clinical studies with human subjects.
No AI Component: The device described is a mechanical medical device (chest drainage and autotransfusion system), not an AI/ML-driven device. Therefore, questions about AI assistance, standalone algorithm performance, training sets, or expert ground truthing for an AI model are not relevant.
Bench Testing over Clinical Trials for Performance: The "study" mentioned is a series of bench tests designed to compare functional aspects and material safety with predicate devices. This is a common approach for 510(k) submissions where the technology is well-established, and the device represents modifications or combinations of existing cleared technologies.

Based on the provided text, here is an articulation of the closest equivalent information to your request, with an emphasis on why certain aspects are not applicable:

1. A table of acceptance criteria and the reported device performance

Performance Metric Tested (Acceptance Criteria Implied: "met specification" or "comparable")	Reported Device Performance (Pleur-evac Sahara Plus S-1150 / S-100)
Suction Control Accuracy (at each set point)	Met specification on each of the units.
Airflow Capacity	Comparable to currently marketed Thora-Klex and Pleur-evac Chest Drainage Systems.
Response to Patient Air Leak	Comparable to currently marketed Pleur-evac Chest Drainage Systems.
System Cracking Pressure Performance	Functionally comparable to currently marketed Thora-Klex Chest Drainage System.
High Negative Pressure Relief Valve Performance	Functionally comparable to currently marketed Thora-Klex Chest Drainage System.
Negative Pressure Indicator Performance	Functionally comparable to currently marketed Thora-Klex Chest Drainage System.
Autotransfusion Bag Performance	Substantial equivalence demonstrated between Pleur-evac Model A-6000 with A-1500 Bag and Pleur-evac Sahara Plus Model S-1150 with S-100 Bag (when subjected to simulated patient pressure).
Carrying Handle Strength	Tested and compared (specific result not detailed, but implied satisfactory for equivalence).
Floorstand Performance	Tested and compared (specific result not detailed, but implied satisfactory for equivalence).
Hanger to Post Strength	Tested and compared (specific result not detailed, but implied satisfactory for equivalence).
Biocompatibility (patient tube and injection site materials)	Met the requirements of ISO 10993 Part-1. Suitable for use.
Biocompatibility (other blood-contacting materials)	Relying on results from predicate device 510(k) #K911656A and #K854301, as materials are identical.
Blood Pathway and Blood Flow Reinfusion	Equivalent to Pleur-evac Plus Model A-9150 (same mesh filter, port size, tubing, spike port). No additional testing performed.

Study Proving Acceptance Criteria:

The "study" was a series of bench tests (laboratory-based performance evaluations) comparing the new device's functional aspects to its predicate devices. The objective was to demonstrate substantial equivalence, meaning the new device performs similarly and is as safe and effective as the predicate devices that are already legally marketed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document does not specify the number of units/samples tested for each performance metric (e.g., how many S-1150 units were tested for suction control accuracy). For bench testing of this nature, usually, a defined number of production units are subjected to each test, but specific quantities are often not detailed in the public 510(k) summary.
Data Provenance: The data is from prospective bench testing conducted by the manufacturer, Deknatel DSP Worldwide Inc., likely at their facilities (implied, no specific country mentioned, but the submitter is based in Fall River, MA, USA). The data is not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This is a mechanical device, and its performance is assessed against engineering specifications and comparison to predicate devices, not against a "ground truth" derived from expert clinical assessment in the way an AI/diagnostic device would be. The "ground truth" here is the established performance characteristics and safety profile of the predicate devices, as determined by previous FDA clearances.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. As there are no human-readout interpretations or diagnostic classifications involved in this type of device's performance testing, adjudication methods like 2+1 or 3+1 are not relevant. Performance is measured objectively via instruments and engineering standards.

5. 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

Not Applicable. This device does not involve human readers, diagnostic imaging, or AI assistance. It is a mechanical chest drainage and autotransfusion system.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable. There is no AI algorithm in this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For functional performance, the "ground truth" is implied by the established specifications and validated performance of the predicate devices (Thora-Klex Model 0077000, Pleur-evac Model A-6000, Pleur-evac Plus Model A-9150). The new device's performance is gauged against these known benchmarks for comparability.
For biocompatibility, the "ground truth" is adherence to ISO 10993 Part-1 standards and the previously cleared biocompatibility of identical materials in predicate devices.

8. The sample size for the training set

Not Applicable. There is no AI component, and thus no "training set." The device's design is based on the features of existing, cleared predicate devices.

9. How the ground truth for the training set was established

Not Applicable. As there is no AI component or training set, this question is not relevant.

Summary

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K963850

510(k) Summary

APR 22 1997

Submitter:	Deknatel DSP Worldwide Inc.600 Airport RoadFall River, MA 02720
	Tel: (508) 677-6600Fax: (508) 677-6667
Contact:	Dean E. Ciporkin, M.S.Director of Regulatory Affairs
Date Prepared:	April 17, 1997
Trade Name:	Pleur-evac Sahara Plus Model S-1150Continuous Reinfusion Autotransfusion System
Common Name:	Continuous Reinfusion Autotransfusion System
Classification Name:	Autotransfusion Apparatus, Class II, Anesthesiology Devices21 CFR 868.5830

Equivalent Device:

The Pleur-evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion System is substantially equivalent in form, fit, function and intended use to the Thora-Klex Model 0077000 Chest Drainage System, cleared for marketing by FDA under 510(k)s #K801043A and #K830671, the Pleur-evac Model A-6000 Chest Drainage System, cleared for marketing by FDA under 510(k)s #K881252 and #K905768A, and the Pleurevac Plus Model A-9150 Continuous Reinfusion Autotransfusion System, cleared for marketing by FDA under 510(k) #K911656A.

The Model S-100 Autotransfusion Bag, in specific, is substantially equivalent in form, fit, and function to the currently marketed Pleur-evac Model A-1500 Autotransfusion Bag used with the Pleur-evac Model A-8000 Chest Drainage System, cleared for marketing by FDA under 510(k)s #K 854301, #K881252, #K884844A, and used with the Pleurevac Plus Model A-9150 Continuous Reinfusion Autotransfusion System, cleared for marketing by FDA under 510(k) #K911656A.

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Device Description:

Pleur-evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion System

Deknatel DSP Worldwide, Inc., the manufacturer and marketer of Pleur-evac Chest Drainage Systems, 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, and the Model A-9150 Pleur-evac Plus Continuous Reinfusion Autotransfusion System, into a new chest drainage system, the Pleur-evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion System.

The dry one-way seal, negative pressure indicator, and the automatic high negative pressure relief valve of the Pleur-evac Sahara Continuous Reinfusion Autotransfusion System, were transferred from the Thora-Klex Chest Drainage unit. The dry suction regulator, air leak meter, positive pressure relief valve, manual high negative pressure relief valve, floorstand, hangers, and the patient drainage tube configuration of the Pleur-evac Sahara Continuous Reinfusion Autotransfusion System were transferred from the Pleur-evac Model A-6000 Chest Drainage unit. The design configuration of the reinfusion port, reinfusion tube, and spike port for continuous reinfusion were transferred from the Pleur-evac Plus Model A-9150 Continuous Reinfusion Autotransfusion System. Each of these features from the Thora-Klex Model 0077000 and the Pleur-evac Models A-6000 and A-9150 were transferred to the Pleur-evac Sahara unit without design changes.

Minor design changes were made to the collection/reinfusion chamber of the Pleur-evac Sahara Plus Model S-1150 when compared to the Pleur-evac Plus Model A-9150 Continuous Reinfusion Autotransfusion System. The collection/reinfusion chamber on the Pleur-evac Sahara Plus Model S-1150 is shorter and deeper than the Pleur-evac Plus Model A-9150 collection/reinfusion chamber. The purpose of this design change was to increase the capacity in the collection/reinfusion chamber.

The Pleur-evac Model A-6000 Chest Drainage Unit and the Pleur-evac Plus Model A-9150 Continuous Reinfusion Autotransfusion System utilize the same components on the patient drainage tube as used on the Pleur-evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion System. The patient drainage tube includes a tube, snap lock connectors with injection site, and a universal connector. The material for the patient drainage tube and the injection site on the connectors has been changed to be latex free.

Either a Pleur-evac Sahara Model S-100 Autotransfusion Bag, or a blood transfer bag, may be attached to the Pleur-evac Sahara Model S-1150 to serve as a bag reinfusion system. When autotransfusion is completed, the Model S-1150 may serve as a standard chest drainage collection unit. - The Pleur-evac Sahara Model S-100

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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 comes with the Easy-Link Adaptor. When attaching the Pleur-evac Sahara Autotransfusion Bag to the Pleur-evac Sahara Plus Model S-1150, 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 Sahara Plus Model S-1150 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 Pleur-evac Sahara Plus Model S-1150 unit. The connectors are color coded for ease of identification for 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 may 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.

All of the components, manufacturing processes and specifications are the same for the Pleur-evac Sahara Model S-100 Autotransfusion Bag and the currently marketed Pleur-evac Model A-1500 Autotransfusion Bag, which is used with the Pleurevac Model A-6000 Chest Drainage System with Autotransfusion Option, or the Pleurevac Plus Model A-9150 Continuous Reinfusion Autotransfusion System. The differences between the S-100 and the A-1500 Autotransfusion Bags are the Easy-Link Adaptor, and the materials of the Patient Drainage Tube and Injection Site to be latex The Models S-100 and the A-1500 Autotransfusion Bags have similar face free. graphics, 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.

Intended Use:

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Summary of Technological Characteristic Equivalence:

All features and technology employed in the Pleur-evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion System are derived from either of the predicate devices; the Pleur-evac Model A-6000 Chest Drainage System, the Pleur-evac Plus Model A-9150 Continuous Reinfusion Autotransfusion System, or the Thora-Klex Model 0077000 Chest Drainage System.

The components which make up the one-way seal, negative pressure indicator, and the automatic high negative pressure relief valve of the Pleur-evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion System were transferred directly from the Thora-Klex Chest Drainage unit. The components which make up the dry suction regulator, air leak meter, positive pressure relief valve, manual high negative pressure relief valve, and the patient drainage tube of the Pleur-evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion System were transferred directly from the Pleurevac Model A-6000 Chest Drainage unit. The reinfusion port, reinfusion tube, and spike port for continuous reinfusion are from the Pleur-evac Plus Model A-9150 Continuous Reinfusion Autotransfusion System. Each of these from the Thora-Klex and the Pleur-evac Chest Drainage Systems were transferred to the Pleurevac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion System unit without design changes.

The Collection/Reinfusion Chamber in the Pleur-evac Sahara Plus Model S-1150 is larger than the collection/reinfusion chamber in the Pleur-evac Plus Model A-9150. The Pleur-evac Plus Model A-9150 has one compartment, collection/reinfusion chamber with a total capacity of 600 cc. The Pleur-evac Sahara Plus Model S-1150 has a two compartment, collection/reinfusion chamber with a total capacity of approximately 2000cc. Only the blood collected in the first compariment. which is the reinfusion compartment, is able to be reinfused (approximately 1000cc). The second compartment, which is the collection compartment, provides additional collection capacity and is for the overflow of blood from the reinfusion compartment. The Pleurevac Plus Model S-1150 has the same mesh filter, reinfusion port size, reinfusion tubing, and spike port as the Pleur-evac Plus Model A-9150. The flow pathways for blood collection and for blood reinfusion are substantially equivalent.

Summary of Performance Equivalence:

The Pleur-evac Sahara Chest Drainage Systems have undergone testing to assure their conformance to design specifications, safety and functional requirements. Testing was performed to compare the functional aspects of the proposed Pleur-evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion System to the Pleur-evac Model A-6000 Chest Drainage System and the Thora-Klex Model 0077000 Chest Drainage System. The testing also evaluated the effect of the Pleur-evac Sahara Model S-100 Autotransfusion bag connected to the Pleur-evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion unit when subjected to simulated patient pressure.

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Suction control accuracy, airflow capacity, response to patient air leak, system cracking pressure, high negative pressure relief valve performance, negative pressure indicator performance, autotransfusion bag performance, carrying handle strength, floorstand performance, and hanger to post strength were tested and compared.

The Pleur-evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion System has the same mesh filter, reinfusion port size, reinfusion tubing, and spike port as the Pleur-evac Plus Model A-9150 Continuous Reinfusion Autotransfusion System. Therefore, the blood pathway and blood flow reinfused to the patient remains equivalent, and no additional testing was performed.

The suction control accuracy at each of the set points met specification on each of the units. The Pleur-evac Sahara air flow capacity was comparable to that of the currently marketed Thora-Klex and Pleur-evac Chest Drainage Systems. The Pleur-evac Sahara response to air leak was comparable to that of the currently marketed Pleur-evac Chest The Pleur-evac Sahara system and valve cracking pressure Drainage Systems. performance was functionally comparable to that of the currently marketed Thora-Klex Chest Drainage System. The Pleur-evac Sahara high negative pressure relief valve performance was functionally comparable to that of the currently marketed Thora-Klex Chest Drainage System. The Pleur-evac Sahara negative pressure indicator performance was functionally comparable to that of the currently marketed Thora-Klex Chest Drainage System. Substantial equivalence was demonstrated between a Pleurevac Model A-6000 Chest Drainage Unit connected to an A-1500 Autotransfusion Bag, and the Pleur-evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion System connected to a S-100 Pleur-evac Sahara Autotransfusion Bag.

The components of a Pleur-evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion System which come into contact with blood during continuous reinfusion are: the universal connector, the patient tube, the snap-lock connectors and the injection site, the collection/reinfusion chamber, the mesh filter, the reinfusion tubing and the spike port. These parts are made of the identical materials as used with the Pleur-evac Plus Model A-9150 Continuous Reinfusion Autotransfusion System, with exception of the materials for the patient tube and the injection site. The biocompatibility testing for the patient drainage tube and the injection site was performed according to the "Biological Evaluation of Medical Devices", ISO 10993 Part-1. Test results indicate that these materials met the requirements of ISO 10993, and that these materials are suitable for use in the patient drainage tube and the injection site. For the other materials which come in contact with blood during continuous reinfusion, the biocompatibility testing results were included in the Pleur-evac Plus Model A-9150 Continuous Reinfusion Autotransfusion System 510(k) #K911656A.

When the Pleur-evac Plus Model S-1150 Continuous Reinfusion Autotransfusion System is attached to a Pleur-evac Sahara Model S-100 Autotransfusion Bag and connected to a patient, the components which come into contact with blood during autotransfusion are: the universal connector, the patient tube, the snap-lock connectors and injection site, the inside of the Autotransfusion Bag, and the internal components of

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团 07

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the Autotransfusion Bag. The Autotransfusion Bag and internal components of the Pleurevac Sahara Model S-100 Autotransfusion Bag, and the connectors, are made of the identical materials as the Pleur-evac Model A-1500 Autotransfusion Bag. Therefore, the biocompatibility testing results provided in 510(k) #K854301 apply to the bag and internal components of the Pleur-evac Sahara Model S-100 Autotransfusion Bag. .

Regulation Number and Section

§ 868.5830 Autotransfusion apparatus.

(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).