(91 days)
K 854301, K881252, K884844A, K911656A
No
The description focuses on mechanical and material aspects of a chest drainage and autotransfusion system, with no mention of AI or ML capabilities.
Yes
The device is described as a "collection/reinfusion device that is intended for collection and continuous reinfusion of autologous blood," which directly relates to a therapeutic intervention (reinfusion of blood).
No
The device is described as a collection and reinfusion system for autologous blood, and its function involves managing the physical properties of fluid and air, not making medical diagnoses.
No
The device description clearly details physical components such as chambers, tubes, bags, valves, and a floorstand, indicating it is a hardware device with no mention of software functionality.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the "collection and continuous reinfusion of autologous blood" from the thoracic cavity. This is a process performed on the patient's body, not on a sample of the patient's body outside of the body for diagnostic purposes.
- Device Description: The description details a chest drainage system and autotransfusion bag, which are used to manage fluids and blood within the patient's body.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze blood or other bodily fluids to diagnose a condition, monitor a disease, or determine compatibility.
- Performance Studies: The performance studies focus on the functional aspects of the drainage and reinfusion system (suction control, airflow, valve performance, etc.), not on the accuracy of any diagnostic measurements.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on managing and reinfusing blood within the patient's circulatory system.
N/A
Intended Use / Indications for Use
The Pleur-evac Sahara Plus Model S-2150 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.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Deknatel DSP Worldwide, Inc., the manufacturer and marketer of Pleur-evace 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-2150 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 requlator, 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 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-Kiex 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-2150, as compared to the Pleur-evac Plus Model A-9150 Continuous Reinfusion Autotransfusion System. 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-2150 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.
A Pleur-evac Sahara Model S-100 Autotransfusion Bag, or a blood transfer bag, may be attached to the Pleur-evac Sahara Model S-2150 to serve as a bag reinfusion svstem. When autotransfusion is completed, the Model S-2150 may serve as a standard chest drainage collection unit. The Pleur-evac Sahara Model S-100 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 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-2150, 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-2150 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-2150 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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-2150 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 baq connected to the Pleur-evac Sahara Plus Model S-2150 Continuous Reinfusion Autotransfusion unit when subjected to simulated patient pressure. 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 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. There was virtually no difference between the Pleur-evac Model A-6000 Chest Drainage Unit connected to an A-1500 Autotransfusion Bag, and the Pleur-evac Sahara Plus Model S-2150 Continuous Reinfusion Autotransfusion System connected to a S-100 Pleur-evac Sahara Autotransfusion Bag. The carrying handle did not crack when filled to capacity and lifted. The carrying handle strength met the design specification. The Pleur-evac Sahara Model S-2150 was able to be unsupported when the floorstand was opened. The floorstand rotated freely from the closed position to the open position. The strength of the hanger to post met the design specification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K801043A, K830671, K881252, K905768A, K911656A
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.
K 854301, K881252, K884844A, K911656A
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).
Not Found
§ 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).
0
NOV - 8 1996
510(k) Summary 18.
| Submitter: | Deknatel DSP Worldwide Inc.
600 Airport Road
Fall River, MA 02720 |
|----------------------|----------------------------------------------------------------------------------------|
| | Tel: (508) 677-6600
Fax: (508) 677-6667 |
| Contact: | Dean E. Ciporkin, M.S.
Director of Regulatory Affairs |
| Date Prepared: | August 1, 1996 |
| Trade Name: | Pleur-evac Sahara Plus Model S-2150
Continuous Reinfusion Autotransfusion
System |
| Common Name: | Continuous Reinfusion Autotransfusion
System |
| Classification Name: | System, Drainage, Thoracic, Vacuum
Powered Body Fluid Suction Apparatus |
Equivalent Device:
The Pleur-evac Sahara Plus Model S-2150 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-6000 Chest Drainage System, cleared for marketing bv 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.
1
Device Description:
Pleur-evac Sahara Plus Model S-2150 Continuous Reinfusion Autotransfusion System
Deknatel DSP Worldwide, Inc., the manufacturer and marketer of Pleur-evace 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-2150 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 requlator, 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 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-Kiex 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-2150, as compared to the Pleur-evac Plus Model A-9150 Continuous Reinfusion Autotransfusion System. 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-2150 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.
A Pleur-evac Sahara Model S-100 Autotransfusion Bag, or a blood transfer bag, may be attached to the Pleur-evac Sahara Model S-2150 to serve as a bag reinfusion svstem. When autotransfusion is completed, the Model S-2150 may serve as a standard chest drainage collection unit. The Pleur-evac Sahara Model S-100 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
2
collection phase of operation. The frame is removed from 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-2150, 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-2150 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-2150 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 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:
The Pleur-evac Sahara Plus Model S-2150 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.
3
Summary of Technological Characteristic Equivalence:
All features and technology empleyed in the Pleur-evac Sahara Plus Model S-2150 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-2150 Continuous Reinfusion Autotransfusion System were transferred directly from the Thora-Klex Chest Drainage unit. The components which make up the dry suction requlator, air leak meter, positive pressure relief valve, manual high negative pressure relief valve, floorstand, hangers, and the patient drainage tube of the Pleur-evac Sahara Plus Model S-2150 Continuous Reinfusion Autotransfusion System were transferred directly from the Pleur-evac 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 features from the Thora-Klex and the Pleur-evac Chest Drainage Systems were transferred to the Pleur-evac Sahara Plus Model S-2150 Continuous Reinfusion Autotransfusion System unit without design changes.
The Collection/Reinfusion Chamber in the Pleur-evac Sahara Plus Model S-2150 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-2150 has a two compartment, collection/reinfusion chamber with a total capacity of 2100cc. Only the blood collected in the first compartment, the reinfusion compartment, is able to be reinfused (approximately 1000cc). The second compartment, the collection compartment, provides additional collection capacity and is for the overflow of blood from the reinfusion compartment. The Pleur-evac Plus Model S-2150 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-2150 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 baq connected to the Pleur-evac Sahara Plus Model S-2150 Continuous Reinfusion Autotransfusion unit when subjected to simulated patient pressure.
4
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.
ﻟﻤﺴﺴﺴﺴ
ﺴﺴﺔ
The Pleur-evac Sahara Plus Model S-2150 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. There was virtually no difference between the Pleur-evac Model A-6000 Chest Drainage Unit connected to an A-1500 Autotransfusion Bag, and the Pleur-evac Sahara Plus Model S-2150 Continuous Reinfusion Autotransfusion System connected to a S-100 Pleur-evac Sahara Autotransfusion Bag. The carrying handle did not crack when filled to capacity and lifted. The carrying handle strength met the design specification. The Pleur-evac Sahara Model S-2150 was able to be unsupported when the floorstand was opened. The floorstand rotated freely from the closed position to the open position. The strength of the hanger to post met the design specification.
The components of a Pleur-evac Sahara Plus Model S-2150 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 iniection 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.
5
When the Pleur-evac Plus Model S-2150 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 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.