Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical and material properties of a chest drainage and autotransfusion system, with no mention of AI or ML.

Therapeutic

Yes
The device is used for "autotransfusion," which involves the collection and reinfusion of a patient's own blood and for "chest drainage" to evacuate fluid and air, help re-establish normal intra-thoracic pressure, and facilitate lung re-expansion. These actions directly treat medical conditions (trauma, post-operative situations, conditions requiring chest drainage) to restore health or alleviate symptoms.

Diagnostic

No

The device is described as assisting in blood collection and reinfusion, and chest drainage, without any mention of diagnosing a condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components such as Chest Drainage units, Autotransfusion Bags, tubing, connectors, and other hardware. The performance studies also focus on the physical properties and functionality of these hardware components. There is no mention of software as a primary or standalone component.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
Device Function: The described device (Pleur-evac® Autotransfusion System and ATS Bag) is used for the collection and reinfusion of blood from the patient's body (specifically the chest cavity) back into the patient's body. It also functions as a chest drainage system to remove air and fluid.
Lack of Specimen Examination: The device does not perform any analysis or examination of the collected blood or fluid to provide diagnostic information. It is a system for managing and reintroducing the patient's own blood or removing unwanted substances from the chest cavity.

The intended uses and device description clearly indicate a system for managing bodily fluids in vivo (within the body) rather than analyzing specimens in vitro (outside the body).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Indications for Use Statements are as follows:

AUTOTRANSFUSION

1. For the collection of autologuous blood from the patient's pleural cavity or mediastinal area for reinfusion purposes in trauma and post-operative situations
  CHEST DRAINAGE .
1. To evacuate air and/or fluid from the chest cavity or mediastinum
To help prevent air and/or fluid from re-accumulating in the chest cavity or 2. mediastinum.
1. To help re-establish and maintain normal intra-thoracic pressure gradients.
1. To facilitate complete lung re-expansion to restore normal breathing dynamics.

The Pleur-evac® Autotransfusion Bag is indicated as a sterile, single use device used for collection and reinfusion of autologous blood from the thoracic cavity when attached to a Pleur-evac® System. The fluid path is non-pyrogenic.

Product codes (comma separated list FDA assigned to the subject device)

CAC

Device Description

Teleflex Medical offers a line of Chest Drainage and Autotransfusion Systems. This line includes Chest Drainage units with a variety of suction and seal technologies. The three lines are the Wet Suction/Wet Seal, Dry Suction/Wet Seal, and Dry Suction/Dry Seal technologies. The Dry Suction/Dry Seal are branded the Sahara Series. Each technology of Chest Drainage devices can be coupled with an Autotransfusion (ATS) Bag for reinfusion capability. In addition, there is the S-1150-08LF, Pleur-evac Sahara® Plus Continuous Reinfusion Autotransfusion System that can be reinfused from the Drainage Unit. This submission will cover the Sahara reinfusion unit and the ATS Bags that can be mated with the different technology Chest Drainage Units.

The Pleur-evac Sahara® Plus Continuous Reinfusion Autotransfusion System (S-1150-08LF) is provided as a sterile unit intended for single patient use. The fluid path is non-pyrogenic. The Pleur-evac Sahara Plus System is used for the collection and continuous reinfusion of autologous blood. By attaching the Pleur-evac Sahara Autotransfusion Bag (S-100-08LF), the Pleur-evac Sahara Plus System serves as a bag reinfusion system. When autotransfusion is completed, the Pleur-evac Sahara Plus System can serve as a chest drainage collection unit.

The Autotransfusion(ATS) Bag is a sterile, non-pyrogenic, single-use, blood collection and reinfusion device intended for the post-surgical, chest-drainage market. The ATS Bag attaches to the appropriate Pleur-evac Chest Drainage System. The S-100-08LF attached to a Sahara branded Pleur-evac® unit and an A-1500-08LF attaches to a standard Pleur-evac® unit.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

pleural cavity or mediastinal area
thoracic cavity

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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 bench testing has been performed to verify that the performance of the proposed Pleur-evac® Autotransfusion Systems are substantially equivalent to the predicate device, and that the Pleur-evac® Autotransfusion System tubing will perform as intended.

Performance Test: Kink Resistance
Summary: The proposed and predicate patient tubing were visually inspected for kink resistance. This test simulated the various radiuses the tubing could be subjected to during coiling and/or packaging.
Result: The results showed that the proposed patient tubing has a greater ability to withstand kinking.

Performance Test: Leak Integrity
Summary: The proposed tubing was subjected to positive and negative pressures to determine the capability of withstanding leakage.
Result: The proposed tubing passed the leak integrity test with no leaks at tubing joints.

Performance Test: Tubing Clamp Leak
Summary: The proposed tubing in a clamped configuration was subjected to positive and negative pressures to determine the capability of withstanding leakage.
Result: The proposed tubing passed the leak test with no leaks at the clamp.

Performance Test: Tubing Collapse
Summary: The proposed and predicate patient tubing was exposed to a high amount of negative pressure and visually inspected for tubing collapse.
Result: All units passed the tubing collapse test - the proposed tubing did not collapse under imposed high pressure condition.

Performance Test: ATS Connector Pull Test
Summary: The pull test required that the ATS Connector be able to withstand a minimum amount of force without being separated from the proposed tubing.
Result: The proposed tubing withstood the minimum amount of force applied without separation from the ATS Connector.

Performance Test: Back Port Pull Test
Summary: The pull test required that the proposed tubing be able to withstand a minimum amount of force without being separated from the Back Port of the unit.
Result: The proposed tubing withstood the minimum amount of force applied without separation from the Back Port.

Performance Test: Universal Connector Pull Test
Summary: The pull test required that the Universal Connector be able to withstand a minimum amount of force without being separated from the proposed tubing.
Result: The proposed tubing withstood the minimum amount of force applied without separation from the Universal Connector.

Additional Modifications and Performance Testing:
Device Modification: Material Change: Autotransfusion Bag - Top Plate
Description: The design of the Autotransfusion Bag includes a rigid PVC top plate assembled onto the top of a vinyl, flexible bag. The rigid PVC was composed of a copolymer and the manufacturer discontinued the resin. The replacement material (resin) was a homopolymer that was one of the components of the copolymer.
Summary of Performance Testing: Performance testing was completed to assess the Radio Frequency weld strength, Pressure/Decay, Tensile, Burst and Stress. All testing passed minimum requirements. All biocompatibility testing was completed according to ISO 10993-1 and USP .

Device Modification: Material Change: Auto transfusion Bag - IV Strap
Description: The hanger strap material was changed due to supplier material obsolesces. This is a non-patient contacting material.
Summary of Performance Testing: The change to the top plate was validated through a validation study to ensure that the IV strap material met visual acceptance criteria after aging.

Device Modification: Supplier Process Change: Header Bags sterile barrier for transportation
Description: Sealing of the header bags changed from an impulse sealer to a hot bar sealer. This is a non-patient contacting process change.
Summary of Performance Testing: The study investigated three packaging criteria, seal strength, seal width, and seal visual defects that are outlined in Purchasing Specification. All pre-established specifications were met.

Device Modification: Replacement of Sterile Water Bottle with Sterile Water Syringe
Description: Changed water delivery from a bottle of sterile water to a syringe. This is a non-patient contacting material.
Summary of Performance Testing: The component change was validated through design verification activities where four different tests (ship testing, syringe position, tip cover attachment, syringe leakage) were performed to assure safety and performance. To ensure that the prefilled syringe was not negatively impacted by Ethylene Oxide (EtO) a study was performed to measure the amounts of EtO and Ethylene Chlorohydrin after the syringe was sterilized twice. All results passed.

Device Modification: New Mold: Swabbable Stem (ATS Connector component)
Description: New mold for swabbable stem component which results in dimensional changes. The patient contacting material and function of the component was unchanged.
Summary of Performance Testing: The functional tests performed include leak testing and needles injection after the swabbable stem was assembled within the ATS connector assembly. A dimensional inspection of swabbable stems was also performed to determine whether the new components produced by the mold met drawing dimensions. All results passed.

Device Modification: Male ATS Connector
Description: Change in component design. The patient contacting material and function of the component was unchanged.
Summary of Performance Testing: The functional tests included finger engagement, disengagement force, Male ATS connector disengagement clearance and ATS connector separation force. A dimensional inspection was also performed to determine whether the new components produced by the mold met drawing dimensions. All results passed.

Device Modification: Mold Location and Manufacturer Change: Air Flow Meter
Description: Mold location change due to cost savings efforts to consolidate molding supplier. This is a non-patient contacting component.
Summary of Performance Testing: The functional tests included correct flow path, no leaks through front of air flow meter and air flow measurement. A dimensional inspection was performed to determine whether the new components produced by the mold met drawing dimensions. All results passed.

Device Modification: Material and Mold Location Change: Slide Clamp
Description: Mold location change due to cost savings efforts to consolidate molding supplier. Material change due to supplier material obsolesces. This is a non-patient contacting component.
Summary of Performance Testing: The design verification activities included dimensional inspection on all mold cavities and functional testing to determine if the tubing leaked while clamped. All results passed.

Device Modification: Mold Location Change: Hanger
Description: Mold location change due to cost savings efforts to consolidate molding supplier. This is a non-patient contacting component.
Summary of Performance Testing: Functional testing consisted of verifying hanger fit and form, and hanger strength. Dimensional measurements were executed as part of a first article inspection. All results passed.

Device Modification: Mold Location Change: Swivel Arm
Description: Mold location change due to cost savings efforts to consolidate molding supplier. This is a non-patient contacting component.
Summary of Performance Testing: Functional testing consisted of verifying swivel arm deflection, lock override, removal force, actuation force and rotational resistance. Dimensional measurements were executed as part of a first article inspection and critical dimension study. All results passed.

Device Modification: Material Change: Swivel Arm
Description: Mold location change due to cost savings efforts to consolidate molding supplier. This is a non-patient contacting component.
Summary of Performance Testing: Functional testing consisted of verifying swivel arm deflection, lock override, removal force, actuation force and rotational resistance. Dimensional measurements were executed as part of a first article inspection and critical dimension study. All results passed.

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.

K031554, K962856

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.

Not Found

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

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).

Summary

0

/20953

Pleur-evac® Autotransfusion Systems

DEC 1 0 2012 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Pleur-evac® Autotransfusion Systems

A. Name, Address, Phone and Fax Number of Applicant

Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-433-8049 919-433-4996 Fax:

B. Contact Person

Natalie Smith Regulatory Affairs Specialist

Lorraine DeLong Manager RA/OE Surgical

C. Date Prepared

March 28, 2012

D. Device Name

Trade Name: Pleur-evac Sahara® Plus Continuous Reinfusion Autotransfusion System, Pleur-evac® Autotransfusion Bag, Pleur-evac® Sahara Autotransfusion Bag

Common Name: Autotransfusion Apparatus

Classification Name: Autotransfusion Apparatus

E. Device Description

Teleflex Medical offers a line of Chest Drainage and Autotransfusion Systems. This line includes Chest Drainage units with a variety of suction and seal technologies. The three lines are the Wet Suction/Wet Seal, Dry Suction/Wet Seal, and Dry Suction/Dry Seal technologies. The Dry Suction/Dry Seal are branded the Sahara Series. Each technology of Chest Drainage devices can be coupled with an Autotransfusion (ATS) Bag for reinfusion capability. In addition, there is the S-1150-08LF, Pleur-evac Sahara® Plus Continuous Reinfusion Autotransfusion System that can be reinfused from the Drainage Unit. This submission will cover the Sahara reinfusion unit and the ATS Bags that can be mated with the different technology Chest Drainage Units.

The Pleur-evac Sahara® Plus Continuous Reinfusion Autotransfusion System (S-1150-08LF) is provided as a sterile unit intended for single patient use. The fluid path is non-

Teleflex Medical, Inc.

1

pyrogenic. The Pleur-evac Sahara Plus System is used for the collection and continuous reinfusion of autologous blood. By attaching the Pleur-evac Sahara Autotransfusion Bag (S-100-08LF), the Pleur-evac Sahara Plus System serves as a bag reinfusion system. When autotransfusion is completed, the Pleur-evac Sahara Plus System can serve as a chest drainage collection unit.

The Autotransfusion(ATS) Bag is a sterile, non-pyrogenic, single-use, blood collection and reinfusion device intended for the post-surgical, chest-drainage market. The ATS Bag attaches to the appropriate Pleur-evac Chest Drainage System. The S-100-08LF attached to a Sahara branded Pleur-evac® unit and an A-1500-08LF attaches to a standard Pleur-evac® unit.

F. Indications for Use

AUTOTRANSFUSION

l . For the collection of autologuous blood from the patient's pleural cavity or mediastinal area for reinfusion purposes in trauma and post-operative situations

CHEST DRAINAGE

1. To evacuate air and/or fluid from the chest cavity or mediastinum
1. To help prevent air and/or fluid from re-accumulating in the chest cavity or mediastinum.
1. To help re-establish and maintain normal intra-thoracic pressure gradients.
1. To facilitate complete lung re-expansion to restore normal breathing dynamics.

The Pleur-evac® Autotransfusion Bag is indicated as a sterile, single use device used for collection and reinfusion of autologous blood from the thoracic cavity when attached to a Pleur-evac® System. The fluid path is non-pyrogenic.

G. Contraindications

Pleur-evac® Autotransfusion Systems are contraindicated for:

· Pericardial, mediastinal, or systemic infections
· Pulmonary and respiratory infection or infestation
Presence of malignant neoplasms
Coagulopathies
Suspected thoraco-abdominal injuries with possible enteric contamination
Impaired renal function
· Intraoperative thoracic or mediastinal cavity use of topical thrombin, microfibrillar hemostatic agents or providine-iodine antiseptic gels or solutions and non I.V. compatible antibiotics

2

H. Substantial Equivalence

The proposed Pleur-evac® Plus Continuous Autotransfusion System is substantially equivalent to the predicate devices:

Predicate Device	Manufacturer	510(k) No.	Date Cleared
Pleur-evac® Sahara Plus
Continuous Reinfusion
Autotransfusion System	Genzyme Biosurgery	K031554	July 25, 2003
Pleur-evac® Sahara
Adult/Sahara Chest Drainage
System Models S-1100, S-1200,
S-2100 and S-2200 with Model
S-100 Autotransfusion Bag	Deknatel DSP
Worldwide
Incorporated	K962856	September 10, 1996

I. Comparison To Predicate Devices

The proposed Pleur-evac® Autotransfusion Systems have the same technology, indications for use and functional characteristics as the predicate systems. The proposed modification is a change in the material and manufacturing process of the collection tubing of the Pleur-evac Sahara® Plus Continuous Reinfusion Autotransfusion System.

J. Materials

All patient contacting materials are in compliance with ISO10993-1.

K. Technological Characteristics

A comparison of the technological characteristics of the proposed Pleur-evac® Autotransfusion Systems and the predicate has been performed. The results of this comparison demonstrate that the Pleur-evac® Autotransfusion System tubing is equivalent to the marketed predicate devices in performance characteristics. There were no technological changes made to the proposed device.

L. Performance Data

The bench testing has been performed to verify that the performance of the proposed Pleur-evac® Autotransfusion Systems are substantially equivalent to the predicate device, and that the Pleur-evac® Autotransfusion System tubing will perform as intended. .

| Performance

Test	Summary	Result
Kink Resistance	The proposed and predicate patient
tubing were visually inspected for
kink resistance. This test simulated
the various radiuses the tubing could
be subjected to during coiling and/or
packaging.	The results showed that
the proposed patient
tubing has a greater
ability to withstand
kinking.

A Summary of the performance testing completed is shown below:

Teleflex Medical, Inc.

3

| Performance

Test	Summary	Result
Leak Integrity	The proposed tubing was subjected
to positive and negative pressures to
determine the capability of
withstanding leakage.	The proposed tubing
passed the leak integrity
test with no leaks at
tubing joints.
Tubing Clamp
Leak	The proposed tubing in a clamped
configuration was subjected to
positive and negative pressures to
determine the capability of
withstanding leakage.	The proposed tubing
passed the leak test with
no leaks at the clamp.
Tubing Collapse	The proposed and predicate patient
tubing was exposed to a high
amount of negative pressure and
visually inspected for tubing
collapse.	All units passed the
tubing collapse test - the
proposed tubing did not
collapse under imposed
high pressure condition.
ATS Connector
Pull Test	The pull test required that the ATS
Connector be able to withstand a
minimum amount of force without
being separated from the proposed
tubing.	The proposed tubing
withstood the minimum
amount of force applied
without separation from
the ATS Connector.
Back Port Pull
Test	The pull test required that the
proposed tubing be able to withstand
a minimum amount of force without
being separated from the Back Port
of the unit.	The proposed tubing
withstood the minimum
amount of force applied
without separation from
the Back Port.
Universal
Connector Pull
Test	The pull test required that the
Universal Connector be able to
withstand a minimum amount of
force without being separated from
the proposed tubing.	The proposed tubing
withstood the minimum
amount of force applied
without separation from
the Universal Connector.

M. Pre-Clinical Testing

The sterilization cycle has been validation to meet the requirements of AAMI/ANSI/ISO 11135-1:2007 Sterilization of health care products Ethylene Oxide - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices, AAMI/ANSI/ISO 11737-1:2006 Sterilization of medical devices – Microbiological methods – Part 1: Determination of the population of microorganisms on product, and AAMI/ANSI/ISO 10993-7:2008 Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals.

The Biological Evaluation of the devices met the requirements of AAMI/ANSI/ISO 10993-1:2009 Biological Evaluation of Medical Devices – Part 1: Evaluation and testing, ISO10993-4 AMD1:2006 Biological Evaluation of Medical Devices - Part

4

4: Selection of tests in interactions with blood AMENDMENT 1, AAMI/ANSVISO 10993-5:2009 Biological Evaluation of Medical Devices – Part 5: Tests for In Vitro 10993-512007 Diological Evaluation 1: 2006 Biological Evaluation of Medical Devices - Pat 10: Tests for irritation and delayed-type hypersensitivity AMENDMENT 1, AAMI/ANSI/ISO 10993-11:2006 Biological Evaluation of Medical Devices – Part 11: Tests for systemic toxicity, AAMI/ANSI/ISO 10993-12 :2007 Biological Evaluation of Medical Devices – Part 12 Sample preparation and :2007 Divins - Taterials, AAMI ST72:2002/(R)2010 Bacterial endotoxins - Test methodologies, routine monitoring, and alternatives to batch testing, ASTM F-2382-04:2009 Standard Test Method for Assessment of Intravascular Medical Device 0 1:2009 Gainaardal Thromboplastin Time (PTT), ASTM F-756-08:2009 Guideline, Standard Practice for Assessment of Hemolytic Properties of Materials, ASTM F2148-07:2007 Standard Practice for Evaluation of Delayed Contact I LT 10 orsitivity using the Murine Local Lymph Node Assay (LLNA) and United States Pharmacopeia 35, National Formulary 30, 2012. Pyrogen Test.

The packaging and shelf life has been validated to meet the requirements of File packaging and 2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems, AAMI/ANSI/ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes, ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices, ASTM D4169:2009 Standard Practice for Performance Testing of Shipping Containers and Systems, ASTM D999:2008 Standard Test Methods for or Smipping Containers, and ASTM D5276 Standard Test Method for Drop Test for Loaded Containers by Free Fall.

N. Summary of Letter to File Modifications

Additional modifications were made to the device since the last clearance. These modifications and a summary of the performance testing are shown below:

| Device

Modification	Description of Modification	Summary of Performance Testing
Material
Change:
Autotransfusion
Bag - Top Plate	The design of the
Autotransfusion Bag includes a
rigid PVC top plate assembled
onto the top of a vinyl, flexible
bag. The rigid PVC was
composed of a copolymer and
the manufacturer discontinued
the resin. The replacement
material (resin) was a
homopolymer that was one of
the components of the
copolymer.	Performance testing was completed to
assess the Radio Frequency weld
strength, Pressure/Decay, Tensile, Burst
and Stress. All testing passed minimum
requirements.
All biocompatibility testing was
completed according to ISO 10993-1
and USP .
Device
Modification	Description of Modification	Summary of Performance Testing
Material
Change: Auto
transfusion Bag

IV Strap | The hanger strap material was
changed due to supplier
material obsolesces. This is a
non-patient contacting
material. | The change to the top plate was
validated through a validation study to
ensure that the IV strap material met
visual acceptance criteria after aging. |
| Supplier Process
Change: Header
Bags sterile
barrier for
transportation | Sealing of the header bags
changed from an impulse
sealer to a hot bar sealer. This
is a non-patient contacting
process change. | The study investigated three packaging
criteria, seal strength, seal width, and
seal visual defects that are outlined in
Purchasing Specification. All pre-
established specifications were met. |
| Modification:
Replacement of
Sterile Water
Bottle with
Sterile Water
Syringe | Changed water delivery from a
bottle of sterile water to a
syringe. This is a non-patient
contacting material. | The component change was validated
through design verification activities
where four different tests (ship testing,
syringe position, tip cover attachment,
syringe leakage) were performed to
assure safety and performance. To
ensure that the prefilled syringe was not
negatively impacted by Ethylene Oxide
(EtO) a study was performed to measure
the amounts of EtO and Ethylene
Chlorohydrin after the syringe was
sterilized twice. All results passed. |
| New Mold:
Swabbable Stem
(ATS Connector
component) | New mold for swabbable stem
component which results in
dimensional changes. The
patient contacting material and
function of the component was
unchanged. | The functional tests performed include
leak testing and needles injection after
the swabbable stem was assembled
within the ATS connector assembly. A
dimensional inspection of swabbable
stems was also performed to determine
whether the new components produced
by the mold met drawing dimensions.
All results passed. |
| Device
Modification | Description of Modification | Summary of Performance Testing |
| Modification:
Male ATS
Connector | Change in component design.
The patient contacting material
and function of the component
was unchanged. | The functional tests included finger
engagement, disengagement force, Male
ATS connector disengagement clearance
and ATS connector separation force. A
dimensional inspection was also
performed to determine whether the new
components produced by the mold met
drawing dimensions. All results passed. |
| Mold Location
and
Manufacturer
Change: Air
Flow Meter | Mold location change due to
cost savings efforts to
consolidate molding supplier.
This is a non-patient contacting
component. | The functional tests included correct
flow path, no leaks through front of air
flow meter and air flow measurement. A
dimensional inspection was performed
to determine whether the new
components produced by the mold met
drawing dimensions. All results passed. |
| Material and
Mold Location
Change: Slide
Clamp | Mold location change due to
cost savings efforts to
consolidate molding supplier.
Material change due to supplier
material obsolesces. This is a
non-patient contacting
component. | The design verification activities
included dimensional inspection on all
mold cavities and functional testing to
determine if the tubing leaked while
clamped. All results passed. |
| Mold Location
Change: Hanger | Mold location change due to
cost savings efforts to
consolidate molding supplier.
This is a non-patient contacting
component. | Functional testing consisted of verifying
hanger fit and form, and hanger strength.
Dimensional measurements were
executed as part of a first article
inspection. All results passed. |
| Mold Location
Change: Swivel
Arm | Mold location change due to
cost savings efforts to
consolidate molding supplier.
This is a non-patient contacting
component. | Functional testing consisted of verifying
swivel arm deflection, lock override,
removal force, actuation force and
rotational resistance. Dimensional
measurements were executed as part of a
first article inspection and critical
dimension study. All results passed. |
| Material
Change: Swivel
Arm | Mold location change due to
cost savings efforts to
consolidate molding supplier.
This is a non-patient contacting
component. | Functional testing consisted of verifying
swivel arm deflection, lock override,
removal force, actuation force and
rotational resistance. Dimensional
measurements were executed as part of a
first article inspection and critical
dimension study. All results passed. |

Teleflex Medical, Inc.

Page 8.5

5

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6

Pleur-evac® Autotransfusion Systems

Traditional 510(k) Section 8 - Summary of Safety and Effectiveness

Teleflex Medical, Inc.

Page 8.7

.

7

O. Conclusion

Based upon the comparative test results, the proposed Pleur-evac® Autotransfusion Systems are substantially equivalent in performance to the predicate devices cleared to market via 510(k) K031554 and K962856. The modifications made to the proposed Pleur-evac® Autotransfusion Systems do not introduce any new issues of safety and effectiveness.

8

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with a serpent entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

DEC 10 2012

Teleflex Medical, Inc. C/O Ms. Lorraine DeLong 2917 Weck Drive, Research Triangle Park, NC 27709

Re: K120953

Trade/Device Name: Pleur-evac Sahara Plus Continuous Reinfusion Autotransfusion System Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II Product Code: CAC Dated: December 4, 2012 Received: December 4, 2012

Dear Ms. DeLong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

9

Page 2 - Ms. Lorraine DeLong

or any Federal statutes and regulations administered by other Federal agencies. You must of any I cather state and the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Of it Fart 607); acceming (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you ucsite specific advice for your as ntess offices/CDRH/CDRHOffices/ucm115809.htm for go to mup/rww.ida:2017100di Boyical Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 1807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Tou may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman

Bram D. Zuckerman, MD Director, Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

10

Indications for Use

Page 1 of 1

510(k) Number:

K120953

Device Name:

Pleur-evac® Autotransfusion Systems

Indications for Use:

The Indications for Use Statements are as follows:

AUTOTRANSFUSION

1. For the collection of autologuous blood from the patient's pleural cavity or mediastinal area for reinfusion purposes in trauma and post-operative situations
  CHEST DRAINAGE .
1. To evacuate air and/or fluid from the chest cavity or mediastinum
To help prevent air and/or fluid from re-accumulating in the chest cavity or 2. mediastinum.
1. To help re-establish and maintain normal intra-thoracic pressure gradients.
1. To facilitate complete lung re-expansion to restore normal breathing dynamics.

The Pleur-evac® Autotransfusion Bag is indicated as a sterile, single use device used for collection and reinfusion of autologous blood from the thoracic cavity when attached to a Pleur-evac® System. The fluid path is non-pyrogenic.

Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR

Over-the-counter use __ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K120953

Teleflex Medical, Inc.