(115 days)
Not Found
No
The summary describes a mechanical drainage system and does not mention any AI or ML components or capabilities.
Yes
The device is indicated for treatment (palliation of dyspnea and providing pleurodesis) of a medical condition (pleural effusion), which are therapeutic functions.
No
The device is indicated for drainage and palliation of symptoms related to pleural effusion, not for diagnosing the condition itself.
No
The device description explicitly states the primary components are a catheter and drainage kits, which are physical hardware components. There is no mention of software as a primary or even secondary component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for draining fluid from the pleural space in a patient's body. This is a therapeutic and palliative intervention, not a diagnostic test performed on a sample in vitro (outside the body).
- Device Description: The description focuses on the physical components used for drainage and insertion, not on analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
The device is a medical device used for managing a medical condition (pleural effusion) through physical intervention (drainage).
N/A
Intended Use / Indications for Use
The Pleurx Pleural Catheter Kits are indicated for intermittent, long term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of the underlying disease. The devices are indicated for 1) the palliation of dyspnea due to pleural effusion and 2) providing pleurodesis (resolution of the pleural effusion).
The Pleurx Drainage Kits and Drainage Line Set are indicated for use only with the Pleurx Catheter for intermittent drainage. The Drainage Line Kit is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle or other appropriate method.
The Pleurx Dressing Kits are indicated for dressing of a catheter and exit site.
The Pleurx Catheter Access Kit is intended to provide access to the Pleurx Catheter for aspiration and catheter maintenance.
The Pleurx Catheter Insertion Stylet is intended to aid in the percutaneous insertion of the Pleurx Catheter into the pleural space.
The Valved Peelable Introducers are intended for use in the percutaneous insertion of a catheter into the pleural space.
Product codes
DWM
Device Description
The Pleurx Pleural Cather System provides patients with a convenient method to relieve pleural effusion symptoms at home. The primary components of the Pleurx Catheter System are the Pleurx Pleural Catheter and the Pleurx Drainage Kits.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pleural space
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Patients at home, healthcare professionals for insertion and maintenance procedures.
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)
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The document lists various performance tests conducted according to AAMI/ANSI/ISO standards for Biocompatibility, Residuals, and Performance. These include tests for:
- Biological evaluation of Medical Devices Part 1: Evaluation and Testing (AAMI/ANSI/ISO 10993-1:2009)
- Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity (AAMI/ANSI/ISO 10993-3: 2003 (R) 2009)
- Selection of Tests for Interaction with Blood (AAMI/ANSI/ISO 10993-4: 2002 (R) 2009)
- Tests for In Vitro Cytotoxicity (AAMI/ANSI/ISO 10993-5: 2009)
- Tests for Local Effects After Implantation (AAMI/ANSI/ISO 10993-6: 2007 (R) 2010)
- Ethylene Oxide Sterilization Residuals (AAMI/ANSI/ISO 10993-7:2008)
- Tests for Irritation and Skin Sensitivity (AAMI/ANSI/ISO 10993-10: 2010)
- Tests for Systemic Toxicity (AAMI/ANSI/ISO 10993-11: 2006)
- Containers - Plastics, Physiochemical Tests (USP )
- Sterile Drainage Catheters and Accessory Devices for Single Use (EN 1617:1997)
- Catheters Other Than Intravascular Catheters - Test Methods for Common Properties (EN 1618:1997)
- Sterile, Single-use Intravascular Catheters (ISO 11070)
- Packaging for Terminally Sterilized Medical Devices (ANSI/AAMI/ISO 11607-1,2:2006)
- Accelerated Aging of Sterile Barrier Systems (ASTM F1980-07)
- Sterilization of healthcare products - Biological Indicators (ISO 11138-1,2:2006)
- Sterilization of Medical Devices - Microbiological Methods Part 1 & 2 (ISO 11737-1,2:2006)
- Medical Device, Validation and Routine Control of Ethylene Oxide Sterilization (ISO 11135:2007)
- Product Adoption and Process Equivalency for Ethylene Oxide Sterilization (AAMI TIR28:2009)
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
N/A - No clinical tests were conducted for this submission.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The results of the non-clinical tests show that the CareFusion Pleurx Pleural Catheter System meets or exceed all performance requirements, and are substantially equivalent to the predicate devices.
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.
K112831, K113854, K110409, K090394, K040150
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
§ 870.5050 Patient care suction apparatus.
(a)
Identification. A patient care suction apparatus is a device used with an intrathoracic catheter to withdraw fluid from the chest during the recovery period following surgery.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for CareFusion. The logo consists of a circular icon on the left and the word "CareFusion" on the right. The icon appears to contain a stylized image of two hands forming a heart shape.
OCT
18
2012
ı ••
,
ー
510(k) SUMMARY K121849
A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.
| SUBMITTER INFORMATION | ||
|---|---|---|
| Name | CareFusion | |
| Address | 1500 Waukegan Road MPWM, McGaw Park, IL 60085 USA | |
| Phone number | (847) 473-7404 | |
| Fax number | (847) 473-7790 | |
| Establishment Registration | ||
| Number | 1423507 | |
| Name of contact person | Joy Greidanus | |
| Date prepared | October 17, 2012 | |
| DESCRIPTION OF DEVICE | ||
| Trade or proprietary name | Pleurx Pleural Catheter System | |
| Common or usual name | Pleural Drainage Catheter | |
| Classification name | Patient Care Suction Apparatus | |
| Classification panel | Anesthesiology | |
| Regulation | Class II per 21CFR §870.5050, Procode DWM | |
| Product Code(s) | Multiple | |
| Legally marketed device(s) to | ||
| which equivalence is claimed | CareFusion Pleurx Catheter Systems: K112831 & K113854 | |
| Bard Aspira Pleural Drainage System: K110409 | ||
| Martech (MEDCOMP) Valved Tearaway Introducer: K090394 | ||
| Greatbatch (MedAmicus) Incorporated FlowGuard Peelable Introducer: | ||
| K040150 | ||
| Reason for 510(k) submission | Expanding the indications for use and adding accessories. | |
| Device description | The Pleurx Pleural Cather System provides patients with a convenient | |
| method to relieve pleural effusion symptoms at home. The primary | ||
| components of the Pleurx Catheter System are the Pleurx Pleural | ||
| Catheter and the Pleurx Drainage Kits. | ||
| Intended use of the device | The Pleurx Pleural Catheter Kits are indicated for intermittent, long term | |
| drainage of symptomatic, recurrent, pleural effusion, including | ||
| malignant pleural effusion and other recurrent effusions that do not | ||
| respond to medical management of the underlying disease. The | ||
| devices are indicated for 1) the palliation of dyspnea due to pleural | ||
| effusion and 2) providing pleurodesis (resolution of the pleural effusion). |
The Pleurx Drainage Kits and Drainage Line Set are indicated for use
only with the Pleurx Catheter for intermittent drainage. The Drainage
Line Kit is used to drain fluid using standard wall suction, water seal
drainage system, vacuum bottle or other appropriate method.
The Pleurx Dressing Kits are indicated for dressing of a catheter and
exit site.
The Pleurx Catheter Access Kit is intended to provide access to the
Pleurx Catheter for aspiration and catheter maintenance.
The Pleurx Catheter Insertion Stylet is intended to aid in the
percutaneous insertion of the Pleurx Catheter into the pleural space.
The Valved Peelable Introducers are intended for use in the
percutaneous insertion of a catheter into the pleural space. | |
| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED
TO THE PREDICATE DEVICE | | |
| Characteristic | New Device | Predicates:
CareFusion Pleurx Catheter System:
K112831 & K113854
Bard Aspira Pleural Catheter System
K110409
Martech (MEDCOMP) Valved Tearaway
Introducer: K090394
Greatbatch (MedAmicus) Incorporated
FlowGuard Peelable Introducer:
K040150 |
| Catheter Description | Internal: fenestrations,
radiopaque markings & cuff
External: valve | Same |
| Method | Percutaneously tunneled -
indwelling | Same |
| Valved Peelable Introducers
description | Peelable sheath, dilator,
hub, valve | Same |
| Access Kit Description | Provides access for sample
aspirations and catheter
maintenance | Same |
| Insertion Stylet | Reduces fluid loss, provides
stiffening | Same |
1
CareFusion – October 2012 - Traditional 510(k): Pleurx Pleural Catheter System
| CareFusion
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:
:
:
:
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2
Fusion
| PERFORMANCE DATA | |
|---|---|
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF | |
| SUBSTANTIAL EQUIVALENCE | |
| Performance Test Summary | |
| Characteristic | Standard/Test/FDA Guidance |
| Biocompatibility | AAMI/ANSI/ISO 10993-1:2009 Biological evaluation of Medical Devices Part 1: |
| Evaluation and Testing | |
| Biocompatibility | AAMI/ANSI/ISO 10993-3: 2003 (R) 2009 Biological Evaluation of Medical Devices - |
| Part 3 Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity | |
| Biocompatibility | AAMI/ANSI/ISO 10993-4: 2002 (R) 2009 Biological Evaluation of Medical Devices - |
| Part 4 Selection of Tests for Interaction with Blood | |
| Biocompatibility | AAMI/ANSI/ISO 10993-5: 2009 Biological Evaluation of Medical Devices - Part 5 |
| Tests for In Vitro Cytotoxicity | |
| Biocompatibility | AAMI/ANSI/ISO 10993-6: 2007 (R) 2010 Biological Evaluation of Medical Devices - |
| Part 6 Tests for Local Effects After Implantation | |
| Residuals | AAMI/ANSI/ISO 10993-7:2008 Biological evaluation of Medical Devices Part 7: |
| Ethylene Oxide Sterilization Residuals | |
| Biocompatibility | AAMI/ANSI/ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10 |
| Tests for Irritation and Skin Sensitivity | |
| Biocompatibility | AAMI/ANSI/ISO 10993-11: 2006 Biological Evaluation of Medical Devices - Part 11 |
| Tests for Systemic Toxicity | |
| Biocompatibility | 'USP Containers - Plastics, Physiochemical Tests |
| Performance | EN 1617:1997 Sterile Drainage Catheters and Accessory Devices for Single Use |
| Performance | EN 1618:1997 Catheters Other Than Intravascular Catheters - Test Methods for |
| Common Properties | |
| Performance | ISO 11070 Sterile, Single-use Intravascular Catheters |
| Performance | ANSI/AAMI/ISO 11607-1,2:2006 Packaging for Terminally Sterilized Medical Devices |
| Performance | ASTM F1980-07 Accelerated Aging of Sterile Barrier Systems |
| Performance | ISO 11138-1,2:2006 Sterilization of healthcare products - Biological Indicators |
| Performance | ISO 11737-1,2:2006 Sterilization of Medical Devices - Microbiological Methods Part |
| 1 & 2 | |
| Performance | ISO 11135:2007 Medical Device, Validation and Routine Control of Ethylene Oxide |
| Sterilization | |
| Performance | AAMI TIR28:2009 Product Adoption and Process Equivalency for Ethylene Oxide |
| Sterilization | |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL | |
| EQUIVALENCE AND/OR OF CLINICAL INFORMATION | |
| N/A - No clinical tests were conducted for this submission | |
| CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA | |
| The results of the non-clinical tests show that the CareFusion Pleurx Pleural Catheter System meets or | |
| exceed all performance requirements, and are substantially equivalent to the predicate devices. |
·
,
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines. The overall design is simple and conveys a sense of national identity and the department's mission.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
OCT 1 8 2012
CareFusion Ms. Joy Greidanus Regulatory Affairs Manager 1500 Waukegan Road McGaw Park, Illinois 60085
Re: K121849
Trade/Device Name: Pleurx Pleural Catheter System Regulation Number: 21 CFR 870.5050 Regulation Name: Patient Care Suction Apparatus Regulatory Class: II Product Code: DWM Dated: September 27, 2012 Received: September 28, 2012
Dear Ms. Greidanus:
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.
4
Page 2- Ms. Greidanus
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 or any Federal statutes and regulations administered by other Federal agencies. You must comply with all 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 device-related adverse events) (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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 Division 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,
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
CareFusion - June 2012 - Traditional 510(k): Pleurx Pleural Catheter System
Image /page/5/Picture/1 description: The image contains the logo for CareFusion. The logo consists of a circular graphic to the left of the company name. The graphic appears to be a stylized, abstract design within a circle, possibly representing interconnectedness or a symbol related to healthcare. The text "CareFusion" is written in a bold, sans-serif font, with the letters closely spaced together.
500 Waukegan Road Gaw Park Illinois 60085-6787 X: 847 473.7790
510(k) Number (if known):
Device Name:
Pleurx Pleural Catheter System
Indications For Use:
The Pleurx Pleural Catheter Kits are indicated for intermittent, long term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of the underlying disease. The devices are indicated for 1) the palliation of dyspnea due to pleural effusion and 2) providing pleurodesis (resolution of the pleural effusion).
The Pleurx Drainage Kits and Drainage Line Set are indicated for use only with the Pleurx Catheter for intermittent drainage. The Drainage Line Kit is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle or other appropriate method.
The Pleurx Dressing Kits are indicated for dressing of a catheter and exit site:
The Pleurx Catheter Access Kit is intended to provide access to the Pleurx Catheter for aspiration and catheter maintenance.
The Pleurx Catheter Insertion Stylet is intended to aid in the percutaneous insertion of the Pleurx Catheter into the pleural space.
The Valved Peelable Introducers are intended for use in the percutaneous insertion of a catheter into the pleural space.
Prescription Use______ (Per 21 CFR 801 Subpart D) And/Or Over-The Counter Use____________ (Per 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
y Shultr
eslology, General Hospital
510(k) Number: K121549