(141 days)
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 Pleural Catheter 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Pleurx Pleural Catheter System:
The provided document is a 510(k) summary for the Pleurx Pleural Catheter System, primarily focusing on establishing substantial equivalence to predicate devices. As such, it details non-clinical tests rather than clinical studies with human participants. Therefore, many of the requested points related to clinical studies, ground truth establishment, expert adjudication, and human reader performance will not be applicable.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Standard / Test | Reported Device Performance |
|---|---|
| Biocompatibility: ISO 10993-1:2009 | Meets or exceeds all performance requirements |
| Residuals: ISO 10993-7:2008 | Meets or exceeds all performance requirements |
| Performance: EN 1617:1997 | Meets or exceeds all performance requirements |
| Performance: EN 1618:1997 | Meets or exceeds all performance requirements |
| Performance: ANSI/AAMI/ISO 11607-1,2:2006 | Meets or exceeds all performance requirements |
| Performance: ISO 11138-1,2:2006 | Meets or exceeds all performance requirements |
| Performance: ISO 11737-1,2:2006 | Meets or exceeds all performance requirements |
| Performance: ISO 11135:2007 | Meets or exceeds all performance requirements |
| Specification: ASTM F560-08 | Meets or exceeds all performance requirements |
Study Details
-
Sample size used for the test set and the data provenance:
- The document does not describe a test set in the context of a clinical study or a dataset for an AI/algorithm. The tests listed are non-clinical, laboratory-based performance, biocompatibility, and sterilization validation tests on the device itself.
- Data provenance: Not applicable in the context of clinical data. The tests are laboratory-based, not using patient data from specific countries.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No "ground truth" in the sense of clinical diagnoses or interpretations by experts was established for these non-clinical engineering and material tests. The "ground truth" for these tests would be the specifications and requirements defined by the referenced standards.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There was no adjudication process described for clinical interpretations or diagnoses.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done. This device is a physical medical device (catheter system), not an AI/software device that assists human readers.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was done. This is a physical medical device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" is defined by the specific requirements and methodologies outlined in the referenced ISO, EN, and ASTM standards (e.g., specific thresholds for chemical residuals, packaging integrity, material properties, sterilization efficacy). These are objective, measurable criteria, not subjective expert consensus or clinical outcomes.
-
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device, so there is no "training set."
-
How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI model, this question does not apply.
Summary of the Study:
The document describes a submission for a Pleurx Pleural Catheter System, which is a physical medical device. The "study" referenced in the acceptance criteria section consists of a series of non-clinical performance, biocompatibility, and sterilization validation tests. These tests were conducted against established international and national standards (ISO, EN, ANSI/AAMI, ASTM). The purpose of these tests was to demonstrate that the new device meets the necessary safety and performance requirements and is substantially equivalent to existing predicate devices. No clinical studies or studies involving human data, AI algorithms, or expert interpretations were conducted or reported for this 510(k) submission. The conclusion explicitly states: "N/A - No clinical tests were conducted for this submission."
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化 112831 510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.
ﺔ ﺗ
| SUBMITTER INFORMATION | |
|---|---|
| Name | CareFusion |
| Address | 1500 Waukegan Road MPWM, McGaw Park, IL 60085 USA |
| Phone number | (847) 473-7404 |
| Fax number | (847) 473-7990 |
| EstablishmentRegistration Number | 1423507 |
| Name of contact person | Joy Greidanus |
| Date prepared | February 10, 2012 |
| NAME OF DEVICE | |
| Trade or proprietaryname | 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 marketeddevice(s) to whichequivalence is claimed | CareFusion Pleurx Catheter Kit and the Denver Pleurx Drainage Kit/VacuumBottle : K051084 & K052436Bard Aspira Pleural Drainage System: K110409 |
| Reason for 510(k)submission | Change to materials, expanding the indications for use, and updates to theinstructions for use. |
| Device description | The Pleurx Pleural Catheter System provides patients with a convenientmethod to relieve pleural effusion symptoms at home. The primarycomponents of the Pleurx Catheter System are the Pleurx PleuralCatheter and the Pleurx Drainage Kits. |
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| Intended use of the device | The Pleurx Pleural Catheter Kits are indicated forintermittent, long term drainage of symptomatic,recurrent, pleural effusion, including malignantpleural effusion and other recurrent effusions that donot respond to medical management of theunderlying disease. The devices are indicated for1) the palliation of dyspnea due to pleural effusionand 2) providing pleurodesis (resolution of thepleural effusion). |
|---|---|
| The Pleurx Drainage Kits and Drainage Line Set areindicated for use only with the Pleurx Catheter forintermittent drainage. The Drainage Line Kit is usedto drain fluid using standard wall suction, water sealdrainage system, vacuum bottle or other appropriatemethod. | |
| The Pleurx Dressing Kits are indicated for dressingof a catheter and exit site. |
יי
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED .
. . . . . . . . . . . . . . . . . . TO.THE PREDICATE DEVICE
| Characteristic | New Device | Predicates:CareFusion Pleurx Pleural CatheterSystem (K051084, K052436)Bard Aspira Pleural Catheter System(K110409) |
|---|---|---|
| Catheter Description | Internal: fenestrations, radiopaquemarkings & cuffExternal: valve | Same |
| Method | Percutaneously tunneled - indwelling | Same |
| Means of Drainage | Wall suction, water seal drainagesystem, portable suction, vacuumbottles or other appropriate method | Wall suction, water seal drainage system,vacuum bottles, syringe, drainage bag orother appropriate method |
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
| Performance Test Summary | |
|---|---|
| Characteristic | Standard/Test/FDA Guidance |
| Biocompatibility | ISO 10993-1:2009 Biological evaluation of Medical Devices Part 1: Evaluation andTesting |
| Residuals | ISO 10993-7:2008 Biological evaluation of Medical Devices Part 7: Ethylene OxideSterilization Residuals |
| Performance | EN 1617:1997 Sterile Drainage Catheters and Accessory Devices for Single Use |
| Performance | EN 1618:1997 Catheters Other Than Intravascular Catheters - Test Methods forCommon Properties |
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| Performance | ANSI/AAMI/ISO 11607-1,2:2006 Packaging for Terminally Sterilized Medical Devices |
|---|---|
| Performance | ISO 11138-1,2:2006 Sterilization of Healthcare products - Biological Indicators |
| Performance | ISO 11737-1,2:2006 Sterilization of Medical Devices - Microbiological Methods Part1 & 2 |
| Performance | ISO 11135:2007 Medical Device, Validation and Routine Control of Ethylene OxideSterilization |
| Specification | ASTM F560-08 (excluding part 7) Standard Specification for Unalloyed Tantalum forSurgical Implants |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIALEQUIVALENCE AND/OR OF CLINICAL INFORMATION | |
| N/A - No clinical tests were conducted for this submission | |
| CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA |
ﺔ ﻓ
The results of the non-clinical tests show that the CareFusion Pleural Catheter System meets or exceed all performance requirements, and is substantially equivalent to the predicate devices.
·
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Joy Greidanus Manager, Regulatory Affairs CareFusion 1500 Waukegan Road McGaw Park, Illinois 60085
FEB 1 6. 2012'
Re: K112831
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: February 13, 2012 Received: February 14, 2012
Dear Ms. Griedanus:
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 me reachar Food, Drag, Drag, and Cherefore, 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 (1 wirly of 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.
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Page 2 - Ms. Griedanus
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Nh fac
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
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Image /page/5/Picture/0 description: The image shows the CareFusion logo. The logo consists of a stylized globe with a shield-like shape embedded within it on the left, followed by the word "CareFusion" in a bold, sans-serif font on the right. The globe and text are both in black against a white background.
1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.7404 FAX 847 473 7790
Indication for Use
Pleurx Pleural Catheter System
510(k) Number (if known):
Device Name:
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.
Prescription Use X_ (Per 21 CFR 801.109) or Over-The Counter Use (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schattner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control. Dental Devices
V 112831
510(k) Number:
11
§ 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).