(380 days)
The PleuraFlow Catheter is indicated for use as an adjunctive device during open surgical procedures in order to prevent fluid accumulation within the operative site after closure of the surgical wound. The device is indicated for use in thoracic surgical procedures.
The PleuraFlow Catheter System is comprised of a silicone drainage tube and a shuttle assembly and guide tube. The PleuraFlow drainage tube is 20 inches in length with graduated measurements in inches from the first side hole and will be available in standard sizes from 20Fr to 32Fr versions. There is a barium stripe in the tube to facilitate visualization. A connector at the proximal end of the device connects to a commercially available drainage system. Within the catheter is a tube clearance apparatus to facilitate clearing of the drainage tube. The tube clearance apparatus is composed of a PTFE-coated guide wire that has a loop set on its distal end, bent at a 90-degree angle. The clearance apparatus is sized such that it cannot exit the end of the drainage tube or the side holes. The tube clearance apparatus is magnetically driven by an attached internal magnet coupled to an external magnet contained within the shuttle assembly.
The PleuraFlow Catheter System is described in a 510(k) summary, which outlines its design, indications for use, and the basis for its substantial equivalence to predicate devices. The performance data section describes a "User Preference Study" to demonstrate the device's safety and effectiveness.
Here's an analysis of the provided information concerning acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state formal, quantitative acceptance criteria in the typical sense (e.g., "Device must achieve X% successful clearance"). Instead, it presents qualitative findings from a user preference study as evidence of acceptable performance.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Acceptable time for assembly and ease of placement (by surgeons) | Findings from the study indicated that the time for assembly and ease of placement were acceptable to the surgeons. |
| Acceptable ease of use of the clearance mechanism (by ICU nurses) | Findings from the study indicated that ... ease of use of the clearance mechanism ... were acceptable to the ICU nurses. |
| Adequacy of chest tube clearance (by ICU nurses) | Findings from the study indicated that ... adequacy of chest tube clearance were acceptable to the ICU nurses. |
| Device is helpful and easy to use | It was concluded that the device was helpful and easy to use, and performed as intended in the clinical setting. (This is a summary conclusion based on the feedback). |
| Device performs as intended in the clinical setting | It was concluded that the device was helpful and easy to use, and performed as intended in the clinical setting. (This is a summary conclusion based on the feedback, aligning with the indication for use to "prevent fluid accumulation within the operative site after closure of the surgical wound" and "indicated for use in thoracic surgical procedures" by facilitating clearance). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: A total of 19 patients were enrolled in the User Preference Study.
- Data Provenance: The study appears to be prospective and conducted within a clinical setting (patients undergoing cardiac surgery through a median sternotomy). The country of origin is not explicitly stated, but given the FDA 510(k) submission, it is likely that the study was conducted in the United States or a country with similar regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not describe establishing a 'ground truth' in the traditional sense for the device's primary function (e.g., whether fluid accumulation was truly prevented or not, or a quantitative measure of clearance efficiency). Instead, the study focused on user preference and assessment of various aspects of the device's usability and perceived performance.
The "experts" involved were the healthcare professionals interacting with the device:
- Surgeons: Responsible for placing the chest tube.
- Nurses: Responsible for patient care prior to chest tube removal, including using the clearance mechanism.
- Physician Assistants or Residents: Responsible for removing the chest tube.
The number of each type of professional is not specified, beyond the implication that multiple individuals from each group provided feedback through the questionnaire. Their specific qualifications (e.g., years of experience, specialization) are also not detailed.
4. Adjudication Method for the Test Set:
There is no mention of an adjudication method for the "ground truth" or for resolving discrepancies in user feedback. The study involved collecting questionnaire responses from different user groups, and the findings were reported as collective "acceptances" or "conclusions." This was not a study relying on diagnostic accuracy or objective measurements requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study was a user preference study comparing the PleuraFlow system to a "standard chest tube" by placing both in the same patients. It did not assess human readers' diagnostic performance with or without AI assistance, as the device is a medical device for fluid drainage, not an AI-powered diagnostic tool. Therefore, an effect size of human readers improving with AI vs. without AI assistance is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) Was Done:
Not applicable. The PleuraFlow Catheter System is a physical medical device, not a software algorithm. Therefore, "standalone" algorithm performance is not relevant. The study assessed the device's performance in a clinical setting with human interaction and assessment.
7. The Type of Ground Truth Used:
The "ground truth" for this study was primarily based on user feedback and qualitative assessment of the device's usability and perceived performance by healthcare professionals (surgeons, nurses, PAs/residents) in a real-world clinical setting. It was not based on objective clinical outcomes (like reduced incidence of fluid accumulation quantified) or pathology reports. The study concluded that the device was "helpful and easy to use, and performed as intended in the clinical setting" based on this subjective user feedback.
8. The Sample Size for the Training Set:
Not applicable. This study is for a physical medical device and does not involve AI or machine learning, and therefore there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set, the establishment of ground truth for a training set is not relevant.
{0}------------------------------------------------
093565
510(k) Summary
ﺮ ﺍﻟﻤﺮﺍﺟﻊ
The following information is provided as required by 21 CFR § 807.87 for PleuraFlow Catheter System 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
| Applicant: | Clear Catheter Systems2200 NE Neff, Suite 204Bend, Oregon 97701 |
|---|---|
| Contact Person: | Edward Boyle, MD |
| Contact Person: | Marie MarlowM Squared Associates, Inc.901 King St, Suite 200Alexandria, VA 22314Phone: 703-562-9800Fax: 703-562-9797DEC - 3 2010 |
| Date of Submission: | November 17, 2009 |
| Proprietary Name: | PleuraFlow Catheter System |
| Common Name: | Accessory to powered suction pump |
| Regulatory Class: | II |
| Product Codes: | OTK |
| Predicate Device(s): | The primary predicate device used to demonstrate substantialequivalence is the Deutsch Anti-Blockage Wound Drain(K052286). |
| Device Description: | The PleuraFlow Catheter System is comprised of a siliconedrainage tube and a shuttle assembly and guide tube. ThePleuraFlow drainage tube is 20 inches in length withgraduated measurements in inches from the first side holeand will be available in standard sizes from 20Fr to 32Frversions. There is a barium stripe in the tube to facilitatevisualization. A connector at the proximal end of the deviceconnects to a commercially available drainage system.Within the catheter is a tube clearance apparatus to facilitateclearing of the drainage tube. The tube clearance apparatus iscomposed of a PTFE-coated guide wire that has a loop set on |
{1}------------------------------------------------
its distal end, bent at a 90-degree angle. The clearance apparatus is sized such that it cannot exit the end of the drainage tube or the side holes. The tube clearance apparatus is magnetically driven by an attached internal magnet coupled to an external magnet contained within the shuttle assembly.
Indication for use: The PleuraFlow Catheter is indicated for use as an adjunctive device during open surgical procedures in order to prevent fluid accumulation within the operative site after closure of the surgical wound.
The device is indicated for use in thoracic surgical procedures.
Substantial Equivalence:
The PleuraFlow Catheter has the same or similar intended use, indications for use, principle of operation, and performance characteristics as predicate devices and is, therefore, substantially equivalent to the predicate devices.
Performance Data: The safety and effectiveness of the PleuraFlow Catheter has been demonstrated through data collected from clinical and nonclinical bench tests and analysis.
A total of 19 patients were enrolled in a User Preference Study. Patients undergoing cardiac surgery through a median sternotomy had two chest tubes placed in the midline; one standard chest tube and a PleuraFlow system. A study questionnaire was completed by the surgeon placing the chest tube, the nurse taking care of the patient prior to removal of the chest tube, and by the Physician Assistant or Resident who removed the chest tube. Findings from the study indicated that the time for assembly and ease of placement were acceptable to the surgeons, and that ease of use of the clearance mechanism and adequacy of chest tube clearance were acceptable to the ICU nurses. It was concluded that the device was helpful and easy to use, and performed as intended in the clinical setting.
Conclusion:
The evaluation of the PleuraFlow Catheter does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to the predicate devices.
{2}------------------------------------------------
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Clear Catheter Systems % M Squared Associates, Inc. Ms. Monica Early Dougherty 901 King Street, Suite 200 Alexandria, Virginia 22314
Re: K093565
Trade/Device Name: PleuraFlow Catheter System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OTK Dated: October 19, 2010 Received: October 20, 2010
DEC - 3 2010
Dear Ms. Dougherty:
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. Iisting 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
{3}------------------------------------------------
Page 2 - Ms. Monica Early Dougherty
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/CDRHQffices/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 vours.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Section 4: Indications for Use Statement
To be assigned Ko 93 565 510(k) Number:
Device Name: PleuraFlow Catheter System
Indications for Use: The PleuraFlow Catheter is indicated for use as an adjunctive device during open surgical procedures in order to prevent fluid accumulation within the operative site after closure of the The device is indicated for use in surgical wound. thoracic surgical procedures.
| Prescription Use | X |
|---|---|
| (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)
NukRPQdl fir mkn
(Division Signical. Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number K093565
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.