The Asept Pleural Drainage System is intended for long-term, intermittent drainage of symptomatic, recurrent, pleural effusions; including malignant pleural effusions and other pleural effusions that do not respond to treatment of the underlying disease.

Device Description

The Asept Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity to relieve symptoms associated with pleural effusion. The catheter is implanted in the patient's pleural cavity enabling the patient to perform intermittent pleural effusion drainage at home or hospital. The primary components of the system are the Asept indwelling Pleural Catheter and the Asept Drainage Kit. The proximal end of the indwelling catheter has a valve that prevents fluid or air from moving in or out of the pleural space until the valve is breached. The valve can be breached by the Asept Pleural Drainage catheter connected to wall suction or pleurovac or vacuum bottles. The Asept Pleural Drainage System provides patients with a convenient way to relieve pleural effusion symptoms at home.

AI/ML Overview

The provided text describes the "Asept Pleural Drainage System" and its safety and effectiveness summary for a 510(k) submission. However, it explicitly states that clinical studies were not deemed necessary and that in vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to a legally marketed predicate device.

Therefore, based on the provided text, a conventional study demonstrating the device meets stated acceptance criteria through human-in-the-loop, multi-reader, or standalone AI performance, with ground truth established by experts, does not exist. The approval was based on in vitro testing and substantial equivalence to a predicate device, not on a clinical trial with acceptance criteria for device performance.

Here's a breakdown of the requested information based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from BS EN 1618-1997)	Reported Device Performance
Leakage	Adequate (implied by "assure reliable design and performance")
Flow rate	Adequate (implied by "assure reliable design and performance")
Tensile strength	Adequate (implied by "assure reliable design and performance")
Corrosion	Adequate (implied by "assure reliable design and performance")

Note: The specific quantitative acceptance criteria values from BS EN 1618-1997 are not provided in the document, nor are specific quantitative performance results for the Asept Pleural Drainage System for these parameters. The document only states that "in vitro testing was performed... to assure reliable design and performance in accordance with BS EN 1618-1997."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable. The document states, "Clinical studies were not deemed necessary since in vitro testing was sufficient..."
Data Provenance: Not applicable. The testing was in vitro (laboratory-based) with device components, not involving human data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. Ground truth for clinical outcomes was not established as there were no clinical studies. The "ground truth" for the in vitro tests would be the accepted standards defined in the BS EN 1618-1997 specification, which are objective engineering/material performance metrics.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study was not performed. Clinical studies were not deemed necessary.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

No. This device is a medical catheter system, not an algorithm or AI. Standalone performance as typically described for AI/algorithm assessment is not relevant here.

7. The Type of Ground Truth Used

The ground truth used was objective engineering and material performance standards as defined by BS EN 1618-1997. This standard likely specifies acceptable ranges or thresholds for parameters like leakage, flow rate, tensile strength, and corrosion.

8. The Sample Size for the Training Set

Not applicable. There was no "training set" in the context of an AI or statistical model. The device development process would involve iterative design and testing, but not a formally defined "training set" as in machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there was no training set in the context of AI, there was no ground truth established for it. The "ground truth" for the in vitro tests was the objective performance criteria specified in the relevant engineering standard.

Summary

{0}------------------------------------------------

510(k) Summary of Safety and Effectiveness

The following section is included as required by the Safe Medical Device Act (SMDA) of 1990.

Name:	PFM Medical, Inc
Address:	2605 Temple Heights Drive
	Suite A
	Oceanside, CA 92056
Contact Person:	SALVADORE F. PALOMARES, RAC

NOV - 6 2009

510(k) Summary of Safety and Effectiveness

1 2307

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:

Trade Name:	Asept Pleural Drainage System
Common Name:	Tunneled Thoracic Catheter and Accessories
Classification:	DWM

Equivalent Devices:
Manufacturer:	Denver Biomedical (Cardinal Health)
Name:	Pleurx Pleural Catheter
510(k) #:	K010642/K011831/K051084/K052436

Device Description:

Intended Use:

The Asept Pleural Drainage System is intended for long-term, internittent drainage of symptomatic, recurrent, pleural effusions; including malignant pleural effusions and other pleural effusions that do not respond to treatment of the underlying disease.

Performance Data:

In vitro testing was performed on the Asept Pleural Drainage System to assure reliable design and performance in accordance with BS EN 1618-1997. Testing includes leakage, flow rate, tensile strength, and corrosion.

Clinical studies were not deemed necessary since in vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to legally marketed predicate device.

Biocompatibility:

Materials used in the Asept Pleural Drainage System meet the requirements of ISO 10993 or identical to legally marketed device.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services-USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. In the center of the seal is an emblem that features a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

PFM Medical, Incorporated C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services L.L.C. 1394 25th Street Northwest Buffalo, Minnesota 55313

NOV - 6 2009

Re: K093307

Trade/Device Name: Asept Pleural Drainage System Regulation Number: 21 CFR 870.5050 Regulation Name: Patient Care Suction Apparatus Regulatory Class: II Product Code: DWM Dated: October 21, 2009 Received: October 22, 2009

Dear Mr. Job:

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.

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.

{2}------------------------------------------------

Page 2- Mr. Job

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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Susan Francis

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

{3}------------------------------------------------

510(k):

Asept Pleural Drainage System Device Name:

The Asept Pleural Drainage System is intended for Indications for Use: long-term, intermittent drainage of symptomatic, recurrent, pleural effusions, including malignant pleural effusions and other pleural effusions that do not respond to treatment of the underlying disease.

× Prescription Use (Per 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)

Susan Pearce
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K093307

Regulation Number and Section

§ 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).