The Denver® Pleurx® Pleural Catheter Kit and the Denver® Pleurx® Drainage Kit are indicated for intermittent, long-term drainage of symptomatic, recurrent pleural effusion, including malignant pleural effusion and other pleural effusions that do not respond to medical management of the underlying disease. The devices are indicated for 1) the relief of symptoms associated with pleural effusion, and 2) to provide a means for the instillation of physician-prescribed medications into the pleural space, and 3) to provide a means for pleurodesis (resolution of the pleural effusion).

Device Description

The Pleurx Pleural Catheter is a silicone tube that is partially implanted in the chest cavity. A cuff is included in the tunneled portion of the catheter. The cuff promotes tissue ingrowth, which helps to anchor the catheter and may provide a barrier against infection. The external portion of the catheter remains closed until it is opened with a specific drainage line. When the drainage line is in place, a vacuum source can be used to drain fluid that builds up in the chest cavity.

AI/ML Overview

This 510(k) summary describes a modification to an already legally marketed device, the Denver Pleural Catheter. Therefore, the "study" described is a series of tests to demonstrate that the modified device is substantially equivalent to the original device, rather than a clinical study proving efficacy or safety from scratch.

Here's the breakdown of the acceptance criteria and the "study" that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for modified components)	Reported Device Performance (as summarized in the 510(k))
Tubing:
1. Dimensional specifications equivalent to previous tubing	Found to be equivalent
2. Physical property specifications equivalent to previous tubing	Found to be equivalent
3. Bond strength between tubing and external valve assembly remains within specification	Within specification
4. Bond strength between tubing and cuff material meets approved specification	Meets approved specification
5. Meets acceptable standards for biocompatibility for long-term tissue contact	Meets acceptable standards (long-term contact with tissue)
Fabric (for velour cuff):
1. Material specifications (both are polyester double velour) equivalent to original fabric	Equivalent (both polyester double velour)
2. Fabric has previously been cleared by FDA for use as cuff material in the chest wall	Cleared for use as cuff material in chest wall

Note: The 510(k) states that the catheters made of the modified materials have been found "substantially equivalent" to the legally marketed catheter, implying that the performance of the new components aligns with the established performance and safety profile of the original device.

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

Sample Size: The document does not explicitly state the numerical sample sizes used for each test (e.g., how many tubing samples were tested for bond strength or biocompatibility). It describes the types of tests performed.
Data Provenance: Not explicitly stated, but given the context of a 510(k) submission by a medical device manufacturer, these tests would typically be performed in-house or by accredited contract labs specializing in medical device testing. The data would be prospective for the modified components, meaning the tests were conducted specifically to evaluate these new materials. There is no information on country of origin for the data, but it would be expected to adhere to US regulatory standards for medical devices.

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

Not Applicable in this context. This 510(k) is about material changes to a device, not about evaluating a diagnostic algorithm or a clinical outcome. Therefore, there is no "ground truth" to be established by experts in the sense of medical diagnosis or clinical interpretation. The "ground truth" here is adherence to engineering specifications and regulatory standards for biocompatibility. These standards are established by regulatory bodies and industry norms, and adherence is verified through laboratory testing.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic imaging, to resolve discrepancies between readers. For material testing, acceptance is determined by meeting predetermined numerical specifications (e.g., bond strength within a certain range, biocompatibility test results showing no adverse reaction).

5. 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. This document is a 510(k) for a physical medical device (a catheter) and its material changes. It does not involve AI or human readers, and therefore no MRMC study was conducted.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is a physical medical device, not an algorithm, so "standalone performance" in that sense is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for the modified components is based on pre-defined engineering specifications, physical property standards, established biocompatibility standards (e.g., ISO 10993 for medical devices), and FDA-cleared predicate material performance. The goal was to demonstrate that the new materials meet these established benchmarks and perform equivalently to the materials in the already cleared device.

8. The Sample Size for the Training Set

Not Applicable. This is a physical medical device, not an AI model, so there is no training set. The "training" for such a device would be the extensive research and development that led to the original design and the selection of materials conforming to standards.

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

Not Applicable. As there is no training set for an AI model, this question is not relevant. The "ground truth" in the context of device development for the original catheter would have been an iterative process of design, testing, and validation against a combination of engineering requirements, clinical needs, safety standards, and ultimately, a successful FDA clearance based on substantial equivalence to a predicate device.

Summary

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JUN 2 8 2001

510(k) Summary

Sponsor Information

Denver Biomedical, Inc. 14998 W. 6th Ave., Bldg. E700 Golden, CO 80401 303-279-7500

Contact Person: Jeff Hill, RA/QA Coordinator

This 510(k) summary was prepared on June 6, 2001.

Device Identification

This special 510(k) is for a modification to the Denver Pleural Catheter. The modification is a change in supplier for the tubing used to fabricate the catheter and a change in the velour fabis a change in supplier for the cathere made of the modified materials has been found substantially equivalent to the legally marketed catheter.

Intended Use

The Pleurx Pleural Catheter 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 Pleurx Pleural Catheter is a silicone tube that is partially implanted in the chest cavity. A cuff is included in the tunneled portion of the catheter. The cuff promotes tissue ingrowth, which helps io anchor the catheter and may provide a barrier against infection. The external portion of the te anoner the causes and and remains closed until it is opened with a specific drainage line. When the drainage line is in place, a vacuum source can be used to drain fluid that builds up in the chest cavity.

Summary of the change

The special 510(k) covers two material changes: a change in supplier for the tubing used to fabricate the catheter and a change in the fabric used to fabricate the cuff.

The new tubing has been found to be equivalent to the previous tubing by

1. Comparing the dimensional specifications
1. Comparing the physical property specifications
Testing to ensure that the bond strength between the tubing and the external valve assembly 3. remains within specification.
1. Testing to ensure that the bond strength between the tubing and the cuff material meets the approved specification.

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1. Testing to verify that the tubing meets acceptable standards for biocompatibility for a device in long-term contact with tissue.
  The new fabric has been found to be equivalent to the original fabric by a review of material specifications (both are polyester double velour) and by selecting a fabric that has previously been cleared by FDA for use as a cuff material in the chest wall.

Special 510(k): Pleurx Material Changes

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 a stylized image of an eagle with three wavy lines representing its wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 8 2001

Ms. Bonnie Vivian Denver Biomedical, Inc. 14998 W. 6th Ave., Bldg. E-700 Golden, CO 80401

Re: K011831

Trade Name: Pleurx pleural catheter and drainage kits Regulation Number: 870.5050 Regulatory Class: II (two) Product Code: 74 DWM Dated: June 11, 2001 Received: June 12, 2001

Dear Ms. Vivian:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

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Page 2 - Ms. Bonnie Vivian

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nredicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours.

Denk Tillh

-James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

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Koll83 510(k) Number (if known):_ Device Name: Pleura Pleural Catheter

Indications For Use:

The Denver® Pleurx® Pleural Catheter Kit and the Denver® Pleurx® Drainage Kit are
nt of the The Denver® Pleurx® Pleural Catheter Kir and and more of symptomatic, recurrent pleural effusion,
indicated for intermittent, long-term drainage of symptomatic, cost respond indicated for intermittent, long-lenn urantege or offer and other that do not respond to
including malignant pleural effusion and other are indicated for 1) the including malignant pleural circusion and out of the devices are indicated for 1 ) the medical management of the underlying discuser below be and the pleurodesis (resolution of the pleural effusion).

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number KO11831
of Cardiovascular scular & Respiratory

(Optional Format 3-10-98)

Prescription Use Only

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).