The Denver Pleural Effusion Shunt is indicated for use in patients with chylothorax, intractable aseptic pleural effusion. The Denver Pleural Effusion Shunt with External Pump Chamber is indicated for adult, pediatric, and neonatal patients with: chylothorax, intractable pleural effusion.

Device Description

The Denver Pleural Effusion Shunt with External Pump Chamber has three major components: 1. A 15.5 Fr silicone catheter, which is implanted in the pleural space and collects the accumulated pleural effusion fluid. In the shunt with the externalized pump chamber, the catheter is tunneled subcutaneously and incorporates a polyester cuff. 2. A valved pump chamber, which is either implanted or remains external to the body. The patient compresses the pump chamber to transfer fluid from the pleural space to the peritoneum. 3. A second 15.5 Fr. silicone catheter, similar to the first, which terminates in the abdominal cavity. This catheter also bears a polyester cuff in the shunt with the externalized pump chamber. Except for the polyester cuff, all components of the shunt are made of silicone rubber.

AI/ML Overview

This 510(k) summary describes a modification to an existing device, the Denver Pleural Effusion Shunt, specifically a change in the supplier of the silicone tubing used to fabricate the catheters. The focus of the submission and testing is to demonstrate that the modified device is substantially equivalent to the original device, not to prove the efficacy or safety of the device against specific clinical acceptance criteria in a new study. Therefore, traditional "acceptance criteria" for clinical performance are not explicitly stated or met in the same way a de novo device would.

Instead, the acceptance criteria for this submission revolve around confirming that the new silicone tubing performs equivalently to the old tubing and does not negatively impact the overall device performance or safety.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied for Material Change)	Reported Device Performance
Material Equivalence: New tubing must be "very similar" to the existing tubing and meet original material specifications.	"The new tubing is very similar to the existing tubing." "The specifications of the original material have been matched as closely as possible."
Bonding Performance: New tubing must bond well to other shunt components.	"Testing has verified that the tubing bonds well to the other components of the shunts."
Biocompatibility: New tubing (and finished devices containing it) must be biocompatible.	"Biocompatibility testing has been carried out on the raw elastomer of the silicone tubing and on the finished devices."
Substantial Equivalence: Modified devices must be substantially equivalent to the original devices.	"The modified devices have been found to be substantially equivalent to the original devices." (FDA concurs with this finding).

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

The document does not provide details on the specific sample sizes for the bonding or biocompatibility tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for these tests. Given the nature of a material change submission, these tests would typically be laboratory-based (in-vitro) rather than clinical studies on human subjects.

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

This section is not applicable to this 510(k) submission. The "ground truth" for a material change submission is primarily established through engineering tests (material characterization, bonding strength, etc.) and biocompatibility tests, which are evaluated against established standards and internal specifications, not by expert consensus on clinical outcomes.

4. Adjudication Method for the Test Set:

This section is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies involving multiple expert readers to resolve discrepancies in diagnoses or assessments. The tests described here are laboratory-based.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers' performance changes with and without AI assistance, which is irrelevant to a material change submission for a mechanical device.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):

This section is not applicable. This device is a mechanical shunt, not an AI algorithm. Therefore, there is no "standalone performance" in the context of AI. The performance of the device (e.g., fluid transfer, patency) is inherent to its mechanical design and material properties.

7. Type of Ground Truth Used:

The "ground truth" for this submission primarily relies on:

Material Specifications: Comparing the properties of the new silicone tubing to the established specifications of the original tubing.
Performance Standards: Demonstrating the new tubing's ability to bond properly and the biocompatibility of the material using recognized test methods (e.g., ISO standards for biocompatibility).
Substantial Equivalence Principles: The core ground truth for the 510(k) is the comparison to the predicate device to determine substantial equivalence.

8. Sample Size for the Training Set:

This section is not applicable. "Training set" refers to data used to train machine learning algorithms. This submission is for a mechanical medical device, not an AI/ML product.

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

This section is not applicable for the same reasons as point 8.

Summary

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KO12235

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OCT - 4 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 March 30, 2001.

Device Identification

This special 510(k) is for a modification to the Denver Pleural Effusion Shunt and Pleural Effusion Shunt with External Pump Chamber. The modification is a change in the supplier of the silicone tubing used to fabricate the catheters. The new tubing is very similar to the existing tubing, and the modified devices have been found to be substantially equivalent to the original devices.

Intended Use

The Denver Pleural Effusion Shunt with external pump chamber is used to palliate symptoms of recurrent pleural effusion, an accumulation of fluid in the cavity around the lungs.

Device Description

The Denver Pleural Effusion Shunt with External Pump Chamber has three major components:

1. A 15.5 Fr silicone catheter, which is implanted in the pleural space and collects the accumulated pleural effusion fluid. In the shunt with the externalized pump chamber, the catheter is tunneled subcutaneously and incorporates a polyester cuff.
1. A valved pump chamber, which is either implanted or remains external to the body. The patient compresses the pump chamber to transfer fluid from the pleural space to the peritoneum.
A second 15.5 Fr. silicone catheter, similar to the first, which terminates in the abdominal cav-3. ity. This catheter also bears a polyester cuff in the shunt with the externalized pump chamber.

Except for the polyester cuff, all components of the shunt are made of silicone rubber.

Summary of the change

The change that was the subject of the special 510(k) was a change in the silicone tubing used to manufacture the catheters. The original silicone tubing is no longer available. The specifications of the originl material have been matched as closely as possible. Testing has verified that the tubing bonds well to the other components of the shunts. Biocompatibility testing has been carried out on the raw elastomer of the silicone tubing and on the finished devices.

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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.

Public Health Service

OCT - 4 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Denver® Biomedical, Inc. c/o Nancy Sauer, RAC RDD Consultants, Inc. 401 Spruce Street LOUISVILLE CO 80027

Re: K012235 Trade/Device Name: Denver® Pleural Effusion Shunt and Denver® Pleural Effusion Shunt with External Pump Chamber Regulation Number: 21 CFR §876.5955 Regulation Name: Peritoneo-venous shunt Regulatory Class: II Product Code: 78 KPM Dated: September 11, 2001 Received: September 17, 2001
Dear Ms. Sauer:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamined 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.

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); 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.

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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 our labeling regulation (21 CFR Part 801), please 11 you accirce of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page

510(k) Number (if known): KO12235

Device Name: Demier Plaural Effusion Shunts

Indications For Use:

The Denver Pleural Effusion Shunt is indicated for use in patients with

• chylothorax

• intractable aseptic pleural effusion

The Denver Pleural Effusion Shunt with External Pump Chamber is indicated for adult, pediatric, and neonatal patients with:

• chylothorax

· intractable pleural effusion

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carolyn Y. Neiland

Radiological Devices
510(k) Number K01223

(Optional Format 3-10-98)

Prescription Use ✓

Regulation Number and Section

§ 876.5955 Peritoneo-venous shunt.

(a)
Identification. A peritoneo-venous shunt is an implanted device that consists of a catheter and a pressure activated one-way valve. The catheter is implanted with one end in the peritoneal cavity and the other in a large vein. This device enables ascitic fluid in the peritoneal cavity to flow into the venous system for the treatment of intractable ascites.(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(2) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” and
(3) Backflow specification and testing to prevent reflux of blood into the shunt.