chronic liver disease whose ascites has not responded to surgical correction of their underlying disease and to medical management.
persistent ascites who are not considered candidates for portal-venous shunting.
persistent ascites that is non-responsive to standard medical management.
peritoneal intra-abdominal neoplasms with massive ascites to help relieve abdominal distension and intra-abdominal pressure.
Peritoneo-venous shunting should also be considered for patients with hepatorenal syndrome and idiopathic ascites.

Device Description

The Denver Ascites shunt is made of a fenestrated peritoneal catheter, which collects the ascites fluid; a one-way valve, which allows flow from the peritoneum to the venous system but no reverse flow; and a venous catheter, which discharges the ascites fluid into the central venous system.
The fluid transfer happens automatically when the patient lies down, because of the pressure differential between the peritoneal cavity and the central venous system. The spontaneous rate of transfer can be supplemented by manual pumping of the chamber. Pumping may also help limit buildup of fibrinous debris in the chamber.
All components of the shunt are made of silicone rubber.

AI/ML Overview

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Similar formulation and physical properties to previous tubing	The tubing produced by the new supplier is "very similar in formulation and physical properties" to the tubing previously used.
Dimensional specifications comparison	The dimensional specifications of the new tubing were compared. (Specific details of "within specification" are not provided in this summary).
Physical property specifications comparison	The physical property specifications of the new tubing were compared. (Specific details of "within specification" are not provided in this summary).
Bond strength between tubing and shunt body within specification	Testing was conducted to ensure the bond strength between the new tubing and the shunt body remains within specification. (Specific details of "within specification" are not provided in this summary).
Friction fit between tubing and nylon connectors within specifications	Testing was conducted to ensure the friction fit between the new tubing and the nylon connectors used in shunt revision is within specifications. (Specific details of "within specification" are not provided in this summary).
Expected response to surface treatment process for reduced friction	Testing was conducted to ensure the new tubing responds as expected to a surface treatment process that reduces surface friction. (Specific details of "expected response" are not provided in this summary).
Biocompatibility for long-term contact with blood meets acceptable standards	Testing was conducted to verify that the tubing meets acceptable standards for biocompatibility for a device in long-term contact with blood. (Specific details of "acceptable standards" or the results of the biocompatibility tests are not provided in this summary).
Substantial equivalence to legally marketed shunt (overall device performance)	The shunt with the tubing produced by the new supplier has been found to be substantially equivalent to the legally marketed shunt. This is the overarching conclusion related to the device performance in meeting the acceptance criteria for this 510(k) modification.

2. Sample size used for the test set and data provenance:

The document does not explicitly state the sample size for the test set regarding the various physical and biocompatibility tests. It broadly mentions "comparing" and "testing to ensure/verify" without enumerating samples.
The data provenance is not specified (e.g., country of origin).
The study is retrospective in nature, focusing on the characterization and comparison of the new tubing material against established specifications of the previously used tubing and the legally marketed device.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

This information is not provided. The ground truth for the test set for device performance heavily relies on established engineering specifications, material science standards, and biocompatibility guidelines rather than expert consensus on interpretative outputs (like in imaging devices).

4. Adjudication method for the test set:

This information is not applicable and not provided. The tests described are objective measurements against pre-defined specifications, not subjective interpretations 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 type of study is typically performed for diagnostic or AI-assisted interpretation devices to assess human performance with and without AI. This submission is for a material change in a medical device (Denver Ascites Shunt).

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

This question is not applicable to this medical device submission. The device is a physical shunt; there is no "algorithm" in the sense of a software-based diagnostic or assistive tool. The "standalone" performance refers to the device's physical and biological integrity as a component of the shunt system.

7. The type of ground truth used:

The ground truth used for this study is based on established engineering specifications, material property standards, and biocompatibility standards. These are objective, quantitative criteria for material composition, physical dimensions, mechanical properties (bond strength, friction fit), and biological safety. The "legally marketed shunt" served as the primary reference for substantial equivalence.

8. The sample size for the training set:

This information is not applicable and not provided. This modification involves a change in a physical component (tubing) of a medical device, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established:

This information is not applicable. As stated above, there is no "training set" in the context of an AI/ML algorithm for this device modification.

Summary

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KO11862

Page 1 of 2

JUL 1 2 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 11, 2001.

Device Identification

This special 510(k) is for a modification to the Denver Ascites Shunts and Denver PAK: Percutane-I mis opecial 910(x) is to to a speritoneovenous) Shunt. The modification is a change in supplier for the tubing used to fabricate the peritoneal cottagers and the venous catheter of the surgicallythe tubing used to tablied on py the new supplier is very similar in formulation and physical properties to the tabing made of all seen used previously. The shunt with the tubing produced by the new supplier has been found to be substantially equivalent to the legally marketed shunt.

Intended Use

The Denver Ascites Shunts are used to symptomatically treat intractable ascites due to dissemi-I ne Denver Hotelsease, hepatic disease, and other underlying diseases and conditions that cause ascites fluid to build up in the abdominal cavity.

Device Description

The Denver Ascites shunt is made of a fenestrated peritoneal catheter, which collects the ascites r nic Delver I setted on and ich allows flow from the peritoneum to the venous system but no reverse flow; and a venous catheter, which discharges the ascites fluid into the central venous system.

The fluid transfer happens automatically when the patient lies down, because of the pressure differential between the peritoneal cavity and the central venous system. The spontaneous rate of transfer can be supplemented by manual pumping of the chamber. Pumping may also help limit buildup of fibrinous debris in the chamber.

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 supplier for the tubing that forms the peritoneal catheters of all ascites shunts and the venous catheter of the surgically-placed shunts.

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

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1. Comparing the dimensional specifications
Comparing the physical property specifications 2.
Testing to ensure that the bond strength between the tubing and the shunt body remains 3. within specification.
Testing to ensure that the friction fit between the tubing and the nylon connectors used in 4. shunt revision is within specifications. ،
Testing to ensure that the new tubing responds as expected to a surface treatment process that 5. reduces surface friction.
Testing to verify that the tubing meets acceptable standards for biocompatibility for a device in 6. long-term contact with blood.

ક્વ

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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 stylized eagle with three curved lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 2 2001

Ms. Bonnie B. Vivian President and CEO Denver® Biomedical, Inc. 14998 W. 6th Avenue, Bldg. E-700 GOLDEN CO 80401

Re: K011862

Denver® Ascites Shunt and Percutaneous Access Kit with Ascites Shunt Dated: June 11, 2001 Received: June 14, 2001 Regulatory Class: II 21 CFR §876.5955/Procode: 78 KPM

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 (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). 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.

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.

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Page 2 - Ms. Bonnie Vivian

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 predicate device results in a classification for your device and thus, permits your device to proceed to the market. If aconed four and since 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) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Addrivinally, for questions on the ply 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,

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): A 011862

Device Name: Denver Ascites Shunts

Indications For Use:

Peritoneo-venous shunting is indicated for patients with:

chronic liver disease whose ascites has not responded to surgical correction of their
es and the starter to see and modical management. . chronic liver disease whose aseres has not
persistent ascites who are not considered candidates for portal-venous shunting. .
persistent ascites that is non-responsive to standard medical management. .
permaterial intra-abdominal neoplasms with massive ascites to help relieve
s and and intra-abdominal pressure.

neeritoneo-wenous shunting should also be considered for patients with hepatorenal
s and the became in any delignethic ascites Peritoneo-venous shanting ond idiopathic ascites.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancye Broaddus
(Division(Sign-Off))

Division of Reproductive, Abdominal. and Radiological Devices 510(k) Number _

(Optional Format 3-10-98)

Prescription Use
(Per 21 CFR 801.109)

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.