(208 days)
Drainage of persistent ascites from the abdominal cavity into the venous system, for use in patients with: *chronic liver disease whose ascites has not responded to surgical correction of their portal hypertension nor to standard medical management *persistent ascites who are not considered candidates for portal-venous shunting *persistent ascites which is non-responsive to standard medical management *primary or metastatic intra-abdominal neoplasms with massive ascites to help relieve intra-abdominal pressure *persistent ascites with hepatorenal syndrome, chylous ascites, and idiopathic ascites
The devices have the same intended use, materials, configuration and dimensional specifications as the currently marketed Denver® Ascites Shunts (K894756) and Denver® Ascites Shunt Percutaneous Access Kits (K913728). The devices differ in that: The devices covered by this submission undergo a surface 1) treatment as part of the manufacturing process. No TDMAC-Heparin is applied to the devices covered by this 2) submission.
The provided text describes a 510(k) premarket notification for the Denver® Ascites Shunts and Denver® Ascites Shunt Percutaneous Access Kits. This document focuses on demonstrating substantial equivalence to existing devices, not on proving device performance through a clinical study with acceptance criteria in the manner typically associated with new AI/software devices.
Therefore, many of the requested fields cannot be directly answered from the provided text as it describes a different type of regulatory submission. The submission is for a medical device (a shunt) and focuses on manufacturing process changes rather than a new diagnostic or therapeutic algorithm.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the context of a clinical performance study. The "acceptance criteria" here implicitly revolve around demonstrating substantial equivalence to previously cleared devices (K894756 and K913728) based on having the "same intended use, materials, configuration and dimensional specifications," with the only differences being "a surface treatment as part of the manufacturing process" and "No TDMAC-Heparin is applied."
- Reported Device Performance: Not reported in terms of specific clinical metrics (e.g., sensitivity, specificity, accuracy). The submission asserts that the "manufacturing process changes... should not raise new issues of safety and/or effectiveness."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. The document does not describe a performance study with a test set. It focuses on comparison to a predicate device and manufacturing process changes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No test set or ground truth establishment by experts is described in this regulatory submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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
- Not applicable. This device is a physical shunt, not an AI software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. Since no clinical performance study is described, no ground truth is created or used in the context of algorithm evaluation.
8. The sample size for the training set
- Not applicable. No training set for an AI algorithm is mentioned.
9. How the ground truth for the training set was established
- Not applicable. No training set or ground truth establishment for a training set is mentioned.
Summary of what the document actually states regarding "acceptance criteria" (implicitly substantial equivalence) and "proof":
The document argues for the substantial equivalence of the Denver® Ascites Shunts and Denver® Ascites Shunt Percutaneous Access Kits to previously cleared devices (K894756 and K913728) based on the following:
- Acceptance Criteria (implicit for 510(k) pathway): The new device must have the same intended use, materials, configuration, and dimensional specifications as the predicate devices, and any differences (in this case, a surface treatment and absence of TDMAC-Heparin) should not raise new issues of safety and/or effectiveness.
- Study/Justification for Meeting Criteria: The "study" here is essentially the detailed comparison presented in the submission.
- Comparison Basis: The devices have the "same intended use, materials, configuration and dimensional specifications" as the Denver® Ascites Shunts (K894756) and Denver® Ascites Shunt Percutaneous Access Kits (K913728).
- Differences:
- "The devices covered by this submission undergo a surface treatment as part of the manufacturing process."
- "No TDMAC-Heparin is applied to the devices covered by this submission."
- Proof of Equivalence despite differences: The submitter states, "The manufacturing process changes that are the subject of this submission should not raise new issues of safety and/or effectivenenss." They further support this by stating the devices are "substantially equivalent to Smith & Nephew Ventilation Tubes in that they both undergo this surface treatment as part of the manufacturing process," implying a precedent for the safety of the surface treatment itself.
In essence, the "study" is a regulatory comparison and justification rather than a typical clinical performance trial with predefined endpoints and statistical analyses.
{0}------------------------------------------------
K973/29 P½
MAR 17 1998
Summary of Safety and Effectiveness Denver® Ascites Shunts Denver® Ascites Shunt Percutaneous Access Kits
SUBMITTER INFORMATION
Denver Biomaterials, Inc. 14998 W. 6th Avenue, Bldg. E700 Golden, Colorado 80401 USA
Bonnie Vivian Vice President
DEVICE COMMON NAME
Peritoneovenous Shunt
DEVICE CLASSIFICATION NAME
Peritoneo-venous Shunt
IDENTIFICATION OF SUBSTANTIALLY EQUIVALENT DEVICE (S)
The devices are substantially equivalent to the currently marketed Denver® Ascites Shunts and Denver® Ascites Shunt Percutaneous Access Kits. The devices have the same intended use, materials, configuration and dimensional specifications as the currently marketed Denver® Ascites Shunts (K894756) and Denver® Ascites Shunt Percutaneous Access Kits (K913728).
The devices differ in that:
The devices covered by this submission undergo a surface 1) treatment as part of the manufacturing process. No TDMAC-Heparin is applied to the devices covered by this 2) submission.
The devices are also substantially equivalent to Smith & Nephew Ventilation Tubes in that they both undergo this surface treatment as part of the manufacturing process.
The manufacturing process changes that are the subject of this submission should not raise new issues of safety and/or effectivenenss.
INTENDED USE
Drainage of persistent ascites from the abdominal cavity into the venous system, for use in patients with:
{1}------------------------------------------------
*chronic liver disease whose ascites has not responded to "chronic fiver dibease whole portal hypertension nor to standard medical management
*persistent ascites who are not considered candidates for portalvenous shunting
*persistent ascites which is non-responsive to standard medical management
*primary or metastatic intra-abdominal neoplasms with massive ascites to help relieve intra-abdominal pressure
*persistent ascites with hepatorenal syndrome, chylous ascites, and idiopathic ascites
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 7 1998
Ms. Bonnie B. Vivian Vice President Denver Biomaterials, Inc. 14998 W. 6th Avenue, Bldg. E700 Golden, Colorado 80401
Re: K973129 Denver Ascites Shunts and Percutaneous Access Kits December 18, 1997 Dated: Received: December 19, 1998 Regulatory Class: III 21 CFR 876.5955/Product Code: 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 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.q., 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.
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Page - 2 - Ms. Bonnie B. Vivian
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 predicate 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) 594-4613. 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,
Robert R Satting/
$\xi$
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
INDICATIONS FOR USE
510(k) Number: к 97 3/29
Denver® Ascites Shunts Device Name: Denver® Ascites Shunt Percutaneous Access Kits
Indications
For Use:
Drainage of persistent ascites from the abdominal cavity into the venous system, for use in patients with: *chronic liver disease whose ascites has not
responded to surgical correction of their portal hypertension nor to standard medical management
*persistent ascites who are not considered candidates for portal-venous shunting
*persistent ascites which is non-responsive to standard medical management
*primary or metastatic intra-abdominal neoplasms with massive ascites to help relieve intraabdominal pressure
*persistent ascites with hepatorenal syndrome, chylous ascites, and idiopathic ascites
-------Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert D. Rathbun
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use: Yes
(Per 21 CFR 801.109)
Over-The-Counter Use: No
OR
§ 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.