(208 days)
No
The document explicitly states that the devices have the same intended use, materials, configuration, and dimensional specifications as previously cleared devices, with the only difference being a surface treatment. There is no mention of AI, ML, image processing, or any data-driven performance metrics typically associated with AI/ML devices.
Yes
The device is intended for the drainage of persistent ascites to relieve symptoms, which is a therapeutic intervention.
No
This device is described as an ascites shunt used for drainage of fluid, indicating a therapeutic or palliative function rather than diagnosis.
No
The device description explicitly states it is a physical device (shunt and access kits) with material and dimensional specifications, and undergoes a surface treatment. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for the drainage of ascites from the abdominal cavity into the venous system. This is a therapeutic procedure performed on the patient's body, not a test performed on a sample taken from the patient's body to diagnose or monitor a condition.
- Device Description: The device is described as an "Ascites Shunt," which is a physical implant used to redirect fluid within the body. This is consistent with a therapeutic device, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze samples (like blood, urine, or tissue), detect analytes, or provide diagnostic information.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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
Product codes
78 KPM
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdominal cavity, venous system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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.
3
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