(265 days)
Not Found
No
The summary describes a mechanical device for fluid transfer and does not mention any AI/ML components or related performance metrics.
Yes
The device is described as a fully implantable device that transfers fluid from the peritoneal space to the circulatory system to provide symptom relief for patients with intractable ascites, which directly treats a medical condition.
No
The device, an Ascites Shunt, is designed to transfer fluid from the peritoneal space to the circulatory system for symptom relief. Its function is to treat a condition by diverting fluid, not to diagnose a disease or condition.
No
The device description clearly states it is a "fully implantable device" and the performance studies describe bench-level testing on the "Ascites Shunt" which involves physical components and testing like displacement volume, resealing capacity, and biocompatibility, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a "fully implantable device that transfers fluid from the peritoneal space to the circulatory system." This is a therapeutic device designed to manage a physical condition (ascites) by moving fluid within the body.
- Intended Use: The intended use describes treating intractable ascites by shunting fluid, not by analyzing samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, this device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Peritoneovenous shunting is indicated for patients with malignant intractable ascites (including patients with chylous ascites, hepatorenal syndrome, and idiopathic ascites), not responding to standard medical management, and not considered candidates for portal-venous shunting
The 17Fr valved peel-away introducer is intended for use in the percutaneous insertion of catheters in the peritoneal space.
The 15.5Fr Pigtail Revision Catheter is indicated for revising the peritoneal catheter of an BD Curve Ascites Shunt.
Product codes (comma separated list FDA assigned to the subject device)
KPM, DYB
Device Description
The Ascites Shunt is a fully implantable device that transfers fluid from the peritoneal space to the circulatory system to provide symptom relief for patients with malignant or non-malignant intractable ascites.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneal space, circulatory 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)
Bench-level testing was carried out on Ascites Shunt to demonstrate substantial equivalence. The performance testing requirements were determined by the predicate devices and further defined by the standards listed below. The testing and evaluation conducted includes displacement volume, resealing capacity, interface testing, declogging, aging, biocompatibility, sterilization, and EO residuals.
N/A - No clinical tests were conducted for this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 2, 2017
CareFusion Tamara Brev Regulatory Affairs Advisor 75 North Fairway Drive Vernon Hills, IL 60061
Re: K170405
Trade/Device Name: BD Curve Ascites Shunt Regulation Number: 21 CFR§ 876.5955 Regulation Name: Peritoneo-Venous Shunt Regulatory Class: II Product Code: KPM, DYB Dated: September 29, 2017 Received: October 2, 2017
Dear Tamara Brey:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) 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. 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, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170405
Device Name
BD Curve Ascites Shunt
Indications for Use (Describe)
Peritoneovenous shunting is indicated for patients with malignant intractable ascites (including patients with chylous ascites, hepatorenal syndrome, and idiopathic ascites), not responding to standard medical management, and not considered candidates for portal-venous shunting
The 17Fr valved peel-away introducer is intended for use in the percutaneous insertion of catheters in the peritoneal space.
The 15.5Fr Pigtail Revision Catheter is indicated for revising the peritoneal catheter of an BD Curve Ascites Shunt.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) SUMMARY- K170405
A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.
| SUBMITTER INFORMATION | ||
|---|---|---|
| Name | CareFusion | |
| Address | 75 North Fairway Drive, Vernon Hills, IL 60061 USA | |
| Phone number | (847) 362-9485 | |
| Fax number | (312) 949-9245 | |
| Establishment Registration | ||
| Number | 1423507 | |
| Name of contact person | Tamara Brey | |
| Date prepared | November 1, 2017 | |
| DESCRIPTION OF DEVICE | ||
| Trade or proprietary name | BD Curve Ascites Shunt | |
| Device name | Ascites Shunt | |
| Classification name | Peritoneo-Venous Shunt | |
| Classification panel | Gastroenterology/Urology | |
| Regulation | Class II per 21CFR §876.5955 | |
| Product Code(s) | KPM, DYB | |
| Legally marketed device(s) to | ||
| which equivalence is claimed | Denver Ascites Shunt And Percutaneous Access Kit With Ascites Shunt: | |
| K011862 | ||
| Medcomp, Inc. - Valved Tearaway Introducer Generation II: K132498 | ||
| CareFusion – Valved Peelable Introducers: K122422 | ||
| Reason for 510(k) submission | This 510(k) submission is for minor design modifications to the Ascites | |
| Shunt pump chamber and the peritoneal catheter. A minor design | ||
| modifications to the peritoneal revision catheter design and addition of a | ||
| new placement accessory. Updates to labeling include a revision of | ||
| placement techniques and updated patient selection considerations. | ||
| Device description | The Ascites Shunt is a fully implantable device that transfers fluid from the | |
| peritoneal space to the circulatory system to provide symptom relief for | ||
| patients with malignant or non-malignant intractable ascites. | ||
| Intended use of the device | Peritoneovenous shunting is indicated for patients with malignant or non- | |
| malignant intractable ascites (including patients with chylous ascites, | ||
| hepatorenal syndrome, and idiopathic ascites), not responding to standard | ||
| medical management, and not considered candidates for portal-venous | ||
| shunting. | ||
| The 17Fr valved peel-away introducer is intended for use in the | ||
| percutaneous insertion of catheters in the peritoneal space. | ||
| The 15.5Fr Pigtail Revision Catheter is indicated for revising the peritoneal | ||
| catheter of a BD Curve Ascites Shunt. | ||
| Characteristic | New Device | Predicates: |
| CareFusion Denver Ascites Shunt PAK: | ||
| K011862 | ||
| Medcomp, Inc. - Valved Tearaway | ||
| Introducer Generation II: K132498 | ||
| CareFusion - Valved Peelable Introducers: | ||
| K122422 | ||
| Ascites Shunt Overall | ||
| Design | Shunt with pump chamber | |
| (Single Valved and Double | ||
| Valved) with venous and | ||
| peritoneal catheters | Same as predicate: CareFusion Denver | |
| Ascites Shunt PAK: K011862 | ||
| Ascites Shunt Materials | ||
| of Construction | Tubing: Silicone with a barium | |
| sulfate stripe and silique surface | ||
| treatment. | ||
| Pump Chamber Material: | ||
| Silicone with silique surface | ||
| treatment | Same as predicate: CareFusion Denver | |
| Ascites Shunt PAK: K011862 | ||
| Ascites Shunt Placement | ||
| Technique | Minimally invasive (Seldinger | |
| technique) for all shunts | Same as predicate: CareFusion Denver | |
| Ascites Shunt PAK: K011862 | ||
| Ascites Shunt | ||
| Design Intent | Placed percutaneously to | |
| manage ascites by recirculating | ||
| ascitic fluid from the peritoneal | ||
| space to the circulatory system | Same as predicate: CareFusion Denver | |
| Ascites Shunt PAK: K011862 | ||
| Valved Peelable | ||
| Introducer Overall Design | Peel-away introducer sheath | |
| which contains an integral valve | ||
| seal and dilator comprised of a | ||
| cylindrical tube with a locking | ||
| hub | Same as predicate: Medcomp, Inc. - | |
| Valved Tearaway Introducer Generation II: | ||
| K132498 | ||
| Valved Peelable | ||
| Introducer Design Intent | To obtain peritoneal access and | |
| facilitate catheter insertion while | ||
| minimizing air/fluid leakage. | Same as predicate: CareFusion - Valved | |
| Peelable Introducers: K12242 | ||
| Pigtail Revision Catheter | ||
| Design Intent | Placed percutaneously to | |
| replace occluded peritoneal limb | ||
| of Ascites shunt. | Same as predicate: CareFusion Denver | |
| Ascites Shunt PAK: K011862 | ||
| CONCLUSION OF DEVICE COMPARISON | ||
| The technological characteristics of the proposed devices are substantially equivalent to the predicates |
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SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Bench-level testing was carried out on Ascites Shunt to demonstrate substantial equivalence. The performance testing requirements were determined by the predicate devices and further defined by the standards listed below. The testing and evaluation conducted includes displacement volume, resealing capacity, interface testing, declogging, aging, biocompatibility, sterilization, and EO residuals.
Performance Test Summary
5
| Biocompatibility | ISO 10993-1: Part 1, Biological Evaluation of Medical Devices: Evaluation and
Testing within a Risk Management Process. |
|--------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | ISO 10993-5:2009/(R) 2014: Part 5, Biological Evaluation of Medical Devices --
Tests For In Vitro Cytotoxicity |
| Biocompatibility | ISO 10993-7 Second Edition 2008-10-15: Part 7, Biological Evaluation Of Medical
Devices - Ethylene Oxide Sterilization Residuals [Including: Technical Corrigendum
1 (2009)] |
| Biocompatibility | ISO 10993-12, 2012 Biological Evaluation Of Medical Devices - Part 12: Sample
Preparation and Reference Materials. |
| Biocompatibility | ISO 10993-17:2002: Part 17, Biological evaluation of medical devices -
Establishment of allowable limits for leachable substances |
| Biocompatibility | ISO 10993-18:2005: Part 18, Biological evaluation of medical devices - Chemical
characterization of materials |
| Sterilization | ISO 11135 2nd Ed: Sterilization of Health-Care Products -Ethylene Oxide -
Requirements for the Development, Validation and Routine Control of a Sterilization
Process for Medical Devices |
| Sterilization | ISO 11138-1 2nd Ed: Sterilization of Health Care Products - Biological Indicators -
Part 1: General Requirements |
| Sterilization | ISO 11737-1 2nd Ed: Sterilization of Medical Devices – Microbiological Methods
Part 1 |
| Sterilization | AAMI TIR28:2009(R) 2013: Product Adoption and Process Equivalency for Ethylene
Oxide Sterilization |
| Sterilization | ANSI/AAMI ST72:2011: Bacterial endotoxins - Test methods, routine monitoring,
and alternatives to batch testing |
| Packaging | AAMI / ANSI / ISO 11607-1:2006/(R)2010: Packaging For Terminally Sterilized
Medical Devices - Part 1:Requirements For Materials, Sterile Barrier Systems And
Packaging Systems [Including: Amendment 1 (2014)] |
| Packaging | AAMI/ANSI/ISO 11607-2:2006/(R)2010: Packaging For Terminally Sterilized Medical
Devices - Part 2: Validation Requirements For Forming, Sealing And Assembly
Processes [Including: Amendment 1 (2014)] |
| Risk Management | BS EN ISO 14971: 2012 Medical Devices. Application of Risk Management to
Medical Devices. |
| Performance | EN ISO 14630: Non-active Surgical Implants - General Requirements |
| Performance | BS EN 1617: 1997 Sterile Drainage Catheters and Accessory Devices for Single Use |
| Performance | BS EN 1618: 1997 Catheters other than Intravascular Catheters - Test Methods for
Common Properties |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL
EQUIVALENCE AND/OR OF CLINICAL INFORMATION | |
| | N/A - No clinical tests were conducted for this submission. |
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The results of the non-clinical tests show that the CareFusion Ascites Shunt is as safe, as effective, and performs as well as the legally marketed predicate devices.