(265 days)
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.
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.
The provided text is a 510(k) summary for the BD Curve Ascites Shunt. It primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. It explicitly states that no clinical tests were conducted. Therefore, the study described is a non-clinical bench-level testing study.
Here's the breakdown based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists "Performance Test Summary" but does not explicitly provide a table of acceptance criteria with corresponding device performance values. Instead, it lists the standards against which various performance characteristics were evaluated. The conclusion states that the device "performs as well as the legally marketed predicate devices."
| Performance Characteristic | Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|---|
| Displacement Volume | Implicit: Meeting predicate equivalence and relevant standards | Met standards and performed as well as predicate |
| Resealing Capacity | Implicit: Meeting predicate equivalence and relevant standards | Met standards and performed as well as predicate |
| Interface Testing | Implicit: Meeting predicate equivalence and relevant standards | Met standards and performed as well as predicate |
| Declogging | Implicit: Meeting predicate equivalence and relevant standards | Met standards and performed as well as predicate |
| Aging | Implicit: Meeting predicate equivalence and relevant standards | Met standards and performed as well as predicate |
| Biocompatibility | ISO 10993-1, -5, -7, -12, -17, -18 | Met standards and performed as well as predicate |
| Sterilization | ISO 11135, ISO 11138-1, ISO 11737-1, AAMI TIR28, ANSI/AAMI ST72 | Met standards and performed as well as predicate |
| EO Residuals | ISO 10993-7 | Met standards and performed as well as predicate |
| Packaging | AAMI/ANSI/ISO 11607-1, -2 | Met standards and performed as well as predicate |
| Risk Management | BS EN ISO 14971 | Met standards and performed as well as predicate |
| Performance | EN ISO 14630, BS EN 1617, BS EN 1618 | Met standards and performed as well as predicate |
Note: The detailed quantitative acceptance criteria and specific performance results are not provided in this summary but are implicitly confirmed as "met" by the conclusion of substantial equivalence.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided text for each specific test. The term "bench-level testing" implies laboratory-based tests on device samples, but the exact number of units tested for each characteristic is not given.
- Data Provenance: The testing was "bench-level," indicating it was conducted in a laboratory setting, likely at the manufacturer's facility or a contracted testing lab. There is no information regarding the country of origin of the "data" as it pertains to patient data, as this was a non-clinical study. The study is prospective in the sense that the testing was conducted specifically for this 510(k) submission, but it is not a clinical prospective study on human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable. For non-clinical bench testing, "ground truth" as it relates to expert clinical judgment is not established. Performance is measured against predefined technical specifications and international standards (e.g., ISO, AAMI).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This question is not applicable for non-clinical bench testing. Performance is typically assessed against quantitative thresholds or qualitative observations by laboratory personnel, not by medical experts adjudicating clinical outcomes.
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:
This question is not applicable. The device is an Ascites Shunt, a physical medical device, not an AI-based diagnostic or assistive software. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is not applicable. The device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the non-clinical tests consisted of established international and national standards (e.g., ISO, AAMI, ANSI, BS EN) and the performance characteristics of legally marketed predicate devices. The device's performance was compared to these defined standards and predicate device characteristics to demonstrate substantial equivalence, rather than to clinical "ground truth" like pathology or outcomes data.
8. The sample size for the training set:
This question is not applicable as this was a non-clinical study for a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
This question is not applicable for the same reason as above.
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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.
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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
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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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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 RegistrationNumber | 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) towhich equivalence is claimed | Denver Ascites Shunt And Percutaneous Access Kit With Ascites Shunt:K011862Medcomp, Inc. - Valved Tearaway Introducer Generation II: K132498CareFusion – Valved Peelable Introducers: K122422 | |
| Reason for 510(k) submission | This 510(k) submission is for minor design modifications to the AscitesShunt pump chamber and the peritoneal catheter. A minor designmodifications to the peritoneal revision catheter design and addition of anew placement accessory. Updates to labeling include a revision ofplacement techniques and updated patient selection considerations. | |
| Device description | The Ascites Shunt is a fully implantable device that transfers fluid from theperitoneal space to the circulatory system to provide symptom relief forpatients 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 standardmedical management, and not considered candidates for portal-venousshunting.The 17Fr valved peel-away introducer is intended for use in thepercutaneous insertion of catheters in the peritoneal space.The 15.5Fr Pigtail Revision Catheter is indicated for revising the peritonealcatheter of a BD Curve Ascites Shunt. | |
| Characteristic | New Device | Predicates: |
| CareFusion Denver Ascites Shunt PAK:K011862Medcomp, Inc. - Valved TearawayIntroducer Generation II: K132498CareFusion - Valved Peelable Introducers:K122422 | ||
| Ascites Shunt OverallDesign | Shunt with pump chamber(Single Valved and DoubleValved) with venous andperitoneal catheters | Same as predicate: CareFusion DenverAscites Shunt PAK: K011862 |
| Ascites Shunt Materialsof Construction | Tubing: Silicone with a bariumsulfate stripe and silique surfacetreatment.Pump Chamber Material:Silicone with silique surfacetreatment | Same as predicate: CareFusion DenverAscites Shunt PAK: K011862 |
| Ascites Shunt PlacementTechnique | Minimally invasive (Seldingertechnique) for all shunts | Same as predicate: CareFusion DenverAscites Shunt PAK: K011862 |
| Ascites ShuntDesign Intent | Placed percutaneously tomanage ascites by recirculatingascitic fluid from the peritonealspace to the circulatory system | Same as predicate: CareFusion DenverAscites Shunt PAK: K011862 |
| Valved PeelableIntroducer Overall Design | Peel-away introducer sheathwhich contains an integral valveseal and dilator comprised of acylindrical tube with a lockinghub | Same as predicate: Medcomp, Inc. -Valved Tearaway Introducer Generation II:K132498 |
| Valved PeelableIntroducer Design Intent | To obtain peritoneal access andfacilitate catheter insertion whileminimizing air/fluid leakage. | Same as predicate: CareFusion - ValvedPeelable Introducers: K12242 |
| Pigtail Revision CatheterDesign Intent | Placed percutaneously toreplace occluded peritoneal limbof Ascites shunt. | Same as predicate: CareFusion DenverAscites 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
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| Biocompatibility | ISO 10993-1: Part 1, Biological Evaluation of Medical Devices: Evaluation andTesting 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 MedicalDevices - Ethylene Oxide Sterilization Residuals [Including: Technical Corrigendum1 (2009)] |
| Biocompatibility | ISO 10993-12, 2012 Biological Evaluation Of Medical Devices - Part 12: SamplePreparation 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 - Chemicalcharacterization of materials |
| Sterilization | ISO 11135 2nd Ed: Sterilization of Health-Care Products -Ethylene Oxide -Requirements for the Development, Validation and Routine Control of a SterilizationProcess 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 MethodsPart 1 |
| Sterilization | AAMI TIR28:2009(R) 2013: Product Adoption and Process Equivalency for EthyleneOxide 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 SterilizedMedical Devices - Part 1:Requirements For Materials, Sterile Barrier Systems AndPackaging Systems [Including: Amendment 1 (2014)] |
| Packaging | AAMI/ANSI/ISO 11607-2:2006/(R)2010: Packaging For Terminally Sterilized MedicalDevices - Part 2: Validation Requirements For Forming, Sealing And AssemblyProcesses [Including: Amendment 1 (2014)] |
| Risk Management | BS EN ISO 14971: 2012 Medical Devices. Application of Risk Management toMedical 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 forCommon Properties |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIALEQUIVALENCE 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.
§ 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.