(90 days)
The ReFlow System Mini, used as components of a shunt system, is for use in the treatment of patients with hydrocephalus or conditions where draining of cerebrospinal fluid (CSF) is medically indicated. The miniaturized ReFlow Flusher may be used by a qualified clinician as a tool to facilitate a noninvasive retrograde fluid flush of the ReFlow Ventricular Catheter to unblock inlet holes or open its relief membrane to restore, increase, or maintain CSF flow. The ReFlow System Mini is not intended to change the diagnosis, treatment, or follow-up of patients with proximal catheter occlusions. Under the care, direction of the treating physician, the ReFlow System Mini may be used as directed for noninvasive flushing by a trained healthcare professional in-clinic or by a trained caregiver or adult patient in a non-clinical environment.
The ReFlow System Mini (RSM), consists of the ReFlow Mini Flusher and ReFlow Ventricular Catheter, both implantable components of a cerebrospinal fluid (CSF) shunt system used in the treatment of patients with hydrocephalus and other CSF disorders when draining of CSF is medically indicated. The catheter is surgically implanted in the ventricle of the brain and connected distally to the Mini Flusher. The Mini Flusher is then connected to a commercially available flow/pressure regulating valve (not provided as part of the ReFlow System Mini).
The flusher contains a fluid reservoir and when implanted as part of a shunt system, may be used at the treating physician's discretion as a tool to non-invasively facilitate a one-way retrograde pulse of fluid through the ventricular catheter to potentially restore or maintain flow in the shunt system by unblocking the proximal catheter. The flusher is noninvasively actuated by depressing the flusher dome, which is palpable underneath the patient's scalp, to send a controlled and limited pulse of a consistent volume of fluid (patient's CSF or sterile saline introduced from the priming procedure before implant) within the closed system. In cases where inlet holes are not able to be unblocked by a flush actuation, the flush will open the ReFlow Ventricular Catheter emergency relief membrane to provide a secondary fluid pathway to restore or increase CSF flow in the shunt system.
After flushing the device, palpation to confirm the dome has returned to its original shape may be used to determine that the reservoir has refilled prior to flushing a second time. Refilling of the flusher reservoir can be confirmed by palpation of the dome, indicating that CSF from the ventricles is able to flow through the ventricular catheter to the ReFlow Mini Flusher. The clinician must use his/her medical judgment and standard practice at his/her institution to care for the patient pre, during, and post utilization of the ReFlow System Mini.
The ReFlow System Mini does not regulate the flow/pressure of the shunt system. A flow regulating shunt valve is not provided with the ReFlow System Mini. During passive flow, fluid from the ventricular catheter flows freely through the Mini Flusher to the regulating valve. The ReFlow System Mini is designed to be compatible with most commercially available flow/pressure requlative valves with standard inlet connectors. Additionally, the Reflow Mini Flusher component utilizes a common barbed connector designed to be compatible with most commercially available ventricular catheters in addition to the ReFlow Ventricular Catheter.
This document describes the ReFlow System Mini, a device used in the treatment of hydrocephalus. The device consists of a miniaturized flusher and a ventricular catheter, designed to facilitate non-invasive retrograde fluid flushing to restore or maintain CSF flow. The submission (K221918) seeks to demonstrate substantial equivalence to a predicate device (ReFlow Ventricular Catheter and Flusher System, K172006).
1. Table of Acceptance Criteria and Reported Device Performance:
The document summarizes performance data rather than providing a detailed table of acceptance criteria and specific numerical performance metrics. However, based on the provided text, the acceptance criteria are generally "met specifications for intended use" and "substantially equivalent to the predicate device."
| Test Category | Test Method Summary | Reported Device Performance and Conclusion |
|---|---|---|
| Particulate Testing | Units undergo particulate testing to evaluate that the number of particulates generated from both exterior and interior lumen of the ReFlow Mini Flusher, under simulated use conditions, does not pose any safety risks. | All results met acceptance criteria and demonstrate that the RSM performance is suitable for its intended use and is substantially equivalent to the predicate device. |
| Design Verification Bench Testing | Conducted testing and reported results in accordance with ISO 7197:2006 (E), Neurosurgical Implants - Sterile, single-use hydrocephalus shunts and components and ASTM F647: 94(2014), Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application. | All results met acceptance criteria and demonstrate the RSM is suitable for its intended use and is substantially equivalent to the predicate device. |
| Reliability and System Level Functional Test | Testing was conducted to verify the reliability of the ReFlow System Mini to function during its expected useful life and meet requirements of ISO 7197:2006 (E), Neurosurgical Implants - Sterile, single-use hydrocephalus shunts and components and ASTM F647: 94(2014), Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application. | All results met acceptance criteria and demonstrate the RSM is suitable for its intended use and is substantially equivalent to the predicate device. |
| Usability and Human Factors Testing | Human Factors and Usability evaluations for critical tasks according to ReFlow Mini labeling were conducted in accordance with ANSI/AAMI HE 75, Human Factors Engineering Design of Medical Devices, IEC 62366:2007, Medical Devices - Application of Usability Engineering to Medical Devices, and FDA Guidance (Jun 22, 2011) Human Factors Draft Guidance. | RSM is deemed to meet its specifications for its intended use and is substantially equivalent to the predicate device. In all cases, the acceptance criteria were met, and the device performed as expected according to its specifications and in compliance with applicable recognized standards. In all instances, the RSM functioned as intended and were as expected. These test results confirm that RSM complies with the recognized standards, the design specifications and performance requirements for the intended use, and is substantially equivalent to the predicate. |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document mentions that usability and human factors testing demonstrated that flushing can be performed by "a trained healthcare provider (other than the treating physician), a caregiver, or adult patient" without special skills or education. However, it does not specify the sample size for this human factors test set, nor the country of origin of the data, or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document states that human factors and usability performance testing demonstrated that the device could be used by "a trained healthcare professional in-clinic or by a trained caregiver or adult patient in a non-clinical environment" under the direction of the treating physician. However, it does not specify the number of experts used to establish a 'ground truth' for the test set or their qualifications, as the testing seems focused on user performance rather than expert assessment of outcomes in a clinical trial.
4. Adjudication Method for the Test Set:
The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test set. The performance data focuses on technical and functional compliance rather than diagnostic or clinical effectiveness that would typically require such adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The evaluation focuses on the safety and performance of the device itself, and its equivalence to a predicate device, rather than comparing human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The device described is a physical medical device (shunt system components) and not an algorithm or AI-powered system. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable here. The device's function involves human interaction for actuation (flushing).
7. The Type of Ground Truth Used:
The ground truth used for these tests is based on engineering and performance standards (ISO 7197:2006, ASTM F647: 94(2014), ANSI/AAMI HE 75, IEC 62366:2007, and FDA Guidance for Human Factors) and whether the device operates as designed to restore or maintain CSF flow, without posing safety risks. The "ground truth" here is the successful demonstration that the device's functional and safety characteristics meet these established engineering and usability requirements.
8. The Sample Size for the Training Set:
This information is not provided in the document, as the device is a physical medical device, not a machine learning model that would typically have a "training set."
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as the device is not a machine learning model, and therefore, there is no "training set" or ground truth for such a set in the context of this submission.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a bold, sans-serif font and the full name, "U.S. Food & Drug Administration," written below it in a smaller font.
September 29, 2022
Anuncia Medical, Inc. Natalie Eagleburger Senior Director, Regulatory, Clinical, Quality 1355 N Scottsdale Rd. Suite 370 Scottsdale, Arizona 85257
Re: K221918
Trade/Device Name: ReFlow System Mini Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt And Components Regulatory Class: Class II Product Code: JXG Dated: June 30, 2022 Received: July 1, 2022
Dear Natalie Eagleburger:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
{1}------------------------------------------------
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K221918
Device Name ReFlow System Mini
Indications for Use (Describe)
The ReFlow System Mini, used as components of a shunt system, is for use in the treatment of patients with hydrocephalus or conditions where draining of cerebrospinal fluid (CSF) is medically indicated. The miniaturized ReFlow Flusher may be used by a qualified clinician as a tool to facilitate a noninvasive retrograde fluid flush of the ReFlow Ventricular Catheter to unblock inlet holes or open its relief membrane to restore, increase, or maintain CSF flow. The ReFlow System Mini is not intended to change the diagnosis, treatment, or follow-up of patients with proximal catheter occlusions. Under the care, direction of the treating physician, the ReFlow System Mini may be used as directed for noninvasive flushing by a trained healthcare professional in-clinic or by a trained caregiver or adult patient in a non-clinical environment.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
ReFlow System Mini
1. SUBMITTER
Anuncia Medical. Inc. 1355 North Scottsdale Rd, Suite 370 Scottsdale, AZ 85257, USA
| Phone: | 978-942-5600 |
|---|---|
| Contact Person: | Natalie Eagleburger |
| Date Prepared: | September 28, 2022 |
II. DEVICE
Trade Name: ReFlow System Mini Common or Usual Name: CSF Shunt System Classification Name: Shunt, Central Nervous System and Components Requlatory Class: Class II Product Code and Regulation: JXG, 21CFR 882.5550
lll. PREDICATE DEVICE
Primary Predicate
ReFlow Ventricular Catheter and Flusher System (K172006) This predicate has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The ReFlow System Mini (RSM), consists of the ReFlow Mini Flusher and ReFlow Ventricular Catheter, both implantable components of a cerebrospinal fluid (CSF) shunt system used in the treatment of patients with hydrocephalus and other CSF disorders when draining of CSF is medically indicated. The catheter is surgically implanted in the ventricle of the brain and connected distally to the Mini Flusher. The Mini Flusher is then connected to a commercially available flow/pressure regulating valve (not provided as part of the ReFlow System Mini).
The flusher contains a fluid reservoir and when implanted as part of a shunt system, may be used at the treating physician's discretion as a tool to non-invasively facilitate a one-way retrograde pulse of fluid through the ventricular catheter to potentially restore or maintain flow in the shunt system by unblocking the proximal catheter. The flusher is noninvasively actuated by depressing the flusher dome, which is palpable underneath the patient's scalp, to send a controlled and limited pulse of a consistent volume of fluid (patient's CSF or sterile saline introduced from the priming procedure before implant) within the closed system. In cases where inlet holes are not able to be unblocked by a flush actuation, the flush will open the ReFlow Ventricular Catheter emergency relief membrane to provide a secondary fluid pathway to restore or increase CSF flow in the shunt system.
After flushing the device, palpation to confirm the dome has returned to its original shape may be used to determine that the reservoir has refilled prior to flushing a second time. Refilling of the flusher reservoir can be confirmed by palpation of the dome, indicating that CSF from the ventricles is able to flow through the ventricular catheter to the ReFlow Mini Flusher. The clinician must use his/her medical judgment and standard practice at his/her institution to care for the patient pre, during, and post utilization of the ReFlow System Mini.
The ReFlow System Mini does not regulate the flow/pressure of the shunt system. A flow regulating shunt valve is not provided with the ReFlow System Mini. During passive flow, fluid from the ventricular catheter flows freely through the Mini Flusher to the regulating valve. The ReFlow System Mini is designed to be compatible with most commercially available flow/pressure requlative valves with standard inlet connectors. Additionally, the Reflow Mini Flusher component utilizes a common barbed connector designed to be compatible with most commercially available ventricular catheters in addition to the ReFlow
{4}------------------------------------------------
Ventricular Catheter Description
The ReFlow Ventricular Catheter is made from silicone elastomer and barium sulfate, with an inner diameter of 1.27 mm and an outer diameter of 2.54 mm. The Ventricular Catheter is 150 mm in length and is supplied with 20 inlet holes (4 rows of 5 holes at the proximal end). There is a thin silicone relief membrane at the proximal end of the catheter distal to the inlet holes. The relief membrane is designed to open via manual depression of the Mini Flusher dome to provide a noninvasive and consistent method to restore or increase flow in a suspected non-flowing or slow-flowing shunt system. The relief membrane has only been tested as a one-time use feature. This Ventricular Catheter is MR safe and not made with natural rubber latex.
A stainless-steel stylet is provided with the ReFlow Ventricular Catheter for insertion of the catheter into the ventricle. This stylet is MR Unsafe and not made with natural rubber latex.
Flusher Description
The ReFlow Mini Flusher contains a fluid reservoir encased in a flexible silicone housing. The device utilizes a common barbed connector that allows direct connection to the ventricular catheter. The device has a flush dome (reservoir). The ReFlow System Mini offers a noninvasive means to facilitate a retrograde flush of the ventricular catheter to either unblock inlet holes or open its relief membrane to restore, increase, or maintain CSF flow. Retrograde flushing of the ventricular catheter is performed by depression of the flusher dome. When actuated as per the treating physician's guidance and instruction, the flusher sends a controlled and limited retrograde pulse of fluid (CSF or sterile saline from the priming procedure before implant) towards the ventricular catheter to either maintain or resume flow by opening the suspected blocked inlet holes or open the relief membrane of the ReFlow Ventricular Catheter to restore flow in the shunt system.
The ReFlow Mini Flusher does not regulate the flow of the shunt system or inhibit the function of the flow regulating valve. During passive flow, fluid from the ventricular catheter flows freely through the Mini Flusher. A flow regulating shunt valve is not provided with the ReFlow System Mini. The ReFlow Mini Flusher is compatible with shunt valves with standard barbed connections.
The Mini Flusher is MR safe and is not made with natural rubber latex.
V. INDICATIONS FOR USE
The ReFlow System Mini, used as components of a shunt system, is for use in the treatment of patients with hydrocephalus or conditions where draining of cerebrospinal fluid (CSF) is medically indicated. The miniaturized ReFlow Flusher may be used by a qualified clinician as a tool to facilitate a noninvasive retrograde fluid flush of the ReFlow Ventricular Catheter to unblock inlet holes or open its relief membrane to restore, increase, or maintain CSF flow. The ReFlow System Mini is not intended to change the diagnosis, treatment, or follow-up of patients with proximal catheter occlusions. Under the care, direction, and instruction of the treating physician, the ReFlow System Mini may be used as directed for noninvasive flushing by a trained healthcare professional in-clinic or by a trained caregiver or adult patient in a non-clinical environment.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| SUBJECT DEVICEAnunciaReFlow System Mini(K221918) | PRIMARY PREDICATEAnunciaReFlow Ventricular System(K172006) | Equivalence Comparison | |
|---|---|---|---|
| Regulation | 21CFR882.5550 | 21CFR882.5550 | Same |
| Class | Class II | Class II | Same |
| SUBJECT DEVICEAnunciaReFlow System Mini(K221918) | PRIMARY PREDICATEAnunciaReFlow Ventricular System(K172006) | Equivalence Comparison | |
| Product Code | JXG | JXG | Same |
| Trade Name | Shunt, Central NervousSystem and Components | Shunt, Central NervousSystem and Components | Same |
| Intended Use | The ReFlow System Mini,used as components of ashunt system, is for use inthe treatment of patients withhydrocephalus or conditionswhere draining or shunting ofcerebrospinal fluid (CSF) ismedically indicated. Theminiaturized ReFlow Flushermay be used by a qualifiedclinician as a tool to facilitatea noninvasive retrogradefluid flush of the ReFlowVentricular Catheter tounblock inlet holes or openits relief membrane torestore, increase, ormaintain CSF flow. TheReFlow System Mini is notintended to change thediagnosis, treatment, orfollow-up of patients withproximal catheter occlusions.Under the care, direction,and instruction of the treatingphysician, the ReFlowSystem Mini may be used asdirected for noninvasiveflushing by a trainedhealthcare professional in-clinic or by a trainedcaregiver or adult patient in anon-clinical environment. | The ReFlow VentricularCatheter and Flusher System(ReFlow System) is for use inthe treatment of patients withhydrocephalus, ascomponents of a shunt systemwhen draining or shunting ofcerebrospinal fluid (CSF) isindicated. The ReFlowFlusher may be used by aqualified clinician as a tool tofacilitate a non-invasiveretrograde fluid flush of theReFlow Ventricular Catheter tounblock inlet holes or open itsrelief membrane to restore orincrease CSF flow in a non-flowing shunt. The ReFlowflusher is not intended tochange standard of carepractices for diagnosis,treatment, or follow-up ofpatients with proximal catheterocclusions. | Intended Use: EquivalentIndications: Equivalent |
| Indications forUse | Treatment of hydrocephalusor conditions where drainingor shunting of cerebrospinalfluid (CSF) is medicallyindicated, as components ofa shunt system. | Treatment of hydrocephalus,as components of a shuntsystem when draining orshunting of cerebrospinal fluid(CSF) is indicated | Equivalent |
| Drains CSF to reduceintracranial pressure andCSF volume and restore,increase, or maintain flow ina shunt. | Drains CSF to reduceintracranial pressure and CSFvolume and restore orincrease in suspected non-flowing shunt | Equivalent. | |
| Proximal pumping of thereservoir to restore,increase, or maintain CSFflow in a shunt. | Proximal pumping of thereservoir to temporarily restoreor increase CSF flow insuspected non-flowing shunts. | Equivalent | |
| Implantable | Implantable | Same | |
| Single use | Single use | Same | |
| SUBJECT DEVICEAnunciaReFlow System Mini(K221918) | PRIMARY PREDICATEAnunciaReFlow Ventricular System(K172006) | Equivalence Comparison | |
| TargetPopulation | Patients with hydrocephalusor conditions where drainingor shunting of cerebrospinalfluid (CSF) is medicallyindicated | Patients with hydrocephalus | Equivalent |
| AnatomicalSites | Brain ventricle and head | Brain ventricle and head | Same |
| Where Used | Operating Room (implant)Clinical and Non-ClinicalEnvironments per treatingphysician discretion(actuation or flushing) | Operating Room (implant)Clinical and Non-ClinicalEnvironments per treatingphysician discretion (actuationor flushing) | Same |
| Energy Used | None | None | Same |
| Human Factors | Labeling indicates size andlength | Labeling indicates size andlength | Same |
| Labeling indicates flow vs.pressure labels | Labeling indicates flow vs.pressure labels | Same | |
| Can be activated (flushed)by healthcare provider,caregiver, or adult patientunder the direction, training,and guidance of the treatingphysician. | Can be activated (flushed) bya qualified clinician | Equivalent. Flushing by atrained health care provider(other than the treatingphysician), a caregiver, oradult patient under the careof and as directed by thetreating physician wasdemonstrated by humanfactors and usabilityperformance testing to notrequire special skills oreducation. | |
| Can be manipulated withgloved hand | Can be manipulated withqloved hand | Same | |
| Design | Designed to be placed in theventricle of the brain andunder the scalp | Designed to be placed in theventricle of the brain andunder the scalp | Same |
| Flexible catheter to remainimplanted in the brain | Flexible catheter to remainimplanted in the brain | Same | |
| Series of holes at distal endof the catheter for fluidmovement | Series of holes at distal end ofthe catheter for fluidmovement | Same | |
| 20 flow holes | 20 flow holes | Same | |
| 4 lines of 5 holes | 4 lines of 5 holes | Same | |
| Bullet shaped tip | Bullet shaped tip | Same | |
| SUBJECT DEVICEAnunciaReFlow System Mini(K221918) | PRIMARY PREDICATEAnunciaReFlow Ventricular System(K172006) | Equivalence Comparison | |
| A single relief membranedistal to the proximal holes ofthe catheter to open at athreshold pressure fortemporarily restoration offluid movement | A single relief membrane distalto the proximal holes of thecatheter to open at a thresholdpressure for temporarilyrestoration of fluid movement | Same | |
| Length from proximal tip tothe most distal holes andrelief membrane is 0.720" | Length from proximal tip to themost distal holes and reliefmembrane is 0.720" | Same | |
| Catheter is not impregnatedwith antimicrobial agents. | Catheter is not impregnatedwith antimicrobial agents. | Same | |
| Barium sulfate-filled catheter | Barium sulfate-filled catheter | Same | |
| Inner diameter of catheter:0.050" | Inner diameter of catheter:0.050" | Same | |
| Outer diameter of catheter:0.100" | Outer diameter of catheter:0.100" | Same | |
| Catheter length: 15cminitially (other commonlengths may be offered) | Catheter length: 15cm initially(other common lengths maybe offered) | Same | |
| Length markings: 1 dot at10cm and 2 dots at 15cm | Length markings: 1 dot at10cm and 2 dots at 15cm | Same | |
| Stylet for catheter insertion | Stylet for catheter insertion | Same | |
| Reservoir (Rickham orcomparable). Not tested ormade as a claim. | Reservoir (Rickham orcomparable). Not tested ormade as a claim. | Same | |
| Right angle clipcompatible (not provided) | Right angle clipcompatible (not provided) | Same | |
| Flushing - unidirectionalcontrol by occluders | Flushing - unidirectionalcontrol by occluders | Same | |
| Flush direction only towardsventricle (proximal) | Flush direction only towardsventricle (proximal) | Same | |
| Restore, increase, ormaintain flow through acatheter | Increases flow through a non-flowing catheter | Equivalent | |
| Flow regulation (allowspassive flow for use in-linewith a one-way check valveto regulate flow in system) | Flow regulation (allowspassive flow for use in-linewith a one-way check valve toregulate flow in system) | Same | |
| Fluid filled reservoir less than0.5mL | Fluid filled reservoir less than0.5 mL | Same | |
| Barb fittings for connection toventricular catheter andshunt valve | Barb fittings for connection toventricular catheter and shuntvalve | Same | |
| Series of channels to allowfluid movement from domeinto ventricular catheter andfluid from the ventricularcatheter to dome and rest ofshunt system | Series of channels to allowfluid movement from dome intoventricular catheter and fluidfrom the ventricular catheter todome and rest of shunt system | Same | |
| SUBJECT DEVICEAnunciaReFlow System Mini(K221918) | PRIMARY PREDICATEAnunciaReFlow Ventricular System(K172006) | Equivalence Comparison | |
| Inner channel diameter:greater than 1mm | Inner channel diameter:greater than 1mm | SamePassive flow channeldiameter meets ISO7197:2006 | |
| 19mm in length, 23mm inwidth, 9mm in height | 40mm in length 17mm in width10mm height | Equivalent to predicate andsize/dimension acceptable touser per human factorsstudies conducted | |
| Reservoir and shuntaccessories withstand useforces | Reservoir and shuntaccessories withstand useforces | Same | |
| Can be used withdimensionally compatibleshunt system components | Can be used withdimensionally compatibleshunt system components | Same | |
| Low profile for implantationunder the scalp | Low profile for implantationunder the scalp | Same | |
| Soft and flexible outerhousing | Soft and flexible outer housing | Same | |
| n/a | Rigid sections in the housingto seat valves | n/a | |
| Occluders (distal drainagechannel is occluded duringflush) | Occluders (distal drainagechannel is occluded duringflush) | Same | |
| Complies with ASTMF647094 Section 6.4.1 withrespect to Printing to indicatedirection of flow and position | Complies with ASTM F647094Section 6.4.1 with respect toPrinting to indicate direction offlow and position | Equivalent | |
| Performance | Retrograde pulse into theventricular catheter (createdby manual pumping -depressing dome/flusherwith a fixed reservoirvolume) | Retrograde pulse into theventricular catheter (createdby manual pumping -depressing dome/flusher witha fixed reservoir volume) | Same |
| One way flow between thereservoir and ventricularcatheterwhen device is pumped | One way flow between thereservoir and ventricularcatheterwhen device is pumped | Same | |
| Reservoir refills afterpumping | Reservoir refills after pumping | Same | |
| Normal shunt functionresumes after pumping | Normal shunt functionresumes after pumping | Same | |
| Catheter diverts fluid fromventricle | Catheter diverts fluid fromventricle | Same | |
| Relief membrane remainsopen after activating | Relief membrane remainsopen after activating | Same | |
| SUBJECT DEVICEAnunciaReFlow System Mini(K221918) | PRIMARY PREDICATEAnunciaReFlow Ventricular System(K172006) | Equivalence Comparison | |
| Materials | Ventricular Catheter: siliconewith BaSO4 filler, reliefmembrane silicone | Ventricular Catheter: siliconewith BaSO4 filler, reliefmembrane silicone | Same |
| Valves: silicone | Valves: silicone | Same | |
| Dome/outer housing: silicone | Dome/outer housing: silicone | Same | |
| Biocompatibility | Tissue contact tested perISO 10993:Biological Evaluation ofMedical Devices | Tissue contact tested per ISO10993:Biological Evaluation ofMedical Devices | Same |
| Non-pyrogenic | Non-pyrogenic | Same | |
| Compatibilitywithenvironmentand otherdevices | Safe in an x-ray environment | Safe in an x-ray environment | Same |
| Compatible with currentshunt systems andaccessories | Compatible with current shuntsystems and accessories | Same | |
| Compatible with long termCSF contact and saline | Compatible with long termCSF contact and saline | Same | |
| Radiopacity | BaSO4 filled siliconeelastomer | BaSO4 filled siliconeelastomer | Same |
| Sterility | Terminally sterilized for 10-6SAL with no damage tosystem components.Validated perANSI/AAMI/ISO11137-2; Sterilization ofhealth care products- Radiation | Terminally sterilized for 10-6SAL with no damage tosystem components.Validated per ANSI/AAMI/ISO11137-2; Sterilization of healthcare products- Radiation | Same |
| MechanicalSafety | Manual flushing (pumping)generates equivalentventricular suction/flushingwith no valve damage oralteration | Manual flushing (pumping)generates equivalentventricular suction/flushingwith no valve damage oralteration | Same |
| Chemical Safety | Saline, CSF | Saline, CSF | Same |
| MRLabeling | MR Safe | MR Safe | Same |
| RadiationSafety | X-ray Safe | X-ray Safe | Same |
| Packaging | Packaging maintains sterilityand protects device. Tray,pouch, box. Catheter andflusher packaged together. | Packaging maintains sterilityand protects device. Tray,pouch, box. Catheter andflusher packaged together. | Equivalent |
| K221918, Page 8 of 9 | |||
| SUBJECT DEVICEAnunciaReFlow System Mini(K221918) | PRIMARY PREDICATEAnunciaReFlow Ventricular System(K172006) | Equivalence Comparison | |
| Shelf Life | Labeled shelf life (expiration)will be based on real timeand accelerated aging shelf-life studies from 6 months upto 5 years. | Labeled shelf life (expiration)will be based on real time andaccelerated aging shelf-lifestudies up to 3 years. | Equivalent |
{5}------------------------------------------------
K221918, Page 3 of 9
{6}------------------------------------------------
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Testing was conducted on the ReFlow System Mini to demonstrate that it meets defined design requirements and can perform in a manner equivalent to devices currently on the market used for its intended use. Testing included verification and validation bench testing and human factors evaluations in a simulated clinical use model per the available guidance. The design, testing, and technical information provided for the RSM also comply with the applicable sections of ISO 7197:2006 (E), Neurosurgical Implants - Sterile, single-use hydrocephalus shunts and components [Including: Technical Corrigendum 1 (2007)) and ASTM F647: 94 (2014), Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application. The table below summarizes the performance testing conducted.
| Test | Test Method Summary | Results and Conclusions |
|---|---|---|
| Particulate | Units will undergo particulate testing to evaluatethat the number of particulates generated fromboth exterior and interior lumen of the ReFlowMini Flusher, under simulated use conditions,does not pose any safety risks. | All results met acceptance criteria and demonstratethat the RSM performance is suitable for its intendeduse and is substantially equivalent to the predicatedevice. |
| DesignVerificationBench Testing | Conducted testing and reported results inaccordance ISO 7197:2006 (E), NeurosurgicalImplants - Sterile, single-use hydrocephalus shuntsand components and ASTM F647: 94(2014),Standard Practice for Evaluating and SpecifyingImplantable Shunt Assemblies for NeurosurgicalApplication. | All results met acceptance criteria and demonstrate theRSM is suitable for its intended use and is substantiallyequivalent to the predicate device. |
| Reliability andSystem LevelFunctional Test | Testing was conducted to verify the reliability of theReFlow System Mini to function during its expecteduseful life and meet requirements of ISO 7197:2006(E), Neurosurgical Implants - Sterile, single-usehydrocephalus shunts and components and ASTMF647: 94(2014), Standard Practice for Evaluatingand Specifying Implantable Shunt Assemblies forNeurosurgical Application. | All results met acceptance criteria and demonstrate theRSM is suitable for its intended use and is substantiallyequivalent to the predicate device. |
| Usability andhuman factorstesting | Human Factors and Usability evaluations forcritical tasks according to ReFlow Mini labelingwere conducted in accordance with ANSI/AAMIHE 75, Human Factors Engineering Design ofMedical Devices, IEC 62366:2007, MedicalDevices - Application of Usability Engineering toMedical Devices, and FDA Guidance (Jun 22,2011) Human Factors Draft Guidance. | RSM is deemed to meet its specifications for its intendeduse and is substantially equivalent to the predicatedevice. In all cases, the acceptance criteria were met,and the device performed as expected according to itsspecifications and in compliance with applicablerecognized standards. |
{11}------------------------------------------------
Good Manufacturing Practices. In all instances, the RSM functioned as intended an were as expected. These test results confirm that RSM complies with the recognized standa the design specifications and performance requirements for the intended use, and is substantially equivalent to the predicate.
VIII. CONCLUSIONS
The ReFlow System Mini is substantially equivalent to the primary predicate the ReFlow Ventricular System (K172006). The ReFlow System Mini and its predicate device share the same Product Code and classification as components of a CSF Shunt System. The ReFlow System Mini has the intended use as the primary predicate device and equivalent indications for use. The ReFlow Ventricular System also has a very similar design and similar technological characteristics as the primary predicate device. Minor differences in design do not raise different questions of safety and efficacy when all listed warnings and cautions are followed.
The results from preclinical evaluations demonstrate that the technological and performance characteristics of the ReFlow System Mini meet defined design requirements. Performance data demonstrate that the ReFlow System Mini performs as intended and is substantially equivalent to its predicate. This conclusion is based upon the device equivalence in the device's (1) design, (2) material technological characteristics, (3) material suppliers, (4) principles of operation, (5) and intended use.
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).