(27 days)
Not Found
No
The device description and performance studies focus on mechanical function (fluid flushing, pressure, flow) and human factors, with no mention of AI or ML algorithms for diagnosis, treatment decisions, or data analysis.
Yes
Explanation: The device is used in the treatment of patients with hydrocephalus or conditions where draining of cerebrospinal fluid (CSF) is medically indicated, and aims to restore, increase, or maintain CSF flow, which are therapeutic actions.
No
The device is a component of a shunt system used to treat hydrocephalus by facilitating cerebrospinal fluid (CSF) flow. Its function is to unblock the ventricular catheter through non-invasive flushing, not to diagnose a condition. The text explicitly states, "The ReFlow System Mini components are not intended to change the diagnosis, treatment, or follow-up of patients with proximal catheter occlusions."
No
The device description clearly states that the ReFlow System Mini consists of implantable hardware components: the ReFlow Mini Flusher and the ReFlow Ventricular Catheter.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The ReFlow System Mini and ReFlow Mini Flusher are implantable devices used within the body to manage cerebrospinal fluid flow. They do not analyze or test biological samples in vitro (outside the body).
- The intended use is for treatment and management of a medical condition (hydrocephalus and CSF disorders). IVDs are used for diagnosis, monitoring, or screening, not for direct therapeutic intervention within the body.
- The device description focuses on mechanical function and fluid dynamics within the shunt system. It describes how the device facilitates fluid flow and potentially unblocks catheters, which are physical actions within the patient's body.
Therefore, the ReFlow System Mini and ReFlow Mini Flusher are considered medical devices, but not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The ReFlow® System Mini and the ReFlow® Mini Flusher, used as components of a shunt system, are for use in the treatment of patients with hydrocephalus or conditions where draining of cerebrospinal fluid (CSF) is medically indicated. The miniaturized ReFlow Mini Flusher may be used by a qualified clinician as a tool to facilitate a noninvasive retrograde fluid flush of the shunt ventricular catheter to unblock inlet holes to restore, increase, or maintain CSF flow. When used with the ReFlow Ventricular Catheter, the flush can also open the ReFlow Ventricular Catheter's relief membrane to restore, increase, or maintain CSF flow. The ReFlow System Mini components are 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 Mini Flusher 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.
Product codes (comma separated list FDA assigned to the subject device)
JXG
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 ReFlow Mini Flusher is also sold separately. A ventricular catheter is surgically implanted in the ventricle of the brain and connected distally to the ReFlow Mini Flusher. The ventricular catheter may be the ReFlow Ventricular Catheter or a commercially available ventricular catheter (only the ReFlow Ventricular Catheter is provided as part of the ReFlow System Mini). The ReFlow 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, increase, or maintain CSF flow in the shunt system by potentially 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. The fluid flush generated by the flusher is intended to potentially unblock shunt ventricular catheter inlet holes. In cases when the ReFlow Mini Flusher is used with the ReFlow Ventricular Catheter, 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 if inlet holes are not able to be unblocked by the flush actuation. Once this relief membrane is open, subsequent flushes with the flusher may not be sufficient to unblock the secondary fluid pathway, which may become occluded in a manner similar to that of the proximal catheter inlet holes.
After flushing the ReFlow Mini Flusher, 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 and the ReFlow Mini Flusher do not regulate the flow/pressure of the shunt system. A flow regulating shunt valve is not provided with the ReFlow System Mini or ReFlow Mini Flusher. During passive flow, fluid from the ventricular catheter flows freely through the ReFlow Mini Flusher to the flow regulating valve. The ReFlow System Mini and the ReFlow Mini Flusher are designed to be compatible with most commercially available flow/pressure regulative 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Brain ventricle and head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified clinician, trained healthcare professional in-clinic, trained caregiver in a non-clinical environment, adult patient in a non-clinical environment.
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)
Design Verification Bench Testing:
- Study Type: Pressure 1m Water Column Leak Test, Occlusion Studies, and Pressure Flow Characterization
- Test Method Summary: Conducted testing and reported results in accordance 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.
- Key Results: All results met acceptance criteria and demonstrate the RSM is suitable for its intended use and is substantially equivalent to the predicate device.
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
§ 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).
0
Image /page/0/Picture/0 description: The image shows 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 and name on the right. The FDA part of the logo is in blue, with the acronym "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it.
December 29, 2022
Anuncia Medical, Inc. Natalie Eagleburger VP of Regulatory, Clinical and Quality 1355 N Scottsdale Rd, Suite 370 Scottsdale, Arizona 85257
Re: K223603
Trade/Device Name: ReFlow System Mini and ReFlow Mini Flusher Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt And Components Regulatory Class: Class II Product Code: JXG Dated: December 2, 2022 Received: December 2, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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.
Digitally signed by Adam D. Adam D. Pierce -S Date: 2022.12.29 Pierce -S 15:47:35 -05'00'
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) K223603
Device Name ReFlow® System Mini ReFlow® Mini Flusher
Indications for Use (Describe)
The ReFlow® System Mini and the ReFlow® Mini Flusher, used as components of a shunt system, are for use in the treatment of patients with hydrocephalus or conditions where draining of cerebrospinal fluid (CSF) is medically indicated. The miniaturized ReFlow Mini Flusher may be used by a qualified clinician as a tool to facilitate a nominvasive retrograde fluid flush of the shunt ventricular catheter to unblock inlet holes to restore, increase, or maintain CSF flow. When used with the ReFlow Ventricular Catheter, the flush can also open the ReFlow Ventricular Catheter's relief membrane to restore, increase, or maintain CSF flow. The ReFlow System Mini components are 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 Mini Flusher 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.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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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: | December 29, 2022 |
. DEVICE
Trade Name: 510(k) Number: K223603 Common or Usual Name: Classification Name: Regulatory Class: Class II Product Code and Regulation:
ReFlow® System Mini, ReFlow® Mini Flusher CSF Shunt System Shunt, Central Nervous System and Components JXG, 21CFR 882.5550
PREDICATE DEVICE lll.
Primary Predicate
ReFlow® System Mini (K221918)
This predicate has not been subject to a design-related recall.
DEVICE DESCRIPTION IV.
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 ReFlow Mini Flusher is also sold separately. A ventricular catheter is surgically implanted in the ventricle of the brain and connected distally to the ReFlow Mini Flusher. The ventricular catheter may be the ReFlow Ventricular Catheter or a commercially available ventricular catheter (only the ReFlow Ventricular Catheter is provided as part of the ReFlow System Mini). The ReFlow 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, increase, or maintain CSF flow in the shunt system by potentially 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. The fluid flush generated by the flusher is intended to potentially unblock shunt ventricular catheter inlet holes. In cases when the ReFlow Mini Flusher is used with the ReFlow Ventricular Catheter, 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 if inlet holes are not able to be unblocked by the flush actuation. Once this relief membrane is open, subsequent flushes with the flusher may not be sufficient to unblock the secondary fluid pathway, which may become occluded in a manner similar to that of the proximal catheter inlet holes.
After flushing the ReFlow Mini Flusher, 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.
4
The ReFlow System Mini and the ReFlow Mini Flusher do not regulate the flow/pressure of the shunt system. A flow regulating shunt valve is not provided with the ReFlow System Mini or ReFlow Mini Flusher. During passive flow, fluid from the ventricular catheter flows freely through the ReFlow Mini Flusher to the flow requlating valve. The ReFlow System Mini and the ReFlow Mini Flusher are designed to be compatible with most commercially available flow/pressure regulative 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.
The ReFlow System Mini components are provided in two packaging configurations as follows: ReFlow® System Mini
- Package Contents: ReFlow Ventricular Catheter and ReFlow Mini Flusher System .
- Ventricular Catheter (Qty: 1) o
- Flusher (Qty: 1) o
- o Stylet (Qty: 1)
ReFlow® Mini Flusher
- Package Contents: ReFlow Mini Flusher only .
- o Flusher (Qty: 1)
ReFlow® 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.
ReFlow® Mini 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.
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V. INDICATIONS FOR USE
The ReFlow® System Mini and the ReFlow® Mini Flusher, used as components of a shunt system, are for use in the treatment of patients with hydrocephalus or conditions where draining or shunting of cerebrospinal fluid (CSF) is medically indicated. The miniaturized ReFlow Mini Flusher may be used by a qualified clinician as a tool to facilitate a noninvasive retrograde fluid flush of the shunt ventricular catheter to unblock inlet holes to restore, increase, or maintain CSF flow. When used with the ReFlow Ventricular Catheter, the flush can also open the ReFlow Ventricular Catheter's relief membrane to restore, increase, or maintain CSF flow. The ReFlow System Mini components are 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 Mini Flusher 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 Indications for Use statement cleared in the predicate submission K221918 did not contain language distinguishing the use of the ReFlow Mini Flusher component with other ventricular catheters from its use specifically with the ReFlow Ventricular Catheter. The intent of this premarket submission is to clarify the indication statement to distinguish this use and align it with the intended use in the predicate labeling. This clarification does not raise different questions of safety and effectiveness.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The subject device incorporates the same technological characteristics as that of the predicate device and the design is identical to the currently cleared version. A change has been made to package the ReFlow Mini Flusher component by itself (without the ReFlow Ventricular Catheter) in addition to the predicate configuration that contains both implantable components (and a non-implantable stylet used to facilitate catheter placement). Both subject and predicate devices are implantable components of a cerebrospinal fluid (CSF) shunt system used in the treatment of patients with hydrocephalus and other CSF disorders when draining or shunting of CSF is medically indicated.
| | SUBJECT DEVICE
Anuncia ReFlow® System Mini and
ReFlow® Mini Flusher
(K223603) | PRIMARY PREDICATE
Anuncia ReFlow® System Mini
(K221918) | Equivalence
Comparison |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Regulation | 21CFR882.5550 | 21CFR882.5550 | Same |
| Class | Class II | Class II | Same |
| Product Code | JXG | JXG | Same |
| Trade Name | Shunt, Central Nervous System and
Components | Shunt, Central Nervous System and
Components | Same |
| Indications for
Use | The ReFlow® System Mini and the ReFlow®
Mini Flusher, used as components of a shunt
system, are for use in the treatment of
patients with hydrocephalus or conditions
where draining or shunting of cerebrospinal
fluid (CSF) is medically indicated. The
miniaturized ReFlow Mini Flusher may be
used by a qualified clinician as a tool to
facilitate a noninvasive retrograde fluid flush of
the shunt ventricular catheter to unblock inlet
holes to restore, increase, or maintain CSF
flow. When used with the ReFlow Ventricular
Catheter, the flush can also open the ReFlow
Ventricular Catheter's relief membrane to
restore, increase, or maintain CSF flow. The
ReFlow System Mini components are 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 Mini Flusher 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, components of a
shunt system, is for use in the treatment of
patients with hydrocephalus or conditions
where draining or shunting 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
standard care practices for diagnosis,
treatment, or follow-up of patients with
proximal catheter occlusions. As part of
standard of care clinical practice, and under
the care, direction, and instruction of the
treating physician, the ReFlow System Mini 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. | Intended Use:
Same
Indications:
Equivalent |
| Target
Population | Patients with hydrocephalus or conditions
where draining or shunting of cerebrospinal
fluid (CSF) is medically indicated | Patients with hydrocephalus or conditions
where draining or shunting of cerebrospinal
fluid (CSF) is medically indicated | Same |
| Anatomical Sites | Brain ventricle and head | Brain ventricle and head | Same |
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| K223603 | Page 4 of 4 | ||
|---|---|---|---|
| SUBJECT DEVICE | |||
| Anuncia ReFlow® System Mini and | |||
| ReFlow® Mini Flusher | |||
| (K223603) | PRIMARY PREDICATE | ||
| Anuncia ReFlow® System Mini | |||
| (K221918) | Equivalence | ||
| Comparison | |||
| Compatibility | |||
| with | |||
| environment and | |||
| other devices | Compatible with current shunt systems and | ||
| accessories | Compatible with current shunt systems and | ||
| accessories | Same | ||
| Sterility | Terminally sterilized for 10-6 SAL with no | ||
| damage to system components. | |||
| Validated per ANSI/AAMI/ISO | |||
| 11137-2; Sterilization of health care products - | |||
| Radiation | Terminally sterilized for 10-6 SAL with no | ||
| damage to system components. | |||
| Validated per ANSI/AAMI/ISO | |||
| 11137-2; Sterilization of health care products - | |||
| Radiation | Same | ||
| Packaging | Packaging maintains sterility and protects | ||
| device. Tray, pouch, box. Packaging | |||
| configuration includes catheter and flusher | |||
| packaged together as well as flusher | |||
| component packaged separately. | Packaging maintains sterility and protects | ||
| device. Tray, pouch, box. Catheter and flusher | |||
| packaged together. | Equivalent |
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 |
|---|---|---|
| Design Verification | ||
| Bench Testing: | ||
| Pressure 1m Water | ||
| Column Leak Test, | ||
| Occlusion Studies, | ||
| and Pressure Flow | ||
| Characterization | Conducted testing and reported results in | |
| accordance 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. |
Manufacturing and traceability of devices tested were conducted in accordance with 21 CFR Part 820 Good Manufacturing Practices. In all instances, the RSM functioned as intended and the results observed were as expected. These test results confirm that RSM complies with the recognized standards, meets the design specifications and performance requirements for the intended use, and is substantially equivalent to the predicate.
CONCLUSIONS VIII.
The ReFlow System Mini is substantially equivalent to the primary predicate device (K221918). The ReFlow System Mini and its predicate share the same Product Code and classification as components of a CSF Shunt System. The ReFlow System Mini has the same intended use as the primary predicate device and equivalent indications for use. The ReFlow System Mini also has an identical design and technological characteristics as the primary predicate device. Minor clarifications for use 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's (1) design, (1) design, (2) material technological characteristics, (3) material suppliers, (4) principles of operation, (5) and intended use.