(90 days)
Not Found
No
The description focuses on a mechanical device for flushing a shunt system and does not mention any computational or learning capabilities.
Yes
The device is used in the treatment of patients with hydrocephalus or conditions where draining of cerebrospinal fluid (CSF) is medically indicated, which is a therapeutic purpose.
No
The device is designed to facilitate a noninvasive retrograde fluid flush to unblock catheters or open membranes, restoring or maintaining CSF flow. It is explicitly stated that the "ReFlow System Mini is not intended to change the diagnosis, treatment, or follow-up of patients with proximal catheter occlusions." Its function is therapeutic (restoring flow), not diagnostic (identifying a condition).
No
The device description explicitly states that the ReFlow System Mini consists of implantable components (ReFlow Mini Flusher and ReFlow Ventricular Catheter), which are hardware. The device's function relies on the physical actuation of the flusher dome and the flow of CSF, not solely on software processing or analysis.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for the "treatment of patients with hydrocephalus or conditions where draining of cerebrospinal fluid (CSF) is medically indicated." It's a component of a shunt system used to manage CSF flow within the body.
- Device Description: The description details an implantable system (catheter and flusher) that physically interacts with and manages CSF within the patient's body. It describes a mechanical action (flushing) to restore or maintain flow.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. This device does not perform any such tests on samples. It is a therapeutic device designed to manage a physiological condition.
Therefore, the ReFlow System Mini is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / 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 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.
Product codes
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 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.
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
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.
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
| Test | Test Method Summary | Results and Conclusions |
|---|---|---|
| Particulate | Units will 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 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. |
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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)
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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: | 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 DEVICE
Anuncia
ReFlow System Mini
(K221918) | PRIMARY PREDICATE
Anuncia
ReFlow Ventricular System
(K172006) | Equivalence Comparison |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation | 21CFR882.5550 | 21CFR882.5550 | Same |
| Class | Class II | Class II | Same |
| | SUBJECT DEVICE
Anuncia
ReFlow System Mini
(K221918) | PRIMARY PREDICATE
Anuncia
ReFlow Ventricular System
(K172006) | Equivalence Comparison |
| Product Code | JXG | JXG | Same |
| Trade Name | Shunt, Central Nervous
System and Components | Shunt, Central Nervous
System and Components | Same |
| Intended 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 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 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. | The ReFlow Ventricular
Catheter and Flusher System
(ReFlow System) is for use in
the treatment of patients with
hydrocephalus, as
components of a shunt system
when draining or shunting of
cerebrospinal fluid (CSF) is
indicated. The ReFlow
Flusher may be used by a
qualified clinician as a tool to
facilitate a non-invasive
retrograde fluid flush of the
ReFlow Ventricular Catheter to
unblock inlet holes or open its
relief membrane to restore or
increase CSF flow in a non-
flowing shunt. The ReFlow
flusher is not intended to
change standard of care
practices for diagnosis,
treatment, or follow-up of
patients with proximal catheter
occlusions. | Intended Use: Equivalent
Indications: Equivalent |
| Indications for
Use | Treatment of hydrocephalus
or conditions where draining
or shunting of cerebrospinal
fluid (CSF) is medically
indicated, as components of
a shunt system. | Treatment of hydrocephalus,
as components of a shunt
system when draining or
shunting of cerebrospinal fluid
(CSF) is indicated | Equivalent |
| | Drains CSF to reduce
intracranial pressure and
CSF volume and restore,
increase, or maintain flow in
a shunt. | Drains CSF to reduce
intracranial pressure and CSF
volume and restore or
increase in suspected non-
flowing shunt | Equivalent. |
| | Proximal pumping of the
reservoir to restore,
increase, or maintain CSF
flow in a shunt. | Proximal pumping of the
reservoir to temporarily restore
or increase CSF flow in
suspected non-flowing shunts. | Equivalent |
| | Implantable | Implantable | Same |
| | Single use | Single use | Same |
| | SUBJECT DEVICE
Anuncia
ReFlow System Mini
(K221918) | PRIMARY PREDICATE
Anuncia
ReFlow Ventricular System
(K172006) | Equivalence Comparison |
| Target
Population | Patients with hydrocephalus
or conditions where draining
or shunting of cerebrospinal
fluid (CSF) is medically
indicated | Patients with hydrocephalus | Equivalent |
| Anatomical
Sites | Brain ventricle and head | Brain ventricle and head | Same |
| Where Used | Operating Room (implant)
Clinical and Non-Clinical
Environments per treating
physician discretion
(actuation or flushing) | Operating Room (implant)
Clinical and Non-Clinical
Environments per treating
physician discretion (actuation
or flushing) | Same |
| Energy Used | None | None | Same |
| Human Factors | Labeling indicates size and
length | Labeling indicates size and
length | Same |
| | Labeling indicates flow vs.
pressure labels | Labeling indicates flow vs.
pressure labels | Same |
| | Can be activated (flushed)
by healthcare provider,
caregiver, or adult patient
under the direction, training,
and guidance of the treating
physician. | Can be activated (flushed) by
a qualified clinician | Equivalent. Flushing by a
trained health care provider
(other than the treating
physician), a caregiver, or
adult patient under the care
of and as directed by the
treating physician was
demonstrated by human
factors and usability
performance testing to not
require special skills or
education. |
| | Can be manipulated with
gloved hand | Can be manipulated with
qloved hand | Same |
| Design | Designed to be placed in the
ventricle of the brain and
under the scalp | Designed to be placed in the
ventricle of the brain and
under the scalp | Same |
| | Flexible catheter to remain
implanted in the brain | Flexible catheter to remain
implanted in the brain | Same |
| | Series of holes at distal end
of the catheter for fluid
movement | Series of holes at distal end of
the catheter for fluid
movement | 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 DEVICE
Anuncia
ReFlow System Mini
(K221918) | PRIMARY PREDICATE
Anuncia
ReFlow Ventricular System
(K172006) | Equivalence Comparison | |
| A single relief membrane
distal to the proximal holes of
the catheter to open at a
threshold pressure for
temporarily restoration of
fluid movement | A single relief membrane distal
to the proximal holes of the
catheter to open at a threshold
pressure for temporarily
restoration of fluid movement | Same | |
| Length from proximal tip to
the most distal holes and
relief membrane is 0.720" | Length from proximal tip to the
most distal holes and relief
membrane is 0.720" | Same | |
| Catheter is not impregnated
with antimicrobial agents. | Catheter is not impregnated
with 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: 15cm
initially (other common
lengths may be offered) | Catheter length: 15cm initially
(other common lengths may
be offered) | Same | |
| Length markings: 1 dot at
10cm and 2 dots at 15cm | Length markings: 1 dot at
10cm and 2 dots at 15cm | Same | |
| Stylet for catheter insertion | Stylet for catheter insertion | Same | |
| Reservoir (Rickham or
comparable). Not tested or
made as a claim. | Reservoir (Rickham or
comparable). Not tested or
made as a claim. | Same | |
| Right angle clip
compatible (not provided) | Right angle clip
compatible (not provided) | Same | |
| Flushing - unidirectional
control by occluders | Flushing - unidirectional
control by occluders | Same | |
| Flush direction only towards
ventricle (proximal) | Flush direction only towards
ventricle (proximal) | Same | |
| Restore, increase, or
maintain flow through a
catheter | Increases flow through a non-
flowing catheter | Equivalent | |
| Flow regulation (allows
passive flow for use in-line
with a one-way check valve
to regulate flow in system) | Flow regulation (allows
passive flow for use in-line
with a one-way check valve to
regulate flow in system) | Same | |
| Fluid filled reservoir less than
0.5mL | Fluid filled reservoir less than
0.5 mL | Same | |
| Barb fittings for connection to
ventricular catheter and
shunt valve | Barb fittings for connection to
ventricular catheter and shunt
valve | Same | |
| Series of channels to allow
fluid movement from dome
into ventricular catheter and
fluid from the ventricular
catheter to dome and rest of
shunt system | Series of channels to allow
fluid movement from dome into
ventricular catheter and fluid
from the ventricular catheter to
dome and rest of shunt system | Same | |
| | SUBJECT DEVICE
Anuncia
ReFlow System Mini
(K221918) | PRIMARY PREDICATE
Anuncia
ReFlow Ventricular System
(K172006) | Equivalence Comparison |
| | Inner channel diameter:
greater than 1mm | Inner channel diameter:
greater than 1mm | Same
Passive flow channel
diameter meets ISO
7197:2006 |
| | 19mm in length, 23mm in
width, 9mm in height | 40mm in length 17mm in width
10mm height | Equivalent to predicate and
size/dimension acceptable to
user per human factors
studies conducted |
| | Reservoir and shunt
accessories withstand use
forces | Reservoir and shunt
accessories withstand use
forces | Same |
| | Can be used with
dimensionally compatible
shunt system components | Can be used with
dimensionally compatible
shunt system components | Same |
| | Low profile for implantation
under the scalp | Low profile for implantation
under the scalp | Same |
| | Soft and flexible outer
housing | Soft and flexible outer housing | Same |
| | n/a | Rigid sections in the housing
to seat valves | n/a |
| | Occluders (distal drainage
channel is occluded during
flush) | Occluders (distal drainage
channel is occluded during
flush) | Same |
| | Complies with ASTM
F647094 Section 6.4.1 with
respect to Printing to indicate
direction of flow and position | Complies with ASTM F647094
Section 6.4.1 with respect to
Printing to indicate direction of
flow and position | Equivalent |
| Performance | Retrograde pulse into the
ventricular catheter (created
by manual pumping -
depressing dome/flusher
with a fixed reservoir
volume) | Retrograde pulse into the
ventricular catheter (created
by manual pumping -
depressing dome/flusher with
a fixed reservoir volume) | Same |
| | One way flow between the
reservoir and ventricular
catheter
when device is pumped | One way flow between the
reservoir and ventricular
catheter
when device is pumped | Same |
| | Reservoir refills after
pumping | Reservoir refills after pumping | Same |
| | Normal shunt function
resumes after pumping | Normal shunt function
resumes after pumping | Same |
| | Catheter diverts fluid from
ventricle | Catheter diverts fluid from
ventricle | Same |
| | Relief membrane remains
open after activating | Relief membrane remains
open after activating | Same |
| | SUBJECT DEVICE
Anuncia
ReFlow System Mini
(K221918) | PRIMARY PREDICATE
Anuncia
ReFlow Ventricular System
(K172006) | Equivalence Comparison |
| Materials | Ventricular Catheter: silicone
with BaSO4 filler, relief
membrane silicone | Ventricular Catheter: silicone
with BaSO4 filler, relief
membrane silicone | Same |
| | Valves: silicone | Valves: silicone | Same |
| | Dome/outer housing: silicone | Dome/outer housing: silicone | Same |
| Biocompatibility | Tissue contact tested per
ISO 10993:
Biological Evaluation of
Medical Devices | Tissue contact tested per ISO
10993:
Biological Evaluation of
Medical Devices | Same |
| | Non-pyrogenic | Non-pyrogenic | Same |
| Compatibility
with
environment
and other
devices | Safe in an x-ray environment | Safe in an x-ray environment | Same |
| | Compatible with current
shunt systems and
accessories | Compatible with current shunt
systems and accessories | Same |
| | Compatible with long term
CSF contact and saline | Compatible with long term
CSF contact and saline | Same |
| Radiopacity | BaSO4 filled silicone
elastomer | BaSO4 filled silicone
elastomer | 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 |
| Mechanical
Safety | Manual flushing (pumping)
generates equivalent
ventricular suction/flushing
with no valve damage or
alteration | Manual flushing (pumping)
generates equivalent
ventricular suction/flushing
with no valve damage or
alteration | Same |
| Chemical Safety | Saline, CSF | Saline, CSF | Same |
| MR
Labeling | MR Safe | MR Safe | Same |
| Radiation
Safety | X-ray Safe | X-ray Safe | Same |
| Packaging | Packaging maintains sterility
and protects device. Tray,
pouch, box. Catheter and
flusher packaged together. | Packaging maintains sterility
and protects device. Tray,
pouch, box. Catheter and
flusher packaged together. | Equivalent |
| | | | K221918, Page 8 of 9 |
| | SUBJECT DEVICE
Anuncia
ReFlow System Mini
(K221918) | PRIMARY PREDICATE
Anuncia
ReFlow Ventricular System
(K172006) | Equivalence Comparison |
| Shelf Life | Labeled shelf life (expiration)
will be based on real time
and accelerated aging shelf-
life studies from 6 months up
to 5 years. | Labeled shelf life (expiration)
will be based on real time and
accelerated aging shelf-life
studies up to 3 years. | Equivalent |
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K221918, Page 3 of 9
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8
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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 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 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, |
- 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. |
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.