ReFlow System Mini

K221918 · Anuncia Medical, Inc. · JXG · Sep 29, 2022 · Neurology

Device Facts

• Record ID: K221918
• Device Name: ReFlow System Mini
• Applicant: Anuncia Medical, Inc.
• Product Code: JXG · Neurology
• Decision Date: Sep 29, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

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 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.

Device Story

Implantable CSF shunt component consisting of a ventricular catheter and a miniaturized flusher; used for hydrocephalus treatment. Catheter implanted in brain ventricle; connected to flusher under scalp. Flusher contains fluid reservoir; noninvasively actuated by manual depression of palpable dome. Operation: manual depression sends controlled retrograde pulse of fluid (CSF or saline) through catheter to unblock inlet holes or open emergency relief membrane. Used in OR for implant; flushing performed in-clinic or non-clinical settings by clinicians, trained caregivers, or patients. Output: restored/maintained CSF flow. Benefits: noninvasive method to manage proximal catheter occlusions without surgical revision.

Clinical Evidence

Bench testing only. Included particulate testing, design verification, reliability/system-level functional testing, and human factors/usability evaluations. All tests met acceptance criteria.

Technological Characteristics

Materials: silicone elastomer, barium sulfate. Dimensions: 150mm catheter length, 1.27mm ID, 2.54mm OD. Principle: manual retrograde fluid pulse via flexible silicone dome. Connectivity: compatible with standard barbed connectors for shunt valves. Sterilization: radiation (10^-6 SAL). Standards: ISO 7197:2006, ASTM F647:94.

Indications for Use

Indicated for patients with hydrocephalus or conditions requiring CSF drainage as part of a shunt system. Used to facilitate noninvasive retrograde flushing of the ventricular catheter to unblock inlet holes or open a relief membrane to restore/maintain CSF flow.

Regulatory Classification

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.

Predicate Devices

• ReFlow Ventricular Catheter and Flusher System (K172006)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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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### 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

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# 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<br>Anuncia<br>ReFlow System Mini<br>(K221918) | PRIMARY PREDICATE<br>Anuncia<br>ReFlow Ventricular System<br>(K172006) | Equivalence Comparison |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation | 21CFR882.5550 | 21CFR882.5550 | Same |
| Class | Class II | Class II | Same |
| | SUBJECT DEVICE<br>Anuncia<br>ReFlow System Mini<br>(K221918) | PRIMARY PREDICATE<br>Anuncia<br>ReFlow Ventricular System<br>(K172006) | Equivalence Comparison |
| Product Code | JXG | JXG | Same |
| Trade Name | Shunt, Central Nervous<br>System and Components | Shunt, Central Nervous<br>System and Components | Same |
| Intended Use | The ReFlow System Mini,<br>used as components of a<br>shunt system, is for use in<br>the treatment of patients with<br>hydrocephalus or conditions<br>where draining or shunting of<br>cerebrospinal fluid (CSF) is<br>medically indicated. The<br>miniaturized ReFlow Flusher<br>may be used by a qualified<br>clinician as a tool to facilitate<br>a noninvasive retrograde<br>fluid flush of the ReFlow<br>Ventricular Catheter to<br>unblock inlet holes or open<br>its relief membrane to<br>restore, increase, or<br>maintain CSF flow. The<br>ReFlow System Mini is not<br>intended to change the<br>diagnosis, treatment, or<br>follow-up of patients with<br>proximal catheter occlusions.<br>Under the care, direction,<br>and instruction of the treating<br>physician, the ReFlow<br>System Mini may be used as<br>directed for noninvasive<br>flushing by a trained<br>healthcare professional in-<br>clinic or by a trained<br>caregiver or adult patient in a<br>non-clinical environment. | The ReFlow Ventricular<br>Catheter and Flusher System<br>(ReFlow System) is for use in<br>the treatment of patients with<br>hydrocephalus, as<br>components of a shunt system<br>when draining or shunting of<br>cerebrospinal fluid (CSF) is<br>indicated. The ReFlow<br>Flusher may be used by a<br>qualified clinician as a tool to<br>facilitate a non-invasive<br>retrograde fluid flush of the<br>ReFlow Ventricular Catheter to<br>unblock inlet holes or open its<br>relief membrane to restore or<br>increase CSF flow in a non-<br>flowing shunt. The ReFlow<br>flusher is not intended to<br>change standard of care<br>practices for diagnosis,<br>treatment, or follow-up of<br>patients with proximal catheter<br>occlusions. | Intended Use: Equivalent<br>Indications: Equivalent |
| Indications for<br>Use | Treatment of hydrocephalus<br>or conditions where draining<br>or shunting of cerebrospinal<br>fluid (CSF) is medically<br>indicated, as components of<br>a shunt system. | Treatment of hydrocephalus,<br>as components of a shunt<br>system when draining or<br>shunting of cerebrospinal fluid<br>(CSF) is indicated | Equivalent |
| | Drains CSF to reduce<br>intracranial pressure and<br>CSF volume and restore,<br>increase, or maintain flow in<br>a shunt. | Drains CSF to reduce<br>intracranial pressure and CSF<br>volume and restore or<br>increase in suspected non-<br>flowing shunt | Equivalent. |
| | Proximal pumping of the<br>reservoir to restore,<br>increase, or maintain CSF<br>flow in a shunt. | Proximal pumping of the<br>reservoir to temporarily restore<br>or increase CSF flow in<br>suspected non-flowing shunts. | Equivalent |
| | Implantable | Implantable | Same |
| | Single use | Single use | Same |
| | SUBJECT DEVICE<br>Anuncia<br>ReFlow System Mini<br>(K221918) | PRIMARY PREDICATE<br>Anuncia<br>ReFlow Ventricular System<br>(K172006) | Equivalence Comparison |
| Target<br>Population | Patients with hydrocephalus<br>or conditions where draining<br>or shunting of cerebrospinal<br>fluid (CSF) is medically<br>indicated | Patients with hydrocephalus | Equivalent |
| Anatomical<br>Sites | Brain ventricle and head | Brain ventricle and head | Same |
| Where Used | Operating Room (implant)<br>Clinical and Non-Clinical<br>Environments per treating<br>physician discretion<br>(actuation or flushing) | Operating Room (implant)<br>Clinical and Non-Clinical<br>Environments per treating<br>physician discretion (actuation<br>or flushing) | Same |
| Energy Used | None | None | Same |
| Human Factors | Labeling indicates size and<br>length | Labeling indicates size and<br>length | Same |
| | Labeling indicates flow vs.<br>pressure labels | Labeling indicates flow vs.<br>pressure labels | Same |
| | Can be activated (flushed)<br>by healthcare provider,<br>caregiver, or adult patient<br>under the direction, training,<br>and guidance of the treating<br>physician. | Can be activated (flushed) by<br>a qualified clinician | Equivalent. Flushing by a<br>trained health care provider<br>(other than the treating<br>physician), a caregiver, or<br>adult patient under the care<br>of and as directed by the<br>treating physician was<br>demonstrated by human<br>factors and usability<br>performance testing to not<br>require special skills or<br>education. |
| | Can be manipulated with<br>gloved hand | Can be manipulated with<br>qloved hand | Same |
| Design | Designed to be placed in the<br>ventricle of the brain and<br>under the scalp | Designed to be placed in the<br>ventricle of the brain and<br>under the scalp | Same |
| | Flexible catheter to remain<br>implanted in the brain | Flexible catheter to remain<br>implanted in the brain | Same |
| | Series of holes at distal end<br>of the catheter for fluid<br>movement | Series of holes at distal end of<br>the catheter for fluid<br>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<br>Anuncia<br>ReFlow System Mini<br>(K221918) | PRIMARY PREDICATE<br>Anuncia<br>ReFlow Ventricular System<br>(K172006) | Equivalence Comparison | |
| A single relief membrane<br>distal to the proximal holes of<br>the catheter to open at a<br>threshold pressure for<br>temporarily restoration of<br>fluid movement | A single relief membrane distal<br>to the proximal holes of the<br>catheter to open at a threshold<br>pressure for temporarily<br>restoration of fluid movement | Same | |
| Length from proximal tip to<br>the most distal holes and<br>relief membrane is 0.720"…