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.

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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "ReFlow® System Mini and ReFlow® Mini Flusher" and declares it substantially equivalent to a predicate device (K221918). However, it does not contain the detailed information necessary to fully answer all the questions regarding acceptance criteria and the study proving the device meets these criteria in the context of an AI/human-in-the-loop performance study.

The document focuses on the mechanical and functional aspects of a medical device (a CSF shunt system component) rather than an AI-powered diagnostic or assistive tool. Therefore, terms like "multi-reader multi-case (MRMC) comparative effectiveness study," "human readers improve with AI vs without AI assistance," "standalone (algorithm only) performance," "ground truth establishment for training set," and "number of experts for ground truth" are not applicable or detailed in this submission.

The document does mention "human factors evaluations in a simulated clinical use model," but provides no details on how many participants, their qualifications, or how performance was measured in a quantitative manner that would relate to comparative effectiveness of human performance with and without an AI.

Despite the limitations of the provided text for an AI-focused study, I can extract the following information based on the typical content of a 510(k) submission for a physical medical device:

Acceptance Criteria and Device Performance (Based on the provided text, heavily interpreted for a physical device, NOT an AI study)

The document primarily refers to bench testing and compliance with recognized standards for medical device performance.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Standard	Reported Device Performance/Conclusion
Mechanical/Functional Performance	Pressure 1m Water Column Leak Test	"All results met acceptance criteria and demonstrate the RSM is suitable for its intended use..."
	Occlusion Studies	"All results met acceptance criteria and demonstrate the RSM is suitable for its intended use..."
	Pressure Flow Characterization	"All results met acceptance criteria and demonstrate the RSM is suitable for its intended use..."
Material Compatibility	(Implied by compliance with standards like ISO 7197)	"The ReFlow System Mini performs as intended and is substantially equivalent to its predicate." (Implies material and design compatibility)
Sterility	Terminally sterilized for 10-6 SAL per ANSI/AAMI/ISO 11137-2	"Terminally sterilized for 10-6 SAL with no damage to system components."
Packaging Integrity	Packaging maintains sterility and protects device	"Packaging maintains sterility and protects device."
Biocompatibility	(Not explicitly detailed, but usually a requirement for implanted devices and would fall under design requirements met via ISO standards)	(Not explicitly stated, but assumed to be proven by meeting design requirements and substantial equivalence.)
Human Factors	Simulated clinical use model	"conducted ... human factors evaluations in a simulated clinical use model per the available guidance." (No specific quantitative performance metrics provided in the document.)
Interoperability/Compatibility	Compatibility with current shunt systems and accessories	"Compatible with current shunt systems and accessories."
Overall Performance	Adherence to design specifications and performance requirements for intended use	"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."

Based on the provided text, the following points cannot be fully answered as they are typically relevant to AI/Software as a Medical Device (SaMD) performance studies, not the mechanical device described:

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not specified for the bench tests. For human factors, no sample size is mentioned.
Data Provenance: The "data" comes from bench testing of the physical device components. There's no mention of patient data (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable in the context of mechanical bench testing. "Ground truth" for this device would be established by physical measurements and engineering specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. Adjudication is relevant for subjective expert review, not objective bench testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not done. This is a physical device, not an AI assisting human readers. The human factors evaluation mentioned is typically about usability and safety, not diagnostic performance with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. The device is a physical component of a shunt system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the device's performance is based on engineering specifications and compliance with recognized industry standards (e.g., ISO 7197:2006, ASTM F647:94), measured through bench testing.

8. The sample size for the training set:

Not applicable. This is a mechanical device, not an AI model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. See point 8.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K223603

Device Name ReFlow® System Mini ReFlow® Mini Flusher

Indications for Use (Describe)

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:	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.

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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 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 DEVICEAnuncia ReFlow® System Mini andReFlow® Mini Flusher(K223603)	PRIMARY PREDICATEAnuncia ReFlow® System Mini(K221918)	EquivalenceComparison
Regulation	21CFR882.5550	21CFR882.5550	Same
Class	Class II	Class II	Same
Product Code	JXG	JXG	Same
Trade Name	Shunt, Central Nervous System andComponents	Shunt, Central Nervous System andComponents	Same
Indications forUse	The ReFlow® System Mini and the ReFlow®Mini Flusher, used as components of a shuntsystem, are for use in the treatment ofpatients with hydrocephalus or conditionswhere draining or shunting of cerebrospinalfluid (CSF) is medically indicated. Theminiaturized ReFlow Mini Flusher may beused by a qualified clinician as a tool tofacilitate a noninvasive retrograde fluid flush ofthe shunt ventricular catheter to unblock inletholes to restore, increase, or maintain CSFflow. When used with the ReFlow VentricularCatheter, the flush can also open the ReFlowVentricular Catheter's relief membrane torestore, increase, or maintain CSF flow. TheReFlow System Mini components are notintended to change the diagnosis, treatment,or follow-up of patients with proximal catheterocclusions. Under the care, direction, andinstruction of the treating physician, theReFlow Mini Flusher may be used as directedfor noninvasive flushing by a trainedhealthcare professional in-clinic or by atrained caregiver or adult patient in a non-clinical environment.	The ReFlow™ System Mini, components of ashunt system, is for use in the treatment ofpatients with hydrocephalus or conditionswhere draining or shunting of cerebrospinalfluid (CSF) is medically indicated. Theminiaturized ReFlow Flusher may be used bya qualified clinician as a tool to facilitate anoninvasive retrograde fluid flush of theReFlow Ventricular Catheter to unblock inletholes or open its relief membrane to restore,increase, or maintain CSF flow. The ReFlowSystem Mini is not intended to changestandard care practices for diagnosis,treatment, or follow-up of patients withproximal catheter occlusions. As part ofstandard of care clinical practice, and underthe care, direction, and instruction of thetreating physician, the ReFlow System Mini beused as directed for noninvasive flushing by atrained healthcare professional in-clinic or bya trained caregiver or adult patient in a non-clinical environment.	Intended Use:SameIndications:Equivalent
TargetPopulation	Patients with hydrocephalus or conditionswhere draining or shunting of cerebrospinalfluid (CSF) is medically indicated	Patients with hydrocephalus or conditionswhere draining or shunting of cerebrospinalfluid (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 DEVICEAnuncia ReFlow® System Mini andReFlow® Mini Flusher(K223603)	PRIMARY PREDICATEAnuncia ReFlow® System Mini(K221918)	EquivalenceComparison
Compatibilitywithenvironment andother devices	Compatible with current shunt systems andaccessories	Compatible with current shunt systems andaccessories	Same
Sterility	Terminally sterilized for 10-6 SAL with nodamage to system components.Validated per ANSI/AAMI/ISO11137-2; Sterilization of health care products -Radiation	Terminally sterilized for 10-6 SAL with nodamage to system components.Validated per ANSI/AAMI/ISO11137-2; Sterilization of health care products -Radiation	Same
Packaging	Packaging maintains sterility and protectsdevice. Tray, pouch, box. Packagingconfiguration includes catheter and flusherpackaged together as well as flushercomponent packaged separately.	Packaging maintains sterility and protectsdevice. Tray, pouch, box. Catheter and flusherpackaged 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 VerificationBench Testing:Pressure 1m WaterColumn Leak Test,Occlusion Studies,and Pressure FlowCharacterization	Conducted testing and reported results inaccordance ISO 7197:2006 (E), NeurosurgicalImplants - Sterile, single-use hydrocephalusshunts and components and ASTM F647:94(2014), Standard Practice for Evaluating andSpecifying Implantable Shunt Assemblies forNeurosurgical Application.	All results met acceptance criteria anddemonstrate the RSM is suitable for its intendeduse and is substantially equivalent to thepredicate 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.

Regulation Number and Section

§ 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).