proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System

K161853 · Aesculap, Inc. · JXG · Feb 27, 2017 · Neurology

Device Facts

• Record ID: K161853
• Device Name: proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System
• Applicant: Aesculap, Inc.
• Product Code: JXG · Neurology
• Decision Date: Feb 27, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Miethke proGAV Programmable Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum. The Miethke proGAV 2.0 Adjustable Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum. The Miethke proSA Adjustable Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.

Device Story

Programmable/adjustable shunt systems (proGAV, proGAV 2.0, proSA) manage hydrocephalus by shunting CSF from lateral ventricles to peritoneum; valve mechanisms (leaf spring/ball) controlled by internal magnets; titanium housing. Physician uses external manual tools (verification compass, adjustment disc, Check-mate) to set/verify pressure levels pre- and post-operatively. Subject devices remove requirement for radiographic (X-ray) confirmation of pressure settings, relying instead on non-invasive verification tools. Benefits include reduced radiation exposure for patients during routine pressure adjustments.

Clinical Evidence

Bench testing only. Verification studies compared non-invasive measurement tools (Verification Tool, Verification Compass) against radiographic (X-ray) confirmation. Results demonstrated measurement agreement and met all acceptance criteria, supporting the removal of mandatory X-ray verification.

Technological Characteristics

Titanium alloy (Ti4Al6V) housing; Neodym Ferrite Boron magnets; Alpha Sapphire ball; leaf spring mechanism. Adjustable differential pressure (proGAV/proGAV 2.0) or gravitational (proSA) valves. Dimensions 1.5 x 1.5 mm. Sterile, single-use, steam sterilized. Manual external adjustment/verification tools.

Indications for Use

Indicated for patients requiring cerebrospinal fluid (CSF) shunting from the lateral ventricles of the brain into the peritoneum.

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

• Miethke proGAV Programmable Shunt System (K062009 / K103003)
• Miethke proGAV 2.0 Adjustable Shunt System (K141687)
• Miethke proSA Adjustable Shunt System (K120559)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, arranged in a cascading manner, representing the department's focus on people and health.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 27, 2017

Aesculap, Inc. Kathy A. Racosky Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K161853

Trade/Device Name: Miethke proGAV Programmable Shunt System, Miethke proGAV 2.0 Adjustable Shunt System, Miethke proSA Adjustable Shunt System Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt and Components Regulatory Class: Class II Product Code: JXG Dated: January 20, 2017 Received: January 23, 2017

Dear Ms. Racosky:

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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Carlos L. Pena-S

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K161853

#### Device Name

Miethke proGAV Programmable Shunt System Miethke proGAV 2.0 Adjustable Shunt System Miethke proSA Adjustable Shunt System

Indications for Use (Describe)

The Miethke proGAV Programmable Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.

The Miethke proGAV 2.0 Adjustable Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.

The Miethke proSA Adjustable Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

#### 510(k) SUMMARY

| | Miethke proGAV Programmable Shunt System<br>February 15, 2017 |
|--------------------|--------------------------------------------------------------------------------------------------------------------|
| COMPANY: | Aesculap®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 2916714 |
| CONTACT: | Kathy A. Racosky<br>610-984-9291 (phone)<br>610-791-6882 (fax)<br>[e-mail] |
| TRADE NAME: | Aesculap Miethke proGAV Programmable Shunt System |
| COMMON NAME: | Hydrocephalus Shunt System |
| CLASSIFICATION: | Class II |
| | CLASSIFICATION NAME: Shunt, Central Nervous System and Components |
| REGULATION NUMBER: | 882.5550 |
| PRODUCT CODE: | JXG |

## DEVICE DESCRIPTION

The proGAV is a "programmable" shunt that can be set for a range of pressures. The valve in the proGAV is a leaf spring and ball mechanism that is mechanically controlled by internal magnets. The outer case for the device is made of titanium. The shunt comes with a manual device to verify the pressure setting and another to set or re-set the pressure. These manual accessories are both for external use by the physician. Various Miethke shunt system accessories such as shunt assistants, catheters, connectors, deflectors and reservoirs are also offered with the proGAV .

## INDICATIONS FOR USE

The Miethke proGAV Programmable Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.

## SUBSTANTIAL EQUIVALENCE

Comparative information presented in the 510(k) supports the substantial equivalence of the subject proGAV Programmable Shunt System to the predicate proGAV Programmable Shunt System (K062009 / K103003). The proGAV Programmable Shunt System is substantially equivalent to the identified predicate with respect to performance characteristics, design, principles of operation and materials. The difference between the subject device and the

{4}------------------------------------------------

predicate is the removal of the required radiographic verification stated in the indications for use and labeling.

# TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))

The Aesculap Miethke proGAV Programmable Shunt System is substantially equivalent to the predicate Miethke proGAV Programmable Shunt System. The subject device is shown to be substantially equivalent and has the same performance characteristic to its predicate device through comparison in design, principles of operation, and materials. The proGAV device characteristics are summarized below.

| | Miethke proGAV<br>Programmable Shunt System<br>K161853 | Miethke proGAV<br>Programmable Shunt System<br>K103003/K062009 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication: | The Miethke proGAV<br>Programmable Shunt System is<br>intended to shunt cerebrospinal<br>fluid (CSF) from the lateral<br>ventricles of the brain into the<br>peritoneum. | The Miethke proGAV<br>Programmable Shunt System is<br>intended to shunt cerebrospinal<br>fluid (CSF) from the lateral<br>ventricles of the brain into the<br>peritoneum. Adjustments of the<br>proGAV shunt can be verified by<br>using the verification instrument<br>but must be confirmed by<br>radiograph (X-ray). |
| Adjustable | Same | Yes |
| ValveType | Same | Adjustable differential pressure |
| Material: | | |
| Housing | Same | Titanium Alloy Ti4Al6V |
| Magnets | Same | Neodym Ferrite Boron |
| Ball | Same | Alpha Sapphire |
| Spring | Same | Titanium Alloy Ti4Al6V |
| Design | Same | Circular |
| Magnet: | | |
| # of magnets | Same | 2 |
| Dimensions | Same | 1.5 x 1.5 mm |
| Volume | Same | 5.3 mm3 |
| Pressure levels: | Same | Adjustable<br><br>0 - 20 cmH2O |
| Sterile/ Single Use | Same | Yes |
| Sterilization | Same | Steam |
| Packaging: | Same | Double Peel Pouch |

{5}------------------------------------------------

| | Miethke proGAV<br>Programmable Shunt System<br>K161853 | Miethke proGAV<br>Programmable Shunt System<br>K103003/K062009 |
|-----------------------------------------------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Tools: | | |
| Verification tool<br>Masterdisc<br>Verification Compass<br>Adjustment tool<br>Adjustment disc | Same | Manually wipe with an alcohol<br>base cleaner (>75% alcohol). May<br>not be re-sterilized. |
| Check-mate | Same | For use in a sterile surgical field.<br>Sterile, reusable, may be re-<br>sterilized |
| Tool settings and<br>readings: | Same | 0 - 20 cmH2O |

# PERFORMANCE DATA

Bench testing on the proposed device, proGAV Programmable Shunt System, included the following:

- Verification testing assessing the measurement agreement between X-ray confirmation . and the proGAV Verification Tool when used with the proGAV Programmable Shunt System
- . Verification testing assessing the measurement between X-ray confirmation and the proGAV Verification Compass when used with the proGAV Programmable Shunt System

Test results demonstrated the substantial equivalence between the required radiographic verification method and the non-invasive method with the proGAV Verification Tool and proGAV Verification Compass. The test results met the acceptance criteria. Results of verification testing have demonstrated that the proposed proGAV Programmable Shunt System is substantially equivalent to the predicate proGAV Programmable Shunt System.

{6}------------------------------------------------

Page 1 of 3

## 510(k) SUMMARY

| Miethke proGAV 2.0 Adjustable Shunt System | |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| February 15, 2017 | |
| COMPANY: | Aesculap®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 2916714 |
| CONTACT: | Kathy A. Racosky<br>610-984-9291 (phone)<br>610-791-6882 (fax)<br>[e-mail] |
| TRADE NAME: | Aesculap Meithke proGAV 2.0 Programmable Shunt System |
| COMMON NAME: | Hydrocephalus Shunt System |
| CLASSIFICATION: | Class II |
| CLASSIFICATION NAME: | Shunt, Central Nervous System and Components |
| REGULATION NUMBER: | 882.5550 |
| PRODUCT CODE: | JXG |

## DEVICE DESCRIPTION

proGAV 2.0 is an adjustable differential pressure valve that can be set for a range of pressures. The proGAV 2.0 valve is comprised of a titanium housing that contains a leaf spring and ball mechanism that is mechanically controlled by internal magnets. Manual devices are available to locate, verify the pressure setting and to set or re-set the pressure pre and postoperatively. These manual accessories are for external use by the physician. The device will be distributed by itself or in combination with the ShuntAssistant valve or proSA valve. The proGAV 2.0 adjustable differential pressure valve includes the same legally marketed accessories that are available with the Miethke Shunt Systems.

## INDICATIONS FOR USE

The Miethke proGAV 2.0 Adjustable Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.

## SUBSTANTIAL EQUIVALENCE

Comparative information presented in the 510(k) supports the substantial equivalence of the subject proGAV 2.0 Adjustable Shunt System to the predicate proGAV 2.0 Adjustable Shunt

{7}------------------------------------------------

System (K141687). The proGAV 2.0 Adjustable Shunt System is substantially equivalent to the identified predicate with respect to performance characteristics, design, principles of operation and materials. The difference between the subject device and the predicate is the removal of the required radiographic verification stated in the indications for use and labeling.

## TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))

The Aesculap Miethke proGAV 2.0 Adjustable Shunt System is substantially equivalent to the predicate Miethke proGAV 2.0 Adjustable Shunt System. The subject device is shown to be substantially equivalent and has the same performance characteristic to its predicate device through comparison in design, principles of operation, and materials. The proGAV 2.0 device characteristics are summarized below.

| | Miethke proGAV 2.0 Adjustable<br>Shunt System<br>K161853 | Miethke proGAV 2.0 Adjustable<br>Shunt System<br>K141687 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication: | The Miethke proGAV 2.0<br>Adjustable Shunt System is<br>intended to shunt cerebrospinal<br>fluid (CSF) from the lateral<br>ventricles of the brain into the<br>peritoneum. | The Miethke proGAV 2.0<br>Adjustable Shunt System is<br>intended to shunt cerebrospinal<br>fluid (CSF) from the lateral<br>ventricles of the brain into the<br>peritoneum. Adjustments of the<br>proGAV 2.0 shunt can be verified<br>by using the verification<br>instrument but must be confirmed<br>by radiograph (X-ray). |
| Adjustable | Same | Yes |
| ValveType: | Same | Adjustable differential pressure |
| Material: | | |
| Housing | Same | Titanium Alloy Ti4Al6V |
| Magnets | Same | Neodym Ferrite Boron |
| Ball | Same | Alpha Sapphire |
| Spring | Same | Titanium Alloy Ti4Al6V |
| Design | Same | Circular |
| Magnet: | | |
| # of magnets | Same | 4 |
| Dimensions | Same | 1.5 x 1.5 mm |
| Volume | Same | 10.6 mm3 |
| Pressure levels: | Same | Adjustable |
| | Same | 0 - 20 cmH2O |
| Sterile/ Single Use | Same | Yes |
| Sterilization | Same | Steam |
| Packaging: | Same | Double Peel Pouch |

{8}------------------------------------------------

| | Miethke proGAV 2.0 Adjustable<br>Shunt System | Miethke proGAV 2.0 Adjustable<br>Shunt System |
|----------------------------------------|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| | K161853 | K141687 |
| <b>proGAV 2.0 Tools:</b> | | |
| Compass | Same | Manually wipe with an alcohol |
| Adjustment tool | Same | base cleaner (>75% alcohol).<br>May not be re-sterilized. |
| <b>Compatible w/<br/>proGAV Tools:</b> | | |
| | Same | Verification tool, Verification<br>compass, Master disk, Adjustment<br>tool, Adjustment disk, Check-<br>mate |
| Tool settings and<br>readings: | Same | 0 – 20 cmH2O |

## PERFORMANCE DATA

Bench testing on the proposed device, proGAV 2.0 Adjustable Shunt System, included the following:

- Verification testing assessing the measurement agreement between X-ray confirmation . and the proGAV 2.0 Compass when used with the proGAV 2.0 Adjustable Shunt System
- Verification testing assessing the measurement between X-ray confirmation and the proGAV Verification Compass when used with the proGAV 2.0 Adjustable Shunt System
- Verification testing assessing the measurement agreement between X-ray confirmation and the proGAV Verification Tool when used with the proGAV 2.0 Adjustable Shunt System

Test results demonstrated the substantial equivalence between the required radiographic verification method and the non-invasive method with the proGAV 2.0 Compass, proGAV Verification Compass and proGAV Verification Tool. The test results met the acceptance criteria. Results of verification testing have demonstrated that the proposed proGAV 2.0 Adjustable Shunt System is substantially equivalent to the predicate proGAV 2.0 Adjustable Shunt System.

{9}------------------------------------------------

#### 510(k) SUMMARY

| Miethke proSA Adjustable Shunt System | |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| February 15, 2017 | |
| COMPANY: | Aesculap®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 2916714 |
| CONTACT: | Kathy A. Racosky<br>610-984-9291 (phone)<br>610-791-6882 (fax)<br>[e-mail] |
| TRADE NAME: | Aesculap Miethke proSA Adjustable Shunt System |
| COMMON NAME: | Hydrocephalus Shunt System |
| CLASSIFICATION: | Class II |
| CLASSIFICATION NAME: | Shunt, Central Nervous System and Components |
| REGULATION NUMBER: | 882.5550 |
| PRODUCT CODE: | JXG |

## DEVICE DESCRIPTION

proSA is an adjustable gravitational valve that can be set for a range of pressures. The proSA valve is comprised of a titanium housing that contains a tantalum weight, leaf spring and ball mechanism that is mechanically controlled by internal magnets. Several manual devices are available to verify the pressure setting and to set or re-set the pressure pre and postoperatively. These manual accessories are for external use by the physician. The device will be distributed by itself or in combination with the miniNAV valve or proGAV valve. The proSA adjustable gravitational valve includes the same legally marketed accessories that are available with the Miethke Shunt Systems.

## INDICATIONS FOR USE

The Miethke proSA Adjustable Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.

## SUBSTANTIAL EQUIVALENCE

Comparative information presented in the 510(k) supports the substantial equivalence of the subject proSA Adjustable Shunt System to the predicate proSA Adjustable Shunt System

{10}------------------------------------------------

(K120559). The proSA Adjustable Shunt System is substantially equivalent to the identified predicate with respect to performance characteristics, design, principles of operation and materials. The difference between the subject device and the predicate is the removal of the required radiographic verification stated in the indications for use and labeling.

## TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))

The Aesculap Miethke proSA Adjustable Shunt System is substantially equivalent to the predicate Miethke proSA Adjustable Shunt System. The subject device is shown to be substantially equivalent and has the same performance characteristic to its predicate device through comparison in design, principles of operation, and materials. The proSA device characteristics are summarized below.

| | Miethke proSA Adjustable<br>Shunt System<br>K161853 | Miethke proSA Adjustable<br>Shunt System<br>K120559 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication: | The Miethke proSA Adjustable<br>Shunt System is intended to shunt<br>cerebrospinal fluid (CSF) from<br>the lateral ventricles of the brain<br>into the peritoneum. | The Miethke proSA Adjustable<br>Shunt System is intended to shunt<br>cerebrospinal fluid (CSF) from<br>the lateral ventricles of the brain<br>into the peritoneum. Adjustments<br>of the proSA shunt can be verified<br>by using the verification<br>instrument but must be confirmed<br>by radiograph (X-ray). |
| Adjustable | Same | Yes |
| ValveType | Same | Adjustable Gravitational valve |
| Material: | | |
| Housing | Same | Titanium Alloy Ti4Al6V |
| Magnets | Same | Neodym Ferrite Boron |
| Ball | Same | Alpha Sapphire |
| Spring | Same | Titanium Alloy Ti4Al6V |
| Weight | Same | Tantalum |
| Design | Same | Circular |
| Magnet: | | |
| # of magnets | Same | 2 |
| Dimensions | Same | 1.5 x 1.5 mm |
| Volume | Same | 5.3 mm3 |
| Pressure levels: | Same | Adjustable |
| | | |
| | Same | 0 - 40 cmH2O |
| Sterile/ Single Use | Same | Yes |
| Sterilization | Same | Steam |
| Packaging: | Same | Double Peel Pouch |

{11}------------------------------------------------

| | Miethke proSA Adjustable<br>Shunt System | Miethke proSA Adjustable<br>Shunt System |
|-----------------------------------------------------------------------------------------------|------------------------------------------|--------------------------------------------------------------------------------------------|
| | K161853 | K120559 |
| <b>Tools:</b> | | |
| Verification tool<br>Masterdisc<br>Verification Compass<br>Adjustment tool<br>Adjustment disc | Same | Manually wipe with an alcohol<br>base cleaner (>75% alcohol). May<br>not be re-sterilized. |
| Check-mate | Same | For use in a sterile surgical field.<br>Sterile, reusable, may be re-<br>sterilized |
| Tool settings and<br>readings: | Same | 0 - 40 cmH2O |

# PERFORMANCE DATA

Bench testing on the proposed device, proSA Adjustable Shunt System, included the following:

- Verification testing assessing the measurement between X-ray confirmation ● and the proSA Verification Tool when used with the proSA Adjustable Shunt System
- Verification testing assessing the measurement between X-ray confirmation and the proSA Verification Compass when used with the proSA Adjustable Shunt System

Test results demonstrated the substantial equivalence between the required radiographic verification method and the non-invasive method with the proSA Verification Tool and proSA Verification Compass. The test results met the acceptance criteria. Results of verification testing have demonstrated that the proposed proSA Adjustable Shunt System is substantially equivalent to the predicate proSA Adjustable Shunt System.