StrataMR Valves and Shunts

K152700 · Medtronic Neurosurgery · JXG · Apr 7, 2016 · Neurology

Device Facts

• Record ID: K152700
• Device Name: StrataMR Valves and Shunts
• Applicant: Medtronic Neurosurgery
• Product Code: JXG · Neurology
• Decision Date: Apr 7, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medtronic StrataMR™ Valves and Shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the peritoneal cavity. The design enables the physician to noninvasively adjust valve pressure/performance level pre- and post-implantation by using magnetic adjustment tools without the need for radiographic confirmation.

Device Story

Implantable adjustable valve system for hydrocephalus management; drains CSF from brain ventricles to peritoneal cavity or right atrium. Device incorporates ball-and-cone pressure valve in series with siphon control mechanism. Physician uses external magnetic adjustment tool to non-invasively modify valve pressure/performance settings pre- and post-implantation; no radiographic confirmation required. Design improvements over predicate include modified internal component geometries/materials and stronger adjustment tool magnet to enhance resistance to unintended adjustment during MRI exposure. Device includes central reservoir for needle access/flushing and radiopaque markers for X-ray identification of settings. Benefits include precise, adjustable CSF flow control and reduced need for invasive procedures to change valve settings.

Clinical Evidence

Bench testing only. Testing included resistance to leakage, reservoir needle puncture, dynamic breaking strength, pressure/flow performance (ISO 7197), siphon control, overpressure/bursting pressure, long-term stability, X-ray identification, and post-MRI functional testing. MRI safety testing performed per ASTM standards. Design validation included surgeon evaluation of readability and adjustability in cadavers. Biocompatibility testing included cytotoxicity, irritation, acute systemic toxicity, pyrogenicity, sensitization, genotoxicity, and subchronic/subacute toxicity.

Technological Characteristics

Materials: molded polypropylene base, silicone elastomer housing. Mechanism: ball-and-cone pressure valve in series with siphon control diaphragm. Features: five discrete magnetic pressure settings, radiopaque tantalum-impregnated direction arrow, central reservoir. Connectivity: none. Sterilization: not specified. Standards: ISO 7197 (pressure/flow), ISO 10993 (biocompatibility), ASTM F2052, F2213, F2182, F2119 (MRI safety).

Indications for Use

Indicated for patients requiring continuous CSF flow from brain ventricles to the right atrium or peritoneal cavity for hydrocephalus management.

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

• Medtronic PS Medical Strata Type Valve (K060681)

Submission Summary (Full Text)

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

April 7, 2016

Medtronic Neurosurgery Mr. Deep Pal Manager, Regulatory Affairs 125 Cremona Drive Goleta, California 93117

Re: K152700

Trade/Device Name: Medtronic StrataMR™ Valves and Shunts Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt and Components Regulatory Class: Class II Product Code: JXG Dated: March 4, 2016 Received: March 7, 2016

Dear Mr. Deep Pal:

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

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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 yours,

Carlos L. Pena -కొວຽມ

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

Enclosure

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# Indications for Use

510(k) Number (if known) K152700

Device Name Medtronic StrataMRTM Valves and Shunts

#### Indications for Use (Describe)

The Medtronic StrataMR™ Valves and Shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the peritoneal cavity. The design enables the physician to noninvasively adjust valve pressure/performance level pre- and post-implantation by using magnetic adjustment tools without the need for radiographic confirmation.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510(k) Summary - K152700

This 510(k) summary is submitted in accordance with the requirements of 21 CFR 807.92.

| 510(k) Owner: | Medtronic Neurosurgery<br>125 Cremona Drive<br>Goleta, CA 93117-5503 USA |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Contact Name: | Deep Pal<br>Manager, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Summary Prepared: | March 25, 2016 |
| Trade or Proprietary Name: | Medtronic StrataMR™ Valves and Shunts |
| Common Name: | Hydrocephalus Shunt |
| Classification Name: | Shunt, Central Nervous System and Components<br>(21 CFR §882.5550, Product Code JXG) |
| Predicate Device: | Medtronic PS Medical Strata Type Valve (K060681) |

### Device Description:

The Medtronic StrataMR™ valves are implantable adjustable valves for the management of hydrocephalus. The valves and their associated catheters drain Cerebrospinal Fluid (CSF) from the ventricles in the brain into the peritoneal cavity or the right atrium of the heart, where it is absorbed by the body. The Medtronic StrataMR™ valve incorporates a ball and cone pressure valve in series with a normally closed siphon control mechanism. Flow control is achieved and retrograde flow is prevented by combined resistance of the ball and cone and siphon control diaphragm. Before and after implantation, the pressure/flow characteristics of the Medtronic StrataMR™ valve can by modified by means of a magnetic adjustment tool.

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## Indications for Use:

The Medtronic StrataMR™ valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design enables the physician to non-invasively adjust valve pressure/performance level pre- and post-implantation by using magnetic adjustment tools without the need for radiographic confirmation.

## Summary of Technological Characteristics Compared to the Predicate Device:

The StrataMR™ valve incorporates the same basic technological characteristics as the predicate device, which include: (1) adjustable magnetic valve mechanism with five discrete pressure level settings, (2) occluders for selective flushing, (3) plastic needle guard base, (4) central reservoir, which may be injected with a 25-gauge or smaller non-coring needle, (5) radiopaque tantalum-impregnated direction arrow for showing flow direction, (6) indicators for valve performance level identification (discernible by x-ray), and (7) integrated siphon control mechanism (Delta Chamber). Both StrataMR™ and the predicate device are fabricated with a molded polypropylene base invested in a silicone elastomer housing with a concave bottom.

Changes to the device design relative to the predicate did not affect the fundamental technology, but were made to improve resistance to adjustment during MR exposure. These changes include:

- · Modifications to the geometries and specific material formulations of internal valve mechanism components
- Modifications to the ergonomics of the adjustment tools and incorporation of a stronger adjustment tool magnet to accommodate the changes to the valve mechanism

# Bench Testing:

The following bench testing was submitted in support of substantial equivalence.

| Test | Test Method Summary | Results |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Resistance to<br>leakage | Resistance to leakage was measured using air.<br>The valves were required to show no leakage<br>for 5 minutes with a differential pressure from<br>inside to outside of 1 m H2O. | All valves met acceptance<br>criteria, demonstrating that there<br>are no concerns regarding valve<br>integrity/ leakage relative to the<br>predicate device. |
| Reservoir dome<br>needle puncture | Reservoir domes were required to show no<br>leakage when repeatedly punctured with a non-<br>coring needle under pressure. | |
| Dynamic breaking<br>strength | Tension was applied in the flow direction,<br>leading to an elongation of the shunt of 10% or<br>a maximum force of 5 N. Shunts were required<br>to exhibit no break, rupture or disconnection<br>after 100,000 cycles $1.0 \pm 0.2$ Hz. | |
| Test | Test Method Summary | Results |
| Pressure/flow | Pressure/flow performance was tested<br>according to ISO 7197:2006. The measured<br>pressure has to remain inside the<br>manufacturer's specifications. | |
| Siphon control<br>device casing<br>effect | This test compared valve pressure at -50 cm<br>hydrostatic pressure with valve pressure at 0 cm<br>hydrostatic pressure. The difference was<br>required to meet manufacturer's specifications. | |
| Ability to withstand<br>overpressure | After application of positive pressure of 1 m<br>water to the open shunt per ISO 7197:2006,<br>valves were required to meet pre-established<br>pressure/flow specifications. | All valves met acceptance<br>criteria, demonstrating that there<br>are no concerns regarding<br>pressure/flow performance<br>relative to the predicate device. |
| Bursting pressure | After application of positive pressure of 2 m<br>water per ISO 7197:2006, valves were required<br>to meet pre-established pressure/flow<br>specifications. | |
| Long term stability | Valves were placed in a water bath with a<br>temperature of 37°C ± 5 while pumping water<br>through the valves at an average flow rate of 20<br>mL/h for 28 days. During this time, valves were<br>required to maintain pre-established<br>pressure/flow specifications. | |
| Identification of<br>shunts in vivo | Valves underwent X-ray imaging. The valve<br>identification markers must be visible and the<br>valve setting must be readable in the X-ray<br>images. | All valves met acceptance<br>criteria, demonstrating that there<br>are no concerns regarding<br>identification of the valve via X-<br>ray relative to the predicate<br>device. |
| Post-MRI<br>functional testing | Valves were exposed to multiple MRI exposures<br>in clinically relevant orientation. After MRI<br>exposure, valves were required to: (1) maintain<br>the pre-conditioning pressure setting, (2) be<br>able to be read and adjusted, and (3) meet pre-<br>established pressure/flow specifications. | All valves met acceptance<br>criteria, demonstrating that there<br>are no concerns regarding valve<br>performance after MRI exposure<br>relative to the predicate device. |
| Test | Test Method Summary | Results |
| Design validation<br>testing | Surgeon evaluators read and adjusted valves,<br>both prior to and after implantation in cadavers. | In all cases evaluators were able<br>to successfully read and adjust<br>the valves, demonstrating that<br>there are no concerns related to<br>valve readability/ adjustability<br>relative to the predicate device. |
| MRI safety testing | - Magnetically induced displacement force<br>testing per ASTM F2052-15<br>- Magnetically induced torque testing per<br>ASTM F2213-06<br>- Radio frequency induced heating testing per<br>ASTM F2182-11a<br>- Image artifact testing per ASTM F2119-07 | Test results demonstrated that<br>StrataMR valves are MR<br>conditional and that there are not<br>MRI safety concerns relative to<br>the predicate device when<br>scanned according to the MR<br>conditions specified in the<br>labeling. |

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In all cases, the results of bench testing met applicable pre-established acceptance criteria and raised no concerns regarding safety and effectiveness relative to the predicate device. Therefore, the bench testing summarized above supports the substantial equivalence of StrataMR™ and the predicate device.

## Biocompatibility Testing:

The following biocompatibility testing was submitted in support of substantial equivalence.

| StrataMR Shunt | | |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Test | Test Method Summary | Results |
| Cytotoxicity | Test method: per ISO 10993-5:2009<br>ISO MEM Elution using L929 cells in triplicate.<br>Extracted at 37°C for 24 hr in MEM and incubated<br>at 37°C for 48 hr). Examined microscopically for<br>abnormal cell morphology and cellular<br>degeneration. | Pass<br>Extract showed no<br>evidence of causing cell<br>lysis or toxicity (score = 0).<br>Test article met<br>requirements of the test<br>(score ≤ 2). |
| Irritation | Test method: per ISO 10993-10:2010<br>ISO Intracutaneous Study in Rabbits. Extracted<br>separately in sodium chloride (saline) and<br>sesame oil at 70°C for 24 hr. Observations for<br>erythema and edema conducted at 24, 48, and<br>72 hr after injection. | Pass<br>Scores = 0.0 for saline and<br>0.1 for oil. Extracts met<br>requirements of the test<br>(score of 1.0 or less). |
| StrataMR Shunt | | |
| Test | Test Method Summary | Results |
| Acute systemic toxicity | Test method: per ISO 10993-11:2006<br>ISO Systemic Toxicity Study in Mice. Extracted<br>separately in sodium chloride (saline) and<br>sesame oil at 70°C for 24 hr. Observations for<br>signs of systemic toxicity conducted at times 0, 4,<br>24, 48, and 72 hrs after injection. | Pass<br>No mortality or evidence of<br>systemic toxicity from<br>extracts. Extracts met<br>requirements of the test. |
| Material-mediated<br>pyrogenicity study | Test method: per ISO 10993-11:2006 & USP<br><151><br>USP Material-Mediated Pyrogen Study. Extracted<br>in sterile, nonpyrogenic sodium chloride (saline)<br>at 70°C for 24 hr. Rectal temperatures measured<br>prior to injection and at 30 min intervals between<br>1 and 3 hours after injection. | Pass<br>Total temperature rise<br>during 3 hr period was<br>0.5°C (max rise of 0.2°,<br>0.2°, and 0.1°C for three<br>rabbits). Test article judged<br>nonpyrogenic. Total temp<br>rise within acceptable USP<br>limits (no single animal<br>showed rise of ≥0.5°C and<br>total temp rise was not<br>>3.3°C). |
| Sensitization | Test method: per ISO 10993-10:2010<br>ISO Guinea Pig Maximization Test. Extracted<br>separately in sodium chloride (saline) and<br>sesame oil at 70°C for 24 hr. Sites were scored<br>for dermal reactions at 24 and 48 hr after<br>challenge patch removal. | Pass<br>Test article not a sensitizer<br>(grade = 0 for saline and<br>oil). Extracts showed no<br>evidence of causing<br>delayed dermal contact<br>sensitization. |
| Genotoxicity | Test method: per ISO 10993-3:2003<br>Bacterial Reverse Mutation Study (AMES) using<br><i>Salmonella typhimurium</i> strains TA98, TA100,<br>TA1535, TA1537, and <i>Escherichia coli</i> strain<br>WP2 <i>uvrA</i> , with and without metabolic activation.<br>Extracted separately in 95% ethanol and saline at<br>70°C for 24 hr. Mean number of revertants for<br>test plates compared to mean number for<br>negative controls after 2 days incubation at 37°C.<br>Test method: per ISO 10993-3:2003<br>Mouse Lymphoma Assay using L5178Y/TK+/- cell<br>line, heterozygous at thymidine (TK) locus, with<br>and without metabolic activation. Extracted<br>separately in RPMI0 culture medium (37°C for 72<br>hr) and 95% ethanol (70°C for 24 hr).<br>Test method: per ISO 10993-3:2003 | Pass<br>Both extracts<br>nonmutagenic to all test<br>strains (no case of ≥ 2-fold<br>increase in mean number<br>of revertants for TA98,<br>TA100, and WP2 <i>uvrA</i> ; no<br>case of ≥ 3-fold increase<br>for TA1535 and TA1537).<br>Pass<br>Both extracts not<br>mutagenic. Extracts did<br>not cause a ≥ 2-fold<br>increase in mean mutant<br>frequency.<br>Pass |
| | Mouse Peripheral Blood Micronucleus Study to | Test article did not induce |

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| StrataMR Shunt | | | | |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Test | Test Method Summary | Results | | |
| | determine cytogenetic damage resulting in<br>micronuclei in mouse peripheral blood. Extracted<br>separately in sodium chloride (saline) and<br>sesame oil at 70°C for 24 hr. Mice injected<br>intraperitoneally for 3 days and observed for<br>general health. Blood collected on day 4 to<br>evaluate reticulocytes for micronuclei. | micronuclei in mice. No<br>significant increase in %<br>micronucleated<br>reticulocytes for both<br>extracts. No biologically<br>relevant changes in %<br>reticulocytes. | | |
| Subchronic/subacute<br>toxicity | Test method: per ISO 10993-11:2006<br>ISO Four Week Toxicity Study in Rat, Repeated<br>Parenteral Administration of Two Extracts.<br>Extracted separately in sodium chloride (saline)<br>and sesame oil at 70°C for 24 hr. Daily IV<br>injections of saline extract and intraperitoneal<br>injections of oil extract on days 1, 4, 8, 12, 15, 19,<br>22, and 26. Observed daily for general health and<br>weekly for detailed health exams. Body weight<br>measured at days 0, 8, 15, 22, 28, and 29. Blood<br>samples taken on day 29 for hematology and<br>clinical chemistry. | Pass<br>Extract did not produce<br>systemic toxicity in rats.<br>Clinical observations, body<br>weights, hematology,<br>clinical chemistry, necropsy<br>results, organ weights,<br>organ/body weight ratios,<br>and organ/brain weight<br>ratios were similar between<br>test and control groups. No<br>microscopic changes due<br>to test article. | | |
| Implantation | Test method: per ISO 10993-6:2007<br>ISO Subcutaneous Implantation Study in Rabbits,<br>13 Weeks. StrataMR with catheter injected<br>subcutaneously for 13 weeks. Implant sites<br>examined macroscopically and microscopically to<br>define any tissue response. | Pass<br>Macroscopic reaction not<br>significant compared to<br>negative control article.<br>Microscopic evaluation<br>score = 2.3 compared to<br>control. Test article<br>classified as nonirritant<br>compared to negative<br>control (score = 0.0-2.9) | | |

| StrataMR Adjustment Tools Components | | | | |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Test | Test Method Summary | Results | | |
| Cytotoxicity | Test articles: adjustor, locator, and indicator<br>housings<br>Test method: per ISO 10993-5:2009<br>ISO MEM Elution using L929 cells in triplicate.<br>Extracted at 37°C for 24 hr in MEM and incubated at<br>37°C for 48 hr). Examined microscopically for<br>abnormal cell morphology and cellular degeneration. | Pass<br>Extracts showed no<br>evidence of causing<br>cell lysis or toxicity<br>(scores = 0). Test<br>articles met<br>requirements of the<br>test (score ≤ 2). | | |

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| StrataMR Adjustment Tools Components | | | | |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Test | Test Method Summary | Results | | |
| Irritation | Test article: adjustor housing<br>Test method: per ISO 10993-10:2010<br>ISO Intracutaneous Study in Rabbits. Extracted<br>separately in sodium chloride (saline) and sesame<br>oil at 70°C for 24 hr. Observations for erythema and<br>edema conducted at 24, 48, and 72 hr after injection. | Pass<br>Scores = 0.0 for<br>saline and 0.2 for oil.<br>Extracts met<br>requirements of the<br>test (score of 1.0 or<br>less). | | |
| Acute systemic toxicity | Test article: adjustor housing<br>Test method: per ISO 10993-11:2006<br>Extracted separately in sodium chloride (saline) and<br>sesame oil at 70°C for 24 hr. Observations for signs<br>of systemic toxicity conducted at times 0, 4, 24, 48,<br>and 72 hrs after injection. | No mortality or<br>evidence of systemic<br>toxicity from extracts.<br>Extracts met<br>requirements of the<br>test. | | |
| Sensitization | Test article: adjustor housing<br>Test method: per ISO 10993-10:2010<br>ISO Guinea Pig Maximization Test. Extracted<br>separately in sodium chloride (saline) and sesame<br>oil at 70°C for 24 hr. Sites were scored for dermal<br>reactions at 24 and 48 hr after challenge patch<br>removal. | Pass<br>Test article not a<br>sensitizer (grade = 0<br>for saline and oil).<br>Extracts showed no<br>evidence of causing<br>delayed dermal<br>contact sensitization. | | |

In all cases, StrataMR™ valves and adjustment tools passed biocompatibility testing, demonstrating that the StrataMR™ design does not raise any biocompatibility concerns relative to the predicate device. Therefore, the biocompatibility testing summarized above supports the substantial equivalence of StrataMR™ to the predicate device.

# Conclusion:

Based on the indications for use, design and technology similarities, and performance testing performed on the proposed device, it can be concluded that the Medtronic StrataMR™ valves and shunts are substantially equivalent to the Strata II Valves cleared under K060681.