Who is the manufacturer of StrataMR Valves and Shunts?

Medtronic Neurosurgery filed the 510(k) submission for StrataMR Valves and Shunts (K152700).

What is the FDA product code for StrataMR Valves and Shunts?

JXG. It is classified under 21 CFR 882.5550 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for StrataMR Valves and Shunts?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like StrataMR Valves and Shunts?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

StrataMR Valves and Shunts

Q: What are the predicate devices for StrataMR Valves and Shunts?

Medtronic PS Medical Strata Type Valve (K060681).

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

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 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)

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 {2}------------------------------------------------ # 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> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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 - K152700 This 510(k) summary is submitted in accordance with the requirements of 21 CFR 807.92. | 510(k) Owner: | Medtronic Neurosurgery 125 Cremona Drive Goleta, CA 93117-5503 USA | |----------------------------|------------------------------------------------------------------------------------------------------------------------------| | Contact Name: | Deep Pal Manager, Regulatory Affairs Telephone: (817) 788-6685 Fax: (805) 571-8480 Email: deep.pal@medtronic.com | | 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 (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. {4}------------------------------------------------ ## 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 leakage | Resistance to leakage was measured using air. The valves were required to show no leakage for 5 minutes with a differential pressure from inside to outside of 1 m H2O. | All valves met acceptance criteria, demonstrating that there are no concerns regarding valve integrity/ leakage relative to the predicate device. | | Reservoir dome needle puncture | Reservoir domes were required to show no leakage when repeatedly punctured with a non- coring needle under pressure. | | | Dynamic breaking strength | Tension was applied in the flow direction, leading to an elongation of the shunt of 10% or a maximum force of 5 N. Shunts were required to exhibit no break, rupture or disconnection after 100,000 cycles $1.0 \pm 0.2$ Hz. | | | Test | Test Method Summary | Results | | Pressure/flow | Pressure/flow performance was tested according to ISO 7197:2006. The measured pressure has to remain inside the manufacturer's specifications. | | | Siphon control device casing effect | This test compared valve pressure at -50 cm hydrostatic pressure with valve pressure at 0 cm hydrostatic pressure. The difference was required to meet manufacturer's specifications. | | | Ability to withstand overpressure | After application of positive pressure of 1 m water to the open shunt per ISO 7197:2006, valves were required to meet pre-established pressure/flow specifications. | All valves met acceptance criteria, demonstrating that there are no concerns regarding pressure/flow performance relative to the predicate device. | | Bursting pressure | After application of positive pressure of 2 m water per ISO 7197:2006, valves were required to meet pre-established pressure/flow specifications. | | | Long term stability | Valves were placed in a water bath with a temperature of 37°C ± 5 while pumping water through the valves at an average flow rate of 20 mL/h for 28 days. During this time, valves were required to maintain pre-established pressure/flow specifications. | | | Identification of shunts in vivo | Valves underwent X-ray imaging. The valve identification markers must be visible and the valve setting must be readable in the X-ray images. | All valves met acceptance criteria, demonstrating that there are no concerns regarding identification of the valve via X- ray relative to the predicate device. | | Post-MRI functional testing | Valves were exposed to multiple MRI exposures in clinically relevant orientation. After MRI exposure, valves were required to: (1) maintain the pre-conditioning pressure setting, (2) be able to be read and adjusted, and (3) meet pre- established pressure/flow specifications. | All valves met acceptance criteria, demonstrating that there are no concerns regarding valve performance after MRI exposure relative to the predicate device. | | Test | Test Method Summary | Results | | Design validation testing | Surgeon evaluators read and adjusted valves, both prior to and after implantation in cadavers. | In all cases evaluators were able to successfully read and adjust the valves, demonstrating that there are no concerns related to valve readability/ adjustability relative to the predicate device. | | MRI safety testing | - Magnetically induced displacement force testing per ASTM F2052-15 - Magnetically induced torque testing per ASTM F2213-06 - Radio frequency induced heating testing per ASTM F2182-11a - Image artifact testing per ASTM F2119-07 | Test results demonstrated that StrataMR valves are MR conditional and that there are not MRI safety concerns relative to the predicate device when scanned according to the MR conditions specified in the labeling. | {5}------------------------------------------------ {6}------------------------------------------------ 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 ISO MEM Elution using L929 cells in triplicate. Extracted at 37°C for 24 hr in MEM and incubated at 37°C for 48 hr). Examined microscopically for abnormal cell morphology and cellular degeneration. | Pass Extract showed no evidence of causing cell lysis or toxicity (score = 0). Test article met requirements of the test (score ≤ 2). | | Irritation | Test method: per ISO 10993-10:2010 ISO Intracutaneous Study in Rabbits. Extracted separately in sodium chloride (saline) and sesame oil at 70°C for 24 hr. Observations for erythema and edema conducted at 24, 48, and 72 hr after injection. | Pass Scores = 0.0 for saline and 0.1 for oil. Extracts met requirements of the test (score of 1.0 or less). | | StrataMR Shunt | | | | Test | Test Method Summary | Results | | Acute systemic toxicity | Test method: per ISO 10993-11:2006 ISO Systemic Toxicity Study in Mice. Extracted separately in sodium chloride (saline) and sesame oil at 70°C for 24 hr. Observations for signs of systemic toxicity conducted at times 0, 4, 24, 48, and 72 hrs after injection. | Pass No mortality or evidence of systemic toxicity from extracts. Extracts met requirements of the test. | | Material-mediated pyrogenicity study | Test method: per ISO 10993-11:2006 & USP <151> USP Material-Mediated Pyrogen Study. Extracted in sterile, nonpyrogenic sodium chloride (saline) at 70°C for 24 hr. Rectal temperatures measured prior to injection and at 30 min intervals between 1 and 3 hours after injection. | Pass Total temperature rise during 3 hr period was 0.5°C (max rise of 0.2°, 0.2°, and 0.1°C for three rabbits). Test article judged nonpyrogenic. Total temp rise within acceptable USP limits (no single animal showed rise of ≥0.5°C and total temp rise was not >3.3°C). | | Sensitization | Test method: per ISO 10993-10:2010 ISO Guinea Pig Maximization Test. Extracted separately in sodium chloride (saline) and sesame oil at 70°C for 24 hr. Sites were scored for dermal reactions at 24 and 48 hr after challenge patch removal. | Pass Test article not a sensitizer (grade = 0 for saline and oil). Extracts showed no evidence of causing delayed dermal contact sensitization. | | Genotoxicity | Test method: per ISO 10993-3:2003 Bacterial Reverse Mutation Study (AMES) using Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, and Escherichia coli strain WP2 uvrA , with and without metabolic activation. Extracted separately in 95% ethanol and saline at 70°C for 24 hr. Mean number of revertants for test plates compared to mean number for negative controls after 2 days incubation at 37°C. Test method: per ISO 10993-3:2003 Mouse Lymphoma Assay using L5178Y/TK+/- cell line, heterozygous at thymidine (TK) locus, with and without metabolic activation. Extracted separately in RPMI0 culture medium (37°C for 72 hr) and 95% ethanol (70°C for 24 hr). Test method: per ISO 10993-3:2003 | Pass Both extracts nonmutagenic to all test strains (no case of ≥ 2-fold increase in mean number of revertants for TA98, TA100, and WP2 uvrA ; no case of ≥ 3-fold increase for TA1535 and TA1537). Pass Both extracts not mutagenic. Extracts did not cause a ≥ 2-fold increase in mean mutant frequency. Pass | | | Mouse Peripheral Blood Micronucleus Study to | Test article did not induce | {7}------------------------------------------------ {8}------------------------------------------------ | StrataMR Shunt | | | | | |---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--| | Test | Test Method Summary | Results | | | | | determine cytogenetic damage resulting in micronuclei in mouse peripheral blood. Extracted separately in sodium chloride (saline) and sesame oil at 70°C for 24 hr. Mice injected intraperitoneally for 3 days and observed for general health. Blood collected on day 4 to evaluate reticulocytes for micronuclei. | micronuclei in mice. No significant increase in % micronucleated reticulocytes for both extracts. No biologically relevant changes in % reticulocytes. | | | | Subchronic/subacute toxicity | Test method: per ISO 10993-11:2006 ISO Four Week Toxicity Study in Rat, Repeated Parenteral Administration of Two Extracts. Extracted separately in sodium chloride (saline) and sesame oil at 70°C for 24 hr. Daily IV injections of saline extract and intraperitoneal injections of oil extract on days 1, 4, 8, 12, 15, 19, 22, and 26. Observed daily for general health and weekly for detailed health exams. Body weight measured at days 0, 8, 15, 22, 28, and 29. Blood samples taken on day 29 for hematology and clinical chemistry. | Pass Extract did not produce systemic toxicity in rats. Clinical observations, body weights, hematology, clinical chemistry, necropsy results, organ weights, organ/body weight ratios, and organ/brain weight ratios were similar between test and control groups. No microscopic changes due to test article. | | | | Implantation | Test method: per ISO 10993-6:2007 ISO Subcutaneous Implantation Study in Rabbits, 13 Weeks. StrataMR with catheter injected subcutaneously for 13 weeks. Implant sites examined macroscopically and microscopically to define any tissue response. | Pass Macroscopic reaction not significant compared to negative control article. Microscopic evaluation score = 2.3 compared to control. Test article classified as nonirritant compared to negative control (score = 0.0-2.9) | | | | StrataMR Adjustment Tools Components | | | | | |--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--| | Test | Test Method Summary | Results | | | | Cytotoxicity | Test articles: adjustor, locator, and indicator housings Test method: per ISO 10993-5:2009 ISO MEM Elution using L929 cells in triplicate. Extracted at 37°C for 24 hr in MEM and incubated at 37°C for 48 hr). Examined microscopically for abnormal cell morphology and cellular degeneration. | Pass Extracts showed no evidence of causing cell lysis or toxicity (scores = 0). Test articles met requirements of the test (score ≤ 2). | | | {9}------------------------------------------------ | StrataMR Adjustment Tools Components | | | | | |--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--| | Test | Test Method Summary | Results | | | | Irritation | Test article: adjustor housing Test method: per ISO 10993-10:2010 ISO Intracutaneous Study in Rabbits. Extracted separately in sodium chloride (saline) and sesame oil at 70°C for 24 hr. Observations for erythema and edema conducted at 24, 48, and 72 hr after injection. | Pass Scores = 0.0 for saline and 0.2 for oil. Extracts met requirements of the test (score of 1.0 or less). | | | | Acute systemic toxicity | Test article: adjustor housing Test method: per ISO 10993-11:2006 Extracted separately in sodium chloride (saline) and sesame oil at 70°C for 24 hr. Observations for signs of systemic toxicity conducted at times 0, 4, 24, 48, and 72 hrs after injection. | No mortality or evidence of systemic toxicity from extracts. Extracts met requirements of the test. | | | | Sensitization | Test article: adjustor housing Test method: per ISO 10993-10:2010 ISO Guinea Pig Maximization Test. Extracted separately in sodium chloride (saline) and sesame oil at 70°C for 24 hr. Sites were scored for dermal reactions at 24 and 48 hr after challenge patch removal. | Pass Test article not a sensitizer (grade = 0 for saline and oil). Extracts showed no evidence of causing delayed dermal 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.

StrataMR Valves and Shunts

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Indications for Use

Device Story

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Technological Characteristics

Indications for Use

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Identification

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Submission Summary (Full Text)

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StrataMR Valves and Shunts

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Indications for Use

Device Story

Clinical Evidence

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Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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