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 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.

AI/ML Overview

The provided document describes the Medtronic StrataMR™ Valves and Shunts and details the testing performed to demonstrate its substantial equivalence to a predicate device (Medtronic PS Medical Strata Type Valve (K060681)). The information focuses on bench testing and biocompatibility testing, rather than a study involving AI performance or human reader studies.

Therefore, many of the requested criteria regarding AI performance, human reader studies, and large-scale data sets (like training or test sets for AI) are not applicable to this device's submission and the testing described. The device is a physical medical device (a shunt valve), not a software or AI-driven diagnostic tool.

Here's an analysis of the provided text in relation to your questions, highlighting what is present and what is absent/not applicable:

Analysis of Acceptance Criteria and Proving Device Performance

The core of the submission relies on demonstrating substantial equivalence to a previously cleared predicate device. This means the acceptance criteria are largely tied to meeting performance benchmarks that are comparable to or better than the predicate, as well as showing the new design changes (primarily for improved MR resistance) do not introduce new safety or efficacy concerns.

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a summary of bench tests with their methods and results. The "acceptance criteria" are implied by the "Results" column stating "All valves met acceptance criteria," or by explicitly stating values (e.g., for biocompatibility).

Test	Test Method Summary	Acceptance Criteria Implied/Stated	Reported Device Performance
Bench Testing
Resistance to leakage	Measured using air. Required no leakage for 5 minutes with a differential pressure of 1 m H2O.	No leakage for 5 minutes with 1 m H2O differential pressure.	All valves met acceptance criteria, demonstrating no concerns regarding valve integrity/leakage relative to the predicate device.
Reservoir dome needle puncture	Show no leakage when repeatedly punctured with a non-coring needle under pressure.	No leakage after repeated punctures.	Results not explicitly stated as "met acceptance criteria" in table, but overall conclusion states "all cases, the results of bench testing met applicable pre-established acceptance criteria."
Dynamic breaking strength	Tension applied in flow direction (10% elongation or 5 N max force). No break, rupture, or disconnection after 100,000 cycles at 1.0 ± 0.2 Hz.	No break, rupture, or disconnection after 100,000 cycles.	Results not explicitly stated as "met acceptance criteria" in table, but overall conclusion states "all cases, the results of bench testing met applicable pre-established acceptance criteria."
Pressure/flow	Tested according to ISO 7197:2006. Measured pressure to remain inside manufacturer's specifications.	Measured pressure must be within manufacturer's specifications.	Results not explicitly stated as "met acceptance criteria" in table, but overall conclusion states "all cases, the results of bench testing met applicable pre-established acceptance criteria."
Siphon control device casing effect	Compared valve pressure at -50 cm hydrostatic pressure with 0 cm. Difference to meet manufacturer's specifications.	Difference in pressure must meet manufacturer's specifications.	Results not explicitly stated as "met acceptance criteria" in table, but overall conclusion states "all cases, the results of bench testing met applicable pre-established acceptance criteria."
Ability to withstand overpressure	After application of positive pressure (1 m water per ISO 7197:2006), valves to meet pre-established pressure/flow specifications.	Valves must meet pre-established pressure/flow specifications.	All valves met acceptance criteria, demonstrating no concerns regarding pressure/flow performance relative to the predicate device.
Bursting pressure	After application of positive pressure (2 m water per ISO 7197:2006), valves to meet pre-established pressure/flow specifications.	Valves must meet pre-established pressure/flow specifications.	Results not explicitly stated as "met acceptance criteria" in table, but overall conclusion states "all cases, the results of bench testing met applicable pre-established acceptance criteria."
Long term stability	Valves in water bath (37°C ± 5) with pumping water (20 mL/h) for 28 days. Valves to maintain pre-established pressure/flow specifications.	Valves must maintain pre-established pressure/flow specifications after 28 days.	Results not explicitly stated as "met acceptance criteria" in table, but overall conclusion states "all cases, the results of bench testing met applicable pre-established acceptance criteria."
Identification of shunts in vivo	X-ray imaging. Valve identification markers must be visible and valve setting readable.	Valve identification markers visible and valve setting readable in X-ray images.	All valves met acceptance criteria, demonstrating no concerns regarding identification of the valve via X-ray relative to the predicate device.
Post-MRI functional testing	Exposed to multiple MRI exposures in clinically relevant orientation. Valves to maintain pre-conditioning pressure setting, be readable and adjustable, and meet pre-established pressure/flow specifications.	Maintain pre-conditioning pressure setting, be readable/adjustable, and meet pre-established pressure/flow specifications after MRI.	All valves met acceptance criteria, demonstrating no concerns regarding valve performance after MRI exposure relative to the predicate device.
Design validation testing	Surgeon evaluators read and adjusted valves, pre- and post-implantation in cadavers.	Evaluators must be able to successfully read and adjust valves.	In all cases evaluators were able to successfully read and adjust the valves, demonstrating no concerns related to valve readability/adjustability relative to the predicate device.
MRI safety testing	Magnetically induced displacement force (ASTM F2052-15), magnetically induced torque (ASTM F2213-06), radio frequency induced heating (ASTM F2182-11a), image artifact testing (ASTM F2119-07).	Test results demonstrated MR conditional and no MRI safety concerns relative to predicate when scanned per labeling conditions.	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.
Biocompatibility Testing (Shunt)
Cytotoxicity	ISO MEM Elution. Incubated at 37°C for 48 hr. Examined microscopically for abnormal cell morphology and cellular degeneration.	Extract must show no evidence of causing cell lysis or toxicity (score = 0). Test article must meet requirements (score ≤ 2).	Pass. Extract showed no evidence of causing cell lysis or toxicity (score = 0). Test article met requirements of the test (score ≤ 2).
Irritation	ISO Intracutaneous Study in Rabbits. Extracted separately in saline and sesame oil. Observations for erythema and edema at 24, 48, and 72 hr.	Scores ≤ 1.0.	Pass. Scores = 0.0 for saline and 0.1 for oil. Extracts met requirements of the test (score of 1.0 or less).
Acute systemic toxicity	ISO Systemic Toxicity Study in Mice. Extracted separately in saline and sesame oil. Observations for signs of systemic toxicity at 0, 4, 24, 48, and 72 hrs.	No mortality or evidence of systemic toxicity.	Pass. No mortality or evidence of systemic toxicity from extracts. Extracts met requirements of the test.
Material-mediated pyrogenicity study	USP Material-Mediated Pyrogen Study. Extracted in saline. Rectal temperatures measured prior to injection and at 30 min intervals between 1 and 3 hours.	Total temperature rise during 3 hr period ≤ 0.5°C (max rise of 0.2°, 0.2°, and 0.1°C for three rabbits). No single animal showed rise of ≥0.5°C and total temp rise < 3.3°C. Test article judged nonpyrogenic.	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.
Sensitization	ISO Guinea Pig Maximization Test. Extracted separately in saline and sesame oil. Dermal reactions scored at 24 and 48 hr.	Not a sensitizer (grade = 0). No evidence of causing delayed dermal contact sensitization.	Pass. Test article not a sensitizer (grade = 0 for saline and oil). Extracts showed no evidence of causing delayed dermal contact sensitization.
Genotoxicity	Bacterial Reverse Mutation Study (AMES). Mouse Lymphoma Assay. Mouse Peripheral Blood Micronucleus Study. Evaluations for mutagenicity and cytogenetic damage.	Nonmutagenic (e.g., no ≥ 2-fold increase in mean number of revertants for specified strains; no ≥ 2-fold increase in mean mutant frequency) and no induction of micronuclei.	Pass. Both extracts nonmutagenic to all test strains. Test article did not induce micronuclei in mice. No significant increase in % micronucleated reticulocytes.
Subchronic/subacute toxicity	ISO Four Week Toxicity Study in Rat, Repeated Parenteral Administration. Daily IV or intraperitoneal injections. Observations for general health, detailed health exams, body weight, blood samples, necropsy.	No systemic toxicity in rats. Clinical observations, body weights, hematology, clinical chemistry, necropsy results, organ weights and ratios similar between test and control groups. No microscopic changes due to test article.	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	ISO Subcutaneous Implantation Study in Rabbits, 13 Weeks. Implant sites examined macroscopically and microscopically.	Macroscopic reaction not significant compared to negative control. Microscopic evaluation score ≤ 2.9 (nonirritant).	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).
Biocompatibility Testing (Adjustment Tools Components)
Cytotoxicity	ISO MEM Elution.	Extracts show no evidence of causing cell lysis or toxicity (score = 0). Test articles meet requirements (score ≤ 2).	Pass. Extracts showed no evidence of causing cell lysis or toxicity (scores = 0). Test articles met requirements of the test (score ≤ 2).
Irritation	ISO Intracutaneous Study in Rabbits.	Scores ≤ 1.0.	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	Extracted in saline and sesame oil. Observations for signs of systemic toxicity.	No mortality or evidence of systemic toxicity.	No mortality or evidence of systemic toxicity from extracts. Extracts met requirements of the test.
Sensitization	ISO Guinea Pig Maximization Test.	Not a sensitizer (grade = 0). No evidence of causing delayed dermal contact sensitization.	Pass. Test article not a sensitizer (grade = 0 for saline and oil). Extracts showed no evidence of causing delayed dermal contact sensitization.

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

Sample Size: The document does not explicitly state the number of units tested for each bench test, but it consistently refers to "all valves" meeting acceptance criteria, implying a representative sample was used. For biocompatibility, specific numbers of animals (e.g., rabbits, mice, guinea pigs) are implied by the test methods (e.g., "triplicate" for cytotoxicity, "in rabbits/mice/guinea pigs" for others).
Data Provenance: The data is from "Bench Testing" and "Biocompatibility Testing" performed by Medtronic. The studies appear to be prospective bench and animal studies conducted in a lab setting, not retrospective or prospective human clinical data. The country of origin of the data is implied to be where Medtronic's testing facilities are located (likely USA or a facility adhering to international standards).

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

Experts: For "Design validation testing," it states "Surgeon evaluators read and adjusted valves, both prior to and after implantation in cadavers."
Qualifications: "Surgeon evaluators" are mentioned. Their specific qualifications (e.g., years of experience, subspecialty) are not detailed in this summary. This is not a diagnostic device where "ground truth" in the clinical sense (e.g., presence of disease based on expert consensus) would be established by radiologists/pathologists. Instead, it's about the functionality and adjustability of a physical device by its intended users.

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

Not Applicable: This type of adjudication method is typically used in clinical studies involving interpretation of medical images or patient data, especially when establishing ground truth for AI algorithms. For bench testing of a physical device, this concept does not apply. The "Design validation testing" involved surgeons directly interacting with the device, and the "results" refer to their successful manipulation of the device.

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 Applicable: This product is a physical medical device (a shunt valve), not an AI-assisted diagnostic tool. No MRMC study was performed, and thus no effect size related to AI assistance for human readers is available or relevant.

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

Not Applicable: As mentioned, this is a physical device, not an algorithm. Therefore, no standalone algorithm performance testing was conducted.

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

For the bench testing, the "ground truth" is defined by the objective, quantifiable specifications (e.g., no leakage, specific pressure/flow ranges, presence of visible markers, successful adjustment) as determined by established engineering and quality control standards (e.g., ISO, ASTM, manufacturer's specifications).
For the design validation testing, the "ground truth" for adjustability/readability was established through direct interaction by medical professionals ("surgeon evaluators") performing the actions the device is designed for, likely against a checklist of successful outcomes.
For biocompatibility testing, the "ground truth" is established through standardized biological assays and animal studies, with results compared to pre-defined acceptable biological responses (e.g., no cytotoxicity, non-irritating, non-sensitizing, non-toxic).

8. The sample size for the training set

Not Applicable: This device does not involve machine learning or AI, so there is no training set in the AI sense.

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

Not Applicable: As there is no AI training set, this question is not relevant.

Summary

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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 (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

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Indications for Use

510(k) Number (if known) K152700

Device Name Medtronic StrataMRTM Valves and Shunts

Indications for Use (Describe)

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

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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 Neurosurgery125 Cremona DriveGoleta, CA 93117-5503 USA
Contact Name:	Deep PalManager, Regulatory AffairsTelephone: (817) 788-6685Fax: (805) 571-8480Email: 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:

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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 toleakage	Resistance to leakage was measured using air.The valves were required to show no leakagefor 5 minutes with a differential pressure frominside to outside of 1 m H2O.	All valves met acceptancecriteria, demonstrating that thereare no concerns regarding valveintegrity/ leakage relative to thepredicate device.
Reservoir domeneedle puncture	Reservoir domes were required to show noleakage when repeatedly punctured with a non-coring needle under pressure.
Dynamic breakingstrength	Tension was applied in the flow direction,leading to an elongation of the shunt of 10% ora maximum force of 5 N. Shunts were requiredto exhibit no break, rupture or disconnectionafter 100,000 cycles $1.0 \pm 0.2$ Hz.
Test	Test Method Summary	Results
Pressure/flow	Pressure/flow performance was testedaccording to ISO 7197:2006. The measuredpressure has to remain inside themanufacturer's specifications.
Siphon controldevice casingeffect	This test compared valve pressure at -50 cmhydrostatic pressure with valve pressure at 0 cmhydrostatic pressure. The difference wasrequired to meet manufacturer's specifications.
Ability to withstandoverpressure	After application of positive pressure of 1 mwater to the open shunt per ISO 7197:2006,valves were required to meet pre-establishedpressure/flow specifications.	All valves met acceptancecriteria, demonstrating that thereare no concerns regardingpressure/flow performancerelative to the predicate device.
Bursting pressure	After application of positive pressure of 2 mwater per ISO 7197:2006, valves were requiredto meet pre-established pressure/flowspecifications.
Long term stability	Valves were placed in a water bath with atemperature of 37°C ± 5 while pumping waterthrough the valves at an average flow rate of 20mL/h for 28 days. During this time, valves wererequired to maintain pre-establishedpressure/flow specifications.
Identification ofshunts in vivo	Valves underwent X-ray imaging. The valveidentification markers must be visible and thevalve setting must be readable in the X-rayimages.	All valves met acceptancecriteria, demonstrating that thereare no concerns regardingidentification of the valve via X-ray relative to the predicatedevice.
Post-MRIfunctional testing	Valves were exposed to multiple MRI exposuresin clinically relevant orientation. After MRIexposure, valves were required to: (1) maintainthe pre-conditioning pressure setting, (2) beable to be read and adjusted, and (3) meet pre-established pressure/flow specifications.	All valves met acceptancecriteria, demonstrating that thereare no concerns regarding valveperformance after MRI exposurerelative to the predicate device.
Test	Test Method Summary	Results
Design validationtesting	Surgeon evaluators read and adjusted valves,both prior to and after implantation in cadavers.	In all cases evaluators were ableto successfully read and adjustthe valves, demonstrating thatthere are no concerns related tovalve readability/ adjustabilityrelative to the predicate device.
MRI safety testing	- Magnetically induced displacement forcetesting per ASTM F2052-15- Magnetically induced torque testing perASTM F2213-06- Radio frequency induced heating testing perASTM F2182-11a- Image artifact testing per ASTM F2119-07	Test results demonstrated thatStrataMR valves are MRconditional and that there are notMRI safety concerns relative tothe predicate device whenscanned according to the MRconditions specified in thelabeling.

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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 10993-5:2009ISO MEM Elution using L929 cells in triplicate.Extracted at 37°C for 24 hr in MEM and incubatedat 37°C for 48 hr). Examined microscopically forabnormal cell morphology and cellulardegeneration.	PassExtract showed noevidence of causing celllysis or toxicity (score = 0).Test article metrequirements of the test(score ≤ 2).
Irritation	Test method: per ISO 10993-10:2010ISO Intracutaneous Study in Rabbits. Extractedseparately in sodium chloride (saline) andsesame oil at 70°C for 24 hr. Observations forerythema and edema conducted at 24, 48, and72 hr after injection.	PassScores = 0.0 for saline and0.1 for oil. Extracts metrequirements of the test(score of 1.0 or less).
StrataMR Shunt
Test	Test Method Summary	Results
Acute systemic toxicity	Test method: per ISO 10993-11:2006ISO Systemic Toxicity Study in Mice. Extractedseparately in sodium chloride (saline) andsesame oil at 70°C for 24 hr. Observations forsigns of systemic toxicity conducted at times 0, 4,24, 48, and 72 hrs after injection.	PassNo mortality or evidence ofsystemic toxicity fromextracts. Extracts metrequirements of the test.
Material-mediatedpyrogenicity study	Test method: per ISO 10993-11:2006 & USP<151>USP Material-Mediated Pyrogen Study. Extractedin sterile, nonpyrogenic sodium chloride (saline)at 70°C for 24 hr. Rectal temperatures measuredprior to injection and at 30 min intervals between1 and 3 hours after injection.	PassTotal temperature riseduring 3 hr period was0.5°C (max rise of 0.2°,0.2°, and 0.1°C for threerabbits). Test article judgednonpyrogenic. Total temprise within acceptable USPlimits (no single animalshowed rise of ≥0.5°C andtotal temp rise was not>3.3°C).
Sensitization	Test method: per ISO 10993-10:2010ISO Guinea Pig Maximization Test. Extractedseparately in sodium chloride (saline) andsesame oil at 70°C for 24 hr. Sites were scoredfor dermal reactions at 24 and 48 hr afterchallenge patch removal.	PassTest article not a sensitizer(grade = 0 for saline andoil). Extracts showed noevidence of causingdelayed dermal contactsensitization.
Genotoxicity	Test method: per ISO 10993-3:2003Bacterial Reverse Mutation Study (AMES) usingSalmonella typhimurium strains TA98, TA100,TA1535, TA1537, and Escherichia coli strainWP2 uvrA , with and without metabolic activation.Extracted separately in 95% ethanol and saline at70°C for 24 hr. Mean number of revertants fortest plates compared to mean number fornegative controls after 2 days incubation at 37°C.Test method: per ISO 10993-3:2003Mouse Lymphoma Assay using L5178Y/TK+/- cellline, heterozygous at thymidine (TK) locus, withand without metabolic activation. Extractedseparately in RPMI0 culture medium (37°C for 72hr) and 95% ethanol (70°C for 24 hr).Test method: per ISO 10993-3:2003	PassBoth extractsnonmutagenic to all teststrains (no case of ≥ 2-foldincrease in mean numberof revertants for TA98,TA100, and WP2 uvrA ; nocase of ≥ 3-fold increasefor TA1535 and TA1537).PassBoth extracts notmutagenic. Extracts didnot cause a ≥ 2-foldincrease in mean mutantfrequency.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 inmicronuclei in mouse peripheral blood. Extractedseparately in sodium chloride (saline) andsesame oil at 70°C for 24 hr. Mice injectedintraperitoneally for 3 days and observed forgeneral health. Blood collected on day 4 toevaluate reticulocytes for micronuclei.	micronuclei in mice. Nosignificant increase in %micronucleatedreticulocytes for bothextracts. No biologicallyrelevant changes in %reticulocytes.
Subchronic/subacutetoxicity	Test method: per ISO 10993-11:2006ISO Four Week Toxicity Study in Rat, RepeatedParenteral Administration of Two Extracts.Extracted separately in sodium chloride (saline)and sesame oil at 70°C for 24 hr. Daily IVinjections of saline extract and intraperitonealinjections of oil extract on days 1, 4, 8, 12, 15, 19,22, and 26. Observed daily for general health andweekly for detailed health exams. Body weightmeasured at days 0, 8, 15, 22, 28, and 29. Bloodsamples taken on day 29 for hematology andclinical chemistry.	PassExtract did not producesystemic toxicity in rats.Clinical observations, bodyweights, hematology,clinical chemistry, necropsyresults, organ weights,organ/body weight ratios,and organ/brain weightratios were similar betweentest and control groups. Nomicroscopic changes dueto test article.
Implantation	Test method: per ISO 10993-6:2007ISO Subcutaneous Implantation Study in Rabbits,13 Weeks. StrataMR with catheter injectedsubcutaneously for 13 weeks. Implant sitesexamined macroscopically and microscopically todefine any tissue response.	PassMacroscopic reaction notsignificant compared tonegative control article.Microscopic evaluationscore = 2.3 compared tocontrol. Test articleclassified as nonirritantcompared to negativecontrol (score = 0.0-2.9)

StrataMR Adjustment Tools Components
Test	Test Method Summary	Results
Cytotoxicity	Test articles: adjustor, locator, and indicatorhousingsTest method: per ISO 10993-5:2009ISO MEM Elution using L929 cells in triplicate.Extracted at 37°C for 24 hr in MEM and incubated at37°C for 48 hr). Examined microscopically forabnormal cell morphology and cellular degeneration.	PassExtracts showed noevidence of causingcell lysis or toxicity(scores = 0). Testarticles metrequirements of thetest (score ≤ 2).

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StrataMR Adjustment Tools Components
Test	Test Method Summary	Results
Irritation	Test article: adjustor housingTest method: per ISO 10993-10:2010ISO Intracutaneous Study in Rabbits. Extractedseparately in sodium chloride (saline) and sesameoil at 70°C for 24 hr. Observations for erythema andedema conducted at 24, 48, and 72 hr after injection.	PassScores = 0.0 forsaline and 0.2 for oil.Extracts metrequirements of thetest (score of 1.0 orless).
Acute systemic toxicity	Test article: adjustor housingTest method: per ISO 10993-11:2006Extracted separately in sodium chloride (saline) andsesame oil at 70°C for 24 hr. Observations for signsof systemic toxicity conducted at times 0, 4, 24, 48,and 72 hrs after injection.	No mortality orevidence of systemictoxicity from extracts.Extracts metrequirements of thetest.
Sensitization	Test article: adjustor housingTest method: per ISO 10993-10:2010ISO Guinea Pig Maximization Test. Extractedseparately in sodium chloride (saline) and sesameoil at 70°C for 24 hr. Sites were scored for dermalreactions at 24 and 48 hr after challenge patchremoval.	PassTest article not asensitizer (grade = 0for saline and oil).Extracts showed noevidence of causingdelayed dermalcontact 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.

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).