(199 days)
Medtronic PS Medical Strata Type Valve (K060681)
Not Found
No
The description focuses on mechanical and magnetic adjustment mechanisms for CSF flow, with no mention of AI or ML for decision-making, analysis, or control.
Yes
The device is designed to provide continuous cerebrospinal fluid flow, a direct therapeutic intervention for hydrocephalus.
No
This device is a shunt used to divert cerebrospinal fluid, which is a therapeutic function, not a diagnostic one. While its performance can be adjusted and monitored, this does not constitute diagnostic capability as it does not identify or characterize a disease.
No
The device description clearly states that the Medtronic StrataMR™ valves are "implantable adjustable valves" and "associated catheters," which are physical hardware components. The summary also details bench testing and biocompatibility testing related to these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside the body.
- Device Function: The Medtronic StrataMR™ Valves and Shunts are implantable devices designed to manage hydrocephalus by draining cerebrospinal fluid within the body.
- Intended Use: The intended use clearly describes a surgical implant for continuous fluid flow from the brain into other parts of the body.
- Device Description: The description confirms it's an implantable valve and associated catheters.
The device is a medical device, specifically an implantable surgical device, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JXG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ventricles of the brain, right atrium of the heart, peritoneal cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing:
- Resistance to leakage: All valves met acceptance criteria, demonstrating that there are no concerns regarding valve integrity/ leakage relative to the predicate device.
- Reservoir dome needle puncture: Not Found
- Dynamic breaking strength: Not Found
- Pressure/flow: Not Found
- Siphon control device casing effect: Not Found
- Ability to withstand overpressure: All valves met acceptance criteria, demonstrating that there are no concerns regarding pressure/flow performance relative to the predicate device.
- Bursting pressure: Not Found
- Long term stability: Not Found
- Identification of shunts in vivo: 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: All valves met acceptance criteria, demonstrating that there are no concerns regarding valve performance after MRI exposure relative to the predicate device.
- Design validation testing: 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: 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:
- Cytotoxicity: Pass. Extract showed no evidence of causing cell lysis or toxicity (score = 0). Test article met requirements of the test (score ≤ 2).
- Irritation: 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: Pass. No mortality or evidence of systemic toxicity from extracts. Extracts met requirements of the test.
- Material-mediated pyrogenicity study: 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: Pass. Test article not a sensitizer (grade = 0 for saline and oil). Extracts showed no evidence of causing delayed dermal contact sensitization.
- Genotoxicity: 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. Test article did not induce micronuclei in mice. No significant increase in % micronucleated reticulocytes for both extracts. No biologically relevant changes in % reticulocytes.
- Subchronic/subacute toxicity: 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: 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).
- Cytotoxicity (Adjustment Tools): Pass. Extracts showed no evidence of causing cell lysis or toxicity (scores = 0). Test articles met requirements of the test (score ≤ 2).
- Irritation (Adjustment Tools): 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 (Adjustment Tools): No mortality or evidence of systemic toxicity from extracts. Extracts met requirements of the test.
- Sensitization (Adjustment Tools): Pass. Test article not a sensitizer (grade = 0 for saline and oil). Extracts showed no evidence of causing delayed dermal contact sensitization.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Medtronic PS Medical Strata Type Valve (K060681)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 |
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.