(101 days)
The Codman Certas Plus Electronic Tool Kit allows the non-invasive reading or adjustment of the Codman Certas and Certas Plus Programmable Valves.
The Certas Plus Electronic Tool Kit is used to non-invasively read or adjust the setting of a Certas or Certas Plus Programmable Valve before and after implantation in the treatment of hydrocephalus. The Certas Plus Electronic Tool Kit consists of the following tools: Locator/Indicator Tool, Adjustment Tool and X-Ray Overlay Tool. The Locator/Indicator Tool facilitates correct placement of the Adjustment Tool over a pre-implanted valve in the packaging or a post-implanted valve, and measures the valve's magnetic field to display the valve setting. The Adjustment Tool adjusts the valve to one of the 8 valve settings. The magnets in the Adjustment Tool couple with the magnets in the rotating construct of the valve, causing the rotating construct to lift and follow the Adjustment Tool as it is rotated to one of 8 valve settings.
The Codman Certas Plus Electronic Tool Kit is a non-invasive device used to read and adjust the setting of Certas and Certas Plus Programmable Valves, which are used in the treatment of hydrocephalus. The device's substantial equivalence to a predicate device (Codman Certas Tool Kit, K143111) was established through comprehensive verification and validation testing, as detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria Summary | Reported Device Performance |
|---|---|---|
| Verification Testing | ||
| Comprehensive Design Verification Study | Design outputs adequately met specified design inputs, including: - Product requirements verified against drawing specifications - Expected performance of indication and adjustment features - Tool screen sequence and iconography features - Mechanical performance of assembly and carrying case - Successful indication across range of tissue thickness - Electronic components not exceeding rated maximums (thermal, operating temperature, electrical voltage, current capacity) | PASS |
| Electrical Safety and Ingress Testing | Protect against ingress with an IP4X rating (Per IEC 60601-1, Edition 3.1) | PASS |
| Force Tests | Device capable of performing intended function after a minimum of 2700 cycles. | PASS |
| User Feedback Verification | Verify user interaction requirements associated with screen and user feature design/function. - Measure time to receive indication from device. - Confirm users receive appropriate feedback during adjustment. - Verify system failure messages. | PASS |
| Environmental Testing | Durability across typical operational conditions. - Environmental storage conditions will not affect functionality. | PASS |
| Transit Testing | Device and case secure during transit. - Case shall prevent damage to the product in normal conditions of transit, handling, and storage (in accordance with ISTA 3A, including vibration, drop, and environmental conditioning for packaged products for parcel delivery system shipments 70kg (150 lb) or less). | PASS |
| Disinfection Compatibility | Efficacy of reprocessing procedure to achieve low-level disinfection using 70% Isopropyl Alcohol Surface Wipes. - No appreciable signs of deterioration of enclosure after 1000 disinfection cycles. | PASS |
| Validation Testing - Biocompatibility | ||
| Cytotoxicity | No cytotoxicity or cell lysis noted in test wells; no pH shift observed at 48 hours. | Non-cytotoxic (PASS) |
| Sensitization | No evidence of causing delayed dermal contact sensitization in guinea pig. | Not considered a sensitizer (PASS) |
| Irritation | No erythema or edema observed on skin of animals treated with test article extract. Primary Irritation Index for sodium chloride and sesame oil extracts calculated to be 0.0. Irritation responses categorized as negligible. | Non-Irritant (PASS) |
| Validation Testing - Simulated Post-Implantation Use | ||
| System Safety Study | Clinicians evaluated the maximum acceptable rate for false positives and maximum success rate for completing a full procedure on a simulated head model with clinically relevant implant locations to create angular variability. | PASS |
| Qualitative Assessment of Clinical Acceptability | Clinicians provided qualitative assessment of: - Patient comfort (anticipated) - Clarity of information on screen - Acceptability for use in retro-auricular placement - Ease of use - Clinical acceptability - Identification of images for low battery, critical low battery, and graphics system failure screen with intent. | PASS |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the sample sizes for most of the verification and validation tests.
- Comprehensive Design Verification Study, Electrical Safety and Ingress Testing, Environmental Testing, Transit Testing, and Disinfection Compatibility, Force Tests: The document states that "All samples in design verification testing met predefined acceptance criteria," but does not specify the number of samples for each test.
- User Feedback Verification: The number of users involved is not specified, but the test aimed to "Measure the time to receive an indication from the device" and "Confirm that users receive appropriate feedback during adjustment."
- Biocompatibility Testing: Guinea pigs were used for sensitization testing, and animals were used for irritation testing. The exact number of animals is not specified but is implicitly compliant with ISO 10993 standards.
- Simulated Post-Implantation Use: This involved "clinicians" evaluating the device on a "simulated head model." The number of clinicians and simulated procedures is not specified.
Data Provenance: The studies appear to be internal company studies, likely conducted at Integra LifeSciences Corp. or its contract research organizations. The data provenance is retrospective for the purpose of the 510(k) submission, meaning the tests were performed prior to this submission to demonstrate the device's characteristics. The country of origin of the data is not specified, but given the company location (Mansfield, Massachusetts, USA), the studies were likely conducted in the USA or by international partners.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Verification Testing (e.g., Comprehensive Design Verification, Electrical Safety, etc.): The "ground truth" for these engineering and performance tests is generally based on established engineering standards, specifications, and objective measurements (e.g., passing specific force thresholds, IP ratings, or electrical safety limits). No external experts are described as establishing ground truth in this context; rather, the device's performance is compared against predetermined engineering requirements.
- Biocompatibility Testing: The "ground truth" is established by the results of standardized biological tests (cytotoxicity, sensitization, irritation) and their interpretation against ISO 10993 standards. The qualifications of the personnel performing and interpreting these tests are not explicitly stated, but they would be expected to be trained professionals in toxicology and biocompatibility testing.
- Simulated Post-Implantation Use: For the "System Safety Study" and "Qualitative Assessment of Clinical Acceptability," "clinicians" were involved. Their exact number and specific qualifications (e.g., neurosurgeons, nurses, etc.) are not provided. The term "clinicians" suggests healthcare professionals who would typically use such a device.
4. Adjudication Method for the Test Set
For the engineering and biocompatibility tests, the adjudication method is typically objective measurement against defined quantitative or qualitative acceptance criteria specified in the test protocols or relevant standards. A "PASS" result indicates the criteria were met.
For the Simulated Post-Implantation Use involving clinicians:
- System Safety Study: Clinicians "evaluated the maximum acceptable rate for false positives and maximum success rate for completing a full procedure." This implies a consensus or pre-defined threshold for acceptable performance that the clinicians' observations were judged against. The specific adjudication method (e.g., majority vote, pre-set tolerance levels) is not detailed.
- Qualitative Assessment of Clinical Acceptability: Clinicians provided qualitative assessments. This often involves structured questionnaires or interviews where their feedback is aggregated. The document states "All acceptance criteria were met," indicating that their qualitative feedback was overwhelmingly positive or met predefined levels of satisfaction. The exact method of combining or adjudicating these qualitative responses (e.g., if multiple clinicians responded differently to a question) is not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was explicitly described. The studies focused on demonstrating the device's performance against pre-defined functional, safety, and user-interaction criteria, establishing substantial equivalence to the predicate device. There is no mention of comparing human readers' performance with and without AI assistance, as this device itself is a tool for adjusting and reading existing programmable valves, not an AI diagnostic system.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The Codman Certas Plus Electronic Tool Kit is a physical medical device (electro-mechanical tool) with a user interface, not a standalone AI algorithm. Its performance is intrinsically linked to its interaction with a programmable valve and a human user.
7. Type of Ground Truth Used
- Verification Testing: Ground truth was based on adherence to engineering design specifications, established industry standards (e.g., IEC 60601-1 for electrical safety, ISTA 3A for transit), and internal product requirements.
- Biocompatibility Testing: Ground truth was based on the results of standardized biological tests interpreted according to ISO 10993-1.
- Simulated Post-Implantation Use: Ground truth was derived from clinician evaluations on a simulated head model, comparing the device's operational characteristics (e.g., false positive rates, success rates, clarity of information, ease of use) against predefined acceptable clinical performance and user experience expectations.
8. Sample Size for the Training Set
No training set is mentioned in the context of the provided document. The device is not described as involving machine learning or AI that would require a distinct training set for algorithm development. The testing described focuses on validation and verification of a hardware device and its software components.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was mentioned or implied for this device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other related products.
October 25, 2018
Integra LifeSciences Corp. Nancv MacDonald Regulatory Affairs Manager 11 Cabot Blvd. Mansfield, Massachusetts 02048
Re: K181902
Trade/Device Name: Codman Certas Plus Electronic Tool Kit Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt and Components Regulatory Class: Class II Product Code: JXG Dated: September 25, 2018 Received: September 26, 2018
Dear Nancy MacDonald:
We have reviewed vour 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 Mav 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
{1}------------------------------------------------
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Xiaolin Zheng -S
for 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) K181902
Device Name
Codman Certas Plus Electronic Tool Kit
Indications for Use (Describe)
The Codman Certas Plus Electronic Tool Kit allows the non-invasive reading or adjustment of the Codman Certas and Certas Plus Programmable Valves.
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) |
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
I. Submitter Integra LifeSciences Corp. 11 Cabot Blvd Mansfield, MA 02048
Primary Contact: Nancy MacDonald Phone: (781) 971-5664
Secondary Contact: Jocelyn Raposo Phone: (781) 971-5688
Date of Preparation: September 25, 2018
II. Device
| 510(k) Number | K181902 |
|---|---|
| Name of Device | Codman Certas Plus Electronic Tool Kit |
| Common Name | Hydrocephalus Shunt |
| Classification Name | Central Nervous System Fluid Shunt and Components(21 CFR 882.5550) |
| Regulatory Class | II |
| Product Code | JXG |
III. Predicate The predicate device for this submission is:
Device
| 510(k) Number | Date Cleared | Title |
|---|---|---|
| K143111 | February 19, 2015 | Codman Certas Tool Kit |
IV. Device The Certas Plus Electronic Tool Kit is used to non-invasively read or adjust the Description setting of a Certas or Certas Plus Programmable Valve before and after implantation in the treatment of hydrocephalus. The Certas Plus Electronic Tool Kit consists of the following tools: Locator/Indicator Tool, Adjustment Tool and X-Ray Overlay Tool. The Locator/Indicator Tool facilitates correct placement of the Adjustment Tool over a pre-implanted valve in the packaging or a post-implanted valve, and measures the valve's magnetic field to display the valve setting. The Adjustment Tool adjusts the valve to one of the 8 valve settings. The magnets in the Adjustment Tool couple with the magnets in the rotating construct of the valve, causing the rotating construct to lift and follow the Adjustment Tool as it is rotated to one of 8 valve settings.
{4}------------------------------------------------
The Indications for Use statement for the Certas Plus Electronic Tool Kit is V. Indications for Use identical to the predicate Certas Tool Kit: The Codman Certas Plus Electronic Tool Kit allows the non-invasive reading or adjustment of the valve setting for the Codman Certas and Certas Plus Programmable Valves. VI. Compared to the predicate device, the proposed Certas Plus ElectronicTool Kit Comparison includes the modifications listed in Table 1. to Predicate Device
| Table 1: Similarities and Differences – Certas Tool Kit and Certas Plus Electronic Tool Kit | ||
|---|---|---|
| Certas Took Kit(Predicate) | Certas Plus Electronic Tool Kit(this submission) | |
| 510(k) Number | K143111 | K181902 |
| Indications for Use | The Codman Certas Tool Kit allows thenon-invasive reading or adjustment of thevalve setting. | The Codman Certas Plus Electronic ToolKit allows the non-invasive reading oradjustment of the valve setting for theCodman Certas and Certas PlusProgrammable Valves. |
| Handheld Tools | Locator tool (low profile + adjustableheight)Indicator toolAdjustment tool | Locator/Indicator toolAdjustment tool |
| OperatingPrinciple | Locator Tool: Facilitates correctplacement of the Adjustment Tool andIndicator Tool over an implanted valve. | The Locator and Indicator Tools havebeen combined into one tool.Locator/Indicator Tool facilitates correctplacement of the Adjustment Tool over animplanted valve. |
| Indicator Tool: Incorporates a detectionwheel (indication dial) that aligns thevalve's magnetic field to display the valvesetting. | The Locator/Indicator Tool incorporates adetection wheel (indication dial) thatmeasures the valve's magnetic field todisplay the valve setting. | |
| Adjustment Tool: The magnets in theAdjustment Tool couple with the magnetsin the rotating construct of the valve,causing the rotating construct to lift andfollow the Adjustment Tool as it is rotatedto one of 8 valve settings. | Adjustment Tool: The magnets in theAdjustment Tool couple with the magnetsin the rotating construct of the valve,causing the rotating construct to lift andfollow the Adjustment Tool as it is rotatedto one of 8 valve settings. | |
| Energy Type | Mechanical, magnetic energy, not batteryoperated | Locator/Indicator: Battery operatedAdjustment Tool: Magnetic energy |
| Table 1: Similarities and Differences – Certas Tool Kit and Certas Plus Electronic Tool Kit | ||
| Certas Took Kit(Predicate) | Certas Plus Electronic Tool Kit(this submission) | |
| Location/IndicationFeedback | Location: No location feedback; the user isrequired to manually palpate to determinethe valve locationIndication: display a mechanical indicationdial for the determination of valveperformance setting | Location: LED screen is used to displaylocation feedback to aid in the alignmentof the Locator/Indicator Tool with thevalve mechanism centerIndication: LED screen is used to displayan indication dial for the determination ofvalve performance settings. |
| Materials - PatientContacting | • Polycarbonate• Polycarbonate, Aluminum withanodized surface, Decal• Acetal Copolymer | • Polycarbonate and acrylonitrilebutadiene styrene (PC/ABS)• Pad Printing Ink (blue)• Pad Printing Ink (White) |
| Materials - NotPatient Contacting(Locator Tool) | There are various Locator and IndicatorTool materials including, but not limitedto:• Polycarbonate• Acetal (Delrin) | Locator/Indicator Tool:• PC/ABS• MuMetal ASTM-A753 Alloy 4• Brass• Polycarbonate• ROHS Compliant Electronics• Nickel plated Stainless Contact andCopper Wire• Polyimide• Insulated Copper Wire• CR 123A, Lithium Battery• Thermal Transfer Polyester• Polyester Film |
| Materials - NotPatient Contacting(Adjustment Tool) | There are various Adjustment Toolmaterials including, but not limited to:• Polycarbonate• Acetal (Delrin) | Adjustment Tool:• PC/ABS TPE• PC/ABS• Neodymium Magnets• Stainless Steel• Thermal Transfer Polyester |
| ProtectiveCarrying Case | Yes | Yes |
| Accessory tool | X-ray overlay | X-ray overlay |
| Sterilization | NA, non-sterile | NA, non-sterile |
{5}------------------------------------------------
VII. The following performance data is provided in support of the substantial Performance equivalence determination for this submission. Data
Verification Testing
The following table summarizes the design verification activities. All samples in design verification testing met predefined acceptance criteria, and the proposed device passed design verification test activities. These test results, in conjunction with the similarities to the predicate device, demonstrate that the Certas Plus Electronic Tool Kit is substantially equivalent to the predicate device.
{6}------------------------------------------------
| Table 2: Design Verification Activities Codman Certas Plus Electronic Tool Kit | ||
|---|---|---|
| Test | Test Method Summary | Results |
| ComprehensiveDesignVerification Study | Testing verified that design outputs adequately metthe specified designed inputs including but not limitedto the following:Product requirements verified against drawingspecifications for predicate Performed to verify expected performance ofindication and adjustment features Verify tool screen sequence and iconographyfeatures Verify mechanical performance of assembly andcarrying case Ensure that a successful indication is providedacross the range of tissue thickness Verify that electronic components areincorporated such that their rated maximums arenot exceeded during normal use. This includescomponent thermal rating, operating temperature,electrical voltage withstanding, electrical currentcapacity and other parameters applicable tospecific components | PASS |
| Electrical Safetyand IngressTesting | Protect against ingress with a IP4X rating. Per IEC60601-1 (Edition 3.1) | PASS |
| Force Tests | Device capable performing intended function afterminimum 2700 cycles | PASS |
| User FeedbackVerification | Verify user interaction requirements associatedwith screen and user feature design and function. Measure the time to receive an indication fromthe device. Confirm that users receive appropriate feedbackdevice during adjustment Verify system failure messages. | PASS |
| Environmental | Environmental chamber testing durability acrosstypical operational conditions. Demonstrate thatenvironmental storage conditions experienced by thetool kit will not affect its functionality. | PASS |
| Transit Testing | Confirm that device and case are secure duringtransit and that case shall prevent damage to theproduct in normal conditions of transit, handling,and storage in accordance with ISTA 3A. Vibration, drop, and environmental conditioning (Packaged-Products for Parcel DeliverySystem Shipments 70kg (150 lb) or Less(standard, small, flat or elongated). | PASS |
| DisinfectionCompatibility | Demonstrate efficacy of the reprocessingprocedure used to disinfect reusable componentsof the device to achieve low level disinfectionusing 70% Isopropyl Alcohol Surface Wipes. Confirm no appreciable signs of deterioration ofthe enclosure after 1000 disinfection cycles. | PASS |
{7}------------------------------------------------
Validation Testing
Biocompatibility Testing
Codman performed a biocompatibility evaluation in accordance with ISO 10993-1 Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process and FDA guidance, Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a risk management process', published June 16, 2016.
The Certas Plus Electronic Tool Kit is considered a surface device with limited skin contact (≤ 24 hours). Biocompatibility testing performed on the subject device, the Certas Plus Electronic Tool Kit, with successful results, confirming that no new issues of safety with successful results, confirming that no new issues of safety and effectiveness are raised. The following tests in Table 3 were conducted on the patient contacting components: cytotoxicity, sensitization and irritation. The device met all predefined acceptance criteria and passed biocompatibility testing.
| Table 3: Biocompatibility Testing for the Locator/Indicator Bottom Housing ofthe Proposed Device | ||
|---|---|---|
| BiocompatibilityTest | Summary ofResults | Conclusion |
| Cytotoxicity | No cytotoxicity or cell lysis wasnoted in any of the test wells. No pHshift was observed at 48 hours. | Non-cytotoxic |
| Sensitization | The test article extracts showed noevidence of causing delayed dermalcontact sensitization in the guineapig. The test article was notconsidered a sensitizer in the guineapig test. | Not considered asensitizer |
| Irritation | There was no erythema and no edemaobserved on the skin of the animalstreated with the test article extract.The Primary Irritation Index for thetest article extracts of sodiumchloride and sesame oil were bothcalculated to be 0.0. The irritationresponses to the test article extracts ofsodium chloride and sesame wascategorized as negligible. | Non-Irritant |
All tests results are acceptable and conform to the acceptance criteria outlined in the applicable ISO 10993 standards. The test results demonstrate that the materials in the proposed device are non-cytotoxic, non-sensitizing, and nonirritating and thus biocompatible per ISO 10993-1. Therefore, the proposed Certas Plus Electronic Tool Kit is substantially equivalent to the predicate device with respect to biocompatibility.
{8}------------------------------------------------
Simulated Post-Implantation Use
Codman conducted validation testing with clinicians which included a system safety study and qualitative assessment of clinical acceptability. All acceptance criteria were met.
| Table 4: Design Validation – Certas Plus Electronic Tool Kit | ||
|---|---|---|
| Test | Test Method Summary | Results |
| System Safety Study | Clinicians evaluated the maximum acceptable ratefor false positives and maximum success rate forcompleting a full procedure. Testing conducted ona simulated head model with clinically relevantimplant locations to create angular variability. | PASS |
| QualitativeAssessment ofClinical Acceptability | After completing simulated use testing with theCertas Plus Electronic Tool Kit, clinicians wereasked to:• Provide a qualitative assessment of:◦ Patient comfort (anticipated)◦ Clarity of information on screen◦ acceptability for use in retro-auricularplacement◦ Ease of use◦ Clinical acceptability• Identify images of low battery, critical lowbattery and graphics system failure screen andasked to identify the intent. | PASS |
Design Validation testing of the Certas Plus Electronic Tool Kit confirmed that the design outputs meet the customer requirements and confirm various user needs for the individual tools. These results demonstrate the safe and effective use of the Certas Plus Valve and the Certas Plus Electronic Tool Kit as a system for post-implant adjustment of the valve.
Animal Studies
No animal studies were required as appropriate verification and validation of the modifications were achieved based on the similarities of the proposed device to the predicate device, and from results of bench and biocompatibility testing.
Clinical Studies
No clinical studies were required as appropriate verification and validation of the modifications was achieved based on the similarities of the proposed device to the predicate device, and from results of bench and biocompatibility testing.
{9}------------------------------------------------
The Certas Plus Electronic Tool Kit passed the verification and validation testing, demonstrating that it performs similarly to the predicate device, the Certas Tool Kit, with respect to design verification and validation testing.
VIII. Based upon the intended use, design, materials, function, comparison to the Conclusion predicate device, and testing performed by Codman, it is concluded that the Certas Plus Electronic Tool Kit is substantially equivalent to the predicate device.
§ 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).