(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.
§ 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).