(101 days)
Not Found
No
The device description and performance studies focus on mechanical and electronic interactions with the valve, with no mention of AI or ML algorithms for analysis, prediction, or decision-making.
No
The device is used to non-invasively read or adjust the setting of a Codman Certas or Certas Plus Programmable Valve, which is used for the treatment of hydrocephalus. However, the device itself is a tool for adjusting the valve, not a therapeutic device.
No
This device is used to read and adjust the setting of a programmable valve, not to diagnose a medical condition. While it "measures the valve's magnetic field to display the valve setting," this is a measurement of the device's state, not a diagnostic assessment of the patient's condition.
No
The device description explicitly lists physical tools (Locator/Indicator Tool, Adjustment Tool, X-Ray Overlay Tool) that are part of the device and perform physical functions (locating, adjusting, overlaying). This indicates it is a hardware device with potentially some software components, but not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to non-invasively read or adjust the setting of an implanted valve used in the treatment of hydrocephalus. This is a therapeutic and monitoring function related to an implanted medical device, not a diagnostic test performed on biological samples in vitro.
- Device Description: The device interacts with an implanted valve using magnetic fields to read and adjust its setting. It does not analyze biological samples like blood, urine, or tissue.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological specimens.
- Detection or measurement of analytes in biological samples.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on in vitro analysis.
The device is clearly designed to interact with and manage an implanted medical device (the programmable valve) within the patient's body, which falls under the category of a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
The Codman Certas Plus Electronic Tool Kit allows the non-invasive reading or adjustment of the Codman Certas and Certas Plus Programmable Valves.
Product codes (comma separated list FDA assigned to the subject device)
JXG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Verification Testing:
All samples in design verification testing met predefined acceptance criteria, and the proposed device passed design verification test activities. These tests include:
- Comprehensive Design Verification Study: Verified product requirements, performance of indication and adjustment features, tool screen sequence and iconography, mechanical performance, successful indication across tissue thickness range, and electronic component parameters.
- Electrical Safety and Ingress Testing: Protected against ingress with an IP4X rating per IEC 60601-1 (Edition 3.1).
- Force Tests: Device capable of performing intended function after minimum 2700 cycles.
- User Feedback Verification: Verified user interaction requirements, measured time to receive indication, confirmed appropriate feedback during adjustment, and system failure messages.
- Environmental: Durability across typical operational conditions and effect of environmental storage conditions on functionality.
- Transit Testing: Device and case secure during transit, preventing damage in normal conditions of transit, handling, and storage in accordance with ISTA 3A (Vibration, drop, and environmental conditioning).
- Disinfection Compatibility: Efficacy of reprocessing procedure (70% Isopropyl Alcohol Surface Wipes) and no appreciable signs of deterioration of enclosure after 1000 disinfection cycles.
Biocompatibility Testing:
Testing performed on the subject device, the Certas Plus Electronic Tool Kit, for surface device with limited skin contact (≤ 24 hours), with successful results.
| Biocompatibility Test | Summary of Results | Conclusion |
|---|---|---|
| Cytotoxicity | No cytotoxicity or cell lysis was noted in any of the test wells. No pH shift was observed at 48 hours. | Non-cytotoxic |
| Sensitization | The test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The test article was not considered a sensitizer in the guinea pig test. | Not considered a sensitizer |
| Irritation | There was no erythema and no edema observed on the skin of the animals treated with the test article extract. The Primary Irritation Index for the test article extracts of sodium chloride and sesame oil were both calculated to be 0.0. The irritation responses to the test article extracts of sodium chloride and sesame was categorized as negligible. | Non-Irritant |
All tests results are acceptable and conform to the acceptance criteria outlined in the applicable ISO 10993 standards.
Simulated Post-Implantation Use:
Validation testing with clinicians included a system safety study and qualitative assessment of clinical acceptability. All acceptance criteria were met.
- 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.
- 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, and identified the intent of low battery/system failure screens.
Animal Studies: No animal studies were required.
Clinical Studies: No clinical studies were required.
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.
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
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) |
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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 the | |
| non-invasive reading or adjustment of the | ||
| valve setting. | 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. | ||
| Handheld Tools | Locator tool (low profile + adjustable | |
| height) | ||
| Indicator tool | ||
| Adjustment tool | Locator/Indicator tool | |
| Adjustment tool | ||
| Operating | ||
| Principle | Locator Tool: Facilitates correct | |
| placement of the Adjustment Tool and | ||
| Indicator Tool over an implanted valve. | The Locator and Indicator Tools have | |
| been combined into one tool. | ||
| Locator/Indicator Tool facilitates correct | ||
| placement of the Adjustment Tool over an | ||
| implanted valve. | ||
| Indicator Tool: Incorporates a detection | ||
| wheel (indication dial) that aligns the | ||
| valve's magnetic field to display the valve | ||
| setting. | The Locator/Indicator Tool incorporates a | |
| detection wheel (indication dial) that | ||
| measures the valve's magnetic field to | ||
| display the valve setting. | ||
| Adjustment Tool: 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. | Adjustment Tool: 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. | ||
| Energy Type | Mechanical, magnetic energy, not battery | |
| operated | Locator/Indicator: Battery operated | |
| Adjustment 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/Indication | ||
| Feedback | Location: No location feedback; the user is | |
| required to manually palpate to determine | ||
| the valve location |
Indication: display a mechanical indication
dial for the determination of valve
performance setting | Location: LED screen is used to display
location feedback to aid in the alignment
of the Locator/Indicator Tool with the
valve mechanism center
Indication: LED screen is used to display
an indication dial for the determination of
valve performance settings. |
| Materials - Patient
Contacting | • Polycarbonate
• Polycarbonate, Aluminum with
anodized surface, Decal
• Acetal Copolymer | • Polycarbonate and acrylonitrile
butadiene styrene (PC/ABS)
• Pad Printing Ink (blue)
• Pad Printing Ink (White) |
| Materials - Not
Patient Contacting
(Locator Tool) | There are various Locator and Indicator
Tool materials including, but not limited
to:
• Polycarbonate
• Acetal (Delrin) | Locator/Indicator Tool:
• PC/ABS
• MuMetal ASTM-A753 Alloy 4
• Brass
• Polycarbonate
• ROHS Compliant Electronics
• Nickel plated Stainless Contact and
Copper Wire
• Polyimide
• Insulated Copper Wire
• CR 123A, Lithium Battery
• Thermal Transfer Polyester
• Polyester Film |
| Materials - Not
Patient Contacting
(Adjustment Tool) | There are various Adjustment Tool
materials including, but not limited to:
• Polycarbonate
• Acetal (Delrin) | Adjustment Tool:
• PC/ABS TPE
• PC/ABS
• Neodymium Magnets
• Stainless Steel
• Thermal Transfer Polyester |
| Protective
Carrying Case | Yes | Yes |
| Accessory tool | X-ray overlay | X-ray overlay |
| Sterilization | NA, non-sterile | NA, non-sterile |
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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 |
| Comprehensive | ||
| Design | ||
| Verification Study | Testing verified that design outputs adequately met | |
| the specified designed inputs including but not limited | ||
| to the following: | ||
| Product requirements verified against drawing | ||
| specifications for predicate Performed to verify expected performance of | ||
| indication and adjustment features Verify tool screen sequence and iconography | ||
| features Verify mechanical performance of assembly and | ||
| carrying case Ensure that a successful indication is provided | ||
| across the range of tissue thickness Verify that electronic components are | ||
| incorporated such that their rated maximums are | ||
| not exceeded during normal use. This includes | ||
| component thermal rating, operating temperature, | ||
| electrical voltage withstanding, electrical current | ||
| capacity and other parameters applicable to | ||
| specific components | PASS | |
| Electrical Safety | ||
| and Ingress | ||
| Testing | Protect against ingress with a IP4X rating. Per IEC | |
| 60601-1 (Edition 3.1) | PASS | |
| Force Tests | Device capable performing intended function after | |
| minimum 2700 cycles | PASS | |
| User Feedback | ||
| Verification | Verify user interaction requirements associated | |
| with screen and user feature design and function. Measure the time to receive an indication from | ||
| the device. Confirm that users receive appropriate feedback | ||
| device during adjustment Verify system failure messages. | PASS | |
| Environmental | Environmental chamber testing durability across | |
| typical operational conditions. Demonstrate that | ||
| environmental storage conditions experienced by the | ||
| tool kit will not affect its functionality. | PASS | |
| Transit Testing | Confirm that device and case are secure during | |
| transit and that case shall prevent damage to the | ||
| product in normal conditions of transit, handling, | ||
| and storage in accordance with ISTA 3A. Vibration, drop, and environmental conditioning (Packaged-Products for Parcel Delivery | ||
| System Shipments 70kg (150 lb) or Less | ||
| (standard, small, flat or elongated). | PASS | |
| Disinfection | ||
| Compatibility | Demonstrate efficacy of the reprocessing | |
| procedure used to disinfect reusable components | ||
| of the device to achieve low level disinfection | ||
| using 70% Isopropyl Alcohol Surface Wipes. Confirm no appreciable signs of deterioration of | ||
| the 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 of
| the Proposed Device | ||
|---|---|---|
| Biocompatibility | ||
| Test | Summary of | |
| Results | Conclusion | |
| Cytotoxicity | No cytotoxicity or cell lysis was | |
| noted in any of the test wells. No pH | ||
| shift was observed at 48 hours. | Non-cytotoxic | |
| Sensitization | The test article extracts showed no | |
| evidence of causing delayed dermal | ||
| contact sensitization in the guinea | ||
| pig. The test article was not | ||
| considered a sensitizer in the guinea | ||
| pig test. | Not considered a | |
| sensitizer | ||
| Irritation | There was no erythema and no edema | |
| observed on the skin of the animals | ||
| treated with the test article extract. | ||
| The Primary Irritation Index for the | ||
| test article extracts of sodium | ||
| chloride and sesame oil were both | ||
| calculated to be 0.0. The irritation | ||
| responses to the test article extracts of | ||
| sodium chloride and sesame was | ||
| categorized 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 rate | |
| for false positives and maximum success rate for | ||
| completing a full procedure. Testing conducted on | ||
| a simulated head model with clinically relevant | ||
| implant locations to create angular variability. | PASS | |
| Qualitative | ||
| Assessment of | ||
| Clinical Acceptability | After completing simulated use testing with the | |
| Certas Plus Electronic Tool Kit, clinicians were | ||
| asked to: | ||
| • Provide a qualitative assessment of: | ||
| ◦ Patient comfort (anticipated) | ||
| ◦ Clarity of information on screen | ||
| ◦ acceptability for use in retro-auricular | ||
| placement | ||
| ◦ Ease of use | ||
| ◦ Clinical acceptability | ||
| • Identify images of low battery, critical low | ||
| battery and graphics system failure screen and | ||
| asked 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.