(27 days)
To provide for access and allow for visualization of the surgical field during brain and spinal surgery. Indications may include subcortical access to diseases such as the following:
- Primary/Secondary Brain Tumors
- · Vascular Abnormalities/Malformations
· Intraventricular Tumors/Cysts
The NICO BrainPath and accessories are designed to provide minimally invasive access to neurological tissues. The design specifically supports the creation of an atraumatic surgical corridor to access the brain. These BrainPath devices are part of what is being called the BrainPath Approach™, which integrates the expanding neurosurgical armamentarium of trajectory planning and navigation, optics, corridor resection and biopsy, and tissue preservation. To date, the BrainPath technology has been used to successfully access primary and secondary brain tumors, vascular abnormalities or malformations, and intraventricular tumors and cysts.
The BrainPath consists of multiple-sized reusable and re-sterilizable obturators with coordinating single patient use disposable sheaths. The obturator and sheath are assembled in the operating room immediately prior to use. After placement, the obturator is removed leaving behind the sheath which provides a 13.5 mm or 11 mm surgical corridor.
The provided text focuses on the 510(k) premarket notification for the NICO BrainPath device, specifically for an updated version (K172433) compared to a predicate device (K150378). This is a submission for device substantial equivalence, not a study proving the device meets acceptance criteria in terms of diagnostic performance or clinical outcomes for an AI/algorithm-based medical device.
Therefore, many of the requested criteria regarding AI/ML device performance evaluation (e.g., sample sizes for training/test sets, expert adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable to this document.
However, I can extract the acceptance criteria and "performance" findings relevant to a medical device's physical and functional properties, as presented in this 510(k) submission.
Here's a breakdown of the relevant information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical/Engineering):
The document describes non-clinical testing performed to demonstrate that modifications to the NICO BrainPath still meet applicable design and performance requirements and support substantial equivalence to the predicate device. The "acceptance criteria" can be inferred as the expected "Pass" or "Non-cytotoxic," "Non-sensitizer," "Non-irritant" results for the respective tests.
| Testing | Acceptance Criteria (Implied) | Reported Device Performance (Result/Conclusion) |
|---|---|---|
| Cytotoxicity - MEM Elution: 72 hour incubation | Non-cytotoxic | Non-cytotoxic |
| Sensitization - Maximization (2 extracts) | Non-sensitizer | Non-sensitizer |
| Irritation - Intracutaneous Reactivity (2 extracts) | Non-irritant | Non-irritant |
| Simulated Use to demonstrate the BrainPath has the ability to interface with third-party Instruments and meets design input requirements | Pass | Pass |
| Packaging & Shelf Life – shipping/distribution simulation, environmental conditions, aging, visual packaging inspection, bubble and seal strength packaging testing, and functional testing following aging, environmental and shipping simulation | Pass | Pass |
| Specification Review | Pass | Pass |
| Cleaning Validation (Reusable Devices) – Establishment of cleaning validation per miles soil test using bioburden endotoxin and protein testing | Pass | Pass |
| Sterility Validation (Reusable Devices) – Steam autoclaving, IUSS, and hydrogen peroxide gas plasma | Pass | Pass |
| Sterility Validation (Single-Use) – B&F testing, VDmax for SAL 10-6, along with routine Endotoxin testing | Pass | Pass |
| Sterilization Tray Drop Test | Pass | Pass |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify exact numerical sample sizes for each non-clinical test (e.g., number of devices tested for biocompatibility, number of packaging units, etc.). It generally states "All" devices/components were subjected to relevant tests.
- Data Provenance: The data provenance is internal to NICO Corporation's testing and validation processes. The document does not mention the country of origin of "data" in a patient/clinical sense, as this is laboratory/engineering testing. It is retrospective in the sense that the testing was conducted prior to the 510(k) submission to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to the data presented. The document describes laboratory and engineering tests (e.g., biocompatibility, sterilization, simulated use, packaging). "Ground truth" in the context of expert consensus (like for image interpretation in AI) is not relevant here. Compliance with established standards (e.g., ASTM, ISO standards for biocompatibility) would be the "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable to the data presented. Adjudication methods are typically used for establishing ground truth in clinical or image-based studies where human interpretative variability exists. For engineering tests, results are typically objective Pass/Fail or numerical measurements against defined specifications.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This question is not applicable. This device is a physical surgical tool (self-retaining retractor), not an AI/ML-based diagnostic or assistive software that interacts with human "readers" or interpreters.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. This device is a physical surgical tool, not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the non-clinical tests is adherence to established engineering specifications, validated test methodologies, and recognized industry standards (e.g., for biocompatibility, sterility, packaging integrity). For example, a "Pass" for sterility validation means the device met the acceptance criteria for a Sterility Assurance Level (SAL) of 10-6.
8. The sample size for the training set:
- This question is not applicable. There is no "training set" in the context of an AI/ML device. The device is a physical product, and its design is based on engineering principles and previous versions (predicate device).
9. How the ground truth for the training set was established:
- This question is not applicable. As there is no training set for an AI/ML algorithm, this concept does not apply. The "ground truth" for the device's design and manufacturing is established through defined product specifications, design control processes, and compliance with quality system regulations (e.g., 21 CFR Part 820).
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Public Health Service
Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 7, 2017
NICO Corporation Sean Spence Regulatory Affairs Manager 250 E 96th St. Suite 125 Indianapolis, Indiana 46240
Re: K172433
Trade/Device Name: NICO BrainPath Regulation Number: 21 CFR 882.4800 Regulation Name: Self-Retaining Retractor for Neurosurgery Regulatory Class: Class II Product Code: GZT Dated: August 10, 2017 Received: August 11, 2017
Dear Mr. Spence:
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 of medical device
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related 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.
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 (DICE) 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 (DICE) 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,
Michael J. Hoffmann -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
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Indications for Use
510(k) Number (if known) K172433
Device Name NICO BrainPath
Indications for Use (Describe)
To provide for access and allow for visualization of the surgical field during brain and spinal surgery. Indications may include subcortical access to diseases such as the following:
- Primary/Secondary Brain Tumors
- · Vascular Abnormalities/Malformations
· Intraventricular Tumors/Cysts"
| Type of Use (Select one or both, as applicable) | Recreational Use (Part 21 CFR 201.327(p)) Sunscreen Use (21 CFR 201.327(c)) | Recreational Use (Part 21 CFR 201.327(p)) | Sunscreen Use (21 CFR 201.327(c)) |
|---|---|---|---|
| Recreational Use (Part 21 CFR 201.327(p)) | |||
| Sunscreen Use (21 CFR 201.327(c)) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for NICO Corporation. The letters "NICO" are in a bold, sans-serif font, with the "O" being a filled circle in a golden color. Below the letters is the word "CORPORATION" in a smaller, sans-serif font.
NICO BrainPath®
21 CFR §807.92 Date Prepared: 06 September 2017
510(k) Number: K172433
| Submitter/Manufacturer: | NICO Corporation250 E. 96th Street, Suite 125Indianapolis, IN 46240 |
|---|---|
| Contact Person: | Sean Spence, RACRegulatory Affairs ManagerOffice: 317.660.7118 |
| Trade Name: | NICO® BrainPath® |
| Common/Usual Name: | Self-retaining retractor for neurosurgery |
| Classification / Panel: | 21 CFR §882.4800 / Neurology |
| Product Codes: | GZT |
| Predicate Device: | K150378, NICO BrainPath |
Device Description
The NICO BrainPath and accessories are designed to provide minimally invasive access to neurological tissues. The design specifically supports the creation of an atraumatic surgical corridor to access the brain. These BrainPath devices are part of what is being called the BrainPath Approach™, which integrates the expanding neurosurgical armamentarium of trajectory planning and navigation, optics, corridor resection and biopsy, and tissue preservation. To date, the BrainPath technology has been used to successfully access primary and secondary brain tumors, vascular abnormalities or malformations, and intraventricular tumors and cysts.
The BrainPath consists of multiple-sized reusable and re-sterilizable obturators with coordinating single patient use disposable sheaths. The obturator and sheath are assembled in the operating room immediately prior to use. After placement, the obturator is removed leaving behind the sheath which provides a 13.5 mm or 11 mm surgical corridor. Table 1 outlines the available BrainPath configurations.
| Name | Sheath Inner-Diameter (mm) | Sheath Length (mm) | Obturator Tip (mm) |
|---|---|---|---|
| 13.5 mm x 50 mm (ST) | 50 | 7.5 | |
| 13.5 mm x 50 mm | 50 | ||
| 13.5 mm x 60 mm | 13.5 | 60 | |
| 13.5 mm x 75 mm | 75 | ||
| 13.5 mm x 95 mm | 95 | 15 | |
| 11 mm x 50 mm | 50 | ||
| 11 mm x 60 mm | 11 | 60 | |
| 11 mm x 75 mm | 75 |
Table 1: BrainPath Configurations
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The BrainPath accessories include a Manipulation Tool which is used for manipulating the position of the sheath after it has been placed, Shepherd's Hooks which are for attaching to various commercially available retractor arms, a 95 mm Stylet for use with the 95 mm obturator, and a Sterilization Tray for sterilization of the reusable components (i.e., obturators, manipulation tools, and 95 mm stylet).
| BrainPath Component | Sterile or Non-Sterile | Single-Use or Reusable |
|---|---|---|
| Sheath (all sizes) | Sterile | Single-Use |
| Obturators (all sizes) | Non-Sterile | Reusable |
| Manipulation Tool | Non-Sterile | Reusable |
| 95mm Stylet | Non-Sterile | Reusable |
| Sterilization Tray | Non-Sterile | Reusable |
| Shepherd's Hooks (all types) | Sterile | Single-Use |
Table 2: NICO BrainPath Components Supplied
Intended Use
To provide for access and allow for visualization of the surgical field during brain and spinal surgery. Indications may include subcortical access to diseases such as the following:
- Primary/Secondary brain tumors -
- Vascular abnormalities/malformations -
- -Intraventricular tumors/cysts
Comparison to Predicate
The subject BrainPath iteration is nearly identical to the predicate NICO BrainPath (K150378). Modifications include a concave proximal sheath ring geometry to reduce optical glare, and a product line extension to include a 13.5 mm x 95 mm and 11 mm set of offerings. The 95 mm length Obturator also necessitated the creation of a new 95 mm stylet accessory. Table 3 provides additional details on how the subject and predicate devices compare.
| Predicate DeviceNICO BrainPath | Subject DeviceNICO Brain Port | |
|---|---|---|
| Device Name | BrainPath | Identical |
| Intended Use | To provide for access and allow for visualization of the surgical field during brain and spinal surgery.Indications may include subcortical access to diseases such as the following:- Primary/Secondary brain tumors- Vascular abnormalities/malformations- Intraventricular tumors/cysts | Identical |
| Principle ofOperation | Consists of an "obturator-like" component and a “sheath-like” component which are assembled, inserted, and disassembled to provide corridor access | Identical |
| Operation andplacement | Handheld and can be assisted by third-party navigation (if desired) | Identical |
| Predicate DeviceNICO BrainPath | Subject DeviceNICO Brain Port | |
| ShippingConfiguration | Obturator and sheath packaged and shippedseparately and paired during surgical case | Identical |
| Reusable or SinglePatient Use | Single Patient Use and Reusable | Identical |
| Method ofSterilization / SAL | Disposables: Gamma (sheath/hooks) / 10-6Reusables: Autoclave/hydrogen peroxide gas plasma | Identical |
| Biocompatibility | Demonstrated based on externallycommunicating device in direct contact withtissue/bone/dentin for a limited duration | Identical |
| Materials ofManufacture | Obturator: AluminumSheath: COC | Identical |
| Cross Sectionalanalysis ofObturator/ Sheath | Obturator/Sheath combination has a circularcross section | Identical |
| Depth markings | Incremental depth markings on both sheath andobturator. | Identical |
| Sheath innerdiameter (mm)options | 13.5 mm | 13.5 mm and 11 mm |
| Sheath Lengths | 13.5 mm diameter: 50, 60, and 75 mm | 13.5 mm dia.: 50, 60, 75, and 95 mm11 mm dia.: 50, 60, 75 mm |
| General Shape ofObturator Tip | Distal end of obturator has a conical shape with arounded tip and no opening. | Identical |
| Obturator Tip | For the blue, standard tip obturators, the tipextends 15 mm beyond the sheath. For the Gold-ST, shallow-tip obturator, the tip extends 7.5 mmbeyond the sheath. | Identical, new offerings all have 15 mm tips |
| Third-Partyinstrumentation | Obturator component interfaces with third-partyinstruments. | Identical |
| Surface of Sheath | Inner diameter and horizontal proximal surfaceof the knurled ring are textured. | Identical |
| Proximal End ofSheath | Knurled ring and proximal portion of the sheathhas holes, slots, and tabs. | Updated knurled ring with concave geometryto reduce optical glare, still includes holes,slots and tabs. |
| Manipulation Tool | "Manipulation Tool” is textured to preventglare/shine from surgical lighting. | Identical |
| Shepherd's Hooks | Three Shepherd's Hooks available to facilitateinterfacing with common third-party retractors. | Identical |
| 95mm Stylet | None | For use with 13.5 mm x 95 mm Obturator as a |
Table 3: Comparison Table
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Non-Clinical Testing
The following tests were confirmed or repeated to demonstrate that the subject device modifications met applicable design and performance requirements, and supports a determination of substantial equivalence:
Table 4: Non-Clinical Testing
| Testing | Device(s) Supported | Result/Conclusion |
|---|---|---|
| Cytotoxicity - MEM Elution: 72 hour incubation | All | Non-cytotoxic |
| Sensitization - Maximization (2 extracts) | Non-sensitizer | |
| Irritation - Intracutaneous Reactivity (2 extracts) | All | Non-irritant |
| Simulated Use to demonstrate the BrainPath has the ability tointerface with third-party Instruments and meets design inputrequirements | All | Pass |
| Packaging & Shelf Life – shipping/distribution simulation,environmental conditions, aging, visual packaging inspection,bubble and seal strength packaging testing, and functionaltesting following aging, environmental and shipping simulation | All | Pass |
| Specification Review | All | Pass |
| Cleaning Validation (Reusable Devices) – Establishment ofcleaning validation per miles soil test using bioburdenendotoxin and protein testing | Obturator, ManipulationTools, Stylet, andSterilization Tray | Pass |
| Sterility Validation (Reusable Devices) – Steam autoclaving,IUSS, and hydrogen peroxide gas plasma | Obturators, ManipulationTools, Stylet, andSterilization Tray | Pass |
| Sterility Validation (Single-Use) – B&F testing, VDmax forSAL 10-6, along with routine Endotoxin testing | BrainPath Sheath andShepherd's Hooks | Pass |
| Sterilization Tray Drop Test | Obturators, ManipulationTools, Stylet, andSterilization Tray | Pass |
Conclusion
Risk assessment, biocompatibility, non-clinical testing, design validation, and compliance with recognized standards have demonstrated that the subject NICO BrainPath modifications do not raise different questions of safety or effectiveness when compared to the predicate. Therefore, the results of these analyses provide reasonable assurance that the NICO BrainPath has a similar safety and effectiveness profile as the predicate device and supports a determination of substantial equivalence.
§ 882.4800 Self-retaining retractor for neurosurgery.
(a)
Identification. A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.(b)
Classification. Class II (performance standards).