(27 days)
Not Found
No
The description focuses on the mechanical design and function of the device for creating a surgical corridor, with no mention of AI or ML capabilities. The "BrainPath Approach" mentions trajectory planning and navigation, but this is a common feature in surgical devices and doesn't inherently imply AI/ML.
No
The device is described as providing access and visualization of the surgical field and creating an atraumatic surgical corridor, rather than directly treating a disease or condition. Therapeutic devices generally aim to cure, mitigate, treat, or prevent disease.
No
The device is described as providing minimally invasive access and visualization during brain and spinal surgery, creating a surgical corridor for intervention, rather than diagnosing a condition.
No
The device description clearly states that the device consists of physical components (reusable obturators and disposable sheaths) and describes their physical function in creating a surgical corridor. It also details non-clinical testing related to material properties, sterilization, and physical performance, which are characteristic of hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide for access and allow for visualization of the surgical field during brain and spinal surgery." This describes a surgical tool used during a procedure to facilitate access and visualization, not a device used to examine specimens in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a system of obturators and sheaths designed to create a surgical corridor. This is consistent with a surgical access device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely mechanical and procedural, facilitating surgical access.
N/A
Intended Use / Indications for 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"
Product codes (comma separated list FDA assigned to the subject device)
GZT
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.
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain and spinal
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)
Non-Clinical Testing:
- Cytotoxicity - MEM Elution: 72 hour incubation: All devices supported, Result/Conclusion: Non-cytotoxic
- Sensitization - Maximization (2 extracts): All devices supported, Result/Conclusion: Non-sensitizer
- Irritation - Intracutaneous Reactivity (2 extracts): All devices supported, Result/Conclusion: Non-irritant
- Simulated Use to demonstrate the BrainPath has the ability to interface with third-party Instruments and meets design input requirements: All devices supported, Result/Conclusion: 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: All devices supported, Result/Conclusion: Pass
- Specification Review: All devices supported, Result/Conclusion: Pass
- Cleaning Validation (Reusable Devices) – Establishment of cleaning validation per miles soil test using bioburden endotoxin and protein testing: Obturator, Manipulation Tools, Stylet, and Sterilization Tray supported, Result/Conclusion: Pass
- Sterility Validation (Reusable Devices) – Steam autoclaving, IUSS, and hydrogen peroxide gas plasma: Obturators, Manipulation Tools, Stylet, and Sterilization Tray supported, Result/Conclusion: Pass
- Sterility Validation (Single-Use) – B&F testing, VDmax for SAL 10-6, along with routine Endotoxin testing: BrainPath Sheath and Shepherd's Hooks supported, Result/Conclusion: Pass
- Sterilization Tray Drop Test: Obturators, Manipulation Tools, Stylet, and Sterilization Tray supported, Result/Conclusion: Pass
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.
K150378, NICO BrainPath
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
§ 882.4800 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).
0
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
1
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
2
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 Corporation
250 E. 96th Street, Suite 125
Indianapolis, IN 46240 |
|-------------------------|-----------------------------------------------------------------------------|
| Contact Person: | Sean Spence, RAC
Regulatory Affairs Manager
Office: 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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Image /page/4/Picture/0 description: The image shows the logo for NICO Corporation. The logo consists of the word "NICO" in a bold, sans-serif font, with the "O" being a circle filled with a golden color. Below the word "NICO" is the word "CORPORATION" in a smaller, sans-serif font.
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 Device
NICO BrainPath | Subject Device
NICO 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 of
Operation | Consists of an "obturator-like" component and a “sheath-like” component which are assembled, inserted, and disassembled to provide corridor access | Identical |
| Operation and
placement | Handheld and can be assisted by third-party navigation (if desired) | Identical |
| | Predicate Device
NICO BrainPath | Subject Device
NICO Brain Port |
| Shipping
Configuration | Obturator and sheath packaged and shipped
separately and paired during surgical case | Identical |
| Reusable or Single
Patient Use | Single Patient Use and Reusable | Identical |
| Method of
Sterilization / SAL | Disposables: Gamma (sheath/hooks) / 10-6
Reusables: Autoclave/hydrogen peroxide gas plasma | Identical |
| Biocompatibility | Demonstrated based on externally
communicating device in direct contact with
tissue/bone/dentin for a limited duration | Identical |
| Materials of
Manufacture | Obturator: Aluminum
Sheath: COC | Identical |
| Cross Sectional
analysis of
Obturator/ Sheath | Obturator/Sheath combination has a circular
cross section | Identical |
| Depth markings | Incremental depth markings on both sheath and
obturator. | Identical |
| Sheath inner
diameter (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 mm
11 mm dia.: 50, 60, 75 mm |
| General Shape of
Obturator Tip | Distal end of obturator has a conical shape with a
rounded tip and no opening. | Identical |
| Obturator Tip | For the blue, standard tip obturators, the tip
extends 15 mm beyond the sheath. For the Gold-
ST, shallow-tip obturator, the tip extends 7.5 mm
beyond the sheath. | Identical, new offerings all have 15 mm tips |
| Third-Party
instrumentation | Obturator component interfaces with third-party
instruments. | Identical |
| Surface of Sheath | Inner diameter and horizontal proximal surface
of the knurled ring are textured. | Identical |
| Proximal End of
Sheath | Knurled ring and proximal portion of the sheath
has holes, slots, and tabs. | Updated knurled ring with concave geometry
to reduce optical glare, still includes holes,
slots and tabs. |
| Manipulation Tool | "Manipulation Tool” is textured to prevent
glare/shine from surgical lighting. | Identical |
| Shepherd's Hooks | Three Shepherd's Hooks available to facilitate
interfacing 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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Image /page/6/Picture/0 description: The image shows the logo for NICO Corporation. The letters "N," "I," and "C" are in black, and the "O" is in gold. Underneath the letters, the word "CORPORATION" is written in smaller, black letters.
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 to | ||
| interface with third-party Instruments and meets design input | ||
| requirements | All | 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 | All | Pass |
| Specification Review | All | Pass |
| Cleaning Validation (Reusable Devices) – Establishment of | ||
| cleaning validation per miles soil test using bioburden | ||
| endotoxin and protein testing | Obturator, Manipulation | |
| Tools, Stylet, and | ||
| Sterilization Tray | Pass | |
| Sterility Validation (Reusable Devices) – Steam autoclaving, | ||
| IUSS, and hydrogen peroxide gas plasma | Obturators, Manipulation | |
| Tools, Stylet, and | ||
| Sterilization Tray | Pass | |
| Sterility Validation (Single-Use) – B&F testing, VDmax for | ||
| SAL 10-6, along with routine Endotoxin testing | BrainPath Sheath and | |
| Shepherd's Hooks | Pass | |
| Sterilization Tray Drop Test | Obturators, Manipulation | |
| Tools, Stylet, and | ||
| Sterilization 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.