(119 days)
No
The device description focuses on the mechanical aspects of creating a surgical corridor and mentions compatibility with trajectory planning and navigation software, but does not describe any AI/ML functionality within the BrainPath device itself.
No.
The device is designed to provide access and visualization during brain and spinal surgery, creating a surgical corridor to a lesion or abnormality; it does not directly treat or cure any condition.
No
The device is described as providing minimally invasive access and visualization of the surgical field, creating a surgical corridor, and facilitating surgical procedures like biopsy and resection. It does not appear to gather or analyze data for diagnostic purposes.
No
The device description clearly outlines physical components such as obturators, sheaths, manipulation tools, shepherd's hooks, and a sterilization tray, indicating it is a hardware device with accessories.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The NICO BrainPath and Accessories are described as surgical tools designed to provide access and visualization during brain and spinal surgery. They are used during a surgical procedure to create a corridor to the surgical site.
- Lack of Specimen Analysis: The description does not mention the device being used to collect, prepare, or analyze any specimens from the patient's body for diagnostic purposes. Its function is purely mechanical and related to surgical access.
Therefore, the NICO BrainPath and Accessories fall under the category of surgical instruments rather than In Vitro Diagnostics.
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
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 most areas of the brain. The BrainPath also facilitates the expanding neurosurgical armamentarium of trajectory planning software (e.g., Synaptive® Medical Inc. BrightMatter® Planning Software, K140337), navigation (e.g., Synaptive BrightMatter Navigation System, K142024), optics, corridor resection (e.g., NICO Myriad), and biopsy. 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 surgical corridor to the lesion or abnormality. Table 1 outlines the four currently available BrainPath configurations.
The BrainPath Accessories include a "manipulation tool," which is similar to a dental probe and is used for manipulating the position of the sheath after it has been placed. The accessories also include "shepherd's hooks" for attaching to various commercially available retractors, and a sterilization tray for the reusable components (i.e., obturators and manipulation tools).
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. Device(s): BrainPath Sheath, Obturator, and Manipulation Tool. Result/Conclusion: Non-cytotoxic.
- Sensitization - Maximization (2 extracts). Device(s): BrainPath Sheath and Obturator. Result/Conclusion: Non-sensitizer.
- Irritation - Intracutaneous Reactivity (2 extracts). Result/Conclusion: Non-irritant.
- Simulated Use to demonstrate the BrainPath has the ability to interface with 3rd Party Instruments and meets design input requirements. Device(s): BrainPath Sheath, Obturator, and Manipulation Tool. Result/Conclusion: Pass.
- Packaging & Shelf Life - shipping/distribution simulation, environmental conditions, aging, visual packaging inspection, bubble and burst packaging testing, and functional testing following aging, environmental and shipping simulation. Device(s): BrainPath Sheath and Obturator. Result/Conclusion: Pass.
- Specification Review. Device(s): BrainPath Sheath, Obturator, and Manipulation Tool. Result/Conclusion: Pass.
- Cleaning Validation (Reusable Device) – Establishment of cleaning validation per miles soil test using bioburden endotoxin and protein testing. Device(s): BrainPath Obturator. Result/Conclusion: Pass.
- Sterility Validation (Reusable Device) - Steam autoclaving, IUSS, and hydrogen peroxide gas plasma. Device(s): Obturators, Manipulation Tool, and Sterilization Tray. Result/Conclusion: Pass.
- Sterility Validation (Single-Use) - B&F testing, VDmax for SAL 10-6, along with routine Pyrogenicity testing. Device(s): BrainPath Sheath and Shepherd's Hooks. Result/Conclusion: Pass.
- Sterilization Tray Drop Test from 4 ft. Device(s): Obturator and Manipulation Tool. Result/Conclusion: Pass.
- Cytotoxicity - MEM Elution: 72 hour incubation. Device(s): Shepherd's Hooks. Result/Conclusion: Non-cytotoxic.
- Specification Review. Device(s): Shepherd's Hooks. Result/Conclusion: Pass.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol composed of three stylized human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 12, 2015
NICO Corporation Mr. Sean Spence, RAC Regulatory Affairs Manager 250 E. 96th Street, Suite 125 Indianapolis, Indiana 46240
Re: K150378
Trade/Device Name: NICO® BrainPath® and Accessories Regulation Number: 21 CFR 882.4800 Regulation Name: Self-Retaining Retractor for Neurosurgery Regulatory Class: Class II Product Code: GZT Dated: May 13, 2015 Received: May 14, 2015
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 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 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 yours,
Carlos L. Pena -S 同心
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) K150378
Device Name NICO BrainPath and Accessories
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) | |
|---|---|
| ☑ Research Use (Part 21 CFR 201.26(a) and (b)) | |
| ☐ Over-The-Counter Use (21 CFR 201.66) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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NICO® BrainPath®
21 CFR §807.92 Date Prepared: 03 June 2015
510(k) Number: K150378
| 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® and Accessories |
| Common/Usual Name: | Self-retaining retractor for neurosurgery |
| Classification: | 21 CFR §882.4800 |
| Product Codes: | GZT |
| Predicate Device: | K120691, NICO Brain Port (previous name) |
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 most areas of the brain. The BrainPath also facilitates the expanding neurosurgical armamentarium of trajectory planning software (e.g., Synaptive® Medical Inc. BrightMatter® Planning Software, K140337), navigation (e.g., Synaptive BrightMatter Navigation System, K142024), optics, corridor resection (e.g., NICO Myriad), and biopsy. 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 surgical corridor to the lesion or abnormality. Table 1 outlines the four currently available BrainPath configurations.
| General Name | Sheath
Length (mm) | Obturator Tip
Length (mm) |
|-----------------------------|-----------------------|------------------------------|
| 50 mm Shallow-Tip (ST-Gold) | 50 | 8 |
| 50 mm BrainPath | 50 | 15 |
| 60 mm BrainPath | 60 | 15 |
| 75 mm BrainPath | 75 | 15 |
Table 1: BrainPath Configurations
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The BrainPath Accessories include a "manipulation tool," which is similar to a dental probe and is used for manipulating the position of the sheath after it has been placed. The accessories also include "shepherd's hooks" for attaching to various commercially available retractors, and a sterilization tray for the reusable components (i.e., obturators and manipulation tools).
| 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 |
| 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 Brain Port (K120691). Following the previous clearance the Brain Port name was changed to BrainPath®. Modifications to the design include creation of the ST-Gold shallow tip 50 mm obturator that provides access to shallow abnormalities by having a 7.5 mm obturator tip instead of 15 mm. The proximal end of the sheath was modified to include slots which enable the management of surgical patties, which are commonly used during neurosurgical procedures. Additionally, tabs were added to the proximal end of the sheath to facilitate retention of Shepherd's hooks, which may be used to help position the sheath during surgery. Finally, the surface finish on the inner diameter and proximal head of the sheath was textured to reduce optical glare during surgery. Table 3 provides additional details on how the subject and predicate devices compare.
| | Subject Device
NICO BrainPath | Predicate Device
NICO Brain Port |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Device Name | BrainPath | Brain Port |
| Intended Use | To provide for access and allow for visualization of the surgical field during brain and spinal surgery. | Identical |
| Indications for Use | Indications may include subcortical access to diseases such as the following:
- Primary/Secondary brain tumors
- Vascular abnormalities/malformations
- Intraventricular tumors/cysts | None specifically identified |
| 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 |
| | Subject Device | Predicate Device |
| | NICO BrainPath | NICO Brain Port |
| Operation and
placement | Handheld and can be assisted by third-party navigation
(if desired) | Identical |
| 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 | Gamma for disposable component (sheath)
Autoclave/hydrogen peroxide gas plasma for reusable
components | 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 diameter
dimensions | Available sheath diameter is 13.5 mm (inner diameter)
and 15.8 mm (outer diameter). | Identical |
| Sheath lengths | Available sheath lengths are 50 mm, 60 mm, and 75
mm. | Identical |
| 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. | The three blue standard tip
obturators are identical. The
Gold-ST was not part of the
original Brain Port submission. |
| 3rd party
instrumentation | Obturator component interfaces with third party
instruments. | Identical |
| Surface of Sheath | Used Ink Y. Inner diameter and horizontal proximal
surface of the knurled ring are textured. | Used Ink X. Sheath was "clear"
and smooth. Surface texturing
was not part of the previous
submission. |
| Proximal End of
Sheath | Knurled ring and distal portion of the sheath has holes,
slots, and ears. | Knurled ring on sheath includes
holes for securing. Slots and ears
were not part of the original
Brain Port submission. |
| Manipulation Tool | "Manipulation Tool" is textured to prevent glare/shine
from surgical lighting. | "Manipulation Tool" was
offered but was not textured on
the distal portion. |
| Shepherd's Hooks | Three Shepherd's Hooks available to facilitate
interfacing with common third party retractors. | Shepherd's Hooks were not
mentioned in the previous
submission |
Table 3: Comparison Table
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Image /page/6/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 golden color. Below the letters is the word "CORPORATION" in a smaller, sans-serif font.
Non-Clinical Testing
The following tests were confirmed or repeated to demonstrate that the subject device modifications met applicable design and performance requirements:
Table 4: Non-Clinical Testing
| Testing | Device(s) | Result/Conclusion |
|---|---|---|
| Cytotoxicity - MEM Elution: 72 hour incubation | BrainPath Sheath, | |
| Obturator, and | ||
| Manipulation Tool | Non-cytotoxic | |
| Sensitization - Maximization (2 extracts) | BrainPath Sheath and | |
| Obturator | Non-sensitizer | |
| Irritation - Intracutaneous Reactivity (2 extracts) | Non-irritant | |
| Simulated Use to demonstrate the BrainPath has the ability to | ||
| interface with 3rd Party Instruments and meets design input | ||
| requirements | BrainPath Sheath, | |
| Obturator, and | ||
| Manipulation Tool | Pass | |
| Packaging & Shelf Life - shipping/distribution simulation, | ||
| environmental conditions, aging, visual packaging inspection, | ||
| bubble and burst packaging testing, and functional testing | ||
| following aging, environmental and shipping simulation | BrainPath Sheath and | |
| Obturator | Pass | |
| Specification Review | BrainPath Sheath, | |
| Obturator, and | ||
| Manipulation Tool | Pass | |
| Cleaning Validation (Reusable Device) – Establishment of | ||
| cleaning validation per miles soil test using bioburden | ||
| endotoxin and protein testing | BrainPath Obturator | Pass |
| Sterility Validation (Reusable Device) - Steam autoclaving, | ||
| IUSS, and hydrogen peroxide gas plasma | Obturators, Manipulation | |
| Tool, and Sterilization | ||
| Tray | Pass | |
| Sterility Validation (Single-Use) - B&F testing, VDmax for | ||
| SAL 10-6, along with routine Pyrogenicity testing | BrainPath Sheath and | |
| Shepherd's Hooks | Pass | |
| Sterilization Tray Drop Test from 4 ft. | Obturator and | |
| Manipulation Tool | Pass | |
| Cytotoxicity - MEM Elution: 72 hour incubation | Shepherd's Hooks | Non-cytotoxic |
| Specification Review | Shepherd's Hooks | Pass |
Conclusion
Risk assessments, biocompatibility, non-clinical testing, design validation, and compliance with recognized standards have demonstrated that the subject NICO BrainPath does not raise different questions of safety or effectiveness when compared to the predicate. Therefore, the results of these tests 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.