(119 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 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.
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).
This document is a 510(k) premarket notification for the NICO® BrainPath® and Accessories, a medical device for neurosurgery. It does not describe a study that proves the device meets specific acceptance criteria related to its clinical efficacy in the context of an AI/ML powered device. Instead, it focuses on demonstrating substantial equivalence to a predicate device (NICO Brain Port, K120691) through non-clinical testing.
Therefore, many of the requested elements for an AI/ML powered medical device study are not applicable or cannot be extracted from this document, as this is a traditional medical device submission.
Here's a breakdown of the available information based on your request, with an emphasis on what is present in the document and what is not:
1. A table of acceptance criteria and the reported device performance
The document provides a table of "Non-Clinical Testing" with "Result/Conclusion". These are the acceptance criteria and performance for a traditional medical device, not an AI/ML powered one.
| Testing | Device(s) | Acceptance Criteria (Implicit) | Reported Device Performance (Result/Conclusion) |
|---|---|---|---|
| Cytotoxicity - MEM Elution: 72 hour incubation | BrainPath Sheath, Obturator, and Manipulation Tool | Must be non-cytotoxic | Non-cytotoxic |
| Cytotoxicity - MEM Elution: 72 hour incubation | Shepherd's Hooks | Must be non-cytotoxic | Non-cytotoxic |
| Sensitization - Maximization (2 extracts) | BrainPath Sheath and Obturator | Must be non-sensitizer | Non-sensitizer |
| Irritation - Intracutaneous Reactivity (2 extracts) | BrainPath Sheath and Obturator | Must be non-irritant | 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 | Must successfully interface and meet design requirements | 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 | Must pass packaging and shelf life criteria | Pass |
| Specification Review | BrainPath Sheath, Obturator, and Manipulation Tool | Must meet specifications | Pass |
| Specification Review | Shepherd's Hooks | Must meet specifications | Pass |
| Cleaning Validation (Reusable Device) – Establishment of cleaning validation per miles soil test using bioburden endotoxin and protein testing | BrainPath Obturator | Cleaning validation must be established as per protocol | Pass |
| Sterility Validation (Reusable Device) - Steam autoclaving, IUSS, and hydrogen peroxide gas plasma | Obturators, Manipulation Tool, and Sterilization Tray | Must meet sterility validation requirements | Pass |
| Sterility Validation (Single-Use) - B&F testing, VDmax for SAL 10-6, along with routine Pyrogenicity testing | BrainPath Sheath and Shepherd's Hooks | Must meet sterility validation requirements | Pass |
| Sterilization Tray Drop Test from 4 ft. | Obturator and Manipulation Tool | Must pass drop test | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document describes non-clinical engineering and biocompatibility testing for a surgical device, not a study involving patient data or test sets in the context of AI/ML.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. Ground truth, in the context of diagnostic accuracy, is not established in this type of submission. The "ground truth" for the non-clinical tests is based on established engineering standards and validated methods (e.g., ISO standards for biocompatibility, cleaning validation protocols).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No adjudication method is described as this is not a study assessing diagnostic performance.
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
- No. An MRMC comparative effectiveness study was not done. This device is a surgical instrument, not an AI-powered diagnostic tool. The document states that the BrainPath "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." This indicates it can be used with other technologies, some of which may be software-based, but BrainPath itself is not an AI/ML device, and no MRMC study on its comparative effectiveness with AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. A standalone algorithm performance study was not done. The device is a physical surgical tool and does not operate as an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical tests is based on established scientific and engineering principles, such as:
- Biocompatibility standards: (e.g., ISO 10993 for Cytotoxicity, Sensitization, Irritation).
- Sterilization validation methods: (e.g., for steam autoclaving, gas plasma, gamma irradiation).
- Mechanical and functional specifications: (e.g., ability to interface with other instruments, packaging integrity).
- These are not "expert consensus" or "pathology" in the clinical sense, but rather adherence to predefined and validated test methodologies and acceptance limits.
8. The sample size for the training set
- Not Applicable. There is no training set mentioned as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, there is no ground truth establishment for it.
In summary: This document is a 510(k) submission for a physical surgical device, the NICO® BrainPath®, demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not pertain to the development or validation of an AI/ML powered medical device, and thus, most of the requested information regarding AI/ML study design and criteria is not present.
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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
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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
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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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Image /page/3/Picture/0 description: The image shows the logo for NICO Corporation. The letters "NIC" are in black, and the "O" is in gold. Underneath the letters is the word "CORPORATION" in a smaller font.
NICO® BrainPath®
21 CFR §807.92 Date Prepared: 03 June 2015
510(k) Number: K150378
| 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® 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 | SheathLength (mm) | Obturator TipLength (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 DeviceNICO BrainPath | Predicate DeviceNICO 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 andplacement | Handheld and can be assisted by third-party navigation(if desired) | Identical |
| ShippingConfiguration | Obturator and sheath packaged and shipped separatelyand paired during surgical case. | Identical |
| Reusable or SinglePatient Use | Single Patient Use and Reusable | Identical |
| Method ofSterilization | Gamma for disposable component (sheath)Autoclave/hydrogen peroxide gas plasma for reusablecomponents | Identical |
| Biocompatibility | Demonstrated based on externally communicatingdevice in direct contact with tissue/bone/dentin for alimited duration | Identical |
| Materials ofManufacture | Obturator: AluminumSheath: COC | Identical |
| Cross Sectionalanalysis ofObturator/ Sheath | Obturator/Sheath combination has a circular crosssection. | Identical |
| Depth markings | Incremental depth markings on both sheath andobturator. | Identical |
| Sheath diameterdimensions | 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 75mm. | Identical |
| 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 tip extends 15mm beyond the sheath. For the Gold-ST, shallow-tipobturator, the tip extends 7.5 mm beyond the sheath. | The three blue standard tipobturators are identical. TheGold-ST was not part of theoriginal Brain Port submission. |
| 3rd partyinstrumentation | Obturator component interfaces with third partyinstruments. | Identical |
| Surface of Sheath | Used Ink Y. Inner diameter and horizontal proximalsurface of the knurled ring are textured. | Used Ink X. Sheath was "clear"and smooth. Surface texturingwas not part of the previoussubmission. |
| Proximal End ofSheath | Knurled ring and distal portion of the sheath has holes,slots, and ears. | Knurled ring on sheath includesholes for securing. Slots and earswere not part of the originalBrain Port submission. |
| Manipulation Tool | "Manipulation Tool" is textured to prevent glare/shinefrom surgical lighting. | "Manipulation Tool" wasoffered but was not textured onthe distal portion. |
| Shepherd's Hooks | Three Shepherd's Hooks available to facilitateinterfacing with common third party retractors. | Shepherd's Hooks were notmentioned in the previoussubmission |
Table 3: Comparison Table
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Image /page/5/Picture/0 description: The image shows the logo for NICO Corporation. The logo is in black and gold. The word "NICO" is in large, bold letters, with the "O" being gold. Below the word "NICO" is the word "CORPORATION" in smaller, thinner letters.
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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, andManipulation Tool | Non-cytotoxic |
| Sensitization - Maximization (2 extracts) | BrainPath Sheath andObturator | Non-sensitizer |
| Irritation - Intracutaneous Reactivity (2 extracts) | Non-irritant | |
| Simulated Use to demonstrate the BrainPath has the ability tointerface with 3rd Party Instruments and meets design inputrequirements | BrainPath Sheath,Obturator, andManipulation Tool | Pass |
| Packaging & Shelf Life - shipping/distribution simulation,environmental conditions, aging, visual packaging inspection,bubble and burst packaging testing, and functional testingfollowing aging, environmental and shipping simulation | BrainPath Sheath andObturator | Pass |
| Specification Review | BrainPath Sheath,Obturator, andManipulation Tool | Pass |
| Cleaning Validation (Reusable Device) – Establishment ofcleaning validation per miles soil test using bioburdenendotoxin and protein testing | BrainPath Obturator | Pass |
| Sterility Validation (Reusable Device) - Steam autoclaving,IUSS, and hydrogen peroxide gas plasma | Obturators, ManipulationTool, and SterilizationTray | Pass |
| Sterility Validation (Single-Use) - B&F testing, VDmax forSAL 10-6, along with routine Pyrogenicity testing | BrainPath Sheath andShepherd's Hooks | Pass |
| Sterilization Tray Drop Test from 4 ft. | Obturator andManipulation 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.
§ 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).