V-GUIDE FOR VENTRICULOSTOMIES

K141559 · Arc Surgical, LLC · HAW · Feb 27, 2015 · Neurology

Device Facts

• Record ID: K141559
• Device Name: V-GUIDE FOR VENTRICULOSTOMIES
• Applicant: Arc Surgical, LLC
• Product Code: HAW · Neurology
• Decision Date: Feb 27, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The V-Guide is designed to be used for frontal placement of an intraventricular catheter during a ventriculostomy. The device is for use with intraventricular catheters

Device Story

V-Guide is a sterile, single-use neurological stereotactic instrument used by surgeons during ventriculostomy procedures. It provides a localized reference guide for frontal placement of 3.3mm intraventricular catheters. The device consists of a base assembly, three stainless steel impression pins (16 gauge) acting as legs, a pierce sagittal assembly, and a pierce barrel. The surgeon places the device over the burr hole; the device allows for orientation of the sagittal and lateral planes to 0° for perpendicular insertion. If the catheter position is unsatisfactory, the surgeon can adjust the angle to the cranium. The device facilitates accurate catheter placement, confirmed by cerebrospinal fluid flow, potentially improving surgical outcomes by providing an objective method for trajectory adjustment.

Clinical Evidence

Bench testing only. Accuracy testing performed using a bench model with a target at 6cm depth. The V-Guide demonstrated accuracy of ±3.0mm at 90° (0° sagittal/lateral). Results compared to the predicate device showed comparable performance.

Technological Characteristics

Materials: ABS plastic body, 16-gauge stainless steel legs with aluminum hubs. Form factor: Base assembly with three legs, pierce sagittal assembly, and barrel. Energy source: None (manual). Connectivity: None. Sterilization: Gamma radiation (SAL 10^-6). Compatibility: 3.3mm OD intraventricular catheters.

Indications for Use

Indicated for frontal placement of an intraventricular catheter during a ventriculostomy in patients requiring such procedures.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

• Ghajar Intraventricular Catheter Guide (K854475)

Reference Devices

• Monoject Standard Hypodermic Needle (K854547)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 27, 2015

Arc Surgicals Manufacturing LLC. Craig Pagan Consultant 1135 W Nasa Blvd Ste 500 Melbourne, Florida 32901

Re: K141559

> Trade/Device Name: V-guide for Ventriculostomies Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: June 10, 2014 Received: June 12, 2014

Dear Craig Pagan,

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -S

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) K141559

Device Name V-Guide for Ventriculostomies

Indications for Use (Describe)

The V-Guide is designed to be used for frontal placement of an intraventricular catheter during a ventriculostomy. The device is for use with intraventricular catheters

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| <div> <span style="font-size:12px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span style="font-size:12px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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## 510(k) Summary

### Submitter's name, address, telephone number, a contact person and date (1) summary was prepared:

ARC Surgicals Manufacturing LLC 3259 Progress Drive Suite 166 Orlando, FL 32826 Tel: [phone] Contact: Habeel Gazi, Director Email: [e-mail] June 9, 2014 Date Prepared:

#### Name(s) of device: (2)

| Proprietary/Trade Name: | V-Guide for Ventriculostomies |
|-------------------------|-------------------------------------|
| Common Name: | Neurological stereotaxic instrument |
| Classification Name: | Stereotaxic Instrument |
| Classification Panel: | Neurology |
| Product Code: | HAW |
| Regulatory Class: | II |
| Regulation Number | 21 CFR 882.4560 |

### Legally Marked Predicate Device to which the submitter claims substantial (3) equivalence:

Arc Surgical Manufacturing's V-Guide for Ventriculostomies is substantially equivalent to the Sparta Instrument Corporation's Ghajar Intraventricular Catheter Guide – K854475.

#### (4) Description of device(s):

V-Guide for Ventriculostomies (Reorder # 7000)

The V-Guide is a sterile, single use, Neurological Stereotactic Instrument that provides the surgeon with a localized reference guide for performing Ventriculostomies. The device is compatible with 3.3mm ventricular catheters. The device consists of a Base Assembly, three Impression Pins (16 Gauge Stainless Steel needles with aluminum hubs) that act as legs for the Base, a Pierce Sagittal assembly and a Pierce Barrel.

The device allows the user to orient the sagittal plane to 0° and the lateral plane to 0°. This aligns the device to a perpendicular track to the entry point. A standard 3.3mm catheter is then passed through the guide into the brain at the predetermined distance

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as in a standard Ventriculostomy. If the flow of cerebrospinal fluid is noted and the surgeon is satisfied the position of the catheter, the V-guide can be removed from the catheter by removing the barrel. If the surgeon is not satisfied with the position of the catheter, the catheter is removed and this technique can be repeated with different angles to allow for an objective change in direction of the catheters angle to the cranium.

#### Indications for Use: (5)

The V-Guide is designed to be used for frontal placement of an intraventricular catheter during a ventriculostomy. The device is for use with intraventricular catheters.

#### Comparison of Technological Characteristics to Predicate Device: (6)

The V-Guide for Ventriculostomies has the same technological characteristics as the predicate device, the Ghajar Guide (K854475) as described below:

- devices are designed to guide catheters for Ventriculostomies ●
- devices have 3 legs that position the device over the burr hole ●
- devices are designed to place catheters at 90° (perpendicular) to the skull ●
- devices are visually placed over the burr hole
- devices are hand held during insertion of the catheter
- both devices are made of plastic material ●

## Differences:

The main difference between the V-Guide and the predicate Ghajar Guide is that the V-Guide allows the user to make objective changes in the direction of the catheters angle to the cranium.

| Product<br>Information | V-Guide<br>This submission | Ghajar Intraventricular<br>Catheter Guide | Similarities and<br>Differences |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Classification | Class II | Class II | Same |
| Regulation Number | 21 CFR 882.4560 | 21 CFR 882.4560 | Same |
| Product Code | HAW | HAW | Same |
| Indications for Use | The V-Guide is designed<br>to be used for frontal<br>placement of an<br>intraventricular catheter<br>during a ventriculostomy.<br>The device is for use with<br>intraventricular catheters. | The Ghajar Guide is<br>designed to be used as a<br>device for anterior<br>placement of an<br>intraventricular catheter at<br>ninety degrees to the skull<br>surface. | Both devices are<br>indicated for frontal or<br>anterior placement of<br>intraventricular<br>catheters.<br><br>The Ghajar Guide is only<br>indicated for placement<br>at 90 degrees to the skull |

# Substantial Equivalence Comparison

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| Product<br>Information | V-Guide<br>This submission | Ghajar Intraventricular<br>Catheter Guide | Similarities and<br>Differences |
|---------------------------|-----------------------------------------------|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | surface, whereas the V<br>Guide allows the<br>physician make objective<br>changes in the direction<br>of the catheters angle to<br>the skull. |
| Catheter<br>Compatibility | 3.3mm | 1.30 - 3.25mm | V-Guide is compatible<br>with one size catheter -<br>3.3mm OD whereas the<br>Ghajar Guide is<br>compatible with catheter<br>from 1.30 – 3.25mm<br>OD. |
| Materials | ABS with Stainless Steel<br>Legs (See note 1) | Plastic | The bodies of both<br>devices are the same -<br>plastic. The Legs of the<br>V Guide are made of<br>stainless steel rather than<br>plastic. Comparative<br>testing shows<br>comparable<br>performance. |
| Accuracy | $\pm$ 3mm at 6cm target<br>depth | Unknown | Same – based on bench<br>test data the V Guide<br>was comparable to the<br>Ghajar guide. |
| Sterilization<br>Method | Gamma | Ethylene Oxide | Sterilization process is<br>different, but SAL 10-6 is<br>the same. |
| Single Use | Yes | Yes | Same |
| Packaging | PETG Tray with Tyvek<br>lid | PETG Tray with Tyvek lid | Same |

Biocompatibility of the Stainless Steel Legs was established based on the Note 1: Covidien product # 8881200052 Monoject™ Standard Hypodermic Needle, Aluminum Hub, 16 G x 1" (1.651 mm x 2.5 cm) A. The FDA classifies this product is a class II device, which is cleared under 510k K854547.

#### (7) Performance Data:

The following nonclinical testing was performed in order to evaluate the substantial equivalence of the V-Guide to the predicate device:

- Accuracy Testing at 90° at 90° (Sagittal angle adjustment set at 0 and ● Lateral Angle (Barrel) set at 0) the V-Guide will be accurate to ± 3.0mm with a target depth of 6 cm.

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This test verified the accuracy of the device using a bench model with a target at 6 cm depth. The accuracy of the V-Guide was compared to the predicate device (Ghajar Guide) using the same bench model. The results of the tests shows that the V-Guide is comparable to the accuracy of the predicate device.

#### Conclusions: (8)

Based on the non-clinical performance data performed comparing the Arc Surgicals Manufacturing V-Guide to the predicate device, it is concluded that the data supports the safety of the device and the hardware verification demonstrate that the V-Guide device should perform as intended in the specified use conditions. The data demonstrate that the V-Guide device performs comparably to the predicate device that is currently marketed for the same intended use.