Who is the manufacturer of SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA?

Surgivision, Inc. filed the 510(k) submission for SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA (K102101).

What is the FDA product code for SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA?

HCD. It is classified under 21 CFR 882.4060 as a Class 1 device in the Neurology panel.

What is the regulatory pathway for SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA

Q: What are the predicate devices for SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA?

Adson Cannula (9Fr x 14 cm; stainless steel).

K102101 · Surgivision, Inc. · HCD · Jan 26, 2011 · Neurology

Device Facts

Record ID	K102101
Device Name	SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA
Applicant	Surgivision, Inc.
Product Code	HCD · Neurology
Decision Date	Jan 26, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4060
Device Class	Class 1
Attributes	Therapeutic

Indications for Use

The MR Compatible Ventricular Cannula is intended for injection of Cytarabine or removal of CSF from the ventricles during intracranial procedures. The device is not intended for implant. The device is intended for "single patient use only."

Device Story

Ventricular cannula for intracranial access; used in MRI diagnostic/surgical rooms. Device inputs: manual manipulation by physician; outputs: fluid injection (Cytarabine) or CSF aspiration. Features rigid ceramic body; non-reactive silica lumen; proximal lumen extension (3ft or 9ft) for remote operation outside MRI bore. Designed for MR compatibility; allows physician to perform procedures while patient is inside scanner. Benefits: enables real-time visualization during placement and remote fluid management without removing device or requiring non-MR safe equipment near scanner. Single-patient use; sterile.

Clinical Evidence

Bench testing only. Includes design verification, pressure withstand, injection/aspiration flow testing, lateral tip deflection, transit testing (ASTM D4169), and accelerated aging. Biocompatibility testing per ISO 10993 (cytotoxicity, pyrogen, sensitization, toxicity). Cytarabine injection and primate CSF aspiration validated in bench studies.

Technological Characteristics

Rigid ceramic body; non-reactive silica fluid lumen; PVC proximal extension tubing. Female luer connector. MR compatible/safe. Sterilized via radiation (ISO 11137-2). Dimensions: 16ga or 14ga; 4ft or 10ft lengths. No side holes. Manual operation.

Indications for Use

Indicated for patients requiring injection of Cytarabine into or aspiration of CSF from brain ventricles during intracranial procedures. Not for implant. Prescription use only.

Regulatory Classification

Identification

A ventricular cannula is a device used to puncture the ventricles of the brain for aspiration or for injection. This device is frequently referred to as a ventricular needle.

Predicate Devices

Adson Cannula (9Fr x 14 cm; stainless steel)

Submission Summary (Full Text)

{0}------------------------------------------------ #### 510(k) Summary : This 510(k) summary is being submitted in accordance with the requirements of 21 CFR Part 807.92 for the SurgiVision MR Compatible Ventricular Cannula. #### 1. Company Making the Submission: JAN 2 6 2011 6 | Name of Owner: | SurgiVision, Inc. | |----------------|--------------------------| | Address: | 5 Musick | | | Irvine, CA 92618 | | Telephone: | 949-900-6833 | | Fax: | 949-900-6834 | | Contact: | Edward Waddell | | E-mail: | ewaddell@surgivision.com | #### Device Name: 2. | Common Name: | Ventricular Cannula | |--------------------|--------------------------------------| | Proprietary Name: | MR Compatible Ventricular Cannula | | Classification: | Class I | | Regulation Number: | 882.4060 | | Product Code: | HCD | #### Predicate Device: 3. Adson Cannula (9Fr x 14 cm; stainless steel) (class I, 510(k)-exempt) #### Description of Device: 4. The Cannula has a stepped distal tip with a 30 cm rigid ceramic stylet protecting the fluid lumen while providing rigidity to the distal portion of the device. Soft this in areets the lumen in the center portion and at the distal end where it terminates at a female luer fitting. The fluid containing central lumen is manufactured from non-reactive silica. The cannula will be marketed in the following sizes: - 16 ga Ventricular Cannula, .008" ID x 4ft - 16 ga Ventricular Cannula. .008" ID x 10ft - 14 ga Ventricular Cannula, .021" ID x 4ft 14 ga Ventricular Cannula, .021" ID x 10ft Surgi Vision, Inc. Section 5 510(k) Submission Page # {1}------------------------------------------------ #### 5. Intended Use Statement: The MR Compatible Ventricular Cannula is intended for injection of Cytarabine or removal of CSF from the ventricles during intracranial procedures. The device is not intended for implant. The device is intended for "single patient use only." ## 6. Summary of the Technological Characteristics of the Device Compared to the Predicate Device | | SurgiVision Ventricular Cannula (VC) | Predicate Device: Adson Ventricular Cannula | Discussion | |--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification | 21 CFR 882.4060 | 21 CFR 882.4060 | Equivalent | | Product Code | HCD | HCD | Equivalent | | Intended Use | Injection of Cytarabine to the ventricles of the brain or aspiration of CSF from the ventricles of the brain | Injection or aspiration of fluid in the ventricles of the brain | Equivalent | | Indications for Use | Gains access to the brain ventricles | Gains access to the brain ventricles | Equivalent | | | Allows Injection of Cytarabine into the brain ventricles | Allows injection of fluids into the brain ventricles | VC validated using Cytarabine | | | Allows aspiration of CSF from the brain ventricles | Allows aspiration of fluids from the brain ventricles | VC validated using primate CSF | | | Not implantable | Not implantable | Equivalent | | | Single Patient Use | Reusable | VC is validated for single patient use. Component materials do not lend to multiple use and re- sterilization | | Target Population | Pt.s needing injection of Cytarabine to the brain ventricles or aspiration of CSF from the brain ventricles | Pt.s needing aspiration or injection of fluids from the brain ventricles | VC validated using Cytarabine and primate CSF | | Anatomical Sites | Brain ventricle | Brain ventricle | Equivalent | | | Operating Room | Operating Room | Equivalent | | Where Used | MRI Diagnostic / Surgical Room | N/A | VC device is MR Compatible/ MR Safe, whereas the predicate device is not indicated for MR environments | | Energy used | N/A | N/A | Equivalent | | Human Factors | Labeling indicates size and length | Labeling indicates size and length | Equivalent | | | Labeling contains flow vs. pressure tables | No information provided | VC provides additional information to the | | | SurgiVision Ventricular Cannula (VC) | Predicate Device: Adson Ventricular Cannula | Discussion | | | | | physician regarding flow and pressures for the various sizes | | | Can be manipulated with gloved hand | Can be manipulated with gloved hand | Equivalent | | | Designed to be placed through a prepared opening through the skull and dura into the brain ventricle | Designed to be placed through a prepared opening through the skull and dura into the brain ventricle | Equivalent | | | Rigid section to enter the brain | Rigid section to enter the brain | Equivalent | | Design | Straight section to enter the brain | Straight section to enter the brain | Equivalent | | | Hole at distal end for fluid movement | Hole at distal end for fluid movement | Equivalent | | | No side holes | Three .055" (1.4 mm) side holes located 11 mm to 21 mm from the distal end | The VC can only transfer fluids from the distal end | | | No marking on body of device | CM markings on body | VC Device length is provided with the instructions | | | Length of rigid section: 10.5" (30 cm) | Length of rigid section: 5.5" (14 cm) | The VC has a longer length to facilitate handling of the device when the patient is within the bore of an MR scanner | | | Inside diameter: .008" (0.2 mm) to .021" (0.53 mm) | Inside diameter: .079" (2.0 mm) | Both devices are moving fluids and their different inside / outside diameters result in different flow rates. | | | Outside diameter: .065" (1.6 mm) and .080" (2.0 mm) | Outside diameter: .120" (3.0 mm) | | | | No Stylet | Stylet | VC has stepped features for dimensional transitions at the tip and the predicate device uses a stylet to create the transitions | | | SurgiVision Ventricular Cannula (VC) | Predicate Device: Adson Ventricular Cannula | Discussion | | | | | VC does not have a stylet that would have to be removed prior to assisted injection or aspiration VC allows immediate un-assisted aspiration of CSF from ventricle (with visualization by physician) during placement | | | Lumen extension (3 foot) allows remote (end of scanner bore) injection/aspiration | No Proximal Extension present | VC has an incorporated proximal lumen extension, this provides a single lumen extending from the rigid cannula to the proximal connector | | | Lumen extension (9 foot) allows remote (outside of scanner 5 gauss line) Injection/aspiration using a non-MRI safe pump | No Proximal Extension Present | VC has an incorporated proximal lumen extension; this provides a single lumen extending from the rigid cannula to the proximal connector. This extension provides a continuous lumen that is MR compatible and can connect to a remote, not MR safe pump for injection/aspiration. | | Performance | Sufficiently rigid to pass through brain tissue without additional support | Sufficiently rigid to pass through brain tissue without additional support | Equivalent | | Performance | Contains a channel through which fluids can be removed (aspiration) or placed (injection) into the ventricle | Contains a channel through which fluids can be removed (aspiration) or placed (injection) into the ventricle | Equivalent | | | Flow rate of: 0.3 ml/hr (.008" I.D.) to 25.0 ml/hr (.021" I.D.) at 0.7 PSI | Flow rate of 16,000 ml/hr at 0.7 PSI | Both devices are moving fluids and the different flow rates result only from their different diameters | | Materials | Rigid body: Ceramic | Rigid body: Stainless Steel or Sterling Silver | Both devices use rigid material for the body, VC provides a | | | SurgiVision Ventricular Cannula (VC) | Predicate Device: Adson Ventricular Cannula | Discussion | | | | | rigid body that is MR Compatible due to ceramic material | | | Stylet: N/A | Stylet: Stainless Steel or Sterling Silver | VC has features that provide rigidity and tip transition which are accomplished by the stylet | | | Through lumen: Polymer covered silica | Through lumen: Stainless Steel or Sterling Silver | Both devices have a continuous through lumen but the VC is MR compatible | | | Lumen extension (outer support tubing): PVC extrusion | No lumen extension. | VC is provided with lumen extension | | | Proximal Connector: Female Luer connector | Proximal Connector: Female Luer connector | Equivalent | | Biocompatibility | Tissue contact tested per ISO 10993: Biological Evaluation of Medical Devices | Presumed | Equivalent | | Compatibility with environment and other devices | Safe in a 1.5T MRI environment | Not safe in a 1.5T MRI environment | VC device is designed for MR environment | | | Female Luer connector on proximal end fits all male luer connectors (e.g. syringe tips) | Female Luer connector on proximal end fits all male luer slip connectors (e.g. syringe tips) | Equivalent | | Sterility | Yes per ANSI/AAMI/ISO 11137- 2: Sterilization of health care products -- Radiation | Provided non-sterile and sterilized on-site | Equivalent | | Electrical Safety | N/A | N/A | Equivalent | | Mechanical safety | N/A | N/A | Equivalent | | Chemical Safety | Silica lumen non-reactive | Stainless steel | Equivalent | | Thermal Safety | MRI Safe. All brain contacting components tested safe in a 1.5T environment | Not MRI safe | VC use is not restricted to non-MRI environment | | Radiation safety | N/A | N/A | Equivalent | SurgiVision, Inc. Section 5 510(k) Submission Page # -7.6 {2}------------------------------------------------ K102101 ## 510(k) (Traditional) Submission Section 5, 510(k) Summary SurgiVision, Inc. . Section 5 510(k) Submission Page # 3 of 6 {3}------------------------------------------------ K102101 # 510(k) (Traditional) Submission SurgiVision, Inc. . Section 5 510(k) Submission Page # 26 {4}------------------------------------------------ ## 长10210 | ## 510(k) (Traditional) Submission Section 5, 510(k) Summary Summarizing the differences noted above: - The SurgiVision MR Compatible Ventricular Cannula (VC) is single patient use and is . not re-sterilizable. - The VC is provided sterilized and pyrogen free in Tyvek packaging. . - The VC is MR safe and can be used within an MR environment. ● - The VC Is MN sale and can oe association to the physician regarding flow rates ● as a function of pressure. The predicate provides no such information. - The VC has no side holes in the lumen . - The VC has no depth marking on the barrel as the physician will be adjusting location . with direct visualization under MR using a stereotactic frame - While and the rigid section of the VC is longer than the predicate for ease of . handling within the MR bore. SurgiVision, Inc. Section 5 510(k) Submission Page # {5}------------------------------------------------ K102101 - . The VC does not require a stylet for entry to the ventricles that requires removal prior to injection or aspiration. - The VC has an integral extension for injection or aspiration external to the bore. . - t The VC and predicate flow rates differ because of the different lumen sizes and extension. These recognized differences between the VC and the predicate are intended to meet the needs of the MR work environment and do not represent changes that effect the safety or effectiveness of the device. ## 7. Testing: Testing to applicable standards has been completed with acceptable outcomes. The following testing has been performed: - Sterilization and Shelf Life, including sterilization validation using the . VDmax25 procedure of ISO 11137-2. - Biocompatibility Testing including cytotoxicity, material mediated . pyrogen, ISO maximization study, intracutaneous toxicity and systemic toxicity with acceptable results. - Performance Testing Bench, including design verification testing, . comparison testing with the predicate Adson Cannula, pressure withstand testing and injection/aspiration testing, lateral tip deflection testing, transit testing in conformance to D4169 and accelerated aging testing. - Cytarabine injection testing and aspiration of primate CSF was completed . with acceptable results.. These tests demonstrated that the MR Compatible Ventricular Cannula functions as intended and is substantially equivalent to legally marketed predicate device. #### Rx or OTC: 8. The MR Compatible Ventricular Cannula is an Rx prescription device per 21 CFR Part 801, Subpart D. ## 9. Substantial Equivalence: The MR Compatible Ventricular Cannula has the same indications for use as the The Mice device, Adson Cannula. While there are technological differences between predical cornect, Notentricular Cannula and the Adson Cannula, such as the device matcrial, construction and dimensions, these differences do not raise new types of material, consultion and entions when all listed warnings and cautions are followed. The MR Compatible Ventricular Cannula is substantially equivalent to the marketed Adson Cannula. SurgiVision, Inc. Date: 1/22/21 Edward Waddell, Director of Regulatory Affairs Surgi Vision, Inc. Section 5 510(k) Submission Page # 006 {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is black, and the text is also black. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 SurgiVision, Inc. c/o Mr. Edward Waddell Director, Regulatory Surgi Vision, Inc. 5 Musick Irvine, CA 92618 JAN 26 2011 Re: K102101 Trade/Device Name: SurgiVision MR Compatible Ventricular Cannula Regulation Number: 21 CFR 882.4060 Regulation Name: Ventricular cannula Regulatory Class: Class I Product Code: HCD Dated: January 17, 2011 Received: January 18, 2011 Dear Mr. Waddell: 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. : : . . . and the contraction of the comments of the comments of the comments of : . . . . . . . . . . . . . {7}------------------------------------------------ Page 2 - Mr. Edward Waddell 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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, . . . . . . . . Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ Indications for Use Statement KI02101 510(k) Number (if known): Device Name: SurgiVision, Inc. MR Compatible Ventricular Cannula Indications for Use: The MR Compatible Ventricular Cannula is intended for injection of Cytarabine or removal of CSF from the ventricles during intracranial procedures. The device is not intended for implant. The device is intended for "single patient use only." Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) R. Peterson (Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices 510(k) Number K102101 Page __ of _

SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

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SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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Special Control Matches

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