(183 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and function of a cannula for fluid injection/removal, with no mention of AI or ML.
No.
A therapeutic device is one that treats a disease or condition. This device is used for injection of medication or removal of fluid for diagnostic purposes, which are not therapeutic uses.
No
This device is intended for the injection of medication (Cytarabine) or removal of CSF during intracranial procedures, which are therapeutic or interventional actions, not diagnostic ones.
No
The device description clearly details physical components like a cannula, stylet, and luer fitting, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the injection of Cytarabine or removal of CSF from the ventricles during intracranial procedures. This is a direct intervention on a patient's body for therapeutic (injection) or diagnostic/therapeutic (removal of CSF) purposes.
- Device Description: The description details a physical cannula designed for insertion into the body.
- Performance Studies: The performance studies focus on the physical and functional aspects of the device in a clinical setting (sterilization, biocompatibility, pressure withstand, injection/aspiration, etc.).
- Predicate Device: The predicate device is an Adson Cannula, which is a surgical instrument used for similar procedures.
IVD devices are used to examine specimens (like blood, urine, or CSF) outside the body to provide information about a person's health. This device is used inside the body for direct patient care.
N/A
Intended Use / 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."
Product codes (comma separated list FDA assigned to the subject device)
HCD
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Brain ventricle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating Room, MRI Diagnostic / Surgical Room
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)
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.
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.
Adson Cannula
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
§ 882.4060 Ventricular cannula.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.
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
510(k) (Traditional) Submission Section 5, 510(k) Summary
SurgiVision, Inc.
.
Section 5 510(k) Submission Page #
3 of 6
3
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
- . 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
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