(115 days)
No
The summary describes a device that uses electrical stimulation and EMG signals for nerve localization, but there is no mention of AI or ML being used for data processing, analysis, or decision-making. The device appears to be a passive tool for delivering stimulation and connecting to a separate EMG system.
No.
The device is used to locate motor nerves by stimulating them, not to treat a disease or condition.
Yes
The device aids in the "location of motor nerves" by enabling the surgeon to "direct a stimulus signal from a commercial EMG system to electrodes on the device enabling nerve root location." This process of localizing nerves based on their response to electrical stimulation is a diagnostic function within an intraoperative setting.
No
The device description explicitly details physical components made of Pebax® tubing, stainless steel, and ABS plastic, along with wires and electrodes. It also mentions mechanical performance tests and electrical safety testing, indicating a hardware component.
Based on the provided information, the Baxano Neuro Check™ Device is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "location of motor nerves in settings where visualization is compromised" by directing a stimulus signal to electrodes on the device. This is an in vivo application, meaning it interacts directly with the patient's body during a surgical procedure.
- Device Description: The device is designed to be placed within the neural foramen and connected to a commercial EMG system to stimulate nerves. This is a direct interaction with the patient's nervous system.
- Mechanism of Action: The device works by delivering electrical stimulation to nerves and relies on the patient's physiological response (detected by the EMG system) to locate the nerves. This is not a test performed on samples of biological material outside the body.
- Performance Studies: The performance studies mentioned are related to mechanical performance, electrical safety, and electromagnetic compatibility, which are typical for medical devices used in vivo, not IVDs.
- Predicate Devices: The predicate devices listed are also systems and probes used for intraoperative neuromonitoring, which are in vivo devices.
In Vitro Diagnostic (IVD) devices are defined as those intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The Baxano Neuro Check™ Device does not fit this definition.
N/A
Intended Use / Indications for Use
The Baxano Neuro Check™ Device is intended for use with an iO-Flex cutting and biting device for location of motor nerves in settings where visualization is compromised.
Product codes (comma separated list FDA assigned to the subject device)
ETN
Device Description
The modified Neuro Check Device with iO-Flex Wire are provided sterile and disposable after single-patient use.
The Neuro Check Device is designed to be pulled into the neural foramen by the iO-Flex Wire to enable the surgeon to direct a stimulus signal from a commercial EMG system to electrodes on the device enabling nerve root location prior to using a Baxano cutting and biting device. The Neuro Check Device is manufactured from biocompatible Pebax® tubing and stainless steel with a handle molded from ABS. The proximal end of the device handle has a pair of wires that connect to commercially available EMG systems.
The iO-Flex Wire is manufactured from nickel-titanium wire and connects to the distal end of the Neuro Check Device for placement in the neural foramen. No changes were made to the previously cleared iO-Flex Wire design (K100958) other than packaging modifications to include it within the Neuro Check Device packaging for surgeon convenience.
Since the previous clearance of the Neuro Check Device (K092729; October 2, 2009) changes were made to the physician labeling (the Instructions For Use) intended to provide compatibility with enhanced output stimulus signals of commercially-available intra-operative electromyography (EMG) neuromonitoring systems for motor nerve localization. Specifically, the maximum allowable EMG stimulation current amplitude to the Neuro Check Device was increased from 30 milliamps to 50 milliamps and the maximum current pulse width from 300 microseconds to 500 microseconds to support the stimulation parameters of commercially available EMG systems. There were no design modifications of the Neuro Check Device necessary to conform to the new electrical stimulation specifications.
In addition, several design modifications were implemented since the last Neuro Check Device clearance. These modifications include integrating the separate Switch Box into the Neuro Check Device handle, eliminating the need for this external accessory. The handle itself is now molded from ABS plastic instead of being machined from the same material. Two radiopaque platinum-iridium marker bands were added to the distal flexible section to assist with fluoroscopic positioning of the device. A slight bend is made in the distal flexible segment to assist in orienting the Neuro Check Device as it is positioned with respect to the patient. Lastly, the iO-Flex Wire was added to the Neuro Check Device package for user convenience.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal column
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, OR team
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)
Mechanical performance tests were conducted to verify that the device meets design specifications and performance characteristics, based upon the intended use. The modified Neuro Check Device was subjected to electrical safety and compatibility testing and was certified to following standards, including all applicable normative reference standards:
• IEC 60601-1: 1988 +A1:1991 +A2:1995 Medical Electrical Equipment Part 1: General Requirements for Safety
• IEC 60601-2-40: 1998 Medical Electrical Equipment Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment
• IEC 60601-1-2: 2001 + A1:2004 Medical Electrical Equipment Part 1-2: General Requirements for Safety Collateral Standard: Electromagnetic Compatibility
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.
K092729, K062765, K061113, K924723
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.
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
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.
0
Қ 110696
JUL – 7 2011
Image /page/0/Picture/2 description: The image shows the word "BAXANO" in a bold, sans-serif font. A thin, curved line runs diagonally across the letter "X", adding a unique visual element to the word. The letters are all capitalized and evenly spaced, creating a balanced and legible composition.
510(k) Summary
| Submitter Identification | Baxano, Inc.
655 River Oaks Parkway
San Jose, CA 95134
Tel: (408) 514-2200
Fax: (408) 514-2221 |
|--------------------------|------------------------------------------------------------------------------------------------------------|
| Contact Person | Edward J. Sinclair, V.P. of CA/RA/QA
Tel: 408-514-2220 |
| Date Prepared | June 30, 2011 |
| Device Name | |
|---|---|
| Proprietary Name | Neuro Check™ Device with iO-Flex™ Wire |
| Common Name | Nerve locator |
| Classification Name | Surgical nerve stimulator/locator |
| Classification | 21 CFR §874.1820 |
| Device Class | Class II |
| Product Code | ETN |
Predicate Device
The modified Neuro Check Device is substantially equivalent to one or
more of the following predicate devices listed in Table 1 below:
| Predicate Device | Product Code | 510(k) Number | Clearance Date | |
|---|---|---|---|---|
| Baxano Neuro Check™ Device | ETN | K092729 | 10/02/2009 | |
| NuVasive NeuroVision JJB and | ||||
| M5 System and Probes | GWF | K062765 | 01/24/2007 | |
| Medtronic NIM Eclipse and | ||||
| Probes (formerly Axon Systems | ||||
| OrthoMon System) | GWF, IKN | K061113 | 05/23/2006 | |
| Cadwell Sierra Wave | ||||
| EMG/NCV/EP | GWF | K924723 | 03/23/1993 |
1
Neuro Check™ Device with iO-Flex™ Wire are provided sterile and Device Description disposable after single-patient use.
The Neuro Check Device is designed to be pulled into the neural foramen by the iO-Flex Wire to enable the surgeon to direct a stimulus signal from a commercial EMG system to electrodes on the device enabling nerve root location prior to using a Baxano cutting and biting device. The Neuro Check Device is manufactured from biocompatible Pebax® tubing and stainless steel with a handle molded from ABS. The proximal end of the device handle has a pair of wires that connect to commercially available EMG systems.
The iO-Flex Wire is manufactured from nickel-titanium wire and connects to the distal end of the Neuro Check Device for placement in the neural foramen. No changes were made to the previously cleared iO-Flex Wire design (K100958) other than packaging modifications to include it within the Neuro Check Device packaging for surgeon convenience.
Since the previous clearance of the Neuro Check Device (K092729; October 2, 2009) changes were made to the physician labeling (the Instructions For Use) intended to provide compatibility with enhanced output stimulus signals of commercially-available intra-operative electromyography (EMG) neuromonitoring systems for motor nerve localization. Specifically, the maximum allowable EMG stimulation current amplitude to the Neuro Check Device was increased from 30 milliamps to 50 milliamps and the maximum current pulse width from 300 microseconds to 500 microseconds to support the stimulation parameters of commercially available EMG systems. There were no design modifications of the Neuro Check Device necessary to conform to the new electrical stimulation specifications.
In addition, several design modifications were implemented since the last Neuro Check Device clearance. These modifications include integrating the separate Switch Box into the Neuro Check Device handle, eliminating the need for this external accessory. The handle itself is now molded from ABS plastic instead of being machined from the same material. Two radiopaque platinum-iridium marker bands were added to the distal flexible section to assist with fluoroscopic positioning of the device. A slight bend is made in the distal flexible segment to assist in orienting the Neuro Check
2
Device as it is positioned with respect to the patient. Lastly, the iO-Flex Wire was added to the Neuro Check Device package for user convenience. The Baxano Neuro Check™ Device is intended for use with an iO-Flex™ Intended Use cutting and biting device for location of motor nerves in settings where visualization is compromised. The modified Neuro Check Device with iO-Flex Wire is substantially Technological equivalent to the predicate Neuro Check Device (K092729) and the iO-Flex Characteristics and Substantial Wire (K100958). No changes were made to the previously cleared iO-Flex Wire design other than packaging modifications to include it with the Equivalence Neuro Check Device for surgeon convenience. The Neuro Check Device with iO-Flex Wire has the same indications for use and fundamental scientific technology as its predicate. Modification of the Neuro Check Device labeling allows for an increase in maximum EMG stimulation current to 50 milliamps (from 30 milliamps) and maximum pulse width to 500 microseconds (from 300 microseconds). This change provides compatibility with the range of settings typically associated with EMG intraoperative neuromonitoring systems and enhances the surgeon's ability to elicit an EMG response in patients whose nerves are less responsive to electrical stimulus. The predicate NuVasive NeuroVision M5 System and Probes (K062765) and Cadwell Sierra Wave EMG System (K924723) are cleared for stimulation current of 0-100 milliamps. The Cadwell Sierra Wave EMG System (K924723) is cleared for a stimulation pulse width of up to 1000 microseconds. Based upon the indications for use, technological characteristics and performance test results, changes to the Neuro Check Device with iO-Flex Wire do not raise new questions of safety or effectiveness. A summary of the Neuro Check Device technological characteristics compared to the legally marketed predicate devices is provided in Table 2 and 3 below.
3
| Attribute | Modified Neuro
Check Device
(K110696) | Predicate Neuro
Check Device
(K092729) | Change |
|---------------------------------------|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------|-------------------------------------------------|
| Shaft Length | 4.5 inches | 4.6 inches | Equivalent |
| Handle Length | 6 inches | 2 inches | Handle is longer to
accommodate
switching |
| Lead Length | 152 inches | Probe cable: 72 inches
Twisted Wire Cable:
80 Inches | No change in total
lead length |
| Tip Diameter/
Exposure | 0.06 inches | 0.06 inches | No change |
| Shaft Material | 304 Stainless Steel | 304 Stainless Steel | No change |
| Shaft Insulation | Pebax | Pebax | No change |
| Handle Material | ABS | ABS | No change |
| Lead Wire
Material | 28AWG Stranded
Copper | Probe cable: 28AWG
Tinned Copper
Twisted Wire Cable:
28AWG Stranded
Copper | No change (Probe
cable is obsolete) |
| Lead Wire
Insulation | PVC | Probe cable: FEP
medical grade
Twisted Wire Cable:
PVC | No change (Probe
cable is obsolete) |
| Active surface
area | 0.018 square inches | 0.018 square inches | No change |
| Dimensions of
electrodes | Rectangular
shaped: 0.022
inches width x
0.069 inches length | Rectangular shaped:
0.022 inches width x
0.069 inches length | No change |
| Number of
electrodes | 12 (6 on white side,
6 on black side) | 12 (6 on white side,
6 on black side) | No change |
| Distance
between
electrode pair | 0.040 inches | 0.042 inches | Equivalent |
Table 2. Physical Attributes
.
:
4
| Feature /
Technological
Characteristic | Modified Baxano
Neuro Check Device
(K110696) | Baxano Neuro Check
Device
(K092729) | NuVasive
NeuroVision JJB
and M5 Systems
(K062765) | Medtronic NIM-
Eclipse
(K061113) | Cadwell Sierra
Wave
EMG/NCV/EP
(K924723) |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Intended Use /
Indications for
Use | The Baxano Neuro Check
Device is intended for use
with an iO-Flex cutting and
biting device for location
of motor nerves in settings
where visualization is
compromised. | For use with Baxano iO-
Flex cutting and biting
devices for localization of
motor nerves in settings
where visualization is
compromised. | The NeuroVision JJB
System is used for
intraoperative monitoring
and neurological status
assessment by the
administration of brief
electrical stimulus pulses
to neural tissues and the
EMG monitoring of the
associated muscle
groups. The System is
used in conjunction with
other NuVasive devices
to assist in gaining
controlled access to, and
visualization of the spine. | The OrthoMon system
is intended for use to
record, monitor and
stimulate/record
biopotential signals
including
electromyograph
(EMG), evoked
response and
nerve/muscle potentials
and for the
intraoperativė diagnosis
of acute dysfunction in
corticospinal axonal
conduction.
The system provides
feedback to the surgeon
and OR team to assist in
the localization and
assessment of spinal
nerves and verification
of placement of spinal
instrumentation to avoid
injury to at risk nerve
roots. | Unable to locate; not
available on FDA's web
site. |
| Device Class | II | II | II | II | II |
| Product Code | ETN | HAE and ETN | GWF | GWF, IKN | GWF |
| Regulation
Number | 21 CFR 874.1820 | 21 CFR 882.4840
21 CFR 874.1820 | 21 CFR 882.1870 | 21 CFR 882.1870
21 CFR 890.1375 | 21 CFR 882.1870 |
| Feature /
Technological
Characteristic | Modified Baxano
Neuro Check Device
(K110696) | Baxano Neuro Check
Device
(K092729) | NuVasive
NeuroVision JJB
and M5 Systems
(K062765) | Medtronic NIM-
Eclipse
(K061113) | Cadwell Sierra
Wave
EMG/NCV/EP
(K924723) |
| Clearance Date | | 10/02/2009 | 01/24/2007 | 05/23/2006 | 03/23/1993 |
| Device
Classification
Name | Surgical Nerve Stimulator /
Locator (ETN) | Surgical Nerve Stimulator
/ Locator (ETN) | Stimulator, Electrical,
Evoked Response | Stimulator, Electrical,
Evoked Response | Stimulator, Electrical,
Evoked Response |
| Surgical
Procedure | Minimally invasive
procedures involving the
spinal column where
visualization is
compromised | Minimally invasive
procedures involving the
spinal column where
visualization is
compromised | Minimally invasive
procedures involving the
spinal column where
anatomical restrictions
safely permit use. | Procedures that involve
nerve location and
mapping; including
spinal surgery. | Procedures that involve
nerve location and
mapping. |
| Stimulation
Probes | Monopolar and Bipolar | Monopolar and Bipolar | Monopolar | Monopolar and Bipolar | Unknown |
| Stimulation
Current
Amplitude | 0 mA - 50 mA | 0 mA - 30 mA | 0 mA - 80 mA JJB
0 mA - 100 mA M5 | 0 mA - 50 mA | 0-100 mA |
| Stimulation
Current Pulse
Width | 150 - 500 µsec | 150 - 300 µsec | 200 µsec | 50- 300 µsec | 50 - 1000 µsec |
| Stimulation
Current
Frequency | 3.0 - 5.0 Hz | 3.0 - 5.0 Hz | 5.0 Hz (standard) | Supports Stimulation
Frequency 1- 10 Hz | Supports Stimulation
Frequency up to 50 Hz |
| Power | Passive: To be used in
conjunction with standard
EMG monitoring systems | Passive: To be used in
conjunction with standard
EMG monitoring systems | AC Power | AC Power | AC Power |
Table 3. Substantial Equivalence Comparison Table
Page 5
5
: .
Page 6
:
6
| Feature /
Technological
Characteristic | Modified Baxano
Neuro Check Device
(K110696) | Baxano Neuro Check
Device
(K092729) | NuVasive
NeuroVision JJB
and M5 Systems
(K062765) | Medtronic NIM-
Eclipse
(K061113) | Cadwell Sierra
Wave
EMG/NCV/EP
(K924723) |
|----------------------------------------------|----------------------------------------------------|----------------------------------------------------------------------|------------------------------------------------------------|---------------------------------------------------------|----------------------------------------------------------------------------------|
| Probe Patient
Contact
Materials | Stainless Steel | Stainless Steel | Stainless Steel | Stainless Steel | Stainless Steel |
| Safety | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-40 | UL 60601-1
IEC 60601-1-2
CAN/CSA C22.2#601.1
IEC 60601-2-40 | Information not
publically available | IEC 60601-1 protected
pin design
EN/IEC 60601-1-2 | UL2601-1, CSA601-1,
EN60601-1
EN60601-1-1
EN60601-2-40
EN60601-1-1-2 |
| Sterilization | E-beam | E-beam | EtO for reusable probes;
unknown for disposable | EtO for reusable probes;
unknown for disposable | Unknown |
| Software | None | None | Proprietary | Proprietary | Proprietary / Optional |
and the comments of the country
.
.
7
| Non-Clinical
Tests | Mechanical performance tests were conducted to verify that the device
meets design specifications and performance characteristics, based upon the
intended use. The modified Neuro Check Device was subjected to
electrical safety and compatibility testing and was certified to following
standards, including all applicable normative reference standards: |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | • IEC 60601-1: 1988 +A1:1991 +A2:1995 Medical Electrical
Equipment Part 1: General Requirements for Safety |
| | • IEC 60601-2-40: 1998 Medical Electrical Equipment Part 2-40:
Particular requirements for the safety of electromyographs and
evoked response equipment |
| | • IEC 60601-1-2: 2001 + A1:2004 Medical Electrical Equipment Part
1-2: General Requirements for Safety Collateral Standard:
Electromagnetic Compatibility |
| Sterilization
Data | The Neuro Check Device with iO-Flex Wire is sterilized by electron beam
irradiation, identical to the method used by the predicate Neuro Check
Device and the iO-Flex Wire (K081742, K092729 and K100958). The
sterilization process has been validated by an approved contract facility to
provide a sterility assurance level (SAL) of 10-6 in accordance with ISO
11137-1:2006 and ISO 11137-2:2006. The device is not labeled as non-
pyrogenic. |
| Conclusions | Baxano has determined that the non-clinical and sterilization testing
demonstrate that the modified Neuro Check Device with iO-Flex Wire is as
safe, as effective, and performs as well as the legally marketed predicated
devices. |
:
.
.
8
Image /page/8/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three curved lines representing the wings and a stylized tail. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Baxano, Incorporated c/o Mr. Edward Sinclair Vice President, Clinical Regulatory & Quality Affairs 655 River Oaks Parkway San Jose, California 95134
JUL = 7 2011
Re: K110696
Trade/Device Name: Neuro Check Device with iO-Flex Wire Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: May 24, 2011 Received: May 25, 2011
Dear Mr. Sinclair:
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
9
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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,
Melvin R. Felder, MD
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
10
Indications for Use
K-11-6-696 510(k) Number (if known):
Device Name: Baxano Neuro Check™ Device with iO-Flex™ Wire
Indications For Use:
The Baxano Neuro Check™ Device is intended for use with an iO-Flex cutting and biting device for location of motor nerves in settings where visualization is compromised.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Michael J. Hyman
(Division Sigh-C Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
Page 1 of 1
510(k) Number K110646