EPAD

K132616 · Safeop Surgical, Inc. · GWF · Jan 24, 2014 · Neurology

Device Facts

• Record ID: K132616
• Device Name: EPAD
• Applicant: Safeop Surgical, Inc.
• Product Code: GWF · Neurology
• Decision Date: Jan 24, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1870
• Device Class: Class 2

Intended Use

The EPAD is intended for use in monitoring neurological status by recording somatosensory evoked potentials (SSEP) or assessing the neuromuscular junction (NMJ).

Device Story

EPAD system monitors neurological status via SSEP or NMJ assessment. Inputs: electrical stimulation signals applied to patient limbs; physiological responses captured via 11 disposable, wet-gel cutaneous electrodes. Headbox contains amplifiers, ADCs, and DSPs to process signals. Tablet computer (Android OS) provides user interface, displaying waveforms. Bluetooth or USB connects headbox to tablet. Algorithm detects changes in evoked potential latency (>10%) and amplitude (>50%) relative to baseline, alerting clinician to check for artifacts or position deficits. Used in clinical/surgical settings by healthcare providers. Output: real-time waveform visualization and automated alerts. Benefits: enables intraoperative monitoring of nerve integrity and neuromuscular function, assisting clinical decision-making regarding patient positioning or surgical intervention.

Clinical Evidence

Bench testing only. Testing included software V&V, biocompatibility (ISO 10993-1), accelerated aging, electrical safety (IEC 60601-1, 60601-2-40), EMC (IEC 60601-1-2), and wireless coexistence. Functional performance testing validated signal quality (noise, CMRR, filters, gain) and alert algorithm sensitivity to waveform changes (>50% amplitude, >10% latency) under varying noise conditions.

Technological Characteristics

System comprises headbox, tablet, and disposable wet-gel electrodes. Sensing: cutaneous electrodes (ANSI/AAMI EC12:2000). Stimulation: constant current 0-100 mA, 0-50 V. Connectivity: Bluetooth/USB. Software: Android-based. Electrical safety: IEC 60601-1, IEC 60601-2-40. Sterilization: non-sterile, single-use electrodes.

Indications for Use

Indicated for monitoring neurological status via somatosensory evoked potentials (SSEP) or neuromuscular junction (NMJ) assessment in patients requiring intraoperative or clinical neurological monitoring.

Regulatory Classification

Identification

An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.

Predicate Devices

• Protektor 32 (K093304)
• NeuroEPG (K123843)

Submission Summary (Full Text)

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### EPAD™ 510(k)

Revised Section 4: 510(k) Summary

K132616

| 4.1 Date Prepared | January 23, 2014 | JAN 24 2014 |
|-------------------------------------------|------------------------------------------------------------------------------------------------|-------------|
| 4.2 Contact Person | Curt LaBelle, MD<br>CEO, SafeOp Surgical, Inc.<br>T: [phone]<br>[e-mail] | |
| 4.3 Device Trade Name | EPAD ^TM (Evoked Potential Assessing Device). | |
| 4.4 Classification Name<br>and Regulation | Evoked Response Electrical Stimulator<br>21 CFR 882.1870, GWF, Class II | |
| 4.5 Device Manufacturer | SafeOp Surgical, Inc.<br>263 Tresser Blvd<br>Stamford, CT 06901 | |
| 4.6 Predicate Device(s) | Protektor 32, K093304<br>NeuroEPG, K123843 | |

### 4.7 Indications for Use

The EPAD is intended for use in monitoring neurological status by recording somatosensory evoked potentials (SSEP) or assessing the neuromuscular junction (NMJ).

### Summary Device Description 4.8

The EPAD system consists of the following components/accessories:

EPAD Headbox EPAD Headbox Power Supply EPAD Tablet Computer (includes power supply and USB cable) Stimulator Left Blue Cable Assembly (110 inches) Stimulator Right Yellow Cable Assembly (110 inches) Acquisition Left Red Cable Assembly (91 inches) Acquisition Right White Cable Assembly (92 inches) Stimulator Left Blue Short Cable Assembly (67 inches) Stimulator Right Yellow Short Cable. Assembly (67 inches) Acquisition Left Red Short Cable Assembly (44 inches)

Revised 510(k) Summary - Page 1 of 14

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## Revised Section 4: 510(k) Summary

Acquisition Right White Short Cable Assembly (72 inches) Adapter Cable for EPAD Headbox (for leakage current testing)

Upper Limb Electrodes package

Lower Limb Electrodes package

The EPAD Headbox contains a complete data acquisition system that has built-in amplifiers, analog to digital converters, and digital signal processors. User interface is via tablet touchscreen computer provided with the EPAD System and running the Android operating system. The EPAD software application is preloaded onto the tablet. Data can be transferred to an external computer for archiving purposes. Communication between the EPAD Headbox and tablet is via Bluetooth wireless or USB connection.

Electrode cables are provided for left and right stimulation and left and right acquisition, color coded for correct connection to the EPAD Headbox: Custom cutaneous electrodes for stimulus and acquisition are provided by SafeOp for use with the EPAD. A total of 11 electrodes are applied for full patient monitoring (upper and lower limbs). The SafeOp electrodes are wet qel, single patient use, disposable, and biocompatible for short term (<24 hours) use on intact skin.

### Technological Comparison to Predicate Device 4.8

The following table provides a detailed side-by-side comparison of technical characteristics of the proposed device to the named predicate devices. The table also includes a discussion of each difference and iustification for substantial equivalence.

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feOp Surgical,

ction 4: 510(k) Summ

Discussion of
Differences &
ustification for S EPAD modes are a sub
he modes offered by the modes offered by th
Protektor. lo differenc Predicate
NeuroEPG
K123843)* SSEP, AE Yes SEP, BAEP, AEP, VE
EG, TcMEP, EMG Predicate
rotektor 32
K093304)* res Proposed
afeOp EPAD שירות המורשים של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המ SEP, NM neral Specification (es Aicroprocesso
controlled Categor dications Operating modes use

ction 4 - Page 3

PAD™ 510(

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EPAD™ 510(k)

SafeOp Surgical, Inc.

Section 4: 510(k) Summary

| Category | Proposed<br>SafeOp EPAD™ | Predicate<br>Protektor 32<br>(K093304)* | Predicate<br>NeuroEPG<br>(K123843)** | Discussion of<br>Differences &<br>Justification for SE |
|-------------------------|---------------------------------------------------------------|-----------------------------------------|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| User interface | Tablet (Google Nexus 7) | Laptop or desktop PC | PC | Alternate I/O technology:<br>touchpad tablet vs keyboard<br>computer. Hardware and<br>software testing presented in<br>510(k) demonstrate safety,<br>effectiveness and SE. |
| Operating<br>System | Google Android | Windows XP | Microsoft Windows<br>(2000 or XP) | Alternate operating system.<br>Android OS validated for<br>EPAD as part of software<br>V&V. |
| Interface<br>connection | Bluetooth or USB | USB | USB | Alternate communication<br>protocol. Compliance with<br>FDA guidance for RF<br>Wireless Technology in<br>Medical Devices and<br>applicable FCC regulations.. |
| Power supply | 100 to 240 VAC, 50-60 Hz<br>(input); 15 VDC, 1.6A<br>(output) | 90 to 264 VAC, 47-63 Hz | Not stated | No difference |

.

Section 4 - Page 4 of 14

.

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feOp Surgical, I

ction 4: 510(k) Summ

Physical size different design. EPP
EPA Discussion of
Differences &
istification for S annot compare, weight
ated for predicates. PAD has lower power
Sumption in du features
Sumption in du fersioner in the count
Province and management in the comments of the comments of the comments of stimulation st o difference NeuroEPG
K123843)* Predicate Not stated Not stated lot state lot state ative humidity: 36 rotektor 3
K093304)* nperature: 10°C Predicate lot stated 60 W 5% .8" x 4.7" x 0.4"
19.9cm x 12cm x 1 cr mperature: 10° to 40
ax 35°C for Tablet ax 35°C for Tablet ax 35°C for supply)
wer supply)
lative Humidity: 30% Proposed
feOp EPAD eadbox:
eadbox: < 2 | ablet: < 1 Ib 24 W Category Power
consumptio Operating
nvironmer Dimension Veigh

ection 4 - Page 5

PAD™ 510(

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feOp Surgical,

PAD™ 510(

ction 4: 510(k) Summ

Discussion of
Differences &
stification for S difference from Prote Trigger in/out not needs
三PAD because EPAD because EPAD o
not support external
stimulators. wer stimulus channels were stimulus No difference No differenc No differenc e BF (IEC 60601-1)
er optic signal link ontinuously
djustable level with
ser selectable level with
taximum range int urrent: 0 to 25 m
oltage: 0 to 50 V Predicate
NeuroEPG
K123843)* onstant curre Not statec lot stated fot stated 2KΩ load es, TTL pulse throu
NC connector be BF (IEC 60601)
parate isolation bo Predicate
rotektor 32
K093304)* onstant currer 0 to 100 mA Up to 16 imulus (for peripheral nerve stimulation modes onl Yes , stimulus and acquisit
th handled via EPAD;
port for external e BF (IEC 60601-11)
Jation amplifiers wit
AD Headbox Proposed
feOp EPAD onstant currer to 100 m/ imulators Jp to 6 (es fety feature Patient isolation Stimulus
intensity levelt Electrocauter
detection rigger in/ou imulus typ Categor Number of
stimulator channels

ction 4 - Page 6

10
9
8
7
6
5
4
3
2
1
0

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EPAD™ 510(k)

SafeOp Surgical, Inc.

.

Section 4: 510(k) Summary

| Category | Proposed<br>SafeOp EPAD™ | Predicate<br>Protektor 32.<br>(K093304)* | Predicate<br>NeuroEPG<br>(K123843)** | Discussion of<br>Differences &<br>Justification for SE |
|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Max voltage | 380 VDC with 3.8 kΩ load<br>impedance | 400 VDC with 4 kΩ load<br>impedance | Not stated | Slightly lower maximum<br>driving voltage but same<br>expected maximum current. |
| Pulse duration<br>(pulse width) | Choose from 0.1, 0.2 or 0.3<br>msec settings | Choose from 0.05,<br>0.1,.0.2, 0.5 and 1.0 msec<br>settings | 10 µsec to 1 msec | EPAD pulse durations are<br>within those offered by<br>predicates, appropriate for<br>EPAD modes. |
| Repetition rate | 0.1 to 50 Hz | 0.3 to 1000 Hz | 0.1 to 100 Hz | EPAD frequencies are within<br>those offered by predicates,<br>appropriate for EPAD<br>modes. |
| Stim output<br>indicator | Yes - Amber LED | Yes - Amber LED | Not stated | No difference |
| Category | Proposed<br>SafeOp EPADTM | Predicate<br>Protektor 32<br>(K093304)* | Predicate<br>NeuroEPG<br>(K123843)** | Discussion of<br>Differences &<br>Justification for SE |
| Waveform Acquisition<br>Number of<br>acquisition<br>channels | Up to 8, 6 currently active | 32 | Not stated | Fewer acquisition channels<br>needed for EPAD due to<br>fewer operating<br>modes/electrodes. |
| Waveform<br>display | Yes | Yes | Yes | No difference |
| Timebase | 2 ms/division to 10<br>ms/division | 0.5 ms/division to 500<br>ms/division | Not stated | Timebase range for EPAD<br>waveforms is within that<br>offered by predicates,<br>appropriate for EPAD<br>modes. |
| Sensitivity | 0.5 µV/division to 20<br>µV/division | 0.1 µV/division to 5<br>mV/division | Not stated | EPAD sensitivity range is<br>within that offered by<br>predicates, appropriate for<br>EPAD modes. |
| Rejection | Independent rejection for<br>each channel plus cautery<br>detection ground lead | Independent rejection for<br>each channel | Yes, artifact rejection<br>threshold of 25 μV | No difference |
| Input<br>Impedance | >50 MΩ | >50 MΩ | Not stated | No difference |
| Common mode<br>rejection ratio<br>(CMRR) | >93 dB | >93 dB | Not stated | No difference |
| Category | Proposed<br>SafeOp EPAD™ | Predicate<br>Protektor 32<br>(K093304)* | Predicate<br>NeuroEPG<br>(K123843)** | Discussion of<br>Differences &<br>Justification for SE |
| Low frequency<br>filter | 0.1 Hz to 500 Hz | 0.1 Hz to 500 Hz | Not stated | No difference |
| High frequency<br>filter | 30 Hz to 3 kHz | 30 Hz to 15 kHz | Not stated | The Protektor is a general<br>purpose device with broad<br>neurological monitoring<br>modes. As such it is<br>capable of acquiring signals<br>using high frequency filters<br>(HFF) up to 15 kHz. The<br>SSEP and NMJ tests of the<br>EPAD only require a HFF of<br>3 kHz. |
| Notch filter | 50 or 60 Hz | 50 or 60 Hz | Not stated | No difference |
| Noise level | < 20nV/√Hz | < 20nV/√Hz | Not stated | No difference |
| Electrodes | | | | |
| Anatomical<br>sites | SSEP: Upper/lower limbs<br>and head/neck | SSEP: Upper/lower limbs<br>and head/neck<br>AEP: Head | SSEP: Upper/lower<br>limbs and head/neck<br>AEP: Head | EPAD electrodes are<br>appropriate for peripheral<br>nerve monitoring |
| Type | Custom cutaneous<br>electrodes for use with<br>EPAD only<br>Single, double and triple<br>electrodes | Any standard surface or<br>needle electrodes with<br>standard lead wire | Custom cutaneous<br>electrodes for use with<br>NeuroEPG only<br>Multiple electrode<br>configurations available | EPAD electrodes meet<br>functional test requirements<br>per AAMI/ANSI EC12:2000:<br>Disposable ECG Electrodes |

. '

. .

Section 4 - Page 7 of 14

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Section 4: 510(k) Summary

、

EPAD™ 510(k)

Section 4 - Page 8 of 14

4-page of

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# Section 4: 510(k) Summary

EPAD™ 510(K)

Section 4 - Page 9 of 14

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feOp Surgical,

ction 4: 510(k) Summ

PAD electrodes meet
Inctional test requirement
er AAMI/ANSI EC1200
isposable ECG Electroni VAD electrodes meet
notional test requirements
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sposable ECG Electronic 9AD electrodes meet
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K123843)* Predicate Not stated lot statec lot stated 6 mm "TouchProof"
pport any standard rotektor 32
K093304)* Predicate Not applicable Not applicab lot applicab wires lon-sterile, single patier
se, disposable afeOp EPAD Proposed comatic three 0.75 mArms/c Wet gel . onductive ge rrent densit Category onnector Sterility

Protektor User and Service Ma

NeuroEPG 510(k) Summary for K123

ection 4 - Page 10 -

PAD™ 510(K

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# Section 4: 510(k) Summary

### 4.9 Discussion of Differences

The key differences between the EPAD and the predicate devices are as follows:

- . The EPAD is used for a limited subset of testing (SSEP NMJ) as compared to the predicate devices that perform these types of tests in addition to others (e.g., auditory and visual evoked potentials). This is the main reason driving the technical differences. However, all of the technical characteristics for EPAD are within those previously cleared for these types of devices.
- . The EPAD System includes an algorithm to detect changes in evoked potential latency and amplitude as compared to baseline and alert the user to check the waveforms for artifact or possible position deficit. This feature is not offered on the predicate devices. However, this does not raise new questions of safety and effectiveness because it is an optional adjunct to standard waveform viewing.
- The EPAD System includes custom electrodes while the Protektor . is labeled for use with off-the-shelf cutaneous electrodes. However, other evoked potential devices have been cleared with custom electrodes, including the named NeuroEPG. The EPAD electrode design is based on well-established principles for cutaneous electrodes and the electrodes meet the requirements of the ANSI/AAMI EC12:2000 standard (Section 5.2.2, Tests for Functionality).

### 4.10 Nonclinical Testing

The following nonclinical testing was conducted to demonstrate the safety and effectiveness of the EPAD System and support substantial equivalence to the predicate devices.

Software verification and validation testing was conducted in accordance with FDA's Guidance on the Content of Premarket Submissions for Software Contained in Medical Devices. The results of this testing demonstrated that all software requirements have been fulfilled and all software hazards have been mitigated. There are no unresolved anomalies in the EPAD software.

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# Section 4: 510(k) Summary

Biocompatibility testing on the patient contacting materials of the EPAD electrodes to the requirements of ISO 10993-1: Biological evaluation of medical devices-Part 1, Evaluation and Testing, demonstrated that the electrodes are safe for short term (<24 hours) contact with intact skin. Specific testing included cytotoxicity, sensitization, and irritation/intracutaneous reactivity.

Accelerated aging testing was conducted on the EPAD electrodes to establish a 15 month shelf life. All tests conducted following the accelerated aging of the electrodes in their final packaging were passed. The testing included the following:

- . Impedance monitoring
- Visual inspection .
- Testing in accordance with section 5.2.2 of ANSI/AAMI . EC12:2000 for Disposable ECG Electrodes:
- 10-Hz AC impedance, individual pair o
- Combined offset instability and internal noise ୍
- DC voltage offset, Bias test
- Electrode Impedance values on forearm .
- Electrode evoked potential responses .

### Electrical Safety and electromaqnetic compatibility testing was

conducted to the following standards. All tests passed with no need for device modifications:

- UL60601-1: Medical Electrical Equipment Part 1: General . Requirements for Safety, 186 ed with revisions through April 2006
- IEC 60601-1-1: Medical Electrical Equipment Part 1-1: General . Requirements for Safety-Collateral Standard: Safety Requirements for Medical Electrical Systems, 200 ed, 2000
- IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General . Requirements for Safety -; Electromagnetic Compatibility -Requirements and Tests, 3rd ed, 2007
- IEC 60601-2-40: Particular Requirements for the Safety of . Electromyographs and Evoked Response Equipment, 1st ed, 1998

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# Section 4: 510(k) Summary

FCC Certification Testing was conducted by the manufacturer of the EPAD Tablet to certify the Bluetooth wireless technology component to the FCC regulations under 47 CFR Part 15. All tests passed.

Functional Performance Testing was conducted by the EPAD system contract manufacturer to validate system performance requirements. All test results met the test protocol acceptance criteria

- EPAD Signal Quality Tests These tests were conducted to . validate the quality of the waveform signals from the Headbox to the Tablet
- Noise level peak to peak on each channel ୍
- CMRR adjustment on each channel o
- Low Frequency Filter on each channel ୍
- High Frequency Filter on each channel ্
- DC offset on each channel ○
- Cross talk between each channel o
- Gain on each channel ੇ
- o Qualification of impedance circuit on each lead of each channel
- Wireless Coexistence Testing To evaluate the EPAD Bluetooth communication performance in the presence of multiple wireless devices all transmitting simultaneously. There was no observed decline in data transmission between the EPAD Headbox and Tablet under the test conditions.
- Alert Algorithm Testing The functionality of the EPAD algorithm . designed to alert the clinician to check the evoked potential waveforms for evidence of possible position deficit was tested under minimal, moderate, and extreme noise conditions. The EPAD was able to detect waveform changes of reduced amplitude (>50%) and increased latency (>10%) under all noise conditions.

### Conclusions Regarding Substantial Equivalence 4.11

The information and testing presented in this 510(k) demonstrate that the EPAD Evoked Potential Assessing Device is safe and effective for its intended use and substantially equivalent to the named predicate devices. The EPAD has the same intended use and substantially equivalent

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# Section 4: 510(k) Summary

indications for use. The main difference between the EPAD and the predicate devices is that the EPAD was designed specifically for peripheral nerve response (somatosensory evoked potential (SSEP)) and neuromuscular junction (NMJ) monitoring, while the predicate devices offer a broader range of monitoring modes, including auditory evoked responses. However, the technical specifications for electrical stimulation and waveform acquisition using the EPAD are within those of the predicate devices based on the publicly available information.

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Image /page/14/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.

Public Health Service

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

January 24, 2014

Safeop Surgical, Inc. c/o Ms. Sheila Hemeon-Heyer 125 Cherry Lane Amherst, MA 01002

Re: K132616

Trade/Device Name: EPAD Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked response clectrical stimulator Regulatory Class: Class II Product Code: GWF. IKN, GXY Dated: December 23, 2013 Received: December 27, 2013

Dear Ms. Hemeon-Heyer:

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 cvaluate 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 cither class II (Special Controls) or class III (PMA), it may be subject to additional controls. Tixisting 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

{15}------------------------------------------------

Page 2 - Ms. Hemeon-Heyer

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practicc 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resources/orYou/Industry/default.htm. 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/ReportalProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sincerely vours.

# 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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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

### 510(k) Number (if known) K132616

### Device Name EPAD

### Indications for Use (Describe)

The EPAD is intended for use in monitoring neurological status by recording somatosensory evoked potentials (SSEP) or assessing the neuromuscular junction (NMJ).

Type of Use (Select one or both, as applicable)

🇿 Prescription Use (Part 21 CFR 801 Subpart D)

[] Over-The-Counter Use (21 CFR 801 Subpart C)

、------ -- -------

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Carlos L. Pena -S 2014.01.24 17:44:37 -05'00'

FORM FDA 3881 (1/14)

1774174741131134146741

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