Predicate Devices

MEDRAD Mark 7 Arterion Injection System K113133, K112086

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on software control for user-programmed injections and a hand controller for variable flow, with no mention of AI or ML terms or functionalities.

Therapeutic

No.
The device is used to inject contrast medium for diagnostic imaging (angiographic studies), not for treating a disease or condition.

Diagnostic

No

The device is an injector system used to administer contrast medium for angiographic studies, which are imaging procedures. It facilitates the imaging process by enabling the visualization of structures, but it does not directly analyze or interpret the images to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "software-controlled medical device" and describes physical components like an injector head, disposable syringes, and a hand controller, indicating it is a hardware system with software control, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided text, the MEDRAD Mark 7 Arterion Injection System is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for "injecting contrast medium and common flushing solutions into humans for angiographic studies." This describes a procedure performed on a living human, not a test performed on a sample taken from a human.
Device Description: The description details a system for injecting substances into a patient, including a syringe, injector head, and hand controller. This aligns with an in-vivo medical device, not an in-vitro diagnostic device.
Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances within those samples
- Providing information for diagnosis, monitoring, or treatment based on sample analysis.

In summary, the MEDRAD Mark 7 Arterion Injection System is a device used for administering substances directly into a patient for imaging purposes, which is the definition of an in-vivo medical device, not an in-vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The MEDRAD Mark 7 Arterion Injection System is intended to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.

The MEDRAD Mark 7 Arterion Syringe, Quick Fill Tube and other MEDRAD supplied disposables are specifically intended for single use only with the MEDRAD Mark 7 Arterion Injection System for angiographic studies.

The MEDRAD Twist & Go Syringe, Quick Fill Tube and other MEDRAD supplied disposables are specifically intended for single use only with the MEDRAD Mark 7 Arterion Injection System for angiographic studies.

Product codes (comma separated list FDA assigned to the subject device)

DXT

Device Description

The MEDRAD Mark 7 Arterion Injector is a software-controlled medical device used to inject contrast agents from a 150 ml disposable syringe. Commonly referred to as an automated injection system, it is designed to allow a user to fill a disposable syringe and perform an injection with a user-programmed volume and flow rate.

For the Mark 7 Arterion Injector System, the MEDRAD VFlow Hand Controller is provided sterile for single patient use only. The hand controller provides the operator the ability to precisely control and instantaneously adjust variable flow rates of contrast during contrast injection and puffing operations.

When the injector is in the variable rate injection mode, the flow rate increases incrementally as the hand controller plunger is depressed, and decreases as the hand controller is released. In the fixed rate injection mode, the hand controller acts as a start switch, and release of the device ceases all flow. The VFlow Hand Controller requires the same amount of force to depress the plunger regardless of the set flow rate, volume, and pressure limit or the viscosity of the delivered contrast media. Additionally, the VFlow Hand Controller allows the clinician to step away from the radiation source during an injection.

The Twist & Go Syringe function is the same as the Mark 7 Arterion Syringe. The syringes are both supplied sterile and are designed to be loaded into the automated injector head from the front of the injector (front loading). The clear polycarbonate material used in both syringes improves visualization of residual air compared to opaque polypropylene. The Twist & Go Syringe enables single-handed attachment of the Twist & Go High Pressure Connector Tubing to the syringe.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

Bench and laboratory testing were performed to support a determination of substantial equivalence to the predicate devices. Results from the testing provide assurance that the proposed devices conform to the requirements for their intended use. This included the following testing:

Performance
Safety
EMC
Package Integrity
Environmental
Pressure, burst, wet friction testing (syringe)
System level testing with a MEDRAD automated injector (syringe)

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.

MEDRAD Mark 7 Arterion Injection System K113133, K112086

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

Regulation Number and Section

§ 870.1650 Angiographic injector and syringe.

(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Summary

0

Image /page/0/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" arranged in a cross shape, with the letters "B", "A", "Y", "E", and "R" forming the arms of the cross. The entire logo is enclosed within a double-lined circle.

MEDRAD, INC.

(412) 767-2400

www.ri.bayer.com

U.S.A.

One Medrad Drive

Indianola, PA 15051

K132928
JAN 23 2014

510(k) Summary

Submitter:

MEDRAD, Inc. / Bayer Medical Care, Inc. One Medrad Drive Indianola, PA 15051

Contact Person:

Lisa A. Ewing Principal Regulatory Affairs Specialist Phone: (412) 406-3780 Fax: (412) 406-4052 Email: lisa.ewing@bayer.com

Date Prepared:

Device Trade Name:

Common Name:

Classification Name:

Product Code:

Classification:

Predicate Device(s):

September 16, 2013

MEDRAD Mark 7 Arterion Injection System MEDRAD Mark 7 Arterion Syringe MEDRAD Twist & Go Syringe

Angiographic Injector and Syringe

Injector and Syringe, Angiographic [21 CFR 870.1650]

DXT

Class II

The subject devices are equivalent to the following devices: MEDRAD Mark 7 Arterion Injection System K113133, December 15, 2011 O

K112086, October 14, 2011 o

1

Image /page/1/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" stacked vertically inside of a circle. The letters are bolded and in a sans-serif font. The circle has a double-line border.

Device Description:

MEDRAD Mark 7 Arterion Injector

The MEDRAD Mark 7 Arterion Injector is a software-controlled medical device used to inject contrast agents from a 150 ml disposable syringe. Commonly referred to as an automated injection system, it is designed to allow a user to fill a disposable syringe and perform an injection with a user-programmed volume and flow rate.

MEDRAD VFlow Hand Controller

For the Mark 7 Arterion Injector System, the MEDRAD VFlow Hand Controller is provided sterile for single patient use only. The hand controller provides the operator the ability to precisely control and instantaneously adjust variable flow rates of contrast during contrast injection and puffing operations.

When the injector is in the variable rate injection mode, the flow rate increases incrementally as the hand controller plunger is depressed, and decreases as the hand controller is released. In the fixed rate injection mode, the hand controller acts as a start switch, and release of the device ceases all flow. The VFlow Hand Controller requires the same amount of force to depress the plunger regardless of the set flow rate, volume, and pressure limit or the viscosity of the delivered contrast media. Additionally, the VFlow Hand Controller allows the clinician to step away from the radiation source during an injection.

2

Image /page/2/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" written twice, once horizontally and once vertically, intersecting at the "Y" to form a cross shape. The logo is enclosed within a circle.

Mark 7 Arterion Syringe and Twist & Go Syringe

The Twist & Go Syringe function is the same as the Mark 7 Arterion Syringe. The syringes are both supplied sterile and are designed to be loaded into the automated injector head from the front of the injector (front loading). The clear polycarbonate material used in both syringes improves visualization of residual air compared to opaque polypropylene. The Twist & Go Syringe enables single-handed attachment of the Twist & Go High Pressure Connector Tubing to the syringe.

The MEDRAD Mark 7 Arterion Injection System is intended to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.

The MEDRAD Mark 7 Arterion Syringe, Quick Fill Tube and other MEDRAD supplied disposables are specifically intended for single use only with the MEDRAD Mark 7 Arterion Injection System for angiographic studies.

The MEDRAD Twist & Go Syringe, Quick Fill Tube and other MEDRAD supplied disposables are specifically intended for single use only with the MEDRAD Mark 7 Arterion Injection System for angiographic studies.

Intended Use:

3

Image /page/3/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" arranged vertically in a circle. The letters are stacked on top of each other, with the "A" in the center. The logo is black and white.

Comparison to Predicate:

Design changes were made to the predicate device which included: updating injector software to include a new variable flow rate option, adding a variable flow rate ("VFIow") hand controller and adding a new configuration of the Arterion Syringe, which is called the Twist and Go Syringe.

Performance Data:

Bench and laboratory testing were performed to support a determination of substantial equivalence to the predicate devices. Results from the testing provide assurance that the proposed devices conform to the requirements for their intended use. This included the following testing:

. Pérformance
Safety .
EMC .
. Package Integrity
Environmental .
. Pressure, burst, wet friction testing (syringe)
System level testing with a MEDRAD . automated injector (syringe)

4

Comparison Tables

.

Table 1. Comparison of Features in MEDRAD Mark 7 Arterion Injection System (predicate) and the modified MEDRAD Mark 7 Arterion Injection System (proposed).

| Specification /
Feature | Predicate Device:
MEDRAD Mark 7
Arterion Injection
System (K113133) | Proposed Device:
MEDRAD Mark 7
Arterion Injection
System | Rationale for
Change |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use /
Intended Use | The MEDRAD Mark
7 Arterion Injection
System is intended
to be used
specifically for the
purposes of injecting
contrast medium and
common flushing
solutions into
humans for
angiographic studies. | The MEDRAD Mark
7 Arterion Injection
System is intended
to be used
specifically for the
purposes of injecting
contrast medium and
common flushing
solutions into
humans for
angiographic studies. | No change. |
| Fill Volume | 1 - 150 ml in 1 ml
increments | 1 - 150 ml in 1 ml
increments | No change. |
| Fill Speed (user
configurable for
AutoFill) | 1 - 10 ml/sec | 1 - 10 ml/sec | No change. |
| Fill Speed (manual
control by user) | 1 - 20 ml/sec | 1 - 20 ml/sec | No change. |
| Fixed Flow Rate | 0.1 to 45.0 ml/sec in
0.1 ml increments
(single and phased
protocols)
0.1 to 59.9 ml/min in
0.1 ml/min
increments (single
ml/min protocol) | 0.1 to 45.0 ml/sec in
0.1 ml increments
(Single and Phased
protocols)
0.1 to 59.9 ml/min in
0.1 ml/min
increments (ml/m
protocol) | No change. |
| Variable Flow Rate | N/A - not available | Variable: 1.0 - 10.0
ml/sec in 0.1 ml/sec
increments | Variable Flow Rate
is being added as an
additional, optional
feature to inject a
set volume of
contrast at a flow
rate determined by
the hand controller. |
| Flow Rate Rise Time | 0.0 to 9.9 seconds in
0.1sec increments | 0.0 to 9.9 seconds in
0.1 sec increments | No change. |
| Delay Time | 0.0-99.9 seconds in
0.1 sec increments | 0.0-99.9 seconds in
0.1 sec increments | No change. |
| Pressure Limit (150
ml syringe) | 100-1200 psi or 689-
8273 kPa in
increments of 1 psi
(kPa) | 100-1200 psi or 689-
8273 kPa in
increments of 1 psi
(kPa) | No change. |
| | | | |
| Syringe Heat
Maintainer | $35°C ± 5°C$ | $35°C ± 5°C$ | No change. |
| Protocol Memory | 40 Protocols | 40 Protocols | No change. |
| Injection History
Memory | 50 Injections | 50 Injections | No change. |
| Information Display | Color LCD | Color LCD | No change. |
| Programming Keys | Software generated
via an LCD touch
screen | Software generated
via an LCD touch
screen | No change. |
| Touch Screen | Yes | Yes | No change. |
| Multi-Phase | 4 phases per
protocol | 4 phases per
protocol | No change. |
| Arming Modes | Single and Multi
arming modes | Single and Multi
arming modes | No change. |
| Syringe System | Single (150 ml)
syringe | Single (150 ml)
syringe | No change. |
| Manual Retract
Control | Yes | Yes | No change. |
| Check for Air Control | Yes | Yes | No change. |
| Variable Flow Option | No | Yes | Variable Flow Rate
is being offered as
an additional,
optional feature to
inject a set volume
of contrast at a flow
rate determined by
the hand controller. |
| Hand Switch
(start switch) | Yes | Yes | No change. |
| Foot Switch
(start switch) | Yes | Yes | No change. |
| Variable Flow Hand
Controller | No | Yes | Hand controller is
being offered as an
additional, optional
accessory for use
with the new
variable flow rate
software feature. |
| Splash Guard | Yes | Yes | No change. |
| Wiper Seal | Yes | Optional | Wiper seal is a
redundant feature
and is not a required |

5

Image /page/5/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" arranged vertically in a circle. The letters are in a bold, sans-serif font and are black. The circle is also black and has a thin outline.

.

:

·

6

.

100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

Image /page/6/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" arranged vertically inside of a circle. The letters are in a bold, sans-serif font and are black in color. The circle is also black and has a slightly textured appearance.

Table 2. Comparison of Features in MEDRAD Mark 7 Arterion Syringe (predicate), MEDRAD Mark 7 Arterion Syringe (proposed) and the MEDRAD Twist & Go Syringe (proposed).

. . . .

| | Component / Feature | Predicate Device:
MEDRAD Mark 7
Arterion Syringe
(K112086, K113133) | Proposed Device:
MEDRAD Mark 7
Arterion Syringe | Proposed Device:
MEDRAD Twist &
Go Syringe | Rationale for Change |
|----------|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Labeling | Intended Use | The MEDRAD Mark 7
Arterion Syringe, Quick
Fill Tube and other
MEDRAD supplied
disposables are
specifically intended for
single use only with the
MEDRAD Mark 7
Arterion Injection
System in the x-ray
angiography
environment. | The MEDRAD Mark 7
Arterion Syringe,
Quick Fill Tube and
other MEDRAD
supplied disposables
are specifically
intended for single use
only with the
MEDRAD Mark 7
Arterion Injection
System for
angiographic studies. | The MEDRAD Twist
& Go Syringe, Quick
Fill Tube and other
MEDRAD supplied
disposables are
specifically intended
for single use only
with the MEDRAD
Mark 7 Arterion
Injection System for
angiographic studies. | No change in intended
use, only updated syringe
product name. |
| | Syringe Volume | 150 mL | 150 mL | 150 mL | No change. |
| | Syringe Length | 8.61 inches | 8.61 inches | 8.61 inches | No change. |
| | Barrel OD | 1.81 inches | 1.81 inches | 1.81 inches | No change. |
| | Barrel ID | 1.60 inches | 1.60 inches | 1.60 inches | No change. |
| | FasTurn Nut at
Syringe Tip | Yes | Yes | No | FasTurn Nut is not
required for Twist & Go
connection |
| | Construction | Dust Cover | Yes (sized to fit syringe
tip with FasTurn nut) | Yes (sized to fit
syringe tip with
FasTurn nut) | Yes (sized to fit
syringe tip without
FasTurn nut) |
| | | Tubing Set
Compatibility | Connects to female luer
on high pressure
connector tubing | Connects to female
luer on high pressure
connector tubing | Connects to Twist &
Go luer connector on
the MEDRAD Twist &
Go High Pressure
Connector Tubing |
| | | Detents | Yes, molded in to
syringe tip | Yes, molded in to
syringe tip | No |

:

7

Image /page/7/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" arranged vertically inside a circle. The letters are stacked on top of each other, with the "A" in the middle being slightly larger than the other letters.

Materials	Syringe Barrel	Polycarbonate	Polycarbonate	Polycarbonate	No change.
	Syringe Barrel ID.
Coating	Silicone	Silicone	Silicone	No change.
	Plunger	Polycarbonate	Polycarbonate	Polycarbonate	No change.
	Plunger Rubber Cover	Polyisoprene	Polyisoprene	Polyisoprene	No change.
	Plunger Coating	Silicone	Silicone	Silicone	No change.
	FasTurn Nut	Polycarbonate	Polycarbonate	N/A	FasTurn Nut is not
required for Twist & Go
connection

Packaging	Dust Cover	Polypropylene	Polypropylene	Polypropylene	No change.
	Type	Tyvek lid covering
polystyrene tray	Tyvek lid covering
polystyrene tray	Tyvek lid covering
polystyrene tray	No change.

Biological	Sterilization	E-beam radiation	Gamma radiation	Gamma radiation	Updated mode of
sterilization; SAL is
unchanged.
	Sterility Assurance
Level (SAL)	10-6	10-6	10-6	No change.
	Shelf Life	2 years	2 years	2 years	No change.
	Pyrogenicity	Non-Pyrogenic Fluid
Path	Non-Pyrogenic Fluid
Path	Non-Pyrogenic Fluid
Path	No change.
	Latex content	Not made with natural
rubber latex	Not made with natural
rubber latex	Not made with
natural rubber latex	No change.
	Performance	Pressure rating	1200 psi	1200 psi	1200 psi

Conclusion:

MEDRAD considers the MEDRAD Mark 7 Arterion Injection System, Mark 7 Arterion Syringe and Twist & Go Syringe to be substantially equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in functional design, materials, indications for use, fundamental scientific technology, and principles of operation.

8

Image /page/8/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The words are arranged on a single line and are centered horizontally.

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

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

January 23, 2014

MEDRAD, Inc. C/O Ms. Lisa A. Ewing Principal Regulatory Affairs Specialist One Medrad Drive Indianola, PA 1505 I

Re: K132928

Trade/Device Name: MEDRAD Mark 7 Arterion Injection System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: II Product Code: DXT Dated: December 23, 2013 Received: December 24, 2013

Dear Ms. Ewing:

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

9

Page 2 - Ms. Lisa A. Ewing

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 (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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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/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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

10

Indications for Use Statement

510(k) Number:

K132928

Device Name:

MEDRAD Mark 7 Arterion Injection System MEDRAD Mark 7 Arterion Syringe MEDRAD Twist & Go Syringe

Indications for Use:

The MEDRAD Mark 7 Arterion Injection System is intended to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.

The MEDRAD Mark 7 Arterion Syringe, Quick Fill Tube and other MEDRAD supplied disposables are specifically intended for single use only with the MEDRAD Mark 7 Arterion Injection System for angiographic studies.

The MEDRAD Twist & Go Syringe, Quick Fill Tube and other MEDRAD supplied disposables are specifically intended for single use only with the MEDRAD Mark 7 Arterion Injection System for angiographic studies.

Prescription Use 2 (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)

M.A. Hillerman

Page 1 of 1