MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519

• K Number: K093406
• Device Name: MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519
• Manufacturer: ANGIODYNAMICS, INC.
• Date Cleared: 2010-03-25 ( 143 days)
• Product Code: LJS
• Regulation Number: 880.5970

Intended Use

The AngioDynamics, Inc. Morpheus® SMART PICC CT and Procedure Kit is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injections of contrast media, and allows for central venous pressure monitoring. For blood sampling, infusion, or therapy use a 4 French or larger catheter. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.

Device Description

The AngioDynamics 6F Triple Lumen Morpheus® SMART PICC CT and Procedure Kits device description is as follows: • 6 French outside diameter, reversed tapered shaft design • Catheter usable length is 55 cm • Shaft inner lumen is a triple lumen design • Catheter shaft tubing is marked with depth indicators • The catheter has one power injectable lumen • The product labeling warns against power injection procedures through the two small lumens, which are clearly identified as non CT. • Three extension legs to facilitate injection through each lumen of the catheter shaft.

Predicate Devices

K070615, K060887, K041420, K040446, K031626, K030415, K053501

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical catheter device and its performance characteristics, with no mention of software, algorithms, or AI/ML capabilities.

Therapeutic

No.
A therapeutic device is one that treats a disease or condition. This device is used for intravenous therapy, power injections of contrast media, and central venous pressure monitoring, which are diagnostic or supportive procedures, not standalone treatments.

Diagnostic

No

The device is a peripherally inserted central catheter (PICC) used for intravenous therapy, contrast media injection, and central venous pressure monitoring, which are therapeutic and monitoring functions, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical catheter with specific dimensions, lumens, and materials. The performance studies also focus on physical properties and performance of the catheter hardware. There is no mention of software as the primary or sole component of the device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

• Intended Use: The intended use clearly describes a device used for accessing the central venous system for intravenous therapy, power injections, and pressure monitoring. These are all procedures performed within the patient's body (in vivo).
• Device Description: The description details a catheter designed for insertion into blood vessels.
• Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or compatibility testing.

IVDs are devices used to perform tests on samples taken from the body, not devices inserted into the body for therapeutic or diagnostic procedures performed directly on the patient.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The AngioDynamics 6F Triple Lumen Morpheus® SMART PICC CT and Procedure Kit is intended for short or long term peripheral access to the central venous system for intravenous therapy, power injections of contrast media, and allows for central venous pressure monitoring. For blood sampling, infusion, or therapy use a 4 French or larger catheter. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.

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

LJS

Device Description

The AngioDynamics 6F Triple Lumen Morpheus® SMART PICC CT and Procedure Kits device description is as follows:
• 6 French outside diameter, reversed tapered shaft design
• Catheter usable length is 55 cm
• Shaft inner lumen is a triple lumen design
• Catheter shaft tubing is marked with depth indicators
• The catheter has one power injectable lumen
• The product labeling warns against power injection procedures through the two small lumens, which are clearly identified as non CT.
• Three extension legs to facilitate injection through each lumen of the catheter shaft.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

central venous system

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)

The document includes a "Summary of Verification Activities" which includes various tests performed on the proposed device (Proposed 6F Triple Catheter (K093406)) and compared to predicate devices. The tests include:

• Tip Whip: Pass for both proposed and predicate devices at T=0 and T=1.
• Tip Displacement: Pass for both proposed and predicate devices at T=0 and T=1.
• CT Injection - Catheter Flow Rate: Proposed device acceptance criteria is "Flow Rate = 5mL/sec ± 0.5mL/sec with 95% confidence that 95% of the population meets specification". Predicate device acceptance criteria is "Flow Rate = 3 to 8mL/sec ± 0.5mL/sec (depending on catheter configuration) with 95% confidence that 95% of the population meets specification." No results are listed for this test.
• CT Injection - CT Lumen Integrity: Pass for both proposed and predicate devices at T=0 and T=1.
• Aspiration: Pass for both proposed and predicate devices at T=0 and T=1.
• Gravity Flow Rate: Pass for both proposed and predicate devices at T=0 and T=1.
• Stylet Withdrawal Testing: Pass for both proposed and predicate devices.
• Wire Withdrawal Testing: Pass for both proposed and predicate devices.
• Static Burst: Pass for both proposed and predicate devices.
• Dynamic Burst: Pass for both proposed and predicate devices.
• Tensile Testing (Extension Leg to Natural Color Hub, Non-CT Extension Leg to Trifurcate, CT Extension Leg to Trifurcate, Shaft to Trifurcate, Catheter Shaft (at nominal OD)): All tests passed for both proposed and predicate devices.
• Pressure Monitoring: Pass for both proposed and predicate devices at T=0 and T=1 ("No difference observed between SVS and catheter in mean pressure, systolic pressure and diastolic pressure as compared to predicate devices").
• Natural Frequency: Pass for both proposed and predicate devices at T=0 and T=1 ("The natural frequency must be equal to or greater than the 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.

K070615, K060887, K041420, K040446, K031626, K030415, K053501

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

Not Found

Regulation Number and Section

§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.

(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”

Summary

0

510(k) Summary of Safety and Effectiveness

MAR 2 5 2010

| General

Provisions	Trade Name: AngioDynamics, Inc. Morpheus® SMART PICC CT and Procedure Kit
	Classification Name: Percutaneous, Implanted, Long-Term, Intravascular Catheters 80 LJS
Name of
Predicate
Devices	The following predicate devices have been identified for the 6F Triple Lumen Morpheus®
SMART PICC CT and Procedure Kits:
	Device Name	510(k) Number	Concurrence Date
	AngioDynamics Morpheus® CT PICC
and Procedure Kits	K070615
K060887
K041420
K040446
K031626
K030415	May 04, 2007
April 24, 2006
July 26, 2004
March 05, 2004
June 19, 2003
April 30, 2003
	Bard Access Systems, Inc. 6 Fr TL
PowerPICC® Catheter	K053501	January 13, 2006
Contact Name	Jodi Lynn Frasier
Senior Regulatory Affairs Professional
Access Business Unit
AngioDynamics, Inc
603 Queensbury, NY 12804
[phone] ext 1676
Date Summary
Prepared	March 01, 2010
Classification	Class II
Performance
Standards	No performance standards have been established under Section 514 of the Food, Drug and
Cosmetic Act for Percutaneous, Implanted, Long-Term, Intravascular Catheters.

Continued on next page

Page 3 of 14

.

.

1

| Intended Use
and Device
Description | Biocompatibility | Summary
Comparing
Technological
Modifications |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The AngioDynamics 6F Triple Lumen Morpheus® SMART PICC CT and Procedure Kit is
intended for short or long term peripheral access to the central venous system for intravenous
therapy, power injections of contrast media, and allows for central venous pressure
monitoring. For blood sampling, infusion, or therapy use a 4 French or larger catheter. For
central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or
larger be used. The device is available as a procedural kit with either a Stylet or a Nitinol
Wire. | The 6F Triple Lumen Morpheus® SMART PICC CT and Procedure Kit have been tested for
biocompatibility per ISO 10993. All data demonstrate this device is biocompatible for its
intended use. | The AngioDynamics 6F Triple Lumen Morpheus® SMART PICC CT and Procedure Kits
device description is as follows:
• 6 French outside diameter, reversed tapered shaft design
• Catheter usable length is 55 cm
• Shaft inner lumen is a triple lumen design
• Catheter shaft tubing is marked with depth indicators
• The catheter has one power injectable lumen
• The product labeling warns against power injection procedures through the two small
lumens, which are clearly identified as non CT.
• Three extension legs to facilitate injection through each lumen of the catheter shaft. |

510(k) Summary of Safety and Effectiveness, Continued

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2

510(k) Summary of Safety and Effectiveness. Continued

Summary Comparing Technological Modifications (continued)

The only modifications that were made are as follows:

• . Expand the existing product line to provide a 6F triple lumen catheter shaft. The existing Morpheus® product line currently provides a 6F and 7F Dual lumen catheter design, while
• The catheter shaft is a single durometer material vs. the dual durometer design of the . existing product portfolio. The material is the same base material as the distal end of the currently marketed Morpheus® PICC CT and Procedure Kits, with the exception of the barium loading. The 6F triple device will have a 20% Barium loading which is the same as the proximal end of the currently marketed Morpheus® PICC CT and Procedure Kits.
• An additional extension leg has been added to facilitate injection through the third . lumen of the catheter shaft. The extension leg materials are identical to those of the currently marketed dual lumen Morpheus® PICC CT and Procedure Kits.
• A natural colored luer will be utilized for the third lumen of the catheter. This luer . has identical specifications as those used on the existing Morpheus® PICC CT and Procedure kits and is of the same material. The only difference is the omission of a colorant (red or blue) so that each lumen has a distinctly colored luer for identification purposes.
• Use of a silicone processing aid, for which leave trace amounts may remain on the ● finished device.

3

510(k) Summary of Safety and Effectiveness, Continued

Summary of Verification Activities

The table immediately following outlines the verification/validation activities completed on the proposed device and compares that to the predicate device.

| Test | Proposed Device
Acceptance
Criteria | Proposed 6F
Triple
Catheter
(K093406)
T=0 | Proposed 6F
Triple Catheter
(K093406) T=1 | Predicate
Device
Acceptance
Criteria | AngioDynamics
Morpheus® CT
PICC and
Procedure Kits
(K070615,
K060887,
K041420,
K040446,
K031626,
K030415) T=0 | AngioDynamics
Morpheus® CT
PICC and
Procedure Kits
(K070615,
K060887,
K041420,
K040446,
K031626,
K030415) T=1 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Tip Whip | Tip “whipping” is
defined as the tip
moving from left to
right during an
injection. Tip
whipping must be
less than or equal to
predicate devices | Pass | Pass | Tip
“whipping” is
defined as the
tip moving
from left to
right during
an injection.
Tip whipping
must be less
than or equal
to predicate
devices | Pass | Pass |
| Tip
Displacement | Tip displacement is
defined as the tip
backing-up during
an injection. Tip
displacement must
be less than or
equal to predicate
devices | Pass | Pass | Tip
displacement
is defined as
the tip
backing-up
during an
injection. Tip
displacement
must be less
than or equal
to predicate
devices | Pass | Pass |

4

. .

Summary of Verification Activities (continued)

Test	Proposed Device Acceptance Criteria	Proposed 6F Triple Catheter (K093406) T=0	Proposed 6F Triple Catheter (K093406) T=1	Predicate Device Acceptance Criteria	AngioDynamics Morpheus® CT PICC and Procedure Kits (K070615, K060887, K041420, K040446, K031626, K030415) T=0	AngioDynamics Morpheus® CT PICC and Procedure Kits (K070615, K060887, K041420, K040446, K031626, K030415) T=1
CT Injection - Catheter Flow Rate	Flow Rate = 5mL/sec ± 0.5mL/sec with 95% confidence that 95% of the population meets specification			Flow Rate = 3 to 8mL/sec ± 0.5mL/sec (depending on catheter configuration) with 95% confidence that 95% of the population meets specification
CT Injection - CT Lumen Integrity	CT Lumen must withstand a minimum of 10 injections at a minimum flow rate of 5mL/sec with a 95% confidence that 80% of the population meets specification	Pass	Pass	CT Lumen must withstand a minimum of 10 injections at a minimum flow rate of 3 to 8mL/sec (depending on catheter configuration) with a 95% confidence that 80% of the population meets specification	Pass	Pass

5

| Test
Aspiration | Proposed Device
Acceptance
Criteria | Proposed 6F.
Triple
Catheter
(K093406)
T=0 | Proposed 6F
Triple Catheter,
(K093406) T=1 | Predicate
Device
Acceptance
Criteria | AngioDynamics
Morpheus® CT
PICC and
Procedure Kits
(K070615,
K060887,
K041420,
K040446,
K031626,
K030415) T=0 | AngioDynamics
Morpheus® CT
PICC and
Procedure Kits
(K070615,
K060887,
K041420,
K040446,
K031626,
K030415) T=1 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| | Minimum
aspiration rate to be
3cc/min using a
10cc syringe
without total
collapse (all three
catheter lumens)
with 95%
confidence that
95% of the
population meets
specification | Pass | Pass | Minimum
aspiration rate
to be 3cc/min
using a 10cc
syringe
without total
collapse (all
three catheter
lumens) with
95%
confidence
that 95% of
the
population
meets
specification | Pass | Pass |
| Gravity Flow
Rate | Minimum gravity
flow rate to be 750
ml/hr for CT lumen
and 182 ml/hr for
non-CT lumens
with 95%
confidence that
95% of the
population meets
specification | Pass | Pass | Minimum
gravity flow
rate to be 750
ml/hr for CT
lumen and
182 ml/hr for
non-CT
lumens with
95%
confidence
that 95% of
the
population
meets
specification | Pass | Pass |

6

ﺑ

Summary of Verification Activities (continued)

| Test | Proposed Device
Acceptance
Criteria | Proposed 6F
Triple
Catheter
(K093406) T=0 | Proposed 6F
Triple Catheter
(K093406) T=1 | Predicate
Device
Acceptance
Criteria | AngioDynamics
Morpheus® CT
PICC and
Procedure Kits
(K070615,
K060887,
K041420,
K040446,
K031626,
K030415) T=0 | AngioDynamics
Morpheus® CT
PICC and
Procedure Kits
(K070615,
K060887,
K041420,
K040446,
K031626,
K030415) T=1 |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Stylet
Withdrawal
Testing | Stylet withdrawal
force must be less
than 2 lbs with 95%
confidence that
95% of the
population meets
specification | | | Stylet
withdrawal
force must be
less than 2 lbs
with 95%
confidence
that 95% of
the
population
meets
specification | | |
| | | Pass | Pass | | Pass | Pass |
| Wire
Withdrawal
Testing | Guidewire
withdrawal force
must be less than 2
lbs with 95%
confidence that
95% of the
population meets
specification | | | Guidewire
withdrawal
force must be
less than 2 lbs
with 95%
confidence
that 95% of
the
population
meets
specification | | |
| | | Pass | Pass | | Pass | Pass |
| Static Burst | Catheter burst
pressure must be
greater than 150 psi
with 95%
confidence that
95% of the
population meets
the specification | | | Catheter burst
pressure must
be greater
than 150 psi
with 95%
confidence
that 95% of
the
population
meets the
specification | | |
| | | Pass | Pass | | Pass | Pass |
| Test | Proposed Device
Acceptance
Criteria | Proposed 6F
Triple
Catheter
(K093406)
T=0 | Proposed 6F
Triple Catheter
(K093406) T=1 | Predicate
Device
Acceptance
Criteria | AngioDynamics
Morpheus® CT
PICC and
Procedure Kits
(K070615,
K060887,
K041420,
K040446,
K031626,
K030415) T=0 | AngioDynamics
Morpheus® CT
PICC and
Procedure Kits
(K070615,
K060887,
K041420,
K040446,
K031626,
K030415) T=1 |
| Dynamic Burst | Catheter dynamic
burst pressure must
be greater than 300
psi with 95%
confidence that
95% of the
population meets
specification | | | Catheter
dynamic burst
pressure must
be greater
than 300 psi
with 95%
confidence
that 95% of
the
population
meets
specification | | |
| | | Pass | Pass | | Pass | Pass |
| | | Tensile Testing | | | | |
| Extension Leg to
Natural Color
Hub | Tensile strength
must be greater
than 5 lbs with 95%
confidence that
99% of the
population meets
the specification | | | Tensile
strength must
be greater
than 5 lbs
with 95%
confidence
that 99% of
the population
meets the
specification | | |
| | | Pass | Pass | | Pass | Pass |
| Non- CT
Extension Leg to
Trifurcate | Tensile strength
must be greater
than 5 lbs with 95%
confidence that
99% of the
population meets
the specification | | | Tensile
strength must
be greater
than 5 lbs
with 95%
confidence
that 99% of
the population
meets the
specification | | |
| | | Pass | Pass | | Pass | Pass |
| | | | | | AngioDynamics
Morpheus® CT
PICC and
Procedure Kits
(K070615,
K060887,
K041420,
K040446,
K031626,
K030415) T=0 | AngioDynamics
Morpheus® CT
PICC and
Procedure Kits
(K070615,
K060887,
K041420,
K040446,
K031626,
K030415) T=1 |
| Test | Proposed Device
Acceptance
Criteria | Proposed 6F
Triple
Catheter
(K093406)
T=0 | Proposed 6F
Triple Catheter
(K093406) T=1 | Predicate
Device
Acceptance
Criteria | | |
| CT Extension
Leg to Trifurcate | Tensile strength
must be greater
than 5 lbs with 95%
confidence that
99% of the
population meets
the specification | Pass | Pass | Tensile
strength must
be greater
than 5 lbs
with 95%
confidence
that 99% of
the
population
meets the
specification | Pass | Pass |
| Shaft to
Trifurcate | Tensile strength
must be greater
than 5 lbs with 95%
confidence that
99% of the
population meets
the specification | Pass | Pass | Tensile
strength must
be greater
than 5 lbs
with 95%
confidence
that 99% of
the
population
meets the
specification | Pass | Pass |
| Catheter Shaft
(at nominal OD) | Tensile strength
must be greater
than 5 lbs with 95%
confidence that
99% of the
population meets
the specification | Pass | Pass | Tensile
strength must
be greater
than 5 lbs
with 95%
confidence
that 99% of
the
population
meets the
specification | Pass | Pass |

:

7

8

.

.

9

| Test | Proposed Device
Acceptance
Criteria | Proposed 6F
Triple
Catheter
(K093406)
T=0 | Proposed 6F
Triple Catheter
(K093406) T=1 | Predicate
Device
Acceptance
Criteria | AngioDynamics
Morpheus® CT
PICC and
Procedure Kits
(K070615,
K060887,
K041420,
K040446,
K031626,
K030415) T=0 | AngioDynamics
Morpheus® CT
PICC and
Procedure Kits
(K070615,
K060887,
K041420,
K040446,
K031626,
K030415) T=1 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Pressure
Monitoring | No difference
observed between
SVS and catheter in
mean pressure,
systolic pressure
and diastolic
pressure as
compared to
predicate devices | Pass | Pass | No difference observed
between SVS and catheter
in mean pressure, systolic
pressure and diastolic
pressure as compared to
predicate devices | Pass | Pass |
| Natural
Frequency | The natural
frequency must be
equal to or greater
than the predicate
device | Pass | Pass | The natural frequency
must be equal to or greater
than the predicate device | Pass | Pass |

Summary of Substantial Equivalence

The 6F Triple Lumen Morpheus® SMART PICC CT and Procedure Kit have been tested and compared to the predicate device. All data gathered demonstrate this device is substantially equivalent. No new issues of safety or efficacy have been raised.

10

Additional Information

Material In addition to the previously submitted information, AngioDynamics would like to identify Change an additional change for the device submitted for the pending 510(k) K093406. A suicone material is used as a processing aid which may leave trace amounts on the device. As a result, this MDX silicone should be identified as a material present and included in the 510(k). All testing previously conducted were on units built with this processing ad and as a result representative of the finished device for which we seek marketing clearance. This was an omission in the original submission.

Biocompatibility MDX Silicone, manufactured by Dow is a commonly used medical grade material. Data Extensive biocompatibility testing has previously been conducted. The following page provides written authorization to allow the Food & Drug Administration to access these data for purpose of this submission review.

Page 13 of 14

11

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/11/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

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

MAR 2 5 2010

AngioDynamics, Incorporated Ms. Jodi Lynn Frasier Senior Regulatory Affairs Professional Access Business Unit 603 Queensbury Avenue Queensbury, New York 12804

Re: K093406

Trade/Device Name: Morpheus® SMART PICC CT and Procedure Kit Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: March 1, 2010 Received: March 2, 2010

Dear Ms. Frasier:

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 1 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.

12

Page 2- Ms. Frasier

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 (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/ucm 115809.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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

the for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

13

Section 6

Statement of Indications For Use

INDICATIONS FOR USE

510(k) Application: Special 510K Application

AngioDynamics, Inc. Morpheus® SMART PICC CT and Procedure Kit Device Name:

Indications for Use:

The AngioDynamics, Inc. Morpheus® SMART PICC CT and Procedure Kit is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injections of contrast media, and allows for central venous pressure monitoring. For blood sampling, infusion, or therapy use a 4 French or larger catheter. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.

Prescription Use X (Per 21 CFR 801.109)

OR

Over-the-Counter Use --------

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Jivision of Anesthesiology, General Hospital ifection Control, Dental Devices

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