Who is the manufacturer of MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519?

AngioDynamics, Inc. filed the 510(k) submission for MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519 (K093406).

What is the FDA product code for MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519?

LJS. It is classified under 21 CFR 880.5970 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519?

510(k) clearance (submission type: Special).

What are the predicate devices for MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519?

AngioDynamics Morpheus® CT PICC and Procedure Kits (K070615, K060887, K041420, K040446, K031626, K030415); Bard Access Systems, Inc. 6 Fr TL PowerPICC® Catheter (K053501).

Who can help prepare an FDA 510(k) submission like MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519

K093406 · AngioDynamics, Inc. · LJS · Mar 25, 2010 · General Hospital

Device Facts

Record ID	K093406
Device Name	MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519
Applicant	AngioDynamics, Inc.
Product Code	LJS · General Hospital
Decision Date	Mar 25, 2010
Decision	SESE
Submission Type	Special
Regulation	21 CFR 880.5970
Device Class	Class 2
Attributes	Therapeutic

Intended 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. The device is available as a procedural kit with either a Stylet or a Nitinol Wire.

Device Story

The Morpheus® SMART PICC is a 6F triple-lumen, peripherally inserted central catheter (PICC) designed for central venous access. It features a reversed tapered shaft (55 cm length) with depth indicators and three extension legs. One lumen is designated for power injection of contrast media; the other two are non-CT lumens. The device is supplied in a procedure kit with either a stylet or nitinol wire. It is used by clinicians in clinical settings to facilitate intravenous therapy, contrast media delivery, and pressure monitoring. The device is placed peripherally to access the central venous system. The output is the delivery of fluids/contrast or the transmission of pressure signals for monitoring. The device benefits patients by providing reliable, long-term venous access while enabling high-flow power injections for CT imaging.

Clinical Evidence

Bench testing only. No clinical data presented. Verification activities included tip whip, tip displacement, CT injection flow rate, CT lumen integrity, aspiration rates, gravity flow rates, stylet/wire withdrawal force, static/dynamic burst pressure, and tensile strength testing. All tests met acceptance criteria comparable to predicate devices.

Technological Characteristics

6F triple-lumen PICC, 55 cm length. Materials include medical-grade silicone (MDX processing aid) and barium sulfate (20% loading). Features reversed tapered shaft, depth markings, and three extension legs. Connectivity: None (mechanical device). Sterilization: Not specified. Software: None.

Indications for Use

Indicated for short or long-term peripheral access to the central venous system for IV therapy, power injection of contrast media, and central venous pressure monitoring. Requires 4F or larger catheter for blood sampling/infusion/therapy and 20G or larger lumen for pressure monitoring.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”

Predicate Devices

AngioDynamics Morpheus® CT PICC and Procedure Kits (K070615, K060887, K041420, K040446, K031626, K030415)
Bard Access Systems, Inc. 6 Fr TL PowerPICC® Catheter (K053501)

Related Devices

K072196 — ANGIODYNAMICS, INC MORPHEUS PICC AND PROCEDURE KIT · AngioDynamics, Inc. · Aug 27, 2007
K070613 — ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT · AngioDynamics, Inc. · Jun 29, 2007
K041420 — ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT · AngioDynamics, Inc. · Jul 26, 2004
K070615 — ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT · AngioDynamics, Inc. · May 4, 2007
K080604 — PRESSURE INJFECTABLE PICC · Arrow International, Inc. · Jun 27, 2008

Submission Summary (Full Text)

{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 (518) 798-1215 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 act Listan 1- Post ----------------------------------------------------------------------------------------------------------------------------------------------------------------------AMET Lien Chare Charl (1) --------------------------------------------------------------------------------------------------------------------------------------------------------------CT Lump Host (Bea) (2) ---- P 【的空】一 (4) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ a Ba wen.CT Lunn 17744 (13) a -------(s) Hant Tri (i) ું ઉદ્ય {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 (800) 638-2041 or (301) 796-7100 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 -------- Please do not write below this line - continue on another page if needed Concurrence of CDRH, Office of Device Evaluation (ODE) Concurre Division Sign-Off) Jivision of Anesthesiology, General Hospital ifection Control, Dental Devices 10(k) Number: K093406 Page 20 of 48

MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

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MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

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