ANGIODYNAMICS, INC MORPHEUS PICC AND PROCEDURE KIT

K072196 · AngioDynamics, Inc. · LJS · Aug 27, 2007 · General Hospital

Device Facts

• Record ID: K072196
• Device Name: ANGIODYNAMICS, INC MORPHEUS PICC AND PROCEDURE KIT
• Applicant: AngioDynamics, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Aug 27, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AngioDynamics, Inc. Morpheus® CT PICC 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 Story

Morpheus® CT PICC is a percutaneously inserted central catheter for central venous access. Device features 3F-5F single lumen or 5F-7F dual lumen shafts with 1 cm ink markings for length adjustment. Used by clinicians for IV therapy, contrast media power injection, and central venous pressure monitoring. Device provides central venous access; enables high-pressure contrast delivery for CT imaging. Performance validated through static/dynamic burst pressure testing and tip displacement analysis. Benefits include reliable central venous access and compatibility with power injection protocols.

Clinical Evidence

No clinical tests were performed. Substantial equivalence is supported by non-clinical bench testing, including catheter burst (static and dynamic), labeled CT flow rate, CT injection tip whip, and tip displacement testing.

Technological Characteristics

Percutaneous, long-term intravascular catheter. Sizes: 3F-5F (single lumen), 5F-7F (dual lumen). Features 1 cm distal ink markings. Designed for power injection of contrast media. Performance metrics include static burst pressure (217-311 psi) and dynamic burst pressure (611-817 psi).

Indications for Use

Indicated for patients requiring 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 4 French or larger catheter for blood sampling/infusion and 20 gauge 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

• Morpheus PICC and Procedure Kit (K041420, K060887, K070613, K070615)

Submission Summary (Full Text)

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## 510(k) Summarv

K072196

Special 510(k) Premarket Notification: Device Modification Morpheus® CT PICC and Procedure Kit

#### Manufacturer and sponsor of the 510(k):

# AUG 27 2007

AngioDynamics, Inc. 603 Queensbury Avenue Queensbury, New York 12804 Establishment registration number: 1319211 Contact: Teri Juckett, Regulatory Affairs Manager 518-798-1215 x 1142 Phone [phone] fax Date: 16 August 2007

## Device Identification:

| Proprietary Name: | AngioDynamics, Inc. Morpheus® CT PICC and Procedure Kit |
|------------------------|-----------------------------------------------------------------|
| Common Name: | Peripheral Inserted Central Catheter |
| Classification Name: | Percutaneous, Implanted, Long-Term, Intravascular Catheter |
| Classification Number: | 21 CFR §880.5970 |
| Classification Panel: | Division of Anesthesia, General Hospital, Infection Control and |
| | Dental Devices |
| Product Code: | LJS |
| Regulatory Class: | II |

## Legally marketed device to which equivalence is claimed:

AngioDynamics, Inc. Morpheus PICC and Procedure Kit, 510(k) K041420, K060887, K070613, K070615)

## Intended Use / Indications

The AngioDynamics, Inc. Morpheus® CT PICC 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, Inc. Morpheus® PICC and Procedure Kits are currently available in sizes ranging from 3F - 5F Single Lumen and 5F - 7F Dual Lumen Catheters. The catheter shaft has ink markings spaced 1 cm apart. These markings start at the hub and proceed distally to the catheters' tip. The markings provide the physician a guide to use when trimming the catheter to the desired length. The Morpheus® CT PIC Catheter is to be labeled at the following CT Injection Flow Rates:

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| Catheter<br>Size | Catheter<br>Length | CT Flow<br>Rate | Avg. Static Burst<br>Pressure<br>(Occluded Catheter) | Avg. Dynamic Burst<br>Pressure<br>(Unoccluded Catheter) |
|------------------|--------------------|-----------------|------------------------------------------------------|---------------------------------------------------------|
| 3F Single | 65 cm | 1 mL/sec | 311 psi | 742 psi |
| 4F Single | 65 cm | 4 mL/sec | 303 psi | 817 psi |
| 5F Single | 65 cm | 7 mL/sec | 260 psi | * |
| 5F Dual | 65 cm | 5 mL/sec | 217 psi | 611 psi |
| 6F Dual | 65 cm | 7 mL/sec | 262 psi | 620 psi |
| 7D Dual | 65 cm | 8 mL/sec | 260 psi | * |

*Dynamic Burst testing was conducted using an extremely high flow with the distal end open; no burst resulted for these sizes.

#### Substantial Equivalence:

The AngioDynamics, Inc. Morpheus® CT PICC and Procedure Kit has similar indications for use, principles of operation, technological characteristics, and performance testing results as compared to the predicate device supporting a determination of substantial equivalence.

#### Test Data:

The AngioDynamics, Inc. Morpheus® CT PICC and Procedure Kit was subjected to the following tests to assure reliable design and performance under the specified testing parameters:

Catheter Burst (Positive Pressure) Static Catheter Burst (Positive Pressure) Dynamic Labeled CT Flow Rate CT Injection Tip Whip Tip Displacement

#### Summary of the clinical performance data

No clinical tests were performed to determine substantial equivalence.

#### Conclusions drawn from the non-clinical performance data

The non-clinical tests demonstrate that the device is equivalent to the performance of currently available Morpheus® CT PICC and Procedure Kit.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 7 2007

Ms. Teri Juckett Regulatory Affairs Manager AngioDynamics, Incorporated 603 Queensbury Avenue Queensbury, New York 12804

Re: K072196

Trade/Device Name: AngioDynamics, Inc. Morpheus® PICC and Procedure Kit Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: August 6, 2007 Received: August 7, 2007

Dear Ms. Juckett:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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#### Page 2 - Ms. Juckett

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Confidential

## INDICATIONS FOR USE

510(k) Application: Special 510K Device Modification

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

Indications for Use:

The AngioDynamics, Inc. Morpheus® CT PICC 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**
(Per 21 CFR 801.109)

OR

Over-the-Counter Use . . . . .

Please do not write below this line - continue on another page if needed

AngioDynamics Morpheus® PICC and Procedure Kit 510(k) Design History File 336

510(k) Number: K072196