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:

AI/ML Overview

This 510(k) summary describes a special 510(k) premarket notification for a device modification to the AngioDynamics Morpheus® CT PICC and Procedure Kit. This submission focuses on non-clinical performance data (bench testing) to demonstrate substantial equivalence to predicate devices, particularly regarding the ability to withstand specified CT injection flow rates.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly defined by the reported performance metrics of the various catheter sizes, which are then compared to a predicate device or internal standards to ensure reliability and safety for their intended use, particularly for power injections of contrast media. The device must demonstrate sufficient static and dynamic burst pressure resistance for its labeled CT flow rates.

Catheter Size	Catheter Length	Acceptance Criteria (Implied) - Withstand pressure at specified CT Flow Rate	Reported Device Performance (Avg. Static Burst Pressure)	Reported Device Performance (Avg. Dynamic Burst Pressure)	Labeled CT Flow Rate
3F Single	65 cm	Sufficient to allow 1 mL/sec CT Flow	311 psi	742 psi	1 mL/sec
4F Single	65 cm	Sufficient to allow 4 mL/sec CT Flow	303 psi	817 psi	4 mL/sec
5F Single	65 cm	Sufficient to allow 7 mL/sec CT Flow	260 psi	No burst resulted at extremely high flow rates	7 mL/sec
5F Dual	65 cm	Sufficient to allow 5 mL/sec CT Flow	217 psi	611 psi	5 mL/sec
6F Dual	65 cm	Sufficient to allow 7 mL/sec CT Flow	262 psi	620 psi	7 mL/sec
7D Dual	65 cm	Sufficient to allow 8 mL/sec CT Flow	260 psi	No burst resulted at extremely high flow rates	8 mL/sec

Note: The acceptance criteria are implicitly met if the device demonstrates these burst pressures at the indicated flow rates, ensuring safe operation within the specified parameters. The "Acceptance Criteria (Implied)" column indicates the functional requirement that the device is intended to meet.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample size used for each specific test (e.g., number of catheters tested for burst pressure). However, the tests are described as "non-clinical tests" and "bench testing." Therefore, the data provenance is from laboratory tests, not human or patient data. The country of origin for the data is implicitly the United States, given the manufacturer's location and FDA submission. The nature of the data is prospective, as these tests are conducted specifically to evaluate the modified device's performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This submission relies on non-clinical (bench) testing, not on expert evaluation of clinical data or images. The "ground truth" is established through physical measurements and engineering standards.

4. Adjudication Method for the Test Set

Not applicable. As this involves bench testing, there is no adjudication method in the sense of expert review of discrepancies. The results are physical measurements. Quality control procedures and adherence to test protocols would ensure the reliability of the measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is a 510(k) submission for a non-AI medical device (a catheter) and involves non-clinical performance data. Therefore, an MRMC study or AI assistance is irrelevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a 510(k) submission for a non-AI medical device (a catheter). There is no algorithm or standalone performance in the context of AI.

7. The Type of Ground Truth Used

The "ground truth" in this context is the physical performance characteristics of the catheter, specifically its resistance to burst pressure under various flow conditions. This is established through direct, quantifiable physical measurements in a laboratory setting, such as:

Pressure readings (psi): Measured by specialized equipment during static and dynamic burst tests.
Flow rates (mL/sec): Precisely controlled by infusion pumps during testing.
Observation of catheter integrity: Visual confirmation of whether a burst occurs.

This is a form of engineering/performance data ground truth.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is a physical medical device and not an AI/machine learning model. The modification is evaluated through direct performance testing.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI/machine learning model. The product's intended performance is established through engineering design, material selection, and rigorous physical testing.

Summary

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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 518-798-3625 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

Device Description

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CatheterSize	CatheterLength	CT FlowRate	Avg. Static BurstPressure(Occluded Catheter)	Avg. Dynamic BurstPressure(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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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)

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

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.”