(20 days)
Not Found
No
The summary does not mention AI, ML, image processing, or any related concepts. The device description focuses on physical characteristics and intended use for intravenous therapy and monitoring.
No
The device is a peripherally inserted central catheter (PICC) used for intravenous therapy, not a therapeutic device itself.
No
The device is a peripherally inserted central catheter (PICC) used for intravenous therapy, power injections of contrast media, central venous pressure monitoring, blood sampling, infusion, or therapy. It is not described as analyzing or interpreting biological signals or images to diagnose a condition.
No
The device description clearly details physical components like catheters with ink markings and different lumen sizes, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for accessing the central venous system for intravenous therapy, power injections, and central venous pressure monitoring. These are all procedures performed on the patient's body, not on samples taken from the patient's body.
- Device Description: The description details a catheter designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LJS
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:
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, *
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)
No clinical tests were performed to determine substantial equivalence. The non-clinical tests demonstrate that the device is equivalent to the performance of currently available Morpheus® CT PICC and Procedure Kit.
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.
K041420, K060887, K070613, K070615
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
§ 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.”
0
510(k) Summarv
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
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:
1
| Catheter
Size | Catheter
Length | CT Flow
Rate | Avg. Static Burst
Pressure
(Occluded Catheter) | Avg. Dynamic Burst
Pressure
(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.
2
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.
3
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
4
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