(7 days)
Not Found
No
The document describes a standard vascular access system with no mention of AI or ML capabilities in its intended use, device description, or performance studies.
No.
The device facilitates repeated venous access for injection, infusion therapy, and blood sampling, but it does not intrinsically provide therapeutic treatment itself. It's an access system for therapies, not a therapy device.
No
This device is designed for repeated venous access for injection or infusion therapy and/or venous blood sampling, which are therapeutic and collection functions, not diagnostic.
No
The device description clearly states it is comprised of physical components like a vascular access port, catheter, locking mechanism, and introduction components, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for accessing the peripheral venous system for injection, infusion, and blood sampling. This is a direct interaction with the patient's circulatory system for therapeutic and diagnostic purposes, not for testing samples in vitro (outside the body).
- Device Description: The description details components like a vascular access port, catheter, and introduction components, all designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of reagents, assays, or any process for analyzing biological samples in vitro.
IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro to provide information for diagnosis, monitoring, or screening. This device is used in vivo (within the body) to facilitate access to the circulatory system.
N/A
Intended Use / Indications for Use
The Vortex® MP Peripheral Access System is indicated for peripheral placement in the mid-arm, above the antecubital space and well below the subaxillary area, when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.
Product codes
LJT
Device Description
The Vortex® MP Peripheral Access System is a device comprised of a vascular access port, a catheter, locking mechanism and introduction components. The Vortex MP® Port is available in a titanium configuration with a self sealing silicone septum designed to maintain integrity after repeated punctures with an non-coring needle. The catheter is offered in polyurethance and silicone models. The products are packaged in sterile trays with introduction components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mid-arm, above the antecubital space and well below the subaxillary area
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The Vortex® MP Peripheral Access System design was evaluated through HMP risk and qualified through design verification testing following established Design Control procedures.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.
(a)
Identification. A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.
0
K 032754
510(k) Summary
SEP 1 2 2003
510(K) SUMMARY [AS REQUIRED BY 21 CFR 807.92(C)]
Submitter's Name / Contact Person
Manufacturer Horizon Medical Products, Inc. One Horizon Way Manchester, Georgia 31816
Contact Scott Moeller Director of Quality Assurance and Regulatory Affairs
General Information
| Trade Name | Vortex® MP Peripheral Access System | |
|---|---|---|
| Common Name | Vascular access port | |
| Classification Name | Subcutaneous, implanted, intravascular infusion port and catheter | |
| Classification Number: | 21 CFR §880.5965 | |
| Classification Panel: | General Hospital | |
| Product Code: | LJT | |
| Equivalent Device | Horizon Medical Products MicroPort 2 Peripheral Access System (K994196) |
Device Description
The Vortex® MP Peripheral Access System is a device comprised of a vascular access port, a catheter, locking mechanism and introduction components. The Vortex MP® Port is available in a titanium configuration with a self sealing silicone septum designed to maintain integrity after repeated punctures with an non-coring needle. The catheter is offered in polyurethance and silicone models. The products are packaged in sterile trays with introduction components.
Intended Use / Indications
The Vortex® MP Peripheral Access System is indicated for peripheral placement in the mid-arm, above the antecubital space and well below the subaxillary area, when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.
Substantial Equivalence Comparison
The Vortex® MP Peripheral Access System and the predicate MicroPort 2 Peripheral Access System share an identical intended use and fundamental scientific technology. The subject and predicate devices are substantially similar in configuration, dimensions, and materials. The Vortex® MP Peripheral Access System design was evaluated through HMP risk and qualified through design verification testing following established Design Control procedures. No new questions of safety or effectiveness were raised for the Vortex® MP Peripheral Access System.
1
Image /page/1/Picture/1 description: The image is a black and white circular logo. The logo contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. Inside the circle is a symbol that looks like a stylized bird with three curved lines representing its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 2 2003
Mr. Scott Moeller Director of Quality Assurance and Regulatory Affairs Horizon Medical Products, Incorporated One Horizon Way Manchester. Georgia 31816
Re: K032754
Trade/Device Name: Vortex MP Peripheral Assess System Regulation Number: 880.5965 Regulation Name: Subcutaneous Implant Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: September 4, 2003 Received: September 5, 2003
Dear Mr. Moeller:
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.
2
Page 2 - Mr. Moeller
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 (301) 594-4618. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Runner
Susan Runner, DDS, MA Interim 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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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): _ レクタブ54
Page 1 of 1
Device Name: Vortex MP Peripheral Access System
Indications for Use:
The Vortex® MP Peripheral Access System is indicated for peripheral placement in the mid-arm, above the antecubital space and well below the subaxillary area, when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.
Patricia Cuscentz
esthesiology. General Hospital. ontrol Dental D
510(k) Number: K032754
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)