(15 days)
The Vortex® MP Vascular Access System is indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.
The Vortex® MP Vascular 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 a non-coring needle. The catheter is offered in polyurethane and silicone models. The products are packaged in sterile trays with introduction components.
The provided document is a 510(k) Pre-market Notification for a device modification of the Horizon Medical Products, Inc. Vortex® MP Vascular Access System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets specific performance acceptance criteria through clinical studies as would typically be described for a novel device or AI/ML product.
Therefore, many of the requested categories (such as sample sizes for test sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and large-scale training set details) are not applicable to this type of regulatory submission. The submission focuses on design verification testing to ensure the modified device maintains the same performance and safety profile as its predicate.
Here's an analysis based on the information available:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
Summary: The submission states that the Vortex® MP Vascular Access System was evaluated through HMP risk analysis and qualified through design verification testing following established Design Control procedures. The conclusion is that "No new questions of safety or effectiveness were raised for the Vortex MP Vascular Access System."
This indicates that the "acceptance criteria" were met by demonstrating that the modified device's performance aligns with the predicate device (Horizon Medical Products Vortex® MP Peripheral Access System, K032754) through engineering and design verification tests, rather than a clinical trial with specific performance metrics like sensitivity/specificity often seen in AI/ML device evaluations.
1. Table of Acceptance Criteria and Reported Device Performance
Given this is a 510(k) for a modification and an "equivalent device" claim, explicit acceptance criteria with quantitative performance metrics for a clinical study are not provided in this summary. The "acceptance criteria" are implied to be adherence to design specifications and safety/effectiveness equivalence to the predicate device.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Functional equivalence to predicate device (Vortex® MP Peripheral Access System K032754) | "The subject and predicate devices utilize the identical fundamental scientific technology and are identical in configuration and dimensions. The subject and predicate devices are substantially similar in materials of construction." |
| Safety and Effectiveness maintained after modification | "The Vortex MP Vascular Access System was evaluated through HMP risk analysis and qualified through design verification testing following established Design Control procedures. No new questions of safety or effectiveness were raised for the Vortex MP Vascular Access System." |
| Self-sealing septum integrity after repeated punctures | "The Vortex MP® Port is... designed to maintain integrity after repeated punctures with a non-coring needle." (This is a design feature, its performance likely verified during design testing). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The document refers to "design verification testing," which typically involves engineering bench testing, material testing, and functional testing on a sample of devices, rather than a clinical test set with patient data. The quantity of devices tested is not specified in this summary.
- Data Provenance: Not applicable. No patient data or clinical data provenance is mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. This type of submission does not involve expert adjudication of a test set in the way an AI/ML product would.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No test set requiring adjudication by experts is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is not relevant for a 510(k) general device modification.
6. If a Standalone Study was Done
- Standalone Study: Not applicable. The term "standalone" performance typically refers to the algorithmic performance of an AI system without human interaction. This document describes a physical medical device.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the "design verification testing," the ground truth would be defined by engineering specifications, material standards, and performance benchmarks derived from the predicate device and relevant industry standards. It is not based on "expert consensus, pathology, or outcomes data" in a clinical sense.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. There is no concept of a "training set" for this type of physical device modification submission.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable, as there is no training set.
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Premarket Notification – Special 510(k): Device Modification
Horizon Medical Products, I Horizon Medical Products, Inc. Vortex® MP Vascular Access System
Image /page/0/Picture/2 description: The image shows a handwritten sequence of characters and numbers. The sequence starts with a character that resembles a stylized 'K', followed by the numbers '033473'. The handwriting is somewhat rough, giving the sequence a casual and informal appearance.
510(k) Summary
510(K) SUMMARY [AS REQUIRED BY 21 CFR 807,92(C){
Submitter's Name / Contact Person
| Manufacturer | Contact |
|---|---|
| Horizon Medical Products, Inc. | Scott Moeller |
| One Horizon Way | Director of Quality Assurance and Regulatory Affairs |
| Manchester, Georgia 31816 |
General Information
| Trade Name | Vortex® MP Vascular Access System | |
|---|---|---|
| Common Name | Vascular access port | |
| Classification Name | Classification Number:Classification Panel:Product Code: | Subcutaneous, implanted, intravascular infusion port and catheter21 CFR §880.5965General HospitalLJT |
| Equivalent Device | Horizon Medical Products Vortex® MP Peripheral Access System(K032754) |
Device Description
The Vortex® MP Vascular 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 a non-coring needle. The catheter is offered in polyurethane and silicone models. The products are packaged in sterile trays with introduction components.
Intended Use / Indications
The Vortex® MP Vascular Access System is indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.
Substantial Equivalence Comparison
The subject and predicate devices utilize the identical fundamental scientific technology and are identical in configuration and dimensions. The subject and predicate devices are substantially similar in materials of construction. The Vortex MP Vascular Access System was evaluated through HMP risk analysis and qualified through design verification testing following established Design Control procedures. No new questions of safety or effectiveness were raised for the Vortex MP Vascular Access System.
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Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three stylized human profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 2003
Mr. Scott Moeller Director of Quality Assurance and Regulatory Affairs Horizon Medical Products, Incorporated One Horizon Way Manchester, Georgia 31816
Re: K033473
Trade/Device Name: Modification to Vortex MP Vascular Access Port Regulation Number: 880.5965 Regulation Name: Subcutaneous Implanted Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: October 31, 2003 Received: November 3, 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.
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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 (OS) 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,
Clupis
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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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): _ LO33413
Page 1 of 1
Vortex MP Vascular Access System Device Name:
Indications for Use:
The Vortex® MP Vascular Access System is indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Latica Cuscante
510(k) Number: K053475
§ 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.