(7 days)
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.
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.
This 510(k) summary (K032754) is for a medical device, the Vortex® MP Peripheral Access System, not a software or AI-powered diagnostic device. Therefore, many of the requested criteria, such as "acceptance criteria," "reported device performance," "sample sizes for test and training sets," "ground truth establishment," "MRMC studies," or "standalone performance," are not applicable in the context of AI/software validation.
The document describes a traditional substantial equivalence determination for a physical medical device. The manufacturer is demonstrating that their new device is as safe and effective as a legally marketed predicate device, not validating a new algorithm or diagnostic tool.
Here's a breakdown of what can be extracted from the provided text, and where the information relevant to AI/software validation is missing or not applicable:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not provide explicit quantitative acceptance criteria or reported performance metrics in the way one would expect for an AI diagnostic study (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device through design evaluation and verification testing.
| Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Safety and effectiveness substantially equivalent to predicate device | "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." |
| Maintains integrity after repeated punctures with a non-coring needle | "titanium configuration with a self sealing silicone septum designed to maintain integrity after repeated punctures with an non-coring needle." |
| Appropriate for indicated peripheral placement and venous access | 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." |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable/not reported in the context of an AI/software validation. The "design verification testing" would involve engineering tests on device prototypes, the specific "sample size" of which is not detailed here.
- Data Provenance: Not applicable. This refers to the testing of a physical device, not patient data in terms of its origin (country, etc.). The testing would have been conducted by the manufacturer (Horizon Medical Products, Inc.).
- Retrospective or Prospective: Not applicable. This refers to experimental design for data collection, not the physical testing of a medical device's components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. Ground truth in this context would relate to the performance of the physical device components during engineering testing, typically assessed against design specifications and industry standards by engineers, not medical experts establishing a diagnostic "ground truth."
- Qualifications of Experts: Not applicable for establishing ground truth in this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. This pertains to resolving disagreements among multiple human readers for diagnostic image interpretation, which is not relevant here.
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:
- MRMC Study: No, an MRMC study was not done. This is exclusively a physical medical device.
- Effect Size of AI Improvement: Not applicable. The device does not incorporate AI for diagnostic or interpretative tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. There is no algorithm to evaluate in a standalone manner.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: For a physical device, "ground truth" would refer to established engineering and material science principles, performance specifications (e.g., septum resealability, material biocompatibility, structural integrity), and comparisons against the predicate device's known characteristics. It's not clinical "ground truth" in the diagnostic sense.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This device is not an AI/ML model that undergoes a "training" phase.
9. How the ground truth for the training set was established:
- How Ground Truth for Training Set was Established: Not applicable.
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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.
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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.
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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 (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)
§ 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.