(57 days)
A system is indicated when a patient requires repeated venous access for injection (bolus) or infusion therapy and/or venous blood sampling.
PORT-A-CATH® II Dual-Lumen Low Profile™ Systems are similar in design and function to the current commercially available PORT-A-CATH® II Dual-Lumen Systems. These systems differ from current commercially available PORT-A-CATH® systems in that the portal is dimensionally smaller and a dual-lumen polyurethane catheter is being offered. These systems consist of one low profile dual-lumen portal (titanium/polysulfone), one radiopaque catheter (polyurethane), one catheter connector, one access needle, one blunt needle and one vein pick. Introducer sets and a Fluoro-Free™ system will also be made available.
The provided document describes the 510(k) premarket notification for the PORT-A-CATH® II Dual-Lumen Low Profile™ Systems. This type of filing is for demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness. Therefore, the document focuses on functional testing and biocompatibility to demonstrate that the new device is as safe and effective as existing, legally marketed devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria in a table format with specific thresholds. Instead, the acceptance is based on the device functioning "according to specification" and the materials being "biocompatible," implying general safety and functional equivalence to predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Functional Equivalence to predicate devices in mechanical performance. | "Results of the testing indicated that PORT-A-CATH® II Dual-Lumen Low Profile™ Systems function according to specification." |
| Biocompatibility of all system components. | "Biocompatibility testing was conducted on all system components." "…the materials used in the system are biocompatible." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document states "In-vitro mechanical testing was conducted" and "Biocompatibility testing was conducted," but does not provide details on the number of units tested for these in-vitro studies.
- Data Provenance: The document implies the tests were conducted by the manufacturer, SIMS Deltec, Inc. The data is retrospective for the purpose of the 510(k) submission, as it was generated prior to the submission date. The country of origin for the data is not explicitly stated, but the applicant is based in St. Paul, Minnesota, USA, suggesting the testing was likely performed in the US.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable. The "ground truth" for this medical device, in the context of its 510(k) submission, is its compliance with established engineering specifications and biocompatibility standards, not an expert assessment of clinical images or patient outcomes.
- Qualifications of Experts: Not applicable for establishing ground truth in this submission. The "experts" involved would be the engineers, scientists, and regulatory affairs personnel at SIMS Deltec, Inc. who performed and interpreted the functional and biocompatibility tests.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. This device is not an AI algorithm requiring adjudication of interpretations. The acceptance is based on compliance of physical and material properties with technical specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was it done? No. This type of study is relevant for AI algorithms or diagnostic tools where human interpretation is involved. The PORT-A-CATH® II is an implantable access system, not a diagnostic device.
- Effect Size of Human Readers: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Was it done? No. This is not an AI algorithm. The performance of the device is assessed through engineering tests and material studies, not an algorithm's output.
7. Type of Ground Truth Used:
- Ground Truth: The "ground truth" for this device's acceptance is based on adherence to engineering specifications for functional performance (e.g., flow rates, pressure resistance, structural integrity) and biocompatibility standards (e.g., ISO 10993 series for medical devices). The document references "Guidance on 510(k) Submissions for Implanted Infusion Ports, October 1990," which would outline the specific tests and performance criteria for such devices.
8. Sample Size for the Training Set:
- Sample Size: Not applicable. This is not an AI algorithm. There is no "training set" in the context of the device's design verification and validation for this 510(k) submission.
9. How the Ground Truth for the Training Set was Established:
- How Established: Not applicable. As there is no AI algorithm or training set, this question is not relevant.
{0}------------------------------------------------
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
JAN 2 2 1998
PORT-A-CATH® II Dual-Lumen Low Profile™ Systems
November 25, 1997
GENERAL INFORMATION I.
:
| Applicant's Name and Address: | SIMS Deltec, Inc.1265 Grey Fox RoadSt. Paul, MN 55112 |
|---|---|
| Contact Person: | Lisa StoneManager, Regulatory AffairsTel. (612) 628-7224 |
| Common/Usual Name: | Subcutaneously Implanted Intravascular InfusionPort and Catheter |
| Proprietary Name: | PORT-A-CATH® II Dual-Lumen Low Profile™Implantable Access Systems |
| Equivalence Device Comparison: | PORT-A-CATH® II Dual-Lumen ImplantableAccess Systems(manufactured by SIMS Deltec, Inc.)LifePort® Low Profile Dual Lumen System(manufactured by Strato/Infusaid) |
DEVICE DESCRIPTION IL
PORT-A-CATH® II Dual-Lumen Low Profile™ Systems are similar in design and function to the current commercially available PORT-A-CATH® II Dual-Lumen Systems.
These systems differ from current commercially available PORT-A-CATH® systems in that the portal is dimensionally smaller and a dual-lumen polyurethane catheter is being offered.
These systems consist of one low profile dual-lumen portal (titanium/polysulfone), one radiopaque catheter (polyurethane), one catheter connector, one access needle, one blunt needle and one vein pick. Introducer sets and a Fluoro-Free™ system will also be made available.
{1}------------------------------------------------
INTENDED USE OF DEVICE III.
The PORT-A-CATH® II Dual-Lumen Low Profile™ Systems are indicated when a The I ORT 11 erreated venous access for injection (bolus) or infusion therapy and/or venous blood sampling.
DEVICE COMPARISON IV.
| PORT-A-CATH® IIDual-Lumen LowProfile™ Systems | PORT-A-CATH® IIDual-Lumen Systems | LifePort® Low ProfileDual Lumen System | |
|---|---|---|---|
| MANUFACTURER | SIMS Deltec, Inc. | SIMS Deltec, Inc. | Strato/Infusaid Inc. |
| INDICATION FOR USE | A system is indicated when apatient requires repeatedvenous access for injection(bolus) or infusion therapyand/or venous bloodsampling. | A system is indicated when apatient requires repeatedvenous access for injection(bolus) or infusion therapyand/or venous bloodsampling. | The LifePort system isindicated for patient therapythat requires repeated entryto the vascular system for thedelivery of medications,fluids, nutritional solutionsand blood products or thewithdrawal of venous bloodsamples. |
| PORTAL DIMENSIONS(Nominal) | |||
| HeightBaseSeptum Diameter | 11.0 mm38.7 (L) mm x 23.5 (W) mm9.5 mm | 16.0 mm50.0 (L) mm x 30.0 (W) mm11.4 mm | 10.8 mm40.8 (L) mm x 26.5 (W) mm10.2 mm |
| MATERIALS | |||
| Portal HousingSeptumCatheter | Titanium/PolysulfoneSiliconePolyurethane | Titanium/PolysulfoneSiliconeSilicone | AcetalSiliconePolyurethane |
| CATHETERDIMENSIONS(Nominal) | |||
| I.D. | 1.0 mm/1.0 mm or1.4 mm/1.4 mm | 1.1 mm/1.1 mm | 1.0 mm/1.0mm |
| O.D.Length | 2.2 mm or 3.2 mm76 cm | 3.4 mm76 cm | 2.2 mm76 cm |
{2}------------------------------------------------
SUMMARY OF STUDIES V.
Functional Testing A.
In-vitro mechanical testing was conducted according to the "Guidance on 510(k) Submissions for Implanted Infusion Ports," October 1990.
Biocompatibility testing was conducted on all system components.
B. Clinical Studies
Clinical studies were not deemed necessary regarding PORT-A-CATH® II Dual-Lumen Low Profile™ Systems due to their similarity in materials, design and function to current SIMS Deltec commercially available systems.
C. Conclusions Drawn from the Studies
The results of the testing indicated that PORT-A-CATH® II Dual-Lumen Low Profile™ Systems function according to specification and the materials used in the system are biocompatible. Therefore, these systems are considered acceptable for human use.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 1998
Ms. Lisa Stone Manager, Regulatory Affairs SIMS Deltec, Incorporated 1265 Grey Fox Road St. Paul, Minnesota 55112
K974471 Re : PORT-A-CATH® II Dual-Lumen Low Profile™ Trade Name: Implantable Access Systems Requlatory Class: Unclassified LJT Product Code: November 25, 1997 Dated: November 26, 1997 Received:
Dear Ms. Stone:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions However, you are responsible to determine that of the Act. the medical devices you use as components in the PORT-A-CATH® II Dual-Lumen Low Profile™ Implantable Access Systems have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510 (k) before including these components in your " PORT-A-CATH® II Dual-Lumen Low Profile™ Implantable Access The general controls provisions of the Act include Systems. requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of
{4}------------------------------------------------
Page 2 - Ms. Stone
Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, the Food and Drug Administration (FDA) action. may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
This letter will allow you to begin marketing your device as described in your 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 the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its internet address "dsmo@fdagr.cdrh.fda.gov".
Sincerely yours
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: PORT-A-CATH® II Dual-Lumen Low Profile™ Implantable Access Systems
Indications for Use:
" A system is indicated when a patient requires repeated venous access for injection (bolus) or infusion therapy and/or venous blood sampling."
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patucia Crescenti
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _
Prescription Use (Per 21 CFR 801.109) OR
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
§ 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.