(34 days)
Not Found
No
The summary describes a mechanical vascular access system and its components. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies focus on mechanical and biological aspects of the device.
Yes
The device is indicated for "vascular access for hemodialysis and apheresis," which are medical treatments designed to directly address and manage health conditions, thus qualifying it as a therapeutic device.
No
This device is a vascular access system used for hemodialysis and apheresis, providing a physical pathway for treatment. It is not described as being used to diagnose conditions or diseases.
No
The device description clearly details physical components like a catheter, port, seal, anchor, and biomaterial, 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 is for "long-term (greater than 30 days) vascular access for hemodialysis and apheresis." This is a therapeutic and access procedure performed directly on a patient, not a test performed on a sample taken from a patient.
- Device Description: The device is described as a "Ported Vascular Access System" that is "inserted percutaneously" into a vein. This is a medical device used for accessing the circulatory system, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (like blood, urine, tissue, etc.) to provide information about a patient's health status, diagnose a condition, or monitor treatment.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body. This device is used in vivo (inside the body) for direct patient care.
N/A
Intended Use / Indications for Use
The DermaPort Ported Vascular Access System (PVAS™) is indicated for long-term (greater than 30 days) vascular access for hemodialysis and apheresis. The system is inserted percutaneously and typically placed in the internal jugular vein of an adult patient. The subclavian vein is an alternate catheter insertion site.
Product codes (comma separated list FDA assigned to the subject device)
MSD
Device Description
The Ported Vascular Access System (PVAS™) has been developed to support central vascular access for hemodialysis and apheresis. This application is for the addition of a 15.5F catheter to the PVAS system and a dilating lead-in to replace the sheath during insertion.
The PVAS port consists of a percutaneous tubular conduit, through which a standard 14.5F or 15.5F polyurethane hemodialysis catheter enters the subcutaneous tunnel. An integral seal surrounds the catheter and prevents microbial migration along the catheter. The PVAS port is enclosed by a silicone anchor that braces the assembly to the skin, and an associated brake holds the catheter in place within the port. A tissue integrating biomaterial surrounds the port, providing anatomical fixation and prevention of microbial migration in a manner analogous to the Dacron cuff of a tunneled catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
internal jugular vein, subclavian vein
Indicated Patient Age Range
adult patient
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)
The design differences were tested to verify the removal of the sheath, addition of dilating lead-in, change in mesh geometry, 15.5 F catheter and new or modified accessories did not impact the function, performance or safety of the device. The performance testing performed to verify these changes consisted of insertion testing, histolopathological analysis of the mesh following implantation in a chronic animal model, biomechanical testing of tissue ingrowth, mesh to port removal force for modified geometry, catheter/port retention testing, microbial ingress and flow versus pressure for new catheter sizes and functional/biocompatibility testing for new accessories. The test methods used to evaluate these changes were equivalent to those applied to the predicate device.
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.
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
§ 876.5540 Blood access device and accessories.
(a)
Identification. A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.(1) The implanted blood access device is a prescription device and consists of various flexible or rigid tubes, such as catheters, or cannulae, which are surgically implanted in appropriate blood vessels, may come through the skin, and are intended to remain in the body for 30 days or more. This generic type of device includes various catheters, shunts, and connectors specifically designed to provide access to blood. Examples include single and double lumen catheters with cuff(s), fully subcutaneous port-catheter systems, and A-V shunt cannulae (with vessel tips). The implanted blood access device may also contain coatings or additives which may provide additional functionality to the device.
(2) The nonimplanted blood access device consists of various flexible or rigid tubes, such as catheters, cannulae or hollow needles, which are inserted into appropriate blood vessels or a vascular graft prosthesis (§§ 870.3450 and 870.3460), and are intended to remain in the body for less than 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle).
(3) Accessories common to either type include the shunt adaptor, cannula clamp, shunt connector, shunt stabilizer, vessel dilator, disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, joint ring, fistula adaptor, and declotting tray (including contents).
(b)
Classification. (1) Class II (special controls) for the implanted blood access device. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided.
(ii) Performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(A) Pressure versus flow rates for both arterial and venous lumens, from the minimum flow rate to the maximum flow rate in 100 milliliter per minute increments, must be established. The fluid and its viscosity used during testing must be stated.
(B) Recirculation rates for both forward and reverse flow configurations must be established, along with the protocol used to perform the assay, which must be provided.
(C) Priming volumes must be established.
(D) Tensile testing of joints and materials must be conducted. The minimum acceptance criteria must be adequate for its intended use.
(E) Air leakage testing and liquid leakage testing must be conducted.
(F) Testing of the repeated clamping of the extensions of the catheter that simulates use over the life of the device must be conducted, and retested for leakage.
(G) Mechanical hemolysis testing must be conducted for new or altered device designs that affect the blood flow pattern.
(H) Chemical tolerance of the device to repeated exposure to commonly used disinfection agents must be established.
(iii) Performance data must demonstrate the sterility of the device.
(iv) Performance data must support the shelf life of the device for continued sterility, package integrity, and functionality over the requested shelf life that must include tensile, repeated clamping, and leakage testing.
(v) Labeling of implanted blood access devices for hemodialysis must include the following:
(A) Labeling must provide arterial and venous pressure versus flow rates, either in tabular or graphical format. The fluid and its viscosity used during testing must be stated.
(B) Labeling must specify the forward and reverse recirculation rates.
(C) Labeling must provide the arterial and venous priming volumes.
(D) Labeling must specify an expiration date.
(E) Labeling must identify any disinfecting agents that cannot be used to clean any components of the device.
(F) Any contraindicated disinfecting agents due to material incompatibility must be identified by printing a warning on the catheter. Alternatively, contraindicated disinfecting agents must be identified by a label affixed to the patient's medical record and with written instructions provided directly to the patient.
(G) Labeling must include a patient implant card.
(H) The labeling must contain comprehensive instructions for the following:
(
1 ) Preparation and insertion of the device, including recommended site of insertion, method of insertion, and a reference on the proper location for tip placement;(
2 ) Proper care and maintenance of the device and device exit site;(
3 ) Removal of the device;(
4 ) Anticoagulation;(
5 ) Management of obstruction and thrombus formation; and(
6 ) Qualifications for clinical providers performing the insertion, maintenance, and removal of the devices.(vi) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices that include subcutaneous ports must include the following:
(A) Labeling must include the recommended type of needle for access as well as detailed instructions for care and maintenance of the port, subcutaneous pocket, and skin overlying the port.
(B) Performance testing must include results on repeated use of the ports that simulates use over the intended life of the device.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(vii) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices with coatings or additives must include the following:
(A) A description and material characterization of the coating or additive material, the purpose of the coating or additive, duration of effectiveness, and how and where the coating is applied.
(B) An identification in the labeling of any coatings or additives and a summary of the results of performance testing for any coating or material with special characteristics, such as decreased thrombus formation or antimicrobial properties.
(C) A Warning Statement in the labeling for potential allergic reactions including anaphylaxis if the coating or additive contains known allergens.
(D) Performance data must demonstrate efficacy of the coating or additive and the duration of effectiveness.
(viii) The following must be included for A-V shunt cannulae (with vessel tips):
(A) The device must comply with Special Controls in paragraphs (b)(1)(i) through (v) of this section with the exception of paragraphs (b)(1)(ii)(B), (b)(1)(ii)(C), (b)(1)(v)(B), and (b)(1)(v)(C), which do not apply.
(B) Labeling must include Warning Statements to address the potential for vascular access steal syndrome, arterial stenosis, arterial thrombosis, and hemorrhage including exsanguination given that the device accesses the arterial circulation.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(2) Class II (performance standards) for the nonimplanted blood access device.
(3) Class II (performance standards) for accessories for both the implanted and the nonimplanted blood access devices not listed in paragraph (b)(4) of this section.
(4) Class I for the cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, and joint ring, accessories for both the implanted and nonimplanted blood access device. The devices subject to this paragraph (b)(4) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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K091760 Page 1 of 2
510(k) Summary
| 510(k) Sponsor: | DermaPort, Inc.
25102 Rye Canyon Loop
Suite 110
Santa Clarita, CA 91355 |
|----------------------|-----------------------------------------------------------------------------------------------------------------|
| Device Name: | PVAS™ Ported Vascular Access System |
| 510(k) Contact: | Jennifer Hessel, Director RA/QA
Phone: (661) 362-7904
Fax: (661) 362-7902
Email: jhessel@dermaport.com |
| Summary Date: | June 10, 2009 |
| Trade Name: | DermaPort Ported Vascular Access System (PVAS™) |
| Common Name: | Hemodialysis Catheter, Implanted |
| Classification Name: | 21 CFR 876.5540 Blood Access Device and Accessories, Class III,
Product Code: MSD |
JUL 20 2009Predicate Device:
510(k) Number: K071202 Manufacture: DermaPort Trade Name: Percutaneous Vascular Access System (PVAS)
1.0 Description of Device
The Ported Vascular Access System (PVAS™) has been developed to support central vascular access for hemodialysis and apheresis. This application is for the addition of a 15.5F catheter to the PVAS system and a dilating lead-in to replace the sheath during insertion.
The PVAS port consists of a percutaneous tubular conduit, through which a standard 14.5F or 15.5F polyurethane hemodialysis catheter enters the subcutaneous tunnel. An integral seal surrounds the catheter and prevents microbial migration along the catheter. The PVAS port is enclosed by a silicone anchor that braces the assembly to the skin, and an associated brake holds the catheter in place within the port. A tissue integrating biomaterial surrounds the port, providing anatomical fixation and prevention of microbial migration in a manner analogous to the Dacron cuff of a tunneled catheter.
1.1 Clinical Application
The clinical application of the DermaPort Ported Vascular Access System and catheter is consistent with clinical applications of the predicate DermaPort Percutaneous Vascular Access System cleared to market by 510(k) K071202.
1
2.0 Intended Use of Device
The indication for use of the PVAS is consistent with the classification of 21 CFR 876.5540 Blood Access Device and Accessories. The indication for use is:
The DermaPort Ported Vascular Access System (PVAS™) is indicated for long-term (greater than 30 days) vascular access for hemodialysis and apheresis. The system is inserted percutaneously and typically placed in the internal jugular vein of an adult patient. The subclavian vein is an alternate catheter insertion site.
3.0 Technological Characteristics
The technical characteristics of the Ported Vascular Access System (PVASTM) are the same as the predicate devices in terms of intended use, insertion method, design, materials, performance, labeling, manufacturing process, and method of sterilization, The modifications include: addition of 15.5F catheters incorporation of dilating lead-in, removal of the sheath, replacement of non-valved dilator with a valved dilator, addition of suture to the kit, and replacement of polycarbonate injection caps with ABS injection caps
4.0 Data Summarv
The design differences were tested to verify the removal of the sheath, addition of dilating lead-in, change in mesh geometry, 15.5 F catheter and new or modified accessories did not impact the function, performance or safety of the device. The performance testing performed to verify these changes consisted of insertion testing, histolopathological analysis of the mesh following implantation in a chronic animal model, biomechanical testing of tissue ingrowth, mesh to port removal force for modified geometry, catheter/port retention testing, microbial ingress and flow versus pressure for new catheter sizes and functional/biocompatibility testing for new accessories. The test methods used to evaluate these changes were equivalent to those applied to the predicate device.
5.0 Conclusions
The modifications to the DermaPort PVAS were evaluated as required by the risk analysis and Design Control requirements. The modified PVAS does not raise new questions of safety or effectiveness.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 200 2009
Ms. Jennifer Hessel Director, Regulatory Affairs and Quality Assurance DermaPort, Inc. 25102 Rye Canyon Loop, Suite 110 SANTA CLARITA CA 91355
Re: K091760
Trade/Device Name: DermaPort Ported Vascular Access System (PVAS) Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: MSD Dated: July 13, 2009 Received: July 15, 2009
Dear Ms. Hessel:
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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit 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 kit. The general controls provisions of the Act include 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 (PMA), it may be subject to 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 - Ms. Jennifer Hessel
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (301) 796-5484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 301-796-6045. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
Herbert Reimer
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known): K09 | 760
Device Name: DermaPort Ported Vascular Access System (PVAS) Indications for Use:
The DermaPort Ported Vascular Access System (PVAS™) is indicated for long-term (greater than 30 days) vascular access for hemodialysis and apheresis. The system is inserted percutaneously and typically placed in the internal jugular vein of an adult patient. The subclavian vein is an alternate catheter insertion site.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K091760
Pile: Special 310(k) PVAS modifications.DOC