(213 days)
Not Found
No
The description focuses on the mechanical components and function of a vascular access system, with no mention of AI or ML capabilities.
Yes
The device is indicated for long-term vascular access for hemodialysis and apheresis, which are medical treatments for kidney failure and blood component separation, respectively. It facilitates these therapeutic procedures.
No
The device is indicated for long-term vascular access for hemodialysis and apheresis, which are treatment procedures, not diagnostic ones.
No
The device description clearly lists multiple hardware components, including an implanted metal port, catheter, guidewire, dilators, needles, and other physical accessories. There is no mention of software as a component of this system.
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 describes a procedure performed on a patient's body for therapeutic purposes (hemodialysis and apheresis), not for examining specimens from the body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The device is a system for facilitating catheter placement and maintaining vascular access. It involves implanted components and procedures performed directly on the patient.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological specimens (blood, urine, tissue, etc.) outside of the body. The components listed are for insertion and maintenance of a catheter within the vascular system.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a medical device used for a therapeutic procedure.
N/A
Intended Use / Indications for Use
The DermaPort Percutaneous Vascular Access System (PVASTM) is indicated for long-term (greater than 30 days) vascular acccss for hemodialysis and apheresis. The system is inserted percutaneously and the catheter is 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 DermaPort Percutaneous Vascular Access System (PVAS) is designed to facilitate catheter placement, reposition, and exchange procedures while maintaining the catheter attachment, bacterial barrier, and fixation functions of the predicate catheter fibrous cuff. The main component of the PVAS is a metal port which is implanted into the subcutaneous tunnel at the catheter exit site on the chest wall. The hemodialysis catheter passes through the metal port which acts as a percutaneous conduit, into the subcutaneous tunnel, and then into the central venous system in the usual fashion. The metal surface of the PVAS port has a porous, tissue integrating coating which allows ingrowth of tissue to anchor the PVAS port. The PVAS port holds the hemodialysis catheter in place.
The DermaPort Percutaneous Vascular Access System (PVAS) consists of the following types of components:
-
- Implanted Hemodialysis 14.5 F Catheter (24 cm, 28 cm or 32 cm lengths)
- Guidewire; 0.038 inch (70 cm or 100 cm lengths) 2.
-
- 16F Tcaraway Set Griplock Hub
-
- 12F Polyethylene Dilator
- ನ್. 14F Polyethylene Dilator
-
- Clear Female Dust Cover
-
- Injection Caps
-
- 18 GA x 2.7" Cyrolite Introducer Needle
-
- Tunneler with Tri ball tip
-
- Tunneler Sleeve
-
- DermaPort Blade
-
- Commercially available alcohol pad
-
- Commercially available adhesive wound dressing
-
- Peel-away Sheath
-
- DermaPort Percutaneous Vascular Access System (PVAS) Port
The catheter is identical to the Hemolilow catheter, with the exception that the fabric cuff on the HemoFlow catheter is omitted.
The Percutancous Vascular Access System (PVAS™) has been developed to support central vascular access for hemodialysis and apheresis. The PVAS port consists of a percutaneous tubular conduit, through which a standard 14.5F 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 fabric cuff of a tunneled catheter.
- DermaPort Percutaneous Vascular Access System (PVAS) Port
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
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 PVAS technical characteristics and construction are substantially equivalent to the predicate device. The difference in construction was qualified with bench and animal testing.
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.
0
ing
510(k) Summary
| Company Name: | DermaPort, Inc.
25102 Rye Canyon Loop
Suite 110
Santa Clarita, CSA 91355 | NOV 30 2007 |
|----------------------|-------------------------------------------------------------------------------------------|-------------|
| Contact: | Buzz Moran, President | |
| Phone: | (661) 362-7900 | |
| Fax: | (661) 362-7902 | |
| Email: | bmoran@dermaport.com | |
| Summary Date: | April 30, 2007 | |
| Trade Name: | DermaPort Percutaneous 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 | |
| Predicate Device(s): | 510(k) Number: K994105
Manufacture: MEDCOMP®
Trade Name: Medcomp Hemo-Flow Catheter | |
510(k) Number: K062901 Manufacture: Med-Conduit Inc. Trade Name: HemoCath II
1.0 Description of Device
The DermaPort Percutaneous Vascular Access System (PVAS) is designed to facilitate catheter placement, reposition, and exchange procedures while maintaining the catheter attachment, bacterial barrier, and fixation functions of the predicate catheter fibrous cuff. The main component of the PVAS is a metal port which is implanted into the subcutaneous tunnel at the catheter exit site on the chest wall. The hemodialysis catheter passes through the metal port which acts as a percutaneous conduit, into the subcutaneous tunnel, and then into the central venous system in the usual fashion. The metal surface of the PVAS port has a porous, tissue integrating coating which allows ingrowth of tissue to anchor the PVAS port. The PVAS port holds the hemodialysis catheter in place.
25102 Rye Canyon Loop, Suite 110, Santa Clarita, CA 91355, Telephone (661) 362-7902
1
The DermaPort Percutaneous Vascular Access System (PVAS) consists of the following types of components:
-
- Implanted Hemodialysis 14.5 F Catheter (24 cm, 28 cm or 32 cm lengths)
- Guidewire; 0.038 inch (70 cm or 100 cm lengths) 2.
-
- 16F Tcaraway Set Griplock Hub
-
- 12F Polyethylene Dilator
- న్. 14F Polyethylene Dilator
-
- Clear Female Dust Cover
-
- Injection Caps
-
- 18 GA x 2.7" Cyrolite Introducer Needle
-
- Tunneler with Tri ball tip
-
- Tunneler Sleeve
-
- DermaPort Blade
-
- Commercially available alcohol pad
-
- Commercially available adhesive wound dressing
-
- Peel-away Sheath
-
- DermaPort Percutaneous Vascular Access System (PVAS) Port
The catheter is identical to the Hemolilow catheter, with the exception that the fabric cuff on the HemoFlow catheter is omitted. The HemoFlow catheter is cleared to market by the FDA via 510(k) number K994105.
The Percutancous Vascular Access System (PVAS™) has been developed to support central vascular access for hemodialysis and apheresis. The PVAS port consists of a percutaneous tubular conduit, through which a standard 14.5F 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 fabric cuff of a tunneled catheter.
2
K 07/1202 Page 3 of 3
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, and the predicate Medcomp Hemo-Flow Catheter. The indication for use is:
The DermaPort Percutaneous Vascular Access System (PVASTM) is indicated for long-term (greater than 30 days) vascular acccss for hemodialysis and apheresis. The system is inserted percutaneously and the catheter is 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 PVAS technical characteristics and construction are substantially equivalent to the predicate device. The difference in construction was qualified with bench and animal testing.
4.0 Conclusions
The DermaPort, Inc. PVAS is substantially equivalent to the predicate device. No new questions of safety or effectiveness are raised.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
NOV 3 0 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Buzz Moran President DermaPort, Inc. 25102 Rye Canyon Loop, Suite 110 SANTA CLARITA CA 91355
Re: K071202
Trade/Device Name: DermaPort Percutaneous Vascular Access System (PVAS™) Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: MSD Dated: November 14, 2007 Received: November 15, 2007
Dear Mr. Moran:
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 (the Act). You may, therefore, market the device, subject to the general controls provisions of 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 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, 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.
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.
4
Page 2 - Mr. Buzz Moran
In addition, we have determined that your device kit contains an alcohol pad which is subject to regulation as a drug.
Our substantially equivalent determination does not apply to the drug component of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug component. For information on applicable Agency requirements for marketing this drug, we suggest you contact:
Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0101
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, please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Herbert Hoover
ncv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): __KOZ/20 Z
Device Name: DermaPort Percutaneous Vascular Access System (PVAS)
Indications for Use:
The DermaPort Percutaneous Vascular Access System (PVAS™) is indicated for long-term (greater than 30 days) vascular access for hemodialysis and apheresis. The system is inscrted percutaneously and the catheter is 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)
Hele Nemen
(Division Sign-Off)
(Div!Sibil of Reproductive, Abdominal and Radiological Nevices 510(k) Number
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