(168 days)
Not Found
No
The device description and performance studies focus on a physical, implanted titanium guide and its mechanical function, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as an "access device accessory" that "facilitates repeated needle access to the vasculature" for procedures like hemodialysis. It acts as a guide for needles rather than actively treating a condition itself.
No
The device is described as an "access device accessory" that "facilitates repeated needle access to the vasculature" for procedures like "hemodialysis." Its function is to guide needles for accurate cannulation, not to diagnose a condition.
No
The device description explicitly states it is a "single piece of titanium device that is implanted subcutaneously," indicating it is a physical hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The VWING Vascular Needle Guide is described as an implanted titanium device that acts as a guide for needles to access blood vessels for procedures like hemodialysis. It is a physical accessory for needle insertion.
- Intended Use: The intended use is for facilitating needle access to arteriovenous fistulas for hemodialysis. This is a procedure performed directly on the patient's body, not a test performed on a sample outside the body.
The device's function is to aid in a medical procedure performed on the patient, not to analyze a biological sample for diagnostic purposes.
N/A
Intended Use / Indications for Use
The VWING Vascular Needle Guide is indicated for use as an access device accessory on arteriovenous fistulas (AVF) for hemodialysis procedures using a constant site or "buttonhole" method of needle insertion.
Product codes
PFH
Device Description
The VWING vascular needle guide has been designed to facilitate repeated needle access to the vasculature. The VWING vascular needle guide is an accessory for constant site or "buttonhole" method of needle insertion and is indicated for use for patient therapies requiring repeated access to the vascular system. such as hemodialysis. It is a single piece of titanium device that is implanted subcutaneously and attached to the outside of the vasculature, including on arteriovenous fistulae (AVF). The VWING acts as a guide for needles and accommodates currently available 15-17 gage needles to accurately cannulate the targeted vessel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Arteriovenous fistulae (AVF)
Indicated Patient Age Range
Not Found
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
The VWING Vascular Needle Guide was verified and validated according to Vital Access procedures for product design and development. Bench testing was performed to demonstrate equivalence of the subject device to the predicate devices. Biocompatibility testing according to ISO 10993-1 was performed. Sterilization validations were performed in accordance with ISO 11137-2. Packaging validations and ship testing were performed in accordance with ISO 11607-1, ISO 11607-2, ASTM F1980-07, ASTM F2096-11. ASTM F88-09, and ASTM D4169-09 to ensure that sterility is maintained throughout the product's labeled shelf life. MR compatibility testing was performed pre FDA Guidance Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment in accordance with ASTM F2052-06. ASTM F2213-06, ASTM F2119-07, and ASTM F2182-11.
Pre-clinical safety and efficacy testing was conducted by using an animal model. Three individual animal tests were conducted ranging in duration from 5 weeks to 6 months. Throughout these pre-clinical tests, the VWING was evaluated for its ability to safely facilitate access to a vessel for hemodialysis procedures.
A first in human clinical evaluation was conducted in New Zealand to demonstrate the feasibility and safety of the VWING as a method of providing dialysis access to patients with difficult to access fistulas using the buttonhole, or single site, cannulation technique.
The VWING was also evaluated in a prospective, multicenter IDE clinical study (SAVE Trial) to demonstrate safety and effectiveness of the device in providing access to previously uncannulatable segments of arteriovenous fistulae. At the three month primary endpoint follow-up, 96% of examined patients achieved access through a VWING. No new concerns of safety and effectiveness for a long-term vascular access device were observed during the trial. The occurrence rate of safety related events was within expectation and demonstrated the safety of the VWING Vascular Needle Guide. The rates of sepsis and study related serious adverse events were very low relative to standard fistula access: 0.04 and 0.31, respectively. All serious adverse events were resolved in the course of the study, leaving the fistula intact and functional. There were no study related deaths.
Key Metrics
At the three month primary endpoint follow-up, 96% of examined patients achieved access through a VWING. The rates of sepsis and study related serious adverse events were very low relative to standard fistula access: 0.04 and 0.31, respectively.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) SUMMARY
| Submitter: | Vital Access Corporation | |
|---|---|---|
| Submitter's Address: | 2302 S Presidents Drive, Suite C | |
| Salt Lake City, UT 84105 | SEP 1 3 2013 | |
| Submitter's Telephone: | (801)433-9390 | |
| Submitter's Contact: | Christopher Phillips, Director of Quality Assurance | |
| and Regulatory Affairs | ||
| Date 510(k) Summary Prepared: | September 6, 2013 | |
| Proprietary Name: | VWING™ | |
| Common or Usual Name: | Vascular Needle Guide | |
| Classification Name: | Subcutaneous, implanted intravascular infusion port | |
| and catheter | ||
| Classification Reference: | 21 CFR § 876.5540 | |
| Proposed Regulatory Class: | Class II | |
| Proposed Product Code: | ||
| Predicate Devices: | K990803 - Medisystems Corp. Medisystems | |
| Buttonhole Needle Sets | ||
| K926139 - BARD Access Systems, Inc. Cathlink 20 | ||
| Titanium Port w/ Att. Polyurethane Cath |
Device Description:
The VWING vascular needle guide has been designed to facilitate repeated needle access to the vasculature. The VWING vascular needle guide is an accessory for constant site or "buttonhole" method of needle insertion and is indicated for use for patient therapies requiring repeated access to the vascular system. such as hemodialysis. It is a single piece of titanium device that is implanted subcutaneously and attached to the outside of the vasculature, including on arteriovenous fistulae (AVF). The VWING acts as a guide for needles and accommodates currently available 15-17 gage needles to accurately cannulate the targeted vessel.
1
Intended Use / Indications for Use:
The VWING Vascular Needle Guide is indicated for use as an access device accessory on arteriovenous fistulas (AVF) for hemodialysis procedures using a constant site or "buttonhole" method of needle insertion.
Comparison of Technological Characteristics:
| | VWINGTM | Bard Cathlink 20
Implanted Port | Medisystems
Buttonhole Needle Sets |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials | Titanium | Titanium | Stainless Steel |
| Design:
Repeated
Access | The device is designed to
provide long-term
repeated access to the
vascular system. | The device is designed to
provide long-term
repeated access to the
vascular system. | Single Access Event |
| Design:
Implantable | The device is designed to
be implanted
subcutaneously and
attached to the exterior
surface of the target
vessel. | The device is designed to
be implanted
subcutaneously and
attached to the
subcutaneous tissues
surrounding a vessel,
with its catheter dwelling
inside the target vessel. | Not implantable |
| Design:
Needle Guide | The access device has a
semi-circular or round
palpation ridge that leads
into a conical funnel.
aiding in finding the
vessel location and
guiding the needle into
the single vessel
cannulation site to allow
access | Needle is guided into the
port by the funnel shaped
entrance and then into the
needle channel. | Needle |
| Design:
Vessel Entry | The device itself has no
intravascular component.
The device guides a
sharp or buttonhole
needle to the vessel wall
where it may enter the
vessel lumen. The
device allows the needle
to be held at a consistent
angle during treatment by
facilitating a single
vessel access site at the
device and a single skin
insertion site as indicated | The device guides a
needle-catheter to its
funnel opening, after
which the needle's
catheter portion passes
through an angled
pathway and through a
silicone septum, allowing
access to the catheter
which extends into the
accessed vessel. | The needle directly
enters a vessel by
passing through the
skin and subcutaneous
tissue, then through the
vessel wall into the
vessel lumen. |
| | | | |
| | by the Instruction for
Use. | | |
| Design:
Base | The vessel side of the
access device is curved to
match the curvature of
the target vessel, creating
a channel that helps to
immobilize patient's
vasculature for access
during cannulation. | Consists of a titanium
base. Elongated design
with a round funnel
shaped entrance. | N/A |
| Design:
Suture Slots | The device has suture
slots along its sides and
at its front and back to
help to secure the implant
to the vessel wall. | The device has suture
slots that are located
along its sides to help
secure the implant. | N/A |
| Design:
Components | The device is composed
of a titanium funnel and
titanium beads which are
sintered to form a single
piece titanium device. | The device is composed
of a titanium port with a
septum, connected to an
indwelling catheter. | A hollow rigid needle
cannula mounted in a
hub bonded to a
flexible tube and
locking connector that
allows attachment to
other compatible
devices. Different
degrees of needle tip
sharpness are offered.
Sharp versions allow
for the creation of the
scar tunnel or
buttonhole. Duller
versions are used for
repeated access of the
created tunnel. |
| Chemical
Composition | N/A | N/A | N/A |
| Energy Source | N/A | N/A | N/A |
2
K130873
Summary of Performance Testing:
The VWING Vascular Needle Guide was verified and validated according to Vital Access procedures for product design and development. Bench testing was performed to demonstrate equivalence of the subject device to the predicate devices. Biocompatibility testing according to ISO 10993-1 was performed. Sterilization validations were performed in accordance with ISO 11137-2. Packaging validations and ship testing were performed in accordance with ISO 11607-1, ISO 11607-2, ASTM F1980-07, ASTM F2096-11. ASTM F88-09, and ASTM D4169-09 to ensure that sterility is maintained throughout the product's labeled shelf life. MR compatibility testing was performed pre FDA Guidance *Establishing Safety and Compatibility of Passive Implants in the
3
Magnetic Resonance (MR) Environment in accordance with ASTM F2052-06. ASTM F2213-06, ASTM F2119-07, and ASTM F2182-11,
Pre-clinical safety and efficacy testing was conducted by using an animal model. Three individual animal tests were conducted ranging in duration from 5 weeks to 6 months. Throughout these pre-clinical tests, the VWING was evaluated for its ability to safely facilitate access to a vessel for hemodialysis procedures.
A first in human clinical evaluation was conducted in New Zealand to demonstrate the feasibility and safety of the VWING as a method of providing dialysis access to patients with difficult to access fistulas using the buttonhole, or single site, cannulation technique.
The VWING was also evaluated in a prospective, multicenter IDE clinical study (SAVE Trial) to demonstrate safety and effectiveness of the device in providing access to previously uncannulatable segments of arteriovenous fistulae. At the three month primary endpoint follow-up, 96% of examined patients achieved access through a VWING. No new concerns of safety and effectiveness for a long-term vascular access device were observed during the trial. The occurrence rate of safety related events was within expectation and demonstrated the safety of the VWING Vascular Needle Guide. The rates of sepsis and study related serious adverse events were very low relative to standard fistula access: 0.04 and 0.31, respectively. All serious adverse events were resolved in the course of the study, leaving the fistula intact and functional. There were no study related deaths.
Conclusions:
The indications for use for the VWING Vascular Needle Guide is substantially equivalent to the indications for use for the predicate devices. Any differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy. Thus, the VWING Vascular Needle Guide is substantially equivalent to the predicate device.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling a bird or abstract human figure, with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Gb0 Silver Spring, MD 20993-0002
September 13, 2013
Vital Access % Christopher Phillips Director of Quality Assurance and Regulatory Affairs Vital Access Corporation 2302 South Presidents Drive, Suite C Salt Lake City, UT 84120
K130873 Re:
Trade/Device Name: VWINGTM Vascular Needle Guide Regulation Number: 21 CFR 876.5540 Regulation Name: Blood access device and accessories Regulatory Class: Class II Product Code: PFH Dated: August 3. 2013 Received: August 5, 2013
Dear Christopher Phillips,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
5
Page 2 - Christopher Phillips
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 Division of Small Manufacturers, International and Consumer Assistance at its to!l-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K130873
VWINGTM Vascular Needle Guide Device Name: The VWING Vascular Needle Guide is indicated for use as Indications for Use: an access device accessory on arteriovenous fistulas (AVF) for hemodialysis procedures using a constant site or "buttonhole" method of needle insertion.
X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert P. Lerner -S