(90 days)
No
The device description and intended use describe a physical medical device (needles and tubing) for dialysis access, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is used for intravenous injection and connection with dialysis blood lines to transport blood, not to provide therapy itself. It is a blood access device.
No
The device, Arterial Venous Fistula Needles, is described for the purpose of transporting blood during dialysis, which is a therapeutic function, not a diagnostic one. No diagnostic indications are mentioned in the "Intended Use / Indications for Use" section.
No
The device description clearly outlines physical components made of materials like PVC, stainless steel, POM, PC, and PP, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for transporting blood to and from a dialyzer during dialysis. This is a direct interaction with the patient's circulatory system for a therapeutic procedure (dialysis), not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a needle and tubing system for accessing blood vessels. This aligns with a medical device used for direct patient intervention, not for laboratory testing of samples.
- Lack of IVD Characteristics: There is no mention of reagents, calibrators, controls, or any other components typically associated with in vitro diagnostic tests. The device is designed to facilitate blood flow, not to analyze blood components.
- Regulation: The device is described as being regulated under 21 CFR 876.5540, which is for "Blood access device and accessories (nonimplanted)". This classification is for devices used in procedures involving blood access, not for in vitro diagnostic tests.
In summary, the device's function is to provide vascular access for dialysis, which is a therapeutic procedure performed on the patient, not an in vitro diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The AVF sets are intended to be used for intravenous injection and connection with dialysis blood lines to transport blood from the artery of the patient to the dialyzer and transport blood after dialysis to the vein of the patient.
Product codes
78 FIE
Device Description
Arterial Venous Fistula Needles are described in blood access device and accessories (nonimplanted) 21 CFR 876.5540 The Disposable Arterial Venous Fistula Needles that we intend to market include 1 type of design: fixed wing. It is offered with or without a clamp. The device consists of a winged needle (14 - 17 gauge) connected to polyvinylchoride AVF tubing which is connected to a AVF luer connector. Needles with a hole (back eye type) and without a hole are available as well and are both 1 inch and 1¼ inches in length. Tubing is available in lengths of 300 mm. The materials used for the components include: polyvinylchloride (PVC), stainless steel (SS), polyoxymethylene (POM), polycarbonate (PC) and polypropylene (PP).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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Image /page/0/Picture/2 description: The image shows the logo for Nipro. The logo consists of a stylized, intertwined ribbon-like symbol on the left, followed by the word "NIPRO" in bold, sans-serif font. The entire logo is in black against a white background.
0877 N.W. 33rd Stree liami. Florida 33172 Fax: (305) 599-8454
SUMMARY OF SAFETY AND EFFECTIVENESS FOR NIPRO® ARTERIAL VENOUS FISTULA NEEDLE
$807.92 (a)(1)
Contact Person:
Luis Candelario General Manager
Date of Summary Preparation: April 27, 1999
$807.92 (a)(2)
Trade Name:
Agulha Para Fistula Arterio-Venosa Aguja Para Fistula Arterio Venosa Common Name: Disposable AVF set Classification Name: Blood Access Device and Accessories (nonimplanted) (21 CFR 876.5540)
Nipro® Arterial Venous Fistula Needle
$807.92 (a)(3)
Legally Marketed Substantially Equivalent Device: Nipro Arterial Venous Fistula Needle, (K955182)
§807.92 (a)(4)
Description of Device: Arterial Venous Fistula Needles are described in blood access device and accessories (nonimplanted) 21 CFR 876.5540 The Disposable Arterial Venous Fistula Needles that we intend to market include 1 type of design: fixed wing. It is offered with or without a clamp. The device consists of a winged needle (14 - 17 gauge) connected to polyvinylchoride AVF tubing which is connected to a AVF luer connector. Needles with a hole (back eye type) and without a hole are available as well
1
K991623 p2 of 2
and are both 1 inch and 1¼ inches in length. Tubing is available in lengths of 300 mm.
| §807.92 (a)(5) | The materials used for the components include:
polyvinylchloride (PVC), stainless steel (SS),
polyoxymethylene (POM), polycarbonate (PC) and
polypropylene (PP). |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The AVF sets are intended to be used for intravenous injection
and connection with dialysis blood lines to transport blood
from the artery of the patient to the dialyzer and transport |
blood after dialysis to the vein of the patient.
$807.92 (a)(6)
Comparison of Technical Characteristics:
The Nipro subject and predicate AVF needles are similar devices, and most technical characteristics are identical
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 9 1999
Nipro Medical Corporation c/o Ms. Kaelyn Hadley Consultant C. L. McIntosh & Associates, Inc. 12300 Twinbrook Parkway, Suite 625 Rockville, MD 20852
Re: K991623 Nipro Arterial Venous Fistula Needle Dated: April 27, 1999 Received: Mav 11, 1999 Requiatory Class: II 21 CFR §876.5540/Procode: 78 FIE
Dear Ms. Hadley:
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 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. 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA 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 our labeling requlation (21 CFR Part 801 and additionally 809,10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours.
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) number (if known): K991623
Device name: Nipro Arterial Venous Fistula Needle, Agula Para Fistula
Indications for use: The AVF sets are intended to be used for intravenous injection and connection with dialysis blood lines to transport blood from the artery of the patient to the dialyzer and transport after dialysis to the vein of the patient.
(Please do not write below this line- continue on another page if needed.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The- Counter-Use
(optional Format 1-2-9)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K991623