(301 days)
Not Found
No
The summary describes a physical medical device (catheter and kit) with an antimicrobial surface. There is no mention of software, algorithms, image processing, AI, ML, or any data analysis that would suggest the use of AI/ML technology.
No.
A therapeutic device is one that treats a disease or condition. This device is used for fluid administration, hemodialysis, apheresis, and hemofiltration, which are supportive functions, and specifically states it "is not intended to be used as a treatment for existing infections."
No
Explanation: The device is a catheter for venous access and fluid administration, providing protection against catheter-related infections. Its purpose is therapeutic (fluid administration, hemodialysis, apheresis, hemofiltration) and protective (antimicrobial surface), not diagnostic.
No
The device description clearly outlines a physical catheter made of polyurethane with various accessory components like needles, syringes, and wire guides. There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for providing venous access for procedures like fluid administration, hemodialysis, apheresis, and hemofiltration. These are all procedures performed on the patient's body, not on samples taken from the patient's body for diagnostic purposes.
- Device Description: The description details a catheter and associated components used for insertion into veins. This aligns with a medical device used for treatment or access, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological specimens (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body).
N/A
Intended Use / Indications for Use
The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid administration, temporary or acute hemodialysis, apheresis and hemofiltration. It may be inserted into the jugular, subclavian, or femoral veins
The ARROWg+ard Blue® antimicrobial surface catheter helps provide protection against catheter-related infections resulting from microorganisms migrating the subcutaneous tract along the exterior surface of the catheter when used for infusion. Clinical data have not been collected that demonstrate the use of the ARROWg+ard Blue® antimicrobial surface in decreasing catheterrelated infections in hemodialysis patients. The catheter is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.
Product codes
78 MPB
Device Description
The materials, construction, and manufacturing processes of both the legally marketed 12 Fr Hemodialysis Catheter and the 7 Fr ARROWg+ard Blue® antimicrobial multilumen central venous catheter have been integrated to generate the proposed device.
The proposed device is a dual-lumen, antimicrobial surface, polyurethane catheter, 12 Fr and 14 Fr in size, with two independent non-communicating lumens, extension lines, Luer hubs, and extension line clamps. A soft tip that is more pliable than the catheter body is grafted onto the distal tip of the catheter. At the proximal end of the juncture hub, the lumens are connected to clear, separate extension lines. Each extension line contains either a red or blue clamp indicating arterial flow (outflow) or venous flow (inflow). Centimeter markings are placed along the length of the indwelling portion of the catheter body to facilitate proper positioning. The catheter is available in a length of 16cm, 20cm and 25cm.
The finished kit consists of the two-lumen, antimicrobial surface catheter packaged with various accessory components that are required during catheterization. These components include a combination of the following: spring wire guides, dilators, introducer needles, catheter over needle assemblies, syringes, pressure transduction probes, scalpels, disposal cups, and medication. The kit contains complete labeling including Instructions for Use, contents sheet, and unit package labels. The contents of the kit are configured in a tray and sealed with a Tyvek® lid. The complete trays are then placed in shipping containers and sterilized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
jugular, subclavian, or femoral veins
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)
The following performance tests are included in the submission.
- In vitro efficacy zone of inhibition
- In vitro safety - elution profile
- Stability tests
- Biocompatibility tests
Conclusions:
The results of the laboratory tests demonstrate that the device is as safe as the legally marketed predicate devices.
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
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
D. 1 4 2000
510(k) SUMMARY
Submitter:
Arrow International, Inc. 2400 Bernville Road Reading, PA 19605
Contact person:
Thomas D. Nickel Vice President. Requiatory Affairs and Quality Assurance Phone: (610) 478-3137 (610) 478-3172 Fax: tom.nickel@arrowintl.com E-mail:
Date summary prepared:
September 14, 2000
Trade name:
Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip® ARROWg+ard Blue® Catheter for High Volume Infusions
Common name:
Two-lumen, short-term access central venous hemodialysis catheter
Classification name:
- Class II at 21 CFR 880.5200, Catheter, Intravascular, short term .
- Class II at 21 CFR 876.5540, Catheter, Hemodialysis, non-implanted .
Legally marketed devices to which the device is substantially equivalent:
- Antimicrobial multi-lumen central venous catheter (K900263) ●
- Arrow large-bore dual lumen hemodialysis kit (K895417)
Description of device:
The materials, construction, and manufacturing processes of both the legally marketed 12 Fr Hemodialysis Catheter and the 7 Fr ARROWg+ard Blue® antimicrobial multilumen central venous catheter have been integrated to generate the proposed device.
The proposed device is a dual-lumen, antimicrobial surface, polyurethane catheter, 12 Fr and 14 Fr in size, with two independent non-communicating lumens, extension lines, Luer hubs, and extension line clamps. A soft tip that is more pliable than the catheter body is grafted onto the distal tip of the catheter. At the proximal end of the juncture hub, the lumens are connected to clear, separate extension lines. Each extension line contains either a red or blue clamp indicating arterial flow (outflow) or venous flow (inflow). Centimeter markings are placed along the length of the indwelling portion of the catheter body to facilitate proper positioning. The catheter is available in a length of 16cm, 20cm and 25cm.
The finished kit consists of the two-lumen, antimicrobial surface catheter packaged with various accessory components that are required during catheterization. These components include a combination of the following: spring wire guides, dilators, introducer needles, catheter over needle assemblies, syringes, pressure transduction probes, scalpels, disposal cups, and medication. The kit contains complete labeling
1
including Instructions for Use, contents sheet, and unit package labels. The contents of the kit are configured in a tray and sealed with a Tyvek® lid. The complete trays are then placed in shipping containers and sterilized.
Intended use of the device:
The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid administration, temporary or acute hemodialysis, apheresis and hemofilitration. It may be inserted into the jugular, subclavian, or femoral veins.
The ARROWg+ard Blue® antimicrobial surface catheter helps provide protection against catheter-related infections resulting from microorganisms migrating the subcutaneous tract along the exterior surface of the catheter when used for infusion. Clinical data have not been collected that demonstrate the use of the ARROWg+ard Blue® antimicrobial surface in decreasing catheter-related infections in hemodialysis patients. The catheter is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.
Technological characteristics:
The proposed device has the same technological characteristics as the predicate devices.
Performance tests:
The following performance tests are included in the submission.
- In vitro efficacy zone of inhibition �
- . In vitro safety - elution profile
- Stability tests �
- Biocompatibility tests .
Conclusions:
The results of the laboratory tests demonstrate that the device is as safe as the legally marketed predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three overlapping profiles, suggesting a sense of community and care. The profiles are positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle, emphasizing the department's national scope and mission.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SFP 1 4 2000
Mr. Thomas D. Nickel Vice President, Regulatory Affairs and Quality Assurance ARROW International 2400 Bernville Road Reading, Pennsylvania 19605
Re: K993933
12 Fr. and 14 Fr. Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip® ARROWg+ard Blue® Antimicrobial Catheter for High Volume Infusions Regulatory Class: II 21 CFR §876.5540/Product Code: 78 MPB Dated: June 13, 2000 Received: June 16, 2000
Dear Mr. Nickel:
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 (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/tray. 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 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, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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.
In addition, we have determined that your device kit contains povidone-iodine swab sticks, povidone-iodine ointment and lidocaine HCI 1%, which are subject to regulation as drugs.
Our substantially equivalent determination does not apply to the drug components of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug components. For information on applicable Agency requirements for marketing these drugs, we suggest you contact:
3
Page 2 - Mr. Thomas Nickel
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 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 (21 CFR Part 801 and additionally 809 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. 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,
David A. Lynn
Daniel G. Schultz, Captain, USPHS Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
K993933 510(k) Number:
Device Name:
Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip® ARROWg+ard Blue® Antimicrobial Catheter for High Volume Infusions
Indications for Use:
The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid administration, temporary or acute hemodialysis, apheresis and hemofiltration. It may be inserted into the jugular, subclavian, or femoral veins
The ARROWg+ard Blue® antimicrobial surface catheter helps provide protection against catheter-related infections resulting from microorganisms migrating the subcutaneous tract along the exterior surface of the catheter when used for infusion. Clinical data have not been collected that demonstrate the use of the ARROWg+ard Blue® antimicrobial surface in decreasing catheterrelated infections in hemodialysis patients. The catheter is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K993933
Prescription Use
(Per 21 CFR 801.109)