(317 days)
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Not Found
No
The description focuses on the physical characteristics and intended use of a catheter, with no mention of AI or ML capabilities.
No
The document describes the device as a short-term central venous access device for hemodialysis, apheresis, and infusion. While these procedures improve a patient's health, the catheter itself is a delivery mechanism and not primarily for therapeutic treatment.
No
Explanation: The device description and intended use clearly state that this is a catheter for central venous access used for procedures like hemodialysis, apheresis, and infusion. There is no mention of it being used to diagnose conditions or process diagnostic information.
No
The device description clearly describes a physical catheter, a tangible medical device, not a software-only application.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "short-term central venous access device for hemodialysis, apheresis, and infusion." This describes a device used within the body for therapeutic or access purposes, not for testing samples outside the body to diagnose conditions.
- Device Description: The description details a catheter, a physical tube inserted into a vein. This is consistent with a medical device for access and delivery, not an IVD which would typically involve reagents, test strips, or analytical equipment.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes or markers
- Providing diagnostic information
- Using reagents or test methods
The device is a medical device used for accessing the central venous system for specific medical procedures.
N/A
Intended Use / Indications for Use
The Mahurkar 8 Fr Catheter is intended to be used as a short-term central venous access device for hemodialysis, apheresis, and infusion.
Product codes
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Device Description
The Mahurkar 8 Fr Catheter, a radiopaque polyurethane tube with two D-shaped lumina, is coated with silicone fluid. The lumina can be distinguished by the colorcoded luer-lock adapters on the clear silicone rubber extensions: the red adapter indicates the proximal lumen, and the blue adapter indicates the distal lumen. During hemodialysis and apheresis, the proximal lumen provides "arterial" outflow from the patient and the distal lumen provides "venous" return.
The Mahurkar 8 Fr Catheter is available in four (4) implantable lengths (9 cm, 12 cm, 15 cm, and 19.5 cm), with straight extensions or curved extensions, and is packaged in catheter kit and catheter tray configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
central venous
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Performance data for the Mahurkar 8 Fr Catheter, including biocompatibility, mechanical characteristics, dynamic flow performance, infusion flow performance, and in vitro hemolysis testing, were compared to that of the predicate devices identified in paragraph (3) of this Summary. These test results demonstrate that the device is substantially equivalent to predicate devices commercially distributed for hemodialysis, apheresis, and infusion.
Key Metrics
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Predicate Device(s)
Mahurkar Dual Lumen Catheters (Quinton Instrument Co .; Bothell, WA), Duo-flow Double Lumen Catheter (MedComp, Inc.; Harleysville, PA), Safe-Dwel Plus Bi-Lumen Catheter (Becton Dickinson Vascular Access; Sandy, UT)
Reference Device(s)
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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
955002
Image /page/0/Picture/1 description: The image shows the logo for Quinton Instrument Co. The logo is in black and white and features the word "Quinton" in a bold, sans-serif font. Below the word "Quinton" is the phrase "instrument co." in a smaller, sans-serif font. The logo is simple and clean, and it is likely used to represent the company's brand.
13 123
510(k) Notification: Mahurkar 8 Fr Dual Lumen Catheter 510(k) SUMMARY
SECTION H 510(k) SUMMARY
This section contains a summary of safety and effectiveness for the Mahurkar 8 Fr Catheter as defined in 21 CFR 807.3 and required by 21 CFR 807.92.
-
(1) Submitter's name, address, telephone number, contact person, date of preparation:
Quinton Instrument Co. 3303 Monte Villa Parkway Bothell, WA 98021-8906 phone: 800-426-0337 FAX: 206-402-2001 Contact person: Jerry Freundlich Date summary was prepared: October 27, 1995 -
(2) Name of the device:
Trade Name - Mahurkar Dual Lumen Catheter Common Names - Hemodialysis Catheter, Apheresis Catheter, Intravascular Catheter Classification Names -21 CFR 876.5540 - Non-Implanted Blood Access Devices and Accessories 21 CFR 880.5200 - Intravascular Catheter -
(3) Identification of predicate devices:
Mahurkar Dual Lumen Catheters (Quinton Instrument Co .; Bothell, WA) Duo-flow Double Lumen Catheter (MedComp, Inc.; Harleysville, PA) Safe-Dwel Plus Bi-Lumen Catheter (Becton Dickinson Vascular Access; Sandy, UT) -
(4) Description of the device:
The Mahurkar 8 Fr Catheter, a radiopaque polyurethane tube with two D-shaped lumina, is coated with silicone fluid. The lumina can be distinguished by the colorcoded luer-lock adapters on the clear silicone rubber extensions: the red adapter indicates the proximal lumen, and the blue adapter indicates the distal lumen. During hemodialysis and apheresis, the proximal lumen provides "arterial" outflow from the patient and the distal lumen provides "venous" return.
The Mahurkar 8 Fr Catheter is available in four (4) implantable lengths (9 cm, 12 cm, 15 cm, and 19.5 cm), with straight extensions or curved extensions, and is packaged in catheter kit and catheter tray configurations.
- (5) Intended use of the device:
The Mahurkar 8 Fr Catheter is intended to be used as a short-term central venous access device for hemodialysis, apheresis, and infusion.
1
Image /page/1/Picture/0 description: The image shows the logo for Quinton Instrument Co. The logo is in black and white and features the word "Quinton" in a bold, sans-serif font. The words "instrument co." are in a smaller font below the word "Quinton". The logo is simple and professional.
K95 5002
510(k) Notification: Mahurkar 8 Fr Dual Lumen Catheter 510(k) SUMMARY
Comparison to predicate devices: (6)
The technological characteristics of the Mahurkar 8 Fr Catheter, including catheter type, intended use, insertion method, anatomical placement of catheter tip, number and shape of lumens, catheter tube material, lumen cross sectional area, are similar to those of the predicate devices identified in paragraph (3) of this Summary. The only difference between the Mahurkar 8 Fr Catheter and the predicate devices is the outer diameter (8 Fr), tip design, and one of the available implantable lengths (9 cm).
Performance data: (7)
Performance data for the Mahurkar 8 Fr Catheter, including biocompatibility, mechanical characteristics, dynamic flow performance, infusion flow performance, and in vitro hemolysis testing, were compared to that of the predicate devices identified in paragraph (3) of this Summary. These test results demonstrate that the device is substantially equivalent to predicate devices commercially distributed for hemodialysis, apheresis, and infusion.