(103 days)
Not Found
No
The summary describes a physical catheter and its mechanical properties and intended uses. There is no mention of software, algorithms, or data processing that would indicate the presence of AI/ML.
No
The device is used for central venous access for various medical procedures like hemodialysis, apheresis, infusion, and monitoring, rather than directly treating a disease or condition.
No
The device is a central venous catheter used for various medical procedures, including hemodialysis, apheresis, and infusion. While it can be used for central venous pressure monitoring, its primary function is not to diagnose a condition but to facilitate treatment and monitoring.
No
The device description clearly describes a physical catheter made of polyurethane with lumens and extensions, 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 clearly states that the catheter is for "short term central venous access for hemodialysis, apheresis, infusion, central venous pressure monitoring and pressure injection of contrast media." These are all procedures performed on the patient's body, not on samples taken from the patient's body.
- Device Description: The description details a physical catheter designed for insertion into a vein. This is a medical device used for direct patient intervention.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This catheter does not fit that description.
N/A
Intended Use / Indications for Use
The MAHURKAR™ Triple Lumen Dialysis Catheter is intended for short term central venous access for hemodialysis, apheresis, infusion, central venous pressure monitoring and pressure injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.
Product codes
NIE
Device Description
The MAHURKAR™ Triple Lumen Dialysis Catheter is a 12 Fr radiopaque polyurethane catheter with two large lumens (arterial and venous) and one smaller medial lumen running longitudinally along the length of the catheter shaft. The two large lumens either have curved or straight extensions and the smaller medial lumen have a straight extension. At the distal end of the catheter there is a tapered green, soft radiopaque catheter tip. Each lumen terminates at a separate location along the catheter shaft, designated as the arterial, venous, or medial outlets. The catheter is available in four implantable lengths (13 cm, 16 cm, and 24 cm) with two clear silicone catheters extensions and three internal lumina distinguished by color coded adapters
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous
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)
Testing was performed to compare the proposed MAHURKAR™ Triple Lumen Catheter to predicate device. The testing that was performed included Pressure Injection testing, including tensile testing and leak and burst testing to ensure catheter mechanical integrity was not diminished after power injections. Additionally Central Venous Pressure testing was conducted to verify that the catheter was capable of being used for accurate pressure monitoring as compared to the predicate device. Results of the verification / validation testing demonstrate that the modified device is substantially equivalent to 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.
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K102605 Page 1 of 2
DEC 2 2 2010
510(k) Summary
Date Summary Was Prepared: 9/8/2010
Submitter's
- Covidien IIc Information: 15 Hampshire Street Mansfield, MA 02048 Phone: 508-261-8000 Fax: 508-261-6644
- Daniel Campion Contact: Manager Regulatory Affairs Coviden Telephone: 508-452-4135 Fax: 508-261-8461
Device Trade
MAHURKAR™ Triple Lumen Dialysis Catheter Name:
Device Common
Catheter, Hemodialysis, Apheresis, Intravascular Name:
Classification Panel: Gastroenterology
Legally Marketed Devices to Which Substantial Equivalence is Claimed:
The MAHURKAR™ Triple Lumen Dialysis Catheter is substantially equivalent to the predicate Mahurkar™ Triple Lumen Dialysis Catheter (K020089) in materials, physical characteristics, and performance characteristics. The expansion of the indications to include Power Injection capabilities through the infusion lumen as well as Central Venous Pressure Monitoring is equivalent to the Bard Power-Trialysis Triple Lumen Dialysis Catheter (K083675).
Device Description:
The MAHURKAR™ Triple Lumen Dialysis Catheter is a 12 Fr radiopaque polyurethane catheter with two large lumens (arterial and venous) and one smaller medial lumen running longitudinally along the length of the catheter shaft. The two large lumens either have curved or straight extensions and the smaller medial lumen have a straight extension. At the distal end of the catheter there is a tapered green, soft radiopaque catheter tip. Each lumen terminates at a separate location along the catheter shaft, designated as the arterial, venous, or medial outlets. The catheter is available in four implantable lengths (13 cm, 16 cm, and 24 cm) with two clear silicone catheters extensions and three internal lumina distinguished by color coded adapters
Intended Use:
The MAHURKAR™ Triple Lumen Dialysis Catheter is intended for short term central venous access for hemodialysis, apheresis, infusion, central venous pressure monitoring and pressure injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.
Performance Data:
Testing was performed to compare the proposed MAHURKAR™ Triple Lumen Catheter to predicate device. The testing that was performed included Pressure Injection testing, including tensile testing and leak and burst testing to ensure catheter mechanical integrity was not diminished after power injections. Additionally Central Venous Pressure testing was conducted to verify that the catheter was capable of being used for accurate pressure monitoring as compared to the predicate device. Results of the
09/08/2010 Page 11 of 209
1
K10 2605 Page 2 of 2
verification / validation testing demonstrate that the modified device is substantially equivalent to the legally marketed predicate devices
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Mr. Daniel Campion Manager, Regulatory Affairs Covidien Vascular Therapies, LLC 15 Hampshire Street MANSFIELD MA 02048
DEC 2 2 200
Re: K102605
Trade/Device Name: MAHURKAR™ Triple Lumen Catheter Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: NIE Dated: November 30, 2010 Received: December 8, 2010
Dear Mr. Campion:
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 to legally marketed referenced as a now have and have a 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. However, you are responsible to determine that the medical devices you use as components in the kit/tray have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally 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, and 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.
3
Page 2 -- Mr. Daniel Campion
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
510(k) Premarket Notification MAHURKAR™ Triple Lumen Dialysis Catheter
Appendix 1 Indications for Use Statement
Device Name:
MAHURKAR™ Triple Lumen Catheter
DEC 2 2 2010
Indications for Use:
The MAHURKAR™ Triple Lumen Catheter is intended for short term central venous access for hemodialysis, apheresis, infusion, central venous pressure monitoring and pressure injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.
Please Do Not Write Below This Line - Continue On Another Page If Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ X (Per 21 CFR 801.109)
OR
Over-The-Counter Use _
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Confidential
09/08/2010 Page 61 of 209