(30 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and functional performance of a catheter, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a central venous catheter used for medical procedures like hemodialysis, apheresis, and infusion, which are therapeutic interventions.
No.
The device is indicated for central venous access for hemodialysis, apheresis, infusion, central venous pressure monitoring, and pressure injection of contrast media, which are therapeutic or interventional uses, not diagnostic.
No
The device description clearly details physical components such as lumens, adapters, extension tubes, hubs, and shafts, indicating it is a hardware medical device.
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, and infusion." These are procedures performed on the patient, not tests performed on samples taken from the patient to diagnose or monitor a condition.
- Device Description: The description details a physical device designed for insertion into a vein to facilitate fluid exchange or monitoring. It does not describe reagents, instruments, or software used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This catheter's function is to provide access to the central venous system for therapeutic and monitoring purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Mahurkar™ Elite Acute Dual Lumen Catheter is intended to be used for short-term central venous access for hemodialysis, apheresis, and infusion.
The Mahurkar™ Elite Acute Triple Lumen Catheter is intended to be used 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
MPB, NIE
Device Description
The Mahurkar™ Elite Acute Dual Lumen Catheter features a two lumen design. The proximal end has color-coded adapters to indicate arterial and venous flow. The adapters are connected to extension tubes which are available in curved or straight configurations. The extension tubes are connected to the hub which is joined to a dual lumen shaft available in pre-curved and straight configurations. The shaft extends to side slots near the distal tip. The dual lumen catheter is available in 12.0 Fr or 13.5 Fr outer diameters and a variety of implant lengths ranging from 13 cm to 30 cm. It is offered as a single device or as convenience kits.
The Mahurkar™ Elite Acute Triple Lumen Catheter features a three lumen design. The proximal end has color-coded adapters to indicate arterial flow, venous flow, and medial infusion. The adapters are connected to extension tubes which are available in curved or straight configurations. The extension tubes are connected to the hub which is joined to a triple lumen shaft that extends to side slots near the distal tip. The triple lumen catheter is available in 12.5 Fr outer diameter and a variety of implant lengths ranging from 13 cm to 30 cm. It is offered as a single device or as convenience kits.
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
Bench top functional and performance testing was completed to support substantial equivalence between the proposed device and the current device. The test regimen evaluated the devices for cleaning agent compatibility, lock solution compatibility, dynamic flow, column strength, clamp functionality, shaft stiffness, tensile strength at various locations, and resistance to kink, leak, burst, catheter collapse, and fatigue. Additionally, the triple lumen catheter has been evaluated for central venous pressure monitoring performance and simulated injection of contrast media. The results of the performance testing show that the proposed devices continue to meet the relevant product specifications.
Biocompatibility testing per ISO 10993: Biological Evaluation of Medical Devices was completed to support biocompatibility of the proposed device. The results of the biocompatibility testing show that the proposed devices continue to be biocompatible for its intended use.
The results of functional, performance, and biocompatibility testing support the determination of substantial equivalence.
Key Metrics
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
K120674 Page 1 of 2
APR - 4 2012
Image /page/0/Picture/2 description: The image shows the word "COVIDIEN" in bold, black letters. To the left of the word is a black square with a white rectangle in the middle. The white rectangle has two black bars on the top and bottom.
510(K) SUMMARY
1. 510(k) Owner:
Covidien 15 Hampshire Street Mansfield, MA 02048 Telephone: (508) 261 - 6596 (508) 261 - 6596 Fax:
Contact: Wing Ng Title: Manager, Regulatory Affairs Date Prepared: March 01, 2012
2. Device:
Trade Names: Mahurkar™ Elite Acute Dual Lumen Catheter Mahurkar™ Elite Acute Triple Lumen Catheter Common Name: Central Venous Catheter Classification Name: Non-Implanted Hemodialysis Catheter (MPB) Non-Implanted Triple Lumen Hemodialysis Catheter (NIE) Regulation Number: 21 CFR 876.5540 Product Code(s): MPB. NIE Classification: Class II
3. Predicate Devices:
| Proposed Device | Predicate Device |
|---|---|
| Mahurkar™ Elite Acute | |
| Dual Lumen Catheter | Mahurkar™ Q Plus 13.5 Fr Dual Lumen |
| Acute Dialysis Catheter (K030209) | |
| Mahurkar™ Elite Acute | |
| Triple Lumen Catheter | Mahurkar™ High Pressure Triple Lumen |
| Acute Dialysis Catheter (K102605) |
4. Device Description:
The Mahurkar™ Elite Acute Dual Lumen Catheter features a two lumen design. The proximal end has color-coded adapters to indicate arterial and venous flow. The adapters are connected to extension tubes which are available in curved or straight configurations. The extension tubes are connected to the hub which is joined to a dual lumen shaft available in pre-curved and straight configurations. The shaft extends to side slots near the distal tip. The dual lumen catheter is available in 12.0 Fr or 13.5 Fr outer diameters and a variety of implant lengths ranging from 13 cm to 30 cm. It is offered as a single device or as convenience kits.
1
K120674 Pgs 2 of 2
The Mahurkar™ Elite Acute Triple Lumen Catheter features a three lumen design. The proximal end has color-coded adapters to indicate arterial flow, venous flow, and medial infusion. The adapters are connected to extension tubes which are available in curved or straight configurations. The extension tubes are connected to the hub which is joined to a triple lumen shaft that extends to side slots near the distal tip. The triple lumen catheter is available in 12.5 Fr outer diameter and a variety of implant lengths ranging from 13 cm to 30 cm. It is offered as a single device or as convenience kits.
5. Intended Use:
The Mahurkar™ Elite Acute Dual Lumen Catheter is intended to be used for short-term central venous access for hemodialysis, apheresis, and infusion.
The Mahurkar™ Elite Acute Triple Lumen Catheter is intended to be used 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.
6. Technological Characteristics:
The proposed devices have the same technological characteristics as compared to their respective predicate devices.
7. Performance Data:
Bench top functional and performance testing was completed to support substantial equivalence between the proposed device and the current device. The test regimen evaluated the devices for cleaning agent compatibility, lock solution compatibility, dynamic flow, column strength, clamp functionality, shaft stiffness, tensile strength at various locations, and resistance to kink, leak, burst, catheter collapse, and fatigue. Additionally, the triple lumen catheter has been evaluated for central venous pressure monitoring performance and simulated injection of contrast media. The results of the performance testing show that the proposed devices continue to meet the relevant product specifications.
Biocompatibility testing per ISO 10993: Biological Evaluation of Medical Devices was completed to support biocompatibility of the proposed device. The results of the biocompatibility testing show that the proposed devices continue to be biocompatible for its intended use.
The results of functional, performance, and biocompatibility testing support the determination of substantial equivalence.
8. Conclusion:
- Based on non-clinical testing results, Covidien has demonstrated that the proposed Mahurkar™ Elite Acute Catheters are substantially equivalent to its respective predicate devices.
2
Image /page/2/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Wing Ng Manager, Regulatory Affairs Covidien 15 Hampshire Street MANSFIELD MA 02048
APR - 4 2012
Re: K120674
Trade/Device Name: Mahurkar™ Elite Acute Dual Lumen Catheter Mahurkar™ Elite Acute Triple Lumen Catheter Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: MPB, NIE Dated: March 1, 2012 Received: March 5, 2012
Dear Mr.Ng:
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 (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 (f.e.; anninonea) and rainer. 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 (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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I Rase be advised that i Dr. I be rice complies with other requirements of the Act or any I Dri has made a acteriminens 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);
3
Page 2 - Mr. Wing Ng
labeling (21 CFR Part 801); 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.
In addition, we have determined that your device kit contains Lidocaine and ChloraPrep, 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:
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 Section 510(k) I mo letter will and my are FDA finding of substantial equivalence of your device to a legally premaince nodicate 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, please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference Compilance at (210) 210 01197 Patt 807.97). You may obtain other general information on your to prematice notification (21 Orethe Division of Small Manufacturers, International and ICsponsibilities and its toll free number (800) 638-2041 or (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Benjamin K. Teeter
Benjam R. Fisher, Ph.D. Difector Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4 Indications for Use Statement
510(k) Number (if known):
Device Name: Mahurkar™ Elite Acute Dual Lumen Catheter Mahurkar™ Elite Acute Triple Lumen Catheter
Indications for Use:
The Mahurkar™ Elite Acute Dual Lumen Catheter is indicated for short-term central venous access for hemodialysis, apheresis, and infusion.
The Mahurkar™ Elite Acute Triple Lumen Catheter is indicated 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.
Prescription Use _ X (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 Estaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Gastro-Renal, and | |
| Upplogical Devices | |
| 510(k) Number = |