The Mahurkar(TM) Acute Single Lumen Catheters provides temporary access for acute hemodialysis. The flexible tubing permits percutaneous insertion into subclavian, jugular, and femoral veins.

The Mahurkar(TM) Acute Dual Lumen Catheters are intended for short-term central venous access for hemodialysis. apheresis, and infusion.

The Mahurkar(TM) Acute Triple Lumen Catheters are intended for short-term central venous access for hemodialysis. apheresis, and infusion.

The Mahurkar(TM) Acute High Pressure Triple Lumen Catheters are intended for short term central venous access for hemodialysis, apheresis, infusion, central venous pressure injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.

Device Description

The Mahurkar™ Acute Single Lumen Catheter is a radiopaque, polyurethane tube that features a single-lumen design on the proximal end. A rotatable suture wing, for securing the catheter to the patient, is attached to the hub and five outflow holes are arranged in a spiral near the tapered tip. The single lumen catheter is available in 8.0 Fr outer diameter and in implant lengths 15 cm and 19.5 cm. An optional, disposable Y-adapter can be used to convert the single extension to a dual.

The Mahurkan™ Acute Dual Lumen Catheter is a radiopaque, polyurethane tube that features a two-lumen design on the proximal end. The color-coded adapters on each lumen 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, by a hub, to a dual lumen shaft that is available in pre-curved and straight configurations. The shaft extends to side slots near the distal tip. The dual lumen catheter is available in 8.0 Fr. 10.0 Fr. 11.5 Fr. or 13.5 Fr outer diameters and a variety of implant lengths ranging from 9 cm to 24 cm. It is offered as a single device or as convenience kits.

The Mahurkar™ Acute Triple Lumen Catheter and the Mahurkar™M Acute High Pressure Triple Lumen Catheter are radiopaque, polyurethane tubes that features a three-lumen design on the proximal end. The color-coded adapters on each lumen 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, by a hub, to a triple lumen shaft that extends to side slots near the distal tip. The triple lumen catheter is available in 12 Fr outer diameter and a variety of implant lengths ranging from 13 cm to 24 cm. They are offered as a single device or as convenience kits.

AI/ML Overview

The FDA 510(k) summary for the Mahurkar™ Acute Single, Dual and Triple Lumen Catheters does not describe acceptance criteria or a study proving the device meets those criteria in the traditional sense of a clinical trial for diagnostic performance.

This submission is for modifications to an already cleared device, primarily regarding changes to priming volumes on labels and instructions for use, and an update to static flow rate tables for the triple lumen catheter to align with ISO 10555-1. Therefore, the "acceptance criteria" and "device performance" are focused on demonstrating that these changes do not negatively impact the device's substantial equivalence to its predicate and that the updated information is accurate and compliant with relevant standards.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of "acceptance criteria" and "reported device performance" as one might expect for a new diagnostic or AI device. Instead, the performance data provided is focused on demonstrating that the modified aspects of the existing device are substantially equivalent to the predicate device and meet relevant regulatory standards.

Acceptance Criteria (Implied from the study objectives)	Reported Device Performance (as per the submission)
Biocompatibility:
- Meet ISO 10993 requirements for an externally communicating, circulating	- The results of the biocompatibility tests (Cytotoxicity, Sensitization, Irritation, Intracutaneous Toxicity, Acute Systemic Injection, Subchronic Toxicity, Genotoxicity - AMES Test, 30-Day Muscle Implantation, Hemolysis Test, USP Rabbit Pyrogen Test) conducted on the Mahurkar™ Acute Catheters meet the ISO 10993 requirements and have been deemed acceptable. - Note: No changes to materials were made for this submission, so previous biocompatibility data was referenced.
Performance Testing (Engineering):
- Priming Volumes: Demonstrate accuracy of new priming volume labels	- "Engineering testing analysis were performed... to establish the equivalence with the predicate devices." - "The test regimen evaluated the devices for priming volumes and cleaning agent compatibility." - Conclusion: Supported the update to the priming volumes printed on the label, IFU and device.
- Cleaning Agent Compatibility: Ensure compatibility with common agents	- "The test regimen evaluated the devices for priming volumes and cleaning agent compatibility." - Specific results not detailed, but implied as satisfactory to support equivalence.
- Static Flow Rates (Triple Lumen): Align with ISO 10555-1 (minimum flowrates)	- "Additionally, the triple lumen catheter has been evaluated for static flow rates of the medial lumens." - Conclusion: Supported the update to the static flow rates of the triple lumen's medial lumen to align with ISO 10555-1.
Substantial Equivalence:
- Demonstrate that material, design, and principle of operation remain the	- "No material, design or principle of operation changes have been made to the Mahurkar™ Acute Catheters, Kits and Trays for the purposes of this submission." - "The Mahurkar™ Acute Single, Dual and Triple Lumen Catheters, kits and trays have equivalent design, materials and principles of operation and technology when compared to the predicate device." - This is the overarching conclusion of the 510(k) summary.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated with specific numbers for each test. The document mentions "the Mahurkar™ Acute Catheters" as the subject of biocompatibility tests and "the devices" for engineering tests. Given this is an engineering and labeling change, the "sample" would likely refer to a certain number of manufactured catheters used for physical testing, rather than patient data.
Data Provenance: The biocompatibility testing was conducted previously and references "Good Laboratory Practice (GLP)." The engineering tests were likely conducted in-house by Covidien, LLC. There is no mention of country of origin for any data or whether it was retrospective or prospective, as these are not relevant for this type of submission focused on engineering changes to an existing device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable to this 510(k) submission. "Ground truth" established by experts, as typically seen in AI/diagnostic device submissions, would involve clinical interpretations or medical diagnoses. This submission pertains to physical device characteristics (priming volumes, flow rates, material compatibility) and regulatory compliance.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1 consensus) are used for clinical interpretive tasks, especially with ambiguous cases, to establish a definitive "ground truth." This is not relevant for the engineering and biocompatibility testing described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance

No. This is not an AI device, nor is it a diagnostic device that would typically undergo MRMC studies. This submission concerns physical catheters.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

For the biocompatibility tests, the "ground truth" would be established by validated laboratory assays and adherence to international standards (ISO 10993). For the priming volumes and flow rates, the "ground truth" would be the physically measured values according to established and validated engineering test methods, with the alignment of flow rates to ISO 10555-1 serving as a standard for accuracy.

8. The Sample Size for the Training Set

Not applicable. This isn't an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, no training set is involved.

In summary: This 510(k) is for minor modifications (labeling and a standard alignment) to an already cleared medical device (catheters). The "study" described focuses on demonstrating that these changes do not alter the substantial equivalence of the device, primarily through engineering performance testing (priming volumes, flow rates, cleaning agent compatibility) and by referencing prior biocompatibility testing. It is not an AI/diagnostic device submission, so many of the requested categories are not relevant.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 17, 2020

Covidien, LLC Carol Ming Principal Regulatory Affairs Specialist 15 Hampshire Street Mansfield. MA 02048

Re: K192302

Trade/Device Name: Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter Regulation Number: 21 CFR 876.5540 Regulation Name: Blood Access Device and Accessories Regulatory Class: II Product Code: MPB, NIE Dated: December 17, 2019 Received: December 19, 2019

Dear Carol Ming:

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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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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 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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) 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

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Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Carolyn Y. Neuland, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192302

Device Name

Mahurkar(TM) Acute Single Lumen Catheter / Mahurkar(TM) Acute Dual Lumen Catheter / Mahurkar(TM) Acute Triple Lumen Catheter / Mahurkar(TM) Acute High Pressure Triple Lumen Catheter

Indications for Use (Describe)

The Mahurkar(TM) Acute Single Lumen Catheters provides temporary access for acute hemodialysis. The flexible tubing permits percutaneous insertion into subclavian, jugular, and femoral veins.

The Mahurkar(TM) Acute Dual Lumen Catheters are intended for short-term central venous access for hemodialysis. apheresis, and infusion.

The Mahurkar(TM) Acute Triple Lumen Catheters are intended for short-term central venous access for hemodialysis. apheresis, and infusion.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

5.1 Submitter Information

Company:	Covidien, llc15 Hampshire StreetMansfield, MA 02048
Contact Person:	Carol MingPr. Regulatory Affairs SpecialistPhone: 508.452.1443
Date Prepared:	October 3, 2019

5.2 Device Names and Classifications:

Trade Name:	MahurkarTM Acute Single Lumen Catheter
Common Name:	Non-Implanted Hemodialysis Catheter
Regulation Number:	21 CFR 876.5540
Regulation Name:	Blood Access Device and Accessories
Product Code:	MPB
Classification:	Class II
Trade Name:	MahurkarTM Acute Dual Lumen Catheter
Common Name:	Non-Implanted Hemodialysis Catheter
Regulation Number:	21 CFR 876.5540
Regulation Name:	Blood Access Device and Accessories
Product Code:	MPB
Classification:	Class II
Trade Name:	MahurkarTM Acute Triple Lumen Catheter
Common Name:	Non-Implanted Triple Lumen Hemodialysis Catheter
Regulation Number:	21 CFR 876.5540
Regulation Name:	Blood Access Device and Accessories
Product Code:	NIE
Classification:	Class II
Trade Name:	MahurkarTM Acute High Pressure Triple Lumen Catheter
Common Name:	Non-Implanted Triple Lumen Hemodialysis Catheter
Regulation Number:	21 CFR 876.5540
Regulation Name:	Blood Access Device and Accessories
Product Code:	NIE
Classification:	Class II

5.3 Predicate Device

Primary Predicate Devices:

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K896252 Argyle™ Single Lumen Catheter K943349 Mahurkar™ Dual Lumen Catheter K030209 Mahurkar™ Dual Lumen High Flow Catheter (Q-PLUS) K020089 Mahurkar™ Triple Lumen Catheter K102605 Mahurkar™ Triple Lumen High Pressure Dialysis Catheter Reference Device: K120674 Mahurkar™ Elite Dual and Triple Lumen Catheters (MPB, NIE)

5.4 Device Description

5.5 Indications for Use

The Mahurkar™ Acute Single Lumen Catheters provides temporary access for acute hemodialysis. The flexible tubing permits percutaneous insertion into subclavian, jugular, and femoral veins.

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The Mahurkar™ Acute Dual Lumen Catheters are intended for short-term central venous access for hemodialysis, apheresis, and infusion.

The Mahurkar™ Acute Triple Lumen Catheters are intended for short-term central venous access for hemodialysis, apheresis, and infusion.

The Mahurkar™ Acute High Pressure Triple Lumen Catheters are 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.

5.6 Comparison to Predicate Device

This submission addresses the Mahurkar™ Acute Single, Dual and Triple Lumen Catheters, kits and trays. The new information presented in this submission includes changes to the Priming Volume printed on the label, printed on the Instructions for Use and printed on the subject devices. In addition, the Mahurkar™ Acute Triple Lumen Catheters' and Mahurkar™ Acute High Pressure Triple Lumen Catheters' medial lumen static flowrate tables will be changed from average flow rates to minimum flowrates to align with ISO 10555-1.

The previously cleared Mahurkar™ Acute Single, Dual and Triple Lumen Catheters are being used as predicate devices. The predicate devices and the proposed catheters are the same devices, as this submission addresses only changing the priming volume on the subject devices. No material, design or principle of operation changes have been made to the Mahurkar™ Acute Catheters, Kits and Trays for the purposes of this submission.

The Mahurkar™ Acute Single, Dual and Triple Lumen Catheters, kits and trays have equivalent design, materials and principles of operation and technology when compared to the predicate device.

Design: The design of the proposed Mahurkar™ Acute Single, Dual and Triple Lumen . Catheters, kits and trays are the same as the predicate device.
. Materials: The materials of the proposed Mahurkar™ Acute Single, Dual and Triple Lumen Catheters, kits and trays are the same as the predicate device.
Principles of Operation and Technology: The technology of the proposed Mahurkar™ Acute ● Single, Dual and Triple Lumen Catheters, kits and trays are the same as the predicate device.

5.7 Performance Data

Biocompatibility:

There were no changes to materials for this submission. Previously, biocompatibility evaluation was conducted for an externally communicating, circulating blood and prolonged exposure (<30 days) device. The series of testing was conducted utilizing the Mahurkar™ Acute Catheters and using Good Laboratory Practice (GLP). The testing procedures are based on the requirements of ISO 10993-1 and the following series of testing was conducted utilizing the Mahurkar™ Acute Catheters.

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Tests Performed:

Cytotoxicity MEM Elution Test ●
Sensitization Guinea Pig Maximization Test ●
. Irritation - Primary Skin Irritation
Intracutaneous Toxicity Test
Acute Systemic Injection Test ●
Subchronic Toxicity ●
Genotoxicity
- o AMES Test for Mutagenicity
. 30-Day Muscle Implantation Test
. Hemolysis Test – Saline Extract Method
USP Rabbit Pyrogen Test ●

The results of the biocompatibility tests conducted on the Mahurkar™ Acute Catheters meet the ISO 10993 requirements and have been deemed acceptable.

Performance Testing:

Engineering testing analysis were performed and are summarized in order to establish the equivalence with the predicate devices. The test regimen evaluated the devices for priming volumes and cleaning agent compatibility. Additionally, the triple lumen catheter has been evaluated for static flow rates of the medial lumens.

Performance Testing (Animal)

None Provided

Performance Testing (Clinical)

None Provided

5.8 Conclusions

Medtronic has demonstrated that the Mahurkar™ Acute Single, Dual and Triple Lumen Catheters, kits and trays are substantially equivalent to the predicate device and support the update to the priming volumes printed on the label, IFU and device and the static flow rates of the triple lumen's medial lumen.

Regulation Number and Section

§ 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.