The Duo-Flow Side x Side Double Lumen Catheter is a non-implanted hemodialysis catheter with two lumens. The red adapter connects to the proximal lumen for "arterial" outflow, and the blue adapter connects to the distal lumen for "venous" return. The catheter is available in various sizes and configurations (curved or straight extensions).

AI/ML Overview

This document describes the premarket notification (510(k)) for the Medcomp® Duo-Flow® Side x Side Double Lumen Catheter. It outlines the device's characteristics, its intended use, and its substantial equivalence to a predicate device.

Key Point: The provided text does not describe an AI/ML medical device. It pertains to a physical medical device (a catheter) and therefore, the concepts of AI-specific acceptance criteria, test sets, ground truth establishment by experts, MRMC studies, standalone performance, and training sets for an AI model are not applicable.

The document primarily focuses on demonstrating the substantial equivalence of the Duo-Flow® Side x Side Double Lumen Catheter to a legally marketed predicate device (Mahurkar™ Acute Dual Lumen Catheter). This is a common pathway for medical device clearance in the US, where new devices are compared to existing ones that have already been cleared for marketing.

Instead of AI-specific performance metrics, the document details:

Indications for Use: What the device is intended for (short-term central venous access for hemodialysis, apheresis, and infusion).
Comparison to Predicate Device: A detailed table (Table 6.1) comparing various attributes of the subject device to the predicate device, including indications for use, definition, location of use, French size, catheter configuration, lengths, duration of use, sterilization method, number of lumens, patient population, insertion site, and kit type. The goal is to show that the new device is fundamentally similar to the predicate.
Bench/Performance Data/Non-Clinical Testing: This section (Table 6.2) lists the applicable standards and performance testing conducted on the physical device to ensure its safety and effectiveness. These are primarily engineering and material tests, not clinical performance studies comparing diagnostic accuracy.
- ISO 10555-1: Intravascular catheters (Air Leak, Liquid Leak, Peak Tensile Force, Gravity Flow)
- ISO 11607-1 & -2: Packaging for terminally sterilized medical devices (Transit and Shelf Life testing)
- ISTA 3A: Packaged products for parcel delivery system shipment (Transit Testing)
- ISO 594-1 & -2: Conical fittings (Luer) for syringes, needles, etc. (Gauging, Liquid Leakage, Air Leakage, Separation Force, Unscrewing Torque, Ease of Assembly, Resistance to Overriding, Stress Cracking)
Biocompatibility: Tests conducted according to ISO 10993 standards to ensure the device is safe for biological contact. These include cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, subacute toxicity, genotoxicity, implantation, and hemocompatibility.

Therefore, to directly answer your request based on the provided text, while acknowledging that it's not an AI device:

1. Table of acceptance criteria and the reported device performance:

Since this is a physical medical device and not an AI/ML diagnostic tool, the "acceptance criteria" are based on meeting established engineering and biocompatibility standards, and demonstrating substantial equivalence to a predicate device. Performance is measured by successful completion of these non-clinical tests.

Acceptance Criteria Category	Specific Test/Standard	Reported Device Performance/Outcome
Material Performance	ISO 10555-1 (Intravascular catheters)	Passed/Meets requirements for: Air Leak, Liquid Leak, Peak Tensile Force, Gravity Flow
Packaging & Sterility	ISO 11607-1 & -2 (Packaging for sterilized medical devices)	Passed/Meets requirements for: Transit and Shelf Life testing
Shipping Validation	ISTA 3A (Packaged products for parcel delivery)	Passed/Meets requirements for: Transit Testing
Connection Integrity	ISO 594-1 & -2 (Conical fittings - Luer)	Passed/Meets requirements for: Gauging, Liquid Leakage, Air Leakage, Separation Force, Unscrewing Torque, Ease of Assembly, Resistance to Overriding, Stress Cracking
Biocompatibility	ISO 10993 series (Biological evaluation of medical devices)	Met biocompatibility requirements for externally communicating medical devices in contact with circulating blood (prolonged duration >24 hours to <30 days) for all tested endpoints: Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Pyrogenicity, Subacute Toxicity, Genotoxicity, Implantation, Hemocompatibility, Chemical Characterization.
Substantial Equivalence	Comparison to Mahurkar™ Acute Dual Lumen Catheter (K955002)	"Raises no new questions of effectiveness compared to the predicate device and is substantially equivalent."

2. Sample size used for the test set and the data provenance:

For this type of device, a "test set" in the AI sense is not applicable. The sample sizes for the various bench/performance/biocompatibility tests are typically determined by the standards themselves (e.g., specific number of catheters for tensile strength, or material samples for biocompatibility), and these details are not provided in this summary. The data provenance is from non-clinical bench testing and laboratory studies by the manufacturer (Medcomp®) to ISO and ASTM standards. It is not patient data from clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. "Ground truth" in the context of an AI device relates to verified diagnostic labels. For a physical medical device, the "ground truth" is established by the specifications of the device, the requirements of the standards, and the physical measurements/observations during testing. No external expert panel is described for establishing a "ground truth" for these engineering and biocompatibility tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This concept applies to human reader consensus for labeling data, which is not relevant here. The tests are defined by standard protocols with clear pass/fail criteria.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI-assisted device. The "effectiveness" is demonstrated by meeting performance standards and clinical equivalence to a predicate device, not by improving human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Not applicable in the AI sense. The "truth" for this device's performance is derived from:

Engineering specifications and design.
Compliance with recognized international standards (ISO, ASTM).
Direct physical measurements and observations during bench testing (e.g., flow rates, tensile strength, Luer taper dimensions).
Laboratory analysis for biocompatibility endpoints.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable.

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). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other related products.

April 23, 2020

Medical Components Inc. (dba MedComp) Courtney Nix Regulatory Affairs Director, North America and Europe 1499 Delp Drive Harleysville, PA 19438

Re: K192807

Trade/Device Name: Duo-Flow Side x Side Double Lumen Catheter Regulation Number: 21 CFR 876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: MPB Dated: March 13, 2020 Received: March 16, 2020

Dear Courtney Nix:

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. 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. 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.

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

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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 (OS) 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.

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 mediation-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 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) K192807

Device Name

Duo-Flow Side x Side Double Lumen Catheter

Indications for Use (Describe)

The Duo-Flow Side x Side Double Lumen Catheter is intended for short-term central venous access for hemodialysis, apheresis, and infusion.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/15 description: The image shows the logo for medCOMP. The logo features a red geometric shape that resembles a stylized house or building. The word "med" is in red, while "COMP" is in black. The logo is simple and modern, with a focus on the company name and a memorable visual element.

Harleysville, PA 19438

Tel: 215-256-4201

Fax. 215-256-1787

www.medcompnet.com

Medcomp®: Duo-Flow® Side x Side Double Lumen Catheter

Section 6		510(k) SUMMARY
A. Submitter Information
	Submitter Name:	Medical Components Inc.(dba Medcomp®)1499 Delp DriveHarleysville, PA 19438
	Address:	2518902
	Registration Number:	Courtney NixRegulatory Affairs Director,North America and EU
	Contact Person:	09/27/2019
	Date of Preparation:
B. Subject Device
	Trade Name:	Duo-Flow® Side x Side Double Lumen Catheter
	Device:	Catheter, Hemodialysis, Non-ImplantedBlood access device and accessories
	Regulation Description:	MPB
	Product Code:	876.5540
	Regulation Number:	II
	Class:	Gastroenterology/Urology
	Review Panel:
C. Predicate Device
	Predicate Trade Name:	Mahurkar™ Acute Dual Lumen Catheter
	510(k) Number:	K955002
	510(k) Holder:	Quinton, Inc.
	Device:	Catheter, Hemodialysis, Non-ImplantedBlood access device and accessories
	Regulation Description:	MPB
	Product Code:	876.5540
	Regulation Number:	II
	Class:	Gastroenterology/Urology
	Review Panel:
D. Device Description:

Red Adapter = proximal lumen O
O Blue Adapter = distal lumen

The proximal lumen provides "arterial" outflow from the patient; the distal lumen provides "venous" return.

Medcomp®: Duo-Flow® Side x Side Double Lumen Catheter Section 6: 510(k) Site Summary

6-1

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Image /page/4/Picture/1 description: The image shows the logo for medCOMP. The logo consists of a red geometric shape that resembles a stylized letter "C" or an incomplete square with rounded corners. Below the geometric shape, the word "medCOMP" is written in a stylized font, with "med" in red and "COMP" in black.

Harleysville, PA 19438

Tel: 215-256-4201

Fax. 215-256-1787

www.medcompnet.com

Medcomp®: Duo-Flow® Side x Side Double Lumen Catheter

The catheter comes in a variety of sizes and is offered with curved or straight extensions.

E. Indications for Use:

The Duo-Flow® Side x Side Double Lumen Catheter is intended for short-term central venous access for hemodialysis, apheresis, and infusion.

F. Comparison to Predicate Device(s):

Table 6.1: 510(k) Summary Design Comparison Matrix

Attribute	Subject DeviceDuo-Flow® Side x Side Double Lumen Catheter	Predicate DeviceMahurkar™ Acute Dual Lumen Catheter (K955002)
PrescriptionIndicationsfor Use	Prescription UseThe Duo-Flow® Side x Side Double Lumen Catheter is intended for short-term central venous access for hemodialysis, apheresis, and infusion	Prescription UseThe catheter is intended for short-term central venous access for hemodialysis, apheresis, and infusion.
Definition(FromProductCode)	Short-term (< 30 days) central venous access for hemodialysis and apheresis.	Short-term (< 30 days) central venous access for hemodialysis and apheresis.
Location ofUse	The operating room is the preferred location for insertion; however, bedside insertion is acceptable if sterile technique is followed.	The operating room is the preferred location for insertion; however, bedside insertion is acceptable if sterile technique is followed.
French Size	9F, 11F, and 12F	8F, 10F, 11.5F and 13.5F
CatheterConfigurationLengths	Straight and Curved Extensions	Straight, Curved Extensions, and Pre-Curved
	FrenchSize91112	Length(s)(cm) 7.5, 10, 12,15, 2010, 12, 15,20, 2413, 15, 20,24	FrenchSize 8F 10 11.5 13.5	Length(s) (cm) 9cm (Straightonly), 12cm,15cm 12, 15, 19.5 13.5, 16, 19.5,24 13.5, 16, 19.5,24
Duration ofUse	Short-term (less than 30 days)	Per K-DOQI guidelines: (1)Remove the catheter when no

Medcomp®: Duo-Flow® Side x Side Double Lumen Catheter Section 6: 510(k) Site Summary

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Image /page/5/Picture/1 description: The image shows the MedComp logo. The logo consists of a red geometric shape that resembles a stylized house or building. Below the geometric shape, the word "medCOMP" is written in a stylized font, with "med" in red and "COMP" in black.

1499 Delp Drive
Harleysville, PA 19438

Tel: 215-256-4201

Fax. 215-256-1787

www.medcompnet.com

Medcomp®: Duo-Flow® Side x Side Double Lumen Catheter

		longer needed, (2) Removefemoral catheters within 3-4 days,and (3) Replace subclavian andjugular catheters every 21 days.
SterilizationMethod	EO	EO
Number ofLumens	2	2
PatientPopulation	Adult	Adult
Insertion Site	Subclavian, jugular or femoral	Subclavian, jugular or femoral
Kit Type	Convenience	Legally Marketed

G. Bench/Performance Data/ Non-Clinical Testing:

Table 6.2: Applicable Standards and Performance Testing

Standard	Standard Title	Revision/Date	PerformanceTesting
ISO 10555-1	Intravascular catheters --sterile and single-useintravascular catheters --part 1: generalrequirements.	Second Edition2013-06-15	Air Leak, Liquid Leak,Peak Tensile Force,Gravity Flow
ISO 11607-1	Packaging for terminallysterilized medical devices- part1: requirements formaterials, sterile barriersystems and packagingsystems[including: amendment 1(2014)].	First Edition2006-04-15	Transit and Shelf Lifetesting
ISO 11607-2	Packaging for terminallysterilized medical devices- part2: validation requirementsfor forming, sealing andassembly processes[including: amendment 1(2014)].	First Edition2006-04-15	Transit and Shelf Lifetesting
ISTA 3A	Packaged products forparcel delivery systemshipment 70 KG (150 lbs)or less	2008	Transit Testing
ISO 594-1	Conical fittings with a 6%	First edition	Gauging

Medcomp®: Duo-Flow® Side x Side Double Lumen Catheter Section 6: 510(k) Site Summary

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Image /page/6/Picture/1 description: The image shows the MedComp logo. The logo features a stylized red geometric shape above the word "medCOMP". The "med" portion of the word is in red, while the "COMP" portion is in black.

Harleysville, PA 19438

Tel: 215-256-4201

Fax. 215-256-1787

www.medcompnet.com

Medcomp®: Duo-Flow® Side x Side Double Lumen Catheter

	(Luer) taper for syringes,needles and certain othermedical equipment - Part1: General requirements	1986-06-15
ISO 594-2	Conical fittings with a 6%(luer) taper for syringes,needles andcertain other medicalequipment - part 2: lockfittings.	Second Edition1998-09-01	Liquid LeakageAir LeakageSeparation ForceUnscrewing TorqueEase of AssemblyResistance toOverridingStress Cracking

H. Biocompatibility

The biocompatibility evaluation for the Duo-Flow® Side x Side Double Lumen Catheter was conducted in accordance with the FDA quidance document: Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process" and International Standard ISO 10993-1 "Biocompatibility Evaluation of Medical Devices - Part 1 Evaluation and Testing Within a Risk Management Process", as recognized by the FDA. The Duo-Flow® Side x Side Double Lumen Catheter met the biocompatibility requirements for externally communicating medical device intended to primarily be in contact with circulating blood for a prolonged contact duration (>24 hours to less than 30 days). The biological endpoints that were met as are follows:

CYTOTOXICITY

o ISO 10993-5:2009, Biological Evaluation of Medical Devices Part 5: Tests for In Vitro Cytotoxicity

SENSITIZATION

o ISO 10993-10:2010, Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin Sensitization

IRRITATION OR INTRACUTANEOUS REACTIVITY

· ISO 10993-10:2010, Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin Sensitization

SYSTEMIC TOXICITY

o ISO 10993-11:2006, Biological Evaluation of Medical Devices Part 11: Tests for Systemic Toxicity

PYROGENICITY

ISO 10993-11:2006, Biological Evaluation of Medical Devices Part 11: 0 Tests for Systemic Toxicity, Annex F

SUBACUTE TOXICITY

Medcomp®: Duo-Flow® Side x Side Double Lumen Catheter Section 6: 510(k) Site Summary

6-4

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Image /page/7/Picture/1 description: The image contains the logo for medCOMP. The logo consists of a red geometric shape that resembles a stylized letter "M" or an abstract building. Below the geometric shape, the word "med" is written in red, lowercase letters, while "COMP" is written in black, uppercase letters. The overall design is clean and modern.

Harleysville, PA 19438

Tel: 215-256-4201

Fax. 215-256-1787

www.medcompnet.com

Medcomp®: Duo-Flow® Side x Side Double Lumen Catheter

O ISO 10993-11:2006, Biological Evaluation of Medical Devices Part 11: Tests for Systemic Toxicity

GENOTOXICITY

o ISO 10993-3:2014, Biological Evaluation of Medical Devices Part 3: Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity

IMPLANTATION

· ISO 10993-6:2016, Biological Evaluation of Medical Devices Part 6: Test for Local Effects After Implantation

HEMOCOMPATIBILITY

0 ASTM F576:2017, Standard Practice for Assessment of Hemolytic Properties of Materials
· ISO 10993-4:2002/A1:2006, Biological Evaluation of Medical Devices Part 4: Selection of Tests for Interactions with Blood
ISO 10993-4:2017, Biological Evaluation of Medical Devices Part 4: O Selection of Tests for Interactions with Blood

OTHER

ISO 10993-18, 2005, Biological Evaluation of Medical Devices, Part 18: O Chemical Characterization of Materials

ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ Summary of Substantial Equivalence

Based on the indications for use, design, safety and performance testing. the proposed device, Duo-Flow® Side x Side Double Lumen Catheter, raises no new questions of effectiveness compared to the predicate device and is substantially equivalent to the predicate device, Mahurkar™ Acute Dual Lumen Catheter (K955002).

Medcomp®: Duo-Flow® Side x Side Double Lumen Catheter Section 6: 510(k) Site Summary

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.