Power Acute Triple Lumen Hemodialysis Catheter

K222170 · Health Line International Corporation · NIE · Jan 13, 2023 · Gastroenterology, Urology

Device Facts

• Record ID: K222170
• Device Name: Power Acute Triple Lumen Hemodialysis Catheter
• Applicant: Health Line International Corporation
• Product Code: NIE · Gastroenterology, Urology
• Decision Date: Jan 13, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5540
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Power Acute Triple Lumen Hemodialysis 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.

Device Story

Thermally reactive polyurethane triple-lumen catheter; rigid at room temperature for bedside insertion; softens at body temperature to minimize vein perforation risk. Features radiopaque cannula with incremental markings; three independent non-communicating lumens; luer-fitted silicone extension legs; color-coded occlusion clamps (red/arterial, blue/venous, purple/medial). Distal end thermally bonded to symmetrically tapered tip with skived side openings. Used by clinicians for short-term central venous access via Seldinger technique in internal jugular, subclavian, or femoral sites. Enables hemodialysis, apheresis, infusion, pressure monitoring, and power injection of contrast media. Output is fluid delivery or withdrawal; clinical decision-making relies on catheter patency and flow performance. Benefits include improved patient comfort and procedural efficiency.

Clinical Evidence

Bench testing only. No clinical data. Performance evaluated via ISO 11135 (sterilization), ISO 11607-1 (shelf life), and ISO 10993-1 (biocompatibility). Functional testing included air/liquid leakage, tensile strength, flow rate, priming volume, kinking, repeated clamping, luer fitting, chemical tolerance, power injection performance, static burst pressure, recirculation rate, and pressure vs. flow rate.

Technological Characteristics

Thermally reactive polyurethane catheter; 12 Fr size; 3 lumens; symmetrical soft tapered tip. Sterilized via Ethylene Oxide. ISO 594-1 compatible luer connectors. Non-pyrogenic; latex-free; DEHP-free. Power injection capable (max 300 psi, 5 mL/sec).

Indications for Use

Indicated for short-term central venous access in adults for hemodialysis, apheresis, infusion, central venous pressure monitoring, and power injection of contrast media (max 5 mL/sec).

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Mahurkar™ Triple Lumen Dialysis Catheter (K102605)

Reference Devices

• Power-Trialysis™ Slim-Cath™ Short-Term Dialysis Catheter (K141531)
• Acute Dual Lumen Hemodialysis Catheter (K200426)

Submission Summary (Full Text)

{0}------------------------------------------------

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 in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.

January 13, 2023

Health Line International Corporation Aaron Faulkner Vice-President, Quality Assurance and Regulatory Affairs 260 North Ace Yeager Court, Unit D Salt Lake City, Utah 84116

Re: K222170

Trade/Device Name: Power Acute Triple Lumen Hemodialysis Catheter Regulation Number: 21 CFR 876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: NIE Dated: December 14, 2022 Received: December 15, 2022

Dear Aaron Faulkner:

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

{1}------------------------------------------------

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.

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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Gema Gonzalez -S

Gema Gonzalez, MS Acting 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

{2}------------------------------------------------

### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K222170

Device Name

Power Acute Triple Lumen Hemodialysis Catheter

Indications for Use (Describe)

The Power Acute Triple Lumen Hemodialysis 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.

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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (6/20)

PSC Publishing Services [phone] EF

{3}------------------------------------------------

| SUBMITTER | Name:<br>Address:<br>FDA Registration #:<br>Contact Name:<br>Telephone:<br>Fax:<br>Email:<br>Date Prepared: | Health Line International Corporation<br>260 North Ace Yeager CT, Unit D<br>Salt Lake City, Utah 84116<br>USA<br>3010882065<br>Aaron G. Faulkner<br>Vice-President, Quality Assurance and Regulatory<br>Affairs<br>801-773-7798 Ext. 109<br>855-228-1336<br>[e-mail]<br>July 19, 2022 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBJECT<br>DEVICE | Name:<br>Regulation Name:<br>Classification Name:<br>Classification Panel:<br>Regulatory Class:<br>Product Code:<br>Regulation Number: | Power Acute Triple Lumen Hemodialysis Catheter<br>Blood access device and accessories<br>Catheter, Hemodialysis, Triple Lumen, Non-<br>Implanted<br>Gastroenterology/Urology<br>Class II<br>NIE<br>21 CFR 876.5540 |
| PREDICATE<br>DEVICE | Name:<br>Regulation Name:<br>Classification Name:<br>Classification Panel:<br>Regulatory Class:<br>Product Code:<br>Regulation Number:<br>Recall Event ID: | Mahurkar™ Triple Lumen Dialysis Catheter<br>(K102605) by Covidien, LLC<br>Blood access device and accessories<br>Catheter, Hemodialysis, Triple Lumen, Non-<br>Implanted<br>Gastroenterology/Urology<br>Class II<br>NIE<br>21 CFR 876.5540<br>82802 |
| REFERENCE<br>DEVICE A | Name:<br>Regulation Name:<br>Classification Name:<br>Classification Panel:<br>Regulatory Class:<br>Product Code:<br>Regulation Number: | Power-Trialysis™ Slim-Cath™ Short-Term Dialysis<br>Catheter (K141531) by C.R. Bard, Inc.<br>Blood access device and accessories<br>Catheter, Hemodialysis, Triple Lumen, Non-<br>Implanted<br>Gastroenterology/Urology<br>Class II<br>NIE<br>21 CFR 876.5540 |
| Recall Event ID: | No recall has been issued to K141531 | |
| Name: | Acute Dual Lumen Hemodialysis Catheter (K200426)<br>by Health Line International Corporation | |
| Regulation Name: | Blood access device and accessories | |
| REFERENCE<br>DEVICE B | Classification Name: | Catheter, Hemodialysis, Non-Implanted |
| | Classification Panel: | Gastroenterology/Urology |
| | Regulatory Class: | Class II |
| | Product Code: | MPB |
| | Regulation Number: | 21 CFR 876.5540 |
| Recall Event ID: | No recall has been issued to K200426 | |

510(k) SUMMARY (21 CFR 807.92)

{4}------------------------------------------------

K222170 Page 2 of 6

DEVICE

DESCRIPTION

510(k) Premarket Notification Submission: Power Acute Triple Lumen Hemodialysis Catheter

The Power Acute Triple Lumen Hemodialysis Catheter is manufactured from a thermally reactive polyurethane material known for its rigidity at room temperature and softness at body temperature. This reactivity allows bedside insertion, while minimizing the risk of vein perforation and providing an overall improvement of patient comfort after insertion. The catheter cannula is radiopaque and incrementally marked to indicate the effective insertion length of the device in centimeters (cm). This cannula is extruded with three independent, non-communicating inner lumens. The lumens are made accessible within the cannula via luer-fitted silicone extension legs on the proximal end of the device, alongside a rigid polyurethane hub marked with the catheter's size in French (Fr) and effective insertion length that is fitted with a freely rotating suture wing. The clear outer extension legs are fitted with red and blue occlusion clamps, which are marked on either face with the lumen's priming volume in milliliters (mL), and respectively identify arterial and venous lumens. The medial, colored, extension leg is fitted with a purple occlusion clamp that is similarly marked with priming volume on its dorsal face, and marked with the maximum flow rate (in cubic centimeters [cc]) and injection pressure (in pounds per square inch [psi]) recommended for power-injected fluids on its ventral face. The distal end of the device is thermally bonded to a flexible, symmetrically tapered tip, which allows for direct outflow, and is skived on the radial and ulnar sides of the cannula.

The size configuration for the Power Acute Triple Lumen Hemodialysis Catheter is shown in the following table.

| SUBJECT DEVICE CONFIGURATION | | | | | |
|------------------------------|-------------|----|----|----|----|
| SIZE (Fr) | LENGTH (cm) | | | | |
| 12 | 12 | 15 | 20 | 24 | 30 |

The Power Acute Triple Lumen Hemodialysis Catheter is intended for short INTENDED USE term central venous access for hemodialysis, apheresis, infusion, central venous pressure monitoring, and pressure injection of contrast media. The

{5}------------------------------------------------

maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.

#### The Power Acute Triple Lumen Hemodialysis Catheter is indicated for short term central venous access for hemodialysis, apheresis, infusion, central INDICATIONS venous pressure monitoring, and pressure injection of contrast media. The FOR USE maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.

Subject Device: Power Acute Triple Lumen Hemodialysis Catheter Predicate Device: Mahurkar™ Triple Lumen Dialysis Catheter (K102605)

| | ATTRIBUTES | SUBJECT DEVICE | PREDICATE DEVICE | | |
|-----------------------------------|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|-------------------------------------------|
| TECHNOLOGICAL<br>CHARACTERISTICS | Intended use | The Power Acute Triple<br>Lumen Hemodialysis<br>Catheter is intended for<br>short term central<br>venous access for<br>hemodialysis, apheresis,<br>infusion, central venous<br>pressure monitoring,<br>and pressure injection<br>of contrast media. The<br>maximum<br>recommended infusion<br>rate is 5 mL/sec for<br>power injection of<br>contrast media. | The Mahurkar™ Triple<br>Lumen Dialysis<br>Catheter is intended<br>for short term central<br>venous access for<br>hemodialysis,<br>apheresis, infusion,<br>central venous<br>pressure monitoring<br>and pressure injection<br>of contrast media. The<br>maximum<br>recommended infusion<br>rate is 5 mL/sec for<br>power injection of<br>contrast media. | | |
| | | | Intended duration | Short term (< 30 days) | Short term (< 30 days) |
| | | | Intended treatment | Acute condition | Acute condition |
| | | | Prescription device | Yes | Yes |
| | | | Insertion sites | Internal jugular<br>Subclavian<br>Femoral | Internal jugular<br>Subclavian<br>Femoral |
| | | | Insertion technique | Seldinger (Over the<br>guidewire) | Seldinger (Over the<br>guidewire) |
| | | | Intended<br>population | Adults | Adults |
| | | | Catheter size | 12 Fr | 12 Fr |
| | | | Catheter OD | 4.20 mm | 4.15 mm |
| | Catheter lengths<br>available (cm) | 12, 15, 20, 24, 30 | 13, 16, 20, 24 | | |
| | Catheter length for<br>comparison | 24 cm | 24 cm | | |
| | | | | | |
| Catheter shaft effective length | 24 cm | 24 cm | | | |
| Insertion markings | Every centimeter | None | | | |
| Catheter shaft material | Polyurethane | Polyurethane | | | |
| Catheter/Extension configuration | Straight Extensions<br>Curved Extensions | Straight Extensions<br>Curved Extensions | | | |
| Catheter cuffed | No | No | | | |
| Tip design | Symmetrical soft tapered tip | Symmetrical soft tapered tip | | | |
| Tip placement | The distal tip should be located just before the junction of the superior vena cava and the right atrium | The distal tip should be located just before the junction of the superior vena cava and the right atrium | | | |
| Number of lumens | 3 | 3 | | | |
| Lumen identification | Color coded clamps:<br>Red (Arterial)<br>Blue (Venous)<br>Purple (Medial) | Color coded luer connectors:<br>Red (Arterial)<br>Blue (Venous)<br>Clear (Medial) | | | |
| Extension legs (Venous, Arterial) | Silicone | Silicone | | | |
| Extension leg (Medial) | Polyurethane | Polyurethane | | | |
| Cross-section geometry | Modified Double “D” with Center Lumen | Modified Double “D” with Off-Center Lumen | | | |
| Sterilization method | Ethylene Oxide | Ethylene Oxide | | | |
| Method of use | Single use | Single use | | | |
| Shelf life | 3 years | 5 years | | | |
| Primary packaging | Tyvek Tray | Tyvek Tray | | | |
| Catheter side openings | 4 holes | 2 holes<br>1 slot | | | |
| Luer Connectors | ISO 594-1 Compatible | ISO 594-1 Compatible | | | |
| Non-Pyrogenic | Yes | Yes | | | |
| Made with latex rubber | No | No | | | |
| Made with DEHP | No | No | | | |
| Power Injection (PI) | Yes | Yes | | | |
| Max PI infusion rate | 5 mL/sec | 5 mL/sec | | | |
| Max PI pressure | 300 psi | 300 psi | | | |

{6}------------------------------------------------

510(k) Premarket Notification Submission: Power Acute Triple Lumen Hemodialysis Catheter

{7}------------------------------------------------

The subject device has similar technological characteristics as compared to the predicate device. Differences, if any, are not critical to the intended use of the subject device (see Section 12.7, Substantial Equivalence Discussion) and do not raise new questions regarding safety and effectiveness.

The Power Acute Triple Lumen Hemodialysis Catheter followed verification and validation activities in accordance with Design Controls as per 21 CFR Section 820.30.

Bench testing was conducted in accordance with FDA-recognized consensus standards to evaluate the performance of the subject device on:

- Air Leakage -
- Liquid Leakage -
- Tensile Strength -
- Catheter Flow Rate -
- Priming Volume -
- -Kinking

-

-

- Repeated Clamping -
- Conical Luer Lock Fittings -
- -Surface Appearance
- Chemical Tolerance -
- Power Injection Performance -
- Static Burst Pressure -

## SAFETY AND PERFORMANCE

- Recirculation Rate Central Venous Pressure Monitoring -
Pressure vs Flow Rate

- TESTING
Functional testing was conducted in accordance with ISO 11135 and ISO 11607-1 to evaluate sterilization and shelf life of the subject device.

Biocompatibility testing and assessment was conducted in accordance with ISO 10993-1 to evaluate the subject device on:

- Cytotoxicity -
- -Sensitization
- -Irritation or Intracutaneous Reactivity
- Acute Systemic Toxicity -
- Material Mediated Pyrogen -
- Bacterial Endotoxin Testing -
- -Subacute Toxicity
- Subchronic Toxicity -
- Genotoxicity -
- Intramuscular Implantation -
- Hemocompatibility, Hemolysis Direct Contact -
- -Hemocompatibility, Hemolysis Indirect Contact

{8}------------------------------------------------

Hemocompatibility, Thrombogenicity In Vitro Blood Loop Assay --Hemocompatibility, Complement Activation Hemocompatibility, Mechanically Induced Hemolysis -Chronic Toxicity --Carcinogenicity Results of the functional, performance and biocompatibility testing support the determination of substantial equivalence. In accordance with FDA 21 CFR Section 807.92, and based on the indications for use, technological characteristics, and safety and performance testing, SUMMARY OF the subject Power Acute Triple Lumen Hemodialysis Catheter met the minimum requirements that are considered adequate for its intended use SUBSTANTIAL EQUIVALENCE and is substantially equivalent in design, materials, sterilization, principles of operation, and indications for use to the currently marketed predicate device.