(307 days)
No
The device description and performance studies focus on the physical properties, functional performance, and biocompatibility of a hemodialysis catheter, with no mention of AI or ML technology.
Yes.
The device is indicated for short-term central venous access for hemodialysis, apheresis, and infusion, all of which are considered therapeutic interventions.
No
This device is a catheter used for central venous access for therapies like hemodialysis, apheresis, and infusion. It is an instrument for delivering or removing substances from the body, not for diagnosing a condition.
No
The device description clearly details a physical catheter made of polyurethane and silicone, with specific physical features and components. The performance studies also focus on the physical properties and biocompatibility of the material and device. There is no mention of any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "short-term central venous access for hemodialysis, apheresis, and infusion." This describes a device used in vivo (within the body) to facilitate medical procedures, not a device used in vitro (outside the body) to examine specimens from the body.
- Device Description: The description details a catheter designed for insertion into veins, with lumens for blood flow and infusion. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
Therefore, this device is a medical device used for therapeutic and procedural purposes, not an IVD.
N/A
Intended Use / Indications for Use
The Acute Dual Lumen Hemodialysis Catheter is indicated for short-term central venous access for hemodialysis, apheresis, and infusion.
Product codes
MPB
Device Description
The Acute Dual Lumen Hemodialysis Catheter is manufactured from thermal reactive polyurethane material known for its rigidity at room temperature which allows bedside insertion, and softness at body temperature minimizing the risk of vein perforation and improving patient comfort after insertion. The catheter shaft is made of radiopaque polyurethane with two independent, non-communicating inner lumens, where the distal end of the catheter, with arranged outflow eyelets, extends to a symmetrical tip configuration. The proximal end of the catheter shaft joins to a polyurethane hub assembly having each inner lumen connected to individual extension tubes. The extension tubes are made of silicone material and are identified by color coded occlusion clamps. The red clamp identifies the lumen which provides "arterial" outflow from the patient, the blue clamp identifies the lumen which provides "venous" inflow return when used for hemodialysis, apheresis and infusion. Lumen priming volume is printed on each ID tag clamp insert, and catheter size and length are printed in the hub. Centimeter markings are placed along the length of the indwelling portion of the catheter body to facilitate proper positioning.
The size configuration for the Acute Dual Lumen Hemodialysis Catheter is shown in the following table:
SIZE (Fr): 12
LENGTH (cm): 12, 15, 20, 24, 30
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Central venous access, Internal jugular, Subclavian, Femoral. The distal tip should be located just before the junction of the superior vena cava and the right atrium.
Indicated Patient Age Range
Adults
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was conducted in accordance with FDA recognized 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
-Recirculation Rate
-Pressure vs Flow Rate
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
-Hemocompatibility, Thrombogenecity 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5540 Blood access device and accessories.
(a)
Identification. A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.(1) The implanted blood access device is a prescription device and consists of various flexible or rigid tubes, such as catheters, or cannulae, which are surgically implanted in appropriate blood vessels, may come through the skin, and are intended to remain in the body for 30 days or more. This generic type of device includes various catheters, shunts, and connectors specifically designed to provide access to blood. Examples include single and double lumen catheters with cuff(s), fully subcutaneous port-catheter systems, and A-V shunt cannulae (with vessel tips). The implanted blood access device may also contain coatings or additives which may provide additional functionality to the device.
(2) The nonimplanted blood access device consists of various flexible or rigid tubes, such as catheters, cannulae or hollow needles, which are inserted into appropriate blood vessels or a vascular graft prosthesis (§§ 870.3450 and 870.3460), and are intended to remain in the body for less than 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle).
(3) Accessories common to either type include the shunt adaptor, cannula clamp, shunt connector, shunt stabilizer, vessel dilator, disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, joint ring, fistula adaptor, and declotting tray (including contents).
(b)
Classification. (1) Class II (special controls) for the implanted blood access device. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided.
(ii) Performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(A) Pressure versus flow rates for both arterial and venous lumens, from the minimum flow rate to the maximum flow rate in 100 milliliter per minute increments, must be established. The fluid and its viscosity used during testing must be stated.
(B) Recirculation rates for both forward and reverse flow configurations must be established, along with the protocol used to perform the assay, which must be provided.
(C) Priming volumes must be established.
(D) Tensile testing of joints and materials must be conducted. The minimum acceptance criteria must be adequate for its intended use.
(E) Air leakage testing and liquid leakage testing must be conducted.
(F) Testing of the repeated clamping of the extensions of the catheter that simulates use over the life of the device must be conducted, and retested for leakage.
(G) Mechanical hemolysis testing must be conducted for new or altered device designs that affect the blood flow pattern.
(H) Chemical tolerance of the device to repeated exposure to commonly used disinfection agents must be established.
(iii) Performance data must demonstrate the sterility of the device.
(iv) Performance data must support the shelf life of the device for continued sterility, package integrity, and functionality over the requested shelf life that must include tensile, repeated clamping, and leakage testing.
(v) Labeling of implanted blood access devices for hemodialysis must include the following:
(A) Labeling must provide arterial and venous pressure versus flow rates, either in tabular or graphical format. The fluid and its viscosity used during testing must be stated.
(B) Labeling must specify the forward and reverse recirculation rates.
(C) Labeling must provide the arterial and venous priming volumes.
(D) Labeling must specify an expiration date.
(E) Labeling must identify any disinfecting agents that cannot be used to clean any components of the device.
(F) Any contraindicated disinfecting agents due to material incompatibility must be identified by printing a warning on the catheter. Alternatively, contraindicated disinfecting agents must be identified by a label affixed to the patient's medical record and with written instructions provided directly to the patient.
(G) Labeling must include a patient implant card.
(H) The labeling must contain comprehensive instructions for the following:
(
1 ) Preparation and insertion of the device, including recommended site of insertion, method of insertion, and a reference on the proper location for tip placement;(
2 ) Proper care and maintenance of the device and device exit site;(
3 ) Removal of the device;(
4 ) Anticoagulation;(
5 ) Management of obstruction and thrombus formation; and(
6 ) Qualifications for clinical providers performing the insertion, maintenance, and removal of the devices.(vi) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices that include subcutaneous ports must include the following:
(A) Labeling must include the recommended type of needle for access as well as detailed instructions for care and maintenance of the port, subcutaneous pocket, and skin overlying the port.
(B) Performance testing must include results on repeated use of the ports that simulates use over the intended life of the device.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(vii) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices with coatings or additives must include the following:
(A) A description and material characterization of the coating or additive material, the purpose of the coating or additive, duration of effectiveness, and how and where the coating is applied.
(B) An identification in the labeling of any coatings or additives and a summary of the results of performance testing for any coating or material with special characteristics, such as decreased thrombus formation or antimicrobial properties.
(C) A Warning Statement in the labeling for potential allergic reactions including anaphylaxis if the coating or additive contains known allergens.
(D) Performance data must demonstrate efficacy of the coating or additive and the duration of effectiveness.
(viii) The following must be included for A-V shunt cannulae (with vessel tips):
(A) The device must comply with Special Controls in paragraphs (b)(1)(i) through (v) of this section with the exception of paragraphs (b)(1)(ii)(B), (b)(1)(ii)(C), (b)(1)(v)(B), and (b)(1)(v)(C), which do not apply.
(B) Labeling must include Warning Statements to address the potential for vascular access steal syndrome, arterial stenosis, arterial thrombosis, and hemorrhage including exsanguination given that the device accesses the arterial circulation.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(2) Class II (performance standards) for the nonimplanted blood access device.
(3) Class II (performance standards) for accessories for both the implanted and the nonimplanted blood access devices not listed in paragraph (b)(4) of this section.
(4) Class I for the cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, and joint ring, accessories for both the implanted and nonimplanted blood access device. The devices subject to this paragraph (b)(4) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 24, 2020
Health Line International Corporation Aaron Faulkner Director of Engineering 5675 West 300 South Salt Lake City, UT 84104
Re: K200426
Trade/Device Name: Acute Dual Lumen Hemodialysis Catheter Regulation Number: 21 CFR 876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: MPB Dated: November 23, 2020 Received: November 25, 2020
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. 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. 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.
1
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.
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 (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 Ouality Center for Devices and Radiological Health
Enclosure
2
510(k) Premarket Notification Submission: Acute Dual Lumen Hemodialysis Catheter
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: 06/30/2020 |
| Indications for Use | See PRA Statement below. |
| 510(k) Number (if known) | K200426 |
|---|---|
| Device Name | Acute Dual Lumen Hemodialysis Catheter |
| Indications for Use (Describe) | The Acute Dual Lumen Hemodialysis Catheter is indicated 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)
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 PRAStaff@fda.hhs.gov
"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 (7/17)
3
510(k) SUMMARY
(21 CFR 807.92)
| Name: | Health Line International Corporation | |
|---|---|---|
| Address: | 5675 West 300 South | |
| Salt Lake City, Utah 84104 | ||
| FDA Registration #: | 3010882065 | |
| Contact Name: | Aaron G. Faulkner | |
| SUBMITTER | Director of Engineering | |
| Telephone: | 801-773-7798 Ext. 109 | |
| Fax: | 855-228-1336 | |
| Email: | agfaulkner@hlic.net | |
| Date Prepared: | February 19, 2020 | |
| SUBJECT | ||
| DEVICE | Name: | Acute Dual Lumen Hemodialysis Catheter |
| Regulation Name: | Blood access device and accessories | |
| Classification Name: | Catheter, Hemodialysis, Non-Implanted | |
| Classification Panel: | Gastroenterology/Urology | |
| Regulatory Class: | Class II | |
| Product Code: | MPB | |
| Regulation Number: | 21 CFR 876.5540 | |
| PREDICATE | ||
| DEVICE | Name: | Mahurkar™ Elite Acute Dual Lumen Catheter |
| (K120674) by Covidien LLC | ||
| Regulation Name: | Blood access device and accessories | |
| 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 K120674 | |
| REFERENCE | ||
| DEVICE | Name: | Niagara™ Slim-Cath® Short-Term Dialysis |
| Catheter (K010778) by C.R. Bard, INC | ||
| Regulation Name: | Blood access device and accessories | |
| 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 K010778 | |
| DEVICE | ||
| DESCRIPTION | The Acute Dual Lumen Hemodialysis Catheter is manufactured from | |
| thermal reactive polyurethane material known for its rigidity at room |
4
temperature which allows bedside insertion, and softness at body temperature minimizing the risk of vein perforation and improving patient comfort after insertion. The catheter shaft is made of radiopaque polyurethane with two independent, non-communicating inner lumens, where the distal end of the catheter, with arranged outflow eyelets, extends to a symmetrical tip configuration. The proximal end of the catheter shaft joins to a polyurethane hub assembly having each inner lumen connected to individual extension tubes. The extension tubes are made of silicone material and are identified by color coded occlusion clamps. The red clamp identifies the lumen which provides "arterial" outflow from the patient, the blue clamp identifies the lumen which provides "venous" inflow return when used for hemodialysis, apheresis and infusion. Lumen priming volume is printed on each ID tag clamp insert, and catheter size and length are printed in the hub. Centimeter markings are placed along the length of the indwelling portion of the catheter body to facilitate proper positioning.
The size configuration for the Acute Dual Lumen Hemodialysis Catheter is shown in the following table:
| SUBJECT DEVICE CONFIGURATION | |||||
|---|---|---|---|---|---|
| SIZE (Fr) | LENGTH (cm) | ||||
| 12 | 12 | 15 | 20 | 24 | 30 |
| INTENDED USE | The Acute Dual Lumen Hemodialysis Catheter is intended to be used for
short-term central venous access for hemodialysis, apheresis, and
infusion. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INDICATIONS
FOR USE | The Acute Dual Lumen Hemodialysis Catheter is indicated for short-term
central venous access for hemodialysis, apheresis, and infusion. |
| TECHNOLOGICAL
CHARACTERISTICS | 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, Substantial Equivalence
Discussion) and do not raise new questions regarding safety and
effectiveness.
Subject Device: Acute Dual Lumen Hemodialysis Catheter
Predicate Device: Mahurkar™ Elite Acute Dual Lumen Catheter (K120674) |
5
Health Line International Corporation
510(k) Premarket Notification Submission: Acute Dual Lumen Hemodialysis Catheter
| ATTRIBUTES | SUBJECT DEVICE | PREDICATE DEVICE |
|---|---|---|
| Intended use | The Acute Dual Lumen | |
| Hemodialysis Catheter | ||
| is intended to be used | ||
| for short-term central | ||
| venous access for | ||
| hemodialysis, | ||
| apheresis, and | ||
| infusion. | The Mahurkar™ Elite | |
| Acute Dual Lumen | ||
| Catheter is intended to | ||
| be used for short-term | ||
| central venous access | ||
| for hemodialysis, | ||
| apheresis, and infusion. | ||
| Intended duration | Short term ( |