(141 days)
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No
The document describes a blood tubing set and an access flow reversing connector for hemodialysis. There is no mention of AI or ML in the intended use, device description, or performance studies. The device appears to be a mechanical and fluidic system.
Yes
The device is a blood tubing set used for hemodialysis therapy, which is a medical treatment designed to remove waste products and excess fluid from the blood. This directly treats a patient's condition (kidney failure), therefore qualifying it as a therapeutic device.
No
The device is a blood tubing set used for hemodialysis therapy and includes a connector for facilitating access flow measurements, but it is not described as performing a diagnostic function itself. The access flow measurement is a test procedure, which implies that the device is an accessory to a diagnostic test rather than being a diagnostic device.
No
The device description clearly states it is a "blood tubing set" and part of the "hemodialysis extracorporeal circuit," which are physical components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a blood tubing set used in hemodialysis to transport blood from the patient through a hemodialyzer and back. This is a therapeutic process, not a diagnostic one.
- Device Description: The description reinforces its role in the extracorporeal circuit for hemodialysis, again focusing on blood transport for treatment.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze blood or other biological samples to provide information for diagnosis, monitoring, or screening. The Access Flow Reversing Connector is for a measurement during the therapeutic process, not for a diagnostic test on a sample.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health status. This device facilitates a treatment, not a diagnostic test.
N/A
Intended Use / Indications for Use
CAREline Twister:
The blood tubing set is indicated for use with a prescribed hemodialyzer. The suitability of a particular bloodline/ hemodialyzer configuration is the responsibility of the physician.
· The Blood Tubing Set is intended for acute and chronic hemodialysis therapy.
• The Fresenius Access Flow Reversing Connector (AFRC) is for use during hemodialysis to reverse the blood flow to and from the arterial and venous vascular access devices during hemodialysis in order to obtain an access flow measurement. The AFRC facilitates the test procedure by eliminating the need to disconnect bloodlines during the test procedure.
· Blood Tubing Set is intended to be used with the Fresenus Medical Care 2008® Series, K, K2 and T Hemodialysis Machines.
CAREline Standard:
The blood tubing set is indicated for use with a prescribed hemodialyzer. The suitability of a particular bloodline/ hemodialyzer configuration is the resonsiblity of the physician.
• The Blood Tubing Set is intended for acute and chronic hemodialysis therapy.
· Blood Tubing Set is intended to be used with the Fresenus Medical Care 2008® Series, K, K.2 and T Hemodialysis Machines.
Product codes (comma separated list FDA assigned to the subject device)
KOC, FJK
Device Description
The CAREline bloodlines are intended for use in acute and chronic hemodialysis therapy. The bloodline is part of the hemodialysis extracorporeal circuit, which transports arterial blood from the patient's arterial access (e.g., fistula or catheter) through a hemodialyzer and back to the patient's venous access.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted in accordance with ISO 8638:2010. Results of the testing listed below support the determination of substantial equivalence.
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Performance testing of connectors (hemodialyzer, vascular access device, and ancillary components)
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. Structural integrity testing
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Biological safety testing (biocompatibility) .
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. Sterility and pyrogenicity testing
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. Structural integrity - Pressure and pull testing
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Pressure testing Access ports and pressure output devices (PODs) ●
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Endurance testing Conducted with Fresenius Medical Care 2008® Series K, K2, . and T Hemodialysis Machines
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Clamp testing Ability to occlude and effects of repeated use .
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. Usability evaluation
Biocompatibility Testing:
The following testing was performed to support the biological safety of the CAREline bloodlines:
- Chemical analysis Extractables and leachables ●
- Cytotoxicity
- Sensitization ●
- Irritation ●
- Systemic Toxicity ●
- Material Mediated Pyrogenicity
- Genotoxicity
- Hemocompatibility .
A toxicological risk assessment was also performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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December 14, 2017
Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann Senior Director, Regulatory Affairs 920 Winter Street Waltham, MA 02451
Re: K172238
Trade/Device Name: CAREline Airless Hemodialysis Blood Tubing Sets Regulation Number: 21 CFR& 876.5820 Regulation Name: Hemodialysis System and Accessories Regulatory Class: II Product Code: KOC, FJK Dated: November 10. 2017 Received: November 13, 2017
Dear Denise Oppermann:
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. 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.
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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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Charles Viviano -S
Benjamin R. Fisher, Ph.D. For Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172238
Device Name
CAREline Airless Hemodialysis Blood Tubing Sets
Indications for Use (Describe)
CAREline Twister:
The blood tubing set is indicated for use with a prescribed hemodialyzer. The suitability of a particular bloodline/ hemodialyzer configuration is the responsibility of the physician.
· The Blood Tubing Set is intended for acute and chronic hemodialysis therapy.
• The Fresenius Access Flow Reversing Connector (AFRC) is for use during hemodialysis to reverse the blood flow to and from the arterial and venous vascular access devices during hemodialysis in order to obtain an access flow measurement. The AFRC facilitates the test procedure by eliminating the need to disconnect bloodlines during the test procedure.
· Blood Tubing Set is intended to be used with the Fresenus Medical Care 2008® Series, K, K2 and T Hemodialysis Machines.
CAREline Standard:
The blood tubing set is indicated for use with a prescribed hemodialyzer. The suitability of a particular bloodline/ hemodialyzer configuration is the resonsiblity of the physician.
• The Blood Tubing Set is intended for acute and chronic hemodialysis therapy.
· Blood Tubing Set is intended to be used with the Fresenus Medical Care 2008® Series, K, K.2 and T Hemodialysis Machines.
| 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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K172238 Page 1 of 6
5. 510(K) SUMMARY
This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR 807.92.
5.1. Submitter's Information
| Name: | Fresenius Medical Care Renal Therapies Group, LLC |
|---|---|
| Address: | 920 Winter Street |
| Waltham, MA | |
| 02451-1457 | |
| Phone: | (781) 699-4479 |
| Fax: | (781) 699-9635 |
| Contact Person: | Denise Oppermann, Senior Director |
| Regulatory Affairs – Devices | |
| Preparation Date: | 24 July 2017 |
5.2. Device Name
| Trade Name: | CAREline Airless Hemodialysis Blood Tubing Set |
|---|---|
| Common Name: | KOC – Accessories, Blood Circuit, |
| Hemodialysis | |
| FJK - Set, Tubing, Blood, With and Without | |
| Anti-regurgitation Valve | |
| Classification Name : | Hemodialysis system and accessories |
| Regulatory Class: | Class II per 21 CFR 876.5820 |
| Product Code: | KOC / FJK |
| Classification Panel: | Gastroenterology-Urology |
5.3. Legally Marketed Predicate Device
Primary Predicate - CombiSet® Blood Tubing with Access Flow 5.3.1. Reversing Connector (Twister®)
CombiSet Blood Tubing with Access Flow Reversing Connector (Twister), K022536, is the primary predicate for the CAREline Airless Hemodialysis Blood Tubing Sets (hereafter referred to as "CAREline bloodlines").
Secondary Predicate - Streamline Airless System Set with Locksite® 5.3.2. Needleless Access Site
Streamline Airless System Set with Locksite Needleless Access Site, K080807, is the secondary predicate for the CAREline bloodlines.
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K172238 Page 2 of 6
5.4. Device Description
The CAREline bloodlines are intended for use in acute and chronic hemodialysis therapy. The bloodline is part of the hemodialysis extracorporeal circuit, which transports arterial blood from the patient's arterial access (e.g., fistula or catheter) through a hemodialyzer and back to the patient's venous access.
5.4.1. Device Identification
The proposed CAREline bloodlines include the following devices (Table 1):
Table 1: Proposed CAREline Bloodlines
| Product | Alternate name |
|---|---|
| CAREline Airless Hemodialysis Blood Tubing Set with | |
| Attached Priming Set | CAREline Standard bloodline |
| CAREline Airless Hemodialysis Blood Tubing Set with | |
| Access Flow Reversing Connector (Twister) and Attached | |
| Priming Set | CAREline Twister® bloodline |
5.4.2. Environment of Use
The CAREline bloodlines are used in environments where acute and chronic hemodialysis are performed.
5.4.3. Brief Written Description of the Device
The CAREline bloodlines are intended for use in acute and chronic hemodialysis therapy. The bloodline is part of the hemodialysis extracorporeal circuit, which transports arterial blood from the patient's arterial access (e.g., fistula or catheter) through a hemodialyzer and back to the patient's venous access.
5.4.4. Materials of Use
The CAREline bloodlines are classified as an external communicating medical device with prolonged exposure (>24 hours