(526 days)
Not Found
No
The device description and performance studies focus on the physical components and standard performance testing of a blood tubing set for hemodialysis, with no mention of AI or ML capabilities.
Yes
The device is described as a "Blood Tubing Set" intended for "acute and chronic hemodialysis therapy," which is a medical treatment.
No
The device description clearly states its mechanical function in transporting blood during hemodialysis and makes no mention of diagnostic capabilities, such as measuring or analyzing bodily fluids for diagnostic purposes.
No
The device description clearly states it is a "single-use, ethylene oxide (EO) sterilized blood tubing set" and part of the "extracorporeal hemodialysis circuit," indicating it is a physical hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for use with a hemodialyzer and hemodialysis machines to transport blood during hemodialysis therapy. This is a therapeutic procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The description details its role in the extracorporeal circuit for transporting blood, which is a functional component of the hemodialysis process.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This blood tubing set facilitates a treatment, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Blood Tubing Set is a sterile, single use, disposable indicated for use with a prescribed hemodialyzer. For use with a compatible hemodialyzer, as per the labeling.
The Blood Tubing Set is intended for acute and chronic hemodialysis therapy.
The Blood Tubing Set is intended to be used with Fresenius Medical Care 2008® Series K, K2 and T Hemodialysis Machines.
Product codes
FJK
Device Description
The CombiSet Bloodline is a single-use, ethylene oxide (EO) sterilized blood tubing set. The CombiSet Bloodline is part of the extracorporeal hemodialysis circuit. During hemodialysis, the extracorporeal circuit 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
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used in environments where acute and chronic hemodialysis are performed.
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: Performance testing
Sample Size: Not specified.
Standalone performance: Not specified.
Key results: All testing met predetermined acceptance criteria. Results of the proposed device's design verification tests met the requirements and demonstrated that, like the predicate device, the CombiSet Bloodline is safe and effective for its intended use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 31, 2023
Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann Senior Director, Regulatory Affairs 920 Winter Street Waltham, MA 02451
Re: K213992
Trade/Device Name: CombiSet Hemodialysis Blood Tubing Set Regulation Number: 21 CFR§ 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FJK Dated: April 28, 2023 Received: May 1, 2023
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. 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.
1
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-regulatoryinformation/postmarketing-safety-reporting-combination-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 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,
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
Indications for Use
510(k) Number (if known)
K213992
Device Name CombiSet Hemodialysis Blood Tubing Set
Indications for Use (Describe)
The Blood Tubing Set is a sterile, single use, disposable indicated for use with a prescribed hemodialyzer. For use with a compatible hemodialyzer, as per the labeling.
The Blood Tubing Set is intended for acute and chronic hemodialysis therapy.
The Blood Tubing Set is intended to be used with Fresenus Medical Care 2008® Series K, K2 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) |
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."
3
Image /page/3/Picture/0 description: The image contains the logo for Fresenius Medical Care. On the left side of the logo is a blue symbol that consists of three downward-pointing chevrons stacked on top of each other. To the right of the symbol, the words "FRESENIUS" and "MEDICAL CARE" are written in blue, with "FRESENIUS" on top and "MEDICAL CARE" on the bottom.
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) 996-9103 |
| Fax: | (781) 699-9635 |
| Contact Person: | Denise Oppermann, Senior Director |
| Preparation Date: | 20 December 2021 |
5.2. Device Name
| Trade Name: | CombiSet Hemodialysis Blood Tubing Set |
|---|---|
| Common Name: | Blood Tubing Set |
| Regulation Name: | Hemodialysis system and accessories |
| Regulatory Class: | Class II per 21 CFR § 876.5820 |
| Product Code: | FJK |
| Product Code Name: | Set, Tubing, Blood, With and Without Anti-regurgitation Valve |
| FDA Review Panel: | Gastroenterology/Urology |
5.3. Legally Marketed Predicate Device
The legally marketed predicate device is the CombiSet SMARTECH Hemodialysis Blood Tubing Sets (hereinafter referred to as "CombiSet SMARTECH") cleared under K201207. The predicate device has not been subject to a design-related recall.
Device Description 5.4.
5.4.1. Device Identification
The CombiSet Hemodialysis Blood Tubing Set (hereinafter referred to as "CombiSet Bloodline") is the subject of this 510(k).
5.4.2. Device Characteristics
The CombiSet Bloodline is a single-use, ethylene oxide (EO) sterilized blood tubing set.
4
Image /page/4/Picture/0 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
5.4.3. Environment of Use
The CombiSet Bloodline is used in environments where acute and chronic hemodialysis are performed.
5.4.4. Brief Written Description of the Device
The CombiSet Bloodline is part of the extracorporeal hemodialysis circuit. During hemodialysis, the extracorporeal circuit 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.
Materials of Use 5.4.5.
The CombiSet Bloodline is classified as externally communicating, circulating blood, prolonged contact (> 24 hours to 30 days) duration. Class II (Category B) device in accordance with FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (4 September 2020).
The materials used for each component of the CombiSet Bloodline are listed in Table 1.
| Component | Material |
|---|---|
| Tubing and Components | Polyvinylchloride (PVC) |
| Polypropylene (PP) | |
| Polyethylene (PE) | |
| Methylmethacrylate acrylonitrile butadiene styrene (MABS) | |
| Polyisoprene | |
| Transducer Protector | Polypropylene (PP) |
| Polytetrafluoroethylene (PFTE) on Polyester | |
| Bonding Solvents | Cyclohexanone |
| TetraMEK (95% Tetrahydrofuran/5% MEK) |
Table 1: Materials of Composition
5.4.6. Key Performance Specifications/Characteristic
The key performance specifications of the CombiSet Bloodline are outlined in Table 2.
Table 2: Key Performance Specifications/Characteristics
| Feature | Specification |
|---|---|
| Maximum Blood Flow Rate | 600 mL/min |
| Maximum Arterial Pressure | -300 mmHg |
| Maximum Venous Pressure | +500 mmHg |
| Pump Segment [Inner/Outer Diameter (ID/OD)] | 8.0 mm/12.0 mm |
5
Image /page/5/Picture/0 description: The image contains the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left, which is made up of three downward-pointing chevrons stacked on top of each other. To the right of the symbol, the words "FRESENIUS MEDICAL CARE" are written in blue, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
5.5. Intended Use
The CombiSet Bloodline is intended for use in acute and chronic hemodialysis therapy.
Indications for Use 5.6.
The Blood Tubing Set is a sterile, single use, disposable indicated for use with a prescribed hemodialyzer. For use with a compatible hemodialyzer, as per the labeling.
The Blood Tubing Set is intended for acute and chronic hemodialysis therapy.
The Blood Tubing Set is intended to be used with Fresenius Medical Care 2008® Series K. K2 and T Hemodialysis Machines.
5.7. Comparison of Technological Characteristics with the Predicate Device
The following technological characteristics of the CombiSet Bloodline are equivalent to those of the predicate CombiSet SMARTECH (K201207):
- Indications for Use
- Principle of Operation
- Technological Characteristics
- Design
- Performance Requirements
5.8. Sterilization Testing
The CombiSet Bloodline is sterilized by exposure to 100% ethylene oxide (EO). The sterility assurance level (SAL) is 10-6. Sterility and non-pyrogenicity are claimed for the fluid pathway of the bloodline.
EO Residual Testing 5.8.1.
Residual testing for EO and ethylene chlorohydrin (ECh) was performed in accordance with AAMI/ANSI/ISO 10993-7:2008/(R)2012 Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals. Acceptable results (i.e.,