(88 days)
Not Found
No
The summary describes a standard hemodialysis blood tubing set and its function within a hemodialysis machine. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The "BVM Module" is mentioned, but its function is described as "monitoring patient blood volume," which is a standard physiological monitoring task, not indicative of AI/ML.
No
The device is a bloodline set for hemodialysis, which transports blood to and from a hemodialyzer. While it's part of a life-sustaining therapy, it does not directly treat a disease or condition; rather, it facilitates the hemodialysis process performed by the hemodialyzer and machine.
No
The primary function of the device is to provide extracorporeal access for blood transport during hemodialysis and to monitor patient blood volume with a BVM module, not to diagnose a disease or condition. It is a blood tubing set used for treatment, not diagnosis.
No
The device description clearly outlines physical components like tubing, a priming set, transducer protectors, a pump segment, and interfaces to machine safety mechanisms, indicating it is a 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 that the device is a "single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis." It's used to transport blood outside the body through a hemodialyzer and back to the patient.
- Device Description: The description reinforces this by explaining its role in the "extracorporeal circuit" and its interaction with the hemodialysis machine.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. It's a component of a therapeutic process (hemodialysis), not a diagnostic test.
IVD devices are typically used to analyze samples like blood, urine, or tissue to detect diseases, conditions, or infections. This device's function is purely mechanical and related to blood transport during a treatment.
N/A
Intended Use / Indications for Use
The Blood Volume Monitor (BVM) Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis. The set is intended for use with a prescribed hemodialyzer.
The BVM Hemodialysis Blood Tubing Set is intended for acute and chronic hemodialysis therapy. The set is intended for use with the Fresenius 2008 Series Hemodialysis Machines equipped with a BVM Module for monitoring patient blood volume during hemodialysis.
Product codes (comma separated list FDA assigned to the subject device)
FJK
Device Description
The Fresenius Blood Volume Monitor (BVM) Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors, Catalog number 03-2795-7 (BVM Bloodline) is designed to work with Fresenius 2008 Series Hemodialysis Machines equipped with a BVM Module.
The bloodline is a part of the extracorporeal circuit by which blood is transported from the patient through a hemodialyzer and back to the patient. The pump segment of the bloodline interfaces with the pump rotor mechanism of the hemodialysis machine which drives the flow of blood through the circuit. The bloodline contains interfaces to the machine safety mechanisms to ensure proper operation. These include transducer monitor lines for arterial and venous pressure monitoring, as well as a venous chamber for the detection of air in the blood path.
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
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was selected through the application of a risk management process, appropriate guidance documents and relevant standards. The results of the validation and verification testing have provided a sound basis for comparison to the predicate bloodline. The following are an example of some of the tests performed to support the determination of substantial equivalence:
- Biological safety - biocompatibility testing
- Sterility and nonpyrogenicity testing
- Structural integrity - pressure and pull testing
- Performance testing of connectors (hemodialyzer, vascular access device and ancillary components) - pressure/dimensional
- Needle access ports- pressure testing after repeated use
- Transducer protectors- pressure testing
- Endurance testing of the complete bloodline using specified hemodialysis machines
- Clamp testing- ability to occlude and effects of repeated use
- Usability evaluation
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.
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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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JUN 1 5 2012
Image /page/0/Picture/1 description: The image shows the logo for Fresenius Medical Care. The logo consists of a stylized downward-pointing chevron made up of three stacked lines on the left. To the right of the chevron are the words "FRESENIUS MEDICAL CARE" in bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
BVM Hemodialysis Blood Tubing Set Traditional 510(k) Notification
510(k) summary
This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content in this 510(k) summary has been provided in conformance with 21 CFR Part 807.92
A. Submitter's Information
| Name: | Fresenius Medical Care North America (FMCNA) |
|---|---|
| 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 | |
| Date of Preparation: | 3/16/2012 |
B. Device Name
| Trade Name: | Blood Volume Monitor (BVM) Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors |
|---|---|
| Common Name: | Blood Tubing Sets (Sterile Fluid Path). |
| Product Code/Classification Panel: | FJK / Gastroenterology-Urology |
| Classification Name: | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve 21 CFR 876.5820 |
C. Legally Marketed Predicate Device (unmodified devices)
Nikkline Blood Tubing Lines with Transducer Protectors (K082719)
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Image /page/1/Picture/0 description: The image shows the Fresenius Medical Care logo. The logo consists of a stylized symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three chevron-like shapes stacked on top of each other, with the top two pointing upwards and the bottom one pointing downwards. The text is in bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
BVM Hemodialysis Blood Tubing Set Traditional 510(k) Notification
D. Device Description
The Fresenius Blood Volume Monitor (BVM) Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors, Catalog number 03-2795-7 (BVM Bloodline) is designed to work with Fresenius 2008 Series Hemodialysis Machines equipped with a BVM Module.
The bloodline is a part of the extracorporeal circuit by which blood is transported from the patient through a hemodialyzer and back to the patient. The pump segment of the bloodline interfaces with the pump rotor mechanism of the hemodialysis machine which drives the flow of blood through the circuit. The bloodline contains interfaces to the machine safety mechanisms to ensure proper operation. These include transducer monitor lines for arterial and venous pressure monitoring, as well as a venous chamber for the detection of air in the blood path.
ﻧﻨ Indications for Use
The Blood Volume Monitor (BVM) Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis. The set is intended for use with a prescribed hemodialyzer.
The BVM Hemodialysis Blood Tubing Set is intended for acute and chronic hemodialysis The set is intended for use with the Fresenius 2008 Series Hemodialysis therapy. Machines equipped with a BVM Module for monitoring patient blood volume during hemodialysis.
F. Technological Characteristics
The BVM Bloodline and the Nikline Blood Tubing Lines with Transducer Protectors (K082719) have equivalent technological characteristics. The BVM Bloodline and the Nikkline share equivalent:
- . Intended Use - provides extracorporeal access during hemodialysis
- . Design/Configuration
- . Basic Scientific Technology - peristaltic pump, pressure monitoring capabilities, air capture chambers
- . Sterility - single use, nonpyrogenic
- Materials primary materials of polyvinyl chloride (PVC) and polypropylene (PP). .
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Image /page/2/Picture/15 description: The image shows the logo for Fresenius Medical Care. The logo consists of a stylized symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons stacked on top of each other. The text is in a bold, sans-serif font.
BVM Hemodialysis Blood Tubing Set Traditional 510(k) Notification
G. Performance Data
Testing was selected through the application of a risk management process, appropriate guidance documents and relevant standards. The results of the validation and verification testing have provided a sound basis for comparison to the predicate bloodline. The following are an example of some of the tests performed to support the determination of substantial equivalence:
- . Biological safety - biocompatibility testing
- Sterility and nonpyrogenicity testing
- . Structural integrity - pressure and pull testing
- Performance testing of connectors (hemodialyzer, vascular access device and . ancillary components) - pressure/dimensional
- Needle access ports- pressure testing after repeated use
- . Transducer protectors- pressure testing
- . Endurance testing of the complete bloodline using specified hemodialysis machines
- Clamp testing- ability to occlude and effects of repeated use ●
- Usability evaluation
H. Conclusion
Based on a cumulative review of the verification and validation testing, the performance of the BVM Bloodline is substantially equivalent to the predicate Nikkline (K082719) and is safe and effective for its intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with outstretched wings, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 1 5 2012
Ms. Denise Oppermann Senior Director Regulatory Affairs, Devices Fresenius Medical Care North America 920 Winter Street WALTHAM MA 02451
Re: K120823
Trade/Device Name: Blood Volume Monitor (BVM) Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors
Regulation Number: 21 CFR§ 876.5820
Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FJK Dated: March 16, 2012 Received: March 21, 2012
Dear Ms. 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 for doo barea in 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 I ou mayy aron's 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 your device 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 I tease of ac now a a determination that your device complies with other requirements of the Act that I Drives interes and regulations administered by other Federal agencies. You must or any I coordi statutes are reguirements, including, but not limited to: registration and listing Comply with an the 110. break and mart 801); medical device reporting (reporting of medical
4
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin K. Tichner
Benjamin R. Fisher, Ph.D. Director Division of Reproductive. Gastro-Renal. and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a stylized symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three chevron-like shapes stacked on top of each other, with the top two pointing upwards and the bottom one pointing downwards. The text is in bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
BVM Hemodialysis Blood Tubing Set Traditional 510(k) Notification
Indication for use statement
510(k) Number (if known): K120823
Device Name:
Blood Volume Monitor (BVM) Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors
Indications for Use:
The Blood Volume Monitor (BVM) Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis. The set is intended for use with a prescribed hemodialyzer.
The BVM. Hemodialysis Blood Tubing Set is intended for acute and chronic hemodialysis therapy. The set is intended for use with the Fresenius 2008 Series Hemodialysis Machines equipped with a BVM Module for monitoring patient blood volume during hemodialysis.
XPrescription Use (Per 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Benjamine R. Fisher 15 JUNE 2012
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K120823