(327 days)
No
The summary describes standard hemodialysis blood circuits and their physical testing, with no mention of AI or ML.
No
The device is described as "tubing segments intended for use in transporting blood," which are ancillary to the hemodialysis process, not a therapeutic device itself.
No
This device is described as "tubing segments intended for use in transporting blood," which indicates it is a therapeutic or assistive device for hemodialysis, not a diagnostic one. It does not identify or characterize a disease or condition.
No
The device description explicitly states it is comprised of "tubing segments," 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 states the device is for "transporting blood from a patient's vascular access device to hemodialyzer systems" and "transporting blood to a patient's vascular access device from such a system." This describes a device used in vivo (within the body) for blood circulation during hemodialysis, not for testing samples in vitro (outside the body).
- Device Description: The description reinforces the intended use, focusing on tubing segments for blood transport during hemodialysis.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening
- Using reagents or assays
The device is a component of a hemodialysis system, which is a life-sustaining treatment, but the tubing itself is a blood transport device, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The configurations can be summarized tubing segments intended for use in transporting blood from a patient's vascular access device to hemodialyzer systems. Also, the tubing segments intended for use in transporting blood to a patient's vascular access device from such a system.
Product codes
KOC
Device Description
B. Braun Medical Inc. intends to introduce into interstate commerce the Braun Hemodialysis Blood Circuits in various configurations. The configurations can be summarized tubing segments intended for use in transporting blood from a patient's vascular access device to hemodialyzer systems. Also, the tubing segments intended for use in transporting blood to a patient's vascular access device from such a system. The various configurations account for user preferences and various hemodialysis systems currently marketed. These all have the similar design and performance characteristics.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; sterility, pyrogenicity (endotoxin/ LAL Method), physical testing, visual examination (in process and finished product).
The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications. The physical testing for the Braun Hemodialysis Blood Circuits are defined in detail in the "Device Master Records".
The Braun Hemodialysis Blood Circuits follow the recommended performance standards outlined by The Association for the Advancement of Medical Instrumentation in the draft standard AAMI RD17R-6/94.
The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control GMP"s.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
APR 3 0 1996
K95263|
II 510 (k) Summary
B. Braun Medical, Inc 824 Twelfth Avenue Bethlehem, PA 18018 (610)691-5400
April 19, 1996
CONTACT: Mark S. Alsberge, Regulatory Affairs Manager
PRODUCT NAME: Hemodialysis Blood Circuits
TRADE NAME: Braun Hemodialysis Blood Circuits
CLASSIFICATION NAME:
Gastroenterology and Urology Class II, 78 KOC,Hemodialysis Blood Circuits 21 CFR 876.5820
SUBSTANTIAL EQUIVALENCE TO:
| 510(k) number | Name | Applicant |
|---|---|---|
| K884243 | Blood Tubing Set | Mediflex |
| International Inc. |
DEVICE DESCRIPTION:
B. Braun Medical Inc. intends to introduce into interstate commerce the Braun Hemodialysis Blood Circuits in various configurations. The configurations can be summarized tubing segments intended for use in transporting blood from a patient's vascular access device to hemodialyzer systems. Also, the tubing segments intended for use in transporting blood to a patient's vascular access device from such a system. The various configurations account for user preferences and various hemodialysis systems currently marketed. These all have the similar design and performance characteristics.
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------intended to be a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be marketed without premarket approval or reclassification. Such a determination is not intended to be applicable to patent infringement suits or any other patent matter related to this product or the technology used to manufacture the product.
1
MATERIAL:
B. Braun Medical certifies that the biocompatibilty tests recommended in the Tripartite Guidance for this cateqory of contact duration will be completed for the materials use in the manufacture of the device.
SUBSTANTIAL EQUIVALENCE:
The Braun Hemodialysis Blood Circuits are equivalent in materials, form, and intended use to the Blood Tubing Set currently marketed by Mediflex International Inc. There are no new issues of safety or effectiveness raised by the Braun Hemodialysis Blood Circuits.
SAFETY AND EFFECTIVENESS:
All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; sterility, pyrogenicity (endotoxin/ LAL Method), physical testing, visual examination (in process and finished product).
The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications. The physical testing for the Braun Hemodialysis Blood Circuits are defined in detail in the "Device Master Records".
The Braun Hemodialysis Blood Circuits follow the recommended performance standards outlined by The Association for the Advancement of Medical Instrumentation in the draft standard AAMI RD17R-6/94.
The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control GMP"s.