(63 days)
Not Found
No
The device is a premixed dialysate solution, which is a chemical product, not a software or hardware device that would typically incorporate AI/ML. The description focuses on the composition and packaging of the solution.
Yes
The device is a premixed dialysate solution used in renal replacement therapy, which is a therapeutic treatment for kidney failure.
No
Explanation: The device is a "premixed dialysate solution" used in renal replacement therapy, which is a therapeutic treatment. There is no indication in the provided text that it diagnoses any condition or disease.
No
The device description clearly states it is a family of premixed dialysate solutions provided in flexible PVC bags, indicating a physical product (liquid and packaging) and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "renal replacement therapy systems that utilize sterile premixed dialysate." This describes a therapeutic use, not a diagnostic one.
- Device Description: The description details a sterile solution used in a therapy system. It doesn't mention any components or processes for analyzing samples from the body to diagnose or monitor a condition.
- Lack of Diagnostic Indicators: There is no mention of analyzing patient samples (blood, urine, etc.), detecting biomarkers, or providing information for diagnosis or monitoring.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device is a therapeutic agent used in a treatment process.
N/A
Intended Use / Indications for Use
B. Braun Premixed Dialysate is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate.
Product codes (comma separated list FDA assigned to the subject device)
KPO
Device Description
The B. Braun Premixed Dialysate Solutions are a family of premixed dialysate solutions which are sterile, non-pyrogenic solutions to be provided in single use flexible PVC bags varying in sizes from 1000 mL to 5000 mL. The premixed dialysate solutions are intended for use with renal replacement therapy systems that utilize sterile premixed dialysate. A family of dialysate solutions will allow the physician to prescribe different electrolyte compositions that meet the specific needs of individual patients.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
0
KO34066
mar - 3 2004
510(k) Summary 8.0
| SUBMITTER: | B. Braun Medical Inc.
901 Marcon Boulevard
Allentown, PA 18109-9341
(610) 266-0500, ext. 2280
Contact: Patricia D. Wilson, Regulatory Affairs Specialist |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | B. Braun Premixed Dialysate |
| COMMON OR USUAL
NAME: | Premixed Dialysate |
| DEVICE
CLASSIFICATION: | Class II, 21 CFR § 876.5820, Hemodialysis System and
Accessories (Product Code KPO) |
| PREDICATE DEVICE: | NxStage Medical, Inc. - NxStage Premixed Dialysate
(K022913)
Gambro Renal Products – Gambro PrismaSate Dialysis
Solutions for Continuous Renal Replacement Therapy
(K013448)
Baxter Healthcare Corporation -Baxter Premixed Dialysate for
Hemodiafiltration (K910270) |
| DESCRIPTION: | The B. Braun Premixed Dialysate Solutions are a family of
premixed dialysate solutions which are sterile, non-pyrogenic
solutions to be provided in single use flexible PVC bags
varying in sizes from 1000 mL to 5000 mL. The premixed
dialysate solutions are intended for use with renal replacement
therapy systems that utilize sterile premixed dialysate. A
family of dialysate solutions will allow the physician to
prescribe different electrolyte compositions that meet the
specific needs of individual patients. |
| INTENDED USE: | B. Braun Premixed Dialysate is indicated for use with renal
replacement therapy systems that utilize sterile premixed
dialysate. |
| SUBSTANTIAL
EQUIVALENCE: | B. Braun believes that, within the meaning of the Medical
Device Amendments of 1976, the B. Braun Premixed
Dialysate addressed in this 510(k) premarket notification
is substantially equivalent to the following medical devices
in commercial distribution: |
1
K034066 page 2 of 2
SUBSTANTIAL EQUIVALENCE (continued):
- NxStage Premixed Dialysate (K022913, cleared 10/21/02) .
- PrismaSate Dialysis Solutions (K013448, cleared 01/15/02) .
- Baxter Premixed Dialysate for Hemodiafiltration . (K910270, cleared 04/18/91)
The B. Braun Premixed Dialysate includes the same chemical composition range, and has the same manufacturing, packaging, and sterilization process as the NxStage Premixed Dialysate (K022913). The B. Braun Premixed Dialysate is also similar to the Gambro PrismaSate Solutions (K013448), and Baxter Premixed Dialysate (K910270), with regard to composition, sterility, and packaging.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes extending from its back.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 3 2004
Ms. Patricia Wilson Regulatory Affairs Specialist B. Braun Medical, Inc. 901 Marcon Boulevard ALLENTOWN PA 18109
Re: K034066
Trade/Device Name: B. Braun Premixed Dialysate Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Codc: 78 KPO Dated: Deccmber 30, 2003 Received: December 31, 2003
Dear Ms. Wilson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreased 976, the enactment date of the Medical Device Amendments, or to conniner of the 11th 11th 20, 11:10 accordance with the provisions of the Federal Food, Drug, de neces that have been require approval of a premarket approval application (PMA). and Cosmetion (110) and the device, subject to the general controls provisions of the Act. The r ou may, diereler, mains of the Act include requirements for annual registration, listing of general controls provisions of nactice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device is elamititional 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 Rase be actived that i Dr Princem that your device complies with other requirements of the Act that 1177 Hass Interes and regulations administered by other Federal agencies. You must of any I edular Battatoo and one of including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 801), as only (QS) regulation (21 CFR Part 820); and if applicable, the electronic rently in and ation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
l'age 2
This letter will allow you to begin marketing your device as described in your Section 510(k)
the first and the first of the said the similars of your device to a locally This letter will allow you to begill marketing your avones of your device of your device to a legally premarket notification. The PDA miding of basification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
r the regulation (2010-11-24, 11-4 in increases on the regulation It you desire specific advice tor your device on on the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the promotion on the regulation entitled, "Misoranding
Office of Compliance at (301) 594-4639. Also, possessed on be includes and and Office of Compliance at (501) 594-1057. This, production of Super the Division of Sma by reference to premarket nouncation (27 or the Act may be obtained from the Division of Small information on your responsionities under the researce at its toll-fried mumber (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-fremation h Manufacturers, International and Collsamler I assistement of the Courcedridsmaldsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement 2.0
Page _
| 510(k) Number (if known): | K034066 |
|---|---|
| --------------------------- | --------- |
Device Name:
B. Braun Premixed Dialysate
Indications For Use:
B. Braun Premixed Dialysate is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use __
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K034066
000005
510(k) Premarket Notification B. Braun Premixed Dialysate