(67 days)
B. Braun Bicarbonate Dialysate is indicated for use with renal replacement therapy systems that utilize sterile bicarbonate dialysate.
The B. Braun Bicarbonate Dialysate Solutions are a family of sterile, non-pyrogenic, bicarbonate dialysate solutions. The solutions will be provided in flexible two-chamber bags, with bicarbonate solution in one chamber and electrolyte solution in the other chamber. The chambers are separated by a peel seam. The 5,000 mL ready-to-use solution is obtained by pressing on the small chamber of the bag until the peel seam opens, and then rocking the bag back and forth to mix the contents.
The provided text describes a 510(k) premarket notification for a medical device: "B. Braun Bicarbonate Dialysate." However, it does not contain any information about acceptance criteria, device performance testing, or a study that proves the device meets such criteria.
The document is a regulatory submission for premarket clearance and focuses on:
- Device Identification: Manufacturer, device name, common name, classification, and product code.
- Predicate Device: Gambro PrismaSate Dialysis Solutions for Continuous Renal Replacement Therapy (K013448).
- Description: Physical characteristics of the device (sterile, non-pyrogenic, bicarbonate dialysate solutions in a two-chamber flexible bag).
- Intended Use: Indicated for use with renal replacement therapy systems that utilize sterile bicarbonate dialysate.
- Substantial Equivalence Claim: The B. Braun Bicarbonate Dialysate is presented as substantially equivalent to the predicate device based on similar composition range, container/closure system, and indications for use.
- FDA Correspondence: An FDA letter confirming the review of the 510(k) and a determination of substantial equivalence (assuming the indications for use are met).
- Indications for Use Statement: A separate page specifically stating the intended use as "for use with renal replacement therapy systems that utilize sterile bicarbonate dialysate."
Therefore, I cannot extract the requested information (acceptance criteria, device performance, study details, sample sizes, ground truth establishment, expert qualifications, etc.) from the provided text, as this type of information is not present. This document is not a study report or a design verification and validation document.
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K041683 Page 1 of 1
AUG 27 2004
510(k) Summary 8.0
| SUBMITTER: | B. Braun Medical Inc.901 Marcon BoulevardAllentown, PA 18109-9341(610) 266-0500, ext. 2516 |
|---|---|
| Contact: Jennifer A. Pung, Senior Analyst, Regulatory Affairs | |
| DEVICE NAME: | B. Braun Bicarbonate Dialysate |
| COMMON OR USUAL NAME: | Bicarbonate Dialysate |
| DEVICE CLASSIFICATION: | Class II, 21 CFR § 876.5820, Hemodialysis System and Accessories (Product Code KPO) |
| PREDICATE DEVICE: | Gambro Renal Products - Gambro PrismaSate Dialysis Solutions for Continuous Renal Replacement Therapy (K013448) |
| DESCRIPTION: | The B. Braun Bicarbonate Dialysate Solutions are a family of sterile, non-pyrogenic, bicarbonate dialysate solutions. The solutions will be provided in flexible two-chamber bags, with bicarbonate solution in one chamber and electrolyte solution in the other chamber. The chambers are separated by a peel seam. The 5,000 mL ready-to-use solution is obtained by pressing on the small chamber of the bag until the peel seam opens, and then rocking the bag back and forth to mix the contents. |
| INTENDED USE: | B. Braun Bicarbonate Dialysate is indicated for use with renal replacement therapy systems that utilize sterile bicarbonate dialysate. |
| SUBSTANTIAL EQUIVALENCE: | The B. Braun Bicarbonate Dialysate has a similar composition range, container/closure system, and indications for use as the PrismaSate Dialysis Solutions marketed by Gambro under the 510(k) Premarket Notification K013448. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or other bird with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 7 2004
Ms. Jennifer A. Pung Senior Analyst, Regulatory Affairs B. Braun Medical, Inc. 901 Marcon Blvd. ALLENTOWN PA 18109-9341
Re: K041683
Trade/Device Name: B. Braun Bicarbonate Dialysate Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 KPO Dated: June 18, 2004 Received: June 21, 2004
Dear Ms. Pung:
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.
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. 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); 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.
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Indications for Use Statement 2.0
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Page _________________________________________________________________________________________________________________________________________________________________________
| 510(k) Number (if known): | K041683 |
|---|---|
| --------------------------- | --------- |
Device Name:
B. Braun Bicarbonate Dialysate
Indications For Use:
Prescription Use
(Per 21 CFR 801.109)
B. Braun Bicarbonate Dialysate is indicated for use with renal replacement therapy systems
. D. Draun Droaise bicarbonate dialysate.
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
X
Daniel A. Syverson
(Division Sign-Off) Division of Reproductive, and Radiological Devices 510(k) Number .
§ 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.