(70 days)
Not Found
No
The 510(k) summary describes a sterile dialysate solution and its packaging, with no mention of AI or ML technology in the intended use, device description, or any other section.
Yes
The device is a dialysate solution used in hemodialysis, which is a therapeutic process for renal replacement therapy.
No
Explanation: The device is a bicarbonate dialysate solution used in hemodialysis, which is a treatment and not a diagnostic process. It does not identify or diagnose a disease or condition.
No
The device description clearly describes a physical product (sterile, non-pyrogenic, bicarbonate dialysate solutions in flexible two-chamber bags) and does not mention any software component as the primary medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "hemodialysis use with renal replacement therapy systems." This describes a therapeutic treatment applied directly to the patient's blood, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description: The description details a solution used in a medical procedure (hemodialysis), not a reagent or instrument used to analyze biological samples.
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic or monitoring information
- Using reagents or assays
Therefore, the B. Braun Modified Bicarbonate Dialysate is a medical device used in a therapeutic procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
B. Braun Modified Bicarbonate Dialysate is indicated for hemodialysis use with renal replacement therapy systems that utilize sterile bicarbonate dialysate.
Product codes
KPO
Device Description
The B. Braun Modified 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.
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)
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
NOV - 9 2005
7.0 510(k) Summary
| SUBMITTER: | B. Braun Medical Inc.
901 Marcon Boulevard
Allentown, PA 18109-9341
(610) 596-2367
Contact: Christine Ford
Sr. Regulatory Affairs Analyst |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | B. Braun Modified 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: | B. Braun Bicarbonate Dialysate |
| DESCRIPTION: | The B. Braun Modified 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 Modified Bicarbonate Dialysate is indicated for hemodialysis use with renal replacement therapy systems that utilize sterile bicarbonate dialysate |
| SUBSTANTIAL EQUIVALENCE: | The B. Braun Modified Bicarbonate Dialysate has a similar composition range and the same container/closure system and indications for use as the B. Braun Bicarbonate Dialysate solutions previously cleared under the B. Braun Medical, Inc. 510(k) Premarket Notification K041683. |
1
Image /page/1/Picture/2 description: The image shows a logo with a bird-like symbol inside a circle. The bird is stylized with three curved lines representing its body and wings. The text "Department of Health & Human Services" is written around the circle's perimeter, with the words arranged to follow the curve of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20050
NOV - 9 2005
Ms. Christine Ford Sr. Regulatory Affairs Analyst B. Braun Medical, Inc. 901 Marcon Blvd. ALLENTOWN PA 18103-9341
Re: K052393
Trade/Device Name: B. Braun Modified Bicarbonate Dialysate Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KPO Dated: October 13, 2005 Received: October 14, 2005
Dear Ms. Ford:
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 (Premarket Approval), it may be subject to such 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.
2
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
2.0 Indications for Use Statement
Page __ l __ of __ 1
510(k) Number (if known): K052393
B. Braun Modified Bicarbonate Dialysate Device Name:
Indications For Use:
B. Braun Modified Bicarbonate Dialysate is indicated for hemodialysis use with renal replacement therapy systems that utilize sterile bicarbonate dialysate.
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
Radiological Devices
510(k) Number K052393