(123 days)
Not Found
No
The summary describes a powder concentrate for hemodialysis and does not mention any AI or ML components or functionalities.
No
The device, Solcart B, is a powder concentrate used to prepare bicarbonate concentrate solution for hemodialysis, not a device that directly administers therapy to a patient. It is a component used in conjunction with a dialysis machine and other solutions to perform hemodialysis, which is a therapeutic process.
No
Explanation: The device is a powder concentrate used to prepare a solution for hemodialysis, which is a treatment process. It is used in conjunction with a dialysis machine, not to diagnose a condition.
No
The device description clearly states that Solcart B is a physical cartridge containing dry sodium bicarbonate, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "bicarbonate hemodialysis for acute and chronic renal failure, or acute intoxication with dialyzable substances." This describes a therapeutic treatment process performed on a patient, not a diagnostic test performed on a sample taken from a patient.
- Device Description: The device is a "powder concentrate used to prepare bicarbonate concentrate solution for use in hemodialysis." This is a component used in the hemodialysis process itself, not a reagent or instrument used to analyze a biological sample for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (like blood, urine, etc.), diagnostic markers, or the generation of diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Solcart B's function is to provide a necessary component for a therapeutic procedure.
N/A
Intended Use / Indications for Use
Solcart B is intended for use in bicarbonate hemodialysis for acute and chronic renal failure, or acute intoxication with dialyzable substances.
Product codes (comma separated list FDA assigned to the subject device)
KPO
Device Description
Solcart B consists of a powder concentrate used to prepare bicarbonate concentrate solution for use in hemodialysis. Solcart B is a non-refillable polypropylene cartridge containing dry sodium bicarbonate [in compliance with European Pharmacopoeia (Ph. Eur.) and United States Pharmacopoeia (USP)] for hemodialysis. It must be used together with a suitable acid concentrate and water meeting the requirements of the Association for the Advancement of Medical Instrumentation (AAMI). Solcart B must only be used with B. Braun dialysis machines provided with a holder for powder bicarbonate cartridges.
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)
The proposed device has been subjected to biocompatibility testing, functional performance testing and stability testing to support safety and effectiveness.
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.
Gambro BiCart® (K013724)
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
K072760 Page 1 of 2
- September 19.
5. 510(k) Summary
| SUBMITTER: | B Braun Medizintechnologie GmbH
Schwarzenberger Weg 73-79
34212, Melsungen
Germany |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Tracy Maddock, Regulatory Affairs Analyst
B. Braun Medical Inc.
901 Marcon Boulevard
Allentown, PA 18109-9341
Phone: (610) 596-2240
Fax: (610) 266-4962
E-mail: tracy.maddock@bbraun.com |
| DEVICE NAME: | Solcart B |
| COMMON OR USUAL
NAME: | Sodium Bicarbonate for Hemodialysis |
| DEVICE
CLASSIFICATION: | Hemodialysis system and accessories
Class II, CFR Title 21 § 876.5820 |
| PREDICATE DEVICE: | Gambro BiCart® (K013724) |
| DESCRIPTION: | Solcart B consists of a powder concentrate used to prepare
bicarbonate concentrate solution for use in hemodialysis.
Solcart B is a non-refillable polypropylene cartridge
containing dry sodium bicarbonate [in compliance with
European Pharmacopoeia (Ph. Eur.) and United States
Pharmacopoeia (USP)] for hemodialysis. It must be used
together with a suitable acid concentrate and water meeting
the requirements of the Association for the Advancement of
Medical Instrumentation (AAMI).
Solcart B must only be used with B. Braun dialysis
machines provided with a holder for powder bicarbonate
cartridges. |
| INTENDED USE: | Solcart B is intended for use in bicarbonate hemodialysis
for acute and chronic renal failure, or acute intoxication
with dialyzable substances. |
1
K072760 Page 2 of 2
SUBSTANTIAL EQUIVALENCE:
The Solcart B cartridges have the same intended use and technological characteristics as the stated predicate device, the Gambro BiCart® cartridges (K013724). There are no differences between the predicate and the proposed device that raise new issues of safety and effectiveness. The proposed device has been subjected to biocompatibility testing, functional performance testing and stability testing to support safety and effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.
JAN 29 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
B. Braun Medizintechnologie GmbH c/o Ms. Tracy Maddock Senior Regulatory Affairs Analyst B. Braun Medical, Inc. 901 Marcon Blvd. ALLENTOWN PA 18109
K072760 Re:
Trade/Device Name: Solcart B Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KPO Dated: January 17, 2008 Received: January 22, 2008
Dear Ms. Maddock:
We have reviewed your Section 510() 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 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.
3
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
4. Indications for Use Statement
Page 1 of 1
| 510(k) Number (if known): | K072760 |
|---|---|
| Device Name: | Solcart B |
Indications For Use:
Solcart B is intended for use in bicarbonate hemodialysis for acute and chronic renal failure, or acute intoxication with dialyzable substances.
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)
Nancic Brogdon
(Division(Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number _