(264 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical compatibility of a powder concentrate for hemodialysis, with no mention of AI or ML technologies.
No
The device is a powder concentrate that prepares a solution for hemodialysis, which is a therapeutic procedure, but the device itself is a component used in the therapy rather than providing the therapy directly.
No
Explanation: The device is a powder concentrate used to prepare a solution for hemodialysis, which is a treatment for renal failure or intoxication. It does not perform any diagnostic function.
No
The device description clearly states that Solcart B is a powder concentrate contained within a polypropylene cartridge, which is a physical component, 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 "bicarbonate hemodialysis for acute and chronic renal failure, or acute intoxication with dialyzable substances." This describes a therapeutic treatment process, not a diagnostic test performed in vitro (outside the body) on biological specimens to provide information about a patient's health.
- 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, which is a treatment.
- No mention of diagnostic testing: The description focuses on the preparation and use of the concentrate within the hemodialysis machine. There is no mention of analyzing biological samples or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
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). The Solcart B cartridge is designed to fit into cartridge holder adapters affixed to the hemodialysis machine. The 1100g cartridge may only be used with B. Braun hemodialysis machines for which the use of powder bicarbonate cartridges is a stated option and the machine is equipped with a holder for the bicarbonate cartridge.
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
NONCLINICAL TESTING: The proposed device was subjected to package and ship tests to demonstrate the acceptability of the packing and shipping configuration. In addition, performance testing was conducted with the proposed Solcart B 1100g cartridge to demonstrate compatibility with B. Braun hemodialysis machines. The stability testing conducted on the Solcart B 1100g cartridge verifies that the product meets the defined specifications.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and validation testing for the proposed Solcart B 1100g cartridge device are complete and all acceptance criteria have been met. The testing demonstrates that there are no differences between the predicate and the proposed devices that raise any new issues of safety or 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.
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.
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K102194 page 1 of 3
| 5. 510(k) SUMMARY | APR 2 5 2011 |
|---|---|
| DATE: | July 30, 2010 |
| APPLICANT: | B. Braun Avitum AG |
| Schwarzenberg Weg 73-79 | |
| 34212 Melsungen Germany | |
| Establishment Registration Number: 3002879653 | |
| SUBMITTER: | B. Braun Medical Inc. |
| 901 Marcon Blvd. | |
| Allentown, PA 18109-9341 | |
| Telephone: (610) 266-0500 | |
| CONTACT: | Angela Caravella |
| Senior Regulatory Affairs Analyst | |
| Telephone: (610) 596-2966 | |
| Facsimle: (610) 596-4962 | |
| E-Mail: angela.caravella@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 | |
| Product Code: KPO | |
| CURRENTLY | |
| MARKETED | |
| DEVICE (PREDICATE): | Solcart B (K072760) |
| 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
1
for the Advancement of Medical Instrumentation (AAMI).
The Solcart B cartridge is designed to fit into cartridge holder adapters affixed to the hemodialysis machine. The 1100g cartridge may only be used with B. Braun hemodialysis machines for which the use of powder bicarbonate cartridges is a stated option and the machine is equipped with a holder for the bicarbonate cartridge.
INTENDED USE:
SUBSTANTIAL EQUIVALENCE:
Solcart B is intended for use in bicarbonate hemodialysis for acute and chronic renal failure, or acute intoxication with dialyzable substances.
The Solcart B cartridge, containing 1100g sodium bicarbonate concentrate powder, has the same intended use and utilizes the same fundamental technology as the predicate device, the currently marketed Solcart B sodium bicarbonate concentrate powder in cartridges labeled to contain 650g and 760g and cleared for market in 510(k) K072760. The proposed Solcart B in the 1100g cartridge can be considered a line extension to the Solcart B 650g and 760g sodium bicarbonate cartridges.
The technological characteristics of the 1100g cartridge for the proposed Solcart B dialysis concentrate powder are equivalent to those of the existing 650g and 760g sodium bicarbonate cartridges. The Solcart B 1100g cartridge is the same as the predicate device in material composition and components. However, the proposed device has a larger body and a larger cartridge cap to accommodate the additional amount of Solcart B dialysis concentrate powder.
Because the powder concentrate has not changed in formulation, the proposed addition of 1100g sodium bicarbonate cartridge size does not pose a significant impact upon the fundamental technology of Solcart B, as identified within the Design Control Activities Summary.
2
NONCLINICAL TESTING:
The proposed device was subjected to package and ship tests to demonstrate the acceptability of the packing and shipping configuration. In addition, performance testing was conducted with the proposed Solcart B 1100g cartridge to demonstrate compatibility with B. Braun hemodialysis machines. The stability testing conducted on the Solcart B 1100g cartridge verifies that the product meets the defined specifications.
CONCLUSION:
Verification and validation testing for the proposed Solcart B 1100g cartridge device are complete and all acceptance criteria have been met. The testing demonstrates that there are no differences between the predicate and the proposed devices that raise any new issues of safety or effectiveness.
3
Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
B. Braun Avitum AG c/o Ms. Angela Caravella Senior Regulatory Affairs Analyst B. Braun Medical, Inc. 901 Marcon Blvd. ALLENTOWN PA 18109-9341
APR 2 5 2011
. Re: K102194
Trade/Device Name: Solcart B Sodium Bicarbonate Powder Dialysis Concentrate, 1100g Cartridge Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KPO Dated: April 12, 2011 Received: April 15, 2011
Dear Ms. Caravella:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting of medical device-related
4
adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Stukert Lemur MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive. Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
4. INDICATIONS FOR USE STATEMENT
Page of of _ -
K102194 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Solcart B Sodium Bicarbonate Powder Dialysis Concentrate, 1100g Cartridge
Indications For Use:
Solcart B Powder Dialysis Concentrate is intended for use in bicarbonate hemodialysis for acute and chronic renal failure, or acute intoxication with dialyzable substances.
X___________________________________________________________________________________________________________________________________________________________________________ Prescription Use (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)
Aoym M. Khan
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K102194