(60 days)
Not Found
No
The device description and intended use are for a dry concentrate cartridge used in hemodialysis, with no mention of software, algorithms, or any computational processing that would suggest AI/ML.
Yes
The device, Gambro BiCart®, is indicated for use in bicarbonate hemodialysis, which is a medical procedure for treating acute and chronic renal failure or acute intoxication. This direct application in treating medical conditions qualifies it as a therapeutic device.
No
Explanation: The device description states that the product is a dry concentrate used to prepare bicarbonate concentrate solution for hemodialysis. It is a consumable component used in the treatment process, not a device that diagnoses a condition.
No
The device description clearly states it is a "dry concentrate used to prepare bicarbonate concentrate solution" and a "non-refillable cartridge containing sodium bicarbonate," indicating it is a physical product, not software.
Based on the provided information, the Gambro BiCart® is not an IVD (In Vitro Diagnostic) device.
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 "dry concentrate used to prepare bicarbonate concentrate solution for use in conventional hemodialysis." This is a component used in the hemodialysis process itself, which is a treatment.
- Lack of Diagnostic Activity: The description does not mention any activity related to analyzing a sample (blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. The Gambro BiCart® is a component used in a therapeutic procedure.
N/A
Intended Use / Indications for Use
Gambro BiCart® is indicated 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
Gambro BiCart® Sodium Bicarbonate for hemodialysis is a dry concentrate used to prepare bicarbonate concentrate solution for use in conventional hemodialysis.
The Gambro BiCart® is a non-refillable cartridge containing sodium bicarbonate, which enables on-line preparation of bicarbonate hemodialysis solution. It is used in conjunction with appropriate acid dialysis concentrate and water meeting Association for the Advancement of Medical Instrumentation (AAMI) guidelines. The resulting dialysate is used in conventional, commercially available hemodialysis machines/monitors which have been adapted to receive the 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)
No clinical testing was performed.
No testing was necessary to determine equivalence to predicate devices.
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
Page 1 of 3
GAMBRO Renal Products
510(k) Premarket Notification
510(k) Summary
8 2002 JAN
BiCart®
Sodium Bicarbonate for Hemodialysis
Contact Information:
GAMBRO Renal Products
1845 Mason Avenue Daytona Beach, FL 32117 Phone: 386-274-2811 Fax: 386-274-2833 Contact: Fei Law
Prepared: November 5, 2001
1
K15124
Page 2 of 3
Image /page/1/Picture/1 description: The image shows the logo for GAMBRO Renal Products. The logo consists of the word "GAMBRO" in bold, followed by the words "Renal Products" in a smaller, less bold font. There is a small circular graphic to the left of the word "GAMBRO."
510(k) Premarket Notification
510(k) Summary
| Name of the device: | Gambro BiCart® | ||
|---|---|---|---|
| Common Name: | Sodium Bicarbonate for Hemodialysis | ||
| Classification Name: | Dialysate Concentrate for Hemodialysis (Liquid or Powder) | ||
| per 21 CFR 876.5820. The Product/Classification Code is | |||
| KPO. | |||
| Predicate Devices: | Gambro BiCart® System | ||
| K873155 cleared 10/26/1987 | |||
| Gambro, Inc. | |||
| Manufactured by Gambro Lundia AB | |||
| Gambro BiCart® 720g | |||
| K940601 cleared 03/22/1994 | |||
| C.G.H Medical, Inc. | |||
| Manufactured by Gambro Lundia AB |
Device Description:
Gambro BiCart® Sodium Bicarbonate for hemodialysis is a dry concentrate used to prepare bicarbonate concentrate solution for use in conventional hemodialysis.
The Gambro BiCart® is a non-refillable cartridge containing sodium bicarbonate, which enables on-line preparation of bicarbonate hemodialysis solution. It is used in conjunction with appropriate acid dialysis concentrate and water meeting Association for the Advancement of Medical Instrumentation (AAMI) guidelines. The resulting dialysate is used in conventional, commercially available hemodialysis machines/monitors which have been adapted to receive the cartridges.
Indications for Use:
Gambro BiCart® is indicated for use in a bicarbonate hemodialysis for acute and chronic renal failure, or acute intoxication with dialyzable substances.
2
MBRO Renal Products
510(k) Premarket Notification
510(k) Summary
Comparison to Predicate Devices:
The Gambro BiCart® Sodium Bicarbonate for Hemodialysis cartridges are equivalent to the Gambro BiCart® System (includes 650g BiCart®) and the Gambro BiCart® 720g which have been previously approved by the FDA under Premarket Notifications K873155 and K940601. This Premarket Notification is intended to add cartridge sizes to existing product offerings. The only functional difference between the different sizes is the quantity of sodium bicarbonate contained in the cartridge. The varying quantities of sodium bicarbonate provide for varying lengths of treatment. The resulting bicarbonate concentrations for all cartridge sizes are identical, and the resulting solution is used in exactly the same way.
| | Gambro BiCart™
System
K873155
cleared 10/26/1987 | Gambro BiCart™
120g
K940601
cleared 03/22/1994 | Gambro BiCart®
(various sizes,
including 650, 720,
and 1150g) |
|------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Manufacturer | Gambro Lundia AB | Gambro Lundia AB | Gambro Lundia AB |
| Indication for Use | Bicarbonate
hemodialysis for
acute and chronic
treatment of renal
failure | Bicarbonate
hemodialysis for
acute and chronic
treatment of renal
failure | To be used in
bicarbonate
hemodialysis
treatment for patients
suffering from acute |
| Indication included
in labeling | In cases of poisoning
by substances which
can be removed by
hemodialysis | In cases of poisoning
by substances which
can be removed by
hemodialysis | renal failure, chronic
renal failure, or acute
intoxication with
dialyzable substances |
| Disposable? | Yes | Yes | Yes |
| Sodium Bicarbonate
Grade | USP & European
Pharmacopoeia | USP & European
Pharmacopoeia | USP & European
Pharmacopoeia |
| Sodium Bicarbonate
Weight Spec. | Target (± 50g) | Target (± 50g) | Target (+30g) |
| Bicarbonate
Concentration | 38 mEq/L | 38 mEq/L | 38 mEq/L |
| Storage Conditions | Store below +40 °C
(+104 °F) | Store below +40 °C
(+104 °F) | Store below +40 °C
(+104 °F) |
| Housing Material | Polypropylene | Polypropylene | Polypropylene |
Comparing the proposed device to the predicate devices, its indication for use, technological characteristics, and chemical composition are identical. We therefore consider this device to be substantially equivalent to existing products in commercial distribution in the United States.
Performance Data
No clinical testing was performed.
No testing was necessary to determine equivalence to predicate devices.
3
Food and Drug Administration 9200 Corporate Boulevard Rockville . MD 20850
8 2002 JAN
Ms. Fei Law Quality Assurance Manager Gambro Renal Products 1845 Mason Avenue . DAYTONA BEACH FL 32117 Re: K013724
Trade/Device Name: Gambro BiCart® Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 KPO Dated: November 5, 2001
Received: November 9, 2001
Dear Ms. Law:
We have reviewed your Section 510(k) premarket notification of intent to market the device we forenced 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.
4
This letter will allow you to begin marketing your device as described in your 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:
| 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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
5
of I Page 1
K013724 510(k) Number (if known):
Gambro BiCart® Device Name:
Indications For Use:
Gambro BiCart® is indicated for use in bicarbonate hemodialysis for acute and chronic renal failure, or acute intoxication with dialyzable substances.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C Bragtim
(Division Sign-Off)
Division of Reproductive, Abidemás,
and Radiological Devices
510(k) Number. Kor
(Optional Format 3-10-98)
Prescription Use