(90 days)
Not Found
No
The document describes sterile dialysate solutions for use in CRRT and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a dialysate solution used in Continuous Renal Replacement Therapy (CRRT) to remove waste products, fluids, and toxins from the blood in patients with acute renal failure, which directly impacts and normalizes the patient's physiological state.
No
The device is a dialysate solution used in Continuous Renal Replacement Therapy (CRRT) to remove waste products from the blood, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a sterile dialysate solution, which is a physical substance, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Gambro PrismaSate solutions are used in a medical procedure (Continuous Renal Replacement Therapy) to remove waste products and excess fluid from a patient's blood. They are a component of the therapy itself, not a test performed on a sample outside the body to diagnose or monitor.
- Intended Use: The intended use is as a "dialysate in Continuous Renal Replacement Therapy," which is a treatment, not a diagnostic test.
- Device Description: The description clearly explains how the solution is used within the CRRT machine to interact with the patient's blood through a semi-permeable membrane. This is a therapeutic process, not an in vitro diagnostic process.
Therefore, the Gambro PrismaSate solutions fall under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Gambro PrismaSate solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy.
Product codes (comma separated list FDA assigned to the subject device)
KPO
Device Description
Gambro PrismaSate solutions are sterile dialysate solutions for use in Continuous Renal Replacement Therapy (CRRT) for the treatment of acute renal failure and in other cases necessitating fluid or solute removal, such as in the case of drug poisoning with dialysable or filterable substances. The solutions are intended to be used in commercially available continuous renal replacement therapy machines as dialysate. A physician prescribes the chemical composition of the solution to be used.
The solutions are perfused through the dialysis fluid compartment of hemofilters/dialyzers. The dialysate is separated from the patient's blood by means of a semi-permeable membrane. Excess waste products, fluids and toxins found in the blood of a patient with acute renal failure pass through the membrane into the dialysate and eventually go to waste. The therapy is aimed at normalizing the blood.
CRRT is used for acute renal failure patients that may be too unstable to tolerate conventional hemodialysis, in which this function occurs much more rapidly (3-4 hours per treatment) and intermittently (3-6 times a week). In CRRT, the balancing is done on a continuous basis, 24 hours a day, in order to mimic kidney function.
Gambro PrismaSate solutions are indicated for use as a Indications for Use: dialysate in Continuous Renal Replacement Therapy.
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): 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.
K910270, K001059, K864265, K011368
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
GAMBRO Renal Products
K 013448
Page 1 of 3
510(k) Premarket Notification
510 (k) Summary
/JAN 1 5 2002
PrismaSate
Dialysis Solutions for Continuous Renal Replacement Therapy
Contact Information:
GAMBRO Renal Products
1845 Mason Avenue Daytona Beach, FL 32117 Phone: 386-274-2811 Fax: 386-274-2833 Contact: Fei Law
Prepared: October 10, 2001
1
Image /page/1/Picture/0 description: The image shows the logo for Gambro Renal Products. The logo consists of the word "GAMBRO" in a bold, sans-serif font, with the words "Renal Products" in a smaller font to the right. There is a stylized "G" to the left of the word "GAMBRO".
510(k) Premarket Notification
510 (k) Summary
| Name of the device: | PrismaSate | Intended Use | Chemical Composition | Sterility | Packaging | |
|---|---|---|---|---|---|---|
| Common Name: | Dialysis Solutions for Continuous Renal Replacement Therapy | |||||
| Ready to Use Sterile Dialysate | Gambro | |||||
| PrismaSate | ||||||
| Dialysis | ||||||
| Solutions for | ||||||
| Continuous | ||||||
| Renal | ||||||
| Replacement | ||||||
| Therapy | Dialysate for use in | |||||
| Continuous Renal | ||||||
| Replacement Therapy. | Sodium 137 - 142 mEq/L | |||||
| Calcium 0 - 4 mEq/L | ||||||
| Potassium 0 - 4 mEq/L | ||||||
| Magnesium 0.5 - 1.5 mEq/L | ||||||
| Bicarbonate 0 - 36 mEq/L | ||||||
| Lactate 0 - 40 mEq/L | ||||||
| Acetate 0 mEq/L | ||||||
| Dextrose 0 - 2 g/L | Terminally | |||||
| Sterilized | PVC Bag | |||||
| Classification Name: | Dialysate Concentrate for Hemodialysis (Liquid or Powder) per | |||||
| 21 CFR 876.5820. The Product/Classification Code is KPO. | Baxter | |||||
| Healthcare | ||||||
| Premixed | ||||||
| Dialysate for | ||||||
| Hemodiafiltration | ||||||
| K 910270 | ||||||
| Cleared | ||||||
| 04/18/1991 | For acute dialysis | |||||
| modalities that employ | ||||||
| hemodiafiltration, such as | ||||||
| continuous arteriovenous | ||||||
| hemodiafiltration (CAVHD) | ||||||
| and continuous venuous- | ||||||
| venous hemodiafiltration | ||||||
| (CWHD), when treatment | ||||||
| of acute renal failure | ||||||
| patients with hypervolemia | ||||||
| and uremia requires high | ||||||
| solute clearance | Sodium 140 mEq/L | |||||
| Calcium 3.5 mEq/L | ||||||
| Potassium 2 mEq/L | ||||||
| Magnesium 1.5 mEq/L | ||||||
| Bicarbonate 0 mEq/L | ||||||
| Lactate 30 mEq/L | ||||||
| Acetate 0 mEq/L | ||||||
| Dextrose 1 g/L | Terminally | |||||
| Sterilized | PVC bag | |||||
| Predicate Devices: | Premixed Dialysate for Hemodiafiltration | |||||
| K910270 cleared 04/18/1991 | ||||||
| Baxter Healthcare Corp. | Dialysis | |||||
| Solutions, Inc. | ||||||
| Novex Pharma | ||||||
| Normocarb | ||||||
| Sterile | ||||||
| Bicarbonate | ||||||
| Renal Dialysis | ||||||
| Concentrate | ||||||
| K 001059 | ||||||
| Cleared | ||||||
| 06/30/2000 | Dialysate concentrate for | |||||
| use in hemodialysis. | ||||||
| (Described as intended for | ||||||
| use in Continuous Renal | ||||||
| Replacement Therapy) | Sodium 140 mEq/L | |||||
| Calcium 0 mEq/L | ||||||
| Potassium 0 mEq/L | ||||||
| Magnesium 1.5 mEq/L | ||||||
| Bicarbonate 35 mEq/L | ||||||
| Lactate 0 mEq/L | ||||||
| Acetate 0 mEq/L | ||||||
| Dextrose 10.2 mEq/L (1.8 g/L) | Manufactured | |||||
| as a sterile | ||||||
| product | Glass vials | |||||
| Normocarb Sterile Bicarbonate Renal Dialysis Concentrate | ||||||
| K001059 cleared 06/30/2000 | ||||||
| Dialysis Solutions, Inc. / Novex Pharma | Dial Medical of | |||||
| Florida | ||||||
| Hemodialysis | ||||||
| Bath | ||||||
| Concentrate | ||||||
| Solutions for | ||||||
| Hemodialysis | ||||||
| K 864265 | ||||||
| Cleared | ||||||
| 03/17/1987 | Formulated to be used in | |||||
| conjunction with a Sodium | ||||||
| Bicarbonate Concentrate in | ||||||
| a three stream artificial | ||||||
| kidney machine. | Sodium* 137 - 143 mEq/L | |||||
| Calcium 0 - 3.5 mEq/L | ||||||
| Potassium 0 - 4 mEq/L | ||||||
| Magnesium 0.5 - 1.5 mEq/L | ||||||
| Bicarbonate* 32 - 36 mEq/L | ||||||
| Lactate 0 mEq/L | ||||||
| Acetate 3 - 4 mEq/L | ||||||
| Dextrose 0 - 2 g/L | Not | |||||
| manufactured | ||||||
| as a sterile | ||||||
| product | PP/PE | |||||
| containers | ||||||
| Hemodialysis Bath Concentrate Solutions for Hemodialysis | ||||||
| K864265 cleared 03/17/1987 | ||||||
| Dial Medical of Florida, Inc. | Gambro Renal | |||||
| Products Dry AC | ||||||
| Acid | ||||||
| Concentrate Mix | ||||||
| for Bicarbonate | ||||||
| Hemodialysis | ||||||
| K011368 | ||||||
| Cleared | ||||||
| 08/02/2001 | For use with concentrated | |||||
| bicarbonate solution in 3- | ||||||
| stream proportioning | ||||||
| artificial kidney equipment | ||||||
| using purified, AAMI | ||||||
| standard water. | Sodium* 137 - 143 mEq/L | |||||
| Calcium 0 - 4 mEq/L | ||||||
| Potassium 0 - 3 mEq/L | ||||||
| Magnesium 0.5 - 1.5 mEq/L | ||||||
| Bicarbonate* 32 - 36 mEq/L | ||||||
| Lactate 0 mEq/L | ||||||
| Acetate 3 - 4 mEq/L | ||||||
| Dextrose 0 - 2 g/L | Not | |||||
| manufactured | ||||||
| as a sterile | ||||||
| product | PP/PE | |||||
| containers | ||||||
| Dry AC Acid Concentrate Mix for Bicarbonate Hemodialysis | ||||||
| K011368 cleared 08/02/2001 | ||||||
| Gambro Renal Products |
Device Description:
Gambro PrismaSate solutions are sterile dialysate solutions for use in Continuous Renal Replacement Therapy (CRRT) for the treatment of acute renal failure and in other cases necessitating fluid or solute removal, such as in the case of drug poisoning with dialysable or filterable substances. The solutions are intended to be used in commercially available continuous renal replacement therapy machines as dialysate. A physician prescribes the chemical composition of the solution to be used.
The solutions are perfused through the dialysis fluid compartment of hemofilters/dialyzers. The dialysate is separated from the patient's blood by means of a semi-permeable membrane. Excess waste products, fluids and toxins found in the blood of a patient with acute renal failure pass through the membrane into the dialysate and eventually go to waste. The therapy is aimed at normalizing the blood.
CRRT is used for acute renal failure patients that may be too unstable to tolerate conventional hemodialysis, in which this function occurs much more rapidly (3-4 hours per treatment) and intermittently (3-6 times a week). In CRRT, the balancing is done on a continuous basis, 24 hours a day, in order to mimic kidney function.
Gambro PrismaSate solutions are indicated for use as a Indications for Use: dialysate in Continuous Renal Replacement Therapy.
Comparison to Predicate Devices:
The Gambro PrismaSate Dialysate Solutions for Continuous Renal Replacement Therapy are equivalent to other dialysate products that are currently approved by the FDA, as demonstrated in the following table:
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Image /page/2/Picture/0 description: The image shows the logo for GAMBRO Renal Products. The word "GAMBRO" is in a bold, sans-serif font, and the words "Renal Products" are in a smaller, italicized font. To the left of the word "GAMBRO" is a circular graphic. The logo is simple and professional.
510(k) Premarket Notification
510 (k) Summary
*final dialysate concentration when mixed with sodium chloride/sodium bicarbonate buffer
Comparing the proposed device to the predicate devices, its ranges of chemical compositions, packaging, and sterility are equivalent to one or more of the predicate devices. Although the upper level of the lactate concentration is higher than the predicate devices, it is within the 30-60 mEq/L range specified by the European Pharmacopoeia Monograph for Solutions for Hemofiltration and Hemodiafiltration, an accepted reference standard. The primary function of the lactate is as a buffer. In this case, the higher lactate concentration brings the pH of the solution closer to the physiological plasma pH. There is no adverse effect on safety or effectiveness of the solution by offering a lactate concentration which is higher than the predicate devices. There are no significant differences in technological characteristics, and its intended use as dialysate is equivalent to the predicate devices.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 5 2002
Ms. Fei Law Quality Assurance Manager Gambro Renal Products 1845 Mason Avenue DAYTONA BEACH FL 32117 Re: K013448 Trade/Device Name: Gambro PrismaSate™ Dialysis Solutions for Continuous Renal Replacement Therapy Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 KPO Dated: October 10, 2001 Received: October 17, 2001
Dear Ms. Law:
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 (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.
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 Cbrogdon
Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
5
of I Page 1
K013448
510(k) Number (if known):
PrismaSate™ Device Name:
Indications For Use:
Gambro PrismaSate™ solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brandon
(Division Sign-On)
Prescription Use
(Divisio (Optional Format 3-10-98 Division and Radiolog 5 10(k) Numbe