(115 days)
Gambro PrismaSate™ solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy.
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 sterile, and packaged in flexible bags.
This document is a 510(k) summary for a medical device called PrismaSate, which are dialysis solutions. It states that the device is substantially equivalent to predicate devices and describes its intended use. However, it does not contain any information about acceptance criteria, device performance results, sample sizes, ground truth establishment, or clinical study methodologies typically associated with proving a device meets acceptance criteria.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance
- Sample sizes used for the test set and data provenance
- Number and qualifications of experts for ground truth
- Adjudication method
- Comparative effectiveness study results (MRMC)
- Standalone performance results
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
This document is primarily for regulatory submission and approval based on substantial equivalence, not a detailed report of a performance study with specific acceptance criteria.
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K072908
Iage lıbl
Image /page/0/Picture/1 description: The image shows the logo for Gambro. The logo consists of a stylized letter "G" in a circle, followed by the word "GAMBRO" in all capital letters. The logo is black and white.
ਡਿਸ਼ 4 2008
510 (k) Summary
- Submitted by: Gambro 1845 Mason Avenue Daytona Beach, FL 32117
- Phone: (386) 274-2811
- Fax: (386) 274-2833
- Contact: Fei Law
- Date 09/28/2007
- Prepared:
- Phone: (386) 274-2811
- Trade Name: PrismaSate
- Dialysis Solutions for Continuous Renal Replacement Therapy (CRRT) Common Name: Ready to Use Sterile Dialysate
- Classification Dialysate Concentrate for Hemodialysis (Liquid or Powder) per Name: 21 CFR 876.5820. The Product/Classification Code is KPO.
- Equivalent PrismaSate Dialysis Solutions for Continuous Renal Replacement Therapy (CRRT) Predicate: Gambro Renal Products, K013448
NxStage Pureflow Solutions NxStage, K042045
- Device Gambro PrismaSate solutions are sterile dialysate solutions for use in Continuous Description: 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 sterile, and packaged in flexible bags.
- Intended Use: Gambro PrismaSate solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy.
CRRT is used 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 perfused through the dialysis fluid compariment 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.
Predicate The modified PrismaSate Dialysis Solutions for Continuous Renal Replacement Device Therapy (CRRT) has the same intended use, indication for use, chemical concentration Comparison: range, and packaging characteristics as the predicate devices. There are no significant technological changes. Based on the above, the device is substantially equivalent to the stated predicates.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird with three stylized wing segments.
4 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Fei Law Quality and Regulatory Manager U. S. Solutions Gambro® 1845 Mason Avenue DAYTONA BEACH FL 32117
Re: K072908
Trade/Device Name: PrismaSate Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KPO Dated: January 15, 2008 Received: January 28, 2008
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 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.
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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/cdrb/industry/support/index.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
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Page 1 of 1
510(k) Number (if known): Ko 7 2908
PrismaSate™ Device Name:
Indications For Use:
Gambro PrismaSate™ solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy.
Prescription Use $
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Concurrence of CDRH, Office of Device Evaluation (QDE)
Hulin Reines
(Division Sigh-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
(Optional Format 3-10-98)
§ 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.