(81 days)
Not Found
No
The device description and intended use are focused on the chemical composition and use of dialysate solutions, with no mention of AI or ML technologies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is a dialysate solution used in Continuous Renal Replacement Therapy, which is a treatment, but the solution itself is a consumable rather than a therapeutic device that performs a direct therapeutic action.
No
The device is a dialysate solution used in Continuous Renal Replacement Therapy, and its intended use is for treatment (fluid/solute removal) rather than diagnosis. Physicians determine the solution's composition based on patient's blood electrolyte levels, suggesting that the diagnostic step happens prior to the use of this therapeutic device.
No
The device description clearly states that the device 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:
- Intended Use: The intended use is "as a dialysate in Continuous Renal Replacement Therapy." This is a therapeutic use, not a diagnostic one.
- Device Description: The description clearly states the solutions are used for "treatment of acute renal failure and in other cases necessitating fluid or solute removal." This is a treatment, not a diagnostic test performed in vitro on a sample from the body.
- Mechanism of Action: The solutions are used to normalize blood composition by mirroring plasma water and removing excess fluid or solutes. This is a direct intervention on the patient's blood in vivo during the dialysis process, not a test performed on a sample outside the body.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. This device is a therapeutic solution used directly in the treatment process.
N/A
Intended Use / Indications for Use
PrismaSATE solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy.
Product codes
KPO
Device Description
PrismaSATE dialysis solutions are ready to use 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 dialyzable or filterable substances. The solutions are intended to be used with commercially available CRRT systems as dialysate. A physician prescribes the chemical composition of the solution to be used. The solutions are sterile, and packaged in flexible bags. The composition of the fluid used in renal therapies mirrors normal plasma water, since normalization of the blood is the objective.
PrismaSATE solutions, like other currently available dialysate solutions, consist of various quantities of the following chemicals: sodium chloride, potassium chloride, magnesium chloride, calcium chloride, dextrose, and a buffer of lactose and/or bicarbonate. The solution is prescribed by a physician; the physician selects the appropriate formulation based on the patient's blood electrolyte level and desired traits. PrismaSATE dialysate solutions are offered in a range of electrolyte concentrations which mirror the range of electrolytes in plasma. The solution may be buffered using lactate, bicarbonate using lactic acid as a pH adjustor, or bicarbonate using hydrochloric acid as a pH-adjusting excipient.. No changes to the available solution formulations are described in this Special 510(k).
The bicarbonate buffered PrismaSATE solutions currently on the market may be packaged in Polyvinyl Chloride (PVC) or in Polyolefin (non-PVC) two compartment bags. The final solution is obtained by breaking a frangible (PVC) or peel seal (non-PVC) between the compartments and mixing both solutions just prior to use. Neither the bag design nor the bag materials are being changed; they are not the subject of this Special 510(k).
The purpose of this Special 510(k) is to expand the PrismaSATE solution formulations buffered with bicarbonate using hydrochloric acid as a pH-adjusting excipient into the polyolefin primary packaging materials.
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 performance data is included in this Special 510(k).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 6, 2017
Baxter Healthcare Corporation Kristen Bozzelli Manager, Regulatory Affairs 32650 North Wilson Road Round Lake, IL 60073
Re: K162887
Trade/Device Name: PrismaSATE dialysis solutions Regulation Number: 21 CFR§ 876.5820 Regulation Name: Hemodialysis System and Accessories Regulatory Class: II Product Code: KPO Dated: December 8, 2016 Received: December 12, 2016
Dear Kristen Bozzelli:
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.
1
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 (reporting of medical device-related 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) TBDK162887
Device Name PrismaSATE dialysis solutions
Indications for Use (Describe)
PrismaSATE solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 5. 510(k) Summary
January 5, 2017
OWNER:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
CONTACT PERSON:
Kristen Bozzelli Manager, Global Regulatory Affairs Baxter Healthcare Corporation 32650 N Wilson Road Round Lake, IL 60073 Telephone: (224) 240-3075 Fax: (224) 240-4119
IDENTIFICATION OF THE DEVICE:
Common Name: Dialysate Solutions for Continuous Renal Replacement Therapy (CRRT) Ready to Use Sterile Dialysate. Trade Name or Proprietary Name: PrismaSATE Classification Panel: Gastroenterology/Urology Classification: 21 CFR 876.5820 Dialysate concentrate for hemodialysis (liquid or powder) Class: Class II Product Code: KPO
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PREDICATE DEVICE:
The predicate devices are the PrismaSATE dialysis solution formulations buffered by bicarbonate using hydrochloric acid as an excipient (pH adjustor) in PVC packaging cleared under K120333, and PrismaSATE dialysis solutions buffered by bicarbonate with lactate in polyolefin primary packaging cleared under K072908.
| Device | Company | Predicate 510(k) | Clearance Date |
|---|---|---|---|
| PrismaSATE dialysate | |||
| solutions, bicarbonate | |||
| buffered with HCl | |||
| excipient in PVC | |||
| packaging | Baxter Healthcare | ||
| (formerly Gambro Renal | |||
| Products, Inc.) | K120333 | May 31, 2012 | |
| PrismaSate dialysate | |||
| solutions bicarbonate | |||
| buffered with lactate in | |||
| polyolefin packaging | Baxter Healthcare | ||
| (formerly Gambro Renal | |||
| Products, Inc.) | K072908 | February 2, 2008 |
| Table 1. Predicate Device(s) | ||
|---|---|---|
DESCRIPTION OF THE DEVICE:
PrismaSATE dialysis solutions are ready to use 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 dialyzable or filterable substances. The solutions are intended to be used with commercially available CRRT systems as dialysate. A physician prescribes the chemical composition of the solution to be used. The solutions are sterile, and packaged in flexible bags. The composition of the fluid used in renal therapies mirrors normal plasma water, since normalization of the blood is the objective.
PrismaSATE solutions, like other currently available dialysate solutions, consist of various quantities of the following chemicals: sodium chloride, potassium chloride, magnesium chloride, calcium chloride, dextrose, and a buffer of lactose and/or bicarbonate. The solution is prescribed by a physician; the physician selects the appropriate formulation based on the patient's blood electrolyte level and desired traits. PrismaSATE dialysate solutions are offered in a range of electrolyte concentrations which mirror the range of electrolytes in plasma. The solution may be buffered using lactate, bicarbonate using lactic acid as a pH adjustor, or bicarbonate using hydrochloric
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acid as a pH-adjusting excipient.. No changes to the available solution formulations are described in this Special 510(k).
The bicarbonate buffered PrismaSATE solutions currently on the market may be packaged in Polyvinyl Chloride (PVC) or in Polyolefin (non-PVC) two compartment bags. The final solution is obtained by breaking a frangible (PVC) or peel seal (non-PVC) between the compartments and mixing both solutions just prior to use. Neither the bag design nor the bag materials are being changed; they are not the subject of this Special 510(k).
The purpose of this Special 510(k) is to expand the PrismaSATE solution formulations buffered with bicarbonate using hydrochloric acid as a pH-adjusting excipient into the polyolefin primary packaging materials. The formulations that are the subject of this submission are described in the Table 2 below.
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| Composition for small compartment (contains 250 ml) | ||||||
|---|---|---|---|---|---|---|
| Formulation | Calcium Chloride | Magnesium Chloride | Water for Injection | |||
| BzK 2/0 | - | 2.44 | q.s. | |||
| BzK 4/2.5 | 3.68 | 3.05 | q.s. | |||
| BzK 0/3.5 | 5.15 | 2.03 | q.s. | |||
| Composition for large compartment (contains 4750 ml) | ||||||
| Formulation | Sodium Chloride | Potassium Chloride | Sodium Bicarbonate | Water for Injection | ||
| BzK 2/0 | 6.46 | 0.157 | 3.09 | q.s. | ||
| BzK 4/2.5 | 6.46 | 0.314 | 3.09 | q.s. | ||
| BzK 0/3.5 | 6.46 | - | 3.09 | q.s. | ||
| Composition after reconstitution in mmol/l | ||||||
| Formulation | Na+ | K+ | Ca2+ | Mg2+ | HCO3- | Cl- |
| BzK 2/0 | 140 | 2 | 0 | 0.6 | 32 | 111.2 |
| BzK 4/2.5 | 140 | 4 | 1.25 | 0.75 | 32 | 116.0 |
| BzK 0/3.5 | 140 | 0 | 1.75 | 0.5 | 32 | 112.5 |
| Composition after reconstitution in mEq/l | ||||||
| Formulation | Na+ | K+ | Ca2+ | Mg2+ | HCO3- | Cl- |
| BzK 2/0 | 140 | 2 | 0 | 1.2 | 32 | 111.2 |
| BzK 4/2.5 | 140 | 4 | 2.5 | 1.5 | 32 | 116.0 |
| BzK 0/3.5 | 140 | 0 | 3.5 | 1.0 | 32 | 112.5 |
Table 2. PrismaSATE dialysate solution bicarbonate buffered with HCl excipient, packaged in polyolefin
INDICATIONS FOR USE:
PrismaSATE solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
The proposed device has the same technological characteristics as the predicate device.
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| Features | Predicate Device
PrismaSATE
K120333 | Predicate Device
PrismaSATE
K072908 | Proposed Device |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Gambro PrismaSATE
Solutions are indicated
for use as a dialysate in
Continuous Renal
Replacement Therapy | Gambro PrismaSATE
Solutions are indicated
for use as a dialysate in
Continuous Renal
Replacement Therapy | Same:
PrismaSATE Solutions
are indicated for use as a
dialysate in Continuous
Renal Replacement
Therapy. |
| Sterile | Steam sterilized, to a
Sterilization Assurance
Level of at least 10-6. | Steam sterilized, to a
Sterilization Assurance
Level of at least 10-6. | Same:
Steam sterilized, to a
Sterilization Assurance
Level of at least 10-6. |
| Non-Pyrogenic | Non-pyrogenic solution | Non-pyrogenic solution | Same:
Non-pyrogenic solution |
| Single Use | Yes | Yes | Same: Yes |
| Solution Formulation | PrismaSATE solution
formulations buffered with
bicarbonate using
hydrochloric acid as
excipient | PrismaSATE solutions
buffered with bicarbonate
with lactate | Same as predicate K120333 |
| Primary Packaging
material | PVC | Polyolefin | Same as predicate
K072908 : Polyolefin |
| Shelf life | 12 months | 18 months | Same as predicate
K072908: 18 months |
Table 3. Device Comparison Table
DISCUSSION OF NONCLINICAL TESTS:
A risk analysis was performed on the proposed combination of PrismaSATE solution formulations buffered with bicarbonate using hydrochloric acid as a pH-adjusting excipient (cleared under K120333) in the polyolefin primary packaging materials (cleared under K072908). No new risks were identified.
Baxter Healthcare Corporation performed design verification for the modification. The result met its acceptance criteria, and supports that the proposed device is appropriately designed for its intended use.
Performance Data:
No performance data is included in this Special 510(k).
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Biocompatibility:
No new materials are introduced in this Special 510(k). No biocompatibility data is necessary.
CONCLUSION:
The design control activities demonstrate that the subject device is substantially equivalent and performs comparably to the predicate device.