(290 days)
Not Found
No
The description focuses on the mechanical and fluid handling aspects of the system, with no mention of AI or ML technologies. The performance studies are related to electrical and safety standards, not algorithmic performance.
No.
The device components are used for mixing and distributing concentrates for dialysate solution, but they do not directly interact with the patient or perform a therapeutic function themselves. The resulting dialysate solution is used in hemodialysis, which is a therapeutic process, but the device described is for preparation and delivery of ingredients, not the therapy itself.
No
This device is designed for mixing and distributing solutions (sodium bicarbonate and acid concentrates) for hemodialysis, not for diagnosing medical conditions or diseases.
No
The device description clearly outlines a system involving physical components like tanks, pumps, and distribution lines for mixing and delivering solutions, indicating it is a hardware-based system with potential software control, not a software-only device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is for mixing and distributing solutions (sodium bicarbonate and acid concentrates) that are then used to create dialysate solutions for hemodialysis. Hemodialysis is a treatment performed on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a system for mixing and distributing fluids to patient stations. This aligns with a device used in a clinical treatment setting, not a laboratory setting for analyzing samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of analytes, or diagnostic purposes.
IVDs are devices intended for use in vitro for the examination of specimens, including blood, tissues, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that definition.
N/A
Intended Use / Indications for Use
The Solution Delivery System Local and Solution Delivery System Remote are intended to be used in a hemodialysis facility for mixing and distribution of sodium bicarbonate (bicarb) and the distribution of acid concentrates to remote points of use where they are mixed with purified water to create the dialysate solutions used in hemodialysis. The Acid Delivery System is intended to be used in a hemodialysis facility for the distribution of acid concentrates to remote points of use where they are mixed with bicarb and purified water to create the dialysate solution used in hemodialysis.
Product codes (comma separated list FDA assigned to the subject device)
FIN
Device Description
The Osmonics Solution Distribution System (SDS) provides semi-automatic mixing of bicarb concentrate and the distribution of bicarb and acid concentrates from storage to hemodialysis patient stations. The mixed bicarb solution is automatically transferred to an elevated reservoir (head tank). The SDS, depending on the model purchased, can transfer up to three different acid concentrates to elevated head tanks from 55-gallon drums or larger bulk acid storage tanks. Bicarb and acid then flow via gravity from the head tanks to the dispensing stations.
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
hemodialysis facility
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)
The Solution Delivery Systems have been manufactured and tested to meet the safety requirements of CSA and UL. The SDS systems comply with CAN/CSA C22.2 no. 601-1-M90: Safety of Medical Electrical Equipment, Part I, General Requirements for Safety and UL std No. 2601-1: Safety of Medical Electrical Equipment, Part I: General Requirements for Safety as certified by Canadian Standards Association.
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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K023011
PAGE 1 OF 2
7848 South 202nd Street Kent, WA 98032-1345 USA
Phone (253) 395-2200 Fax
510(k) SUMMARY
03 Feb 03 DATE PREPARED:
1. SUBMITTER
Osmonics Medical Systems 7848 S. 202nd Street Kent, WA 98032-1345
CONTACT PERSON 2.
Name: Kristine Kaliszewski Phone: (253) 395-2200 ext. 4767 Fax: (253) 395-2363 Email: kkaliszewski@osmonics.com
DEVICE IDENTIFICATION 3.
Trade Name/Proprietary Name: Solution Delivery System Local (SDSL), Solution Delivery Device: System Remote (SDSR) and Acid Delivery System (ADS)
Common Name: Mixing and distribution system for bicarbonate and acid concentrates for dialysis
4. CLASSIFICATION NAME AND REFERENCE
Classification Names: Tank, Holding, Dialysis and Accessories
Classification: Class II, 21 CFR 876.5820 Panel: Gastroenterology Product Code: FIN
5. PREMARKET NOTIFICATION NUMBER: K023011
Image /page/0/Picture/16 description: The image shows the logo for Osmonics Medical Systems. The logo consists of a circular graphic on the left and the word "OSMONICS" in bold, sans-serif font on the right. Below the word "OSMONICS" is the phrase "Medical Systems" in a smaller, less bold font. The circular graphic appears to be a stylized representation of fluid dynamics.
JUN 2 6 2003
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- INDICATION FOR USE: The Solution Delivery System Local and Solution 6. Delivery System Remote are intended to be used in a hemodialysis facility for mixing and distribution of sodium bicarbonate (bicarb) and the distribution of acid concentrates to remote points of use where they are mixed with purified water to create the dialysate solutions used in hemodialysis. The Acid Delivery System is intended to be used in a hemodialysis facility for the distribution of acid concentrates to remote points of use where they are mixed with bicarb and purified water to create the dialysate solution used in hemodialysis.
- DEVICE DESCRIPTION: The Osmonics Solution Distribution System (SDS) 7. provides semi-automatic mixing of bicarb concentrate and the distribution of bicarb and acid concentrates from storage to hemodialysis patient stations. The mixed bicarb solution is automatically transferred to an elevated reservoir (head tank). The SDS, depending on the model purchased, can transfer up to three different acid concentrates to elevated head tanks from 55-gallon drums or larger bulk acid storage tanks. Bicarb and acid then flow via gravity from the head tanks to the dispensing stations.
- STATEMENT OF SUBSTANTIAL EQUIVALENCE: The Osmonics 8. Solution Distribution System is substantially equivalent in intended use, features, functions, and technological characteristics to the G.E.M. Water Systems International Sodium Bicarbonate Mixers/Delivery Systems (K970674).
- PERFORMANCE: SAFETY AND EFFECTIVENESS INFORMATION 9. The Solution Delivery Systems have been manufactured and tested to meet the safety requirements of CSA and UL. The SDS systems comply with CAN/CSA C22.2 no. 601-1-M90: Safety of Medical Electrical Equipment, Part I, General Requirements for Safety and UL std No. 2601-1: Safety of Medical Electrical Equipment, Part I: General Requirements for Safety as certified by Canadian Standards Association.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or waves, arranged in a vertical stack.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 6 2003
Ms. Kristine L. Kaliszewski Regulatory Affairs Manager Osmonics Medical Systems 7848 S. 202nd Street KENT WA 98032-1345
Re: K023011
Trade/Device Name: Solution Delivery System Local (SDSL), Solution Delivery System Remote (SDSR), and Acid Delivery System (ADS) Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis systems and accessories Regulatory Class: II Product Code: 78 FIN Dated: May 14, 2003 Received: May 30, 2003
Dear Ms. Kaliszewski:
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. Iisting 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.
3
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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the 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" (21CFR Part 807.97) you may obtain. 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
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Osmonics Medical Systems 7848 S. 202nd Street Kent. WA 98032-1345
510(k) Number (if known): K023011
Device Name: Solution Delivery System Local (SDSL), Solution Delivery System Remote (SDSR) and Acid Delivery System (ADS)
Indications for Use Statement
The Solution Delivery System Local and Solution Delivery System Remote are intended to be used in a hemodialysis facility for mixing and distribution of sodium bicarbonate (bicarb) and the distribution of acid concentrates to remote points of use where they are mixed with purified water to create the dialysate solutions used in hemodialysis. The Acid Delivery System is intended to be used in a hemodialysis facility for the distribution of acid concentrates to remote points of use where they are mixed with bicarb and purified water to create the dialysate solution used in hemodialysis.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number: K023011
Prescription Use i (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Nauray C. Brogdon
(Division Sig. Off.)
(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devices 510(k) Number.