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.

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.

AI/ML Overview

The provided document describes the Osmonics Medical Systems Solution Delivery System (SDS) and its 510(k) premarket notification (K023011). However, the document does not contain information regarding acceptance criteria, device performance metrics, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or specific study designs (like MRMC or standalone performance evaluations) as typically found in detailed performance studies.

Instead, the document states:

Performance: "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."

This indicates that the device's performance was evaluated against safety standards for electrical and medical equipment, rather than clinical performance metrics or accuracy in specific measurements (which would be more relevant for an AI/CAD device). The document focuses on regulatory compliance based on safety and substantial equivalence to a predicate device, not on diagnostic performance or AI model evaluation.

Therefore, I cannot populate the requested table or answer the detailed questions about acceptance criteria, study design, and performance metrics as they are not present in the provided text. The document pertains to a medical device's safety compliance and regulatory clearance, not the performance evaluation of an AI-driven, diagnostic, or image analysis device.

Summary

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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.

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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

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)

Over-The-Counter Use

Nauray C. Brogdon
(Division Sig. Off.)

(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devices 510(k) Number.

Regulation Number and Section

§ 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.