Baxter's Acid Concentrate is used in the preparation of hemodialysis solutions when mixed and proportioned with the appropriate volumes of purified water and bicarbonate concentrate solution. These acid concentrate products are mixed and proportioned in a three-stream hemodialysis machine, in which the acid concentrate is proportioned into one stream, a bicarbonate concentrate solution is proportioned into the second stream, and purified water that meets AAMI Standards is proportioned into the third stream. These three streams are then mixed to prepare a final proportioned hemodialysis solution. The proportioned hemodialysis solution is then heated to body temperature and passed through the dialysis fluid compartment of a hemodialyzer counter-current to the flow of the patient's blood.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Baxter's Acid Concentrate, a medical device. The information primarily focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance metrics from a formal study for new device acceptance criteria against specific numerical targets.

Here's an analysis based on the provided text, addressing your questions:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the document, specific numerical acceptance criteria and their corresponding reported device performance values are not explicitly stated in a quantifiable table format. The assessment is qualitative, focusing on equivalence.

Acceptance Criterion	Reported Device Performance
Safety	"as safe as the predicate devices"
Effectiveness	"as effective as the predicate devices"
Appropriate Design for Intended Use	"devices are appropriately designed for their intended use."
Compliance with Regulatory Standards	"verified against established standards and guidelines for its intended use."
Chemical Composition	"utilizes... the same chemicals and compositions as the predicate devices."

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not applicable/Not provided. The document does not describe a test set with individual samples for statistical analysis of performance. Instead, it refers to a "risk assessment" and "design verification tests" which are internal to the manufacturer.
Data Provenance: The "assessment of nonclinical data" and "design verification tests" are conducted by Baxter Healthcare Corporation (the manufacturer). This implies internal testing during the device's development and validation. The document does not specify country of origin for any external data, nor if the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not provided. The document does not describe a process of establishing ground truth using external experts for a test set in the way one might for an AI/diagnostic device. The "ground truth" here is the established safety and effectiveness of the predicate devices and compliance with regulatory standards, which is then demonstrated by Baxter's device.

4. Adjudication method for the test set:

Not applicable/Not provided. There is no mention of an adjudication method, as there isn't a described test set requiring expert adjudication for ground truth.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This type of study (MRMC, AI assistance) is not relevant to this device. Baxter's Acid Concentrate is a chemical solution used in hemodialysis, not an imaging or diagnostic device that would involve human readers or AI assistance in interpretation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No. This concept is not applicable to this device. There is no algorithm or AI component in Baxter's Acid Concentrate.

7. The type of ground truth used:

The "ground truth" in this context is the established safety, effectiveness, and chemical composition of the legally marketed predicate devices, as well as relevant established standards and guidelines (e.g., ISO 14971:2003, AAMI Standards). The new device is compared to these established truths to demonstrate substantial equivalence.

8. The sample size for the training set:

Not applicable/Not provided. There is no mention of a "training set" as this is not an AI/machine learning device. The "training" here would be the development and testing performed by the manufacturer to ensure the product meets its specifications and regulatory requirements.

9. How the ground truth for the training set was established:

Not applicable/Not provided. Since there's no training set in the AI/ML sense, there's no ground truth established in that manner. The "ground truth" for the overall development and validation revolves around adherence to established chemical formulations, manufacturing processes, and successful performance in internal design verification tests against industry standards and predicate device characteristics.

Summary

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K09002 Page/01

Traditional 510(k) Premarket Notification Acid Concentrate

Section 5, Summary Page 1 of 3

5. 510(K) SUMMARY
DATE:	December 31, 2008
OWNER:	Baxter Healthcare CorporationOne Deerfield ParkwayDeerfield, IL 60015	AUG - '7 200
CONTACT PERSON:	Donna Djinovich, Manager Global Regulatory Affairs1620 Waukegan Road, MPGR-ALMcGaw Park, IL 60085Telephone: 847-473-6896Fax: 847-785-5116Email: donna_djinovich@baxter.com
DEVICE NAME:	Trade Name: Acid Concentrate

Table 5-1.
Product Codes for Baxter's Acid Concentrate

5M8001A	ACID CONCENTRATE 45X (2.0K, 3.1CA)
5M8002A	ACID CONCENTRATE 45X (2.0K, 2.5CA)
5M8003A	ACID CONCENTRATE 45X (3.0K, 3.0CA)
5M8004A	ACID CONCENTRATE 45X (3.0K, 2.5CA)
5M8005A	ACID CONCENTRATE 45X (2.0K, 2.5CA)
5M8006A	ACID CONCENTRATE 45X (4.0K, 2.5CA)

Common Name: Dialysate Concentrate for Hemodialysis (liquid or powder).

Classification Name: 21 CFR 876.5820 Hemodialysis System and Accessories.

Class Class II

Product Code: KPO

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K090002, Page 2 of 3

Traditional 510(k) Premarket Notification Acid Concentrate

Section 5, Summary Page 2 of 3

PREDICATE DEVICES:

Device	Company	Previous 510(k)	Clearance Date
Renal SystemsHemodialysisConcentrate	Renal Systems, Inc.	K792213	01/04/1980
Renal SystemsHemodialysisConcentrate	Renal Systems, Inc.	K781967	12/07/1978
Rockwell MedicalSupply LLC,HemodialysisConcentrate	Rockwell MedicalSupply LLC	K954527	/ 03/01/1996

Table 5-2. Previous 510(k)s

DEVICE DESCRIPTION:

STATEMENT OF INTENDED USE:

TECHNOLOGICAL CHARACTERISTICS: Acid Concentrate is intended for use as an acid concentrate in hemodialysis therapy.

Acid Concentrate is substantially equivalent to current on market acid concentrate products from Minntech (Centrisol K792213 & K781967) and Rockwell (RenalPure K954527). Baxter's Acid Concentrate utilizes the same intended use as well as the same chemicals and compositions as the predicate devices.

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K090002 Age 3 of 3

Traditional 510(k) Premarket Notification Acid Concentrate

Section 5, Summary Page 3 of 3

ASSESSMENT OF NONCLINICAL DATA:

Baxter Healthcare conducted a risk assessment according to the requirements of ISO 14971:2003 Medical Devices - Application of Risk Management to Medical Devices. Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses. All test results meet the acceptance criteria, and support that the devices are appropriately designed for their intended use.

CONCLUSIONS:

Baxter's Acid Concentrate has been verified against established standards and guidelines for its intended use. Testing demonstrates that the proposed device is as safe and effective as the predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized representation of three human figures in profile, stacked on top of each other. The figures are black and have a flowing, abstract design. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Ms. Donna Djinovich Manager, Global Regulatory Affairs Baxter Healthcare Corporation Renal Devices 1620 Waukegan Road, MPGR-AL MCGAW PARK IL 60085

7 2009

Re: K090002

Trade/Device Name: Acid Concentrate Regulation Number: 21 CFR $876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KPO Dated: July 17, 2009 Received: July 21, 2009

Dear Ms. Djinovich:

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); medical device reporting (reporting of medical

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrl/mdr/ 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 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/cdrh/industry/support/index.html.

Sincerely yours,

Lammy M. Morul

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K090002

Traditional 510(k) Premarket Notification Acid Concentrate

Section 4, Indications For Use Statement Page 1 of 1

4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K090002

Device Name:

Acid Concentrate

Indication(s) for Use:

Acid Concentrate is indicated for use as acid concentrate in hemodialysis therapy.

Prescription Use:	☑
21 CFR 801 Subpart D
Over-the-Counter Use:	☐
21 CFR Subpart C

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 090002 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.