The Fresenius Naturalyte® Granuflo® Dry Acid Concentrate is indicated in the treatment of acute and chronic renal failure during the hemodialysis procedure. This concentrate is formulated to be used with a three-stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates.

Device Description

The Fresenius Naturalyte® Granuflo® Dry Acid Concentrate is designed to be used as direct product replacement for the current Granuflo@ Concentrate (Series 1000, 2400, and 3000). The new product will be available in a non-granulated formula. It is used only during hemodialysis. It is manufactured using the same raw materials. The new Fresenius Naturalyte® Granuflo® Dry Acid Concentrate has the same chemical composition as the predicate devices. It is for single use only. It is supplied non-sterile and is non-pyrogenic.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a medical device: Fresenius Naturalyte® Granuflo® Dry Acid Concentrate.

This document describes a submission for demonstrating substantial equivalence to a predicate device, rather than a study proving the device meets specific acceptance criteria for performance in the way clinical studies often do for novel devices.

Therefore, many of the requested categories for a clinical study on device performance are not applicable or cannot be extracted from this type of regulatory submission. The document explicitly states: "The safety and effectiveness of the Fresenius Naturalyte® Granuflo® Dry Acid Concentrate is supported by the substantial equivalence information, materials data, device description, and performance testing."

Here's a breakdown of what can be inferred or directly stated from the provided text, and where gaps exist:

1. Table of Acceptance Criteria and Reported Device Performance

This information is typically found in detailed test reports or clinical trial summaries. For a 510(k) submission based on substantial equivalence, the "acceptance criteria" revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. The "performance" is generally demonstrated by showing identical or highly similar characteristics to the predicate.

Acceptance Criteria (Implied by 510(k) SE)	Reported Device Performance (from text)
Intended Use: Device must have the same or highly similar intended use as the predicate device.	"The Fresenius Naturalyte® Granuflo® Dry Acid Concentrate is indicated in the treatment of acute and chronic renal failure during the hemodialysis procedure." (Matches predicate's implied use as a dialysate concentrate)
Technological Characteristics: Device must have the same or highly similar technological characteristics as the predicate.	"The new product will be available in a non-granulated formula." (A minor change in form, but overall chemical composition and function are presented as the same) "The new Fresenius Naturalyte® Granuflo® Dry Acid Concentrate has the same chemical composition as the predicate devices.""It is manufactured using the same raw materials.""It is for single use only. It is supplied non-sterile and is non-pyrogenic."
Safety and Effectiveness: Device must be as safe and effective as the predicate device.	"The intended use, technological characteristics, design features, and materials are substantially equivalent to the predicate devices previously cleared for market." "The safety and effectiveness of the Fresenius Naturalyte® Granuflo® Dry Acid Concentrate is supported by the substantial equivalence information, materials data, device description, and performance testing." (No specific quantitative performance metrics are provided in the summary)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable in the context of a "test set" for a clinical study assessing performance in humans. The submission relies on "performance testing" of the product itself, "materials data," and "device description" to demonstrate substantial equivalence to existing predicate devices. Specific sample sizes for such engineering or chemical testing are not provided in this summary.
Data Provenance: The document does not specify the country of origin for any "performance testing" data, nor whether it was retrospective or prospective. Given the nature of a chemical concentrate, direct patient data might not be the primary evidentiary support for substantial equivalence, but rather chemical and functional validation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable. The basis for clearance is substantial equivalence to existing, legally marketed devices (predicates: Granulyte Powder Dialysate Concentrates and Mixer; K911459, and Granulyte Dialysate Concentrate; K922005). The "ground truth" for this type of submission is the established safety and effectiveness of the predicate devices and the demonstration that the new device is essentially the same. Expert consensus would apply to the FDA reviewers comparing the device.

4. Adjudication Method for the Test Set

Not applicable. There's no "test set" in the sense of a set of cases requiring adjudication by multiple experts. The FDA's review process determines substantial equivalence based on the submitted documentation compared to the predicate.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study is typically performed for diagnostic imaging devices or software where human readers interpret results, often with and without AI assistance, to assess the impact of the AI. This device is a chemical concentrate for hemodialysis, and therefore, an MRMC study is not relevant or performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Not applicable. This device is a chemical concentrate, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices. The new device's characteristics (chemical composition, raw materials, intended use, technological characteristics, design features) are compared against these known predicates to demonstrate equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/ML device.

Summary

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K030497
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Fresenius Naturalyte® Granuflo® Dry Acid Concentrate 510(k) Premarket Notification MAY 2 0 2003

510K Summary

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this information serves as a Summary of Safety and Effectiveness for the Fresenius Naturalyte® Granuflo® Dry Acid Concentrate.

Company: Art Eilinsfeld, Director of Regulatory. Affairs Fresenius Medical Care North America 95 Hayden Ave. Lexington, MA 02420 1-800-662-1237

January 14, 2003 Date:

Trade Name: Fresenius Naturalyte® Granuflo® Dry Acid Concentrate

Common Name: Dialysate concentrate for hemodialysis (liquid or powder)

Classification Name and Reference: 21 CFR $876.5820 Dialysate concentrate for hemodialysis (liquid or powder) - Class II

Device Product Code and Panel Code: KPO, 78

Predicate Device(s): Granulyte Powder Dialysate Concentrates and Mixer; (K911459, SE 07/17/1991); Granulyte Dialysate Concentrate; (K922005, SE 03/30/94)

Description:

Intended Use:

Safety and Performance:

The intended use, technological characteristics, design features, and materials are substantially equivalent to the predicate devices previously cleared for market. The safety and effectiveness of the Fresenius Naturalyte® Granuflo® Dry Acid Concentrate is supported by the substantial equivalence information, materials data, device description, and performance testing.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written along the border of the circle.

MAY 2 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Arthur Eilinsfeld Director of Regulatory Affairs Fresenius Medical Care North America 95 Hayden Avenue LEXINGTON MA 02173

Re: K030497

Trade/Device Name: Fresenius Naturalyte® Granuflo® Dry Acid Concentrate Regulatory Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 KPO Dated: February 14, 2003 Received: February 19, 2003

Dear Mr. Eilinsfeld:

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); 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 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 this 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" (21 CFR Part 807.97). 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 Crogdon

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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Image /page/3/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a geometric shape resembling a funnel or inverted pyramid, positioned above the text "Fresenius Medical Care". The geometric shape is made up of several horizontal lines that decrease in length as they descend, culminating in a pointed apex.

Indications for Use Statement

Device Name:

Fresenius Naturalyte® Granuflo® Dry Acid Concentrate

Indications for Use:

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)	✓
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OR
Over-The-Counter Use

Nancy C Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number	K030497
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Fresenius Medical Care North America

Curporate Headquarters: 95 Hayden Avenue Lexington, MA 02420 (781) 402-9800

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.