(90 days)
No
The 510(k) summary describes a dry acid concentrate for hemodialysis and does not mention any AI or ML components or functionalities.
Yes
The device is a concentrate used in the treatment of acute and chronic renal failure during hemodialysis, which is a therapeutic procedure.
No.
The device is a dry acid concentrate used during hemodialysis treatment, indicated for renal failure; it is not described as diagnosing a condition or disease.
No
The device description clearly states it is a "Dry Acid Concentrate," 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 "in the treatment of acute and chronic renal failure during the hemodialysis procedure." This describes a therapeutic intervention performed on a patient, not a test performed on a sample taken from a patient to provide diagnostic information.
- Device Description: The description focuses on its use as a concentrate for hemodialysis, a treatment process.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Measuring a specific analyte or biomarker
The Fresenius Naturalyte® Granuflo® Dry Acid Concentrate is a component used in the hemodialysis process, which is a treatment, not a diagnostic procedure.
N/A
Intended Use / Indications for Use
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.
Product codes
KPO, 78
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.
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)
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.
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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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:
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.
Intended Use:
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.
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.
2
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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Indications for Use Statement
Device Name:
Fresenius Naturalyte® Granuflo® Dry Acid Concentrate
Indications for Use:
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.
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) | ✓ |
|---|---|
| --------------------------------------- | -------------------------------------------------------- |
OR
Over-The-Counter Use
Nancy C Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K030497 |
|---|---|
| --------------- | --------- |
Fresenius Medical Care North America
Curporate Headquarters: 95 Hayden Avenue Lexington, MA 02420 (781) 402-9800