(70 days)
Not Found
No
The summary describes a liquid concentrate for dialysis and explicitly states that the technological characteristics are equivalent to unmodified devices, with no mention of AI/ML or related concepts.
Yes
The device is an acid concentrate for bicarbonate dialysis, which indicates it is used for medical treatment.
No
Explanation: The device is described as an "Acid Concentrate for Bicarbonate Dialysis," which is a consumable used in dialysis, not a piece of equipment designed to diagnose a medical condition.
No
The device description clearly states it is a "Liquid Acid Concentrate," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Acid Concentrate for Bicarbonate Dialysis." This indicates the product is used in the process of dialysis, which is a treatment for kidney failure.
- Device Description: The description confirms it's a liquid concentrate used in dialysis systems.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The focus is on preparing a solution for a medical treatment.
IVDs are specifically designed to perform tests on biological samples to gain diagnostic information. This device is a component used in a therapeutic process (dialysis).
N/A
Intended Use / Indications for Use
Acid Concentrate for Bicarbonate Dialysis
Product codes (comma separated list FDA assigned to the subject device)
KPO
Device Description
The Fresenius Naturalyte Liquid Acid Concentrate is a modified version of the Fresenius Naturalyte Liquid Acid Concentrate. The Fresenius Naturalyte Liquid Acid Concentrates are a device pursuant to 21 CFR §201 [321] (h). The Fresenius modified Naturalyte Liquid Acid Concentrates are substantially equivalent in construction, design, materials, and intended use to the commercially available Fresenius Naturalyte Liquid Acid Concentrates.
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)
Not Found
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.
0
Image /page/0/Picture/0 description: The image shows a black and white drawing of a funnel. The funnel is drawn with thick black lines, and it is wider at the top and narrower at the bottom. The funnel is made up of several sections, each of which is slightly smaller than the one above it. The funnel is empty.
Image /page/0/Picture/1 description: The image shows the text "K070177 Page 1 of 3" in a handwritten style. The text appears to be a document identifier and page number. The handwriting is clear and legible, with the characters well-formed. The text is positioned at the top of the image.
Fresenius Medical Care
MAR 2 9 2007
Fresenius Naturalyte® Liquid Acid Concentrates "Special" 510(k) Premarket Notification
Summary of Safety and Effectiveness
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.
A. Submitter's Information:
| Name: | Fresenius Medical Care North America |
|---|---|
| Address: | 920 Winter Street |
| Waltham, MA 02451 | |
| Phone: | (781)-699-4475 |
| Fax: | (781) 699-9635 |
| Contact Person: | Janet C. Kay, Manager Regulatory Affairs |
| Date of Preparation: | 16 January, 2007 |
B. Device Name:
| Trade Name: | Naturalyte Liquid Acid Concentrate |
|---|---|
| Common/Usual Name: | Dialysate Concentrate for Hemodialysis (liquid) |
| Classification Name: | Hemodialysis systems and accessories |
1
Image /page/1/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a geometric shape resembling an inverted pyramid or funnel, composed of several horizontal lines that decrease in length from top to bottom. Below the geometric shape, the text "Fresenius Medical Care" is written in a clear, sans-serif font. The text is aligned centrally with the geometric shape above it.
Image /page/1/Picture/1 description: The image shows the text "K070177 Page 2 of 3" in a handwritten style. The text appears to be part of a document or record, possibly indicating a page number or identification code. The handwriting is somewhat stylized, with distinct letterforms and spacing.
Fresenius Naturalyte® Liquid Acid Concentrates "Special" 510(k) Premarket Notification
Summary of Safety and Effectiveness
C. Predicate Device Name:
The Fresenius Naturalyte® Liquid Acid Concentrate is a modified version of the Fresenius Naturalyte Liquid Acid Concentrate1996):
- #K810925 (4/23/1981) 9000 series .
- . #K823115 (12/3/1982) - 4000 series
- #K852310 (7/26/1985) - 6000 series
D. Device Description/Indications for Use:
The intended use for the modified device is equivalent to that of the unmodified device:
Intended Use
Acid Concentrate for Bicarbonate Dialysis
- E. Substantial Equivalence:
Substantial Equivalence Decision Making Process
-
- Is the product a device?
YES - The Fresenius Naturalyte Liquid Acid Concentrates are a device pursuant to 21 CFR §201 [321] (h).
- Is the product a device?
2. Does the new device have the same intended use?
- YES The intended use for the modified devices are equivalent to the unmodified devices.
Fresenius modified Fresenius Naturalyte Liquid Acid Concentrates -Intended Use
Acid Concentrate for Bicarbonate Dialysis
Fresenius unmodified Fresenius Naturalyte Liquid Acid Concentrates -Intended Use
Acid Concentrate for Bicarbonate Dialysis
2
Image /page/2/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a stylized image of a funnel or inverted pyramid made up of several horizontal lines. Below the image is the text "Fresenius Medical Care" in a simple, sans-serif font.
Image /page/2/Picture/1 description: The image shows the text "K070177" on the top line. The second line of text says "Page 3 of 3". The text is written in a handwritten style.
Fresenius Naturalyte® Liquid Acid Concentrates "Special" 510(k) Premarket Notification
Summary of Safety and Effectiveness
3. Does the device have technological characteristics that raise new types of safety or effectiveness questions?
NO - The Fresenius Naturalyte Liquid Acid Concentrates are a modified version of the Fresenius Naturalyte Liquid Acid Concentrates. The technological characteristics of the modified devices are equivalent to those of the unmodified devices and raise no new types of safety or effectiveness questions.
4. Does descriptive or performance information demonstrate equivalence?
YES - Fresenius Medical Care North America believes that the information provided in this submission clearly describes the modified Fresenius Naturalyte Liquid Acid Concentrates and demonstrates that it is substantially equivalent to the unmodified devices.
F. Safety Summary
The Fresenius modified Naturalyte Liquid Acid Concentrates are substantially equivalent in construction, design, materials, and intended use to the commercially available Fresenius Naturalyte Liquid Acid Concentrates. In addition, testing of the modified device indicates that the set is safe and effective for its intended use.
G. General Safety and Effectiveness Concerns
The Fresenius modified Naturalyte Liquid Acid Concentrates is to be used with a threestream proportioning systems when calibrated to specified proportions depending on the series and mixed with water. Use with other equipment or without associated bicarbonate concentrate may cause patient injury or death. Not for Parenteral Use.
3
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 caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAR 2 9 2007
Ms. Janet C. Kay Manager of Regulatory Affairs Fresenius Medical Care North America 920 Winter Street WALTHAM MA 02451
Re: K070177
Trade/Device Name: Fresenius Naturalyte® Liquid Acid Concentrates, 9000, 6000 and 4000 Series Regulation Number: 21 CFR $876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KPO Dated: February 26, 2007 Received: February 28, 2007
Dear Ms. Kay:
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 (Premarket Approval), it may be subject to such 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.
Image /page/3/Picture/10 description: The image is a circular seal with the text "1906-2006" at the top. In the center of the seal is the text "FDA Centennial" in a stylized font. There are three stars below the text. The seal is surrounded by the text "U.S. Department of Health and Human Services".
Protecting and Promoting Public Health
4
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
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 this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-011 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-011 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-012 |
| Other | 240-276-010 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
5
Image /page/5/Picture/0 description: The image shows a geometric shape that resembles a multi-tiered, inverted pyramid or cone. It is composed of four distinct layers, each decreasing in size as it descends. The layers are stacked on top of each other, creating a step-like effect. The overall shape is symmetrical and has a clean, minimalist design.
Fresenius Medical Care
Indications for Use
510(k) Number (if known):
Device Name: Fresenius Naturalyte® Liquid Acid Concentrates, 9000, 6000 and 4000 Series.
Indications for Use:
Acid Concentrate for Bicarbonate Dialysis
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.
Page of
(Posted November 13, 2003)
Fresenius Medical Care North America
Corporate Headquarters: 95 Hayden Avenue Lexington, MA 02420 (781) 402-9000