(217 days)
Not Found
No
The device description and summary of performance studies focus on the chemical composition and physical mixing process of the hemodialysis concentrate, with no mention of AI or ML technologies.
Yes
The device is an acid concentrate used in hemodialysis therapy, which is a medical treatment to remove waste products and excess fluid from the blood when kidneys are no longer functioning properly. This direct involvement in a treatment classifies it as a therapeutic device.
No
The device is described as an "acid concentrate" used in the preparation of hemodialysis solutions for therapy, not for diagnosing any condition. Its function is to be mixed with other substances to create a solution for treatment, not to identify or monitor a disease.
No
The device description clearly indicates a physical chemical product (acid concentrate) used in hemodialysis, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as acid concentrate in hemodialysis therapy." This describes a substance used in a medical procedure (hemodialysis) to treat a patient.
- Device Description: The description details how the acid concentrate is mixed with other components to create a hemodialysis solution, which is then used to dialyze a patient's blood. This is a therapeutic process, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition. IVDs are specifically designed for this purpose.
Therefore, this device is a component used in a therapeutic medical procedure (hemodialysis), not a diagnostic test.
N/A
Intended Use / Indications for Use
Acid Concentrate is indicated for use as acid concentrate in hemodialysis therapy.
Product codes
KPO
Device Description
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.
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)
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.
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.
0
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 Corporation | |
| One Deerfield Parkway | ||
| Deerfield, IL 60015 | AUG - '7 200 | |
| CONTACT PERSON: | Donna Djinovich, Manager Global Regulatory Affairs | |
| 1620 Waukegan Road, MPGR-AL | ||
| McGaw Park, IL 60085 | ||
| Telephone: 847-473-6896 | ||
| Fax: 847-785-5116 | ||
| Email: 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
1
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 Systems | |||
| Hemodialysis | |||
| Concentrate | Renal Systems, Inc. | K792213 | 01/04/1980 |
| Renal Systems | |||
| Hemodialysis | |||
| Concentrate | Renal Systems, Inc. | K781967 | 12/07/1978 |
| Rockwell Medical | |||
| Supply LLC, | |||
| Hemodialysis | |||
| Concentrate | Rockwell Medical | ||
| Supply LLC | K954527 | / 03/01/1996 |
Table 5-2. Previous 510(k)s
DEVICE DESCRIPTION:
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.
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.
2
K090002 Age 3 of 3
Traditional 510(k) Premarket Notification Acid Concentrate
Section 5, Summary Page 3 of 3
4
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.
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 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
4
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
5
1
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):
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_