(70 days)
Not Found
Not Found
No
The provided 510(k) summary does not contain any mention of AI, ML, image processing, or descriptions of training/test sets, which are typical indicators of AI/ML technology in medical devices.
Yes
The device is described as a "Hemodialysis System" used for the "treatment of acute and chronic uremic patients," which indicates a therapeutic purpose.
No
The device, the Allient Sorbent Hemodialysis System, is described as a treatment system for uremic patients where hemodialysis is prescribed. Its purpose is therapeutic (treatment), not diagnostic (identifying or characterizing a disease).
No
The device description is not found, but the intended use clearly describes a "Hemodialysis System" including "cartridges," which are physical components, indicating it is not a software-only device.
Based on the provided information, the Allient Sorbent Hemodialysis System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of uremic patients through hemodialysis. This is a therapeutic procedure performed on the patient's body, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description (Not Found): While the description is missing, the intended use clearly points away from IVD.
- No mention of analyzing samples: There is no indication that this device analyzes blood, urine, or any other biological sample to provide diagnostic information.
- Therapeutic function: Hemodialysis is a treatment that filters the patient's blood.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Allient Sorbent Hemodialysis System performs a therapeutic function directly on the patient.
N/A
Intended Use / Indications for Use
The Allient Sorbent Hemodialysis System, including the SORB™ series and HISORB™ series of cartridges is to be used for the treatment of acute and chronic uremic patients where hemodialysis is prescribed by the physician.
Product codes
FKT
Device Description
Allient Sorbent Hemodialysis System
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5600 Sorbent regenerated dialysate delivery system for hemodialysis.
(a)
Identification. A sorbent regenerated dialysate delivery system for hemodialysis is a device that is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a sorbent cartridge and the means to circulate dialysate through this cartridge and the dialysate compartment of the dialyzer. The device is used with the extracorporeal blood system and the dialyzer of the hemodialysis system and accessories (§ 876.5820). The device includes the means to maintain the temperature, conductivity, electrolyte balance, flow rate and pressure of the dialysate, and alarms to indicate abnormal dialysate conditions. The sorbent cartridge may include absorbent, ion exchange and catalytic materials.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three overlapping, curved lines suggesting wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAY 2 5 2007
Mr. David J. Vanella Vice President, Quality Assurance & Regulatory Affairs Renal Solutions®, Inc. 770 Commonwealth Drive, Suite 101 WARRENDALE PA 15086
Re: K070739
Trade/Device Name: Allient Sorbent® Hemodialysis System Regulation Number: 21 CFR §876.5600 Regulation Name: Sorbent regenerated dialysate delivery system for hemodialysis Regulatory Class: II Product Code: FKT Dated: May 2, 2007 Received: May 3, 2007
Dear Mr. Vanella:
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/0/Picture/10 description: The image is a black and white circular logo. The logo contains the letters "FDA" in a bold, stylized font. Above the letters, the numbers "1906-2006" are displayed. Below the letters, the word "Centennial" is written in a cursive font, followed by three stars. The logo is surrounded by text that reads "PROTECTING AND PROMOTING YOUR HEALTH" and "THE SOURCE OF PUBLIC TRUST".
Protecting and Promoting Public Health
1
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.
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) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 vours.
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
2
Attachment 2 - Statement of Indications for Use
Indications for Use
510(k) Number
Ko70739
Device Name:
Allient® Sorbent Hemodialysis System
Indications For Use:
The Allient Sorbent Hemodialysis System, including the SORB™ series and HISORB™ series of cartridges is to be used for the treatment of acute and chronic uremic patients where hemodialysis is prescribed by the physician.
Prescription Use X (Per 21 CFR 801.109) AND/OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C Brogdon
Mivision Sign-Off Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Renal Solutions Inc.
CONFIDENTIAL