(99 days)
Not Found
No
The document describes a traditional hemodialysis system and does not mention any AI or ML components or functionalities.
Yes
The device is used for the "treatment of acute and chronic uremic patients," which indicates a therapeutic purpose.
No
Explanation: The device description states that the Allient Sorbent Hemodialysis System is "for the treatment of acute and chronic uremic patients where hemodialysis is prescribed by the Physician." It explicitly functions as a "traditional re-circulating sorbent hemodialysis system" and describes the process of pumping the patient's blood through a dialyzer and returning it to the patient. This indicates a therapeutic function for treating a condition, rather than a diagnostic function for identifying or characterizing a medical condition or disease.
No
The device description explicitly lists hardware components such as a hemodialysis machine, sorbent cartridges, blood tubing set, dialysate set, and chemicals, indicating it is a physical system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of acute and chronic uremic patients where hemodialysis is prescribed by the Physician." This describes a therapeutic treatment performed directly on the patient, not a diagnostic test performed on a sample taken from the patient.
- Device Description: The description details a system that pumps the patient's blood through a dialyzer and returns it to the patient. This is a process of filtering the blood, which is a treatment, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples (like blood, urine, etc.) to provide diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is clearly therapeutic.
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 (comma separated list FDA assigned to the subject device)
FKT
Device Description
The Allient Sorbent Hemodialysis System is intended for the treatment of THE Allent Oorbont Homoutients where hemodialysis is prescribed by the ohysician.
The Allient System functions as a traditional re-circulating sorbent hemodialysis system. Either single-needle or dual-needle access to the nemodialysis bystem . The system consists of the Allient hemodialysis machine, SORB™ series of sorbent cartridges, a single-use, sterile, disposable blood tubing set, a single-use disposable dialysate set, and various dialysate and infusate chemicals. The patient's blood is pumped from the access through a dialyzer and is returned to the patient.
The modified Allient Sorbent Hemodialysis has the following similarities to the Substantial The modified Allient dialysis which previously received 510(k) clearance: Equivalence
- have the same indicated use, ●
- use the same operating principles, .
- incorporate the same basic system design, .
- incorporates the same accessories and generic materials which are . manufactured, packaged, and sterilized using the same processes.
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
Physician
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.
Allient Sorbent Hemodialysis System K043572, Allient Sorbent Hemodialysis System K043574
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
§ 876.5600 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
Ke6038/ page 1 of 2
Summary of Safety and Effectiveness 510(k) Summary Allient® Sorbent Hemodialysis System
This 510(k) Summary of Safety and Effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The accordance with the requirement have been provided in accordance with 21 CFR 807.92.
| Date | February 13, 2005 | MAY 24 2005 |
|---|---|---|
| Common/Usual | ||
| Name | Sorbent Hemodialysis System | |
| Trade/Proprietary | ||
| Name | Allient® Sorbent Hemodialysis System | |
| Classification | ||
| Name & Device | ||
| Classification | System, Dialysate Delivery, Sorbent Regenerated, Class II | |
| Product Code | FKT | |
| 21 CFR | ||
| Reference | 876.5600 | |
| Owner/Operator | Renal Solutions Inc | |
| 770 Commonwealth Drive | ||
| Warrendale, PA 15086 | ||
| Contact | David J. Vanella, Vice President Quality Assurance & | |
| Regulatory Affairs | ||
| 770 Commonwealth Drive | ||
| Warrendale, PA 15086 | ||
| Phone: 724-772-6900 | ||
| e-mail: david.vanella@renalsolutionsinc.com | ||
| Predicate Device | ||
| Information | Allient Sorbent Hemodialysis System K043572 |
1
K060381 Page 2 of 2
Device Description
The Allient Sorbent Hemodialysis System is intended for the treatment of THE Allent Oorbont Homoutients where hemodialysis is prescribed by the ohysician.
The Allient System functions as a traditional re-circulating sorbent hemodialysis system. Either single-needle or dual-needle access to the nemodialysis bystem . The system consists of the Allient hemodialysis machine, SORB™ series of sorbent cartridges, a single-use, sterile, disposable blood tubing set, a single-use disposable dialysate set, and various dialysate and infusate chemicals. The patient's blood is pumped from the access through a dialyzer and is returned to the patient.
The modified Allient Sorbent Hemodialysis has the following similarities to the Substantial The modified Allient dialysis which previously received 510(k) clearance: Equivalence
- have the same indicated use, ●
- use the same operating principles, .
- incorporate the same basic system design, .
- incorporates the same accessories and generic materials which are . manufactured, packaged, and sterilized using the same processes.
In summary, the Allient Sorbent Hemodialysis System (considering the in Summary, the Ainet within) is, in our opinion, substantially equivalent to the Allient Sorbent Hemodialysis System K043574.
Based on the comparison of technological characteristics to the Allient Conclusion Sorbent Hemodialysis System and certification to design controls, the modified device is substantially equivalent to the cleared Allient Sorbent Hemodialysis System (K043574). The modifications as described above have been evaluated in terms of both safety and effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. 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 4 2006
Mr. David J. Vanella Vice President, Quality Assurance & Regulatory Affairs Renal Solutions®, Inc. 770 Commonwealth Drive WARRENDALE PA 15086
Re: K060381
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: April 26, 2006 Received: May 2, 2006
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 arior 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 I tpp. o an 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/2/Picture/10 description: The image shows the FDA Centennial logo, which includes the years 1906-2006. The logo is circular and contains the letters FDA in bold. Below the logo, the text "Protecting and Promoting Public Health" is written in a decorative font. The image appears to be a scan of a document or a print of the logo.
3
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I lease of advisod that i Dr. i setaily our device complies with other requirements of the Act or any For has made a decermination administered by other Federal agencies. You must comply with all r coclar surfies and regulations as 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 labeling (21 OF R Part 801); 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) I this letter will and w you'ls ought maing of substantial equivalence of your device to a legally premarket notification: "The slassification 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 11 you desire specific act 100 for your as 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 Also, prease note the regulation 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
4
Indication's for Use
510(k) Number
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
and Radiological D 510(k) Number