(64 days)
No
The summary describes a sorbent dialysate regenerative system that uses chemical reprocessing and recirculation. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The software testing mentioned appears to be functional verification, not related to AI/ML algorithms.
Yes
The device is used to perform hemodialysis, which is a therapeutic intervention for uremic patients.
No
Explanation: The device is described as a sorbent dialysate regenerative system used for hemodialysis by reprocessing dialysate. Its purpose is to treat uremic patients, not to diagnose their conditions.
No
The device description explicitly states it consists of two distinct components: the 2008 Machine and the SORB™ Module, both of which are hardware components. The summary also mentions "2008 System Software/ Hardware" testing, further indicating the presence of hardware.
Based on the provided information, the 2008 Sorbent System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use describes the device as being for "adult acute and chronic uremic patients in the presence of a healthcare practitioner where hemodialysis is prescribed on the order of a physician." This clearly indicates a therapeutic purpose (hemodialysis) performed directly on the patient.
- Device Description: The description details a system that "chemically reprocesses used dialysate into fresh, new dialysate" for use in hemodialysis. This is a process that supports the treatment of the patient's blood, not the analysis of a sample taken from the patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are typically used to analyze samples to provide information about a patient's health status. The 2008 Sorbent System is a therapeutic device used to perform hemodialysis, a treatment for kidney failure.
N/A
Intended Use / Indications for Use
The 2008 Sorbent System is intended for adult acute and chronic uremic patients in the presence of a healthcare practitioner where hemodialysis is prescribed on the order of a physician.
Product codes
FKT
Device Description
The 2008 Sorbent System is intended for adult acute and chronic uremic patients in the presence of a healthcare practitioner where hemodialysis is prescribed on the order of a physician.
The 2008 Sorbent System consists of two distinct components:
- the 2008 Machine, and
- the SORB™ Module.
The SORB Module is a sorbent dialysate regenerative system that attaches to the 2008 Machine and replaces the machine's existing single-pass dialysate delivery system.
During treatment, used dialysate is chemically reprocessed into fresh, new dialysate and sent back to the dialyzer instead of being sent down a drain. By recirculating and regenerating the dialysate, the 2008 Sorbent System uses less than 15 liters of potable tap water per treatment compared to a standard sinqle-pass system that uses at least 120 liters of purified water during a standard 4-hour dialysis treatment.
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
Adults (≥ 18 years)
Intended User / Care Setting
In the presence of a healthcare practitioner; Institutional, where competent intervention is present.
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 following list summarizes the 510(k) verification testing activities performed. These activities include performance and software testing, which demonstrates by technical examination that the 2008 Sorbent System meets its performance specifications and is substantially equivalent to the predicate device.
The following tests were conducted for the 2008 Sorbent System (K123835):
- 2008 System Software/ Hardware
- 2008 Machine Functional SW Verification Protocol
- Disinfection testing
- Infusate Delivery testing
- Modes of Operation testing
- Alarms testing
- HISORB+ Cartridge
- Comparison of dialysate chemistries between a reconfigured HISORB+ cartridge and the HISORB+ cartridge
- Modified HISORB+ cartridge performance testing
- Modified HISORB+ cartridge shipping test
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
§ 876.5600 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
K123835
PAGE 1 of 4
Section 6: 510(k) Summary
FEB 1 5 2013
510(k) Summary
Submitter's Information
| Name | Renal Solutions, Inc. |
|---|---|
| Address | 770 Commonwealth Drive |
| Warrendale, Pa 15086 | |
| Phone: (724) 720-2840 | |
| FAX: (724) 720-2874 | |
| Official Contact | David J. Vanella |
| Senior Vice President, Quality Assurance & Regulatory | |
| Affairs | |
| Date Prepared | 12/12/2012 |
Device Information
| Name | 2008 Sorbent System |
|---|---|
| Common/Usual Name | Hemodialysis System |
| Product Code | FKT |
| Classification Name | System, Dialysate Delivery, Sorbent Regenerated |
| Regulation Number | 876.5600 |
| Proprietary Name | 2008 Sorbent System |
| Unmodified Device | 2008 Sorbent System (K093362) |
| Reason for Submission | Modification to existing device |
Device Description
The 2008 Sorbent System is intended for adult acute and chronic uremic patients in the presence of a healthcare practitioner where hemodialysis is prescribed on the order of a physician.
The 2008 Sorbent System consists of two distinct components:
- the 2008 Machine, and .
- . the SORB™ Module.
1
Special 510(k)
Section 6: 510(k) Summary
The SORB Module is a sorbent dialysate regenerative system that attaches to the 2008 Machine and replaces the machine's existing single-pass dialysate delivery system.
During treatment, used dialysate is chemically reprocessed into fresh, new dialysate and sent back to the dialyzer instead of being sent down a drain. By recirculating and regenerating the dialysate, the 2008 Sorbent System uses less than 15 liters of potable tap water per treatment compared to a standard sinqle-pass system that uses at least 120 liters of purified water during a standard 4-hour dialysis treatment.
Intended Use
The intended use of the modified 2008 Sorbent System is identical to the unmodified device, 2008 Sorbent System (K093362).
Indications for Use
The 2008 Sorbent System is intended for adult acute and chronic uremic patients in the presence of a healthcare practitioner where hemodialysis is prescribed on the order of a physician.
Substantial Equivalence
The 2008 Sorbent System (K123835) is substantially equivalent to the unmodified device, 2008 Sorbent System (K093362), in terms of its intended use, environment of use, operating principles, and technology.
Renal Solutions has determined that the differences from the predicate device have no impact on the safety and effectiveness of the device and that the changes to the 2008 Sorbent System do not raise new types of safety or effectiveness questions. The design verification testing demonstrates the device meets the design requirements and supports substantial equivalence. In summary, the 2008 Sorbent Hemodialysis System (K123835) is substantially equivalent to the predicate device (K093362).
| Area | Predicate | Modified Device |
|---|---|---|
| 2008 Sorbent System | ||
| (K093362) | 2008 Sorbent System | |
| (K123835) | ||
| Intended Use / | ||
| Indications for Use | The 2008 Sorbent System is | |
| intended for adult acute and | ||
| chronic uremic patients in the | ||
| presence of a healthcare | ||
| practitioner where hemodialysis is | ||
| prescribed on the order of a | ||
| physician. | Same | |
| Target Population | Adults ( $≥$ 18 years) | Same |
2
K123835
PAGE 3 OF 4
2008 Sorbent System
. Special 510(k)
Section 6: 510(k) Summary
| Area | Predicate | Modified Device |
|---|---|---|
| 2008 Sorbent System | ||
| (K093362) | 2008 Sorbent System | |
| (K123835) | ||
| Environment of Use | Institutional, where competent | |
| intervention is present | Same | |
| Energy Used and/or | ||
| Delivered | AC 120 V ± 10% | |
| • 60 Hz | ||
| • 12.5 A max | Same | |
| Treatment Duration | 3 - 4 hours | Same |
| Sorbent Regenerative | ||
| Model | Spent dialysate is passed through | |
| a sorbent cartridge and | ||
| regenerated into fresh dialysate. | Same | |
| Sorbent Cartridge Type | HISORB+TM Cartridge | Same |
| Sorbent Cartridge | ||
| Layers | Layer 1: Activated Carbon | |
| Layer 2: Enzyme/Enzyme | ||
| Retention | ||
| Layer 3: Zirconium Phosphate | ||
| Layer 4: Zirconium | ||
| Oxide/Zirconium Carbonate | Layer 1: Activated Carbon | |
| Layer 2: Enzyme/Enzyme | ||
| Retention | ||
| Layer 3: Activated Carbon | ||
| Layer 4: Zirconium Phosphate | ||
| Layer 5: Zirconium | ||
| Oxide/Zirconium Carbonate |
2008 Sorbent System Verification (non-clinical) Testing Summary
The following list summarizes the 510(k) verification testing activities performed. These activities include performance and software testing, which demonstrates by technical examination that the 2008 Sorbent System meets its performance specifications and is substantially equivalent to the predicate device.
The following tests were conducted for the 2008 Sorbent System (K123835):
1. 2008 System Software/ Hardware
- · 2008 Machine Functional SW Verification Protocol
- · Disinfection testing
- · Infusate Delivery testing
- · Modes of Operation testing
- · Alarms testing
2. HISORB+ Cartridge
- · Comparison of dialysate chemistries between a reconfigured HISORB+ cartridge and the HISORB+ cartridge
- · Modified HISORB+ cartridge performance testing
- Modified HISORB+ cartridge shipping test
3
K123835
PAGE 4 OF 4
2008 Sorbent System Special 510(k)
Section 6: 510(k) Summary
General Safety and Effectiveness
The modified 2008 Sorbent System (K123835) is an updated version of the 2008 Sorbent System (K093362). The performance and technological characteristics of the modified device are equivalent to those of the unmodified device and raise no new types of safety or effectiveness questions.
Conclusions
The verification (non-clinical) testing information consisting of performance and software testing that was performed verifies that the modified 2008 Sorbent System (K123835) meets its performance specifications and demonstrates that the device is substantially equivalent to the predicate device.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized symbol that resembles an abstract human figure or a caduceus, rendered in black.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 15, 2013
Renal Solutions, Inc. % Mr. David J. Vanella Senior Vice President Quality Assurance & Regulatory Affairs 770 Commonwealth Drive, Suite 101 WARRENDALE PA 15086
Re: K123835
Trade/Device Name: 2008 Sorbent System Regulation Number: 21 CFR§ 876.5600 Regulation Name: Sorbent regenerated dialysate delivery system for hemodialysis Regulatory Class: II Product Code: FKT Dated: January 18, 2013 Received: January 24, 2013
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
5
Page 2 - Mr. David J. Vanella
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 device-related adverse events) (21 CFR 803); 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.
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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Benjamin Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
2008 Sorbent System
Special 510(k)
Section 5: Indications for Use Statement
Indications for Use Statement
123835 510(k) Number (if known): MA K
Device Name: 2008 Sorbent System
Indications for Use:
The 2008 Sorbent System is intended for adult acute and chronic uremic patients in the presence of a healthcare practitioner where hemodialysis is prescribed on the order of a physician.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Benjamir 2013.02.
Renal Solutions, Inc. Division Sign-2008 Sorbent System Special 510(KD)vis inn of R