(64 days)
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.
The provided text describes a Special 510(k) submission for an updated version of a hemodialysis system, the 2008 Sorbent System. This type of submission focuses on demonstrating substantial equivalence to a predicate device (an already legally marketed device) through verification testing for modifications that do not significantly alter the device's fundamental technology, indications for use, or safety and effectiveness.
Here's an analysis based on the provided text, addressing your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative "acceptance criteria" in the traditional sense of a performance study with specific outcome measures and thresholds. Instead, it describes a "verification testing summary" aimed at demonstrating that the modified device meets its design requirements and is substantially equivalent to the predicate device.
The "performance" is implicitly defined by the successful completion of these verification activities, indicating that the modified device functions as intended and safely.
| Acceptance Criteria (Implicit) | Reported Device Performance (as demonstrated by verification testing) |
|---|---|
| 2008 System Software/Hardware Functionality | Success: Meets performance specifications (Functional SW Verification, Disinfection, Infusate Delivery, Modes of Operation, Alarms testing). |
| HISORB+ Cartridge Performance & Equivalence | Success: Dialysate chemistries are comparable, performance (modified cartridge) is acceptable, and passes shipping test. |
| Substantial Equivalence to Predicate Device (K093362) | Success: Design verification testing demonstrates that the device meets design requirements and supports substantial equivalence. (Implies all functional aspects are comparable). |
| General Safety and Effectiveness (no new questions raised) | Success: Performance and technological characteristics are equivalent, raising no new safety or effectiveness questions. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for "test sets" in the context of a clinical study. The testing described is non-clinical verification testing (e.g., software testing, hardware testing, cartridge performance), not a study involving human patients. Therefore, the "sample size" would refer to the number of test runs, prototypes, or cartridges used to perform the verification, which is not detailed.
- Data Provenance: The data is likely internal to the manufacturer, Renal Solutions, Inc., and represents retrospective (or in-house) testing focusing on engineering and performance verification of the device itself, rather than prospective clinical data from patients. There is no information regarding the country of origin of data, as it's not a clinical data set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this submission. The "ground truth" for non-clinical verification testing is typically established by engineering specifications, regulatory standards, and the performance characteristics of the predicate device. The experts involved would be engineers, scientists, and quality assurance personnel within Renal Solutions, Inc., responsible for design, testing, and regulatory affairs. Their specific numbers and qualifications are not detailed here, as this is not a study requiring expert clinical review for ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies where multiple human readers assess cases and discrepancies need to be resolved. This submission describes non-clinical verification testing of a device's functionality and performance against engineering requirements and established safety standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of an MRMC comparative effectiveness study, human readers, or AI assistance. This device is a hemodialysis system, not an imaging or diagnostic AI-powered device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a hemodialysis machine with a sorbent system. It is a physical medical device for treatment, not an algorithm or AI system for standalone performance evaluation. Its operation still requires a healthcare practitioner ("human-in-the-loop") as stated in its Indications for Use.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Engineering Specifications and Design Requirements: The device was tested to ensure it met its own defined performance parameters.
- Predicate Device Performance: The primary ground truth for demonstrating "substantial equivalence" is the established safety and effectiveness of the legally marketed predicate device (2008 Sorbent System, K093362). The modified device's performance was compared to, and intended to be equivalent to, that of the predicate.
- Regulatory Standards: Implicitly, the verification testing would also adhere to relevant industry standards and regulatory guidance for hemodialysis devices.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical hemodialysis system, not a machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as above (not a machine learning model).
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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 DriveWarrendale, Pa 15086Phone: (724) 720-2840FAX: (724) 720-2874 |
| Official Contact | David J. VanellaSenior Vice President, Quality Assurance & RegulatoryAffairs |
| 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 isintended for adult acute andchronic uremic patients in thepresence of a healthcarepractitioner where hemodialysis isprescribed on the order of aphysician. | Same |
| Target Population | Adults ( $≥$ 18 years) | Same |
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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 competentintervention is present | Same |
| Energy Used and/orDelivered | AC 120 V ± 10%• 60 Hz• 12.5 A max | Same |
| Treatment Duration | 3 - 4 hours | Same |
| Sorbent RegenerativeModel | Spent dialysate is passed througha sorbent cartridge andregenerated into fresh dialysate. | Same |
| Sorbent Cartridge Type | HISORB+TM Cartridge | Same |
| Sorbent CartridgeLayers | Layer 1: Activated CarbonLayer 2: Enzyme/EnzymeRetentionLayer 3: Zirconium PhosphateLayer 4: ZirconiumOxide/Zirconium Carbonate | Layer 1: Activated CarbonLayer 2: Enzyme/EnzymeRetentionLayer 3: Activated CarbonLayer 4: Zirconium PhosphateLayer 5: ZirconiumOxide/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
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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.
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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.
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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
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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
§ 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).