(289 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 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 operates in a similar manner to standard hemodialysis systems currently approved for use; it is substantially equivalent to the Fresenius 2008T hemodialysis machine (K080964) and the Renal Solutions Allient® Sorbent Hemodialysis System (K070739). The significant difference between the 2008 Sorbent System and standard single-pass hemodialysis machines is that the 2008 Sorbent System utilizes a sorbent cartridge to purify dialysate made from potable tap water and then regenerates fresh dialysate from spent dialysate (like the Allient Sorbent Hemodialysis System). 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 single-pass system that uses at least 120 liters of purified water during a standard 4-hour dialysis treatment.
The provided text describes the 2008 Sorbent Hemodialysis System, focusing on its substantial equivalence to predicate devices and the verification testing performed. However, it does not include the specific details required to fully answer your request regarding acceptance criteria and a study proving the device meets those criteria, particularly for an AI-powered medical device.
The document is a 510(k) summary for a Sorbent Hemodialysis System, which is a medical device for dialysate delivery, not an AI or software-intensive diagnostic device in the sense your questions imply (e.g., test sets, ground truth, expert consensus, MRMC studies). The "software testing" mentioned is to ensure the device's control software meets its design input requirements, not for evaluating an AI algorithm's diagnostic or predictive performance.
Therefore, many of your requested items cannot be extracted from this document as they are not relevant to the type of device being described.
However, I can extract what is available:
1. A table of acceptance criteria and the reported device performance:
The document outlines categories of testing and general objectives, implying acceptance criteria were defined for each. However, it does not explicitly state the quantitative acceptance criteria or the specific numerical performance results. Instead, it refers to "pre-defined acceptance or pass/fail criteria" and states that testing "demonstrates the device meets its performance specifications."
| Acceptance Criteria Category | Reported Device Performance (as inferred) |
|---|---|
| 2008 Sorbent System Performance Testing | Functional testing conducted to demonstrate the device performs as designed and expected, meeting its performance specifications. (Specific verification tests, protocols, objectives, test articles, methods, procedures, and pre-defined acceptance criteria were documented in the 510(k) submission, but not detailed here). System-level hazard analysis confirmed the device does not perform in an unexpected and/or unsafe manner. |
| 2008 Sorbent System Safety Testing | Product safety testing conducted demonstrating compliance with FDA Consensus Standards, including: Electrical safety (IEC 60601-1), Electromagnetic compatibility (IEC 60601-2-16), Biocompatibility (AAMI / ANSI / ISO 10993-1) for new patient-fluid contacting materials, and Risk Analysis (ISO 14971). |
| 2008 Sorbent System Software Testing | Software testing conducted demonstrating the device software meets the design input requirements. This included structural charts, development procedures, requirements specifications with traceability to hazard analysis, verification and validation test plans (with pass/fail criteria and traceability), system-level test results, and current software version documentation. |
| Overall Substantial Equivalence to Predicate Devices | Demonstrated the device is as safe, as effective, and performs at least as safely and effectively as the Allient Sorbent Hemodialysis System and Fresenius 2008T Hemodialysis System. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given text. The testing described is non-clinical verification testing of a physical medical device, not a study involving patient data in the context of AI performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/provided. The ground truth for this type of device (a hemodialysis system) is established through engineering and performance specifications, adherence to standards, and risk analysis, not expert consensus on diagnostic interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods like 2+1 are typically used in clinical studies involving multiple readers or interpretations, which is not what is described here.
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
An MRMC comparative effectiveness study was not done, as this device is a hemodialysis system and not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The "software testing" refers to the control software of the device, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on engineering specifications, regulatory standards (e.g., IEC, ISO), and performance requirements related to the physical and functional operation of the hemodialysis system. The document lists "pre-defined acceptance or pass/fail criteria" as part of the test protocols.
8. The sample size for the training set
This information is not applicable/provided. This device is a physical medical device, not an AI model trained on a dataset.
9. How the ground truth for the training set was established
This information is not applicable/provided. As above, there is no AI model or training set in the context of this device.
In summary, the provided document describes a 510(k) submission for a Sorbent Hemodialysis System, focusing on its functional, safety, and software verification to demonstrate substantial equivalence to predicate devices. It does not contain the detailed information typically associated with the evaluation of AI-powered diagnostic or predictive medical devices.
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K093362 Page 1 of 4
2008 Sorbent Hemodialysis System 510(k) Premarket Notification Section 5: 510(k) Summary
AUG 1 3 2010
Official Contact David J. Vanella Senior Vice President, Quality Systems Renal Solutions, Inc. 770 Commonwealth Drive Warrendale, Pa, 15086 Phone: (724) 720-2840 FAX: (724) 772-6925 Classification Name System, Dialysate Delivery, Sorbent Regenerated Regulation Number 876.5600 Product Code FKT Common/Usual Name Sorbent Hemodialysis System Proprietary Name 2008 Sorbent Hemodialysis System Predicate Devices Allient Sorbent Hemodialysis System Fresenius 2008T Hemodialysis System Reason for submission New Device
Section 5: 510(k) Summary K093362
Substantial Equivalence
The 2008 Sorbent Hemodialysis System device has the following key similarities to the predicate devices:
- Intended use .
- Environment of use .
- . Operating principle
- Technology .
Renal Solutions has determined that the differences from the predicate devices have no impact on the safety and effectiveness of the device and that the technological characteristics of the 2008 Sorbent System do not raise new types of safety or effectiveness questions. The information provided including design verification, risk management, safety, biocompatibility and comparative testing were performed on the 2008 Sorbent Hemodialysis System to demonstrate the device meets the design requirements and to support substantial equivalence. In summary, the 2008 Sorbent Hemodialysis System is substantially equivalent to the predicate devices.
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K093362 Page 2 of 4
2008 Sorbent Hemodialysis System 510(k) Premarket Notification Section 5: 510(k) Summary
The 2008 Sorbent System incorporates the addition of a module that regenerates spent dialysate and delivers clean dialysate to the dialysis system and required modifications to the 2008 dialysis system. A risk analysis has been established for the 2008 Sorbent System and has includes the potential hazards associated with the device where all hazards have been identified and mitigated to acceptable risk levels.
2008 Sorbent System 510(k) Verification (Non-Clinical) Testing Summary
The verification (non-clinical) testing information consists of performance, safety, and software testing that was performed to verify the 2008 Sorbent System meets its performance specifications and to demonstrate the device is substantially equivalent to the established predicate devices.
The following table summarizes the 510(k) verification testing activities performed. These include performance, safety and software testing, which demonstrates by technical examination that the 2008 Sorbent System meets its performance specifications, the designated (FDA Consensus) standard requirements, and the software design input requirements.
| 510(k) Verification Testing | 510(K) Verification Testing Activities |
|---|---|
| 2008 Sorbent System Performance TestingThe 510(k) contains details of the performance | Functional testing that demonstrates that the deviceperforms as designed and expected, includes thefollowing:• The specific verification tests conducted |
| (verification) testing and includes the results | • A description of all test protocol including: |
| that support the performance characteristics of | • objective of the tests |
| the 2008 Sorbent System. | • test articles used in the tests |
| • test methods and procedures | |
| • pre-defined acceptance or pass/fail criteria. | |
| • System-level hazard analysis evaluation thatconfirms that the device does not perform in anunexpected and/or unsafe manner | |
| 2008 Sorbent System Safety TestingThe 510(k) contains details of the safety | Product safety testing that demonstrates that the deviceperforms per the FDA Consensus Standards, asidentified below: |
| (standards) verification testing and includes theresults that support the safety characteristics ofthe 2008 Sorbent System. | • Electrical safety testing (IEC 60601-1:1988 +A1:1991 + A2:1995 Medical electrical equipment-Part 1:General requirements for safety) |
| Biocompatibility testing was performed on allnew materials that are patient-fluid contacting | • Electromagnetic compatibility (EMC) testing (IEC60601-2-16: 1998-02 Medical electrical equipmentPart 2-16: Particular requirements for the safety ofHemodialysis, haemodiafiltration and haemofiltrationequipment) |
| • Biocompatibility Testing (AAMI / ANSI / ISO 10993-1:2003 Biological evaluation of medical devices Part1: Evaluation & testing) | |
| • Risk Analysis (ISO 14971:2007 Medical devices -Application of risk management to medical device) |
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K093362 Page 3 of 4
2008 Sorbent Hemodialysis System 510(k) Premarket Notification Section 5: 510(k) Summary
| 510(k) Verification Testing | 510(K) Verification Testing Activities |
|---|---|
| 2008 Sorbent System Software TestingThe 510(k) contains details of the softwaretesting and includes the requireddocumentation as required per the documenttitled "Guidance for the Content of PremarketSubmissions for Software". | Software testing that demonstrates the device softwaremeets the design input requirements. The device wastested and includes the followingStructure chart of flow chart describing softwarearchitecture Summary of software development procedures,including changes made to the software Software requirements specification with traceabilityback to the hazard analysis Verification and validation test plans, includingpass/fail criteria and traceability back to therequirements; System level test results Current software version number and date of latestrevision. |
The conclusions drawn from this testing demonstrates that the 2008 Sorbent System is as safe, as effective, and performs at least as safely and effectively as the legally marketed devices identified as predicate devices to which it was compared.
Indications of 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.
General Safety and Effectiveness
The intended use for the 2008 Sorbent System is for treatment of adult acute and chronic uremic patients in the presence of a healthcare practitioner where hemodialysis is prescribed on the order of a physician. The operator must be knowledgeable of hemodialysis methodology and relevant physiology, proficient in healthcare procedures, thoroughly familiar with the contents of the Operator's Manual and fully trained and qualified to operate this 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 operates in a similar manner to standard hemodialysis systems currently approved for use; it is substantially equivalent to the Fresenius 2008T hemodialysis machine (K080964) and the Renal Solutions Allient® Sorbent Hemodialysis System (K070739).
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K093362 Page 4 of 4
2008 Sorbent Hemodialysis System 510(k) Premarket Notification
Section 5: 510(k) Summary
The significant difference between the 2008 Sorbent System and standard single-pass hemodialysis machines is that the 2008 Sorbent System utilizes a sorbent cartridge to purify dialysate made from potable tap water and then regenerates fresh dialysate from spent dialysate (like the Allient Sorbent Hemodialysis System).
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. Bv recirculating and regenerating the dialysate, the 2008 Sorbent System uses less than 15 liters of potable tap water per treatment compared to a standard single-pass system that uses at least 120 liters of purified water during a standard 4-hour dialysis treatment.
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Image /page/4/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN" is arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G6 Silver Spring, MD 20993-0002
Mr. David J. Vanella Senior Vice President, Quality Systems Renal Solutions, Inc. 770 Commonwealth Drive, Suite 101 WARRENDALE PA 15086
ന്നു
പ്രാ 2010 AUG
. Re: K093362
Trade/Device Name: 2008 Sorbent System Regulation Number: 21 CFR §876.5600
Regulation Number: 21 CFR §70.500
Regulation Name: Sorbent regenerated dialysate delivery system for hemodialysis Regulatory Class: II
Product Code: FKT
Dated: August 10, 2010
Received: August 11, 2010
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 indivitions for use stated in the enclosure) to legally marketed predicate devices marked 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 indici warranties. We remind you, however, that device labeling must be truthful and not nisleading.
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 of medical device-related
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Page 2
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/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Huker Lemur us
ferbert P. Lerner, M.D., Director (Acting) 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 Hemodialysis System 510(k) Premarket Notification Section 4: Indications for Use
AUG 1 3 2010
Section 4: Indications for Use Statement
510(k) Number (if known):-N/A K093362
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)
signature
(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Page 10
§ 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).