(163 days)
The SORB+ and HISORB+ Cartridges are to be used only with Renal Solutions' REDY Sorbant Dialysis systems for the treatment of acute and chronic uremic patients where hemodialysis is prescribed by the physician.
Sorbent (or regenerative) dialysis systems use the chemical action of a sorbent cartridge to remove urea and other waste materials from the dialysate and return the fresh dialysate to the dialysate holding tank. This fresh dialysate then passes through a dialyzer, removes additional waste material, and re-circulates through the sorbent cartridge to continue the process. This contrasts to traditional "single pass" dialysis, which uses purified water passing across the dialysate side of a dializer membrane in a single flow-through system to remove urea and other waste materials from the dialysis patient's bloodstream. Wastewater is routed to a drain and not recirculated. By re-circulating and refreshing the dialysate, the Renal Solutions' REDY System uses 6L of water per dialysis treatment. A traditional single pass dialysis system uses at least 120L of purified water during the typical 4 hour dialysis session.
The SORB+ and HISORB+ Cartridges are intended to be used in a Renal Solutions REDY Sorbent Hemodialysis System as the chemical agents that absorb the urea and other waste material from the dialysate stream.
Here's an analysis of the provided text to extract the acceptance criteria and study information:
Acceptance Criteria and Device Performance Study for SORB+ and HISORB+ Cartridges
This document describes the 510(k) summary for the SORB+ and HISORB+ Cartridges, which are sorbent-regenerated dialysate delivery systems for hemodialysis. The focus is on demonstrating substantial equivalence to predicate devices (K811170 - SORB 3160 and K812869 - HISORB 3260).
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list "acceptance criteria" with quantitative targets for each test, but rather states that the device "Pass"ed the tests by conforming to specified standards or predicate device performance. The de facto acceptance criterion for each test was a "Pass" result, indicating conformance.
| Testing Topic | Reference Standards / Implied Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Validation of Maximum Allowable Contamination Levels of Toxic Chemicals in Water Supply for the SORB+ and HISORB+ Cartridges | AAMI/ANSI, RD5-1992 and RD62-2000, RD62, 2001 (Implied acceptance: Conformance to these standards for safe levels of toxic chemicals in water for dialysis) | Pass |
| Limit Test of Endotoxin and Bacteria Removal by SORB+ and HISORB+ Cartridges | AAMI/ANSI (Implied acceptance: Conformance to these standards for acceptable levels of endotoxin and bacterial removal) | Pass |
| Biocompatibility Validation of SORB + and HISORB + Cartridges | ISO 10993 (cytotoxicity, irritation or intracutaneous reactivity, and systemic toxicity (acute)). (Implied acceptance: Conformance to ISO 10993 for these biocompatibility aspects) | Pass |
| Validation Testing of SORB+ and HISORB+ Cartridges | Sorb Technologies published capacity specifications (Implied acceptance: The cartridges meet their published capacity specifications for urea-nitrogen removal. Specifically, SORB+ has a capacity of 9.5-23.5g urea-nitrogen, and HISORB+ has a capacity of 23.5-35.0g urea-nitrogen, for removing patient dialysis waste products within a usual dialysis procedure.) This also includes "effectiveness in purifying water or dialysate to safe levels for dialysis." | Pass |
| Comparison of Performance to Current SORB and HISORB Cartridges (in-vitro testing) | Substantial equivalency to the predicate devices (SORB and HISORB Cartridges) in in-vitro testing. (Implied acceptance: Performance is comparable to the predicate devices.) | Pass |
| Overall Conclusion: Substantial Equivalency to Predicate | "All testing verifies the substantial equivalency of these cartridges to the predicate, SORB and HISORB Cartridges, when used with the Renal Solutions Sorbent Dialysis system for acute and chronic hemodialysis." (Implied acceptance: No unexpected safety or effectiveness issues compared to the predicate.) | Pass |
2. Sample Size for the Test Set and Data Provenance
The document does not specify exact sample sizes for the "test set" (i.e., the number of cartridges tested for each validation). It mentions "various weights [of REDY Chem™ dialysate] used individually and in combination" which hints at a testing regime, but no specific numbers.
The studies were in-vitro testing and "simulated patient use conditions." This suggests the tests were laboratory-based, not involving human patients directly. The provenance is not explicitly stated as retrospective or prospective due to the nature of the in-vitro testing. It would be considered prospective for the specific in-vitro tests conducted. There's no indication of country of origin for the data provided in this summary, but the submitter's address is in Oklahoma City, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to the validation of a medical device like a sorbent cartridge, which relies on chemical and physical performance measurements rather than expert interpretation of images or clinical outcomes. The "ground truth" would be established by objective measurements against predefined chemical and physical standards or specifications, rather than expert consensus.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation or clinical events requiring consensus. For these device performance tests, the outcome is objective (e.g., meeting a chemical purity threshold, acceptable biocompatibility levels). Therefore, no adjudication method as described would be relevant or used in these validation tests. The results would be a direct measurement against a standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done as this device is not an AI diagnostic tool and does not involve human readers for interpretation. The device's performance is measured directly (e.g., chemical capacity, purification levels).
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
This question is not applicable in the context of this device. The device itself is a cartridge, not an algorithm. Its performance is inherently standalone (i.e., the cartridge's chemical and physical function) in that it performs its intended function independently of direct human intervention during the purification process. The "human-in-the-loop" would be the physician prescribing its use and monitoring the patient, but not directly interacting with the cartridge's internal chemical processes. The validation tests (e.g., capacity, biocompatibility) directly assessed the cartridge's standalone performance.
7. The Type of Ground Truth Used
The ground truth used for these tests was primarily:
- Objective Chemical and Physical Standards: Conformance to AAMI/ANSI standards for water purity, endotoxin/bacteria removal.
- Biocompatibility Standards: Conformance to ISO 10993.
- Manufacturer's Published Specifications: Sorb Technologies' published capacity specifications for urea-nitrogen removal.
- Predicate Device Performance: Comparison to the performance of the previously cleared SORB and HISORB Cartridges.
8. The Sample Size for the Training Set
This concept is not applicable. The device is a physical product (sorbent cartridge), not a machine learning model that requires a "training set." The development of the cartridges would have involved R&D, but the validation described herein does not fit the training/testing paradigm of AI/ML.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" is not applicable for this type of device.
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Page 1 of 6
SEP 1 7 2003
Renal Solutions
Appendix 1-B Summary of Safety and Effectiveness 510(k) Summary SORB+ and HISORB+ Cartridges
510(k) K031099
March 31, 2003 Date of Application Renal Solutions Inc, Sorb Technology Division Submitters 3631 SW 54th Street Name Oklahoma City, OK 73119 USA Phone 405-682-1993 FAX- 405-682-2108 Richard G. Confer, V.P. RA and QA Contact Name Renal Solutions 770 Commonwealth Drive, Suite 101 Warrendale, PA 15086 e-mail: rick.confer@renalsolutionsinc.com Trade Name SORB+ and HISORB+ System, Dialysate Delivery, Sorbent Regenerated, Accessory Common Name Classification Class II per 21CFR876.5600 code FKT K811170- SORB 3160- manufactured by Sorb Technology Predicate Device K812869-HISORB 3260- manufactured by Sorb Technology Information
Summary of Safety and Effectiveness
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RenalSolutions
Annendix 1-B Summary of Safety and Effectiveness 510(k) Summary SORB+ and HISORB+ Cartridges
Device Description Sorbent (or regenerative) dialysis systems use the chemical action of a sorbent cartridge to remove urea and other waste materials from the dialysate and return the fresh dialysate to the dialysate holding tank. This fresh dialysate then passes through a dialyzer, removes additional waste material, and re-circulates through the sorbent cartridge to continue the process. This contrasts to traditional "single pass" dialysis, which uses purified water passing across the dialysate side of a dializer membrane in a single flow-through system to remove urea and other waste materials from the dialysis patient's bloodstream. Wastewater is routed to a drain and not recirculated. By re-circulating and refreshing the dialysate, the Renal Solutions' REDY System uses 6L of water per dialysis treatment. A traditional single pass dialysis system uses at least 120L of purified water during the typical 4 hour dialysis session.
KO31099
The SORB+ and HISORB+ Cartridges are intended to be used in a Renal Solutions REDY Sorbent Hemodialysis System as the chemical agents that absorb the urea and other waste material from the dialysate stream. This system is represented schematically in the following diagram.
Two models of SORB Cartridges are available and have sufficient capacity to adsorb patient dialysis waste products presented to them during a usual dialysis procedure within the limits given below. It is recommended that the patient dialyzable volume, pre-dialysis BUN, dialyzer clearance, and treatment time be sufficient to provide the removal of urea-nitrogen within these limits for each model of Sorbant Cartridge:
SORB™ +
The SORB+ Cartridge has an approximate urea-nitrogen capacity of from 9.5 grams to 23.5 grams.
HISORB +
The HISORB+ Cartridge has an approximate urea-nitrogen capacity of from 23.5 grams to 35.0 grams. Both cartridges use the same theory of removing toxins from the dialysate. The initial dialysate is made by dissolving the REDY Chem™ dialysate and dialysate additives in six (6) liters of potable (per EPA requirements) water. The REDY Chems are non-sterile, single use, unit dose packages of various weights used individually and in combination according to the physician's prescription of sodium bicarbonate, sodium chloride, dextrose, and ascorbic acid chloramine reducing agent. The resulting dialysate is added to the machine and pumped to the
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Page 3 of 6
RenalSolutions
Appendix 1-B Summary of Safety and Effectiveness 510(k) Summary SORB+ and HISORB+ Cartridges dialyzer, taking up the uremic toxins from the patient's blood.
Cartridge Construction
Image /page/2/Figure/5 description: The image shows a diagram of a dialysis system with different layers. The layers include Zirconium Oxide & Zr Carbonate Layer, Zirconium Phosphate Layer, Urease Layer, and Activated Carbon & Purification Layer. The diagram also indicates what each layer binds and releases, such as the Zirconium Oxide & Zr Carbonate Layer binding Phosphate, Fluoride, and Heavy Metals, and releasing Acetate, Bicarbonate (more), and Sodium.
The dialysate, after passing through the dialyzer, passes through the SORB+ (or HISORB+) Cartridge where it is purified and partially regenerated. The SORB+ Cartridges are non-sterile products intended for single use only. They contain, in the first layer, activated carbon (AC) as an absorbent purification material and also as a filler material. The primary purpose of the bulk of the AC is to absorb organic wastes from the patient such pure absorbent with no release of counter ions or effect or dependency on the other layers.
The second layer contains immobilized urease enzyme (IU) that breaks down the patient's waste urea into ammonium carbonate. It contains a natural enzyme and purified alumina that acts to bind and immobilize the enzyme in the Sorbent Cartridge in both a combined and a separate layer.
The next layer, containing the cation exchange material zirconium
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Image /page/3/Picture/1 description: The image contains a logo for Renal Solutions. The logo consists of a stylized graphic on the left and the text "Renal Solutions" on the right. The graphic appears to be an abstract representation of interconnected shapes. The text "Renal Solutions" is in a bold, sans-serif font, with "Renal" being larger and darker than "Solutions."
Appendix 1-B Summary of Safety and Effectiveness 510(k) Summary SORB+ and HISORB+ Cartridges
phosphate (ZP) removes the ammonium ion from the IU layer and donates sodium and hydrogen ions in a controlled release, which combine with the remaining carbonate ion to make sodium bicarbonate in proper balance for regenerative dialysis. The ZP also removes other cations from the dialysate such as calcium, magnesium, and potassium, which are essential components of the dialysate.
The final layer in the Sorbent Cartridge contains the anion exchange material hydrous zirconium oxide in the acetate counter ion form (HZO) and sodium zirconium carbonate (SZC). These materials remove the waste metabolite phosphate ions and other highly charged anionic metals from both the initial water source and from the patient, such as fluoride and aluminum.
After the purified and partially regenerated dialysate leaves the Sorbent Cartridge, it is fully reconstituted by the machine by reinfusing the calcium, magnesium, and potassium removed by the Sorbent Cartridge. The fully purified and reconstituted dialysate is then continually pumped back to the dialyzer where the cycle starts again.
The clinical result is dependent upon both the cartridge selection and performance, and the dialysate chemical selection and performance working together. That is, it is also dependent in conjunction with rest of the Dialysis Prescription for the specific patient, his/her condition, the dialyzer selection and performance, the dialysate flow rate, the blood flow rate, the ultrafiltration amount and rate, the length of time of dialysis, and the frequency of dialysis.
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KO31099
Page 5 of 6
Image /page/4/Picture/2 description: The image shows the logo for Renal Solutions. The logo consists of a stylized graphic to the left of the text "Renal Solutions". The graphic appears to be a stylized representation of two interconnected shapes, possibly representing kidneys or a similar concept related to renal health. The text "Renal Solutions" is in a bold, sans-serif font, with "Renal" being larger than "Solutions".
Appendix 1-B Summary of Safety and Effectiveness 510(k) Summary SORB+ and HISORB+ Cartridges
The SORB+ and HISORB+ Cartridges are to be used only with Intended Use Renal Solutions' REDY Sorbant Dialysis systems for the treatment of acute and chronic uremic patients where hemodialysis is prescribed by the physician.
The SORB+ and HISORB+ Cartridges have been tested for Summary of conformance to their design specifications for materials and Testing construction, and chemical performance in simulated patient use The cartridges also have been tested for their conditions. effectiveness in purifying water or dialysate to safe levels for dialysis, biocompatibility, and endotoxin and bacteria removal.
The results of the testing are as follows:
| Testing Topic | Reference Standards | Results |
|---|---|---|
| Validation of MaximumAllowable ContaminationLevels of ToxicChemicals in WaterSupply for the SORB+and HISORB+ Cartridges | AAMI/ANSI, RD5-1992 and RD62-2000,RD62, 2001 | Pass |
| Limit Test of Endotoxinand Bacteria Removal bySORB+ and HISORB+Cartridges | AAMI/ANSI | Pass |
| BiocompatibilityValidation of SORB + andHISORB + Cartridges | ISO 10993cytotoxicity, irritationor intracutaneousreactivity, and systemictoxicity (acute). | Pass |
| Validation Testing ofSORB+ and HISORB+Cartridges | Sorb Technologiespublished capacityspecifications | Pass |
In addition, the performance of the SORB+ and HISORB+ Cartridges was compared to the performance of the current version of the SORB and HISORB Cartridges in in-vitro testing.
The acceptability of the current SORB and HISORB Cartridges for
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K031099 Page 6 of 6
Image /page/5/Picture/1 description: The image shows the logo for Renal Solutions. The logo consists of a circular graphic on the left and the words "Renal Solutions" on the right. The word "Renal" is in bold, while the word "Solutions" is in a lighter, non-bold font.
Appendix 1-B Summary of Safety and Effectiveness 510(k) Summary SORB+ and HISORB+ Cartridges
use in sorbent dialysis systems has been established in clinical testing and during clinical use since their clearance for market. (Refer to K81170 and K812869).
Conclusions
performed on the SORB+ and HISORB+ Cartridges All testing verifies the substantial equivalency of these cartridges to the predicate, SORB and HISORB Cartridges, when used with the Renal Solutions Sorbent Dialysis system for acute and chronic hemodialysis.
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Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name, "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA," arranged in a circular pattern around a central emblem. The emblem consists of a stylized caduceus-like symbol, with three parallel lines representing the branches of the department, and a human profile in the negative space between the lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 7 2003
Mr. Richard Confer Senior V.P. Compliance and Regulatory Affairs Renal Solutions™, Inc. 770 Commonwealth Drive, Suite 101 WARRENDALE PA 15086
Re: K031099
Trade/Device Name: SORB+ and HISORB+ Cartridges Regulation Number: 21 CFR §876.5600 Regulation Name: Sorbent regenerated dialysate delivery system for hemodialysis Regulatory Class: II Product Code: 78 FKT Dated: August 12, 2003 Received: August 13, 2003
Dear Mr. Confer:
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. Iisting 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 (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); 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.
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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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. İ rogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
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Appendix 1-A
Ver/ 3 - 4/24/96 Applicant: Renal Solutions, Inc.
Applicant Name: Christine Hill
510(k) Number (if known): K031099
Device Name: SORB+ and HISORB+ Cartridges
Indications For Use:
The SORB+ and HISORB+ Cartridges are to be used only with Renal Solutions' REDY Sorbant Dialysis systems for the treatment of acute and chronic patients where hemodialysis is prescribed by the physician.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109)
Division 'sign Off
| 510(k) Number | ____________________ |
|---|---|
| --------------- | ---------------------- |
Prescription use V or Over-the-counter ____________________P (Per 21 CFR 801.109)
Over-the-counter
(Optional Format 1-2-96)
David A. Lyon
(Division Sign-Off) Division of Reproductive Abdominal, and Radiological Det 510(k) Number
§ 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).