(163 days)
Not Found
No
The document describes a sorbent dialysis system and cartridges, focusing on chemical processes for waste removal. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device is used for the treatment of acute and chronic uremic patients where hemodialysis is prescribed, which directly addresses a disease state.
No
The device is a sorbent cartridge used in a dialysis system to remove waste materials from dialysate, which is a component of the treatment process for uremic patients. It is a therapeutic device, not a diagnostic one. Diagnostic devices are used to identify a disease or condition.
No
The device description clearly states that the device is a sorbent cartridge, which is a physical component containing chemical agents. It is not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of uremic patients through hemodialysis. This is a therapeutic process, not a diagnostic one.
- Device Description: The device description clearly explains that the cartridges are used to remove waste materials from the dialysate, which is part of the hemodialysis treatment process. It does not mention any use for testing or analyzing samples from the human body to diagnose or monitor a condition.
- Lack of Diagnostic Language: The text does not use any language typically associated with IVDs, such as "diagnosis," "detection," "measurement," "analysis," "specimen," "sample," etc.
- Performance Studies: The performance studies described focus on the safety and efficacy of the cartridges in the dialysis system (contamination levels, endotoxin removal, biocompatibility, in-vitro performance comparison), not on the accuracy or reliability of diagnostic results.
In summary, the SORB+ and HISORB+ Cartridges are components of a therapeutic medical device (a hemodialysis system) used for treating a condition, not for diagnosing or monitoring it.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FKT
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.
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 dialyzer, taking up the uremic toxins from the patient's blood.
Cartridge Construction
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 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.
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
Not Found
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 SORB+ and HISORB+ Cartridges have been tested for conformance to their design specifications for materials and construction, and chemical performance in simulated patient use conditions. The cartridges also have been tested for their 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 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 | Pass |
| Limit Test of Endotoxin and Bacteria Removal by SORB+ and HISORB+ Cartridges | AAMI/ANSI | Pass |
| Biocompatibility Validation of SORB + and HISORB + Cartridges | ISO 10993 cytotoxicity, irritation or intracutaneous reactivity, and systemic toxicity (acute). | Pass |
| Validation Testing of SORB+ and HISORB+ Cartridges | Sorb Technologies published capacity specifications | 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. |
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.
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
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
l
1
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
2
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
3
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.
4
4
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 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 | Pass | |
| Limit Test of Endotoxin | ||
| and Bacteria Removal by | ||
| SORB+ and HISORB+ | ||
| Cartridges | AAMI/ANSI | Pass |
| Biocompatibility | ||
| Validation of SORB + and | ||
| HISORB + Cartridges | ISO 10993 | |
| cytotoxicity, irritation | ||
| or intracutaneous | ||
| reactivity, and systemic | ||
| toxicity (acute). | Pass | |
| Validation Testing of | ||
| SORB+ and HISORB+ | ||
| Cartridges | Sorb Technologies | |
| published capacity | ||
| specifications | 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
5
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.
6
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.
7
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
8
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