(377 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of a dry acid concentrate for hemodialysis, with no mention of AI or ML.
Yes.
The device is an acid concentrate product used in conjunction with a hemodialysis machine to remove waste products and toxins from a patient's blood, which is a therapeutic function.
No
Explanation: The device is an acid concentrate product used for hemodialysis, which is a treatment for kidney failure. It is designed to be part of the solution used in an artificial kidney machine to remove waste products and toxins from a patient's blood. Its function is therapeutic, not diagnostic.
No
The device description clearly states the device is comprised of physical chemical components (USP grade sodium chloride, magnesium chloride, calcium chloride, potassium chloride, dextrose, and acetic acid) and is intended to be used in conjunction with hardware (hemodialysis machines). This is not a software-only device.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states the product is "formulated for use in acute and chronic hemodialysis" and is used in conjunction with other components in a hemodialysis machine. Hemodialysis is a treatment for kidney failure, not a diagnostic test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description details the chemical components of the concentrate and how it is used within a hemodialysis machine to prepare a solution that interacts with the patient's blood through a semi-permeable membrane. This process is therapeutic, not diagnostic.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes (biomarkers, pathogens, etc.)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device is a component used in a therapeutic process (hemodialysis) to remove waste products from the blood. It does not perform a diagnostic function.
N/A
Intended Use / Indications for Use
For DA-100 series:
This acid concentrate product is formulated for use in acute and chronic hemodialysis and to be used in conjunction with MedicaLyteTM bicarbonate, or an equivalent bicarbonate labeled for use in acute and chronic hemodialysis and having the same composition as MedicaLyteTM bicarbonate, in a 36.83X three-stream artificial kidney (hemodialysis) machine.
-Or-
For DA-200 series:
This acid concentrate product is formulated for use in acute and to be used in conjunction with Medical yteTM bicarbonate, or an equivalent bicarbonate labeled for use in acute and chronic hemodialysis and having the same composition as MedicalyteTM bicarbonate, in a 45X three-stream artificial kidney (hemodialysis) machine.
-Or-
For DA-300 series:
This acid concentrate product is formulated for use in acute and to be used in conjunction with MedicaLyteTM bicarbonate, or an equivalent bicarbonate labeled for use in acute and chronic hemodialysis and having the same composition as MedicaLyteTM bicarbonate, in a 35X three-stream artificial kidney (hemodialysis) machine.
Product codes
KPO
Device Description
The Nipro Dry Complete™ dry acid concentrate devices for hemodialysis are comprised of USP grade sodium chloride, USP grade magnesium chloride, USP grade calcium chloride, USP grade potassium chloride, USP grade dextrose, and USP grade acetic acid. These products may be used in conventional, commercially available hemodialysis machines or monitors as one of the necessary components of three-component hemodialysis solution, and are formulated for 36.83X (DA-100 series), 45X (DA-200 series), and 35X (DA-300 series) proportioning dialysis machines. The hemodialysis concentrate solutions presented in this 510(k) premarket notification are intended to be used in an appropriately proportioned three-stream hemodialysis machines (36.83X, 45X, or 35X as specified on the device label) in which bicarbonate concentrate is proportioned into one stream, an acid solution prepared from the Nipro Dry Complete™ dry acid concentrate device is proportioned into a second stream, and water is proportioned into the third stream of the hemodialysis machine proportioning system. These three streams are then mixed by the hemodialysis machine to prepare the final proportioned hemodialysis solution. The final hemodialysis solution is separated from the patient's blood by semi-permeable membranes which permit the passage of waste products and toxins contained in the patient's blood circulating through the hemodialyzer, and such waste products and toxins pass through the semi-permeable membranes into the hemodialysis solution and exit the hemodialyzer with the hemodialysis solution. By such treatment, waste products and toxins are removed from the patient's blood during acute and end-stage renal failure.
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)
Performance testing was conducted on three batches each of DA-100, DA-104, DA-106, DA-113, DA-115, and DA-118 for 36.83X proportioning systems; DA-210, DA-211, DA-213, DA-229, and DA-234 for 45X proportioning systems; and DA-303, DA-308, and DA-314 for 35X proportioning systems. These formulations encompass the entire range of the chemical components present in the devices for each proportioning system and were thus determined to be representative of the proposed formulations. Testing was accomplished by formulating the dialysis liquid concentrate pursuant to the instructions on the device labels and measuring the concentrations of all components to ensure that following the label instructions generates the liquid concentrate specified on the label. All testing was conducted pursuant to ANSI/AAMI/ISO 13958:2014, specifically with reference to sections 4.1.2.2 and 4.1.2.1. All samples of all batches of each device tested were within acceptable limits as set by ANSI/AAMI/ISO 13958:2014. Therefore, the performance of these devices is considered to be satisfactory.
Transportation testing per ASTM D4169-16 has been completed, including environmental conditioning, per ISTA Procedure 3A:2018, simulated distribution cycle testing, and inner package integrity testing. The results indicate that the proposed devices can be shipped and transported so that they may be received and used in a safe and effective way.
Biocompatibility was evaluated for the low density polyethylene bags and high density polyethylene bottles in accordance with Use of International Standard ISO 19003-1 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process."
Endotoxin analysis was performed on three batches each of DA-100, DA-104, DA-106, DA-113, DA-115, and DA-118 for 36.83X proportioning systems; DA-210, DA-211, DA-213, DA-229, and DA-234 for 45X proportioning systems; and DA-303, DA-308, and DA-314 for 35X proportioning systems. These formulations encompass the entire range of the chemical components present in the devices for each proportioning system and were thus determined to be representative of the proposed formulations. Testing was performed in accordance with ANSVAAMI/ISO 13958:2014 Section 4.1.2. under which the limit for endotoxins is 0.5 endotoxin units/mL or less. The standard dialysis fluid generated from the devices was well within the acceptable limits.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Nipro Renal Solutions Corporation USA MedicaPure™ Liquid Acid Concentrate (K901471), Diasol, Inc. Dryasol Acid Concentrate Mix (K993212), Nipro Renal Solutions Corporation USA MedicaLyte™ Bicarbonate Powder (K131202)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services - USA logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 25, 2020
Nipro Renal Solutions Corporation USA % David Marcus Associate McNees Wallace & Nurick LLC 21 East State Street, Suite 1700 Columbus, OH 43215
Re: K193155
Trade/Device Name: Nipro Dry Complete Dry Acid Concentrate for Hemodialysis Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis System and Accessories Regulatory Class: II Product Code: KPO Dated: October 29, 2020 Received: October 30, 2020
Dear David Marcus:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
1
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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Carolyn Y. Neuland, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193155
Device Name
Nipro Dry Complete™ Dry Acid Concentrate for Hemodialysis
Indications for Use (Describe) For DA-100 series:
This acid concentrate product is formulated for use in acute and chronic hemodialysis and to be used in conjunction with MedicaLyteTM bicarbonate, or an equivalent bicarbonate labeled for use in acute and chronic hemodialysis and having the same composition as MedicaLyteTM bicarbonate, in a 36.83X three-stream artificial kidney (hemodialysis) machine.
-Or-
For DA-200 series:
This acid concentrate product is formulated for use in acute and to be used in conjunction with Medical yteTM bicarbonate, or an equivalent bicarbonate labeled for use in acute and chronic hemodialysis and having the same composition as MedicalyteTM bicarbonate, in a 45X three-stream artificial kidney (hemodialysis) machine.
-Or-
For DA-300 series:
This acid concentrate product is formulated for use in acute and to be used in conjunction with MedicaLyteTM bicarbonate, or an equivalent bicarbonate labeled for use in acute and chronic hemodialysis and having the same composition as MedicaLyteTM bicarbonate, in a 35X three-stream artificial kidney (hemodialysis) machine.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(K) SUMMARY UNDER 21 CFR 807.92
This 510(k) summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content in this 510(k) summary has been provided in conformance with 21 CFR Part 807.92.
A. Submitter's Information
| (1) Name: | McNees Wallace & Nurick LLC |
|---|---|
| (2) Address: | 21 East State St., Suite 1700, Columbus, OH 43215 USA |
| (3) Phone: | 614-719-2856 |
| (4) Fax: | 614-469-4653 |
| (5) Contact Person: | David M. Marcus, J.D., Ph.D. |
| (6) Preparation Date: | November 11, 2019 |
| (7) Revised Preparation Date: | October 29, 2020 |
| On Behalf of Applicant Entity (owner of 510(k)) |
| (1) Applicant Name: | Nipro Renal Solutions Corporation USA |
|---|---|
| (2) Applicant Address: | 509 Fishing Creek Rd., Lewisberry, PA 17339 USA |
| (3) Applicant Phone: | 717-938-8391 |
| (4) Applicant Fax: | 717-938-3957 |
| (5) Establishment Reg. No: | 1528807 |
B. Device Name
| (1) Trade Name: | Nipro Dry Complete™ Dry Acid Concentrate for Hemodialysis |
|---|---|
| (2) Common Name: | Dialysis Concentrate for Hemodialysis (Dry Acid) |
| (3) Classification: | Class II, per 21 CFR 876.5820 (Hemodialysis system and accessories) |
| (4) Product Code: | KPO: Gastroenterology/Urology |
C. Legally Marketed Predicate Devices
Nipro Renal Solutions Corporation USA MedicaPure™ Liquid Acid Concentrate (K901471) Diasol, Inc. Dryasol Acid Concentrate Mix (K993212) Nipro Renal Solutions Corporation USA MedicaLyte™ Bicarbonate Powder (K131202)
4
510(K) SUMMARY UNDER 21 CFR 807.92
D. Device Description
The Nipro Dry Complete™ dry acid concentrate devices for hemodialysis are comprised of USP grade sodium chloride, USP grade magnesium chloride, USP grade calcium chloride, USP grade potassium chloride, USP grade dextrose, and USP grade acetic acid. These products may be used in conventional, commercially available hemodialysis machines or monitors as one of the necessary components of three-component hemodialysis solution, and are formulated for 36.83X (DA-100 series), 45X (DA-200 series), and 35X (DA-300 series) proportioning dialysis machines. The hemodialysis concentrate solutions presented in this 510(k) premarket notification are intended to be used in an appropriately proportioned three-stream hemodialysis machines (36.83X, 45X, or 35X as specified on the device label) in which bicarbonate concentrate is proportioned into one stream, an acid solution prepared from the Nipro Dry Complete™ dry acid concentrate device is proportioned into a second stream, and water is proportioned into the third stream of the hemodialysis machine proportioning system. These three streams are then mixed by the hemodialysis machine to prepare the final proportioned hemodialysis solution. The final hemodialysis solution is separated from the patient's blood by semi-permeable membranes which permit the passage of waste products and toxins contained in the patient's blood circulating through the hemodialyzer, and such waste products and toxins pass through the semi-permeable membranes into the hemodialysis solution and exit the hemodialyzer with the hemodialysis solution. By such treatment, waste products and toxins are removed from the patient's blood during acute and end-stage renal failure.
E. Indications for Use
For DA-100 series:
This acid concentrate product is formulated for use in acute and chronic hemodialysis and to be used in conjunction with MedicaLyte™ bicarbonate, or an equivalent bicarbonate labeled for use in acute and chronic hemodialysis and having the same composition as MedicaLyte™ bicarbonate, in a 36.83X three-stream artificial kidney (hemodialysis) machine.
-01-
For DA-200 series:
This acid concentrate product is formulated for use in acute and chronic hemodialysis and to be used in conjunction with MedicaLyte™ bicarbonate, or an equivalent bicarbonate labeled for
5
510(K) SUMMARY UNDER 21 CFR 807.92
use in acute and chronic hemodialysis and having the same composition as MedicaLyte™ bicarbonate, in a 45X three-stream artificial kidney (hemodialysis) machine.
-01-
For DA-300 series:
This acid concentrate product is formulated for use in acute and chronic hemodialysis and to be used in conjunction with MedicaLyte™ bicarbonate, or an equivalent bicarbonate labeled for use in acute and chronic hemodialysis and having the same composition as MedicaLyte™ bicarbonate, in a 35X three-stream artificial kidney (hemodialysis) machine.
F. Technological Characteristics:
Comparing the proposed Dry Complete™ dry acid concentrate devices to the MedicaPure™ Liquid Acid Concentrate (K901471) predicate devices utilize the same chemical compositions and produce the same acid solutions for hemodialysis. The devices also utilize substantially equivalent high density polyethylene bottles, which are made by the same manufacturing process with the same resin by the same manufacturer (CKS Packaging located at 943 Trollingwood Rd., Haw River, North Carolina 27258). The only difference between the bottles of the MedicaPure™ Liquid Acid Concentrate predicate devices (K901471) and the bottles of the proposed Dry Complete™ dry acid concentrate devices is the size of the bottles, which does not present any new hazard to the patients. Thus, there are no significant differences, and a finding of substantial equivalence is appropriate.
Comparing the proposed Nipro Dry Complete™ dry acid concentrate devices to the Diasol, Inc. Dryasol Acid Concentrate Mix (K993212) predicate devices utilize the same chemical compositions and produce the same acid concentrates for thirty-three of the seventy-three proposed devices (with the other proposed devices being substantiated by K901471 as described above). There are no significant differences, and therefore a finding of substantial equivalence is appropriate.
Comparing the proposed Dry Complete™ dry acid concentrate devices to the MedicaLyte™ Bicarbonate Powder (K131202) predicate devices, the powder components of the devices are packaged in identical low density polyethylene bags (same material composition and processing) from the same manufacturer (Elkay Plastics Co., Inc. located at 6000 Sheila Street,
Tab 5: Page 3
6
510(K) SUMMARY UNDER 21 CFR 807.92
Commerce, California 90040). There are no significant differences, and therefore a finding of substantial equivalence is appropriate.
Performance Testing:
Performance testing was conducted on three batches each of DA-100, DA-104, DA-106, DA-113, DA-115, and DA-118 for 36.83X proportioning systems; DA-210, DA-211, DA-213, DA-229, and DA-234 for 45X proportioning systems; and DA-303, DA-308, and DA-314 for 35X proportioning systems. These formulations encompass the entire range of the chemical components present in the devices for each proportioning system and were thus determined to be representative of the proposed formulations. Testing was accomplished by formulating the dialysis liquid concentrate pursuant to the instructions on the device labels and measuring the concentrations of all components to ensure that following the label instructions generates the liquid concentrate specified on the label. All testing was conducted pursuant to ANSI/AAMI/ISO 13958:2014, specifically with reference to sections 4.1.2.2 and 4.1.2.1. All samples of all batches of each device tested were within acceptable limits as set by ANSI/AAMI/ISO 13958:2014. Therefore, the performance of these devices is considered to be satisfactory.
Transportation testing per ASTM D4169-16 has been completed, including environmental conditioning, per ISTA Procedure 3A:2018, simulated distribution cycle testing, and inner package integrity testing. The results indicate that the proposed devices can be shipped and transported so that they may be received and used in a safe and effective way.
Biocompatibility was evaluated for the low density polyethylene bags and high density polyethylene bottles in accordance with Use of International Standard ISO 19003-1 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process."
Endotoxin Analysis on Device Contents:
Endotoxin analysis was performed on three batches each of DA-100, DA-104, DA-106, DA-113, DA-115, and DA-118 for 36.83X proportioning systems; DA-210, DA-211, DA-213, DA-229, and DA-234 for 45X proportioning systems; and DA-303, DA-308, and DA-314 for 35X proportioning systems. These formulations encompass the entire range of the chemical components present in the devices for each proportioning system and were thus determined to be representative of the proposed formulations. Testing was performed in
7
510(K) SUMMARY UNDER 21 CFR 807.92
accordance with ANSVAAMI/ISO 13958:2014 Section 4.1.2. under which the limit for endotoxins is 0.5 endotoxin units/mL or less. The standard dialysis fluid generated from the devices was well within the acceptable limits.
Sterilization and Shelf Life
The devices are not provided in sterilized form, and the devices are non-sterile when used. Stability testing was conducted on aged samples.
All chemistry and bioburden stability testing on aged product was performed to conform to standards as laid out in ANSI/AAMI/ISO 13958:2014, Concentrates for haemodialysis and related therapies. Additionally, the aged product tested well within endotoxin specifications for safe release of this product. Results from package integrity testing were analyzed and accepted based on Acceptance Quality Limit (AQL) criteria developed using ISO 2859-1:2011, Sampling Procedures for Inspection by Attributes, Part 1: Sampling Schemes Indexed by Acceptance Quality Limit (AQL) for Lot-by-Lot Inspection.
G. Conclusion
The proposed Nipro Dry Complete™ dry acid concentrate devices are believed to be substantially equivalent in design, materials, and indications for use to the commercially available Nipro Renal Solutions Corporation USA MedicaPure™ Liquid Acid Concentrate (K901471) predicate devices, Diasol, Inc. Dryasol Acid Concentrate Mix (K993212) predicate devices, and Nipro Renal Solutions Corporation USA MedicaLyte™ Bicarbonate Powder (K131202) predicate devices, and are therefore expected to be as safe, as effective, and perform as well as the predicate devices.