(206 days)
No
The 510(k) summary describes a chemical concentrate for hemodialysis and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is indicated for use in hemodialysis to treat acute and chronic kidney conditions, which is a therapeutic purpose.
No
This device is a concentrate for use in hemodialysis machines and does not itself perform diagnostic functions. It is used as part of a treatment, not to diagnose a condition.
No
The device description clearly states the device is available in liquid and dry forms and contains physical ingredients like salt, sugar, and powders. It is a chemical concentrate, 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 "acute and chronic hemodialysis" and to be used with a hemodialysis machine and bicarbonate concentrate. This describes a therapeutic treatment process, not a diagnostic test performed in vitro (outside the body) on a specimen to provide information about a patient's health.
- Device Description: The device is a concentrate (liquid or powder) that is mixed with water and other components to create a hemodialysis solution. This solution is then used in a hemodialysis machine to filter a patient's blood. This is a treatment, not a diagnostic test.
- Performance Studies: The performance studies described focus on the chemical composition and range of composition of the concentrate, ensuring it meets standards for use in hemodialysis. This is related to the quality and suitability of the product for its intended therapeutic use, not its performance in a diagnostic context.
- Lack of Diagnostic Elements: There is no mention of analyzing patient specimens, detecting biomarkers, or providing diagnostic information about a patient's condition.
In summary, the Rockwell Medical CitraPure® Acid Concentrates are components used in the process of hemodialysis, which is a therapeutic treatment. They are not used to diagnose a disease or condition in vitro.
N/A
Intended Use / Indications for Use
The Rockwell Medical CitraPure® Acid Concentrates powders and liguids are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/monitor and bicarbonate concentrate.
Product codes (comma separated list FDA assigned to the subject device)
KPO
Device Description
The Rockwell Medical CitraPure® Acid Concentrates for Bicarbonate Dialysis are available in liquid and dry forms and contain salt, sugar, and non-sugar powders formulated and intended for use in hemodialysis when mixed or proportioned with the appropriate volume of purified water and bicarbonate concentrate / powder. These solutions and powders when proportioned and mixed with pre-treated or purified water meeting or exceeding AAMI Standards, may be used in conventional and commercially available hemodialysis machines or monitors as hemodialysis solution. The hemodialysis concentrate solutions and powders presented in this 510(k) Notification are intended to be used in three stream hemodialysis machines in which an acidified concentrate is proportioned into one stream, a bicarbonate concentrate solution prepared by mixing bicarbonate, chloride, and sodium concentrate with a specified volume of water is proportioned into the second stream, and purified water is proportioned into the third stream. These three streams are then mixed to prepare a final proportioned hemodialysis solution.
The CitraPure® series formulas are manufactured using the same validated processes, same packaging, and same USP grade ingredients. The only difference is that the raw material ingredient amounts are varied to create different formulas. This 510(k) notification establishes ranges for each concentrate ingredient, with the intent of creating different formulas by varying ingredient quantities within these established ranges using design control. Use of an approved dialysis concentrate formula range is necessary to permit the physicians flexibility to prescribe appropriate treatment meeting specific patient needs.
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)
In vitro testing was performed to determine the chemical composition and range of composition. Testing was conducted per our Design Control processes, using validated equipment and validated analytical methods. Acceptance criteria met requirements of ANSI/AAMI 13958, Concentrates for hemodialysis and related therapies, which specifies that all electrolytes identified on the label shall be present within ±5 % or ±0.1 mEq/l and glucose within ±5 % or ±0.05 g/l (expressed as dialysis fluid concentrations), whichever is greater, of the stated concentration, with the exception of sodium, which shall be present within ±2.5 % of the labelled concentration. The results of these tests confirmed the proposed device is substantially equivalent to the predicate device for these parameters.
Clinical testing was not performed.
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.
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
§ 876.5820 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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized depiction of a human figure in profile, with three overlapping faces suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 20, 2016
Rockwell Medical Robert L. Chioini CEO and President 30142 Wixom Road Wixom, MI 48393
Re: K160847
Trade/Device Name: Rockwell Medical CitraPure® Acid Concetrates Regulation Number: 21 CFR§ 876.5820 Regulation Name: Hemodialysis System and Accessories Regulatory Class: II Product Code: KPO Dated: September 14, 2016 Received: September 16, 2016
Dear Robert L. Chioini:
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. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
1
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (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 contact the Division of Industry and Consumer Education 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. 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
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 Industry and Consumer Education 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,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K160847
Device Name Rockwell Medical CitraPure® Acid Concentrates
Indications for Use (Describe)
The Rockwell Medical CitraPure® Acid Concentrates powders and liguids are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/monitor and bicarbonate concentrate.
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)
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3
510(k) Summary
| Date Prepared: | 9/14/16 |
|---|---|
| Submitter: | Rockwell Medical, Inc. |
| 30142 Wixom Road | |
| Wixom, MI 48393 | |
| Phone: 248-960-9009 Fax: 249-960-9119 | |
| Contact Name: | Rob Chioini, CEO |
| Device Name: | Rockwell Medical CitraPure® Acid Concentrates |
| Device Common Name: | Dialysate Concentrate for Hemodialysis (liquid or powder) |
| Classification: | Concentrate Solutions for Hemodialysis |
| Accessories to Hemodialysis | |
| Class II, 78, KPO | |
| Performance Standards: | No performance standards have been established under |
| Section 514 of the Food, Drug and Cosmetic Act for Class | |
| II Hemodialysis concentrate solutions and powders. | |
| Predicate Device: | Primary Predicate Devices: |
| Advanced Renal Technologies (ART) DRYalysate Acid | |
| Concentrates K980659 | |
| Advanced Renal Technologies (ART) Citrasate Acid | |
| Concentrates K000792 | |
| Reference Predicate Device: | |
| Rockwell Medical CitraPure® Acid Concentrates K062399 | |
| Address, Registration #: | Address and registration number of the manufacturer sites |
| Rockwell Medical | |
| 301 Wixom Road, Wixom, MI 48393 | |
| FDA Registration #: 1835498 | |
| Rockwell Medical | |
| 4051 Freeport Parkway, Grapevine, TX 76051 | |
| FDA Registration #: 1652176 | |
| Rockwell Medical | |
| 604 High Tech Court, Greer SC 29650 | |
| FDA Registration #: 1065847 |
4
Device Description:
The Rockwell Medical CitraPure® Acid Concentrates for Bicarbonate Dialysis are available in liquid and dry forms and contain salt, sugar, and non-sugar powders formulated and intended for use in hemodialysis when mixed or proportioned with the appropriate volume of purified water and bicarbonate concentrate / powder. These solutions and powders when proportioned and mixed with pre-treated or purified water meeting or exceeding AAMI Standards, may be used in conventional and commercially available hemodialysis machines or monitors as hemodialysis solution. The hemodialysis concentrate solutions and powders presented in this 510(k) Notification are intended to be used in three stream hemodialysis machines in which an acidified concentrate is proportioned into one stream, a bicarbonate concentrate solution prepared by mixing bicarbonate, chloride, and sodium concentrate with a specified volume of water is proportioned into the second stream, and purified water is proportioned into the third stream. These three streams are then mixed to prepare a final proportioned hemodialysis solution.
The CitraPure® series formulas are manufactured using the same validated processes, same packaging, and same USP grade ingredients. The only difference is that the raw material ingredient amounts are varied to create different formulas. This 510(k) notification establishes ranges for each concentrate ingredient, with the intent of creating different formulas by varying ingredient quantities within these established ranges using design control. Use of an approved dialysis concentrate formula range is necessary to permit the physicians flexibility to prescribe appropriate treatment meeting specific patient needs.
| Criteria | Specification |
|---|---|
| Formulary Ingredient | |
| Range | Sodium 70 – 110.0 mEq/L |
| Calcium 2.0 – 5.0 mEq/L | |
| Potassium 0.0 – 5.0 mEq/L | |
| Magnesium 0.0 – 2.0 mEq/L | |
| Dextrose 0 - 200 mg/dl | |
| Citric Acid 2.4 mEq/L | |
| Acetate 0 - 0.3 mEq/L | |
| Concentrate Type | Liquid (gallons, drums) |
| Dry powder concentrate (25 gal./kit) | |
| Proportioning Ratios | |
| (Concentrate to Water) | 1:35.83, 1:34.00, and 1:44.00 |
Table 1, CitraPure® Ingredient Ranges
5
Traditional 510K Notification
Modification to CitraPure® Acid Concentrates for Bicarbonate Dialysis
The CitraPure® concentrate formulas we plan to market upon acceptance of this 510(k) include the following. Note: Any future new formulas within the approved ranges that are not on this list will be documented using design control and the design records will be maintained in our design history files.
| Na+ | K+ | Ca++ | Mg++ | Citric Acid | Dextrose |
|---|---|---|---|---|---|
| 70 - 110.0 | 0.0 - 5.0 | 2.0 - 5.0 | 0.0 - 2.0 | 2.4 | 0.0- 200 |
| mEq/L | mEq/L | mEq/L | mEq/L | mEq/L | mg% |
| 100.00 | 1.00 | 2.00 | 1.00 | 2.40 | 100.00 |
| 100.00 | 2.00 | 2.00 | 1.00 | 2.40 | 100.00 |
| 100.00 | 3.00 | 2.00 | 1.00 | 2.40 | 100.00 |
| 100.00 | 1.00 | 2.50 | 1.00 | 2.40 | 100.00 |
| 100.00 | 2.00 | 2.50 | 1.00 | 2.40 | 100.00 |
| 100.00 | 3.00 | 2.50 | 1.00 | 2.40 | 100.00 |
| 100.00 | 2.00 | 3.00 | 1.00 | 2.40 | 100.00 |
| 100.00 | 2.00 | 3.50 | 1.00 | 2.40 | 100.00 |
| 100.00 | 3.00 | 3.00 | 1.00 | 2.40 | 100.00 |
| 100.00 | 2.00 | 2.50 | 1.00 | 2.40 | 200.00 |
| 100.00 | 2.00 | 2.25 | 1.00 | 2.40 | 100.00 |
| 100.00 | 4.00 | 3.00 | 1.00 | 2.40 | 100.00 |
| 100.00 | 2.50 | 2.50 | 1.60 | 2.40 | 100.00 |
| 100.00 | 2.50 | 2.25 | 1.30 | 2.40 | 100.00 |
| 80.00 | 2.00 | 2.00 | 1.50 | 2.40 | 100.00 |
| 80.00 | 4.00 | 2.50 | 1.00 | 2.40 | 100.00 |
| 80.00 | 3.00 | 2.50 | 1.00 | 2.40 | 100.00 |
| 81.00 | 1.00 | 2.50 | 1.00 | 2.40 | 100.00 |
| 81.00 | 2.00 | 2.50 | 1.00 | 2.40 | 100.00 |
| 80.00 | 2.00 | 3.50 | 1.00 | 2.40 | 100.00 |
| 103.00 | 2.00 | 2.50 | 1.00 | 2.40 | 100.00 |
| 100.00 | 2.00 | 2.75 | 1.00 | 2.40 | 100.00 |
| 100.00 | 3.00 | 2.75 | 1.00 | 2.40 | 100.00 |
| 100.00 | 3.00 | 2.25 | 1.00 | 2.40 | 100.00 |
| 100.00 | 2.00 | 3.25 | 1.00 | 2.40 | 100.00 |
| 100.00 | 3.00 | 3.25 | 1.00 | 2.40 | 100.00 |
| 80.00 | 2.00 | 3.50 | 1.00 | 2.40 | 200.00 |
| 81.00 | 2.00 | 2.50 | 1.00 | 2.40 | 200.00 |
| 81.00 | 2.00 | 3.00 | 1.00 | 2.40 | 200.00 |
| 103.00 | 3.00 | 2.50 | 1.00 | 2.40 | 200.00 |
| Na+ | K+ | Ca++ | Mg++ | Citric Acid | Dextrose |
| 70 - 110.0 | |||||
| mEq/L | 0.0 - 5.0 | ||||
| mEq/L | 2.0 - 5.0 | ||||
| mEq/L | 0.0 - 2.0 | ||||
| mEq/L | 2.4 | ||||
| mEq/L | 0.0- 200 | ||||
| mg% | |||||
| 100.00 | 2.00 | 3.00 | 0.75 | 2.40 | 80.00 |
| 80.00 | 2.00 | 3.50 | 1.00 | 2.40 | 80.00 |
| 100.00 | 2.00 | 2.50 | 0.75 | 2.40 | 0.00 |
| 80.00 | 2.00 | 3.50 | 1.00 | 2.40 | 0.00 |
| 100.00 | 5.00 | 2.50 | 0.75 | 2.40 | 100.00 |
| 100.00 | 0.00 | 2.50 | 0.75 | 2.40 | 100.00 |
| 100.00 | 2.50 | 5.00 | 0.75 | 2.40 | 100.00 |
| 100.00 | 2.50 | 2.50 | 0.00 | 2.40 | 100.00 |
| 100.00 | 2.50 | 2.50 | 2.00 | 2.40 | 100.00 |
| 70.00 | 2.50 | 2.00 | 0.75 | 2.40 | 100.00 |
| 110.00 | 2.50 | 2.00 | 0.75 | 2.40 | 100.00 |
Table 2 CitraPure® Concentrate Formulas
6
Table 2 continued. CitraPure® Concentrate Formulas
Predicate Devices:
The Rockwell Medical CitraPure® hemodialysis concentrate powders and liquids with modified formulary ranges are substantially equivalent to the Rockwell Medical CitraPure® Acid Concentrates, Advanced Renal Technologies DRYalysate Acid Concentrates, and Advanced Renal Technologies Citrasate Acid Concentrates.
Indications for Use:
The Rockwell Medical CitraPure® Acid Concentrates powders and liquids are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/monitor and bicarbonate concentrate.
This indication statement is essentially the same as the indication statement for the predicate device.
Technological Characteristics:
Comparing the proposed device to the predicate device, both devices utilize the same range of chemical compositions, same packaging, and same formulations. There are no significant differences.
Summary of Non-clinical Tests:
In vitro testing was performed to determine the chemical composition and range of composition. Testing was conducted per our Design Control processes, using
7
validated equipment and validated analytical methods. Acceptance criteria met requirements of ANSI/AAMI 13958, Concentrates for hemodialysis and related therapies, which specifies that all electrolytes identified on the label shall be present within ±5 % or ±0.1 mEq/l and glucose within ±5 % or ±0.05 g/l (expressed as dialysis fluid concentrations), whichever is greater, of the stated concentration, with the exception of sodium, which shall be present within ±2.5 % of the labelled concentration. The results of these tests confirmed the proposed device is substantially equivalent to the predicate device for these parameters.
Clinical Test Results:
Clinical testing was not performed.
Conclusions:
Testing performed on the Rockwell Medical CitraPure® Acid Concentrate liquid and dry powders with modified formula ranges indicates it is safe, effective, and performed as well as the predicate device, when used in accordance with instructions for use.