Rockwell Medical CitraPure Acid Concetrate

K160847 · Rockwell Medical · KPO · Oct 20, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K160847
• Device Name: Rockwell Medical CitraPure Acid Concetrate
• Applicant: Rockwell Medical
• Product Code: KPO · Gastroenterology, Urology
• Decision Date: Oct 20, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

CitraPure® Acid Concentrates (liquid/powder) function as components in three-stream hemodialysis systems. Device inputs include purified water and bicarbonate concentrate; these are proportioned with CitraPure® to create final hemodialysis solution. Used in clinical settings (hospitals/dialysis centers) by trained healthcare professionals. Physicians select specific formulas from established ranges to meet individual patient electrolyte/dextrose requirements. Output is a proportioned dialysate solution used for extracorporeal blood treatment. Benefits include flexibility in prescribing dialysis solutions tailored to patient needs while maintaining standard hemodialysis therapy.

Clinical Evidence

No clinical data. Bench testing only. In vitro testing verified chemical composition and ranges per ANSI/AAMI 13958, confirming electrolytes and glucose are within specified tolerances (±5% or ±0.1 mEq/L for electrolytes; ±5% or ±0.05 g/L for glucose; ±2.5% for sodium).

Technological Characteristics

Formulated as liquid or dry powder containing USP grade salts, sugars, and citric acid. Proportioning ratios: 1:35.83, 1:34.00, 1:44.00. Ingredients: Sodium (70–110 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). Complies with ANSI/AAMI 13958. Standalone chemical concentrate for use with hemodialysis machines.

Indications for Use

Indicated for patients requiring acute or chronic hemodialysis treatment using compatible hemodialysis machines and bicarbonate concentrates.

Regulatory Classification

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.

Predicate Devices

• Advanced Renal Technologies (ART) DRYalysate Acid Concentrates (K980659)
• Advanced Renal Technologies (ART) Citrasate Acid Concentrates (K000792)

Reference Devices

• Rockwell Medical CitraPure® Acid Concentrates (K062399)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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## 510(k) Summary

| Date Prepared: | 9/14/16 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Rockwell Medical, Inc.<br>30142 Wixom Road<br>Wixom, MI 48393<br>Phone: [phone] Fax: [phone] |
| 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<br>Accessories to Hemodialysis<br>Class II, 78, KPO |
| Performance Standards: | No performance standards have been established under<br>Section 514 of the Food, Drug and Cosmetic Act for Class<br>II Hemodialysis concentrate solutions and powders. |
| Predicate Device: | Primary Predicate Devices:<br>Advanced Renal Technologies (ART) DRYalysate Acid<br>Concentrates K980659 |
| | Advanced Renal Technologies (ART) Citrasate Acid<br>Concentrates K000792 |
| | Reference Predicate Device:<br>Rockwell Medical CitraPure® Acid Concentrates K062399 |
| Address, Registration #: | Address and registration number of the manufacturer sites |
| | Rockwell Medical<br>301 Wixom Road, Wixom, MI 48393<br>FDA Registration #: 1835498 |
| | Rockwell Medical<br>4051 Freeport Parkway, Grapevine, TX 76051<br>FDA Registration #: 1652176 |
| | Rockwell Medical<br>604 High Tech Court, Greer SC 29650<br>FDA Registration #: 1065847 |

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#### 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<br>Range | Sodium 70 – 110.0 mEq/L<br>Calcium 2.0 – 5.0 mEq/L<br>Potassium 0.0 – 5.0 mEq/L<br>Magnesium 0.0 – 2.0 mEq/L<br>Dextrose 0 - 200 mg/dl<br>Citric Acid 2.4 mEq/L<br>Acetate 0 - 0.3 mEq/L |
| Concentrate Type | Liquid (gallons, drums)<br>Dry powder concentrate (25 gal./kit) |
| Proportioning Ratios<br>(Concentrate to Water) | 1:35.83, 1:34.00, and 1:44.00 |

Table 1, CitraPure® Ingredient Ranges

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#### 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<br>mEq/L | 0.0 - 5.0<br>mEq/L | 2.0 - 5.0<br>mEq/L | 0.0 - 2.0<br>mEq/L | 2.4<br>mEq/L | 0.0- 200<br>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

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### 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

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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.