HMB32 Dialysis Solution

K212052 · Haemopharm Biofluids S.R.L. · KPO · Jul 23, 2021 · Gastroenterology, Urology

Device Facts

• Record ID: K212052
• Device Name: HMB32 Dialysis Solution
• Applicant: Haemopharm Biofluids S.R.L.
• Product Code: KPO · Gastroenterology, Urology
• Decision Date: Jul 23, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended for use as a dialysis solution in Continuous Renal Replacement Therapy.

Device Story

HBiofluids HMB32 is a bicarbonate-based dialysis solution for Continuous Renal Replacement Therapy (CRRT). Device consists of a sterile, non-pyrogenic, two-chambered container; one chamber holds acidic solution, other holds basic solution. At point of use, internal membrane is opened to mix contents, creating final ionic composition. Solution is administered to patients in healthcare facilities during CRRT. Benefits include providing necessary electrolyte and fluid balance for patients undergoing renal replacement. Device is operated by healthcare professionals.

Clinical Evidence

Bench testing only. Testing included bag integrity, chemical composition, and biocompatibility. No clinical data was required to establish substantial equivalence.

Technological Characteristics

Bicarbonate-based dialysis solution. Two-chambered container system with internal mixing membrane. Available in 500mL+1500mL and 500mL+4500mL volumes. Final solution contains Na+, K+, Ca++, Mg++, HCO3-, Cl-, and glucose with theoretical osmolarity of 297 mOsm/L. Sterile and non-pyrogenic.

Indications for Use

Indicated for use as a dialysis solution in Continuous Renal Replacement Therapy (CRRT) for patients requiring renal replacement.

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

• Haemofiltration and Dialysis Solutions (K150966)

Submission Summary (Full Text)

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July 23, 2021

Haemopharm Biofluids S.r.l. Francesca Curti Regulatory Affairs Specialist Via dell'Industria 6 Tovo di S. Agata, Sondrio 23030 ITALY

Re: K212052

> Trade/Device Name: HMB32 Dialysis Solution Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KPO Dated: June 25, 2021 Received: June 30, 2021

Dear Francesca Curti:

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.

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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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for 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

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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

#### 510(k) Number (if known)

K212052

Device Name

HMB32 Dialysis solution

Indications for Use (Describe)

Intended for use as a dialysis solution in Continuous Renal Replacement Therapy.

| Type of Use (Select one or both, as applicable) | <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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| FORM FDA 3881 (6/20) | Page 1 of 1 | PSC Publishing Services [phone] EF |
|-------------------------|-------------|-------------------------------------------|
| HMB32 Dialysis Solution | | 29 June 2021 |
| Medtronic Confidential | | 1-33 |

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# 510(k) Summary

| Date Prepared: | July 22, 2021 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Haemopharm Biofluids S.r.l.<br>Via dell'Industria 6<br>23030 Tovo S. Agata<br>Sondrio, Italy<br>Establish Registration Number: 3010242164 |
| Contact Person: | Francesca Curti<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Email: [e-mail] |

#### Device Name and Classification:

| Trade Name: | HBiofluids HMB32 |
|--------------------|-------------------|
| Common Name: | Dialysis Solution |
| Regulation Number: | 21 CFR 876.5820 |
| Product Code: | KPO |
| Classification: | Class II |

### Predicate Device

Haemofiltration and Dialysis Solutions (K150966)

### Device Description

The HBiofluids HMB32 is a bicarbonate-based dialysis solution packaged in a ready to mix, sterile, non-pyrogenic, two-chambered solution container system. One chamber contains the acidic solution and one chamber contains the basic solution. At the point of use, the membrane between the two chambers is opened, and the acidic and basic solutions are mixed to form the final ionic composition of the solution to be used in the Continuous Renal Replacement Therapy (CRRT) treatment. This solution is delivered to the patient while undergoing CRRT treatment in a healthcare facility.

The HBiofluids HMB32 solution will be offered in one formulation, in two different volumes: 500 mL +4500mL and 500mL +1500mL.

| Models | Description |
|--------|--------------------------------------------------|
| MD042 | HBiofluids HMB32 Dialysis solution, 500mL+1500mL |
| MD088 | HBiofluids HMB32 Dialysis solution, 500+4500 mL |

The chemical compositions of the final solutions for these two volumes are shown in the table below.

Alleviating Pain · Restoring Health · Extending Life

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| Ions | Concentration |
|------------------------|---------------|
| Na+ | 140.00 |
| K+ | 2.50 |
| Ca++ | 1.50 |
| Mg++ | 0.75 |
| HCO3- | 32.00 |
| Cl- | 115.00 |
| Glucose | 5.55 |
| Theoretical osmolarity | 297 mOsm/L |

### Indications for Use

Intended for use as a dialysis solution in Continuous Renal Replacement Therapy.

# Comparison to Predicate Devices

The HMB32 Dialysis Solution has the same intended use, design, and principles of operation and technology when compared to the predicate HMB32 Dialysis Solution.

- Intended Use: The intended use is the same as the predicate device.
- Design: The design is the same as the predicate device. ●
- Materials: The materials are substantially equivalent to the predicate device. ●
- Principles of Operation and Technology: The principles of operation are the same as the ● predicate device.
- Performance: The performance of the device is the same as the predicate device.

# Summary of Performance Data

Bench testing was used to demonstrate the performance characteristics of the HBiofluids HMB32 Dialysis solution remain the same. The following testing was performed:

- Bag integrity testing ●
- Composition testing
- Biocompatibility testing

Clinical testing was not required to establish substantial equivalence.

# Conclusion

HBiofluids has demonstrated that the HMB32 Dialysis Solution is substantially equivalent to the predicate device based upon design, test results, and indications for use.