(23 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of a dialysis solution, with no mention of AI or ML technologies.
Yes.
The device is a "dialysis solution" used in "Continuous Renal Replacement Therapy" which is a medical treatment. This fits the definition of a therapeutic device as it is intended to treat a condition.
No
The device is described as a dialysis solution used in Continuous Renal Replacement Therapy (CRRT), which is a treatment, not a diagnostic process. Its purpose is to deliver a solution to the patient, not to identify or monitor a disease state.
No
The device description clearly states it is a "bicarbonate-based dialysis solution packaged in a ready to mix, sterile, non-pyrogenic, two-chambered solution container system." This describes a physical product (a solution and its packaging), not a software-only device. The performance studies also focus on physical characteristics like bag integrity, composition, and biocompatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a dialysis solution in Continuous Renal Replacement Therapy." This is a therapeutic treatment delivered directly to the patient, not a test performed on a sample taken from the patient to diagnose or monitor a condition.
- Device Description: The description details a solution delivered to the patient during CRRT treatment. It's a substance used in the treatment process itself.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, etc.), detecting analytes, or providing diagnostic information. The performance studies focus on the physical and chemical properties of the solution and its container, not on its ability to accurately measure or detect something in a biological sample.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device is a therapeutic agent used in a treatment procedure.
N/A
Intended Use / Indications for Use
Intended for use as a dialysis solution in Continuous Renal Replacement Therapy.
Product codes (comma separated list FDA assigned to the subject device)
KPO
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.
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
healthcare facility
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)
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.
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
§ 876.5820 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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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
---|---|
------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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FORM FDA 3881 (6/20) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 EF |
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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. |
Via dell'Industria 6 | |
23030 Tovo S. Agata | |
Sondrio, Italy | |
Establish Registration Number: 3010242164 | |
Contact Person: | Francesca Curti |
Regulatory Affairs Specialist | |
Phone: +39 0342 77 1019 | |
Email: francesca.curti@medtronic.com |
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.