(235 days)
Not Found
No
The device description and performance studies focus on the chemical composition, packaging, and physical properties of a dialysis solution, with no mention of AI or ML technologies.
No
The device is a dialysis solution, which is used in therapy but is not a therapeutic device itself. It's a consumable that enables the therapy.
No
The document describes a dialysis solution intended for use in Continuous Renal Replacement Therapy, which is a treatment procedure, not a diagnostic procedure.
No
The device is a physical dialysis solution and container system, not a software-only medical device. The description details a chemical solution and its packaging.
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 administered directly to the patient's bloodstream to remove waste products and excess fluid.
- Device Description: The device is a solution for dialysis, which is a treatment process, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
IVDs are used to examine specimens from the human body to provide information for diagnostic purposes. This device is a therapeutic solution used in a treatment process.
N/A
Intended Use / Indications for Use
Intended for use as a dialysis solution in Continuous Renal Replacement Therapy.
Product codes
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 broken, 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.
The HBiofluids HMB32 solution will be offered in one formulation, in two different volumes: 500+4500 ml and 500+1500 ml.
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
Prescription Use
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)
Nonclinical testing was conducted including Biocompatibility via testing per ISO 10993-1, Sterilization Validation via EN ISO 17665-1: 2007 (steam sterilization to an SAL of 10^-6), Pyrogenicity testing using the LAL test, and Stability testing after real-time aging out to 18 months. The testing demonstrated that the HBiofluids HMB32 is safe and effective for use during Continuous Renal Replacement Therapy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked one behind the other, representing the department's focus on people and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 4, 2015
Haemopharm Biofluids Srl (HBiofluids) % Sheila Hemeon-Heyer President Heyer Regulatory Solutions, LLC P.O. Box 2151 Amherst, MA 01004-2151
Re: K150966
Trade/Device Name: HMB32 500 + 4500 ml and 500 + 1500 ml Regulation Number: 21 CFR§ 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KPO Dated: October 29, 2015 Received: October 29, 2015
Dear Sheila Hemeon-Heyer,
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, 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.
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 vours.
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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Indications for Use
510(k) Number (if known)
K150966
Device Name
HMB32 500 + 4500 ml and 500 + 1500 ml
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) | ☑ Research Use Only (21 CFR 201.128 Subject to 501(b))☐ For In-Vitro Use Only (21 CFR 201.128 Subject to 501(b)) | ☑ Research Use Only (21 CFR 201.128 Subject to 501(b)) | ☐ For In-Vitro Use Only (21 CFR 201.128 Subject to 501(b)) |
|---|---|---|---|
| ☑ Research Use Only (21 CFR 201.128 Subject to 501(b)) | ☐ For In-Vitro Use Only (21 CFR 201.128 Subject to 501(b)) |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
| 1. SUBMITTER: | Haemopharm Biofluids srl
Via dell'Industria 6
23030 Tovo S. Agata
Sondrio, Italy |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------|
| 2. CONTACT PERSON: | Giuseppe Tomasini
Phone: 011 39 0535 29323
Mobile: 011 39 3355733390
Fax: 011 39 0535 29177 |
| 3. DATE PREPARED: | April 10, 2015 |
| 4. DEVICE TRADE NAME:
MODEL NUMBERS: | HMB32
(500 + 4500 ml) and (500 + 1500 ml) |
| 5. COMMON NAME:
CLASSIFICATION NAME: | Haemofiltration and Dialysis Solution
Dialysate Concentrate for Hemodialysis
(Liquid or Powder) |
| 6. CLASSIFICATION: | 21 CFR 876.5820, Product Code KPO
Class II |
| 7. PREDICATE DEVICE(S): | K041428, Accusol Dialysis Solutions, Baxter
Healthcare |
8. 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 broken, 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.
The HBiofluids HMB32 solution will be offered in one formulation, in two different volumes: 500+4500 ml and 500+1500 ml. The chemical compositions of the final solutions for these two volumes are shown in the substantial equivalence table below.
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9. INDICATION FOR USE:
Intended for use as a dialysis solution in Continuous Renal Replacement Therapy.
10. COMPARISON TO PREDICATE DEVICE:
The table below provides a technical comparison to the predicate device. There are no significant differences between the HBiofluids HMB32 solution as compared to the predicate Accusol solution.
| Parameter | Predicate Device
ACCUSOL, K041428 | HMB32 |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | For use as a dialysis
solution in continuous
renal replacement
therapy | For use as a dialysis
solution in continuous
renal replacement
therapy |
| Overall design | The solution is supplied
in a carton box
containing two units of 5
liter double chamber
non-PVC bags.
Each bag is over-
wrapped in its
overpouch.
The solution in the bag
is clear and colorless. | The solution is supplied
in a carton box
containing two units of
5 liter or four units of 2
liter double chamber
PVC free bags.
Each bag is over-
wrapped in its
overpouch.
The solution in the bag
is clear and colorless. |
| lonic composition
of final solution
(mmol/l): | | |
| Na+ | 140.00 | 140.00 |
| K+ | 2.00 | 2.50 |
| Ca++ | 1.75 | 1.50 |
| Mg++ | 0.50 | 0.75 |
| HCO3- | 35.00 | 32.00 |
| Cl- | 111.30 | 115.00 |
| Glucose | 5.55 | 5.55 |
| Theoretical
osmolarity | 296 mOsm/l | 297 mOsm/l |
| Solution container
components and
materials | Supplied in a two
chamber container
system. At the time of
use, the contents of the
two chambers are mixed
together creating the | Supplied in a two
chamber container
system. At the time of
use, the contents of the
two chambers are
mixed together creating |
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| Parameter | Predicate Device
ACCUSOL, K041428 | HMB32 |
|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | dialysate solution. The
mixed solution is
delivered to the
dialysate pathway of the
blood tubing path
through the
administration site
consisting of a
membrane tube and a
pull-ring closure and
connected to the bottom
chamber. A medication
port is provided for
optional insertion of
other substances into
the mixed solution prior
to use. | the dialysate solution.
The mixed solution is
delivered to the
dialysate pathway of
the blood tubing path
through the
administration tube
connected to the
bottom chamber, which
is opened and closed
using a luer lock. A
second tube in the large
chamber can be used
for optional insertion of
other substances into
the mixed solution prior
to use. |
| Biocompatibility
of patient
contacting
container/closure
components | Established via testing
per ISO 10993-1 | Established via testing
per ISO 10993-1 |
| Sterilization | moist heat | moist heat |
| Shelf life | 12 months | 12 months |
11. NONCLINICAL TESTING:
Biocompatibility: The HMB32 solution consists of components found in human plasma and is in compliance with the European Pharmacopeia 8.0, "Haemofiltration and haemodiafiltration, solution for," current edition 07/2013:0861. The materials of the container/closure system come into contact with the solution, but do not come into direct contact with the patient. Biological assessments are provided to demonstrate that the materials in contact with the solution are medical grade, meet ISO 10993-1 and USP Class VI plastics requirements, and are commonly used for medical devices and injectable pharmaceuticals.
Sterilization Validation: The steam sterilization method was validated to an SAL of 10° in accordance with EN ISO 17665-1: 2007 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of sterilization process for medical devices.
Pyrogenicity testing conducted using the LAL test confirmed that the solution is not pyrogenic.
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Stability testing conducted after real-time aging out to 18 months confirmed the integrity of both the solution and the container/closure system. The HMB32 product will be labeled with a 12 month shelf life.
12. CONCLUSION:
The information and testing presented in this 510(k) demonstrates that the HBiofluids HMB32 is safe and effective for use during Continuous Renal Replacement Therapy as demonstrated by confirmation of substantial equivalence to the Accusol dialysis solution cleared under K041428.