(68 days)
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Not Found
No
The summary describes a passive hemoconcentrator device with no mention of AI/ML capabilities or data processing.
Yes
The device is described as being "intended for the relief or mitigation of overhydration, reduction of lower molecular weight constituents and to increase formed cellular elements and protein levels in the blood of patients during and/or after cardiopulmonary procedures," which are therapeutic effects.
No
The device is described as a hemoconcentrator used for mitigating overhydration and altering blood constituent levels during and after cardiopulmonary procedures, which are therapeutic rather than diagnostic functions.
No
The device description clearly states it is a physical hemoconcentrator made of polysulphone membrane with barbed luer adaptors, indicating it is a hardware device.
Based on the provided information, the Hemocor HPH Mini Hemoconcentrator is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device that is used on the patient's blood during or after a cardiopulmonary procedure to modify its composition (remove fluid, increase cellular elements and protein). This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The description details a device with a membrane and connections for blood flow, consistent with a device that interacts directly with blood in an extracorporeal circuit.
- Lack of Diagnostic Language: There is no mention of analyzing blood samples, detecting biomarkers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the device's ability to perform ultrafiltration, manage pressure, and reject protein – all related to its function in modifying blood composition, not diagnosing a condition.
IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. The Hemocor HPH Mini Hemoconcentrator operates on the blood in an extracorporeal circuit, which is a different category of medical device.
N/A
Intended Use / Indications for Use
The Hemocor HPH® Mini Hemoconcentrator is intended for the relief or mitigation of overhydration and reduction of lower molecular weight constituents during and/or following cardiopulmonary procedures.
The Hemocor HPH Mini Hemoconcentrator is intended for the relief or mitigation of overhydration, reduction of lower molecular weight constituents and to increase formed cellular elements and protein levels in the blood of patients during and/or after cardiopulmonary procedures.
Product codes (comma separated list FDA assigned to the subject device)
78 KDI
Device Description
The Minntech Hemocor HPH® Mini Hemoconcentrator is made of glycerin-free polysulphone membrane. Barbed luer adaptors of 3/16" and 1/4" for blood path connection and a no-rinse feature provide versatility for insertion of the device into the extracorporeal circuit.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance testing was conducted to determine device effectiveness as a hemoconcentrator: Ultrafiltration Rate vs. Transmembrane Pressure, Pressure Drop vs. Blood Flow Rate, Protein Rejection, Minimum Blood Flow Rate & Blood Path Integrity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Hemocor HPH® 400 Hemoconcentrator
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.
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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
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”
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K980859
Page 1 of 2
MAY 1 2 1998
510(k) SUMMARY
Submitter Information: 1.
| Name: | Minntech Corporation |
|---|---|
| Address: | 14605 28th Avenue North, Minneapolis, Minnesota 55447 |
| Contact Person: | Mark Murphy |
| Date Prepared: | March 3, 1998 |
Device Name: 2.
| Proprietary name: | Minntech Hemocor HPH® Mini Hemoconcentrator |
|---|---|
| Common name: | Hemoconcentrator |
| Classification name: | Autotransfusion Apparatus per 21 CFR 868.5830 |
Predicate Device: 3.
Hemocor HPH® 400 Hemoconcentrator
Device Description: 4.
The Minntech Hemocor HPH® Mini Hemoconcentrator is made of glycerin-free polysulphone membrane. Barbed luer adaptors of 3/16" and 1/4" for blood path connection and a no-rinse feature provide versatility for insertion of the device into the extracorporeal circuit.
ર. Indications for Use:
| Device | Indications |
|---|---|
| Minntech HPH Mini | |
| Hemoconcentrator | The Hemocor HPH® Mini Hemoconcentrator is intended |
| for the relief or mitigation of overhydration and reduction | |
| of lower molecular weight constituents during and/or | |
| following cardiopulmonary procedures. | |
| Minntech HPH 400 | |
| Hemoconcentrator | The Hemocor HPH® Hemoconcentrator is intended for |
| use as an ultrafiltration system to remove excess fluid | |
| during and/or following cardiopulmonary bypass | |
| procedures where acute hemodilution has been employed. |
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K 980859
Page 2 of 2
Technological Characteristics: 6.
| Characteristic | Hemocor HPH Mini
Hemoconcentrator | Hemocor HPH 400
Hemoconcentrator |
|--------------------------------------------|--------------------------------------|-------------------------------------|
| Housing | Polycarbonate | Polycarbonate |
| Potting Material | Polyurethane | Polyurethane |
| Membrane | Polysulphone | Polysulphone |
| Membrane Surface Area | 0.07 m² | 0.3 m² |
| Effective Fiber Length (cm) | 9.4 | 9.4 |
| Maximumum Transmembrane
Pressure (mmHg) | 500 | 500 |
| Max. Blood Flow rate (ml/min) | 500 | 500 |
| Min. Blood Flow rate (ml/min) | 50 | 100 |
| Priming volume (ml) | 14 | 27 |
| Molecular weight cut-off
(daltons) | 65000 | 65000 |
tive summary of the Hemocor HPH® Mini and predicate device is as follows:
7. Performance Testing:
The following performance testing was conducted to determine device effectiveness as a hemoconcentrator: Ultrafiltration Rate vs. Transmembrane Pressure, Pressure Drop vs. Blood Flow Rate, Protein Rejection, Minimum Blood Flow Rate & Blood Path Integrity.
2
Image /page/2/Picture/0 description: The image shows a logo with three stylized human figures in black, arranged in a row and facing the same direction. The figures are simplified, with curved lines suggesting their heads and bodies. The logo is likely used to represent a department or organization focused on human services or public health.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Mark Murphy Regulatory Affairs Associate MINNTECH® Corporation 14605 28th Avenue North Minneapolis, MN 55447
Dear Mr. Murphy:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
Re: K980859
Hemocor HPH Mini Hemoconcentrator
21 CFR 876.5860/Procode: 78 KDI
Dated: March 3, 1998
Regulatory Class: III
Received: March 5, 1998
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivaliation assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your S10(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrb/dsmaldsmamain.html".
Sincerely yours.
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name:
Hemocor HPH Mini Hemoconcentrator
Indications for Use:
The Hemocor HPH Mini Hemoconcentrator is intended for the relief or mitigation of overhydration, reduction of lower molecular weight constituents and to increase formed cellular elements and protein levels in the blood of patients during and/or after cardiopulmonary procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-the -counter-use (Optional Format 1-2-96)
Robert D. Rathung
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K980859