(291 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of the hemoconcentrator, with no mention of AI or ML.
Yes
The device is described as an "ultrafiltration system" that removes excess fluid and solutes from a patient's blood during and/or after cardiopulmonary bypass procedures, which is a therapeutic intervention.
No
This device is a hemoconcentrator used to remove excess fluid and solutes from blood during and/or following cardiopulmonary bypass procedures, which is a therapeutic function, not diagnostic.
No
The device description clearly outlines physical components like polysulfone hollow fibers, a polycarbonate case, and arterial/venous ports, indicating it is a hardware device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is an "ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures." This describes a therapeutic intervention performed directly on the patient's blood within a circulatory support circuit.
- Device Description: The description details how the device physically processes blood to remove fluid and solutes. This is a mechanical process, not a test performed on a sample outside the body to diagnose or monitor a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device is a medical device used in a surgical/clinical setting to directly treat a patient's blood during a procedure.
N/A
Intended Use / Indications for Use
The HPH™ Junior Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution is employed. The device is intended, as is the predicate, for all patients (including all pediatric subgroups) where a small priming volume is desired. In pediatric patients this device must be used only as a part of a cardiopulmonary bypass or circulatory support circuit, with the circuit being connected to the patient.
Product codes
KDI
Device Description
The HPH Junior Hemoconcentrator consists of many individual polysulfone hollow fibers encapsulated into a polycarbonate case. The device has arterial and venous ports on opposite ends of the device. As the patient's blood enters the device through the arterial blood port, it passes through the fiber bundle and then exits the device through the venous blood port and is returned to the patient. As the blood passes through the fiber bundle, ultrafiltration occurs as a result of a hydrostatic pressure gradient that exists across the semipermeable membrane. The resulting hemoconcentration removes large quantities of plasma water, and small and medium sized solutes (such as IL-6, C3a and C5a) are removed from the vascular space thereby concentrating the red cell mass and the plasma proteins.
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
all patients (including all pediatric subgroups) / all pediatric patients
Intended User / Care Setting
Not Found
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)
This equivalence has been shown though functional and safety testing as required by the relevant FDA guidances and ISO standards including ISO 8637:2004E, Cardiovascular Implants and Artificial Organs - Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators. This testing, performed on both the HPH Junior and the HPH Mini for comparison purposes included:
- determination of the static prime volume,
- ultrafiltration performance,
- blood path pressure drop,
- protein sieving of albumin, myoglobin, and inulin,
- structural integrity
- membrane integrity
- hemolysis
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
§ 876.5860 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.”
0
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HPH™ Junior High Performance Hemoconcentrator
510(k) Summary
| Manufacturer: | Minntech Corporation |
|---|---|
| Address: | 14605 28th Ave. N. |
| Minneapolis, MN 55447 | |
| Official Contact: | Lynn Lueders |
| Director, Regulatory Affairs | |
| Minntech Corporation | |
| Device Name: | |
| Trade or Proprietary Name: | HPHTM Junior High Performance |
| Hemoconcentrator | |
| Classification Name: | Per 21 CFR 876.5860 High Permeability |
| Hemodialysis System | |
| Common Name: | Hemoconcentrator |
Minntech Corporation has supplied the following information to the U.S. Food and Drug Administration to support substantial equivalency of the HPH Junior High Performance Hemoconcentrator to other hemoconcentrators currently on the market in the United States.
1. Device Description:
The HPH Junior Hemoconcentrator consists of many individual polysulfone hollow fibers encapsulated into a polycarbonate case. The device has arterial and venous ports on opposite ends of the device. As the patient's blood enters the device through the arterial blood port, it passes through the fiber bundle and then exits the device through the venous blood port and is returned to the patient. As the blood passes through the fiber bundle, ultrafiltration occurs as a result of a hydrostatic pressure gradient that exists across the semipermeable membrane. The resulting hemoconcentration removes large quantities of plasma water, and small and medium sized solutes (such as IL-6, C3a and C5a) are removed from the vascular space thereby concentrating the red cell mass and the plasma proteins.
2. Intended Use:
The HPH Junior Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution is employed. The device is intended, as is the predicate, for all patients (including all pediatric subgroups) where a small priming volume is desired. In pediatric patients this device must be used only as a part of a cardiopulmonary bypass or circulatory support circuit, with the circuit being connected to the patient.
1
HPH™ Junior High Performance Hemoconcentrator 510(k) Summary Page 2
- Comparison to Another Device in Commercial Distribution Within the United 3. States
The HPH Junior Hemoconcentrator is equivalent in materials and performance to other hemoconcentrators manufactured by Minntech, including the HPH Mini (K980859) High Performance Hemoconcentrator. The only difference between the HPH Junior and the HPH Mini is the diameter of the hollow fibers in the units. The HPH Junior contains fibers that have an internal diameter of 200 microns versus the HPH Mini whose fibers have an internal diameter of 630 microns. This allows the HPH Junior to have a lower prime volume (9ml versus 14ml) than the HPH Mini. The HPH Junior is manufactured using the same materials and manufacturing processes as the predicate device.
This equivalence has been shown though functional and safety testing as required by the relevant FDA guidances and ISO standards including ISO 8637:2004E, Cardiovascular Implants and Artificial Organs - Haemodialysers,
Haemodiafilters, Haemofilters and Haemoconcentrators. This testing, performed on both the HPH Junior and the HPH Mini for comparison purposes included:
- determination of the static prime volume, A.
- ultrafiltration performance, B.
- blood path pressure drop, ز
- protein sieving of albumin, myoglobin, and inulin, D.
- structural integrity E.
- membrane integrity F.
- G. hemolysis
- Summary of Substantial Equivalence 4.
Minntech Corporation has provided information to the U.S. FDA to show that the device is safe and effective when used in accordance to its labeling. This information includes evidence that:
- All materials used in the HPH Junior are currently used in Minntech's a. other HPH family of devices. No new materials or manufacturing methods are used to manufacture this device in comparison to the predicate devices.
- b. As described in Section 3. above. Minntech has performed extensive testing on the device to show that, the performance characteristics of the HPH Junior are substantially equivalent to the predicate device.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 1 2006
Ms. Lynn Lueders Director, Regulatory Affairs Minntech® Corporation 14605 28th Avenue N. MINNEAPOLIS MN 55447
Re: K050952
Trade/Device Name: HPH™ Junior High Performance Hemoconcentrator Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: December 12, 2005 Received: December 15, 2005
Dear Ms. Lueders:
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.
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 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. 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); good manufacturing practice requirements as set forth in the quality systems (05) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K050952
Device Name:
HPH Junior Hemoconcentrator
Indications for Use:
The HPH™ Junior Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution is employed. It is indicated for all patients (including all pediatric patients) according to physician assessment of the patient and the Instructions for Use. In pediatric patients this device must be used only as a part of a cardiopulmonary bypass or circulatory support circuit, with the circuit being connected to the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use L (Per 21 CFR 801.109)
OR
Over-the -counter-use (Optional Format 1-2-96)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K050952