(91 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 being used for the "prevention or relief of fluid overload, electrolyte and acid imbalances" and to "remove excess fluid," which indicates a direct therapeutic effect on the patient's physiological state.
No
Explanation: The device, HF Junior Hemoconcentrator, is intended for therapeutic purposes such as fluid removal and solute clearance in patients with renal failure, fluid overload, and other conditions. It does not diagnose any medical condition, but rather treats existing ones.
No
The device description clearly details a physical medical device with hardware components (polysulfone hollow fibers, polycarbonate case, arterial and venous ports) and describes a physical process (ultrafiltration) for its function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The HF Junior Hemoconcentrator is a device that filters blood outside the body (extracorporeal). It removes excess fluid and solutes directly from the patient's blood as it passes through the device.
- Intended Use: The intended use describes treating conditions like fluid overload, electrolyte imbalances, and removing excess fluid in various medical situations. This is a therapeutic intervention, not a diagnostic test performed on a sample.
- Device Description: The description details the physical components and how blood flows through the device for filtration. There is no mention of analyzing a sample or producing a diagnostic result.
The device is a therapeutic medical device used for blood filtration and fluid removal, not for performing diagnostic tests on patient samples.
N/A
Intended Use / Indications for Use
The HF Junior Hemoconcentrator is intended for use in prevention or relief of fluid overload, electrolyte and acid imbalances in cases of acute renal failure with oliguria or anuria. Also, it is used to remove excess fluid in cases of congestive heart failure, pulmonary and cerebral edema, anasarca, ascites, septic shock, burns, etc. In hypervolemic patients requiring parenteral nutrition and/or large volume of medications, the hemofilter may be used to reduce fluid overload. In hypercatabolic patients requiring more intensive solute removal, a sterile dialysate fluid may be made to flow around the fibers via the dialysate ports in order to increase the clearance of small molecules. It is indicated for patients (including pediatric patients) according to physician assessment of the patient and the instructions for use.
Product codes
KDI
Device Description
The HF Junior Hemofilter 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 hemofiltration 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
patients (including 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
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 HF Junior and the HF 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 नि
- hemolysis G.
- aqueous sieving H.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
HF™ Junior Hemofilter 510(k) Summary
AUG - 8 2007
| 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: | HF Junior Hemofilter |
| Classification Name: | Per 21 CFR 876.5860, High Permeability Hemodialysis |
Per 21 CFR 876.5860 Classification Name: System Common Name: Hemofilter
Minntech Corporation has supplied the following information to the U.S. Food and Drug Administration to support substantial equivalency of the HF Junior Hemofilter to other hemofilters currently on the market in the United States.
Device Description: l.
The HF Junior Hemofilter 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 hemofiltration 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 HF Junior Hemoconcentrator is intended for use in prevention or relief of fluid overload, electrolyte and acid imbalances in cases of acute renal failure with oliguria or anuria. Also, it is used to remove excess fluid in cases of congestive heart failure, pulmonary and cerebral edema, anasarca, ascites, septic shock, burns, etc. In hypervolemic patients requiring parenteral nutrition and/or large volume of medications, the hemofilter may be used to reduce fluid overload. In hypercatabolic patients requiring more intensive solute removal, a sterile dialysate fluid may be made to flow around the fibers via the dialysate ports in order to increase the clearance of small molecules. It is indicated for patients (including pediatric patients) according to physician assessment of the patient and the instructions for use.
1
HFTM Junior Hemofilter 510(k) Summary Page 2
Comparison to Another Device in Commercial Distribution Within the United States 3.
The HF Junior is equivalent in materials and performance to other hemofilters manufactured by Minntech, including the HF Minifilter Plus Hemofilter (K962707) cleared for market in October 1996. The only difference between the HF Junior and the HF Minifilter is that the HF Junior has the same fiber as used in our other HF Hemofilter products. The fiber used in the HF Mini has a larger internal diameter (I.D.) than the fiber that we use for our other HF products (including the HF Junior). Except the I.D., the fiber composition is exactly the same for all of the HF devices.
In addition to the HF Mini, the HF Junior is identical in configuration, size, and materials to the HPH Junior (K050952) cleared in January 2006.
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 HF Junior and the HF 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 नि
- hemolysis G.
- aqueous sieving H.
- 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 HF Junior are currently used in Minntech's other HF a. family of devices. No new materials or manufacturing methods are used to manufacture this device in comparison to the predicate devices.
- As described in Section 3. above, Minntech has performed extensive testing on b. the device to show that, the performance characteristics of the HF Junior are substantially equivalent to the predicate device.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
8 2007
Ms. Lynn Lueders Director, Regulatory Affairs Minntech Corporation 14605 28th Avenue North MINNEAPOLIS MN 55447
Re: K071298
Trade/Device Name: Minntech HFTM Junior Hemofilter Regulation Number: 21 CFR 8876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: May 8, 2007 Received: May 9, 2007
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.
Image /page/2/Picture/10 description: The image is a circular seal with the text "1906-2006 FDA Centennial" inside. The letters "FDA" are prominently displayed in the center of the seal. There are three stars below the word "Centennial". The seal is surrounded by a dotted border and has several stars around the perimeter.
Protecting and Promoting Public Health
3
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 (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.
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 vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosur
4
Indications for Use
510(k) Number (if known):
Device Name:
HFTM Junior Hemofilter
Indications for Use:
The HF Junior Hemoconcentrator is intended for use in prevention or relief of fluid overload, electrolyte and acid imbalances in cases of acute renal failure with oliguria or anuria. Also, it is used to remove excess fluid in cases of congestive heart failure, pulmonary and cerebral edema, anasarca, ascites, septic shock, burns, etc. In hypervolemic patients requiring parenteral nutrition and/or large volume of medications, the hemofilter may be used to reduce fluid overload. In hypercatabolic patients requiring more intensive solute removal, a sterile dialysate fluid may be made to flow around the fibers via the dialysate ports in order to increase the clearance of small molecules. It is indicated for patients (including pediatric patients) according to physician assessment of the patient and the instructions for use.
(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)
Nancy C. Brogdon
(Division Sign-Off)
adiological Device 510(k) Number