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.

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.

AI/ML Overview

This 510(k) summary for the HF™ Junior Hemofilter focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing novel acceptance criteria through a clinical study. Therefore, many of the requested data points related to clinical study design (sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, ground truth establishment) are not applicable or explicitly stated in this document. The provided text describes bench testing to confirm performance equivalence.

Here's a breakdown of the available information:

HF™ Junior Hemofilter Acceptance Criteria and Performance (Based on Equivalence Testing)

Acceptance Criteria Category	Specific Test/Characteristic	Reported Device Performance (Relative to Predicate)
Physical Characteristics	Materials	All materials used in the HF Junior are currently used in Minntech's other HF family of devices. No new materials or manufacturing methods are used compared to predicate devices.
	Fiber Composition	The fiber used in the HF Junior has the same composition as other HF Hemofilter products (including the HF Minifilter, which differs only in internal diameter). It is exactly the same as the fiber used in the HPH Junior.
	Configuration, Size	Identical to the HPH Junior (K050952).
Functional Performance	Static Prime Volume	Tested to show substantial equivalence to the predicate device (HF Minifilter Plus and HPH Junior). Specific quantitative values or acceptance ranges are not provided, only that equivalence was shown.
	Ultrafiltration Performance	Tested to show substantial equivalence to the predicate device (HF Minifilter Plus and HPH Junior). Specific quantitative values or acceptance ranges are not provided, only that equivalence was shown.
	Blood Path Pressure Drop	Tested to show substantial equivalence to the predicate device (HF Minifilter Plus and HPH Junior). Specific quantitative values or acceptance ranges are not provided, only that equivalence was shown.
	Protein Sieving (Albumin, Myoglobin, Inulin)	Tested to show substantial equivalence to the predicate device (HF Minifilter Plus and HPH Junior). Specific quantitative values or acceptance ranges for sieving coefficients are not provided, only that equivalence was shown.
	Aqueous Sieving	Tested to show substantial equivalence to the predicate device (HF Minifilter Plus and HPH Junior). Specific quantitative values or acceptance ranges for sieving coefficients are not provided, only that equivalence was shown.
Safety and Integrity	Structural Integrity	Tested to show substantial equivalence to the predicate device (HF Minifilter Plus and HPH Junior). Specific test methods or quantitative results are not provided, only that equivalence was shown.
	Membrane Integrity	Tested to show substantial equivalence to the predicate device (HF Minifilter Plus and HPH Junior). Specific test methods or quantitative results are not provided, only that equivalence was shown.
	Hemolysis (Biocompatibility)	Tested to show substantial equivalence to the predicate device (HF Minifilter Plus and HPH Junior). Specific test methods (e.g., ISO 10993-4) or quantitative results (e.g., % hemolysis) are not provided, only that equivalence was shown.
Regulatory Compliance	Compliance with relevant FDA guidances and ISO standards (e.g., ISO 8637:2004E: Cardiovascular Implants and Artificial Organs - Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators).	This is the overarching "acceptance criterion" for the study – demonstrating compliance with these standards and guidances to prove substantial equivalence to predicates. The testing performed (listed above) satisfies these requirements.

Study Details:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a numerical sample size for the test set (number of devices tested). It refers to "extensive testing" performed on "both the HF Junior and the HF Mini for comparison purposes."
- Data Provenance: The testing was conducted by Minntech Corporation, the manufacturer. The data is retrospective in the sense that it evaluates manufactured devices against established predicate performance. The country of origin for the data is implicitly the United States, given the manufacturer's address.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This was not a clinical study involving expert interpretation of data or images. The "ground truth" for this substantial equivalence submission is the established performance characteristics and safety profile of the predicate devices, as defined by FDA guidances and ISO standards for hemofilters.
Adjudication method for the test set: Not applicable. There was no clinical data requiring expert adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document describes the 510(k) submission for a physical medical device (hemofilter), not an AI/software device. Therefore, no MRMC study or AI-related effectiveness analysis was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/software device. The performance data presented is "standalone" in the sense of the physical device's function, but it's not an algorithm's standalone performance.
The type of ground truth used: For this substantial equivalence submission, the "ground truth" or reference standard for comparison is the established performance and safety characteristics of the predicate devices. These characteristics are defined by:
- Previously cleared Minntech hemofilters (HF Minifilter Plus Hemofilter, K962707, and HPH Junior, K050952).
- Relevant FDA guidances.
- International standards, specifically ISO 8637:2004E, "Cardiovascular Implants and Artificial Organs - Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators."
The sample size for the training set: Not applicable. There was no machine learning or AI model involved, so no "training set."
How the ground truth for the training set was established: Not applicable, as there was no training set. The "ground truth" or reference for evaluating the HF Junior was the performance of the predicate devices as per regulatory standards.

Summary

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HF™ Junior Hemofilter 510(k) Summary

AUG - 8 2007

Manufacturer:	Minntech Corporation
Address:	14605 28th Ave. N.Minneapolis, MN 55447
Official Contact:	Lynn LuedersDirector, Regulatory AffairsMinntech 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.

2. Intended Use:

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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.

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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

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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); 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

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Indications for Use

510(k) Number (if known):

K071298

Device Name:

HFTM Junior Hemofilter

Indications 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

Regulation Number and Section

§ 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.”