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.

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.

AI/ML Overview

The provided text describes the HPH™ Junior High Performance Hemoconcentrator and its substantial equivalence to a predicate device, the HPH Mini. The study focuses on demonstrating this equivalence through functional and safety testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" with numerical targets for each parameter. Instead, it states that the performance characteristics of the HPH Junior are "substantially equivalent" to the predicate device, HPH Mini. The reported device performance is presented as a comparison to the HPH Mini.

Acceptance Criteria (Implied)	Reported Device Performance (HPH Junior)	Predicate Device (HPH Mini) Performance	Notes
Material Equivalence	Uses same materials and manufacturing processes	Uses same materials and manufacturing processes	Explicitly stated as equivalent.
Static Prime Volume	9 ml	14 ml	HPH Junior has a lower prime volume, which is a key distinguishing feature and advantage.
Ultrafiltration Performance	Substantially equivalent	-	Tested and found equivalent to predicate.
Blood Path Pressure Drop	Substantially equivalent	-	Tested and found equivalent to predicate.
Protein Sieving (albumin, myoglobin, inulin)	Substantially equivalent	-	Tested and found equivalent to predicate.
Structural Integrity	Substantially equivalent	-	Tested and found equivalent to predicate.
Membrane Integrity	Substantially equivalent	-	Tested and found equivalent to predicate.
Hemolysis	Substantially equivalent	-	Tested and found equivalent to predicate.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for the testing. It mentions "functional and safety testing" performed on "both the HPH Junior and the HPH Mini for comparison purposes." This implies a retrospective comparison as the HPH Mini is an existing device.

The data provenance is not specified beyond being internal testing conducted by Minntech Corporation to support their 510(k) submission to the U.S. FDA. There is no information regarding the country of origin of the data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The testing appears to be functional and safety testing conducted in a laboratory setting, not involving expert interpretation of patient data or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable as the study did not involve human interpretation or subjective assessment that would require an adjudication method. The testing was objective, measuring physical and performance characteristics.

5. 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

An MRMC study was not done. This type of study is relevant for AI-powered diagnostic devices involving human interpretation, which is not the nature of this hemoconcentrator device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not applicable to a mechanical medical device like a hemoconcentrator. The device itself performs its function (ultrafiltration) in a standalone manner, but there is no "algorithm" in the sense of AI or software processing data that would have a standalone performance.

7. The Type of Ground Truth Used

The "ground truth" for this study is based on objective measurements and engineering specifications as defined by relevant FDA guidances and ISO standards (specifically ISO 8637:2004E). The predicate device (HPH Mini) served as the benchmark for "substantially equivalent" performance.

8. The Sample Size for the Training Set

This information is not applicable as there is no "training set" in the context of this device. The study is a comparison of two physical devices based on their functional and safety characteristics, not a machine learning model.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the same reasons as in point 8.

Summary

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K050952

HPH™ Junior High Performance Hemoconcentrator

510(k) Summary

Manufacturer:	Minntech Corporation
Address:	14605 28th Ave. N.Minneapolis, MN 55447
Official Contact:	Lynn LuedersDirector, Regulatory AffairsMinntech Corporation
Device Name:
Trade or Proprietary Name:	HPHTM Junior High PerformanceHemoconcentrator
Classification Name:	Per 21 CFR 876.5860 High PermeabilityHemodialysis 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:

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.

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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.

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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.

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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

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Indications for Use

510(k) Number (if known): K050952

Device Name:

HPH Junior Hemoconcentrator

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 L (Per 21 CFR 801.109)

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

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.”