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.

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.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device, the Minntech Hemocor HPH® Mini Hemoconcentrator. The information provided focuses on demonstrating substantial equivalence to a predicate device through technological characteristics and performance testing. It does not contain information about the acceptance criteria and study design you've requested for typical AI/algorithm-based device evaluations.

Here's a breakdown of why this document doesn't fit your requested format and what information is missing:

Why this document doesn't fit your request:

Device Type: This is a physical medical device (a hemoconcentrator), not a software/AI algorithm. Therefore, the concepts of "test set," "training set," "ground truth," "experts," "adjudication," "MRMC study," and "standalone performance" as they relate to AI/HIL performance are not applicable.
Regulatory Pathway: This is a 510(k) submission, which focuses on demonstrating substantial equivalence to a legally marketed predicate device. This typically involves comparing device specifications and performance data, not clinical studies with "ground truth" and reader performance metrics in the way your questions imply for AI.
Data Provided: The document details the device's physical characteristics, materials, and generic performance tests (e.g., Ultrafiltration Rate, Pressure Drop). It does not provide detailed information on clinical study design or outcomes related to diagnostic accuracy or human reader improvement.

Attempting to answer your questions based only on the provided text, while acknowledging the mismatch:

Given the nature of the device (a hemoconcentrator) and the provided 510(k) summary, the concepts of "acceptance criteria" and "study" in the context of an AI/algorithm-driven device are not directly applicable. The "acceptance criteria" here would be demonstrating that the device performs as intended and is substantially equivalent to the predicate, and the "study" is the performance testing described.

1. A table of acceptance criteria and the reported device performance

Characteristic	Acceptance Criteria (Implied: Substantially Equivalent to Predicate)	Reported Device Performance (Minntech Hemocor HPH® Mini Hemoconcentrator)
Housing	Same as predicate	Polycarbonate
Potting Material	Same as predicate	Polyurethane
Membrane	Same as predicate	Polysulphone
Membrane Surface Area	Different from predicate (smaller area) – justified by intended use	0.07 m²
Effective Fiber Length (cm)	Same as predicate	9.4
Maximum Transmembrane Pressure (mmHg)	Same as predicate	500
Max. Blood Flow rate (ml/min)	Same as predicate	500
Min. Blood Flow rate (ml/min)	Different from predicate (lower min flow rate)	50
Priming volume (ml)	Different from predicate (smaller volume)	14
Molecular weight cut-off (daltons)	Same as predicate	65000
Device Effectiveness as Hemoconcentrator	Device performs as intended for "relief or mitigation of overhydration and reduction of lower molecular weight constituents" and passes specified functional tests.	Ultrafiltration Rate vs. Transmembrane Pressure studies conducted. Pressure Drop vs. Blood Flow Rate studies conducted. Protein Rejection studies conducted. Minimum Blood Flow Rate & Blood Path Integrity studies conducted.

Note: The "acceptance criteria" are implied by the demonstration of substantial equivalence to the predicate device. The performance characteristics for the new device are directly compared to the predicate, and functional tests are listed as having been conducted to ensure effectiveness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable / Not Provided. For a physical device like this, "test set" and "data provenance" in the context of diagnostic accuracy are not relevant. The "testing" refers to benchtop or in-vitro performance evaluations of the device's physical functions. The document does not specify the number of units tested, the origin of test data, or if it was retrospective/prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. Ground truth, in the sense of expert consensus for diagnostic cases, is not relevant for this physical device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. Adjudication is not relevant for this physical device.

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

No. An MRMC study is not applicable to a physical hemoconcentrator.

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

Not Applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. "Ground truth" as defined for AI/diagnostic algorithms is not relevant here. The "truth" is the device's physical and functional performance against established engineering and medical standards for hemoconcentrators.

8. The sample size for the training set

Not Applicable. This is a physical device, not an AI algorithm. There is no training set.

9. How the ground truth for the training set was established

Not Applicable. This is a physical device, not an AI algorithm. There is no training set or associated ground truth.

Summary

{0}------------------------------------------------

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.

ર. Indications for Use:

Device	Indications
Minntech HPH MiniHemoconcentrator	The Hemocor HPH® Mini Hemoconcentrator is intendedfor the relief or mitigation of overhydration and reductionof lower molecular weight constituents during and/orfollowing cardiopulmonary procedures.
Minntech HPH 400Hemoconcentrator	The Hemocor HPH® Hemoconcentrator is intended foruse as an ultrafiltration system to remove excess fluidduring and/or following cardiopulmonary bypassprocedures where acute hemodilution has been employed.

{1}------------------------------------------------

K 980859
Page 2 of 2

Technological Characteristics: 6.

Characteristic	Hemocor HPH MiniHemoconcentrator	Hemocor HPH 400Hemoconcentrator
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 TransmembranePressure (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:

(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)

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

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.”