The Hemocor HPH® Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed.

Device Description

The Minntech I lemocor HPI 700 Hemoconcentrator is made of glycerin-free, microporous, hollow fiber, polysulfone membrane encased in a polycarbonate chamber meroporous, notiow troot, porty and polycarbonate blood port header caps. The FIPE 700 TS device has attached PVC 1/4" tubing and accessory polycarbonate adapters for blood path connection. The no-rinse device feature provides versatility for inscrtion of the hemococentrator into the extracorporeal circuit.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Minntech Hemocor HPH® 700 Hemoconcentrator and Tubing Set, based on the provided 510(k) summary:

This device is not an AI/ML device, so many of the requested fields are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the Minntech Hemocor HPH® 700 Hemoconcentrator does not explicitly list "acceptance criteria" in the traditional sense of a pass/fail threshold for a performance metric. Instead, it presents a comparison of technological characteristics with a predicate device and outlines performance testing that was conducted to demonstrate device effectiveness and substantial equivalence.

Characteristic / Test	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (HPH® 700)
Technological Characteristics
Housing	Polycarbonate	Polycarbonate
Potting Material	Polyurethane	Polyurethane
Membrane	Polysulfone	Polysulfone
Membrane Surface Area	(Comparable to predicate, though smaller)	0.7 m²
Max Transmembrane Pressure (mmHg)	500 mmHg	500 mmHg
Max. Blood Flow Rate (ml/min)	500 ml/min	500 ml/min
Min. Blood Flow Rate (ml/min)	100 ml/min	50 ml/min
Priming Volume (ml)	70 ml	58 ml
Molecular Weight Cut-off (daltons)	65000 daltons	65000 daltons
Performance Testing	(Demonstrates effectiveness as a hemoconcentrator comparable to predicate)	(Testing conducted to determine effectiveness)
Ultrafiltration Rate vs. Transmembrane Pressure	(Sufficient ultrafiltration for intended use)	Testing conducted
Pressure Drop vs. Blood Flow Rate	(Acceptable pressure drop for intended use)	Testing conducted
Protein Rejection	(Adequate protein rejection)	Testing conducted
Minimum Blood Flow Rate & Blood Path Integrity	(Maintains integrity and function at minimum flow)	Testing conducted

Note on Acceptance Criteria: For legacy medical devices like this, especially for 510(k) submissions, "acceptance criteria" are often implicitly demonstrated by showing substantial equivalence to a legally marketed predicate device. The goal is to show the new device is as safe and effective as the predicate, not necessarily meet pre-defined numerical thresholds beyond what is necessary to support the same indications for use. The technological characteristics table serves as a primary source of this comparison. The performance testing further supports that the device performs as expected for a hemoconcentrator.

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

The 510(k) summary does not specify sample sizes for the performance testing conducted. It only states that testing was conducted. This is typical for 510(k) summaries where detailed pre-clinical test results are often kept in the full submission, not in the publicly available summary.

Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). Given this is a device performance test, it likely refers to in vitro or ex vivo lab testing, rather than human clinical data.

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

This question is not applicable as the ground truth for mechanical device performance (like a hemoconcentrator) is established through technical testing and measurement against engineering specifications and industry standards, not expert clinical consensus.

4. Adjudication Method for the Test Set

This question is not applicable as the ground truth for mechanical device performance is established through technical testing and measurement, not consensus among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or clinical interpretation where human readers are involved. This submission is for a medical device (hemoconcentrator) and its physical performance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

The concept of "standalone performance" for an algorithm or AI is not applicable here. This is a physical medical device, not a software algorithm. The "performance testing" described (Ultrafiltration Rate, Pressure Drop, Protein Rejection, Blood Path Integrity) represents the "standalone" performance of the device in a laboratory setting.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established through:

Bench testing/Laboratory Measurements: Based on established engineering principles, fluid dynamics, membrane science, and medical device performance standards.
Comparison to Predicate Device: The performance of the new device is compared to the known and accepted performance of the legally marketed predicate device (Hemocor HPH® 1000 Hemoconcentrator). Substantial equivalence means the new device performs at least as safely and effectively.

8. The Sample Size for the Training Set

This question is not applicable. This device is not an AI/ML system, so there is no concept of a "training set" for an algorithm.

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

This question is not applicable. As there is no AI/ML component, there is no "training set" or ground truth for such a set.

Summary

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K78 3085

Nov 1 3 1998

510(k) SUMMARY

Submitter Information: 1.

Name:	Minntech Corporation
Address:	14605 28th Avenue North, Minneapolis, Minnesota 55447
Contact Person:	Mark Murphy
Date Prepared:	September 1, 1998

Device Name: 2.

Proprietary name:	Minntech Hemocor HPH® 700 Hemoconcentrator and Tubing Set
Common name:	Hemoconcentrator
Classification name:	Dialyzer, High Permeability per 21 CFR 876.5860

3. Predicate Device:

Hemocor HPH® 1000 Hemoconcentrator

4. Device Description:

న్. Indications for Use:

Device	Indications
Minntech HPH® 700Hemoconcentrator	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.

DE 1 of 2

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6. Technological Characteristics:

Characteristic	Hemocor HPH® 700	Hemocor HPH® 1000
	Hemoconcentrator	Hemoconcentrator
Housing	Polycarbonate	Polycarbonate
Potting Material	Polyurethane	Polyurethane
Membrane	Polysulfone	Polysulfone
Membrane Surface Arca	0.7 m²	1.06 m²
Maximum TransmembranePressure (mmHg)	500	500
Max. Blood Flow rate (ml/min)	500	500
Min. Blood Flow rate (ml/min)	50	100
Priming volume (ml)	58	70
Molecular weight cut-off(daltons)	65000	65000

A comparative summary of the Hemocor HPH® 700 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. Transmembranc Pressure, Pressure Drop vs. Blood Flow Rate, Protein Rejection, Minimum Blood Flow Rate & Blood Path Integrity.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Image /page/2/Picture/2 description: The image shows a logo for the Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the eagle.

NOV 1 3 1998

Mr. Mark Murphy Regulatory Affairs Associate MINNTECH®Corporation 14605 28th Avenue North Minneapolis, MN 55447

Re: K983085 Hemocor HPH® 700 Hemoconcentrator and Tubing Set Dated: September 1, 1998 Received: September 3, 1998 Regulatory Class: III 21 CFR 876.5860/Procode: 78 KDI

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 ಿಗೆ ಮಾಡಿದ್ದಾರೆ.

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 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 equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) 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 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 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/cdrh/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

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Indications for Use

510(k) Number (if known):

K983085

Device Name:

Hemocor HPH 700 Hemoconcentrator

Indications for Use:

The Hemocor HPH 700 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.

(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)

William Yin
(Division Sign-Off)

vision of Reproductive, Abdominal, E nd Radiological Dev 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.”