The HPA Portable Kidney Transport System is intended for preserving and transporting kidneys for transplant.
The HPA Portable Kidney Preservation System, Model J-1000-1 is to be used when prescribed by a physician for the use of storing and preserving a human kidney

Device Description

The HPA Portable Kidney Transport System is a patented, self contained renal preservation system that provides the benefits of machine perfusion with a simplified perfusion circuit. The device provides low flow pulsatile perfusion with regulated arterial pressure limits. Audio and visual alarms are provided for over pressure, over temperature, pump failure, tubing failure, and battery failure conditions.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a medical device, not an AI/ML diagnostic tool, therefore standard performance metrics like sensitivity, specificity, or AUC are not applicable here. Instead, the "acceptance criteria" are implied by the comparison to the predicate device and the demonstration of equivalent, or superior, preservation of kidney function.

Acceptance Criteria (Implied)	Reported Device Performance (HPA)
Preserve canine kidneys as well as the MOX-100 for 24-72 hours.	The HPA preserves canine kidneys as well as the MOX-100 for preservation lasting between 24 and 72 hours.
Preserve canine kidneys for 120 hours.	For preservation lasting 120 hours, the HPA protects the microcirculation better than the MOX-100.
Maintain kidney viability and function post-preservation (evaluated by blood flow, urine output, creatinine levels, and microscopic examination).	The studies demonstrate positive outcomes across these metrics following re-perfusion and sacrifice of test animals.

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

Sample Size: Not explicitly stated as a number of kidneys or observations, but "three studies were performed on mongrel dogs." Each study likely involved multiple kidneys.
Data Provenance: Prospective animal study (mongrel dogs). The country of origin is not specified but implicitly assumed to be the location of Justec Medical Products, Inc. (Holbrook, NY, USA).

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

The document does not mention "experts" in the context of establishing ground truth in the way one would for diagnostic imaging. Instead, the assessment relied on objective physiological and anatomical measures in the dogs:
- Blood flow
- Urine output
- Creatinine levels
- Subsequent microscopic examination (presumably by a veterinary pathologist or histologist, but qualifications are not provided).

4. Adjudication Method for the Test Set

Not applicable as this is not a diagnostic imaging study requiring expert adjudication of reader interpretations. The evaluation metrics are objective measurements.

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

No, an MRMC study was not done. This is a device for organ preservation, not a diagnostic imaging tool for human-in-the-loop performance measurement.

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

Yes, in a way. The "performance" of the HPA device itself was evaluated in a standalone manner, meaning its ability to preserve kidneys was assessed objectively without human intervention during the preservation phase, beyond setting up and monitoring the device. There isn't an "algorithm" in the typical AI/ML sense.

7. The Type of Ground Truth Used

The ground truth was established through a combination of physiological measurements (blood flow, urine output, creatinine levels) and histopathological examination (microscopic examination) of the preserved kidneys after re-perfusion and sacrifice. This constitutes direct evidence of organ viability and damage.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The "development" would have involved engineering and biological testing, not machine learning training.

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

Not applicable, as there is no training set for this type of device.

Summary

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K990229 p.1/2

NOV - 4 1999

510(k) SUMMARY

Submitter Information 1)

Justec Medical Products, Inc. 1724 Church St. Holbrook, NY 11741

Establishment
registration number:	2436793
Phone #:	516-563-1851 ext. 227
FAX #:	516-563-6509
Contact person:	Jeffrey L. Rothman

2) Device Names

Classification Name:	Isolated kidney perfusion and transport system andaccessories (21 CFR 876.5880)
Common/Usual name:	Kidney transporter with disposable cassette
Proprietary name:	HPA, Portable kidney perfusion system

3) Predicate Devices

MOX-100 Renal Preservation System TM2 Transport Module, A pre-amendment device.

Device Description 4)

5) Intended Use

The HPA Portable Kidney Transport System is intended for preserving and transporting kidneys for transplant.

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ର) Comparison of Technological Characteristics

The HPA operates without a membrane oxygenator at lower temperatures, pressures, and pulse rates than the MOX-100. The MOX-100 has provision for oxygen and carbon dioxide tanks, a gas mixer and gas flow controls for mixing of gases with ambient athmosphere. These features are generally not used in clinical practice.

Three studies were performed on mogrel dogs to determine the efficacy of the HPA as compared to the MOX-100. In the studies kidneys were removed, preserved for 24, 72, and 120 hours, and re-perfused by test animals. The kidneys were then evaluated based on blood flow, urine output, creatinine levels, and subsequent microscopic examination after the animals were sacrificed. These studies demonstrate the HPA preserves canine kidneys as well as the MOX-100 for preservation lasting between 24 and 72 hours. For preservation lasting 120 hours the HPA protects the microcirculation better than the MOX-100.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 4 1999

Mr. Jeffrey Rothman Justec Medical Products, Inc. 1724 Church Street Holbrook, NY 11741

Re: K990229 HPA Portable Kidney Preservation System Model J-1000-1 Dated: August 18, 1999 Received: August 20, 1999 Regulatory Class: Il 21 CFR 876.5880/Procode: 78 KDN

Dear Mr. Rothman:

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 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). 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 requlations 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 (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 531 through 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/dsma/dsmamain.html".

Sincerely yours.

CAPT Daniel G. Schultz, M.D. Acting 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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Page 1 of 1

510(k) Number:

K990229

Device Name:

HPA Portable Kidney Preservation System Model J-1000-1

Indications for Use:

The HPA Portable Kidney Preservation System, Model J-1000-1 is to be used when prescribed by a physician for the use of storing and preserving a human kidney

	Concurrence of CDRH, Office of Device Evaluation (ODE)
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Prescription Use(Per 21 CFR 801.109)	or
	Over-The-Counter-Use
	(Optional Format 1-

(Division Sign-Off)
	Division of Reproductive, Abdominal, ENT,and Radiological Devices
510(k) Number	K990229/S 021

Regulation Number and Section

§ 876.5880 Isolated kidney perfusion and transport system and accessories.

(a)
Identification. An isolated kidney perfusion and transport system and accessories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set.(b)
Classification. Class II (performance standards).