HPA PORTABLE KIDNEY PRESERVATION SYSTEM, MODEL J-1000-1

K990229 · Justec Medical Products, Inc. · KDN · Nov 4, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K990229
• Device Name: HPA PORTABLE KIDNEY PRESERVATION SYSTEM, MODEL J-1000-1
• Applicant: Justec Medical Products, Inc.
• Product Code: KDN · Gastroenterology, Urology
• Decision Date: Nov 4, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5880
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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

Device Story

HPA Portable Kidney Transport System is a self-contained renal preservation device; provides low-flow pulsatile perfusion with regulated arterial pressure limits. System utilizes a simplified perfusion circuit without a membrane oxygenator. Device monitors for over-pressure, over-temperature, pump failure, tubing failure, and battery failure, providing audio and visual alarms. Used in clinical settings for kidney preservation and transport prior to transplantation. Healthcare providers use the system to maintain organ viability; output consists of continuous perfusion and status alerts, enabling clinicians to ensure stable storage conditions. Benefits include improved microcirculation protection during extended preservation periods.

Clinical Evidence

Three studies on mongrel dogs compared HPA to MOX-100. Kidneys were preserved for 24, 72, and 120 hours and re-perfused. Endpoints included blood flow, urine output, creatinine levels, and microscopic examination. Results showed HPA preserves canine kidneys equivalent to MOX-100 for 24-72 hours and provides better microcirculation protection at 120 hours.

Technological Characteristics

Self-contained renal preservation system; low-flow pulsatile perfusion; simplified circuit without membrane oxygenator. Operates at lower temperatures, pressures, and pulse rates than predicate. Includes audio/visual alarm system for pressure, temperature, and mechanical failures. Battery-powered.

Indications for Use

Indicated for the storage and preservation of human kidneys for transplant, when prescribed by a physician.

Regulatory Classification

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.

Predicate Devices

• MOX-100 Renal Preservation System TM2 Transport Module

Submission Summary (Full Text)

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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 and<br>accessories (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)

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.

#### 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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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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<br>(Per 21 CFR 801.109) | <div style="display:flex; align-items:center;"><div></div><div>or</div></div> |
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| | Over-The-Counter-Use |
| | (Optional Format 1- |

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