(283 days)
MOX-100 Renal Preservation System, TM2 Transport Module
MOX-100
No
The summary describes a mechanical perfusion system with alarms based on predefined thresholds, not AI/ML algorithms. There is no mention of AI, ML, or related concepts like training or test sets.
No.
The device is described as a system for preserving and transporting kidneys for transplant, not for treating a disease or condition in a patient.
No
The device is described as a system for preserving and transporting kidneys for transplant, not for diagnosing medical conditions. It monitors parameters like pressure and temperature for the preservation process, but these are operational metrics, not diagnostic outputs about a patient's health. The performance studies evaluate the efficacy of kidney preservation, not diagnostic accuracy.
No
The device description clearly outlines hardware components such as a self-contained system, perfusion circuit, pump, and alarm systems (audio and visual), indicating it is not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The primary intended use is the preservation and transport of kidneys for transplant. This is a process that happens outside the body, but it's not about analyzing a sample in vitro to diagnose a condition or monitor a physiological state.
- Device Description: The description focuses on the mechanical aspects of preserving the organ (perfusion, pressure regulation, alarms). It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: There are no mentions of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
- Image processing, AI/ML, or specific imaging modalities, which are often associated with certain types of IVDs.
- Performance Studies: The studies described evaluate the preservation efficacy of the device on the organ itself (blood flow, urine output, creatinine levels after reperfusion, microscopic examination of the tissue). They are not studies evaluating the device's ability to accurately measure or detect something in a sample.
In summary, the HPA Portable Kidney Transport System is a device designed to maintain the viability of an organ ex vivo for the purpose of transplantation. It does not perform any diagnostic testing on biological samples.
N/A
Intended Use / 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.
The HPA Portable Kidney Transport System is intended for preserving and transporting kidneys for transplant.
Product codes
78 KDN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
kidney
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
blood flow, urine output, creatinine levels, microscopic examination
Predicate Device(s)
MOX-100 Renal Preservation System TM2 Transport Module
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
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.
1
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.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three wavy lines representing the department's mission to promote health, well-being, and human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
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
3
Page 1 of 1
510(k) Number:
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) | |
|---|---|
| -- | -------------------------------------------------------- |
| 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 |