(378 days)
SPS-1™
Not Found
No
The device is a cold storage solution, a chemical formulation, and the description focuses on its composition and physical properties. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a cold storage solution used for the flushing and hypothermic storage of organs prior to transplantation, which is a supportive role in the medical procedure rather than directly treating a disease or condition in a patient.
No
The device is a cold storage solution intended for preserving organs for transplantation, not for diagnosing medical conditions.
No
The device description clearly states it is a "solution," which is a liquid substance, not software. The performance studies also focus on the dispensing bag and chemical properties, further indicating a physical product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the flushing and hypothermic storage of organs outside the body in preparation for transplantation. This is a process performed on the organ itself, not on a sample taken from a patient to diagnose a condition or monitor a physiological state.
- Device Description: The description details a solution used for organ preservation, not a reagent or instrument used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), providing diagnostic information, or being used in a laboratory setting for testing purposes.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The BEL-GEN® Cold Storage Solution does not fit this description.
N/A
Intended Use / Indications for Use
The BEL-GEN® Cold Storage Solution is intended for the flushing and the hypothermic storage of kidney, liver and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient.
Product codes (comma separated list FDA assigned to the subject device)
KDL, KDN
Device Description
The BEL-GEN® Cold Storage Solution (BEL-GEN Solution) is clear to light yellow, sterile and pyrogen-free solution. BEL-GEN Solution has an approximate osmolality of 320 mOsm/kg, a sodium concentration of 29 mmol/L, a potassium concentration of 125 mmol/L and a pH of 7.4 at 20°C.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
kidney, liver and pancreas organs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Technological difference in the dispensing bag has been evaluated through biocompatibility, stability and chemical identity testing. Results of these evaluations did not raise any new questions of safety or effectiveness when compared to the predicate device and therefore the BEL-GEN Solution is substantially equivalent to the SPS-1 predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
SPS-1™
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
2 510(k) Summary
Date Prepared: May 29th, 2012
Submitter's Name / Contact Person
| Submitter | Contact Person |
|---|---|
| Waters Medical Systems, LLC | Robert Warren |
| 2112 - 15th Street NW | Phone: 507-288-7777 |
| Rochester, Minnesota 55901 | Email: bobw@wtrs.com |
General Information
| Trade Name | BEL-GEN® Cold Storage Solution |
|---|---|
| Common / Usual Name | Cold Storage Solution |
| Classification | 21 CFR 876.5880 |
| Information | Isolated kidney perfusion and transport system and accessories, Class II |
| Predicate Device | SPS-1™, Organ Recovery Systems, Inc. |
Device Description
The BEL-GEN® Cold Storage Solution (BEL-GEN Solution) is clear to light yellow, sterile and pyrogen-free solution. BEL-GEN Solution has an approximate osmolality of 320 mOsm/kg, a sodium concentration of 29 mmol/L, a potassium concentration of 125 mmol/L and a pH of 7.4 at 20°C.
Intended Use / Indications
The BEL-GEN® Cold Storage Solution is intended for the flushing and the hypothermic storage of kidney, liver and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient.
Substantial Equivalence and Summary of Studies
The BEL-GEN Cold Storage Solution device is substantially equivalent to the SPS-1 Static Preservation Solution. The BEL-GEN and SPS-1 solutions have an identical intended use, chemical composition and principle of operation. Both the subject and predicate device are sterile, non-pyrogenic, transparent solutions dispensed from a bag. Technological difference in the dispensing bag has been evaluated through biocompatibility, stability and chemical identity testing. Results of these evaluations did not raise any new questions of safety or effectiveness when compared to the predicate device and therefore the BEL-GEN Solution is substantially equivalent to the SPS-1 predicate.
K121618 Page lof l
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the caduceus in a circular fashion.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 14, 2013
Waters Medical Systems, LLC % Mr. Robert Warren General Manager 2112 - 15th Street NW ROCHESTER MN 55901
Re: K121618
Trade/Device Name: BEL-GEN® Cold Storage Solution Regulation Number: 21 CFR& 876.5880 Regulation Name: Isolated kidney perfusion and transport system and accessories Regulatory Class: II Product Code: KDL, KDN · Dated: May 31, 2013
Received: June 7, 2013
Dear Mr. Warren:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
2
Page 2 - Mr. Robert Warren
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Herbert PM Derner -S
| for | |
|---|---|
| Benjamin R. Fisher, Ph.D. ____________________________________________________________________________________________________________________________________________________ | |
| -Director -------------------------------------------------------------------------------------------------------------------------------------------------------------------- | |
| Division of Reproductive, Gastro-Renal, | |
| and Urological Devices | |
| Office of Device Evaluation | |
| Center for Devices and Radiological Health |
Enclosure
3
Indications for Use
K121618 510(k) Number (if known):
BEL-GEN® Cold Storage Solution Device Name:
Indications for Use:
The BEL-GEN® Cold Storage Solution is intended for the flushing and the hypothermic storage of kidney, liver and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE-DO NOT-WRITE-BELOW-THIS LINE-CONTINUE-ON-ANOTHER-PAGE-OF-NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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