BEL-GEN COLD STORAGE SOLUTION

K121618 · Waters Medical Systems, LLC · KDL · Jun 14, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K121618
• Device Name: BEL-GEN COLD STORAGE SOLUTION
• Applicant: Waters Medical Systems, LLC
• Product Code: KDL · Gastroenterology, Urology
• Decision Date: Jun 14, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5880
• Device Class: Class 2

Intended 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.

Device Story

BEL-GEN® Cold Storage Solution is a sterile, pyrogen-free, clear to light yellow liquid used for organ preservation. It functions as a flushing and hypothermic storage medium for kidney, liver, and pancreas organs harvested from donors. The solution maintains organ viability during transport prior to transplantation. It is supplied in a bag and used by clinical staff in a transplant or surgical setting. The solution's chemical composition (osmolality ~320 mOsm/kg, sodium 29 mmol/L, potassium 125 mmol/L, pH 7.4) supports organ integrity during cold storage.

Clinical Evidence

Bench testing only. Biocompatibility, stability, and chemical identity testing were performed to evaluate the dispensing bag and confirm equivalence to the predicate.

Technological Characteristics

Sterile, non-pyrogenic solution; osmolality 320 mOsm/kg; sodium 29 mmol/L; potassium 125 mmol/L; pH 7.4 at 20°C. Dispensed from a bag. No energy source or software.

Indications for Use

Indicated for flushing and hypothermic storage of kidney, liver, and pancreas organs during donor removal, transport, and preparation for transplantation.

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

• SPS-1™, Organ Recovery Systems, Inc.

Submission Summary (Full Text)

{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: [phone] |
| Rochester, Minnesota 55901 | Email: [e-mail] |

#### 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.

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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.

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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 [phone] or [phone] 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,<br>and Urological Devices | |
| Office of Device Evaluation<br>Center for Devices and Radiological Health | |

Enclosure

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# 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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# Herbert開@erner -S

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