(151 days)
Not Found
No
The device is a cold storage solution, a chemical formulation for preserving organs, with no mention of software, algorithms, or data processing.
No.
The device is a cold storage solution used for organ preservation, not for treating or curing a disease or medical condition in a patient.
No
This device is a cold storage solution used for preserving organs prior to transplantation, not for diagnosing medical conditions.
No
The device description clearly states it is a "solution" supplied in "bags," indicating a physical substance and packaging, not software.
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 cold storage of organs (kidney, liver, pancreas) for transplantation. This is a direct intervention on the organ itself, not a test performed in vitro (outside the body) on a sample from the body to diagnose a condition or provide information about a physiological state.
- Device Description: The description details a solution used to preserve organs. It doesn't describe a test kit, reagent, or instrument used to analyze a biological sample.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Measuring analytes or biomarkers
- Using reagents for testing
The device is clearly intended for the preservation and preparation of organs for transplantation, which falls under the category of medical devices used in surgical procedures and organ preservation, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Belzer UW® Cold Storage Solution (BTLBUW-001) is indicated for the flushing and cold 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. Belzer UW® Cold Storage Solution (BTLBUW-001) is not indicated for continuous machine perfusion.
Product codes
KDN, KDL
Device Description
Belzer UW® Cold Storage Solution (BTLBUW-001) is a clear to light yellow, sterile, nonpyrogenic solution for hypothermic flushing and storage of organs. The solution has an approximate calculated osmolarity of 320 mosmol/kg, a sodium concentration of 29 mEq/L, a potassium concentration of 125 mEq/L, and a pH of approximately 7.4 at 20°C.
The solution should be used only by medical healthcare staff, adequately trained according to established operating protocols.
The Belzer UW® Cold Storage Solution (BTLBUW-001) is supplied in non-PVC bags: 500 mL bags, shelf carton of 6; 1000 mL in 1-liter bags, shelf carton of 10; and 2000 mL in 2-liter bags, shelf carton of 5. The solution is sterile and is intended for one single use.
The solution should be stored indoors at temperatures controlled between 2° and 25°C (36° and 77°F) until use. Excessive heat and freezing should be avoided. Belzer UW® Cold Storage Solution (BTLBUW-001) should not be used if discolored or if obvious particulate matter, precipitates, or contamination are evident in the solution.
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
medical healthcare staff
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
Non-clinical performance data included biocompatibility, sterilization, and shelf life.
Biocompatibility: demonstrated as substantially equivalent to the predicate device via testing and biological risk assessment.
Sterilization: aseptically filled and sterility assured via 0.2 µm and two 0.1 µm membrane filtration.
Shelf Life: 6 months.
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 31, 2025
Bridge to Life Ltd Mark Harper Compliance Manager 707 Skokie Boulevard, Suite 340 Northbrook, Illinois 60062
Re: K243384
Trade/Device Name: Belzer UW® Cold Storage Solution (BTLBUW-001) Regulation Number: 21 CFR 876.5880 Regulation Name: Isolated kidney perfusion and transport system and accessories Regulatory Class: Class II Product Code: KDN, KDL Dated: February 19, 2025 Received: February 19, 2025
Dear Mark Harper:
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 (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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. 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic.
2
See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Gema Gonzalez -S
Maura Rooney Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity, and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K243384
Device Name Belzer UW® Cold Storage Solution (BTLBUW-001)
Indications for Use (Describe)
Belzer UW® Cold Storage Solution (BTLBUW-001) is indicated for the flushing and cold 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. Belzer UW® Cold Storage Solution (BTLBUW-001) is not indicated for continuous machine perfusion.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
K243384: 510(k) Summary
1.0 SUBMITTER
Bridge to Life Ltd
707 Skokie Blvd. Ste. 340 Northbrook, IL 60062
| Contact Person | : | Mark Harper |
|---|---|---|
| Phone | : | 847-796-3070 |
| Fax | : | 803-753-9798 |
| : | m.harper@b2ll.com | |
| Date Prepared | : | October 30th, 2024 |
2.0 DEVICE
| Common Name : | Organ Cold Storage Solution |
|---|---|
| Proprietary Name : | Belzer UW® Cold Storage Solution (BTLBUW-001) |
| Classification Name : | Isolated kidney perfusion and transport system and accessories |
| Device Classification : | Class II, 876.5880 |
| Product Code : | KDN, KDL |
3.0 PREDICATE DEVICE
| Company | Device | K Number | Date Cleared |
|---|---|---|---|
| Preservation Solutions, Inc | CoStorSol® Solution | K091245 | June 17, 2009 |
4.0 DEVICE DESCRIPTION
Belzer UW® Cold Storage Solution (BTLBUW-001) is a clear to light yellow, sterile, nonpyrogenic solution for hypothermic flushing and storage of organs. The solution has an approximate calculated osmolarity of 320 mosmol/kg, a sodium concentration of 29 mEq/L, a potassium concentration of 125 mEq/L, and a pH of approximately 7.4 at 20°C.
The solution should be used only by medical healthcare staff, adequately trained according to established operating protocols.
The Belzer UW® Cold Storage Solution (BTLBUW-001) is supplied in non-PVC bags: 500 mL bags, shelf carton of 6; 1000 mL in 1-liter bags, shelf carton of 10; and 2000 mL in 2-liter bags, shelf carton of 5. The solution is sterile and is intended for one single use.
The solution should be stored indoors at temperatures controlled between 2° and 25°C (36° and 77°F) until use. Excessive heat and freezing should be avoided. Belzer UW® Cold Storage Solution (BTLBUW-001) should not be used if discolored or if obvious particulate matter, precipitates, or contamination are evident in the solution.
Bridge to Life's Belzer UW® Cold Storage Solution (BTLBUW-001) is substantially CONFIDENTIAL Page 1 of 6 OCTOBER 2024
5
equivalent in composition, safety and efficacy to currently marketed CoStorSol® Solution, which was cleared by the US FDA in prior 510(k) submission K091245
Table 1 provides information about the composition of Bridge to Life's Belzer UW® Cold Storage Solution (BTLBUW-001).
| Component | g/L | Mmol/L |
|---|---|---|
| Pentafraction | 50 | N/A |
| Lactobionic Acid (as Lactone) | 35.83 | 105 |
| Potassium Phosphate monobasic | 3.4 | 25 |
| Magnesium Sulfate heptahydrate | 1.23 | 5 |
| Raffinose pentahydrate | 17.83 | 30 |
| Adenosine | 1.34 | 5 |
| Allopurinol | 0.136 | 1 |
| Total Glutathione | 0.922 | 3 |
| Potassium Hydroxide | 5.61 | 100 |
| Sodium Hydroxide, 5N | 5.0mL/L | 25 |
| Water for Injection | q.s. |
Table 1: Composition of Bridge to Life's Belzer UW® Cold Storage Solution (BTLBUW-001)
5.0 INDICATION FOR USE
Bridge to Life's Belzer UW® Cold Storage Solution (BTLBUW-001) is indicated for the flushing and cold 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. Belzer UW® Cold Storage Solution (BTLBUW-001) is not indicated for continuous machine perfusion.
6.0 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The following table provides a comparison of attributes between the proposed device and the predicate device:
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| Device | BTL's Belzer UW® Cold | ||
| Storage Solution | |||
| (BTLBUW-001) | CoStorSol® Solution | ||
| 510k Number | K243384 | K091245 | |
| Manufacturer | Bridge to Life | ||
| 707 Skokie Blvd, Ste. 340 | |||
| Northbrook, IL 60062 | Preservation Solutions, Inc., | ||
| 980 Proctor Drive, Elkhorn, | |||
| Wisconsin 32121 | - | ||
| Classification & | |||
| Product Code | 876.5880; KDN, KDL | 876.5880; KDN | Same |
| Device Regulation | |||
| Description | Isolated kidney perfusion and | ||
| transport system and accessories | Isolated kidney perfusion and | ||
| transport system and | |||
| accessories | Same | ||
| Common Name | Organ Storage Solution | Organ Storage Solution | Same |
| DESCRIPTION, | |||
| INDICATIONS, | |||
| & INTENDED | |||
| USE | |||
| Device Description | BTL's Belzer UW® Cold Storage CoStorSol® is a clear to light | ||
| Solution (BTLBUW-001) is a | |||
| clear to light yellow, sterile, non-pyrogenic solution for | |||
| hypothermic flushing and | |||
| storage of organs. |
The solution has an approximate
calculated osmolarity of 320
mosmol/kg, a sodium
concentration of 29 mEq/L, a
potassium concentration of 125
mEq/L, and a pH of
approximately 7.4 at 20°C.
The solution is packaged in 500-
mL, 1-L and 2-L bags. | yellow, sterile, non-pyrogenic
solution for hypothermic
flushing and storage of organs.
The solution has an
approximate calculated
osmolarity of 320 mosmol/kg,
a sodium concentration of 29
mEq/L, a potassium
concentration of 125 mEq/L,
and a pH of approximately 7.4
at 20°C.
The solution is packaged in 1-
Liter bags | Same
Subject and predicate
devices are both used as
organ preservation
solutions. Devices are
used in the organ
procurement and
transplant process per
standard organ
preservation practices. |
| Indications for Use | Belzer UW® Cold Storage
Solution (BTLBUW-001) is
indicated for the flushing and
cold 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. Belzer UW® Cold
Storage Solution (BTLBUW-
001) is not indicated for
continuous machine perfusion. | CoStorSol® indicated for the
flushing and cold 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. | Same
Subject and predicate
devices are both used as
organ preservation
solutions. All devices are
used at cold
temperatures, to slow
biological deterioration
in organs removed from
their physiological
environment per
standard organ
preservation practices. |
| Intended Use | Belzer UW® Cold Storage
Solution (BTLBUW-001) is
intended for the flushing and
cold 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. | Intended for the flushing and
cold 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. | Same |
| TECNOLOGICAL
CHARACTERISTICS | | | |
| Storage
Temperature | 2° to 25° C | 2° to 25° C | Same |
| Pre-Cooling | Pre-cool solution prior to use
(2° to 6° C) | Pre-cool solution prior to use
(2° to 6° C) | Same |
| Maintain Cold
Organ
Temperature
During Storage
and Transport | Directly cools the organ
vasculature during hypothermic
storage and transportation (not
for continuous perfusion) to the
patient. | Directly cools the organ
vasculature during
hypothermic storage and
transportation (not for
continuous perfusion) to the
patient. | Same |
| Product State | Liquid - Solution | Liquid - Solution | Same |
| Composition | 50 g/L Pentafraction
35.83 g/L Lactobionic Acid (as
Lactone)
3.4 g/L Potassium Phosphate
monobasic
1.23 g/L Magnesium Sulfate
heptahydrate
17.83 g/L Raffinose
pentahydrate
1.34 g/L Adenosine
0.136 g/L Allopurinol
0.922 g/L Total Glutathione
5.61 g/L Potassium Hydroxide
5.0 mL/L Sodium Hydroxide,
5N
Water for Injection q.s. | 50 g/L Pentafraction
35.83 g/L Lactobionic Acid (as
Lactone)
3.4 g/L Potassium Phosphate
monobasic
1.23 g/L Magnesium Sulfate
heptahydrate
17.83 g/L Raffinose
pentahydrate
1.34 g/L Adenosine
0.136 g/L Allopurinol
0.922 g/L Total Glutathione
5.61 g/L Potassium Hydroxide
5.0 mL/L Sodium Hydroxide,
5N
Water for Injection q.s. | Same |
| Osmolality | 320 mOsmol/kg | 320 mOsmol/kg | Same |
| pH | Approximately 7.4 at 20°C | Approximately 7.4 at 20°C | Same |
| Fluid Volume | 500 ml
1,000 ml
2,000 ml | 1,000 ml | Equivalent
Subject device has more
available size options
than the predicate
device. |
| Single Use Only | Yes | Yes | Same |
| | Primary Container | | |
| | Constructed from Ethylene
Vinyl Acetate (EVA). The film
is flexible, clear and durable.
The container bags are Latex-
Free, PVC-Free and DEHP-Free.
Sterile, non-pyrogenic fluid path. | Constructed from Ethylene
Vinyl Acetate (EVA). The film
is flexible, clear and durable.
The container bags are Latex-
Free, PVC-Free and DEHP-Free.
Sterile, non-pyrogenic fluid path. | Equivalent |
| Protecting
Overwrap Bag | Yes | Yes | Same |
| Shelf Life | 6 Months | 24 Months | Same. Shelf life stability
study is on-going to claim 24
months shelf life. |
| SAFETY | | | |
| Pyrogenicity | Non-Pyrogenic | Non-Pyrogenic | Same |
| Sterility | Sterility assured via 0.2 µm and
two 0.1 µm membrane filtration | Sterility assured via 0.1 µ
membrane filtration | Same |
| Sterilization | Aseptic Fill | Aseptic Fill | Same |
| Biocompatibility | Biocompatible in accordance
with ISO 10993-1/2/5/10/12. | Biocompatible in accordance
with ISO 10993-1/2/5/10/12. | Equivalent |
| Sterile
Dispensing/
Administration | Fluid is dispensed via sterile
port on bag. | Fluid is dispensed via sterile
port on bag. | Same |
| Bag Connections | Fluid delivery and drug
administration ports | Fluid delivery and drug
administration ports | Same |
CONFIDENTIAL
6
CONFIDENTIAL
7
CONFIDENTIAL
OCTOBER 2024
8
7.0 NON-CLINICAL PERFORMANCE DATA
Performance data is provided in support of the substantial equivalence determination. All tests performed are included in this submission.
7.1. Biocompatibility
Belzer UW® Cold Storage Solution (BTLBUW-001) has been demonstrated as substantially equivalent in biocompatibility to the predicate device via testing and biological risk assessment, such that it is safe for its intended use.
7.2 Sterilization
Belzer UW® Cold Storage Solution (BTLBUW-001) is aseptically filled and sterility assured via 0.2 µm and two 0.1 µm membrane filtration.
7.3 Shelf Life
Belzer UW® Cold Storage Solution (BTLBUW-001) has a shelf life of 6 months.
9
8.0 DESIGN CONTROL SUMMARY
All procedural Design Controls were followed, and all design control elements were satisfied.
9.0 SUMMARY OF VERIFICATION & VALIDATION
Verification and validation testing was done on the Belzer UW® Cold Storage Solution (BTLBUW-001). The subject device is substantially equivalent to the predicate device. Any risks to the overall system were addressed in the Risk Analysis. Concerns or risks identified were mitigated by the actual proper use and function Belzer UW® Cold Storage Solution (BTLBUW-001) indicated in the Instructions for Use. It is appropriate to conclude that Belzer UW® Cold Storage Solution (BTLBUW-001) is substantially equivalent to the predicate device K091245.
10.0 CONCLUSION
The subject and predicate devices have the same intended use and are substantially equivalent in technological characteristics and performance (same composition). The Belzer UW® Cold Storage Solution (BTLBUW-001) is safe and effective as the predicate device. The non-clinical data supports and demonstrates the safety of the device.
The conclusion is that Belzer UW® Cold Storage Solution (BTLBUW-001) is substantially equivalent to the legally marketed CoStorSol® Solution and therefore should have clearance for premarket activities in the United States.