(151 days)
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.
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.
The provided text is an FDA 510(k) Premarket Notification summary for a medical device called "Belzer UW® Cold Storage Solution (BTLBUW-001)". This document is for a cold storage solution used for organ preservation, not for an AI-powered diagnostic device.
Therefore, the document does not contain information related to:
- Acceptance criteria for an AI device's performance metrics (e.g., sensitivity, specificity, AUC).
- Sample sizes for test sets and training sets for an AI model.
- Number and qualifications of experts for ground truth establishment.
- Adjudication methods for test sets.
- MRMC comparative effectiveness studies or effect sizes of human reader improvement with AI assistance.
- Standalone algorithm performance.
- Type of ground truth used for AI models (e.g., pathology, outcomes data).
The document focuses on demonstrating substantial equivalence of the new cold storage solution (Belzer UW®) to a legally marketed predicate device (CoStorSol® Solution). The "study" proving the device meets acceptance criteria is primarily a non-clinical comparison of product characteristics and safety/performance testing (biocompatibility, sterility, shelf life).
Here's a breakdown of the relevant information provided in the document:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present "acceptance criteria" in the typical sense of quantitative thresholds for an AI/diagnostic device's performance (e.g., "Sensitivity > X%"). Instead, it compares the proposed device's characteristics to those of its predicate device to establish substantial equivalence.
| Characteristic | Predicate Device (CoStorSol® Solution) | Subject Device (Belzer UW® Cold Storage Solution) | Comparison / "Acceptance" |
|---|---|---|---|
| Device Description | Clear to light yellow, sterile, non-pyrogenic solution for hypothermic flushing and storage of organs. Approx. calculated osmolarity of 320 mosmol/kg, Na 29 mEq/L, K 125 mEq/L, pH approx. 7.4 at 20°C. Packaged in 1-Liter bags. | Clear to light yellow, sterile, non-pyrogenic solution for hypothermic flushing and storage of organs. Approx. calculated osmolarity of 320 mosmol/kg, Na 29 mEq/L, K 125 mEq/L, pH approx. 7.4 at 20°C. Packaged in 500-mL, 1-L, and 2-L bags. | Same (composition/basic properties) |
| Indications for Use | Flushing and cold storage of kidney, liver, and pancreas organs for storage, transportation, and eventual transplantation. | Flushing and cold storage of kidney, liver, and pancreas organs for storage, transportation, and eventual transplantation. Not indicated for continuous machine perfusion. | Same (though subject explicitly states "not for continuous machine perfusion") |
| Intended Use | Flushing and cold storage of kidney, liver, and pancreas organs for storage, transportation, and eventual transplantation. | Flushing and cold storage of kidney, liver, and pancreas organs for storage, transportation, and eventual transplantation. | Same |
| 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 Temp | Directly cools vasculature during hypothermic storage/transport (not for continuous perfusion). | Directly cools vasculature during hypothermic storage/transport (not for continuous perfusion). | Same |
| Product State | Liquid - Solution | Liquid - Solution | Same |
| Composition | Identical list of components (Pentafraction, Lactobionic Acid, Potassium Phosphate monobasic, etc.) and concentrations as subject device. | Identical list of components and concentrations as predicate device (see Table 1 in document). | 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 | 1,000 ml | 500 ml, 1,000 ml, 2,000 ml | Equivalent (more options for subject) |
| Single Use Only | Yes | Yes | Same |
| Primary Container | Constructed from Ethylene Vinyl Acetate (EVA). Flexible, clear, durable. Latex-Free, PVC-Free, DEHP-Free. Sterile, non-pyrogenic fluid path. | Constructed from Ethylene Vinyl Acetate (EVA). Flexible, clear, durable. Latex-Free, PVC-Free, DEHP-Free. Sterile, non-pyrogenic fluid path. | Equivalent |
| Protecting Overwrap Bag | Yes | Yes | Same |
| Shelf Life | 24 Months | 6 Months | Same (Subject states ongoing study for 24 months) |
| Pyrogenicity | Non-Pyrogenic | Non-Pyrogenic | Same |
| Sterility | Assured via 0.1 µm membrane filtration | Assured via 0.2 µm and two 0.1 µm membrane filtration | Same (similar method) |
| Sterilization | Aseptic Fill | Aseptic Fill | Same |
| Biocompatibility | In accordance with ISO 10993-1/2/5/10/12. | In accordance with ISO 10993-1/2/5/10/12. | Equivalent |
| Sterile Dispensing/Admin. | Fluid dispensed via sterile port on bag. | Fluid dispensed via sterile port on bag. | Same |
| Bag Connections | Fluid delivery and drug administration ports | Fluid delivery and drug administration ports | Same |
2. Sample sized used for the test set and the data provenance:
Not applicable for this type of device. The "test set" here refers to specific non-clinical tests (biocompatibility, sterility, shelf life stability). The provenance of organs or patient data is not relevant or mentioned. These tests are laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth for a cold storage solution is established through laboratory analyses and well-defined chemical and biological testing standards, not by expert interpretation of images or patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication is relevant for studies involving human interpretation (e.g., radiology reads), not for direct measurements of solution properties or standard in-vitro biological tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI diagnostic device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance would be established through:
- Chemical analysis to verify composition, osmolarity, and pH.
- Microbiological testing to verify sterility and non-pyrogenicity.
- Biocompatibility testing (in vitro and potentially in vivo animal studies, referenced as ISO 10993 standards) to ensure the material does not cause adverse biological reactions.
- Stability studies to confirm shelf life and maintain properties over time.
- Functional performance testing (e.g., in animal models or ex-vivo organ models, although not explicitly detailed in this summary, would typically be part of the full submission for a device of this nature) to show the solution preserves organs effectively.
8. The sample size for the training set:
Not applicable. This is not an AI diagnostic device.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI diagnostic device.
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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"
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(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.
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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
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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) |
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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
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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® ColdStorage Solution(BTLBUW-001) | CoStorSol® Solution | |
| 510k Number | K243384 | K091245 | |
| Manufacturer | Bridge to Life707 Skokie Blvd, Ste. 340Northbrook, IL 60062 | Preservation Solutions, Inc.,980 Proctor Drive, Elkhorn,Wisconsin 32121 | - |
| Classification &Product Code | 876.5880; KDN, KDL | 876.5880; KDN | Same |
| Device RegulationDescription | Isolated kidney perfusion andtransport system and accessories | Isolated kidney perfusion andtransport system andaccessories | Same |
| Common Name | Organ Storage Solution | Organ Storage Solution | Same |
| DESCRIPTION,INDICATIONS,& INTENDEDUSE | |||
| Device Description | BTL's Belzer UW® Cold Storage CoStorSol® is a clear to lightSolution (BTLBUW-001) is aclear to light yellow, sterile, non-pyrogenic solution forhypothermic flushing andstorage of organs.The solution has an approximatecalculated osmolarity of 320mosmol/kg, a sodiumconcentration of 29 mEq/L, apotassium concentration of 125mEq/L, and a pH ofapproximately 7.4 at 20°C.The solution is packaged in 500-mL, 1-L and 2-L bags. | yellow, sterile, non-pyrogenicsolution for hypothermicflushing and storage of organs.The solution has anapproximate calculatedosmolarity of 320 mosmol/kg,a sodium concentration of 29mEq/L, a potassiumconcentration of 125 mEq/L,and a pH of approximately 7.4at 20°C.The solution is packaged in 1-Liter bags | SameSubject and predicatedevices are both used asorgan preservationsolutions. Devices areused in the organprocurement andtransplant process perstandard organpreservation practices. |
| Indications for Use | Belzer UW® Cold StorageSolution (BTLBUW-001) isindicated for the flushing andcold storage of kidney, liverand pancreas organs at the timeof organ removal from thedonor in preparation forstorage, transportation andeventual transplantation into arecipient. Belzer UW® ColdStorage Solution (BTLBUW-001) is not indicated forcontinuous machine perfusion. | CoStorSol® indicated for theflushing and cold storage ofkidney, liver and pancreasorgans at the time of organremoval from the donor inpreparation for storage,transportation and eventualtransplantation into arecipient. | SameSubject and predicatedevices are both used asorgan preservationsolutions. All devices areused at coldtemperatures, to slowbiological deteriorationin organs removed fromtheir physiologicalenvironment perstandard organpreservation practices. |
| Intended Use | Belzer UW® Cold StorageSolution (BTLBUW-001) isintended for the flushing andcold storage of kidney, liverand pancreas organs at the timeof organ removal from thedonor in preparation forstorage, transportation andeventual transplantation into arecipient. | Intended for the flushing andcold storage of kidney, liverand pancreas organs at thetime of organ removal fromthe donor in preparation forstorage, transportation andeventual transplantation into arecipient. | Same |
| TECNOLOGICALCHARACTERISTICS | |||
| StorageTemperature | 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 ColdOrganTemperatureDuring Storageand Transport | Directly cools the organvasculature during hypothermicstorage and transportation (notfor continuous perfusion) to thepatient. | Directly cools the organvasculature duringhypothermic storage andtransportation (not forcontinuous perfusion) to thepatient. | Same |
| Product State | Liquid - Solution | Liquid - Solution | Same |
| Composition | 50 g/L Pentafraction35.83 g/L Lactobionic Acid (asLactone)3.4 g/L Potassium Phosphatemonobasic1.23 g/L Magnesium Sulfateheptahydrate17.83 g/L Raffinosepentahydrate1.34 g/L Adenosine0.136 g/L Allopurinol0.922 g/L Total Glutathione5.61 g/L Potassium Hydroxide5.0 mL/L Sodium Hydroxide,5NWater for Injection q.s. | 50 g/L Pentafraction35.83 g/L Lactobionic Acid (asLactone)3.4 g/L Potassium Phosphatemonobasic1.23 g/L Magnesium Sulfateheptahydrate17.83 g/L Raffinosepentahydrate1.34 g/L Adenosine0.136 g/L Allopurinol0.922 g/L Total Glutathione5.61 g/L Potassium Hydroxide5.0 mL/L Sodium Hydroxide,5NWater 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 ml1,000 ml2,000 ml | 1,000 ml | EquivalentSubject device has moreavailable size optionsthan the predicatedevice. |
| Single Use Only | Yes | Yes | Same |
| Primary Container | |||
| Constructed from EthyleneVinyl Acetate (EVA). The filmis flexible, clear and durable.The container bags are Latex-Free, PVC-Free and DEHP-Free.Sterile, non-pyrogenic fluid path. | Constructed from EthyleneVinyl Acetate (EVA). The filmis flexible, clear and durable.The container bags are Latex-Free, PVC-Free and DEHP-Free.Sterile, non-pyrogenic fluid path. | Equivalent | |
| ProtectingOverwrap Bag | Yes | Yes | Same |
| Shelf Life | 6 Months | 24 Months | Same. Shelf life stabilitystudy is on-going to claim 24months shelf life. |
| SAFETY | |||
| Pyrogenicity | Non-Pyrogenic | Non-Pyrogenic | Same |
| Sterility | Sterility assured via 0.2 µm andtwo 0.1 µm membrane filtration | Sterility assured via 0.1 µmembrane filtration | Same |
| Sterilization | Aseptic Fill | Aseptic Fill | Same |
| Biocompatibility | Biocompatible in accordancewith ISO 10993-1/2/5/10/12. | Biocompatible in accordancewith ISO 10993-1/2/5/10/12. | Equivalent |
| SterileDispensing/Administration | Fluid is dispensed via sterileport on bag. | Fluid is dispensed via sterileport on bag. | Same |
| Bag Connections | Fluid delivery and drugadministration ports | Fluid delivery and drugadministration ports | Same |
CONFIDENTIAL
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CONFIDENTIAL
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CONFIDENTIAL
OCTOBER 2024
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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.
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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.
§ 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).