(103 days)
No
The device is a preservation solution, and the description focuses on its chemical composition and packaging. There is no mention of any computational or analytical capabilities that would involve AI/ML.
No
The device is an organ preservation solution used for flushing and perfusing explanted organs, not for treating a disease or condition in a living patient.
No
The device is an organ preservation solution used for flushing and continuous hypothermic machine perfusion of explanted abdominal organs. Its purpose is to maintain organ viability, not to diagnose a condition or disease.
No
The device description clearly states it is a solution supplied in bags, which are physical components, 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 in vitro flushing and continuous hypothermic machine perfusion of explanted abdominal organs. This describes a process performed outside the body, but it's a preservation and preparation step for organs intended for transplantation, not a diagnostic test performed on a sample to gain information about a patient's health.
- Device Description: The description details a solution used to maintain the viability of organs. It doesn't describe a test or assay designed to detect or measure substances in a biological sample for diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing information for diagnosis, monitoring, or screening.
- Comparison to Predicate: The predicate device (MaPerSol® Solution) and reference device (EasiSlush® Cold Storage Solution) are also organ preservation solutions, not IVDs.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health status. This device's function is to preserve organs, which is a different category of medical device.
N/A
Intended Use / Indications for Use
Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) is indicated for the in vitro flushing and continuous hypothermic machine perfusion of explanted abdominal organs.
Product codes
KDN, KDL
Device Description
Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) is a clear to straw-colored, sterile, non-pyrogenic solution for the in-vitro flushing and continuous perfusion of explanted abdominal organs. The Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) has the same composition and indication for use as MaPerSol® Organ Preservation Solution.
The solution is consistent with an extracellular solution, based on its sodium/potassium ratio and has a calculated potassium concentration of 25 mEq/L, a sodium concentration of 100 mEq/L, an osmolarity of 300 mosmol/kg, and a pH of approximately 7.4 at 20°C.
The Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) is supplied in single use 1000mL solution bags, made from flexible PVC free material (e.g., laminated EVA film) with at least two integrated ports including ports for delivery and component addition. Each individual bag is enclosed in a protective outer overwrap bag. The solution is sterile and is intended for one single use.
The solution should be used only by medical healthcare staff, adequately trained according to established operating protocols.
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 MPS® (UW Machine Perfusion Solution) (BMPS-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
abdominal 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 testing, Sterility assurance (aseptic filling and membrane filtration), and Shelf Life claims (6 months). Verification and validation testing was done, and it was concluded that the subject device is substantially equivalent to the predicate and reference device, with risks addressed in a Risk Analysis.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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 for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 26, 2025
Bridge to Life Mark Harper Compliance Manager 707 Skokie Boulevard, Suite 340 Northbrook, Illinois 60062
Re: K243840
Trade/Device Name: Belzer MPS® (UW Machine Perfusion Solution) (BMPS-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: December 13, 2024 Received: February 24, 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 (the 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. 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).
2
Sincerely,
Image /page/2/Picture/3 description: The image shows the name "Maura Rooney" followed by "-S". The text is written in a clear, sans-serif font and is prominently displayed against a white background. The letters are large and easily readable.
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) K243840
Device Name
Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)
Indications for Use (Describe)
Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) is indicated for the in vitro flushing and continuous hypothermic machine perfusion of explanted abdominal organs.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X 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
K243840: 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 | : | December 13th 2024 |
2.0 DEVICE
| Proprietary Name : | Belzer MPS® (UW Machine Perfusion Solution) (BMPS-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 | MaPerSol® Solution | K080432 | August 8, 2008 |
4.0 DEVICE DESCRIPTION
Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) is a clear to straw-colored, sterile, non-pyrogenic solution for the in-vitro flushing and continuous perfusion of explanted abdominal organs. The Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) has the same composition and indication for use as MaPerSol® Organ Preservation Solution.
The solution is consistent with an extracellular solution, based on its sodium/potassium ratio and has a calculated potassium concentration of 25 mEq/L, a sodium concentration of 100 mEq/L, an osmolarity of 300 mosmol/kg, and a pH of approximately 7.4 at 20°C.
The Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) is supplied in single use 1000mL solution bags, made from flexible PVC free material (e.g., laminated EVA film) with at least two integrated ports including ports for delivery and component addition. Each individual bag is enclosed in a protective outer overwrap bag. The solution is sterile and is intended for one single use.
The solution should be used only by medical healthcare staff, adequately trained according to established operating protocols.
5
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 MPS® (UW Machine Perfusion Solution) (BMPS-001) should not be used if discolored or if obvious particulate matter, precipitates, or contamination are evident in the solution.
Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) is substantially equivalent in composition, safety and efficacy to currently marketed MaPerSol® Solution, which was cleared by the US FDA in prior 510(k) submission K080432.
Table 1 provides information about the composition of Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001).
| Component | g/L | Mmol/L |
|---|---|---|
| Adenine (free base) | 0.68g | 5 |
| Calcium Chloride (dihydrate) | 0.068g | 0.5 |
| Dextrose (+) | 1.80g | 10 |
| Glutathione (reduced) | 0.92g | 3 |
| HEPES (free acid) | 2.38 g | 10 |
| Hydroxyethyl Starch | 50.0g | N/A |
| Magnesium Gluconate | 1.13 g | 5 |
| Mannitol | 5.4 g | 30 |
| Potassium Phosphate (monobasic) | 3.4 g | 25 |
| Ribose, D(-) | 0.75g | 5 |
| Sodium Gluconate | 17.45 g | 80 |
| Sodium Hydroxide | 0.70g | N/A |
| Sterile Water | To 1000 ml Volume |
Table 1: Composition of Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)
5.0 INDICATION FOR USE
Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) is indicated for the in-vitro flushing and continuous hypothermic machine perfusion of explanted abdominal organs.
6.0 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The following table provides a comparison of attributes between the subject, predicate and reference devices:
| Subject Device | Predicate Device | Reference Device | Comparison | |
|---|---|---|---|---|
| Device | Belzer MPS® (UW Machine Perfusion Solution (BMPS-001)) | MaPerSol® Organ Preservation Solution (UW Machine Perfusion Solution) | EasiSlush® Cold Storage Solution | |
| 510k Number | K243840 | K080432 | K191006 | |
| Manufacturer | Bridge to Life | |||
| 707 Skokie Boulevard | ||||
| Suite 340, Northbrook, | ||||
| IL 60062 | Preservation Solutions, Inc., 980 Proctor Drive, Elkhorn, Wisconsin 53121 | Bridge to Life | ||
| 707 Skokie Boulevard Suite | ||||
| 340, Northbrook, IL 60062 | ||||
| Classification & | ||||
| Product Code | 876.5880; KDN | 876.5880; KDN | 876.5880; KDN | Same |
| Device Regulation | ||||
| Description | Isolated kidney | |||
| perfusion and transport | ||||
| system and accessories | Isolated kidney | |||
| perfusion and transport | ||||
| system and accessories | Isolated kidney perfusion | |||
| and transport system and | ||||
| accessories | Same | |||
| Common Name | Organ Preservation | |||
| Solution | Organ Preservation | |||
| Solution | 0.9% Saline Slush Solution | Same | ||
| DESCRIPTION, | ||||
| INDICATIONS, | ||||
| & INTENDED | ||||
| USE | ||||
| Device Description | BTL's Belzer MPS® | |||
| (UW Machine | ||||
| Perfusion Solution) | ||||
| (BMPS-001) is a clear | ||||
| to straw-colored | ||||
| solution for the in-vitro flushing and | ||||
| continuous machine | ||||
| perfusion of explanted | ||||
| abdominal organs. | ||||
| This solution is | ||||
| consistent with an | ||||
| extracellular solution, | ||||
| based on its | ||||
| sodium/potassium | ||||
| ratio. This solution has | ||||
| a calculated potassium | ||||
| concentration of 25 | ||||
| mEq/L, a sodium | ||||
| concentration of 100 | ||||
| mEq/L, an osmolarity | ||||
| of 300 mosmol/kg, and | ||||
| a pH of approximately | ||||
| 7.4 at 20°C. | ||||
| The solution is | ||||
| packaged in 1-L bags. | MaPerSol® Organ | |||
| Preservation Solution is | ||||
| a clear to straw-colored | ||||
| solution for the in-vitro | ||||
| flushing and temporary | ||||
| continuous perfusion | ||||
| preservation of | ||||
| explanted kidneys. This | ||||
| solution is consistent | ||||
| with an extracellular | ||||
| solution, based on its | ||||
| sodium/potassium ratio. | ||||
| This solution has a | ||||
| calculated potassium | ||||
| concentration of 25 | ||||
| mEq/L, a sodium | ||||
| concentration of 100 | ||||
| mEq/L, an osmolarity of | ||||
| 300 mosmol/kg, and a | ||||
| pH of approximately 7.4 | ||||
| at 20°C. | ||||
| The solution is | ||||
| packaged in 1-Liter | ||||
| bags | EasiSlush® is a clear, | |||
| colorless 0.9% Sodium | ||||
| Chloride solution for | ||||
| preparation of slushed | ||||
| solution to provide | ||||
| hypothermia during the | ||||
| recovery, storage, and | ||||
| transport of donor organs | ||||
| for transplantation. The | ||||
| solution is sterile, non- | ||||
| pyrogenic, isotonic and is | ||||
| contained in a 2L sterile, | ||||
| flexible, non- PVC bag. | Same | |||
| Subject, predicate and | ||||
| reference devices are all | ||||
| used as organ preservation | ||||
| solutions. Devices are used | ||||
| in the organ procurement | ||||
| and transplant process per | ||||
| standard organ | ||||
| preservation practices. | ||||
| Indications for Use | Belzer MPS® (UW | |||
| Machine Perfusion | ||||
| Solution) (BMPS- |
- is indicated for
the in-vitro flushing
and continuous
hypothermic
machine perfusion of
explanted abdominal
organs. | MaPerSol® Organ
Preservation Solution is
indicated for in vitro
flushing and continuous
hypothermic machine
perfusion of explanted
kidneys. | EasiSlush slushed solution
is intended for topical
cooling of in-situ,
abdominal donor organs
during intraoperative
recovery from the donor. It
is also intended to maintain
organ hypothermia during
storage and transport to the
transplant recipient.
EasiSlush™ slushed
solution is used to establish,
and maintain hypothermia
of donor organs during | Same
Subject, predicate and
reference devices are all
used as organ preservation
solutions. All devices are
used at cold hypothermic
temperatures, to slow
biological deterioration in
organs removed from their
physiological environment
per standard organ
preservation practices.
Specifically: |
| | | | | |
| Intended Use | Belzer MPS® (UW
Machine Perfusion
Solution) (BMPS- - is intended for
in-vitro flushing and
continuous
hypothermic
machine perfusion of
explanted abdominal
organs. | MaPerSol® Organ
Preservation Solution is
intended for the in-vitro
flushing and continuous
hypothermic machine
perfusion preservation
of explanted kidneys. | EasiSlush™ slushed
solution is intended for
topical cooling of in-situ ,
abdominal donor organs
during intraoperative
recovery from the donor. It
is also intended to maintain
organ hypothermia during
storage and transport to the
transplant recipient. | Subject device is similar to
the predicate device in
which they are both
intended to flush, perfuse,
or be left in the abdominal
organ.
Use #2 - Similar
During organ perfusion,
subject and predicate
device create hypothermia,
by cooling of organ.
Use #3 - Similar
Subject device is similar to
the reference device in
which both are used for
organ preservation solution
by maintaining organ
hypothermia, by cooling
the organ during
preservation.
Similar
Subject device is an
accessory to organ
preservation solutions. All
devices are intended for use
at cold hypothermia, to
slow biological
deterioration in organs
removed from their
physiological environment
per standard organ
preservation practices. |
| TECNOLOGICAL
CHARACTERISTI
CS | | | | |
| Storage
Temperature | 2° to 25° C | 2° to 25° C | 2° to 25° C | Same |
| Pre-Cooling | Pre-cool solution prior
to use
(2° to 8° C) | Pre-cool solution prior
to use
(2° to 8° C) | Pre-cool solution prior to
use (-4° to -15° C) | Similar
Subject, predicate and
reference solutions are all
pre-cooled to hypothermic
temperature ranges |
| In-Situ Organ
Cooling | Internal cooling of
organ from perfusion
of cold solution
through organ blood
vessels | Internal cooling of
organ from perfusion of
cold solution through
organ blood vessels | External and internal
cooling of organ | Same
Subject, predicate and
reference device are all for
internal cooling of organ
from perfusion of cold
solution through organ
blood vessels. |
| Maintain Cold
Organ Temperature
During Storage and
Transport | Directly cools organ
external and internal
surfaces via contact
with cold solution. | Directly cools organ
external and internal
surfaces via contact with
cold solution. | Directly cools the organ
vasculature during
hypothermic storage and
transportation (not for
continuous perfusion) to
the patient. | Same
Overall system
performance by
cooling/maintaining
hypothermic temperature |
| | | | | of organs are similar for
all devices. |
| Product State | Liquid – Solution | Liquid - Solution | Liquid - Solution | Same |
| Composition | Adenine (free
base) 0.68 g/L
Calcium Chloride
(dihydrate)
0.068 g/L
Dextrose (+)
1.80 g/L
Glutathione (reduced)
0.92 g/L
HEPES (free acid)
2.38 g/L
Hydroxyethyl Starch
50.0 g/L
Magnesium Gluconate
1.13 g/L
Mannitol
5.4 g/L
Potassium Phosphate
(monobasic)
3.4 g/L
Ribose, D(-)
0.75 g/L
Sodium Gluconate
17.45 g/L
Sodium Hydroxide
0.70 g/L
Sterile Water for
Injection
To 1000 mL Volume | Adenine (free base)
0.68 g/L
Calcium Chloride
(dihydrate)
0.068 g/L
Dextrose (+)
1.80 g/L
Glutathione (reduced)
0.92 g/L
HEPES (free acid)
2.38 g/L
Hydroxyethyl Starch
50.0 g/L
Magnesium Gluconate
1.13 g/L
Mannitol
5.4 g/L
Potassium Phosphate
(monobasic)
3.4 g/L
Ribose, D(-)
0.75 g/L
Sodium Gluconate
17.45 g/L
Sodium Hydroxide
0.70 g/L
Sterile Water for
Injection
To 1000 mL
Volume | Buffered saline solution.
0.9% Sodium Chloride
Irrigation USP | Same
Subject and predicate
devices are of the same
exact chemical composition |
| Osmolality | 300 mOsmol/kg | 300 mOsmol/kg | 300 mOsmol/kg | Same |
| pH | Approximately 7.4 at
20°C | Approximately 7.4 at
20°C | 4.5-7.0 (per USP
monograph for 0.9%
Sodium Chloride
Irrigation) | Same
Subject and predicate
devices have the same pH
specifications |
| Fluid Volume | 1,000 ml | 1,000 ml | 1,250ml | Same
Subject device is available
in same volume as the
predicate device. |
| Single Use Only | Yes | Yes | Yes | Same |
| Primary Container | PVC-Free Bag | PVC-Free Bag | PVC-Free Bag | Equivalent |
| Protecting
Overwrap Bag | Yes | Yes | Yes | Same |
| Shelf Life | 6 Months | 24 Months | 24 Months | Same. Shelf life stability
study is on-going to meet 24
months shelf life. |
| Pyrogenicity | Non-Pyrogenic | Non-Pyrogenic | Non-Pyrogenic | Same |
| Sterility | Sterility assured via
0.2 μ and two 0.1 μ
membrane filtrations | Sterility assured via 0.1
μ membrane filtration | Terminally sterilized | Same |
| Sterilization | Aseptic
processing and
sterile filtration | Aseptic processing and
sterile filtration | Terminal gamma irradiation | Same
All devices are sterile. |
| Biocompatibility | Biocompatible in
accordance with ISO
10993-1/2/5/10/12. | 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. | Sterile bag is cut with sterile
instrument and contents
dispensed to desired
location. | Similar |
| Bag Connections | Fluid port provided for
organ flushing | Fluid port provided
for organ flushing | None | Same
Subject and predicate device
are same.
Different
Reference device is not
intended for organ flushing,
so no port is provided. |
6
7
8
9
NON-CLINICAL PERFORMANCE DATA 7.0
7.1. Biocompatibility
Belzer MPS® (UW Machine Perfusion Solution) (BMPS-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 Sterilitv
Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) is aseptically filled and sterility assured via 0.2 µ and two 0.1 µ membrane filtration.
7.3 Shelf Life
Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) has a shelf life claim of 6 months.
8.0 DESIGN CONTROL SUMMARY
All procedural Design Controls were followed, and all design control elements were satisfied.
10
9.0 SUMMARY OF VERIFICATION & VALIDATION
Verification and validation testing was done on the Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001). The subject device is substantially equivalent to the predicate and reference 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 MPS® (UW Machine Perfusion Solution) (BMPS-001) indicated in the Instructions for Use. It is appropriate to conclude that Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) is substantially equivalent to the predicate device K080432.
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 MPS® (UW Machine Perfusion Solution) (BMPS-001) is safe and effective as predicate and reference devices. The non-clinical data supports and demonstrates the safety of the device.
The conclusion is that Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) is substantially equivalent to the legally marketed MaPerSol® Solution and therefore should have clearance for premarket activities in the United States.