(429 days)
The PERF-GEN® Pulsatile Perfusion Solution is intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient.
The PERF-GEN® Pulsatile Perfusion (PERF-GEN Solution) is a clear, sterile, non-pyrogenic, non-toxic solution for the in-vitro flushing and temporary continuous perfusion of explanted kidneys. This solution has an approximate calculated osmolarity of 300 mOsm/kg, a sodium concentration of 100 mEq/L, a potassium concentration of 25 mEq/L, and a pH of approximately 7.4 at room temperature.
The PERF-GEN® Pulsatile Perfusion Solution is a medical device that received a 510(k) clearance based on substantial equivalence to a predicate device, the BELZER-MPS™ UW Machine Perfusion Solution. This regulatory pathway typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive clinical trials to establish new efficacy. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the demonstration of substantial equivalence through comparative testing and analysis against the predicate, rather than performance against pre-defined, quantitative clinical metrics of efficacy.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (Summary of Studies) |
|---|---|
| Identical Intended Use | Met: The PERF-GEN Solution has an identical intended use to the BELZER-MPS UW Machine Perfusion Solution: for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient. |
| Identical Chemical Composition & Principle of Operation | Met: Comparison by infrared, chromatography, and conductivity measurements confirmed that the PERF-GEN Solution and the BELZER-MPS solution are chemically equivalent. They are both sterile, non-toxic, transparent solutions dispensed from a bag, with identical chemical compositions and principles of operation. |
| Biocompatibility | Met: Evaluated through ISO 10993 compliant testing, including cytotoxicity, acute systemic toxicity, hemocompatibility, skin sensitization (guinea pigs), and primary skin irritation. Results showed the PERF-GEN Solution is non-cytotoxic, non-toxic, hemocompatible, non-genotoxic, non-sensitizing, and non-irritating, ensuring safety for intended biocontact. This addresses potential differences in dispensing bag material. |
| Stability/Shelf-Life | Met: Stability studies (up to 1 year real-time aging at recommended storage and several months worst-case conditions) confirmed that aging does not affect product specifications. This supports the 1-year shelf life. This addresses potential differences in dispensing bag material. |
| No New Questions of Safety or Effectiveness | Met: The evaluations of technological differences (primarily dispensing bag material) through biocompatibility, stability, and chemical testing demonstrated that these differences do not impact the specifications of the perfusion solution itself and did not raise any new questions of safety or effectiveness when compared to the predicate device. Therefore, the PERF-GEN Solution was deemed substantially equivalent to the BELZER-MPS predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the traditional sense of a clinical test set for performance, as this was a substantial equivalence submission relying primarily on bench testing and comparison.
- Data Provenance: The studies performed were primarily bench testing (biocompatibility, stability, chemical comparisons) conducted by the manufacturer, Waters Medical Systems, LLC. The "data provenance" refers to the results generated from these in-house or contract laboratory tests. There is no mention of country of origin for clinical data as no clinical trials were presented for this 510(k).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. Ground truth in the context of this 510(k) submission was established through scientific and engineering principles applied to the comparative testing and analysis against the predicate device's known characteristics, rather than expert consensus on clinical outcomes. The FDA's review division (Division of Reproductive, Gastro-Renal, and Urological Devices) evaluated the submitted evidence.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set requiring adjudication in the context of expert review was conducted or reported. Adjudication in this context would refer to the FDA's regulatory review process, where they adjudicate the substantial equivalence claim based on the submitted evidence.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs without AI Assistance
- Not applicable. This device is a pulsatile perfusion solution, a chemical and delivery system for organ preservation, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI-driven performance improvements are irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a solution used in organ preservation, not an algorithm or software. Its performance is evaluated through its physical and chemical properties, and its biological interaction with organs, not through a standalone algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this 510(k) submission was demonstrably equivalent to the predicate device regarding:
- Predicate Device Characteristics: The known, legally marketed, and accepted properties, composition, and performance of the BELZER-MPS UW Machine Perfusion Solution.
- ISO 10993 Standards: Biocompatibility testing followed established international standards, where "ground truth" is defined by the passing criteria of these validated tests.
- Chemical Equivalence: Established through analytical chemistry techniques (infrared, chromatography, conductivity), where "ground truth" is the scientific validation of similar molecular and ionic profiles.
- Stability Standards: Industry-accepted methods for shelf-life determination.
8. The Sample Size for the Training Set
- Not applicable. This medical device is not an AI/ML algorithm that requires a training set. The "training" for this product would conceptually involve its development and formulation, and the testing involved was to validate its properties against established standards and the predicate.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As the device is not an AI/ML algorithm, a "training set" and associated "ground truth" for training are not relevant concepts in this submission.
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Traditional 510(k) Premarket Notification PERF-GEN® Pulsatile Perfusion Solution
510(k) Summarv
Date Prepared: December 20th, 2012
Submitter's Name / Contact Person
| Submitter | Contact Person |
|---|---|
| Waters Medical Systems, LLC | Robert Warren |
| 2112 - 15th Street NW | Phone: 507-288-7777 |
| Rochester, Minnesota 55901 | Fax: 507-252-3700 |
| Email: bobw@wtrs.com |
General Information
| Trade Name | PERF-GEN® Pulsatile Perfusion Solution |
|---|---|
| Common / Usual Name | Cold Storage Solution |
| Product Code | KDL |
| Classification Name | Set, perfusion, kidney, disposable |
| Classification Information | 21 CFR 876.5880Isolated kidney perfusion and transport system and accessories, Class II |
| Predicate Device | BELZER-MPSTM, Trans-Med Corporation (K972066) |
Device Description
The PERF-GEN® Pulsatile Perfusion (PERF-GEN Solution) is a clear, sterile, non-pyrogenic, non-toxic solution for the in-vitro flushing and temporary continuous perfusion of explanted kidneys. This solution has an approximate calculated osmolarity of 300 mOsm/kg, a sodium concentration of 100 mEq/L, a potassium concentration of 25 mEq/L, and a pH of approximately 7.4 at room temperature.
Intended Use / Indications
The PERF-GEN® Pulsatile Perfusion is intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient.
Substantial Equivalence and Summary of Studies
The PERF-GEN Pulsatile Perfusion device is substantially equivalent to the BELZER-MPS UW Machine Perfusion Solution. The PERF-GEN and BELZER-MPS solutions have an identical intended use, chemical composition and principle of operation. Both the subject and predicate device are sterile, non-toxic, transparent solutions dispensed from a bag. Both solutions are sterilized by filtration and aseptically filled in sterile dispensing bags.
The technological difference between PERF-GEN Pulsatile Perfusion compared to the predicate is related to the dispensing bag. The material used for the BELZER-MPS dispensing bags being not specified, it is likely that the bags of PERF-GEN and BELZER-MPS may differ in material. This technological difference has been evaluated
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through biocompatibility, stability and chemical testing to ensure the possible bag material difference does not impact the specifications of the perfusion solution itself.
The biomaterial safety of the PERF-GEN Solution has been evaluated through 1SO 10993 compliant testing, which included cytotoxicity test, acute systemic toxicity, hemocompatibility, skin sensitization test in guinea pigs, and primary skin irritation. Results of this testing showed the PERF-GEN Solution is safe for the intended biocontact. Test results confirmed that the PERF-GEN Solution is non-cytotoxic, non-toxic, hemocompatible, nongenotoxic, non-sensitizing, and non-irritating.
Results of this stability study confirm that up to 1 year real-time aging at the recommended storage conditions and several months worst-case storage conditions do not affect the product specifications. The stability testing has showed that aging of test articles at the recommended storage conditions does not affect the product specifications for the PERF-GEN labeled with 1-year shelf life.
Chemical composition and properties of the PERF-GEN Solution and the predicate BELZER-MPS solution were compared by infrared, chromatography and conductivity measurements. The infrared spectra, the elution profiles and the ionic strengths of PERF-GEN and BELZER-MPS solutions were compared. The results of those chemical testing confirm that both the PERF-GEN solution and the predicate BELZER-MPS solution are chemically equivalent.
Results of evaluations did not raise any new questions of safety or effectiveness when compared to the predicate device and therefore the PERF-GEN Solution is substantially equivalent to the BELZER-MPS predicate.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of an eagle or bird, with three curved lines forming its body and wings. The text is in all caps and reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 16, 2013
Waters Medical Systems, LLC % Robert Warren General Manager 2112 15th Street NW Rochester, MN 55901
Re: K121736
Trade/Device Name: PERF-GEN® Pulsatile Perfusion Solution Regulation Number: 21 CFR§ 876.5880 Regulation Name: Isolated kidney perfusion and transport system and accessories Regulatory Class: II Product Code: KDL Dated: August 1, 2013 Received: August 5, 2013
Dear Robert 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. or any Fourth all the Act's requirements, including, but not limited to: registration and I ou must occipij marting (21 CFR Part 801); medical device reporting (reporting of
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Page 2 - Robert Warren
medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K 121736
PERF-GEN® Pulsatile Perfusion Solution Device Name:
Indications for Use:
The PERF-GEN® Pulsatile Perfusion Solution is intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient.
Prescription Use >< (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)
Page 1 of 1
Benjamin R. Fisher -S 2013.08.16 17:54:34 -04'00'
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K121736 510(k) Number _
§ 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).