KPS-I™, The Kidney Perfusion Solution is intended to be used for in-vitro flushing and temporary 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.

Device Description

KPS-I™, The Kidney Perfusion Solution (UW Machine Perfusion Solution) is a clear, sterile, non-pyrogenic, non-toxic solution for the invitro flushing and temporary continuous perfusion preservation of explanted kidneys. This solution has an approximate calculated osmolarity of 300mOsM, a sodium concentration of 100mEq/L, a votassium concentration of 25mEg/1, and a pH of approximately 7.4 at room temperature. Based upon the sodium/potassium ratio, the composition is thus consistent with that of an extracellular solution.

AI/ML Overview

The provided text is a 510(k) summary for KPS-ITM, The Kidney Perfusion Solution, seeking substantial equivalence to a predicate device, Belzer MPS™. It does not describe a study involving device performance against acceptance criteria in the typical sense of a clinical trial or algorithm performance evaluation. Instead, it argues for substantial equivalence based on identical indications for use, technological characteristics, and formulation.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) are not applicable or cannot be extracted from this document as the submission is not for a new medical device that requires clinical performance data in the same way a diagnostic algorithm or a surgical tool would.

Here's the information that can be extracted, along with explanations for categories that are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied for Substantial Equivalence)	Reported Device Performance (as stated in the 510k)
Indications for Use (Identical to Predicate)	KPS-I™ Indications for Use are "identical in intended use to Belzer MPS™" (for flushing and continuous hypothermic machine perfusion of explanted donor kidneys in preparation for storage, transportation, and eventual transplantation).
Technological Characteristics (Similar to Predicate)	KPS-I™ and Belzer MPS™ are both:Clear, sterile, non-pyrogenic, non-toxic solutions.Contain various components (ions, pH buffers, impermeants, colloids, pharmacologics) to reduce metabolism and preserve physiological conditions.Have a pH value of 7.4 +/- 0.15.Have an osmolarity of 300 +/- 15 mOsm/L.Have a sodium/potassium ratio characteristic of an extracellular solution, suitable for hypothermic machine perfusion.
Formulation (Identical to Predicate)	"The solution formulation is identical" to Belzer MPS™. Both have "an approximate calculated osmolarity of 300mOsM, a sodium concentration of 100mEq/L, a potassium concentration of 25mEq/L, and a pH of approximately 7.4 at room temperature."
Packaging System (Identical to Predicate)	"packaging system that is employed is identical to the predicate device."
Perfusion Time Suitability	KPS-I™ is "suitable for a mean perfusion time of 29 hours +/- 8 hours." (This is a specific performance claim for KPS-I™ and aligns with general expectations for such solutions, not directly stated as an acceptance criterion against the predicate in the same quantitative way as other characteristics, but implied as sufficient for its intended use).

2. Sample Size Used for the Test Set and Data Provenance

This is Not Applicable (N/A) in the context of this 510(k) submission. The submission relies on establishing substantial equivalence to a legally marketed predicate device based on identical indications for use, similar technological characteristics, and identical formulation and packaging, rather than a clinical study with a "test set" of patient data. Performance data provided (e.g., mean perfusion time) would typically come from internal testing or literature, but the specific "sample size" and "provenance" for a test set as described are not detailed because it's not a performance study in the classic sense.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This is Not Applicable (N/A). Ground truth established by experts is typically for evaluating diagnostic or algorithmic performance against a gold standard. This 510(k) is for a medical solution, and its equivalence is based on its composition and functional characteristics relative to a predicate, not on expert interpretations of medical data.

4. Adjudication Method for the Test Set

This is Not Applicable (N/A) for the same reasons as #3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This is Not Applicable (N/A). An MRMC study is relevant for evaluating the impact of an AI or diagnostic device on human reader performance. KPS-I™ is a perfusion solution, not a diagnostic or AI device.

6. Standalone (Algorithm Only) Performance Study

This is Not Applicable (N/A). KPS-I™ is a medical solution, not a standalone algorithm.

7. Type of Ground Truth Used

This is Not Applicable (N/A) in the sense of expert consensus, pathology, or outcomes data used to validate an algorithm or diagnostic tool. The "ground truth" here is the established characteristics and performance of the predicate device (Belzer MPS™), to which KPS-I™ is being compared for substantial equivalence. The claim is that KPS-I™'s characteristics are identical or sufficiently similar to those of the predicate.

8. Sample Size for the Training Set

This is Not Applicable (N/A). There is no machine learning model or algorithm being trained here.

9. How the Ground Truth for the Training Set Was Established

This is Not Applicable (N/A) for the same reason as #8.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" in this context is the 510(k) submission process itself, which aims to demonstrate substantial equivalence to a previously cleared predicate device, Belzer MPS™ (UW Kidney Preservation Solution, K972066). The core of the evidence presented is a comparison table and descriptive text highlighting the identical indications for use, identical solution formulation, similar technological characteristics (e.g., clarity, sterility, pH, osmolarity, presence of key components), and identical packaging system between KPS-I™ and Belzer MPS™.

The argument for meeting "acceptance criteria" (which in this case are defined by the predicate device's characteristics and intended use) is that KPS-I™ is fundamentally the same product as the predicate device. The submission states directly: "Data contained in the 510(k) demonstrates that KPS-I™, The Kidney Perfusion Solution is substantially equivalent to Belzer MPS." The FDA's clearance letter confirms this finding of substantial equivalence based on the provided information.

Summary

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KPS-ITM, The Kidney Perfusion Solution 510(k) Application: K013575 1/15/2002 Page 6 of 10

K013575
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JAN 2 5 2002

510(k) SUMMARY

Organ Recovery Systems, Inc. KPS-I™ The Kidney Perfusion Solution

1. SUBMITTER INFORMATION

A. Organ Recovery Systems, Inc., 701 E. Bay St., Suite 433 MSC 1119 Port City Center Charleston, SC 29403
Federal Identification Number: 36-4256620

B. Official Correspondent:

Stanley J. Harris, Director, Regulatory and Clinical Affairs

Phone: (843) 853-6756 ex. 29 Fax: (843) 722-6657

2. DEVICE IDENTIFICATION

A. Classification Name:	Isolated kidney perfusion and transport system andaccessories (21 CFR 876.5880)
B. Classification:	Class II, Gastroenterology/Urology Panel
C. Common/Usual Name:	Cold Storage Solution
D. Proprietary Name:	KPS-ITM, The Kidney Perfusion Solution

3. PREDICATE DEVICE

Belzer MPS™ (UW Kidney Preservation Solution), Trans-Med Corporation (Elk River, MN), 510(k) Notification Number K972066

Indications for Use: Belzer MPSTM is the UW-gluconate perfusion solution indicated for flushing and continuous hypothermic machine perfusion of explanted donor kidneys.

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KPS-17M, The Kidney Perfusion Solution 510(k) Application: K013575 1/15/2002 Page 7 of 10

K013575
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Device Description: Belzer MPS™ is a clear, sterile, non-pyrogenic, non-toxic solution for the in-vitro flushing and temporary continuous perfusion preservation of explanted kidneys. This solution has an approximate calculated osmolarity of 300mOsM, a sodium concentration of 100mEq/L, a potassium concentration of 25mEq/L, and a pH of approximately 7.4 at room temperature. Based upon the sodium/potassium ratio, the composition of Belzer MPSTM is thus consistent with that of an extracellular solution.

4. DESCRIPTION OF DEVICE

KPS-I™, The Kidney Perfusion Solution (University of Wisconsin Machine Perfusion Solution Formulation)

Indications for Use: KPS-I™, The Kidney Perfusion Solution is intended to be used for in-vitro flushing and temporary 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.

Device Description: KPS-I™, The Kidney Perfusion Solution (UW Machine Perfusion Solution) is a clear, sterile, non-pyrogenic, non-toxic solution for the invitro flushing and temporary continuous perfusion preservation of explanted kidneys. This solution has an approximate calculated osmolarity of 300mOsM, a sodium concentration of 100mEq/L, a votassium concentration of 25mEg/1, and a pH of approximately 7.4 at room temperature. Based upon the sodium/potassium ratio, the composition is thus consistent with that of an extracellular solution.

KPS-I™ should be cooled to about 5 ℃ (4℃ to 8 ℃) prior to use and should be used in a perfusion machine that is capable of maintaining temperature within the above specified range.

It is recommended that the KPS-I™ be stored between 2 ℃ and 8 ℃. The solution should not be frozen or exposed to excessive heat.

KPS-I™, The Kidney Perfusion Solution is suitable for a mean perfusion time of 29 hours +/- 8 hours.

5. SUBSTANTIAL EQUIVALENCE

A. Indications for Use: KPS-I™, The Kidney Perfusion Solution are identical in intended use to Belzer MPSTM
B. Technological Characteristics: KPS-I™, The Kidney Perfusion Solution and Belzer MPS™ are both clear, sterile, non-pyrogenic solutions containing various components in the categories of ions, pH buffers, impermeants, colloids and pharmacologics intended to reduce metabolism and preserve

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KPS-I'M, The Kidney Perfusion Solution 510(k) Application: K013575 1/15/2002 Page 8 of 10

K013575
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physiological conditions of explanted organs during cold storage. They have the same pH value, 7.4 +/-. 15 and an osmolarity of 300 +/-15mOsm/L. . The solutions are the same in that both the KPS-I™, The Kidney Perfusion Solution and Belzer MPS™ contains a sodium/potassium ratio (high/low) characteristic of an extracellular solution enables it to function well for hypothermic machine perfusion.

6. Conclusion

KPS-I™, The Kidney Perfusion Solution has the same intended use as Belzer MPS. The solution formulation is identical and packaging system that is employed is identical to the predicate device. Data contained in the 510(k) demonstrates that KPS-IM, The Kidney Perfusion Solution is substantially equivalent to Belzer MPS.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, placed inside a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 5 2002

Mr. Stan Harris Director, Regulatory and Clinical Affairs Organ Recovery Systems Charleston Research Center 701 East Bay Street, Suite 433 MSC 1119, Port City Center CHARLESTON SC 29403

Re: K013575 Trade/Device Name: KPS-ITM, The Kidney Perfusion Solution Regulation Number: 21 CFR §876.5880 Regulation Name: Isolated kidney perfusion and transport system and accessories Regulatory Class: II Product Code: 78 KDN Dated: October 22, 2001 Received: October 29, 2001

Dear Mr. Harris:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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. 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); 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.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C Brogdon

Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K013575

Device Name: KPS-I™ The Kidney Perfusion Solution

Indications For Use:

KPS-I™ The Kidney 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.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Seppan

(Optional Format 3-10-98)

Prescription Use
(Per 21 CFR 801.109)

Regulation Number and Section

§ 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).