KPS-1™, 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.

Device Description

KPS-1™, 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 potassium concentration of 25mEq/L, 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-1™ should be cooled to about 5°C (4°C to 8°C) 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-1™ be stored between 2 °C and 8 °C. The solution should not be frozen or exposed to excessive heat.

KPS-1™, The Kidney Perfusion Solution is suitable for a mean perfusion time of 29 hours +/~ 8 hours.

KPS-1™ The Kidney Perfusion Solution shelf-life is 6 months from data of aseptic fill. The stability of the perfusion solution was verified by accelerated aging for 6 months equivalency.

AI/ML Overview

The provided text is a compilation of sections from a 510(k) summary and an FDA clearance letter for a medical device called KPS-1, Kidney Perfusion Solution. This document primarily focuses on demonstrating substantial equivalence to a predicate device (KPS-17M), rather than presenting a detailed study proving the device meets specific acceptance criteria through a formal statistically powered performance study.

Therefore, much of the requested information regarding acceptance criteria, specific study design elements (sample size, ground truth establishment, expert involvement, adjudication, MRMC studies, standalone performance), and training set details are not explicitly described in the provided text.

However, based on the information available, here's a breakdown of what can be inferred:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present acceptance criteria in a quantitative table format as one might expect for a performance study. Instead, the "performance" discussed relates to the compositional characteristics and intended use of the solution, which are aligned with the predicate device.

Acceptance Criteria (Inferred from Predicate Equivalence)	Reported Device Performance (KPS-1)
Approximate calculated osmolarity of 300mOsM	Approximate calculated osmolarity of 300mOsM
Sodium concentration of 100mEq/L	Sodium concentration of 100mEq/L
Potassium concentration of 25mEq/L	Potassium concentration of 25mEq/L
pH of approximately 7.4 at room temperature	pH of approximately 7.4 at room temperature
Consistent with extracellular solution based on Na/K ratio	Consistent with extracellular solution based on Na/K ratio
Clear, sterile, non-pyrogenic, non-toxic	Clear, sterile, non-pyrogenic, non-toxic
Suitable for temporary continuous hypothermic machine perfusion of kidneys	Intended for in-vitro flushing and temporary continuous hypothermic machine perfusion of kidneys
Mean perfusion time of 29 hours +/- 8 hours (of predicate)	Suitable for a mean perfusion time of 29 hours +/- 8 hours
Shelf-life of 6 months (of predicate)	Shelf-life is 6 months from date of aseptic fill; stability verified by accelerated aging.

2. Sample size used for the test set and the data provenance

The document does not describe a specific "test set" or clinical study with a defined sample size in the context of proving performance against acceptance criteria. The submission is a 510(k) for device modifications, demonstrating "substantial equivalence" to a predicate, KPS-17M. The "data presented in this submission" refers to information validating that the modified KPS-1 maintains the same technological characteristics and performance as the predicate.

Sample Size: Not applicable/not provided for a clinical performance study.
Data Provenance: The data primarily relates to the chemical and physical properties of the solution, as well as stability testing (accelerated aging). The geographical origin of this data or if it involved human or animal subjects is not specified, but it would typically be laboratory-based testing. It's retrospective in the sense that it evaluates the modified device against established characteristics of the predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable/not provided as there's no mention of a clinical study involving human or animal subjects that required expert ground truth establishment for a test set. The validation is chemical/physical.

4. Adjudication method for the test set

This information is not applicable/not provided as there's no mention of a clinical study or expert review process requiring adjudication.

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

This information is not applicable/not provided. The device is a kidney perfusion solution, not an imaging or diagnostic device that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/not provided. The device is a chemical solution, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context would be the established chemical and physical properties of the predicate device (KPS-17M, University of Wisconsin Machine Perfusion Solution Formulation) and standard analytical methods to verify that the modified KPS-1 solution matches these characteristics. For instance:

Chemical Analysis: To verify osmolarity, sodium, potassium concentrations, and pH.
Sterility/Pyrogenicity Testing: To ensure the solution is free from contaminants.
Stability Testing: Accelerated aging studies to determine shelf-life.

8. The sample size for the training set

This information is not applicable/not provided. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

This information is not applicable/not provided as there is no training set.

Summary

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022391 1 of 3

OCT 21 2002

510(k) SUMMARY

Organ Recovery Systems, Inc. KPS-1, 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 (843) 722-6657 Fax:

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-1, Kidney Perfusion Solution

3. PREDICATE DEVICE

KPS-17M, Kidney Perfusion Solution (K013575) (University of Wisconsin Machine Perfusion Solution Formulation)

Indications for Use: KPS-1, 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.

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Device Description: KPS-17M, 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 potassium concentration of 25mEq/L, 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.

4. DESCRIPTION OF DEVICE

KPS-17M, Kidney Perfusion Solution (University of Wisconsin Machine Perfusion Solution Formulation)

Indications for Use: KPS-1, Kidney Perfusion Solution is intended to be used for in-vitro flushing and temporary continuous bypothermic 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-1™, 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 300m()sM, 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 is thus consistent with that of an extracellular solution.

KPS-1™ should be cooled to about 5°C (4°C to 8°C) 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-1™ be stored between 2 °C and 8 °C. The solution should not be frozen or exposed to excessive heat.

KPS-1™, The Kidney Perfusion Solution is suitable for a mean perfusion time of 29 hours +/~ 8 hours.

KPS-1™ The Kidney Perfusion Solution shelf-life is 6 months from data of aseptic fill. The stability of the perfusion solution was verified by accelerated aging for 6 months equivalency.

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SUBSTANTIAL EQUIVALENCE

A. Indications for Use: The indications for use remain unchanged for the modifications requested within this submission.
B. Technological Characteristics: Unchanged from Original Submission.

5. CONCLUSION

KPS-1™, The Kidney Perfusion Solution has the same intended use as the original submission (K013575) and the data presented in this submission demonstrates that the device modifications to KPS-1™, The Kidney Perfusion Solution is substantially equivalent to original submission (K013575).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its head, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 1 2002

Mr. Stanley J. Harris

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

Re: K022391

Trade/Device Name: KPS-1 ™ 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: September 23, 2002 Received: September 24, 2002

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, listing 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

Nancy 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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KPS-1™, The Kidney Perfusion Solution Special 510(k): Device Modifications July 16, 2002 Page 8 of 86

5. INDICATIONS FOR USE STATEMENT

Device Name: KPS-1™ The Kidney Perfusion Solution

Indications for Use:

Prescription Use
(Per 21 CFR 801.109)

Daniel A. Symm
(Division Sign-Off)

Division of Reproductive, Abdomi and Radiological Devices 510(k) Number

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).