SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L by ORGAN RECOVERY SYSTEMS, INC.

SPS-1TM is intended 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.

Device Description

SPS-1 TM is a clear to light yellow, sterile, non-pyrogenic solution for hypothermic flushing and storage of organs. The solution has an approximate calculated osmolality of 320 mOsm, a sodium concentration of 29 mEq/L, a potassium concentration of 125 mEq/L, and a pH of approximately 7.4 at 20°C.

AI/ML Overview

The provided document (K091656) does not contain information about a study proving the device meets acceptance criteria. Instead, it is a 510(k) summary for a "Static Preservation Solution" that establishes substantial equivalence to predicate devices based on shared manufacturing processes, chemical composition, and intended use.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment are not available in this document.

Here's a breakdown of what can be extracted and what is missing:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a study. The "functional and safety testing" mentions verifying device design met its requirements through biocompatibility, sterility, chemical identification, and particle enumeration in accordance with standards. However, the specific acceptance criteria (e.g., maximum allowable particle count, sterility pass/fail definition) and the results against these are not detailed.
- Reported Device Performance: Not provided in terms of outcome statistics from a study (e.g., organ viability rates, post-transplant function). The document states the primary evidence for equivalence is that the device and predicate devices "are manufactured by the same process, with exactly the same chemical composition and have the same intended use." This implies performance is assumed to be equivalent due to these factors, rather than directly measured in a comparative study.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not applicable. No clinical or comparative study data is presented. The "testing" mentioned refers to laboratory tests (biocompatibility, sterility, etc.), not a test set of patient or organ data.
- Data Provenance: Not applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. No ground truth establishment for a test set is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set requiring adjudication is described.
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 device is a static preservation solution, not an AI-assisted diagnostic tool or system that involves human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a medical solution, not a software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the context of a performance study. For the laboratory testing (biocompatibility, sterility, chemical ID, particle enumeration), the "ground truth" would be the established industry standards and validated test methods for these specific properties.
The sample size for the training set:
- Not applicable. This device is a medical solution, not a machine learning model requiring a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary of Device Acceptance Rationale from the Document:

The acceptance of the SPS-1™ Static Preservation Solution (K091656) by the FDA is based on demonstrating substantial equivalence to existing legally marketed predicate devices (CoStorSol® K083453, K073693, and ViaSpan® K944866).

The key arguments for substantial equivalence are:

The SPS-1™ is manufactured by the same process as the predicate devices.
It has exactly the same chemical composition as the predicate devices.
It has the same intended use (flushing and cold storage of kidney, liver, and pancreas organs for transplantation).

Functional and safety testing mentioned includes biocompatibility, sterility, chemical identification, and particle enumeration, all performed "in accordance with applicable industry standards and/or FDA guidance documents." However, specific results or acceptance criteria for these tests are not detailed in this summary. The primary evidence presented for equivalence relies on the identical nature of the product to already approved devices.

Summary

{0}------------------------------------------------

K091656
Page 1 of 1

Submitter:	Organ Recovery Systems, Inc.
Contact Person:	PJ Pardo,Director, Regulatory, Clinical & Quality Affairs847-824-2600F 847-824-0234Email ppardo@organ-recovery.com
	MAR 11 2010
Date Prepared:	04 Jun 2009
Trade Name:	SPS-1 TM
Common Name	Static Preservation Solution
Classification:	Class IISystem, Perfusion, KidneyIsolated kidney perfusion and transport system and accessories21 CFR §876.5880
Product Code:	KDN
Predicate Device(s):	The subject device is equivalent to the following devices:CoStorSol® K083453 and K073693ViaSpan® K944866
Device Description:	SPS-1 TM is a clear to light yellow, sterile, non-pyrogenic solution for hypothermicflushing and storage of organs. The solution has an approximate calculatedosmolality of 320 mOsm, a sodium concentration of 29 mEq/L, a potassiumconcentration of 125 mEq/L, and a pH of approximately 7.4 at 20°C.
Intended Use:	SPS-1 TM is intended for the flushing and cold storage of kidney, liver, andpancreas organs at the time of organ removal from the donor in preparation forstorage, transportation and eventual transplantation into a recipient.
Functional and SafetyTesting:	To verify that device design met it's functional and performance requirements,representative sample of the device underwent testing such as biocompatibility,sterility, chemical identification and particle enumeration testing in accordancewith applicable industry standards and/or FDA guidance documents. The primaryevidence for equivalence is that SPS-1 TM Static Preservation Solution and thepredicate device are manufactured by the same process, with exactly the samechemical composition and have the same intended use.
Conclusion:	Organ Recovery Systems, Inc., considers the SPS-1 TM Static PreservationSolution to be equivalent to the predicate devices listed above. This conclusion isbased upon the devices' similarities in that they are manufactured by the sameprocess, with exactly the same chemical composition and have the sameindications for use.

510(k) Summary

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features an abstract design resembling a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the central design.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G6 Silver Spring, MD 20993-0002

Mr. P. J. Pardo Director, Regulatory, Clinical & Quality Affairs Organ Recovery Systems, Inc. 1 Pierce Place, Suite 475 W ITASKA IL 60143

MAR ] 1 2010

Re: K091656

Trade/Device Name: SPS-1 " Static Preservation Solution Regulation Number: 21 CFR §876.5880 Regulation Name: Isolated kidney perfusion and transport system and accessories Regulatory Class: II Product Code: KDL Dated: March 5, 2010 Received: March 8, 2010

Dear Mr. Pardo:

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. 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

{2}------------------------------------------------

Page 2 -

adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

K09/656

Indications for Use Statement

Device Name: SPS-1™ Static Preservation Solution

Prescription Use X (Part 21 CFR 801 Subpart D

510(k) Number

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices

Page 14 of 92

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).