Low Potassium Dextran Solution with Tris Diluent is indicated for flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.

Device Description

Low Potassium Dextran (LPD) Solution is a sterile, clear, non-pyrogenic, physiological salt solution for hypothermic flushing, storage, and transportation of human lungs outside the human body. LPD Solution is acidic and is adjusted shortly before use to pH 7.4 by the addition of Tris Diluent.

LPD Solution with Tris Diluent is supplied as 1 liter of LPD Solution in a low density polyethylene (LDPE) bottle (8 per pack), co-packed with one single-use bottle of Tris Diluent. Tris Diluent is also supplied separately in an eight-unit pack. Each container of LPD Solution and Tris Diluent is single-use.

AI/ML Overview

This document is a 510(k) summary for the "Low Potassium Dextran Solution with Tris Diluent." It's a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device, Perfadex® with THAM, rather than presenting a study to prove acceptance criteria for a new, novel device. As such, the information you've requested regarding acceptance criteria, study design, and performance metrics for a new device's evaluation against those criteria is not directly applicable in this context.

This summary focuses on showing that the new device is as safe and effective as a legally marketed predicate device. The "performance data" section primarily describes validation of the new solution's chemical and physical properties and manufacturing processes, ensuring it is comparable to the predicate.

However, I can extract information related to the comparison of the subject device to the predicate where applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not present specific acceptance criteria in terms of clinical performance (e.g., sensitivity, specificity, accuracy) that a medical device (like an AI algorithm) would typically have. Instead, it focuses on demonstrating substantial equivalence to a predicate device. The "performance data" described are primarily related to product specifications and manufacturing controls.

Acceptance Criterion (Implicit)	Reported Device Performance (Low Potassium Dextran Solution with Tris Diluent)
Chemical composition matches predicate (Perfadex and THAM)	Confirmed same chemical composition as Perfadex and THAM, respectively.
Sterility Assurance Level (SAL)	Sterile with SAL of 10-6 (similar to Perfadex and THAM).
Non-pyrogenic	Non-pyrogenic (similar to Perfadex and THAM).
Verified shelf life	Stability testing (chemical characteristics, particulate matter, sterility) verified shelf life as manufactured and sterilized.
Biocompatibility (meets ISO 10993-1)	LPD Solution and LPD Solution after pH adjustment by Tris Diluent meet ISO 10993-1 requirements.
Conformance to USP <161>	Testing showed conformance to USP <161>.
Proper pH adjustment with Tris Diluent	Verification of pH adjustment process.
Verification of fill volume	Verification of fill volume.
Mechanical requirements met (packaging)	Mechanical requirements evaluated (implied to be met without raising safety/effectiveness concerns).
Usability concerns addressed	Summative usability testing did not raise new questions of safety or effectiveness.

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

Not applicable directly. This document does not describe a clinical "test set" in the sense of a dataset for evaluating an AI algorithm or a diagnostic device's performance against clinical ground truth. The "testing" mentioned refers to laboratory and manufacturing validation activities.

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

Not applicable. No expert ground truth establishment for a clinical test set is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. No adjudication method for a clinical test set is described.

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:

Not applicable. This document describes a medical solution for organ preservation, not an AI-assisted diagnostic or assistive device.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable in the context of clinical ground truth. The "truth" here is based on established chemical, physical, and biological standards (e.g., chemical composition, sterility, biocompatibility standards like ISO 10993-1, USP <161>).

8. The sample size for the training set:

Not applicable. This document is for a medical solution, not a machine learning model that requires a training set.

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

Not applicable. As above, this is not a machine learning model.

Summary of the document's intent:

The document's primary purpose is to demonstrate that the "Low Potassium Dextran Solution with Tris Diluent" is substantially equivalent to the predicate device "Perfadex® with THAM." Substantial equivalence is established by showing that the new device has:

The identical intended use.
Similar technological characteristics.
Any differences in technological characteristics do not raise new questions of safety or effectiveness.

The "Performance Data" section supports the claim of similar technological characteristics and that any differences are not concerning by detailing chemical composition analysis, sterility and pyrogenicity testing, stability testing (shelf-life), biocompatibility testing, and verification of other product specifications like pH adjustment and fill volume.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 7, 2016

United Therapeutics Corporation Rita Lee, Ph.D., RAC Senior Scientist, Regulatory Affairs 55 TW Alexander Drive, PO Box 14186 Research Triangle Park, NC 27709

Re: K153384

Trade/Device Name: Low Potassium Dextran Solution with Tris Diluent Regulation Number: 21 CFR§ 876.5880 Regulation Name: Isolated Kidney Perfusion and Transport System and Accessories Regulatory Class: II Product Code: KDN Dated: (Date on orig SE ltr): November 20, 2015 Received: (Date on orig SE ltr): November 23, 2015

Dear Rita Lee,

This letter corrects our substantially equivalent letter of February 19, 2016.

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.

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Page 2 - Rita Lee, Ph.D., RAC

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 (reporting of medical device-related 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 vours.

Image /page/1/Picture/8 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The text is black and appears to be centered on a white background. The letters are clearly legible, and the overall impression is clean and professional.

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)

K153384

Device Name

Low Potassium Dextran Solution with Tris Diluent

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
☒	☐

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510(K) SUMMARY

I. SUBMITTER

United Therapeutics Corporation 55 TW Alexander Drive Research Triangle Park, NC 27709, United States

Phone: 919-485-8350 Fax: 919-313-1298

Contact: Rita Lee, PhD RAC, Senior Scientist, Regulatory Affairs Date Prepared: November 19, 2015

II. DEVICE

Name of Device: Low Potassium Dextran Solution with Tris Diluent Common or Usual Name: Solution for lung preservation Classification Name: Isolated kidney perfusion and transport system and accessories (21 CFR §876.5880)

Regulatory Class: II Product Code: KDN

PREDICATE DEVICE III.

Perfadex® with THAM, K091989

IV. DEVICE DESCRIPTION

INDICATIONS FOR USE / INTENDED USE V.

LPD Solution with Tris Diluent is indicated for flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient. The indications for use and intended use for LPD Solution with Tris Diluent are identical. Both the subject and predicate devices have indications for use statement and intended use.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

LPD Solution with Tris Diluent is substantially equivalent to Perfadex with THAM. LPD Solution with Tris Diluent and Perfadex with THAM have identical intended use. Both LPD Solution and Perfadex are clear, sterile, non-pyrogenic solutions. Perfadex is supplied with THAM. which is added for pH adjustment before use. Similarly. LPD Solution is supplied with Tris Diluent, which is added for pH adjustment before use.

Differences in technological characteristics include packaging, expanded storage conditions, and a change to solution buffering instructions. All technological differences have been evaluated and do not raise any new questions of the safety or effectiveness when compared to the predicate. nor do they affect the safety and effectiveness when compared to the predicate.

PERFORMANCE DATA VII.

Chemical composition testing results have confirmed that LPD Solution and Tris Diluent have the same chemical composition as Perfadex and THAM, respectively.

Results of sterility and pyrogenicity testing on LPD Solution and Tris Diluent have shown that both solutions are sterile with a Sterility Assurance Level (SAL) of 106 and nonpyrogenic, similar to Perfadex and THAM. Stability testing, including analysis of chemical characteristics, particulate matter, and sterility assessment, has been conducted on LPD Solution and Tris Diluent to verify the shelf life. The results have verified the shelf life for LPD Solution and Tris Diluent, as manufactured and sterilized.

Biocompatibility test results have shown that LPD Solution and LPD Solution after pH adjustment by Tris Diluent meet the requirements of ISO 10993-1.

Results of testing for USP <161> conformance, pH adjustment of LPD Solution with Tris Diluent, verification of fill volume, mechanical requirements, and summative usability testing did not raise any new questions of the safety or effectiveness.

VII. CONCLUSION

LPD Solution with Tris Diluent has the identical intended use compared to Perfadex with THAM. Evaluation of differences in technological characteristics did not raise any new questions of the safety or effectiveness of LPD Solution with Tris Diluent compared to the predicate device. Therefore, LPD Solution with Tris Diluent is substantially equivalent to Perfadex with THAM.

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).