← Product Code [MSB](/productcode/MSB) · K261913

# X°Port Heart Preservation System (K261913)

_Traferox Technologies, Inc. · MSB · Sep 16, 2026 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K261913

## Device Facts

- **Applicant:** Traferox Technologies, Inc.
- **Product Code:** [MSB](/productcode/MSB.md)
- **Decision Date:** Sep 16, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.5880
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology
- **Attributes:** Real-World Evidence

## Real-World Evidence

| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
| --- | --- | --- | --- | --- | --- |
| K261913 · Sep 16, 2026 | X°Port Heart Preservation System | Traferox Technologies, Inc. | Retrospective clinical study data; Historical control patient records | The study evaluated the safety and effectiveness of the device by comparing clinical outcomes (graft dysfunction, mechanical support, length of stay, survival) of patients receiving hearts preserved at 10 °C against a historical control group using conventional ice storage. | Retrospective study; Historical controls; Heart transplantation; Clinical outcomes |

### Clinical Evidence

| Study Design | Population | Comparator | Key Endpoints |
| --- | --- | --- | --- |
| Retrospective, single-arm study with historical controls; Retrospective, single-arm study with historical controls | Heart transplant recipients; Sample Size: 143 patients (10 °C group); 299 patients (control group) | Conventional ice preservation (historical control) | Severe primary graft dysfunction, postoperative mechanical circulatory support, renal replacement therapy, ICU length of stay, hospital length of stay, and short-term survival |

## Indications for Use

The X°Port Heart Preservation System is indicated for static hypothermic preservation of donor hearts at 4–10 °C for up to 4 hours using a del Nido (or equivalent) cold storage solution.

## Device Story

X°Port Heart Preservation System provides static hypothermic storage and transport for donor hearts. Device utilizes insulated chamber, internal organ support, and phase-change material (PCM) packs (transition temperature ~8 °C) preconditioned at 4 °C. System maintains internal temperature between 4–10 °C for up to 4 hours. Device includes temperature probe and logger; data displayed on external screen and optional mobile application. Non-sterile, single-use device; does not contact organ directly. Used by transplant teams during organ procurement and transport. Provides stable thermal environment to preserve donor heart viability; enables transplantation of higher-risk donor organs.

## Clinical Evidence

Retrospective, single-arm study with historical controls (n=143 study, n=299 control). Compared 10 °C hypothermic preservation to conventional ice storage. Endpoints included severe primary graft dysfunction, postoperative mechanical circulatory support, renal replacement therapy, ICU/hospital length of stay, and short-term survival. Results showed comparable outcomes between groups, despite the 10 °C group utilizing higher-risk donor organs (older donors, longer preservation times, greater geographic distances).

## Technological Characteristics

Insulated chamber; phase-change material (PCM) cooling packs (transition ~8 °C); temperature probe and logger. Connectivity via external display and optional mobile application. Non-sterile, single-use. Software-based temperature monitoring and logging. Bench testing included electrical, mechanical, thermal, EMC, and cybersecurity validation.

## Regulatory 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.

## Predicate Devices

- SherpaPak Cardiac Transport System ([K180194](/device/K180194.md))

## Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG
ADMINISTRATION

September 16, 2026

Traferox Technologies, Inc.
Ms. Anuradha Iyer
Regulatory Affairs Manager
3505 Laird Rd. Unit 16
Mississauga, ON L5L 5Y7
Canada

Re: K261913

Trade/Device Name: X°Port Heart Preservation System

Regulation Number: 21 CFR 876.5880

Regulation Name: Isolated kidney perfusion and transport system and accessories

Regulatory Class: Class II

Product Code: MSB

Dated: June 8, 2026

Received: June 8, 2026

Dear Ms. Iyer:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K261913 - Ms. Anuradha Iyer

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guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K261913 - Ms. Anuradha Iyer

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

NICOLE M. GILLETTE -S

Nicole Gillette

Assistant Director

DHT2B: Division of Circulatory Support, Structural, and Vascular Devices

OHT2: Office of Cardiovascular Devices

Office of Product Evaluation and Quality

Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

# **Indications for Use**

Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
*See PRA Statement below.*

510(k) Number (*if known*)

K261913

Device Name

X°Port Heart Preservation System

Indications for Use (*Describe*)

The X°Port Heart Preservation System is indicated for static hypothermic preservation of donor hearts at 4–10 °C for up to 4 hours using a del Nido (or equivalent) cold storage solution.

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)

**CONTINUE ON A SEPARATE PAGE IF NEEDED.**

This section applies only to requirements of the Paperwork Reduction Act of 1995.

**\*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.\***

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

*"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."*

FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

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# 510(k) Summary
(K261913)

# Contact Details

21 CFR 807.92(a)(1)

|  Applicant Name: | Traferox Technologies Inc.  |
| --- | --- |
|  Applicant Address: | 3505 Laird Rd. Unit 16 Mississauga ON L5L 5Y7 Canada  |
|  Applicant Contact Telephone: | +1 437 983 8971  |
|  Applicant Contact: | Ms. Anuradha Iyer  |
|  Applicant Contact Email: | aiyer@traferox.com  |

# Device Name

21 CFR 807.92(a)(2)

|  Device Trade Name: | X°Port Heart Preservation System  |
| --- | --- |
|  Common Name: | System and accessories, isolated heart, transport and preservation  |
|  Classification Name | Isolated kidney perfusion and transport system and accessories  |
|  Regulation Number | 876.5880  |
|  Product Code( s) | MSB  |

# Legally Marketed Predicate Devices

21 CFR 807.92(a)(3)

|  Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code  |
| --- | --- | --- |
|  K180194 | SherpaPak Cardiac Transport System | MSB  |

# Device Description Summary

21 CFR 807.92(a)(4)

The X°Port Heart Preservation System is designed to store, preserve, and transport human hearts donated for transplantation at approximately 10 °C. The target temperature range maintained during storage is 4–10 °C. The internal device temperature is displayed and logged on an external screen. Additionally, the internal temperature may be monitored via an optional mobile application.

The system consists of an insulated chamber, specialized phase-change material with a transition temperature of approximately 8 °C, an internal support for the organ, and a temperature probe and logger. The system is a non-sterile single-use device and does not contact the organ. The X°Port Heart Preservation System is intended to be used with the del Nido (or equivalent) cold storage solution.

The X°Port Heart Preservation System operates on the principle of preconditioning and use of specialized phase-change material cooling packs. The cooling packs are preconditioned at 4 °C

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in a temperature-regulated refrigerator for a minimum of 48 hours before setting up the X°Port Heart Preservation System.

### Intended Use/Indications for Use

21 CFR 807.92(a)(5)

The X°Port Heart Preservation System is indicated for static hypothermic preservation of donor hearts at 4–10 °C for up to 4 hours using a del Nido (or equivalent) cold storage solution.

### Indications for Use Comparison

21 CFR 807.92(a)(5)

The subject device differs from the predicate in its indicated organ storage temperature and cold storage solution, specifying 4–10 °C with del Nido (or equivalent) cold storage solution. This difference does not constitute a new intended use, as the overall intended use — organ storage and transportation with a cold storage solution for up to 4 hours — remains the same.

### Technological Comparison

21 CFR 807.92(a)(6)

The subject and predicate devices share the same mode of operation, cooling mechanism, and intended organ storage time. The two devices differ in organ container design and organ storage temperature (4–10 °C vs. 4–8 °C). The differences in the technological characteristics between the subject and predicate devices do not lead to different questions of safety or effectiveness.

### Non-Clinical and/or Clinical Tests Summary & Conclusions

21 CFR 807.92(b)

The following non-clinical bench testing was performed on the X°Port Heart Preservation System to demonstrate the device's safety and effectiveness:

- Basic safety (electrical, mechanical, thermal)
- Electromagnetic compatibility
- Physical testing
- Functional validation (thermal performance)
- Software and cybersecurity testing
- Packaging and shipping testing
- Lifetime testing
- Human factors testing

The clinical evaluation supporting this submission includes one retrospective, single-arm study with historical controls, conducted in the United States. The study assessed the safety and effectiveness of controlled hypothermic donor heart preservation at 10 °C compared with conventional ice preservation.

In total, 143 study patients were included in the 10 °C group and 299 patients were included in the control group. Baseline characteristics were generally similar in the two groups (10 °C:

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average recipient age 54 years, 28.0% female, 69.2% White; control: average recipient age 56 years, 24.1% female, 71.9% White).

The clinical data demonstrate that heart transplant recipient rates of severe primary graft dysfunction, postoperative mechanical circulatory support, renal replacement therapy, intensive care unit length of stay, hospital length of stay, and short-term survival were comparable between the two groups of 10 °C preservation and conventional ice storage. Notably, the 10 °C group included higher-risk donor organs (i.e., older donor hearts, longer preservation times, and organs procured from greater geographic distances).

Overall, the non-clinical and clinical data support that the X°Port Heart Preservation System does not raise any new issues of safety and effectiveness and is substantially equivalent to the predicate device.

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**Source:** [https://fda.innolitics.com/device/K261913](https://fda.innolitics.com/device/K261913)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com