Cannula for Organ Perfusion is a single-use device indicated for hypothermic flushing and replacement of residual blood in donor organs with a legally marketed organ preservation solution at the time of organ removal from the donor during the preparation of these organs for transplantation. This device is indicated for use with gravity flow; no testing has been provided for use with pump systems, such as mechanical perfusion devices.

Device Description

The Cannula for Organ Perfusion is a device designed and intended as a component to an organ perfusion and transport system / organ preservation solution, used in an organ transplantation procedure. The device is a cannula (available in several different sizes) intended for flushing and replacement of residual blood in donor organs with organ preservation solution during the preparation processes of these organs for transplantation. The cannulas are single use, sterile, non-toxic and nonpyrogenic devices. As a component to an organ perfusion and transport system / organ preservation solution, the Cannula for Organ Perfusion is also a Class II medical device, subject to Product Code KDN and MSB, 21 CFR 876.5880: "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." (21 CFR 876.5880(a)).

The Cannulas come in multiple sizes, according to the French catheter scale, including 8F, 10F, 12F, 16F (adjustable to 18F with a slidable ring), 20F (adjustable to 28F with a slidable ring), 25F (adjustable to 34F with a slidable ring). In addition, there is a configuration of the cannula that is intended for "back table" procedures, which is available in a 16F size.

AI/ML Overview

This FDA 510(k) submission describes the "Cannula for Organ Perfusion" device. The document primarily focuses on establishing substantial equivalence to predicate devices rather than providing a detailed study of the device's performance against specific acceptance criteria.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide a table of acceptance criteria with corresponding performance metrics for the device in the manner typically seen for algorithmic or diagnostic devices. Instead, it relies on bench testing results and biocompatibility testing to demonstrate safety and effectiveness.

Here's a re-interpretation of "acceptance criteria" based on the performed tests:

Acceptance Criteria (Inferred from tests)	Reported Device Performance
Tensile strength (ISO 10555-1)	Pass
Leakage and tightness (ISO 10555-1)	Pass
Flow rate (ISO 10555-1)	Adequate flow of liquid
Sterility (SAL 1 x 10^-6)	Achieved via ETO sterilization
Shelf life	Established via real-time aging testing
Biocompatibility: Cytotoxicity	Complies with EN ISO 10993-1
Biocompatibility: Sensitizing effect	Complies with EN ISO 10993-1
Biocompatibility: Intracutaneous reactivity	Complies with EN ISO 10993-1
Biocompatibility: Systemic (acute) toxicity	Complies with EN ISO 10993-1
Biocompatibility: Blood compatibility	Complies with EN ISO 10993-1
Biocompatibility: Rabbit pyrogenicity	Complies with EN ISO 10993-1

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

This information is not provided in the document. The tests performed are bench tests (tensile strength, leakage, flow rate) and biocompatibility tests, which typically do not involve a "test set" in the context of patient data. The "samples" would be individual units of the cannula. There is no mention of country of origin for any data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable/not provided. The device is a physical medical device (cannula) and the tests performed are physical and biological evaluations, not diagnostic or image-based assessments requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable/not provided as there is no "test set" requiring adjudication in the context of this submission. The tests are laboratory-based and measure physical properties or biological responses.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improve with AI vs without AI assistance

This information is not applicable. The device is a physical cannula for organ perfusion, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant to this submission.

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

This information is not applicable. The device is a physical cannula, not an algorithm.

7. The Type of Ground Truth Used

This information is not applicable in the traditional sense of a diagnostic device. For the bench tests, the "ground truth" would be the established engineering and ISO standards against which the device performance is measured (e.g., specific tensile strength values for a "Pass"). For biocompatibility, the "ground truth" is compliance with documented biological safety standards like EN ISO 10993-1, which dictate acceptable levels of biological response.

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 as there is no training set.

Summary

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July 1, 2021

Bridge to Life Ltd. % H. Carl Jenkins Regulatory Affairs Counsel Wood Burditt Group 10 E. Scranton Ave., Ste. 201 Lake Bluff, IL 60044

Re: K203262

Trade/Device Name: Cannula for Organ Perfusion Regulation Number: 21 CFR§ 876.5880 Regulation Name: Isolated Kidney Perfusion and Transport System and Accessories Regulatory Class: II Product Code: KDN, MSB Dated: May 27, 2021 Received: May 28, 2021

Dear H. Carl Jenkins:

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. 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 located 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.

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.

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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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,

Carolyn Y. Neuland, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203262

Device Name

Cannula for Organ Perfusion

Indications for Use (Describe)

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

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The Wood Burditt Group LLC 10 E. Scranton Ave., Suite 201 Lake Bluff, IL 60044 847. 234. 7500 (tel.) 847. 574. 0728 (e-fax) www.woodburditt.com

K203262 -- 510(k) Summary

Date prepared: June 16, 2021

Submitter / Contact Person	H. Carl JenkinsThe Wood Burditt Group10 E. Scranton Ave, Suite 201Lake Bluff, IL 60044(ph) 847-234-7500 x 205(fax) 847-578-0728(email) hcjenkins@woodburditt.com
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Applicant & 510(k) Owner	Bridge to Life Ltd.128 Suber Rd., Suite AColumbia, SC 29210(ph) 847-796-3070FDA Establishment Registration Number: 3009110022FEI Number: 3009110022Owner/Operator Number: 10038889
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Device Information

Trade Name	Cannula For Organ Perfusion
Proprietary Name	Cannula For Organ Perfusion
Common Name	Organ Perfusion Cannula
Classification Name	Isolated Kidney Perfusion and Transport System and Accessories
Classification Panel	Gastroenterology/Urology
Regulation	21 CFR 876.5880
FDA Product Code	KDN; MSB
FDA Classification	II

Reason for 510(k) Submission

The applicant device is a new device.

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Device Description

Image /page/4/Figure/3 description: The image shows a medical instrument with several labeled parts. The instrument is a long, thin tube with a blue flexible connector on one end. The other end has an athraumatic tip, and there are also fixed and slidable rings along the tube's length, labeled d1, d2, and d3 respectively.

Cannula size	d1 mm (F)	d2 mm (F)	d3 mm (F)
8 F	2.7 (8 F)	4.7 (14 F)	-
10 F	3.3 (10 F)	5.3 (16 F)	-
12 F	4.0 (12 F)	6.3 (19 F)	-
16 F	5.3 (16 F)	7.3 (22 F)	8.7 (26 F)
20 F	6.7 (20 F)	9.3 (28 F)	10.7 (32 F)
25 F	8.3 (25 F)	11.3 (34 F)	13.3 (40 F)

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The surgeon performing the organ perfusion procedure will select the appropriate cannula for the particular organ to be perfused.

Indications for Use:

Predicate / Reference Device Summary Table

Based on the comparison of the device features, materials, intended use and performance the Cannula for Organ Perfusion was shown to be substantially equivalent to the lawfully marketed predicate devices indicated in the table below.

Device	Applicant	510(k) #	Featured Element(s) of Substantial Equivalence
Cannula Accessory of the LifePort Kidney Perfusion Transporter	Organ Recovery Systems, Inc.	K021362	Intended Use / Indications for Use
Fresenius Multiorgan Perfusion Cannula	Fresenius	K902394	Intended Use / Indications for Use; Technology; Design

Technological Characteristics and Comparison:

The Cannula for Organ Perfusion is substantially equivalent to the cannula accessory of the LifePort Kidney Perfusion Transporter-specifically, the perfusion cannula component of the LifePort Kidney Perfusion Transporter-in terms of intended use, indications for use, FDA classification and FDA Product Code. Like the subject device, the cannula accessory of the LifePort Kidney Perfusion Transporter is used for flushing and replacement of residual blood in donor organs with organ preservation solution during the preparation processes of these organs for transplantation.

In addition, a comparison of the subject device to the Fresenius Multiorgan Perfusion Cannula demonstrates the safety and efficacy of the Cannula for Organ Perfusion in terms of substantially equivalent design, technology, use and suitability.

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Feature	Subject Device	Predicate / Reference Devices
Intended Use / Indications	Cannula for Organ Perfusionis a single-use deviceindicated for hypothermicflushing and replacement ofresidual blood in donor organswith a legally marketed organpreservation solution at thetime of organ removal fromthe donor during thepreparation of these organs fortransplantation. This device isindicated for use with gravityflow; no testing has beenprovided for use with pumpsystems, such as mechanicalperfusion devices.	LifePort Kidney PerfusionTransporter (K021362):System component cannula for organperfusion, intended to be used in anorgan transplantation procedure.Fresenius Multiorgan PerfusionCannula (K902394):"For placement in the [organ] of aheart beating cadaver to allow in situflushing of the cadaver organs withorgan preservation solution."
Single Use / Disposable	Single Use / Disposable	Fresenius Multiorgan PerfusionCannula (K902394):Single Use / Disposable
Device Design	The Cannula for Organ Perfusionhas a tapered connector atproximal end of the cannula, andan atraumatic distal end; coneshaped.	Fresenius Multiorgan PerfusionCannula (K902394):Perfusion cannula has a proximal endwhich consists of a funnel-shapedconnector (i.e., a cone shape)Perfusion cannula has a distal endwhich consists of an atraumatic tipand cone-shaped cuff.
Sterilization	Ethylene OxideSAL 1 x 10-6	Fresenius Multiorgan PerfusionCannula (K902394):Ethylene OxideSAL 1 x 10-6
Regulation	21 CFR 876.5880	LifePort Kidney PerfusionTransporter (K021362):21 CFR 876.5880
FDA Product Code	KDN; MSB	LifePort Kidney PerfusionTransporter (K021362): KDN
FDA Classification	II	LifePort Kidney PerfusionTransporter (K021362): IIFresenius Multiorgan PerfusionCannula (K902394): II

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Clinical Testing:

No clinical tests were conducted in support of this 510(k) submission.

Non-Clinical Tests Performed:

Bench testing demonstrates that the Cannula for Organ Perfusion is safe, effective and meets device specifications:

Testing related to tensile strength vielded Pass results in accordance with ISO 10555-1. -
Testing related to leakage and tightness yielded Pass results in accordance with ISO -10555-1.
Testing related to flow rate demonstrated adequate flow of liquid in accordance with ISO -10555-1.

Sterilization & Shelf Life:

Product is sterilized using ETO, with a Sterility Assurance Level (SAL) of 10-6.

The shelf life of the product has been established in accordance with real time aging testing results.

Biocompatibility:

All component materials of this medical device carry adequate quality certificates confirming their biological, physical-chemical and mechanical properties, and they are all intended for ETO sterilization.

In particular, the materials used in the manufacturing of the cannula comply with requirements of EN ISO 10993-1.

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In accordance with ISO 10993-1, the Cannula for Organ Perfusion is classified as:

surgical invasive medical device
having external contact with the body through the circulating blood,
remaining in contact with the body for up to 24 hours.

The following biological tests were selected for the Cannula for Organ Perfusion:

cytotoxicity
sensitizing effect
intracutaneous reactivity
systemic (acute) toxicity
blood compatibility
rabbit pyrogenicity

In accordance with ISO 10993-1:2009, all tests were performed using the final product after the sterilization process of the product, using a validated sterilization process.

Additionally, the manufacturer has conducted a separate biological evaluation of the subject medical device. This study included the defined requirements, product classification, description of the adopted test selection criteria, specifications and approvals of materials used to manufacture the evaluated product, a list and summary of biological tests collected or performed and analysis of the data obtained from the evaluation.

Conclusion:

The applicant device is substantially equivalent in its intended use, technology / principal of operation, materials, and performance to the predicate and reference devices identified in this 510(k) submission. There is no significant difference that raises any issues of safety or effectiveness.

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).