The TenderFlow™ Pediatric Arterial Cannula is a surgically invasive device intended for short term use and indicated for cannulation and perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

Device Description

The design of the TenderFlow™ Pediatric Arterial Cannula consists of a dip molded, wire reinforced cannula (single-stage) with thin walls and good flow performance. A non-reinforced clamping site is provided adjacent to the connector. The overall length of the cannula from end to end is approximately 9 inches. The distal portion of the spring reinforced body steps up in size both in internal diameter and outside diameter to enhance flow performance. This stepup diameter is approximately four to five French sizes larger than the tip section. The step occurs distal to the insertion portion of the cannula at approximately 1 to 2 inches from the tip. The length of the step increases with the French size. The tip is integral to the body, is not spring reinforced and is stiffened sufficiently to resist kinking and/or collapse. The pediatric arterial cannula has a ¼" barbed connector in either a vented (with luer cap) or non-vented design. The pediatric arterial cannula also includes an optional introducer with a vent cap. This introducer can be used to stiffen the cannula during insertion and reduce blood loss.

AI/ML Overview

Below is an analysis of the provided text regarding the TenderFlow™ Pediatric Arterial Cannula, focusing on acceptance criteria and the supporting study.

Note: The provided text is a 510(k) premarket notification for a medical device. This type of submission relies on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving absolute safety and effectiveness through extensive de novo studies often seen in drug development or novel medical technologies. Therefore, many of the typical acceptance criteria and study components associated with proving efficacy from scratch will not be explicitly detailed or even present in this document. The focus is on demonstrating that the new device performs similarly enough to the predicate device and does not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria in a 510(k) are typically tied to demonstrating that the modified device performs comparably to the predicate device. The document explicitly states that the performance evaluations were conducted to show substantial equivalence. Specific quantitative acceptance criteria are not provided in this summary, but the type of performance assessed and the general outcome are described.

Acceptance Criterion (Implicitly for Substantial Equivalence)	Reported Device Performance	Comments
Pressure Drop vs. Flow Rate (demonstrate comparable hemodynamic performance)	Performed comparably to the predicate device (Terumo L Series Arterial Cannula).	"Comparison studies of the performance... were conducted for pressure drop versus flow rate with water testing... showed either no or favorable clinically significant performance differences."
Hemolysis Testing (demonstrate comparable blood trauma)	Performed comparably to or better than the predicate device.	"The hemolysis testing compared the unmodified 10 Fr. to the modified 6 Fr. device... The 6 Fr. performed equal to or better than the 10 Fr. unmodified device."
Connector Attachment (demonstrate structural integrity)	Test conducted on the modified device only; assumed to meet internal specifications for integrity.	"All other tests listed below were conducted on the modified device only because these speak to device integrity." Results showed "no or favorable clinically significant performance differences."
Clamping Test (demonstrate structural integrity)	Test conducted on the modified device only; assumed to meet internal specifications for integrity.	(Same as above)
Kink Test (demonstrate resistance to kinking)	Test conducted on the modified device only; assumed to meet internal specifications for integrity.	(Same as above, also: "The tip is stiffened sufficiently to resist kinking.")
Leak Test (demonstrate fluid containment)	Test conducted on the modified device only; assumed to meet internal specifications for integrity.	(Same as above)
Air Venting and Priming (demonstrate proper functionality)	Test conducted on the modified device only; assumed to meet internal specifications for functionality.	(Same as above)
Tensile Test (demonstrate material strength/robustness)	Test conducted on the modified device only; assumed to meet internal specifications for strength.	(Same as above)
Simulated Use Test (demonstrate functionality under simulated conditions)	Test conducted on the modified device only; assumed to meet internal specifications for simulated use.	(Same as above)
Ship Test (demonstrate integrity after shipping)	Test conducted on the modified device only; assumed to meet internal specifications for shipping robustness.	(Same as above)
Shelf Life Test (demonstrate long-term stability)	Test conducted on the modified device only; assumed to meet internal specifications for shelf life.	(Same as above; "material characterization studies... demonstrate stability of the materials, and found the materials to be stable over the expiry of the product.")
Biocompatibility (demonstrate biological safety)	Materials found to be biocompatible.	"The blood contacting materials were found to be biocompatible." Conducted per ISO 10993.
Sterilization (demonstrate effective sterilization)	Conditions validated to provide SAL of 10-6.	"Sterilization conditions have been validated in accordance with AAMI guidelines to provide a Sterility Assurance Level (SAL) of 10-6."

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

The document does not explicitly state the specific sample sizes (number of devices or experimental runs) used for each test (pressure drop, hemolysis, etc.). It mentions performing "comparison studies" and "all other tests" but does not quantify the sample sizes.

Sample Size for Test Set: Not explicitly stated for any of the performance tests.
Data Provenance: The studies appear to be retrospective in the sense that they are laboratory-based engineering and bench testing, performed on manufactured devices. They are not clinical studies on human subjects. The country of origin of the data is implied to be within the company's testing facilities (Terumo Cardiovascular Systems Corporation in Ann Arbor, Michigan, USA), but this is not explicitly stated.

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

This section is not applicable to the type of device and study presented. For a mechanical device like a cannula, "ground truth" is established by direct measurement against engineering specifications and validated test methods, not by expert consensus on observational data. Performance criteria (e.g., pressure drop, hemolysis rate) are objectively measured.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication (e.g., 2+1, 3+1) is a method for resolving discrepancies in expert opinion for qualitative assessments (e.g., image interpretation). The tests described are objective, quantitative measurements in a laboratory setting.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or screening devices where human readers interpret data (e.g., medical images) and the AI's impact on reader performance is being evaluated. The TenderFlow™ Pediatric Arterial Cannula is a physical surgical device, not an AI-driven diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The device is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by:

Objective measurement against engineering specifications: For tests like connector attachment, clamp test, kink test, leak test, tensile test, ship test, and shelf life test. These likely have predefined pass/fail criteria.
Comparative measurements against a predicate device: For pressure drop and hemolysis, the "ground truth" for acceptance is "substantially equivalent or better" performance compared to the legally marketed predicate device.
Compliance with recognized standards: For biocompatibility (ISO 10993) and sterilization (AAMI guidelines), the ground truth is adherence to these established benchmarks.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical device. There is no concept of a "training set" as there would be for an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the reasons stated above.

Summary

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

K063618

TenderFlow™Pediatric Arterial Cannula

Submitter Information:

This Premarket Notification is submitted by:

Christina L. Thomas Telephone: 1-800-262-3304, Ext. 6278 MAR 1 3 2007

This Premarket Notification is submitted on behalf of:

Terumo Cardiovascular Systems Corporation 6200 Jackson Road Ann Arbor, Michigan 48103

Device Names:

Proprietary Name: TenderFlow™ Pediatric Arterial Cannula Common Name: Arterial Cannula Classification: Arterial Cannulae are classified as Class II devices

Predicate Device:

The unmodified device is identified as Terumo's L Series 1863 Arterial Cannula. This device was originally cleared by FDA with K930620, dated May 8, 1993. This device is legally marketed and has not been the subject of Premarket Notification 510(k) clearance.

The TenderFlow™ Pediatric Arterial Cannula is substantially equivalent in intended use, materials, design, technology, principles of operation, and performance to the predicate (unmodified) Terumo L. Series Arterial Cannula.

Intended Use:

The TenderFlow™ Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass procedures. These devices are indicated for up to 6 hours of use.

Principles of Operation and Technology:

The TenderFlow™ Pediatric Arterial Cannula is used in open heart surgery. During open heart surgery blood is drained into a venous cannula just upstream of the heart, at the superior / inferior vena cava and right atrium. The cannula is connected to tubing that routes the blood to a heart / lung machine where the blood is pumped and oxygenated. The blood then continues through this perfusion circuit back to the outlet side of the heart (the patient's aorta), where the blood re-enters the patient's circulatory system via the ascending aorta through an arterial cannulae.

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

Design and Materials:

The tip is integral to the body, is not spring reinforced and is stiffened sufficiently to resist kinking and/or collapse. The pediatric arterial cannula has a ¼" barbed connector in either a vented (with luer cap) or non-vented design. The pediatric arterial cannula also includes an optional introducer with a vent cap. This introducer can be used to stiffen the cannula during insertion and reduce blood loss.

The generic materials used in the TenderFlow™ Pediatric Arterial Cannula are as listed:

· Polyvinvl chloride for the tube
· Stainless steel wire which provides spring reinforcement throughout the body of the cannula
· Rigid PVC and UV cure adhesive for the connector
· ABS for the luer cap
· Silicone vent cap and polypropylene rod for the optional introducer
· Each cannula is printed with a medical grade white ink, pigment color Marabu TPL 970 CDT PN

Performance Evaluations:

The performance of the TenderFlow™ Pediatric Arterial Cannula is substantially equivalent to the performance of the predicate (unmodified) device with regards to pressure drop testing and hemolysis testing. The hemolysis testing compared the unmodified 10 Fr. to the modified 6 Fr. device since these were the two smallest devices in both product families. The 6 Fr. performed equal to or better than the 10 Fr. unmodified device. All test results are available upon request.

Substantial Equivalence Comparison:

The TenderFlow™ Pediatric Arterial Cannula is substantially equivalent to the predicate Terumo L Series Pediatric Arterial Cannula device as follows:

Intended Use:

The TenderFlow™ Pediatric Arterial Cannula and the predicate (unmodified) Terumo L Series Arterial Cannula share the same intended

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

uses. Both are indicated for perfusion of the aorta during bypass surgerv for up to 6 hours of use.

Principles of Operation and Technology: Both the modified and unmodified arterial cannulae are used in open heart surgery to return the oxygenated blood to the patient's ascending aorta.

Design and Materials: The design of the TenderFlow™ Pediatric Arterial Cannula consists of a dip molded, wire reinforced, straight arterial cannula (single-stage) with thin walls, and good flow performance. A nonreinforced clamping site is provided adjacent to the connector. The overall length of the cannula from end to end is approximately 9 inches. The tip is integral to the body, and is not spring reinforced. The tip is stiffened sufficiently to resist kinking. The tip is beveled and tapered.

There are three major differences between the modified and unmodified devices. First, the modified device has the option of a vented connector. Second, the modified device includes an optional introducer system. The other difference is in the lenath. The unmodified predicate arterial cannula is 7.5 inches in length whereas the modified device is ~9 inches in length.

The design and the materials of the (modified) and the (unmodified) L Series Pediatric Arterial Cannula are essentially the same. Differences include those listed above.

The materials used in the two devices are slightly different. Both use polyvinyl chloride for the tube.

The connector on the modified device uses rigid PVC and UV cure adhesive to bond whereas the unmodified predicate device is a press fit bond. The modified device uses polypropylene and silicone elastomer in the optional introducer system and ABS for the optional luer cap.

Comparison studies of the performance of the (modified) Performance: Pediatric Arterial Cannula and the unmodified predicate L Series Pediatric Arterial Cannula were conducted for pressure drop versus flow rate with water testing and the dynamic hemolysis test because these speak to performance. All other tests listed below were conducted on the modified device only because these speak to device integrity.

Connector attachment .
Clamp test .
Kink test .
Leak test .
Air venting and priming .
Tensile test .
Simulated use test ◆
Ship test .

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

· Shelf Life test
These test results showed either no or favorable clinically significant performance differences.

Substantial Equivalence Summary:

In summary, the (modified) TenderFlow™ Pediatric Arterial Cannula and the predicate (unmodified) L Series Pediatric Arterial Cannula are substantially equivalent in intended use, principles of operation and technology, design, and performance. Any noted differences between the devices do not raise new issues of safety and effectiveness.

Additional Safety Information:

Sterilization conditions have been validated in accordance with AAMI . guidelines to provide a Sterility Assurance Level (SAL) of 10-6.
. Post-sterilization release for use will be determined in consideration of maximum Ethylene Oxide, Ethylene Chlorohydrin and Ethylene Glycol (as appropriate) residue limits and maximum levels of patient exposure in accordance with EN ISO 10993-7 and AAM! TIR-19.
. Biocompatibility studies were conducted as recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO 10993: 2003, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing." [External Communicating Devices, Circulating Blood, Limited Exposure (≤ 24 hours) Contact Duration). The blood contacting materials were found to be biocompatible.
. Terumo has conducted material characterization studies - including physiochemical profiles of aged and non-aged devices to demonstrate stability of the materials, and found the materials to be stable over the expiry of the product.

Conclusion:

In summary, the TenderFlow™ Pediatric Arterial Cannula is substantially equivalent in intended use, principles of operation and technology, design and performance to the predicate (unmodified) L Series Terumo Pediatric Arterial Cannula.

{4}------------------------------------------------

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like bird with three tail feathers. The bird is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 2007

Terumo Cardiovascular Systems c/o Ms. Christina L. Thomas Sr. Specialist, Regulatory Management 6200 Jackson Road Ann Arbor, MI 48103

Re. K063618

TenderFlow™ Pediatric Arterial Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: Catheter, Cannula and Tubing Vascular, Cardiopulmonary Bypass Regulatory Class: Class II Product Code: DWF Dated: February 12, 2007 Received: February 16, 2007

Dear Ms. Thomas:

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 such 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.

{5}------------------------------------------------

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 (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. This letter will allow you to begin marketing your device as described in your Section 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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

510(k) Number (if known):

TenderFlow™ Pediatric Arterial Cannula Device Name:

Indications For Use:

These devices are indicated for up to 6 hours of use.

Christina Thomas

Christina Thomas, R.N., B.S.N. Sr. Regulatory Affairs Specialist Terumo Cardiovascular Systems

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

X Prescription Use

Over-The-Counter Use

(Per 21 CFR 801.109)

(Division plan-Off)
Division of Cardiovascula
510(k) Number K063618

Regulation Number and Section

§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.

(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).