ReLeaf catheters are indicated for use where a routine drainage tube is required to drain fluids and exudates during or after surgery. The additional lumens allow for application of anesthetic to relieve postoperative pain.

Device Description

The ReLeaf catheter is comprised of a radiopaque multi-lumen catheter which bifurcates proximally into a single lumen wound drain line and a single lumen anesthetic infusion line. The distal tip of the device is composed of a thin film with one side for anesthetic infusion and the other for wound drainage. The anesthetic infusion and drainage sides of the catheter are clearly marked and mid-shaft depth markings are also present. Proximally the infusion and drain lines are both affixed to an insertion trocar.

AI/ML Overview

The provided FDA 510(k) summary for the ReLeaf™ Catheter focuses on demonstrating substantial equivalence to a predicate device (Axiom Multipurpose Wound Drain, K993592) through bench-top and animal testing. It does not contain information about a study involving human readers, AI assistance, or the specifics of ground truth for a test set in the context of diagnostic accuracy. This is a medical device approval for a physical catheter, not a diagnostic imaging or AI-driven decision support system.

Therefore, many of the requested categories in your prompt are not applicable to the provided document.

However, based on the information provided, here's what can be extracted and inferred within the context of a medical device submission focused on substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this type of device are generally qualitative (meets standards, no new safety/effectiveness issues) and demonstrate performance comparable to the predicate. The "reported device performance" are the results of various bench and animal tests.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Safety & Effectiveness	No new issues of safety or effectiveness introduced compared to predicate.	Performance testing results support a substantial equivalence determination.
Biocompatibility	Compliance with ISO 10993 standards.	Full battery of ISO 10993 testing passed.
Material Performance	Materials suitable for intended use; no impact on safety/effectiveness due to different materials/coatings.	Materials and coatings did not impact safety or effectiveness.
Design Performance	Distal tip design difference does not impact safety/effectiveness; performance confirmed for intended use.	Performance of the ReLeaf catheter confirmed for its intended use in bench testing and simulated use animal testing.
Mechanical Performance	(Implied) Device should function as intended without failure.	Performance testing included insertion force, removal force, leak testing, patency, lumen compression, fatigue strength, tensile strength, tissue adherence. (Results are not explicitly quantified in this summary, but implied to be acceptable).
Leachables	(Implied) No harmful substances leaching from the polymer.	Polymer leachables testing performed. (Implied acceptable results).
Simulated Use	Device performs as expected in a simulated environment.	Simulated use animal testing conducted. (Implied acceptable results).

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

Test Set Sample Size: Not applicable. The "test set" here refers to the actual devices subjected to bench and animal testing. The document does not specify the number of catheters tested for each bench test or the number of animals used.
Data Provenance: Bench-top testing and simulated use animal testing. No country of origin is specified for the animal testing, but the submission is to the U.S. FDA. The data is prospective as it was generated specifically for this 510(k) submission.

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

This concept is not applicable as this is a physical medical device. "Ground truth" for device performance is established through objective measurements in laboratory and animal testing, not expert interpretation of diagnostic data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review of diagnostic cases, not for assessing the physical performance of a catheter.

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 is a medical device for anesthesia and drainage, not an AI-assisted diagnostic tool. No human reader studies comparing AI vs. no AI assistance were conducted or are relevant for this type of device.

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

Not applicable. There is no algorithm or AI component in the ReLeaf™ Catheter.

7. The Type of Ground Truth Used

For Bench Testing: Objective physical measurements, engineering standards, and performance specifications (e.g., tensile strength in Newtons, leak rate, patency flow rates, force measurements for insertion/removal).
For Animal Testing: Physiological responses, tissue reactions, and the functional success of the catheter in a living system, often assessed by veterinary pathologists or researchers.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an AI algorithm for this device. The development of the catheter would involve iterative design, prototyping, and testing, but not in the machine learning sense of a training set.

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

Not applicable. As there's no training set for an AI, establishing ground truth for it is irrelevant in this context.

Summary

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Traditional 510(k) Notification

ReLeaf™ Catheter

SECTION 5

K122661

FEB 2 7 2013

510(k) SUMMARY (21 CFR 870.92) ReLeaf™ Catheter

510(k) Owner:

Vital 5 LLC 570 Research Park Way, Suite 102 North Logan, UT 84341 Tel: 435-752-0307 Fax: 435-213-4878

Contact Person:

T. Wade Fallin Tel: 435-752-0307 e-mail: wade@venturemd.com

Date Prepared:

Trade Name:

Common Name:

Classification:

Product Code:

Predicate Device:

Device Description:

Intended Use:

ReLeafTM Catheter

August 29, 2012

Anesthesia Conduction Catheter and Apparatus Suction

Class II (21 CFR 868.5120) and Class I (21 CFR 878.4680)

BSO and GCY

Axiom Multipurpose Wound Drain (K993592)

ReLeaf catheters are intended for use where a routine drainage tube is required to drain fluids and exudates during or after surgery. The additional lumens allow for application of anesthetic to relieve postoperative pain.

The ReLeaf catheter indication statement is narrower than and fully encompassed by the predicate device's indications. Therefore

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Traditional 510(k) Notification

neither the therapeutic effect nor the safety and effectiveness are impacted.

Vital 5 ReLeaf catheter has similar technological The characteristics to the Axiom Multipurpose Wound Drain. Both devices have multiple lumens for infusion of anesthetics and drainage of fluids within the surgical wound and are manufactured from radiopaque materials allowing for assessment of catheter placement after wound closure.

The materials used to manufacture the two devices and their coatings are different however this does not impact safety or effectiveness as the full battery of ISO 10993 testing has been passed by the ReLeaf catheter. The distal tip of the catheters contain a design difference with the ReLeaf catheter flaring into a broad flat sheet and the predicate remaining cylindrical in shape however this does not impact safety or effectiveness as the performance of the ReLeaf catheter has been confirmed for its intended use in bench testing and simulated use animal testing.

Bench-top and animal testing was conducted to demonstrate that the differences in technological characteristics between the ReLeaf catheter and the predicate do not introduce any new issues of safety or effectiveness. Performance testing included insertion force, removal force, leak testing, patency, lumen compression, polymer leachables. fatigue strength, tensile strength, biocompatibility, tissue adherence and simulated use testing.

The performance testing results support a substantial equivalence determination by demonstrating that the ReLeaf catheter is safe and effective for its intended use.

The ReLeaf catheter is substantially equivalent to the Axiom Multipurpose Wound Drain (K993592). regarding its intended use, indications for use and technological characteristics. No new issues of safety or effectiveness are introduced as a result of the differences in technological characteristics or indication statements.

Vital 5 LLC has determined that the ReLeaf catheter is substantially equivalent to the predicate device and safe and effective for its intended use.

Non-Clinical Performance Data:

Technological

Characteristics:

Conclusions:

Vital 5 LLC

Page 8 of 42

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three bars instead of snakes.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

February 27, 2013

Vital 5 % Mr. T. Wade Fallin President and Chief Executive Officer 570 Research Park Way, Suite 102 North Logan, Utah 84341

Re: K122661

Trade/Device Name: Vital 5 ReLeaf Catheter Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia conduction catheter Regulatory Class: Class II Product Code: BSO, GCY Dated: February 20, 2013 Received: February 21, 2013

Dear Mr. Fallin:

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 mustcomply 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

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Page 2 - Mr. T. Wade Fallin

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, FOR Peter Dag Muimm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Traditional 510(k) Notification

ReLeaf™ Catheter

SECTION 4 Indications for Use Statement

510(K) Number (if know): _____________________________________________________________________________________________________________________________________________________ K122661

Device Name: Vital 5 ReLeaf Catheter

Indications for Use:

Prescription Use X (21 CFR 801 Subpart D) AND / OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Long H. Chen

(Division Sign-off) Division of Surgical Devices 510(k) Number K122661

Vital 5 LLC

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Regulation Number and Section

§ 868.5120 Anesthesia conduction catheter.

(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).