For use with a vascular access device for the administration of drugs and solutions. The Padi-Lock Medical Tubing Length Reducing Apparatus can be connected to the administration set by snaking through the device to shorten the length of the tubing. The device is intended to be used in hospitals and home patient care worere IV tubing is used.

Device Description

The Padi-Lock was designed to control the excess length in IV tubing. This patented device efficiently reduces the slack in tubing that can get tangled or tripped on causing additional patient injury or discomfort. The Padi-Lock hangs freely on the IV tubing. The Padi-lock efficiently reduces up to 32 inches of excess IV tubing. The Padi-Lock is made of polystyrene. The device dimensions are 7.5'' x 4.42'' x 0.28" (L x W x H) with a tube channel designed to fit the outer dimension of IV tubing (0.14"). The tubing is snaked through the device so that it securely sits in the channel for unobstructed flow of the fluid through the tubing.

AI/ML Overview

This document describes the Padi-Lock Medical Tubing Length Reducing Apparatus and its substantial equivalence to a predicate device. Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions that "The devices met the requirements of the predetermined acceptance criteria" and "All devices passed the test" for a functionality bench test. However, it does not explicitly list the quantitative or qualitative acceptance criteria nor the detailed reported device performance against those criteria. It only states that the device successfully met them.

Acceptance Criteria (Implied)	Reported Device Performance
Functionality (e.g., ability to shorten tubing, maintain tubing security, not impede flow)	Devices met predetermined acceptance criteria; All devices passed the test.
Stability of material (polystyrene)	(Not explicitly stated, but implied by passing functionality tests)
Device dimensions and tube channel fit	(Successfully designed to fit 0.14" OD tubing without impacting flow)

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

Sample Size: The document states "All devices passed the test," implying that all test devices that underwent the "User/Performance Testing Protocols" passed. However, the absolute number of devices tested (the sample size used for the test set) is not specified.
Data Provenance: The testing was "Bench testing," indicating it was conducted under controlled laboratory conditions, likely in the US by the manufacturer (Padi-Lock, LLC). It was a retrospective analysis of the device's performance against pre-defined protocols.

3. Number of Experts and Qualifications for Establishing Ground Truth for the Test Set:

Number of Experts: This information is not provided.
Qualifications of Experts: This information is not provided.

Note: Given this was bench testing for a physical apparatus that does not directly interact with patient physiology or diagnostic imaging, the concept of "ground truth established by experts" in the traditional sense of clinical or diagnostic studies may not directly apply. The 'ground truth' in this context would likely be defined by engineering specifications and functional requirements.

4. Adjudication Method for the Test Set:

Adjudication method: This information is not provided. Given the nature of bench testing, it's more likely that direct measurement and observation against specified criteria were used, rather than an adjudication process between multiple human evaluators.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

MRMC study: No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not performed." This type of study typically involves human readers (e.g., radiologists) evaluating cases with and without AI assistance to measure a difference in diagnostic performance. The Padi-Lock device is a physical apparatus, not an AI or diagnostic tool.
Effect size of human reader improvement: Not applicable, as no MRMC study was conducted.

6. If a Standalone (algorithm only without human-in-the-loop performance) study was done:

Standalone study: Yes, in a sense. The "Bench testing... to assess functionality of the Padi-Lock" can be considered a standalone performance evaluation of the device itself, without human intervention in its operation beyond setting up the test. This is not an "algorithm" standalone study as typically understood for AI devices, but rather a functional performance test of the physical device. The device's performance was evaluated based on whether it met pre-determined acceptance criteria for its physical function.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

Type of Ground Truth: The ground truth for the bench testing was based on predetermined engineering specifications and functional requirements defined by the manufacturer and relevant standards (though specific standards are not listed). It's essentially the device's ability to perform its stated function (reducing tubing length effectively, maintaining flow) according to design parameters. This is not clinical ground truth like pathology or outcomes data.

8. The Sample Size for the Training Set:

Sample Size for Training Set: This information is not applicable as the Padi-Lock is a physical medical device, not an AI/machine learning algorithm that requires a "training set."

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

Ground Truth for Training Set: This information is not applicable as the Padi-Lock is a physical medical device, not an AI/machine learning algorithm that requires a "training set" or corresponding ground truth for training.

Summary

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

October 2, 2014

Padi-Lock, Limited Liability Company C/O Ms. Maria F. Griffin Official Correspondent 55 Northern Blvd., Suite 200 Great Neck, NY 11021

Re: K141200

Trade/Device Name: Padi-Lock Medical Tubing Length Reducing Apparatus Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: September 4, 2014 Received: September 4, 2014

Dear Ms. Griffin:

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 - Ms. Griffin

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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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 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,

Susan Runno, DDS, MA

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name

Padi-Lock Medical Tubing Length Reducing Apparatus

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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FORM FDA 3881 (1/14)

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510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is:

1. Submitter's Identification: Padi-Lock, LLC 5747 Fezzor Rd Farmington, MO 63640
  Contact Person: Padi Pettus Tel: 650-567-0061 X304

Date Summary Prepared: April 7, 2014

Trade Name of the Device: Padi-Lock 2.

3. Common or Usual Name: Intravascular Administration Set

4. Classification:

Regulation: 21 CFR 880.5440 Product Code: FPA

ട്. Predicate Device Information:

Clearlink Luer Activated Valve, IV administration and IV extension sets, with the Clearlink Luer Activated Valve, K112893

6. Device Description:

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7. Intended Use:

For use with a vascular access device for the administration of drugs and solutions. The Padi-Lock Medical Tubing Length Reducing Apparatus can be connected to the administration set by snaking the excess tubing through the device to shorten the length of the tubing. The device is intended to be used in hospitals and home patient care where IV tubing is used.

Item	Padi-Lock	Baxter
Indications for Use	For use with a vascular accessdevice for the administration ofdrugs and solutions. The Padi-Lock Medical Tubing LengthReducing Apparatus can beconnected to the administrationset by snaking the excesstubing through the device toshorten the length of thetubing. The device is intendedto be used in hospitals andhome patient care where IVtubing is used.	For use with a vascular access devicefor the administration of drugs andsolutions. The Clearlink LuerActivated Valve is an in-lineinjection site, which can be connectedto standard male luer adapters (e.g.syringes or sets) for continuous orintermittent fluid administration orwithdrawal of fluids.
Size/Dimensions	7.5" x 4.42" x 0.28"(L x W x H)	Tube Length 92"
Materials	Tube Channel: 0.14"Does not contact the fluidpathway	Tube Outer Diameter (OD): 0.14"Materials contact Fluid pathway
Target population	Individuals in hospital or homecare that require the use of anIV administration set.	Individuals in hospital or home carethat require the use of an IVadministration set.

8. Technological Comparison to Predicate Devices:

The Padi-Lock is designed as an accessory to the IV administration set and cannot be used as a stand alone device. The difference of materials does not impact the safety and effectiveness of the device because the device is not used directly on the patient and does not come in contact with the fluid path. The dimension of the channel of the Padi-Lock is the same as the OD of the tubing.

Discussion of Non-Clinical Tests Performed for Determination of Substantial 9. Equivalence are as follows:

Bench testing was performed to assess functionality of the Padi-Lock. The Padi-Lock device was tested according to the User/Performance Testing Protocols. The devices met the requirements of the predetermined acceptance criteria. All devices passed the test

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10. Discussion of Clinical Tests Performed:

Clinical testing was not performed.

Conclusions: 11.

Based on the information provided in this submission we conclude that the Padi-Lock is substantially equivalent to the predicate and is safe and effective for its intended use.

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.