The Hudson RCI® Addipak® Unit Dose Vial, 0.9% Full Normal Saline Solution may be used in conjunction with a non-ventilatory nebulizer for lavage therapy, or for tracheal irrigation.

Device Description

Hudson RCI® AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution is a pre-filled vial of sterile 0.9% saline for inhalation therapy. The content of this product is a 0.90% sodium chloride solution (normal saline). Vials are factory-sealed, made of translucent, color-coded polyethylene, and are available in three sizes (3mL, 5mL, and 15mL). These products are single-use, disposable, and intended for inhalation only.

Hudson RCI® AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution filled with sterile saline solutions conforms to the specifications of the USP monograph for Sodium Chloride Inhalation Solution.

Hudson RCI® AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution have a perforated, break-away twist cap for dispensing the solution. When twisted by the user, the cap breaks away and opens a small hole for solution to pass through. The Hudson RCT® AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution are designed with inverted graduations to allow the clinician to read volume while dispensing the solution.

AI/ML Overview

This document is a 510(k) Pre-market Notification for a medical device called the "Hudson RCI® AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the safety and efficacy of a novel device through extensive clinical trials.

Therefore, the provided document does not contain the kind of information typically associated with AI/ML diagnostic device studies. Specifically, it lacks:

Acceptance Criteria for AI Performance: There's no AI model, so no performance metrics like sensitivity, specificity, AUC, F1-score, etc., are defined or measured.
Sample Size for Test/Training Sets, Data Provenance, Ground Truth Experts/Methods, MRMC Studies, Standalone Performance: These are all concepts related to the evaluation of AI algorithms, which are not applicable to this saline solution product.

Instead, this document describes a non-clinical evaluation comparing a new saline solution product to existing, legally marketed predicate devices. The goal is to demonstrate that the new device is "substantially equivalent" and raises no new questions of safety or effectiveness.

Here's a breakdown of the relevant information provided in the document regarding the acceptance criteria and study for the saline solution product:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present acceptance criteria and performance in a single table for the saline solution itself. Instead, it outlines bench testing conducted to ensure the proposed device performs as intended and is substantially equivalent to predicate devices. The "performance" is demonstrated by meeting the standards of these non-clinical tests.

Test Performed	Principle of Test	Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Leak Test	Leak detection in polyethylene vial by vacuum method	No leaks detected	"performed to verify that the performance...will perform as intended." (No leaks detected)
Twist-Off Test	A manual removal of the twist-off cap to ensure proper dispensing of solution when inverted and squeezed	Cap twists off easily, and solution dispenses properly	"performed to verify that the performance...will perform as intended." (Cap functions as designed)
Ship Test	Shipping simulation (ISTA 1A) to ensure vials are damage-free and do not leak	Vials are damage-free and do not leak after shipping simulation	"performed to verify that the performance...will perform as intended." (Vials withstand shipping simulation successfully)
Biocompatibility	Cytotoxicity, irritation, sensitization, genotoxicity, and implantation testing (ISO 10993-1)	All patient-contacting materials comply with ISO 10993-1	"All patient contacting materials are in compliance with ISO 10993-1."
Material Testing	USP <661> physiochemical test for plastics (nonvolatile residue, heavy metals, buffering capacity)	Meet USP <661> criteria	"found to meet the criteria for nonvolatile residue, heavy metals and buffering capacity."
Solution Purity	Conforms to USP monograph for Sodium Chloride Inhalation Solution	Conforms to USP specifications	"conforms to the specifications of the USP monograph for Sodium Chloride Inhalation Solution."
Sterilization	Per USP <71>	Meets USP <71> sterility requirements	"Per USP <71>" (implies compliance)

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

Test Set Sample Size: Not explicitly stated for each test. The testing is non-clinical bench testing.
Data Provenance: The tests are conducted in a laboratory setting by the manufacturer (Teleflex Medical, Inc.). This is likely an internal, prospective study as part of the product development and regulatory submission. No country of origin for "data" in the sense of patient data is applicable.

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

Not applicable. There is no "ground truth" established by experts in the context of an AI/ML diagnostic device. The evaluation relies on standardized physical, chemical, and biological tests for product performance and safety.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication" in the context of human expert disagreement on interpretations for an AI model. The tests have objective pass/fail criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI/ML diagnostic device, and thus no MRMC study, human reader improvement with AI, or effect size is relevant.

6. Standalone Performance Study

Not applicable in the context of AI. The device is the saline solution itself, and its performance is evaluated in a standalone manner via bench testing as detailed in point 1.

7. The Type of Ground Truth Used

Not applicable in the AI sense. The "ground truth" for this product's evaluation is defined by:

Physical characteristics (e.g., absence of leaks, proper cap function).
Chemical specifications (e.g., 0.90% sodium chloride solution, meeting USP monograph).
Biocompatibility standards (e.g., ISO 10993-1).
Sterility standards (e.g., USP <71>).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable. This is not an AI/ML device, so there is no training set or ground truth establishment for it.

In summary: This document is a regulatory submission for a simple medical device (a saline solution) demonstrating its substantial equivalence to previously approved devices through non-clinical bench testing and adherence to recognized standards. It does not involve any artificial intelligence or machine learning components, and thus the questions pertinent to AI device evaluation are not addressed.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an emblem of a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the emblem. The emblem itself consists of a stylized design of three human profiles facing right.

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

April 29, 2015

Teleflex Medical, Inc. James A. Cochie Sr. Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, NC 27709

Re: K142153

Trade/Device Name: Hudson RCI® AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer (Direct Patient Interface) Regulatory Class: II Product Code: CAF Dated: March 30, 2015 Received: April 1, 2015

Dear Mr. Cochie:

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.

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

Page 2 - Mr. Cochie

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,

Teiashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

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

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

Indications for Use

510(k) Number (if known)

K142153

Device Name

Hudson RCI® Addipak® Unit Dose Vial, 0.9% Full Normal Saline Solution

Indications for Use (Describe)

The Hudson RCI® Addipak® Unit Dose Vial, 0.9% Full Normal Saline Solution may be used in conjunction with a non-ventilatory nebulizer for lavage therapy, or for tracheal irrigation.

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)

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."

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

Section 25 - 510(k) Summary

510(k) SUMMARY

Hudson RCI® AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution

A. Name, Address, Phone and Fax Number of Applicant

Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-433-8083 Fax: 919-433-4996

B. Contact Person

James Cochie Sr. Regulatory Affairs Specialist

C. Date Prepared

July 25, 2014 (Revised April 28, 2015)

D. Device Name

Trade Name:	Hudson RCI® AddiPak® Unit Dose Vial, 0.9% FullNormal Saline Solution
Common Name:	Saline Solution for Inhalation
Classification Name:	Nebulizer (Direct Patient Interface)CFR - 868.5630, Class II

E. Device Description

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

Section 25 – 510(k) Summary

F. Indications for Use

The Hudson RCI® AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution may be used in conjunction with a non-ventilatory nebulizer for lavage therapy, or for tracheal irrigation.

G. Target Population

This device is intended for use on any patient requiring lavage therapy or tracheal irrigation.

H. Environments of Use

This device is intended for home, hospital, and sub-acute facilities.

This product is single use only.

I. Contraindications

There are no known contraindications.

J. Comparative Equivalence Characteristics

The proposed Hudson RCI® AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution is substantially equivalent to the predicate devices:

ComparativeCharacteristics	Proposed Device,Hudson RCI®AddiPak® Unit DoseVial, 0.9% FullNormal SalineSolution	Predicate Device,Hudson RCI®AddiPak® Unit DoseVial, 0.9% FullNormal SalineSolution	Predicate Device,NephronPharmaceuticals,Sodium ChlorideSolution USP, 0.9%
Manufacturer	Teleflex Medical, Inc.	Teleflex Medical, Inc.	NephronPharmaceuticals
510(k) Number	K142153	Pre-amendment	K113033
Indications forUse	The Hudson RCI®AddiPak® Unit DoseVial, 0.9% Full NormalSaline may be used inconjunction with a	The Hudson RCI®AddiPak® Unit DoseVial, 0.9% FullNormal Saline maybe used in	Sterile, single usedevice is intended tobe used as anaccessory tomedicinal

Teleflex Medical, Inc.

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

	non-ventilatorynebulizer for lavagetherapy, or fortracheal irrigation.	conjunction with anon-ventilatorynebulizer for lavagetherapy, or trachealirrigation	nonventilatorynebulizers forrespiratory therapy orfor tracheal irrigationor lavage therapy
Prescription	Yes	Yes	Yes
Environment ofUse	Home, hospital, sub-acute facilities	Home, hospital, sub-acute facilities	Home, hospital, sub-acute facilities
PatientPopulation	Any patient requiringlavage therapy ortracheal irrigation	Any patient requiringlavage therapy ortracheal irrigation	Same
Contraindications	None	None	None
Materials in FluidContact	Vial LDPE - DuPontDPE-20 and DowHEALTH+ 692	Vial LDPE - DuPontDPE-20 andCelanese EVA 7110	Vial LDPE
Solutions	0.90% SalineInhalation Solution,USP: 3ml, 5ml, 15ml	0.90% SalineInhalation Solution,USP: 3ml, 5ml, 15ml	0.9% SalineInhalation Solution,USP: 3ml, 5ml
Vial Design	Pinched seambetween vial and capfor openingNozzle openingdesign to keepcontents within wheninvertedRaised invertedgraduations	Pinched seambetween vial and capfor openingNozzle openingdesign to keepcontents within wheninvertedRaised invertedgraduations	Pinched seambetween vial and capfor openingNozzle openingdesign to keepcontents within wheninvertedRaised invertedgraduations
ManufacturingProcess	Per USP monographBlow-Fill-Seal asepticprocess	Per USP monographBlow-Fill-Seal asepticprocess	Per USP monographBlow-Fill-Seal asepticprocess
Sterilization	Per USP <71>	Per USP <71>	Per USP <71>
Single Use	Yes	Yes	Yes
Shelf Life	2 years from date ofmanufacture	2 years from date ofmanufacture	Unknown
Packaging	3ml and 5ml vialspackaged 100/box, 10boxes/case15ml vials packaged48/box, 3 boxes/case	3ml and 5ml vialspackaged 100/box, 10 boxes/case15ml vials packaged48/box, 3 boxes/case	3ml and 5ml vialspackaged 100/box or30 individuallywrapped and bar-coded vials

Section 25 – 510(k) Summary

K. Non-clinical Comparative Performance Testing

Bench testing has been performed to verify that the performance of the proposed Hudson RCI® AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution is substantially equivalent to the predicate devices, and that the Hudson RCI® AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution will perform as intended.

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

TestPerformed	Reference to Standard (ifapplicable)	Principle of Test
Leak Test	N/A	Leak detection in polyethylene vial byvacuum method
Twist-OffTest	N/A	A manual removal of the twist-off cap toensure proper dispensing of solutionwhen inverted and squeezed
Ship Test	ISTA 1A	Shipping simulation to ensure vials aredamage-free and do not leak

Section 25 - 510(k) Summary

All patient contacting materials are in compliance with ISO 10993-1. Testing included cytotoxicity, irritation, sensitization, genotoxicity and implantation testing.

In addition, the vial material was tested to USP <661> physiochemical test for plastics and found to meet the criteria for nonvolatile residue, heavy metals and buffering capacity.

L. Substantial Equivalence

The proposed Hudson RCI® AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution is substantially equivalent in intended use for lavage therapy and tracheal irrigation, design, performance and principles of operation to the identified predicate devices. The differences between the Hudson RC1® AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution and the predicate devices are minor and raise no new issues of safety and efficacy. The Hudson RC1® AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution are substantially equivalent to the currently marketed predicate device.

Regulation Number and Section

§ 868.5630 Nebulizer.

(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).