PharmaCaribe inhaled saline solutions are used in conjunction with a nebulizer. The contents of these vials are for the induction of sputum production where sputum production is indicated. Concentrations of 0.9%, 3%, 3.5%, 6%, 7%, and 10% with a pH of 7.4

Device Description

The proposed inhaled saline solutions are in 0.9%, 3%, 3.5%, 6%, 7%, and 10% concentrations with a pH of 7.4. They are packaged sterile in 4 ml vials for use as indicated.

AI/ML Overview

This document describes a 510(k) submission for an inhaled saline solution device, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device performance and testing are not applicable.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the device as being "substantially equivalent" to predicate devices, focusing on meeting established standards rather than setting new performance "acceptance criteria" in the sense of a novel device's performance metrics. The "performance" assessment is based on compliance with USP specifications and similarity to the predicate device.

Feature / Criteria	Reported Device Performance (PulmoSal™ Inhaled Saline Solution)	Predicate Device (PharmaCaribe K101424, K113033, and Pulmicort Respules)
Indications for Use	Used in conjunction with a nebulizer for the induction of sputum production. Concentrations of 0.9%, 3%, 3.5%, 6%, 7%, and 10% with a pH of 7.4.	Identical to PharmaCaribe K101424 for sputum induction with a nebulizer. (0.9% saline and pH of 7.4 are additions/match other predicates).
Technology of Manufacturing	Homogeneous aqueous mixtures of sterile water and saline.	Identical to PharmaCaribe K101424.
Mode of Action	Used with a nebulizer to increase sputum production.	Identical to PharmaCaribe K101424.
Formulation	Based upon USP specification except pH of 7.4 (matches pH of lungs). Concentrations: 3%, 3.5%, 6%, 7% and 10% (identical to K101424), 0.9% (identical to K113033).	Predicate concentrations: 3%, 3.5%, 6%, 7% and 10% (K101424). 0.9% (K113033). Predicate pH: USP 4.5 to 7.0 for K101424/K113033; pH of 7.4 for Pulmicort Respules (NDA # N020929).
Materials	Blow-fill-sealed low density polyethylene (LDPE) vial containing sterile, preservative-free, clear, colorless, aqueous solution of sodium chloride. No additives.	Identical to PharmaCaribe K101424.
Environment of Use	Hospital, home, sub-acute care settings.	Identical to PharmaCaribe K101424.
Patient Population	Any patient requiring induction of sputum production.	Identical to PharmaCaribe K101424.
Sterility	Sterile, as per USP <71>.	Sterile.
pH	7.4	USP 4.5 to 7.0 (for K101424). Note: The 7.4 pH is presented as a feature matching the pH of the lungs and the predicate drug Pulmicort Respules (NDA # N020929).
Salinity	Meets USP Specifications (except pH).	Meets USP Specifications.
Identification of Sodium	Per USP (191).	(Implied by USP monograph adherence for predicate).
Sodium Chloride Assay	Per USP Monograph.	Per USP Monograph.
Manufacturing	Per USP monograph (except pH).	Per USP monograph.
Prescription	Yes	Yes
Contraindications	None	None
Materials in fluid contact	Vial LDPE	Vial LDPE
Used with a nebulizer	Yes	Yes

2. Sample size used for the test set and the data provenance:
Not applicable. This is a saline solution, and the testing described is non-clinical (lot release, in-process, and finished product testing) focused on chemical properties and sterility, not clinical efficacy or diagnostic performance. There is no "test set" of patient data in the context of an AI/ML device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth for a diagnostic test set is established in this submission.

4. Adjudication method for the test set:
Not applicable.

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 not an AI/ML diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML diagnostic device.

7. The type of ground truth used:
The "ground truth" for this device is based on United States Pharmacopeia (USP) specifications for saline solutions and analytical testing results (e.g., salinity, pH, identification of sodium, sodium chloride assay, sterility). The comparison to predicate devices also serves as a "ground truth" for substantial equivalence.

8. The sample size for the training set:
Not applicable. This is not an AI/ML device, so there is no training set in that context. The "training" for this device is the established pharmaceutical manufacturing processes and USP standards.

9. How the ground truth for the training set was established:
Not applicable. The manufacturing processes are established by pharmaceutical standards and quality control protocols.

Summary of the Study/Testing:

The study proving the device meets the acceptance criteria is a non-clinical testing summary that demonstrates the product's physicochemical properties and sterility align with relevant standards (USP) and are substantially equivalent to predicate devices. This involves:

Lot Release Testing by Asept Pak: This ensures each lot meets specifications.
In Process Testing: Includes incoming resin certification, water testing, pH measurement, appearance checks, salinity, environmental monitoring, container fill weight monitoring, and visual inspection.
Finished Product Tests: Includes salinity, identification of sodium (USP 191), sodium chloride assay (USP Monograph), and sterility (USP <71>).

The conclusion is based on this performance testing, design features, and comparison to predicate devices, leading to a finding of substantial equivalence. The "study" here is essentially a comprehensive quality control and analytical chemistry assessment, rather than a clinical trial or AI/ML performance study.

Summary

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

510(k) Summary Page 1 of 4 21-Feb-13

MAR 1 3 2013

PharmaCaribe3513 Di Leuca St.Punta Gorda, FL 33950	Tel – (941) 505-0793Fax – (941) 505-0718
Official Contact:	W. Randolph Warner, Managing Partner
Trade Name:	PulmoSalTM inhaled saline solution
Common/Usual Name:	Saline solution
Classification Name:	CAF – Nebulizer (Direct Patient Interface)CFR – 868.5630, Class 2
Device:	Inhaled saline solutions – 0.9%, 3%, 3.5%, 6%, 7%, and 10%with a pH of 7.4
Predicate Device:	PharmaCaribe – Sodium Inhalation solutions - K101424

Device Description:

The proposed inhaled saline solutions are in 0.9%, 3%, 3.5%, 6%, 7%, and 10% concentrations with a pH of 7.4. They are packaged sterile in 4 ml vials for use as indicated.

Indications for Use:

PharmaCaribe inhaled saline solutions are used in conjunction with a nebulizer. The contents of these vials are for the induction of sputum production when used in conjunction with a nebulizer.

Concentrations of 0.9%, 3%, 3.5%, 6%, 7%, and 10% with a pH of 7.4

Patient Population:

Any patient requiring induction of sputum production.

Environment of Use:

Hospital, sub-acute care or home

Contraindications:

None

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

510(k) Summary Page 2 of 4 21-Feb-13

Predicate Device Comparison:

The PulmoSal™ inhaled saline solution is viewed as substantially equivalent to the predicate devices because:

Indications -

Intended to be in conjunction with a nebulizer for sputum production is identical to the . predicate PharmaCaribe Inhaled Saline Solutions (K101424)
Discussion - identical to the predicate PharmaCaribe Inhaled Saline Solutions (K 101424) except the addition of 0.9% saline and a pH of 7.4.

Technology of Manufacturing-

A homogeneous aqueous mixtures of sterile water and saline . Discussion - identical to the predicate PharmaCaribe Inhaled Saline Solutions (K 101424)

Mode of Action -

Used with a nebulizer to increase sputum production .
Discussion - identical to the predicate PharmaCaribe Inhaled Saline Solutions (K101424)

Formulation -

Based upon USP specification except pH of 7.4 which matches the pH of the lungs .
3%, 3.5%, 6%, 7% and 10% solutions identical to the predicate PharmaCaribe Inhaled . Saline Solutions (K 101424)
0.9% solution is identical to the predicate Nephron Pharma Sodium Chloride Inhalation . solution (K113033)

Discussion - the concentrations are identical to the predicates PharmaCaribe Inhaled Saline Solutions (K101424) and Nephron Pharma – Sodium Chloride Inhalation solution (K11303). The pH of 7.4 is identical pH Pulmicort Respules" (budesonide) AstraZeneca, which has a 7.4 pH, was approved under (NDA # N020929 an inhaled drug.

Materials -

Blow-fill-sealed low density polyethylene (LDPE) vial containing sterile, preservative-. free, clear, colorless, aqueous solution of sodium chloride in various concentrations by weight / volume. The formulation contains no additives.
Discussion - identical to the predicate PharmaCaribe Inhaled Saline Solutions (K 101424)

Environment of Use -

Hospital, home, sub-acute care settings .
Discussion - identical to the predicate PharmaCaribe Inhaled Saline Solutions (K 101424)

Patient Population -

Any patient requiring induction of sputum production. ● Discussion - identical to the predicate PharmaCaribe Inhaled Saline Solutions (K 101424)

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

510(k) Summary Page 3 of 4 21-Feb-13

Features	ProposedPulmoSal ™ Inhaled salinesolution	PredicatePharmaCaribe K101424
Indications for use	PharmaCaribe inhaled saline solutionsare used in conjunction with anebulizer.The contents of these vials are for theinduction of sputum production.	PharmaCaribe inhaled salinesolutions are used in conjunctionwith a nebulizer.The contents of these vials are forthe induction of sputum productionwhen used in conjunction with anebulizer.
Prescription	Yes	Yes
Environment of Use	Home, Hospital, Sub-acuteInstitutions	Home, Hospital, Sub-acuteInstitutions
Patient Population	Any patient requiring induction ofsputum production.	Any patient requiring induction ofsputum production.
Contraindications	None	None
Materials in fluid contact	Vial LDPE	Vial LDPE
Sterile water	Yes	Yes
Solutions	3%, 3.5%, 6%, 7% and 10%0.9%	3%, 3.5%, 6%, 7% and 10%0.9% - K113033 - Nephron Pharma- USP pH
pH	7.4	USP 4.5 to 7.0
Manufactured	Per USP monograph except pH	Per USP monograph
Supplied	Sterile	Sterile
Used with a nebulizer	Yes	Yes

Non-clinical Testing Summary -

Asept Pak will perform Lot Release testing. The concentrations meet the USP Specifications with exception having a pH of 7.4, which is a normal physiological value. Additional performance testing includes:

In Process testing includes:

Incoming resin certification and testing .
Current USP water testing .
pH as per USP <791> .
Appearance .
Salinity .
Environmental monitoring per Asept SOPs .
Container Fill weight monitoring ●
Visual 100% inspection .

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

510(k) Summary Page 4 of 4 21-Feb-13

Finished Product Tests

. Salinity
. Identification of Sodium per USP (191)
. Sodium Chloride Assay per USP Monograph
Sterility as per USP <71> .

The above demonstrates that the proposed devices are substantially equivalent to the predicate devices.

Substantial Equivalence Conclusion -

The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to substantially equivalent.

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

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white.

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

March 13, 2013

PharmaCaribe C/O Mr. Paul Dryden President ProMedic. Incorporated 24301 Woodsage Drive BONITA SPRINGS FL 34134

Re: K130091

Trade/Device Name: PulmoSalTM Inhaled Saline Solution Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: February 21, 2013 Received: February 22, 2013

Dear Mr. Dryden:

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.

{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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kwame O. Ulmer for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use Statement

510(k) Number:	K130091 (To be assigned)
Device Name:	PulmoSal TM Inhaled saline solution
Indications for Use:	PharmaCaribe inhaled saline solutions are used in conjunction with a nebulizer. The contents of these vials are for the induction of sputum production where sputum production is indicated.
	Concentrations of 0.9%, 3%, 3.5%, 6%, 7%, and 10% with a pH of 7.4

Prescription Use XX(Part 21 CFR 801 Subpart D)	or	Over-the-counter use __(21 CFR 807 Subpart C)
----------------------------------------------------	----	---------------------------------------------------

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Albert E

c=US, o=U.S. Government,
ou=HHS; ou=FDA, ou=People,
0.9.2342.19200300.100.1.1=130
0059331; cn=Albert E. Moyal -S
2013.03.07 16:55:28 -05'00'

Moyal S L for LS
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K130091

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).