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K Number
K130091
Device Name
PULMOSAL
Manufacturer
PHARMACARIBE
Date Cleared
2013-03-13

(57 days)

Product Code
CAF
Regulation Number
868.5630
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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
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.
More Information

K101424, K113033

Not Found

No
The device is a saline solution, and the summary describes standard chemical and sterility testing, with no mention of AI or ML.

No.
The intended use of the device is for the induction of sputum production, which is a diagnostic aid rather than a direct therapeutic treatment for a disease or condition. While it may assist in diagnosis, it does not treat or prevent a disease.

No

The device is a saline solution used for inducing sputum production, not for diagnosing a condition.

No

The device description clearly states it is an inhaled saline solution packaged in vials, which is a physical substance, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for the "induction of sputum production where sputum production is indicated." This is a therapeutic or diagnostic aid in vivo (within the body), not a test performed in vitro (outside the body) on a sample from the body to diagnose a condition.
  • Device Description: The device is a saline solution for inhalation, used in conjunction with a nebulizer. This is a drug-like product administered to the patient.
  • Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or the use of reagents to detect specific substances.

IVD devices are typically used to perform tests on samples taken from the body to provide information about a patient's health status, diagnose diseases, or monitor treatment. This device's function is to facilitate the collection of a sample (sputum) through a physiological process, not to analyze the sample itself.

N/A

Intended Use / 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

Product codes

CAF

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Hospital, sub-acute care or home

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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
  • Appearance
  • Salinity
  • Environmental monitoring per Asept SOPs
  • Container Fill weight monitoring
  • Visual 100% inspection

Finished Product Tests

  • Salinity
  • Identification of Sodium per USP (191)
  • Sodium Chloride Assay per USP Monograph
  • Sterility as per USP

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K101424, K113033

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

0

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

MAR 1 3 2013

| PharmaCaribe
3513 Di Leuca St.
Punta Gorda, FL 33950 | Tel – (941) 505-0793
Fax – (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 | Proposed
PulmoSal ™ Inhaled saline
solution | Predicate
PharmaCaribe K101424 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | 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. |
| Prescription | Yes | Yes |
| Environment of Use | Home, Hospital, Sub-acute
Institutions | Home, Hospital, Sub-acute
Institutions |
| Patient Population | Any patient requiring induction of
sputum production. | Any patient requiring induction of
sputum 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 .
  • 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 .

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