(142 days)
Not Found
No
The device is sterile water for inhalation and its description and testing focus on its physical, chemical, and biological properties, packaging, and sterilization, with no mention of AI or ML.
No
The device, Sterile Water for Inhalation, USP, is intended to provide sterile water for respiratory humidifier chambers. It is not described as performing a therapeutic function itself, but rather as supplying a component for a larger therapy delivery system.
No
The device, "Sterile Water for Inhalation, USP," is intended to provide sterile water to humidifier chambers for inhalation therapy. Its description and intended use do not involve diagnosing a disease or condition. The performance studies focus on the quality and integrity of the water and its packaging, not on diagnostic capabilities.
No
The device is a physical product (sterile water in bottles) and the summary describes extensive testing related to the physical properties of the water, the packaging, biocompatibility, and sterilization. There is no mention of software as a component or function of the device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to provide sterile water for respiratory humidifier chambers. This is a direct application to a medical device used for patient care (inhalation therapy), not for testing samples taken from the human body.
- Device Description: The description focuses on the container and the sterile water itself, not on reagents, calibrators, or other components typically associated with IVDs.
- Performance Studies: The performance studies focus on the physical and biological properties of the water and its packaging (sterility, purity, biocompatibility, packaging integrity), not on the accuracy or precision of measuring a substance in a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
In summary, the device is a sterile medical product used in conjunction with other medical devices for patient treatment (inhalation therapy), not for diagnostic testing.
N/A
Intended Use / Indications for Use
Sterile Water for Inhalation, USP is intended to provide a supply of sterile water to unfilled respiratory humidifier chambers. It is intended to be used in institutional and non-institutional care settings.
Product codes
BTT
Device Description
Sterile Water for Inhalation, USP is a sterile, single-dose medical device provided in durable Polypropylene (PP) bottles, which are resistant to breakage and designed for safe and easy handling. The bottles are available with two types of closures:
- A 36 mm PP screw cap with a PP/PET aluminium induction seal .
- A 28mm bromobutyl stopper with an aluminium seal .
The bottles are available in the following volume configurations: - . 1000mL PP bottles with either a bromobutyl stopper and aluminium seal, or a PP/PET aluminium induction seal, PP screw cap, and tamper-evident plastic shrink wrap.
- 500mL PP bottles with a PP/PET aluminium induction seal, PP screw cap, and tamper-. evident plastic shrink wrap.
Sterile Water for Inhalation, USP is not for parenteral administration or irrigation. The product is For Inhalation Therapy Only. It is supplied sterile and intended for single use only. Discard any unused portion.
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
institutional and non-institutional care settings.
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)
PHYSICOCHEMICAL AND BIOLOGICAL TESTING: The tests listed below for Sterile Water for Inhalation, USP were performed using USP methods and internally validated procedures. The following tests were conducted on the subject device.
- Total Organic Carbon (TOC) -
- -Water Conductivity
- Process Bioburden -
- Volume in Container -
- Sterility -
- Bacterial Endotoxin -
- -Appearance
Based on these tests, Laboratorios Biogalenic S.A. de C.V. has demonstrated that the device functions as intended, supporting substantial equivalence.
PACKAGING TESTS: Specific tests conducted on the device demonstrate that it performs as intended and supports substantial equivalence. The results from the tests indicate with the criteria for each test and provide valuable data on the expected performance of the packaging, ensuring it functions as required. The observed results are:
- Resistance to Leakage (ASTM D3078-02): No leaking or deformation of bottles. .
- . Hermeticity (ASTM F1929-23): Compliance with hermeticity requirements.
- Resistance to Pressure (ASTM F1140/F1140M): The device withstands the required . pressure limits.
- Resistance to Rupture (ASTM D642): The device resists rupture under specified . conditions.
- Resistance to Damage from Dropping Tests (ISO 15747:2018): The device remains . intact and functional after dropping tests.
These results validate the device packaging integrity and durability, confirming its suitability for the intended use.
BIOCOMPATIBILITY: Biocompatibility testing performed in accordance with ISO 10993-1:2018: Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process. The following testing were performed to demonstrate substantial equivalence:
- In Vitro Cytotoxicity (L929 Cell Line) conducted per ISO 10993-5:2009, Third Edition: Biological Evaluation of Medical Devices: Tests for in vitro cytotoxicity
- Sensitization (Guinea Pig Maximization Test) conducted per ISO 10993-10:2021 Fourth -Edition: Biological Evaluation of Medical Devices: Tests for Skin Sensitization
- Intracutaneous Reactivity conducted per ISO 10993-12:2021, First Edition: Biological -Evaluation of Medical Devices: Tests for Irritation
- Material Mediated Pyrogenicity conducted per ISO 10993-11:2017 Third Edition: -Biological Evaluation of Medical Devices: Tests for Systemic Toxicity
- Extractable/leachable testing per ISO 10993-18:2020/Amd1:2022:Biological Evaluation of Medical Devices: Chemical Characterization of Medical Devices within a Risk Management Process
- Toxicological risk assessment conducted per ISO 10993-17:2023 Biological Evaluation of Medical Devices: Establishment of Allowable Limits for Leachable Substances on the Detected Chemicals within the Extract
STERILIZATION VALIDATION: The sterilization process was performed in accordance with PDA Technical Report No. 1 (Revised 2007), FDA Guidance for Industry for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products, ISO 17665 Sterilization of Health care Products-Moist Heat, which outlines the validation of moist heat sterilization processes, including cycle design, development, qualification, and ongoing control. This process was qualified and is considered robust for controlling hold times during sterilization. The Sterile Water for Inhalation, USP, was validated for sterilization using steamair to achieve a Sterility Assurance Level (SAL) of 10 °. Geobacillus stearothermophilus, known for its resistance to moist heat, was used as a biological indicator, and no growth was observed after being subjected to the sterilization cycle and after incubated for 48 hours at 55°C ± 2 °C no growth occurred indicating that the sterilization conditions were achieved . This process ensures that the Sterile Water for Inhalation, USP is sterile at the point of use. The product was sterilized at 121℃ to 122℃ for a period of 108 minutes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
January 30, 2025
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health & Human Services logo, which features a stylized human figure. To the right of this is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Laboratorios Biogalenic, S.A. DE C.V. Roberto Quiñonez Plant Director Calle Claper, Blvd. Del Ejercito Nacional km 5.5, Soyapango San Salvador, SV 1639 El Salvador
Re: K242717
Trade/Device Name: Laboratorios Biogalenic Sterile Water for Inhalation, USP Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: Class II Product Code: BTT Dated: January 3, 2025 Received: January 3, 2025
Dear Roberto Quiñonez:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Ethan L. Nyberg -S
Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Laboratorios Biogalenic Sterile Water for Inhalation, USP
Indications for Use (Describe)
Sterile Water for Inhalation, USP is intended to provide a supply of sterile water to unfilled respiratory humidifier chambers. It is intended to be used in institutional and non-institutional care settings.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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4
Image /page/4/Picture/0 description: The image shows the logo for "Laboratorios Biogalenic S.A. DE C.V.". The logo features a stylized symbol to the left of the text "BIOGALENIC" in a bold, sans-serif font. Above the text "BIOGALENIC" is the word "LABORATORIOS" in a smaller font. Below the text "BIOGALENIC" is the text "S.A. DE C.V." in a smaller font.
Calle Claper, Blvd. Del Ejercito Nacional km 5.5, Soyapango, San Salvador, 1639 SV
510 (k) SUMMARY
STERILE WATER FOR INHALATION, USP
APPLICANT
| Company Name | : | Laboratorios Biogalenic, S.A. DE C.V. |
|---|---|---|
| Company Address | : | Calle Claper, Blvd. Del Ejercito Nacional km 5.5, |
| Soyapango, San Salvador, 1639 SV | ||
| Company Phone | : | +503-2227-4133 EXT 106 |
| Company Fax | : | +503-2227-4466 |
| Company Email | : | r.q@biogalenic.com.sv, biogal@biogalenic.com.sv |
| Contact Person | : | Roberto Quiñonez |
| Designation | : | Plant Director |
| Phone | : | +503-2227-4133 EXT 106 |
| : | r.q@biogalenic.com.sv | |
| Date Summary Prepared | : | July 25th, 2024 |
DEVICE IDENTIFICATION
| Common Name of the device | Sterile Water for Inhalation, USP |
|---|---|
| Device Trade Name | Laboratorios Biogalenic Sterile Water for Inhalation, |
| USP | |
| Device Classification Name | Respiratory gas humidifier |
| Device Regulation Number | 21 CFR 868.5450 |
| Device Classification | Class II |
| Product code | BTT |
| Classification Panel | Anesthesiology |
5
Image /page/5/Picture/0 description: The image shows the logo for Laboratorios Biogalenic S.A. DE C.V. The logo features a stylized symbol to the left of the text "LABORATORIOS BIOGALENIC". Below the text is "S.A. DE C.V."
Calle Claper, Blvd. Del Ejercito Nacional km 5.5, Soyapango, San Salvador, 1639 SV
510 (k) SUMMARY
STERILE WATER FOR INHALATION, USP
PREDICATE DEVICE
Laboratorios Biogalenic S.A. de C.V. identified the following legally marketed device as
substantially equivalent:
| Predicate Device | Applicant | 510(k) Number |
|---|---|---|
| Sterile Water for Inhalation 1L Flexoval® Bottles | Hometa Inc | K223551 |
DEVICE DESCRIPTION
Sterile Water for Inhalation, USP is a sterile, single-dose medical device provided in durable Polypropylene (PP) bottles, which are resistant to breakage and designed for safe and easy handling. The bottles are available with two types of closures:
- A 36 mm PP screw cap with a PP/PET aluminium induction seal .
- A 28mm bromobutyl stopper with an aluminium seal .
The bottles are available in the following volume configurations:
- . 1000mL PP bottles with either a bromobutyl stopper and aluminium seal, or a PP/PET aluminium induction seal, PP screw cap, and tamper-evident plastic shrink wrap.
- 500mL PP bottles with a PP/PET aluminium induction seal, PP screw cap, and tamper-. evident plastic shrink wrap.
Sterile Water for Inhalation, USP is not for parenteral administration or irrigation. The product is For Inhalation Therapy Only. It is supplied sterile and intended for single use only. Discard any unused portion.
INDICATIONS FOR USE
The Sterile Water for Inhalation. USP is intended to provide a supply of sterile water to unfilled respiratory humidifier chambers. It is intended to be used in institutional and non-institutional care settings.
6
BIOGALENIC
S.A. DE C.V.
Calle Claper, Blvd. Del Ejercito Nacional km 5.5, Soyapango, San Salvador, 1639 SV
510 (k) SUMMARY
STERILE WATER FOR INHALATION, USP
NON-CLINICAL PERFORMANCE TESTING
PHYSICOCHEMICAL AND BIOLOGICAL TESTING: The tests listed below for Sterile Water for Inhalation, USP were performed using USP methods and internally validated procedures. The following tests were conducted on the subject device.
- Total Organic Carbon (TOC) -
- -Water Conductivity
- Process Bioburden -
- Volume in Container -
- Sterility -
- Bacterial Endotoxin -
- -Appearance
Based on these tests, Laboratorios Biogalenic S.A. de C.V. has demonstrated that the device functions as intended, supporting substantial equivalence.
PACKAGING TESTS
Specific tests conducted on the device demonstrate that it performs as intended and supports substantial equivalence. The results from the tests indicate with the criteria for each test and provide valuable data on the expected performance of the packaging, ensuring it functions as required. The observed results are:
- Resistance to Leakage (ASTM D3078-02): No leaking or deformation of bottles. .
- . Hermeticity (ASTM F1929-23): Compliance with hermeticity requirements.
- Resistance to Pressure (ASTM F1140/F1140M): The device withstands the required . pressure limits.
- Resistance to Rupture (ASTM D642): The device resists rupture under specified . conditions.
- Resistance to Damage from Dropping Tests (ISO 15747:2018): The device remains . intact and functional after dropping tests.
These results validate the device packaging integrity and durability, confirming its suitability for the intended use.
7
LABORATORIOS
BIOGALENIC
S.A. DE C.V.
Calle Claper, Blvd. Del Ejercito Nacional km 5.5, Soyapango, San Salvador, 1639 SV
510 (k) SUMMARY
STERILE WATER FOR INHALATION, USP
BIOCOMPATIBILITY
Biocompatibility testing performed in accordance with ISO 10993-1:2018: Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process. The following testing were performed to demonstrate substantial equivalence:
- In Vitro Cytotoxicity (L929 Cell Line) conducted per ISO 10993-5:2009, Third Edition: । Biological Evaluation of Medical Devices: Tests for in vitro cytotoxicity
- Sensitization (Guinea Pig Maximization Test) conducted per ISO 10993-10:2021 Fourth -Edition: Biological Evaluation of Medical Devices: Tests for Skin Sensitization
- Intracutaneous Reactivity conducted per ISO 10993-12:2021, First Edition: Biological -Evaluation of Medical Devices: Tests for Irritation
- Material Mediated Pyrogenicity conducted per ISO 10993-11:2017 Third Edition: -Biological Evaluation of Medical Devices: Tests for Systemic Toxicity
- Extractable/leachable testing per ISO 10993-18:2020/Amd1:2022:Biological Evaluation of Medical Devices: Chemical Characterization of Medical Devices within a Risk Management Process
- Toxicological risk assessment conducted per ISO 10993-17:2023 Biological Evaluation of Medical Devices: Establishment of Allowable Limits for Leachable Substances on the Detected Chemicals within the Extract
STERILIZATION VALIDATION
The sterilization process was performed in accordance with PDA Technical Report No. 1 (Revised 2007), FDA Guidance for Industry for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products, ISO 17665 Sterilization of Health care Products-Moist Heat, which outlines the validation of moist heat sterilization processes, including cycle design, development, qualification, and ongoing control. This process was qualified and is considered robust for controlling hold times during sterilization. The Sterile Water for Inhalation, USP, was validated for sterilization using steamair to achieve a Sterility Assurance Level (SAL) of 10 °. Geobacillus stearothermophilus, known for its resistance to moist heat, was used as a biological indicator, and no growth was observed
8
LABORATORIOS
BIOGALENIC
S.A. DE C.V.
Calle Claper, Blvd. Del Ejercito Nacional km 5.5, Soyapango, San Salvador, 1639 SV
510 (k) SUMMARY
STERILE WATER FOR INHALATION, USP
after being subjected to the sterilization cycle and after incubated for 48 hours at 55°C ± 2 °C no growth occurred indicating that the sterilization conditions were achieved . This process ensures that the Sterile Water for Inhalation, USP is sterile at the point of use. The product was sterilized at 121℃ to 122℃ for a period of 108 minutes.
SUBSTANTIAL EQUIVALENCE
The comparison between the subject device and the predicate device shows that both devices have the same indications for use, specifically, providing a supply of sterile water for inhalation to humidifier chambers. Both devices share the same BTT classification and are manufactured using the same sterile water as the primary material, packaged in disposable plastic containers. They are similar in design and technological characteristics. Various physicochemical, performance, and biological testing have demonstrated that differences in primary packaging and sterilization temperatures do not pose any significant issues. The subject device functions as intended.
The following Substantial Equivalence Comparison Table summarizes the key features of the subject device compared to the predicate device.
9
Image /page/9/Picture/0 description: The image shows the logo for LABORATORIOS BIOGALENIC S.A. DE C.V. The logo features a stylized symbol to the left of the text "LABORATORIOS BIOGALENIC". Below the text is "S.A. DE C.V."
Calle Claper, Blvd. Del Ejercito Nacional km 5.5, Soyapango, San Salvador, 1639 SV
510 (k) SUMMARY
| Section | Proposed Device
(Sterile Water for Inhalation, USP) | Predicate Device
(Sterile Water for Inhalation in 1L
Flexoval ® Bottles) | Result |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| 510(k) Number | This Submission | K223551 | - |
| Manufacturer | Laboratorios Biogalenic S.A. de C.V. | Hometa Inc | - |
| Device Trade Name | Laboratorios Biogalenic Sterile Water for
Inhalation, USP | Sterile Water for Inhalation in 1L
Flexoval ® Bottles | - |
| Generic/ Common Name | Sterile Water for Inhalation, USP | Sterile Water for Inhalation | - |
| Regulation Number | 21 CFR 868.5450 | 21 CFR 868.5450 | Same |
| Regulation Name | Respiratory Gas Humidifier | Respiratory Gas Humidifier | Same |
| Classification Panel | Anesthesiology | Anesthesiology | Same |
| Device Class | Class II | Class II | Same |
| Product Code | BTT | BTT | Same |
| Section | Proposed Device
(Sterile Water for Inhalation, USP) | Predicate Device
(Sterile Water for Inhalation in 1L
Flexoval ® Bottles) | Result |
| Indication For Use | Sterile Water for Inhalation, USP is
intended to provide a supply of sterile water
to unfilled respiratory humidifier chambers.
It is intended to be used in institutional and
non-institutional care settings. | The Sterile Water for Inhalation
Flexoval® Bottle is intended to
provide a supply of sterile water to
unfilled respiratory humidifier
chambers. It is intended to be used in
institutional and non- institutional care
settings by qualified staff.
The Sterile Water for Inhalation is
intended for use in all patient
populations including adults,
pediatrics, infants and neonates. | The predicate device and
proposed device have the
same indications for use |
| Prescription Use or OTC Use | Prescription Use | Prescription Use | Same |
| Single-Use | Yes | Yes | Same |
| Section | Proposed Device
(Sterile Water for Inhalation, USP) | Predicate Device
(Sterile Water for Inhalation in 1L
Flexoval ® Bottles) | Result |
| Design | The device is a flexible PP bottle prefilled
with sterile water. It features a spikeable
bromobutyl closure used to transfer the
sterile water to humidifier chambers using
tubular sets. The bottle includes an
integrated hanger that is used to suspend the
product during usage. Additionally, the
device is available in a flexible pour PP
bottle with a PP/PET aluminum induction
seal and a PP screw cap, also prefilled with
sterile water. The pour bottle is used to
refill the sterile water in humidifier
chambers. | The device is a flexible bottle made of
LDPE. The bottle is prefilled with
sterile water. It has a spikeable rubber
disc that is used to transfer the sterile
water to the humidifier chambers
using tubular sets. It also has an
integrated hanger that is used to
suspend the product during usage. | Similar
(SE#1) |
| Section | Proposed Device
(Sterile Water for Inhalation, USP) | Predicate Device
(Sterile Water for Inhalation in 1L
Flexoval ® Bottles) | Result |
| Model/Sizes | The models include three configurations of PP bottles:
- 1000mL PP bottles with either a bromobutyl stopper and aluminium seal, or a PP/PET aluminium induction seal, PP screw cap, and tamper-evident plastic shrink wrap.
- 500mL PP bottles with a PP/PET aluminium induction seal, PP screw cap, and tamper-evident plastic shrink wrap. | 1000ml flexible bottle made of LDPE.
The bottle is prefilled with same sterile water as the predicate. It has a spikeable rubber disc | Similar
(SE#2) |
| Section | Proposed Device
(Sterile Water for Inhalation, USP) | Predicate Device
(Sterile Water for Inhalation in 1L
Flexoval ® Bottles) | Result |
| Mechanism of Action | Sterile Water for Inhalation, USP, is used to
humidify air in respiratory therapy. It is
transferred to a humidifier chamber where
it is heated to produce water vapor. This
vapor mixes with medical gases or air,
ensuring the delivered air is moist. This
prevents drying of the patient's airways,
maintains mucous membrane moisture,
enhances patient comfort and reduces the
risk of respiratory complications. | The Sterile Water for Inhalation
Flexoval® Bottle, is used to humidify
air in respiratory therapy. It is
transferred to a humidifier chamber
where it is heated to produce water
vapor. This vapor mixes with medical
gases or air, ensuring the delivered air
is moist. This process prevents the
drying of the patient's airways,
maintains mucous membrane
moisture, enhances patient comfort,
and reduces the risk of respiratory
complications. | Same |
| Section | Proposed Device
(Sterile Water for Inhalation, USP) | Predicate Device
(Sterile Water for Inhalation in 1L Flexoval ® Bottles) | Result |
| Biocompatibility | Meets the requirements of ISO 10993 | Meets the requirements of ISO 10993 | Same |
| Spike Access & Hanger | The 1000mL PP bottle with bromobutyl stopper and aluminum seal variant has Spike Access and Hanger | Universal Rubber Disc with 1 Standard Hanger | Similar
(SE#3) |
| Container Clarity | Clear | Clear | Same |
| Chemical Composition | Sterile Water, USP | Sterile Water | Same |
| Packaging Material | Polypropylene | LDPE | Similar
(SE#4) |
| Sterilization Method | Steam Air | Moist Heat | Same |
| Tamper Evidence | Yes | Yes | Same |
| Section | Proposed Device
(Sterile Water for Inhalation, USP) | Predicate Device
(Sterile Water for Inhalation in 1L
Flexoval ® Bottles) | Result |
| Compounding | Water for the compounding is produced
from drinking water that is purified in its
final stage by distillation that demonstrates
the elimination of chemicals,
microorganisms and endotoxins and does
not contain any added substances.
Sterile water is filled in compounding tanks
at 70°C and filled via bottle filling machine
into bottles. | Water for the compounding is
produced from drinking water that is
purified in its final stage by
distillation or other equivalent or
superior technology that demonstrates
the elimination of chemicals,
microorganisms and endotoxins and
does not contain any added
substances. Sterile water is filled in
compounding tanks at 70°C and filled
via BFS into bottles. | Same |
10
Image /page/10/Picture/0 description: The image shows the logo for Laboratorios Biogalenic S.A. de C.V. The logo features a stylized caduceus symbol to the left of the text "LABORATORIOS BIOGALENIC". Below the text is "S.A. DE C.V."
Calle Claper, Blvd. Del Ejercito Nacional km 5.5, Soyapango, San Salvador, 1639 SV
510 (k) SUMMARY
11
Image /page/11/Picture/0 description: The image shows the logo for LABORATORIOS BIOGALENIC S.A. DE C.V. The logo features a stylized caduceus symbol to the left of the text "LABORATORIOS BIOGALENIC". Below the text is "S.A. DE C.V.", which is smaller than the other text.
Calle Claper, Blvd. Del Ejercito Nacional km 5.5, Soyapango, San Salvador, 1639 SV
510 (k) SUMMARY
12
Image /page/12/Picture/0 description: The image shows the logo for Laboratorios Biogalenic S.A. de C.V. The logo features a stylized caduceus symbol to the left of the text "BIOGALENIC". Above the company name is the word "LABORATORIOS", and below it is "S.A. DE C.V."
Calle Claper, Blvd. Del Ejercito Nacional km 5.5, Soyapango, San Salvador, 1639 SV
510 (k) SUMMARY
13
Image /page/13/Picture/0 description: The image shows the logo for LABORATORIOS BIOGALENIC S.A. DE C.V. The logo features a stylized caduceus symbol to the left of the text "LABORATORIOS BIOGALENIC". Below the text is "S.A. DE C.V.", which is smaller than the main text.
Calle Claper, Blvd. Del Ejercito Nacional km 5.5, Soyapango, San Salvador, 1639 SV
510 (k) SUMMARY
14
Image /page/14/Picture/0 description: The image shows the logo for LABORATORIOS BIOGALENIC S.A. DE C.V. The logo consists of a stylized symbol to the left of the text "LABORATORIOS BIOGALENIC" in a bold, sans-serif font. Below the text is "S.A. DE C.V." in a smaller font size. The entire logo is in black and white.
Calle Claper, Blvd. Del Ejercito Nacional km 5.5, Soyapango, San Salvador, 1639 SV
510 (k) SUMMARY
15
Image /page/15/Picture/0 description: The image shows the logo for LABORATORIOS BIOGALENIC S.A. DE C.V. The logo features a stylized caduceus symbol to the left of the text "LABORATORIOS BIOGALENIC". Below the text is "S.A. DE C.V.", which is smaller than the main text.
Calle Claper, Blvd. Del Ejercito Nacional km 5.5, Soyapango, San Salvador, 1639 SV
510 (k) SUMMARY
16
Image /page/16/Picture/0 description: The image shows the logo for Laboratorios Biogalenic S.A. de C.V. The logo features a stylized symbol to the left of the text "BIOGALENIC" in a bold, sans-serif font. Above the text is the word "LABORATORIOS" in a smaller font. Below the main text is "S.A. DE C.V." also in a smaller font.
Calle Claper, Blvd. Del Ejercito Nacional km 5.5, Soyapango, San Salvador, 1639 SV
510 (k) SUMMARY
STERILE WATER FOR INHALATION, USP
CONCLUSION
Based on the available information, Laboratorios Biogalenic, S.A. de C.V. concludes that Sterile Water for Inhalation, USP is substantially equivalent in terms of indications for use, design, and function to the existing legally marketed devices under the Federal Food, Drug, and Cosmetic Act. Therefore, the subject device is determined to be substantially equivalent to the predicate device.