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.

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.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called "Laboratorios Biogalenic Sterile Water for Inhalation, USP." This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.

It's important to note that this document does not describe a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device performance evaluation. Instead, it's a regulatory submission demonstrating the substantial equivalence of a general medical device (sterile water for inhalation) to an existing one. The "acceptance criteria" here refer to regulatory requirements for substantial equivalence, not performance metrics like sensitivity, specificity, or AUC as seen in AI/ML device evaluations.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable to the information provided in this document as it relates to an AI/ML device.

However, I can extract information related to the "performance testing" conducted for this non-AI/ML device to demonstrate its substantial equivalence to the predicate device.

Summary of Acceptance Criteria and Device Performance (Non-AI/ML Device)

The "Laboratorios Biogalenic Sterile Water for Inhalation, USP" is a non-AI/ML medical device. Its acceptance criteria and performance are assessed through physicochemical, biological, packaging, and biocompatibility testing to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Specific Test	Acceptance Criteria (Implied by "demonstrated that the device functions as intended" and "compliance with requirements")	Reported Device Performance (Summary)
Physicochemical & Biological Testing (USP Methods)	Total Organic Carbon (TOC)	Meets USP methods and internally validated procedures.	Functions as intended.
	Water Conductivity	Meets USP methods and internally validated procedures.	Functions as intended.
	Process Bioburden	Meets USP methods and internally validated procedures.	Functions as intended.
	Volume in Container	Meets USP methods and internally validated procedures.	Functions as intended.
	Sterility	Meets USP methods and internally validated procedures (e.g., SAL of 10⁻⁶).	Sterile (no growth of Geobacillus stearothermophilus after sterilization).
	Bacterial Endotoxin	Meets USP methods and internally validated procedures.	Functions as intended.
	Appearance	Meets USP methods and internally validated procedures.	Functions as intended.
Packaging Tests	Resistance to Leakage (ASTM D3078-02)	No leaking or deformation.	No leaking or deformation of bottles.
	Hermeticity (ASTM F1929-23)	Compliance with hermeticity requirements.	Compliance with hermeticity requirements.
	Resistance to Pressure (ASTM F1140/F1140M)	Withstands required pressure limits.	The device withstands the required pressure limits.
	Resistance to Rupture (ASTM D642)	Resists rupture under specified conditions.	The device resists rupture under specified conditions.
	Resistance to Damage from Dropping Tests (ISO 15747:2018)	Remains intact and functional.	The device remains intact and functional.
Biocompatibility	In Vitro Cytotoxicity (ISO 10993-5)	Meets requirements of ISO 10993-1:2018.	Testing performed to demonstrate substantial equivalence.
	Sensitization (ISO 10993-10)	Meets requirements of ISO 10993-1:2018.	Testing performed to demonstrate substantial equivalence.
	Intracutaneous Reactivity (ISO 10993-12)	Meets requirements of ISO 10993-1:2018.	Testing performed to demonstrate substantial equivalence.
	Material Mediated Pyrogenicity (ISO 10993-11)	Meets requirements of ISO 10993-1:2018.	Testing performed to demonstrate substantial equivalence.
	Extractable/leachable testing (ISO 10993-18)	Meets requirements of ISO 10993-1:2018.	Testing performed to demonstrate substantial equivalence.
	Toxicological risk assessment (ISO 10993-17)	Meets requirements of ISO 10993-1:2018.	Testing performed to demonstrate substantial equivalence.
Sterilization Validation	Sterility Assurance Level (SAL)	Achieves SAL of 10⁻⁶.	Achieved SAL of 10⁻⁶ (no Geobacillus stearothermophilus growth).

2. Sample size used for the test set and the data provenance:

The document does not specify a distinct "test set" in the context of an AI/ML algorithm. The tests described are laboratory-based validation tests performed on samples of the manufactured device.
The provenance of the data (e.g., country of origin, retrospective/prospective) is not detailed for these specific tests. These are standard validation tests for manufacturing processes and product integrity.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This concept is not applicable as there is no "ground truth" derived from expert consensus for a diagnostic medical device in this context. The validity of the tests (e.g., sterility, leak resistance) is determined by established scientific methods and standards (USP, ASTM, ISO).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. The tests are laboratory-based with objective outcomes against defined standards.

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, as this is not an AI/ML device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable, as this is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device's performance is established by scientific standards and analytical methods defined in regulations and industry standards (e.g., USP for sterility, ASTM for packaging, ISO for biocompatibility and sterilization). It's not based on expert consensus, pathology, or outcomes data in the way it would be for a diagnostic AI/ML device.

8. The sample size for the training set:

Not applicable, as this is not an AI/ML device. There is no training set for an algorithm.

9. How the ground truth for the training set was established:

Not applicable, as this is not an AI/ML device.

Summary

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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"

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(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).

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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

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K242717

Device Name

Laboratorios Biogalenic Sterile Water for Inhalation, USP

Indications for Use (Describe)

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.

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."

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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
Email	:	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

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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

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.

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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.

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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

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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.

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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 1LFlexoval ® 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 forInhalation, USP	Sterile Water for Inhalation in 1LFlexoval ® 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 1LFlexoval ® Bottles)	Result
Indication For Use	Sterile Water for Inhalation, USP isintended to provide a supply of sterile waterto unfilled respiratory humidifier chambers.It is intended to be used in institutional andnon-institutional care settings.	The Sterile Water for InhalationFlexoval® Bottle is intended toprovide a supply of sterile water tounfilled respiratory humidifierchambers. It is intended to be used ininstitutional and non- institutional caresettings by qualified staff.The Sterile Water for Inhalation isintended for use in all patientpopulations including adults,pediatrics, infants and neonates.	The predicate device andproposed device have thesame 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 1LFlexoval ® Bottles)	Result
Design	The device is a flexible PP bottle prefilledwith sterile water. It features a spikeablebromobutyl closure used to transfer thesterile water to humidifier chambers usingtubular sets. The bottle includes anintegrated hanger that is used to suspend theproduct during usage. Additionally, thedevice is available in a flexible pour PPbottle with a PP/PET aluminum inductionseal and a PP screw cap, also prefilled withsterile water. The pour bottle is used torefill the sterile water in humidifierchambers.	The device is a flexible bottle made ofLDPE. The bottle is prefilled withsterile water. It has a spikeable rubberdisc that is used to transfer the sterilewater to the humidifier chambersusing tubular sets. It also has anintegrated hanger that is used tosuspend the product during usage.	Similar(SE#1)
Section	Proposed Device(Sterile Water for Inhalation, USP)	Predicate Device(Sterile Water for Inhalation in 1LFlexoval ® 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 1LFlexoval ® Bottles)	Result
Mechanism of Action	Sterile Water for Inhalation, USP, is used tohumidify air in respiratory therapy. It istransferred to a humidifier chamber whereit is heated to produce water vapor. Thisvapor mixes with medical gases or air,ensuring the delivered air is moist. Thisprevents drying of the patient's airways,maintains mucous membrane moisture,enhances patient comfort and reduces therisk of respiratory complications.	The Sterile Water for InhalationFlexoval® Bottle, is used to humidifyair in respiratory therapy. It istransferred to a humidifier chamberwhere it is heated to produce watervapor. This vapor mixes with medicalgases or air, ensuring the delivered airis moist. This process prevents thedrying of the patient's airways,maintains mucous membranemoisture, enhances patient comfort,and reduces the risk of respiratorycomplications.	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 1LFlexoval ® Bottles)	Result
Compounding	Water for the compounding is producedfrom drinking water that is purified in itsfinal stage by distillation that demonstratesthe elimination of chemicals,microorganisms and endotoxins and doesnot contain any added substances.Sterile water is filled in compounding tanksat 70°C and filled via bottle filling machineinto bottles.	Water for the compounding isproduced from drinking water that ispurified in its final stage bydistillation or other equivalent orsuperior technology that demonstratesthe elimination of chemicals,microorganisms and endotoxins anddoes not contain any addedsubstances. Sterile water is filled incompounding tanks at 70°C and filledvia BFS into bottles.	Same

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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

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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

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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

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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

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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

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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

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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.

Regulation Number and Section

§ 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).