Over-the-Counter Use: For moistening absorbent wound dreaning minor cuts, minor burns, superficial abrasions, and minor irritations of the skin. Prescription Use: For moistening absorbent wound dressing and for moistening, debriding, and cleaning acute and chronic dernal lesions, such as Stage I-IV pressure ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second-degree burns, cuts, abrasions, and minor skin irritations and for device irrigation.

Device Description

The subject device Sterile Water USP, and Sterile 0.9% Normal Saline USP is a colorless, transparent solution with no preservatives or antimicrobial agents added. It is used only for external irrigation, and not for injection purposes and it is a single use device. The subject device is packaged in clear, polypropylene (PP) bottles capped with PP Screw cap and filled with a sterile, preservative-free, clear, colorless aqueous solution and sealed with a PP/PET aluminum induction seal. The aqueous solution composition is either sterile 0.9% normal saline, both which meet their respective USP monograph criteria and contain no additives. The container and closure system for the 250mL, and 1000mL sizes include PP bottles with a PP screw cap with a PP/PET aluminum induction seal and a tamper evident plastic shrink wrap. The container and closure system for the 100mL size includes a PP bottle with a PP screw cap and a PP/PET aluminum induction seal. These single-use devices are labeled for device irrigation and wound debridement and are not intended for injection. The subject device will function by the mechanical action associated with applying and moving an aqueous solution across a wound or device surface, which facilitates the moisturizing, debridement and irrigation of these surfaces.

AI/ML Overview

The provided text is a 510(k) summary for a medical device clearance, specifically for "Sterile Water USP and Sterile 0.9% Normal Saline USP" for use as sterile irrigation solutions. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific performance acceptance criteria for an AI/software device.

Therefore, the information required to answer your prompt, which is tailored for an AI/software medical device's performance evaluation (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details), is not present in the provided document.

The document discusses performance testing, but these are primarily bench tests, biocompatibility tests, and packaging tests for the physical product (sterile water/saline solution and its container), not performance metrics for an AI/software algorithm.

Here's a breakdown of why each point in your prompt cannot be answered from the provided text:

A table of acceptance criteria and the reported device performance: The document does not define "acceptance criteria" in the context of an AI/software's performance (e.g., accuracy, sensitivity, specificity). It lists various tests (biocompatibility, packaging, non-clinical bench tests for chemical properties and sterility) and reports that the device "complies with the criteria" or "successfully withstood" them. These are not performance metrics for a diagnostic or AI device.
Sample sized used for the test set and the data provenance: Not applicable. There is no AI/software test set. The tests mentioned are for physical product characteristics (e.g., "no bottles exhibited leakage," "containers remained undamaged").
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth established by experts for an AI/software test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no test set in the context of AI/software performance.
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 device is sterile water/saline, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in the AI/software sense is not relevant here. The "truth" for this product is its chemical composition, sterility, and physical integrity, which are verified through standard laboratory tests.
The sample size for the training set: Not applicable. There is no training set for an AI/software.
How the ground truth for the training set was established: Not applicable.

In conclusion, the provided FDA 510(k) summary pertains to a physical medical device (sterile water/saline solution) and its substantial equivalence to a predicate device. It does not contain information about the development, validation, or performance of an AI/software medical device, which would typically involve the type of acceptance criteria and study details you have requested.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

March 6, 2025

Laboratorios Biogalenic S.A. DE C.V. % Manoj Zacharias US Agent Liberty Management Group Ltd. 75 Executive Dr. Suite 114 Aurora, Illinois 60504

Re: K243001

Trade/Device Name: Sterile Water USP and Sterile 0.9% Normal Saline USP Regulatory Class: Unclassified Product Code: FRO Dated: February 7, 2025 Received: February 7, 2025

Dear Manoj Zacharias:

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-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.

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For comprehensive regulatory information about medical devices and radiation-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).

Sincerely,

Mustafa A. Mazher -5

For Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K243001

Device Name

Sterile Water USP and Sterile 0.9% Normal Saline USP

Indications for Use (Describe)

Over-the-Counter Use:

For moistening absorbent wound dreaning minor cuts, minor burns, superficial abrasions, and minor irritations of the skin.

Prescription Use:

For moistening absorbent wound dressing and for moistening, debriding, and cleaning acute and chronic dernal lesions, such as Stage I-IV pressure ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second-degree burns, cuts, abrasions, and minor skin irritations and for device irrigation.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

[AS REQUIRED BY 21 CFR 807.92]

I. SUBMITTER

510(k) Owner's Name	:	LABORATORIOS BIOGALENIC, S.A. DE C.V.
Address	:	Calle Claper, Blvd. Del Ejercito Nacional km 5.5Soyapango, San Salvador, 1639 SV
Telephone	:	+503-2227-4133
Fax	:	+503-2227-4466
Contact person	:	Roberto Quiñonez
Designation	:	Plant Director
Contact Number	:	+503-2227-4133 EXT 106
Contact Email	:	r.q@biogalenic.com.sv, biogal@biogalenic.com.sv
Date of Summary Prepared	:	28.02.2025

II. DEVICE

Trade Name	:	Sterile Water USP and Sterile 0.9% Normal Saline USP
Device Common Name	:	Sterile Water USP and Sterile 0.9% Normal Saline USP
Device Classification Name	:	Dressing, Wound, Drug
Device Classification	:	Unclassified
Classification Panel	:	General and Plastic Surgery
Product Code	:	FRO

III. PREDICATE DEVICE

Predicate Device Name	:	Medline Sterile Water USP and Medline Sterile 0.9% NormalSaline USP
510(k) Number	:	K173276
Device Classification	:	Unclassified
Product Code	:	FRO

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DEVICE DESCRIPTION IV.

These single-use devices are labeled for device irrigation and wound debridement and are not intended for injection. The subject device will function by the mechanical action associated with applying and moving an aqueous solution across a wound or device surface, which facilitates the moisturizing, debridement and irrigation of these surfaces.

Laboratorios Biogalenic	Description
Item Number
78718-00060	100 mL Sterile Water, USP (OTC)
78718-00061	250 mL Sterile Water, USP (OTC)
78718-00062	500 mL Sterile Water, USP (OTC)
78718-00063	1000 mL Sterile Water, USP (OTC)
78718-00047	100 mL Sterile Water, USP (Prescription Use)
78718-00048	250 mL Sterile Water, USP (Prescription Use)
78718-00049	500 mL Sterile Water, USP (Prescription Use)
78718-00050	1000 mL Sterile Water, USP (Prescription Use)
78718-00065	100 mL Sterile 0.9% Normal Saline, USP (OTC)
78718-00066	250 mL Sterile 0.9% Normal Saline, USP (OTC)
78718-00067	500 mL Sterile 0.9% Normal Saline, USP (OTC)
78718-00068	1000 mL Sterile 0.9% Normal Saline, USP (OTC)
78718-00052	100 mL Sterile 0.9% Normal Saline, USP (Prescription Use)
78718-00053	250 mL Sterile 0.9% Normal Saline, USP (Prescription Use)
78718-00054	500 mL Sterile 0.9% Normal Saline, USP (Prescription Use)
78718-00055	1000 mL Sterile 0.9% Normal Saline, USP (Prescription Use)

Laboratorios Biogalenic Sterile Water USP and Sterile 0.9% Normal Saline USP are available in the following configurations:

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V. INDICATIONS FOR USE

For Over-the-Counter Use:

For moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions, and minor irritations of the skin.

For Prescription Use:

For moistening absorbent wound dressings and for moistening, and cleaning acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second-degree burns, cuts, abrasions, and minor skin irritations and for device irrigation.

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS VI.

The Sterile Water USP, and Sterile 0.9% Normal Saline USP medical device contains a colorless, transparent solution without any preservatives or antimicrobial agents added. It is used only for external irrigation and wound debridement, not for injection purposes and it is a single use device. The solution's chemical composition is either sterile saline (0.9% sodium chloride) which comply with their respective USP Monograph standards. The subject device is packaged in clear, polypropylene (PP) bottles capped with PP Screw cap and filled with a sterile, preservativefree, clear, colorless aqueous solution and sealed with a PP/PET aluminum induction seal.

VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Featurescompared	Proposed Device	Predicate Device	Result
Product Name	Sterile Water USP and Sterile0.9% Normal Saline USP	Medline Sterile Water USP andMedline Sterile 0.9% NormalSaline USP	NA
510(k)Number	K243001	K173276	NA
Manufacturer	LABORATORIOS BIOGALENIC,S.A. DE C.V.	Medline Industries, Inc.	NA
Classification	Unclassified	Unclassified	Same
Product Code	FRO	FRO	Same
PrescriptionUse or OTCUse	Both	Both	Same
Contactduration	<24 hours	<24 hours	Same
Featurescompared	Proposed Device	Predicate Device	Result
Single-UseVs. Reusable	Single use	Single use	Same
IndicationFor Use	Over-the-Counter Use:For moistening absorbent wounddressings and cleaning minorcuts, minor burns, superficialabrasions, and minor irritationsof the skin.Prescription Use:For moistening absorbent wounddressings and for moistening,debriding, and cleaning acuteand chronic dermal lesions, suchas Stage I-IV pressure ulcers,stasis ulcers, diabetic ulcers, footulcers, post-surgical wounds,first and second-degree burns,cuts, abrasions, and minor skinirritations and for deviceirrigation.	Over-the-Counter Use:For moistening absorbentwound dressings and cleaningminor cuts, minor burns,superficial abrasions, and minorirritations of the skin.Prescription Use:For moistening absorbentwound dressings and formoistening, debriding, andcleaning acute and chronicdermal lesions, such as StageI-IV pressure ulcers, stasisulcers, diabetic ulcers, footulcers, post-surgical wounds,first and second-degree burns,cuts, abrasions, and minor skinirritations and for deviceirrigation.	Same
TechnologicalCharacteristics	Mechanical action associated withthe application and movement offluid (either Sterile Water orSaline) across a wound or devicesurface to facilitate themoisturizing, debridement, andirrigation of these surfaces.	Mechanical action associatedwith the application andmovement of fluid (eitherSterile Water or Saline) across awound or device surface tofacilitate the moisturizing,debridement, and irrigation ofthese surfaces.	Same

Table 1: General Comparison

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Featurescompared	Proposed Device		Predicate Device		Result
ChemicalComposition	Sterile water USP or 0.9% Sterilenormal saline USP, noantimicrobial or other substanceadded.		Sterile Saline (0.9% SodiumChloride) or Sterile Water forirrigation substantiated to meetUSP; no antimicrobial or othersubstance added.		Same
DesignConfiguration	Content	Container	Content	Container	Similar
	100 mL SterileWater, USP100 mL Sterile0.9% NormalSaline, USP250 mL SterileWater, USP500 mL SterileWater, USP1000 mLSterile Water,USP250 mL Sterile0.9% NormalSaline, USP500 mL Sterile0.9% NormalSaline, USP1000 mLSterile 0.9%Normal Saline,USP	PP bottle with aPP screw cap anda PP/PETaluminuminduction sealPP bottles with aPP screw capwith a PP/PETaluminuminduction sealand a tamperevident plasticshrink wrap	100 mL Sterilewater, USP250 mL Sterilewater, USP100 mL NormalSaline, USP250 mL NormalSaline, USP500 mL SterileWater, USP500 mL NormalSaline, USP	HDPE Bottlesmade frompolyethylene(PE) resin.Include aninduction-heatseal and linerwith apolypropylene(PP) screwcap closure

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Featurescompared	Proposed Device	Predicate Device	Result
PerformanceSpecifications	The sterile water USP and sterile0.9% normal saline USP ismanufactured from respectiveWater for Injection and SodiumChloride for injection that isdesigned, tested and operated inaccordance with the USPmonographs: Water for injectionUSP and Sodium Chloride USP.	The sterile water and sterilesaline is manufactured fromWater for Irrigation that isdesigned, tested and operatedin accordance with the USPmonograph for Water forIrrigation, as specified in USPGeneral Chapter: Water forPharmaceuticalPurposes<1231>	Similar
Material ofpackaging	PP Bottles	HDPE	Different
Sterilization	Terminal (STEAM)	Gamma Sterilization	Different
Shelf Life	2 Years	1 Year	Different

VIII.PERFORMANCE TESTING DATA

A. Biocompatibility Testing

The biocompatibility evaluation of the Sterile Water USP and Sterile 0.9% Normal Saline USP was conducted in accordance with ANSI/AAMI/ISO 10993-1:2018 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process. The results of the evaluation, based on the tests outlined below, confirmed that the devices are biocompatible:

. In Vitro Cytotoxicity (L929 Cell Line) conducted as per ISO 10993-5:2009, Third Edition: Biological Evaluation of Medical Devices: Tests for in vitro cytotoxicity
Intracutaneous Reactivity conducted as per ISO 10993-23:2021, First Edition: Biological . Evaluation of Medical Devices: Tests for Irritation
. Skin Sensitization (Guinea Pig Maximization Test) conducted as per ISO 10993-10:2021 Fourth Edition: Biological Evaluation of Medical Devices: Tests for Skin Sensitization
Acute Systemic Toxicity (in Swiss Albino Mice) conducted as per ISO 10993-11:2017: ● Biological evaluation of medical devices- Part 11: Tests for systemic toxicity
. Material Mediated Pyrogenicity test (in New Zealand white rabbits) conducted as per ISO 10993-11:2017: Biological evaluation of medical devices- Part 11: Tests for systemic toxicity

B. Packaging and Transportation Testing

Packaging and transportation tests have been conducted to demonstrate that the complete packaging system used for Sterile Water, USP, and Sterile 0.9% Normal Saline, USP meets the

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required standards of effectiveness and quality. The Sterile water, USP and Sterile 0.9% Normal Saline, USP complies with the criteria for each test provided below, ensuring the product is safe for use:

Visual inspection of seal (ANSI Z 1.4)- no defects identified. .
Dye Migration Test (ASTM F1929-23)- no bottles exhibited leakage or deformation.
Determination of leaks in flexible packaging by bubble emission (ASTM D3078-02)- No leakage detected and no variation in weight observed.
. Internal Pressurization failure resistance of unrestrained packages (ASTM F1140)- no leakage observed.
. Drop Test of Loaded Containers by Free fall (ASTM D5276-19)- Containers remained undamaged after the fall.
Box compression Test (ASTM D642)- successfully withstood the maximum weight . stack.

C. Non- Clinical Performance Testing (Bench)

Sterile Water USP and Sterile 0.9% Normal Saline USP have been demonstrated to be both effective and safe for their intended purposes, as supported by the results of the non-clinical performance evaluations outlined below:

Sterile Water USP

o Total organic carbon USP <643>
Water Conductivity USP <643> .
. Sterility Test USP <71>
Bacterial endotoxins Test USP <85> .
. Appearance
. Volume in Container

Sterile 0.9% Normal Saline USP

· Sodium Chloride Titration USP Monograph
Identification USP <191>
pH USP <791>
Iron USP <241>
· Volume in Container
· Appearance
· Sterility Test USP <71>
Bacterial Endotoxins Test USP <85>

Clinical Test Data D.

No clinical study was conducted since clinical data is not necessary for Sterile Water USP and Sterile 0.9% Normal Saline USP.

IX. CONCLUSION

Based on testing and comparison to the predicate device, Sterile Water USP and Sterile 0.9% Normal Saline USP for Irrigation are as safe and effective for their intended use as the predicate, Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP.

Regulation Number and Section

N/A