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 care settings by qualified staff. The Sterile Water for Inhalation is intented for use in all patient populations including adults, pediatrics, infants and neonates.

Device Description

The Sterile Water for Inhalation is provided in a Flexoval® bottle which is a flexible plastic bottle with a spikeable cap at the base and is pre-filled with sterile water. The bottle is 1 liter in volume and is made of Low-Density Polyethylene (LDPE). The bottle has one administration port (cap) which is clear and natural in color. The bottle has one standard hanger that is integrated at the base of the bottle also has a multi-color adhesive label affixed by an automatic labeler. The product is sterilized by heat in an autoclave. The device is sold sterile and cannot be re-used: it is discarded after use. The device is intended for use by qualified staff.

AI/ML Overview

This document is a 510(k) Premarket Notification from Hometa Inc. for their "Sterile Water for Inhalation in 1L Flexoval® Bottles." It focuses on demonstrating substantial equivalence to a predicate device, "Sterile Water for Inhalation Flex Bag, USP" by Cardinal Health Inc.

The document does not describe an AI/ML-driven medical device evaluation. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details for an AI/ML device, such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details.

The study described in this document is primarily focused on non-clinical testing to ensure the new device (Sterile Water for Inhalation in Flexoval Bottles) performs equivalently to the existing predicate device (Sterile Water for Inhalation Flex Bag). The testing includes:

Functional Testing (per ISO 15747): Resistance to temperature, pressure, and leakage; penetration ability of the insertion point; adhesion strength and impermeability of the insertion point; transparency; resistance to dropping; and hanger integrity.
Physicochemical and Biological Testing (per USP methods and internal validated methods): Total Organic Carbon, Conductivity, Oxidizable Substances, Process Bioburden, Sterility, and Bacterial Endotoxins.
Sterilization Validation (per ISO 17665): Moist heat sterilization to achieve a Sterility Assurance Level (SAL) of 10^-6, using Geobacillus stearothermophilus as a biological indicator.
Biocompatibility Testing (per ISO 10993 series): Extractable/leachables testing, toxicological risk assessment, cytotoxicity, sensitization testing, intracutaneous reactivity test, and material-mediated pyrogenicity.

The "acceptance criteria" discussed in this document are the standards and requirements for these non-clinical tests to demonstrate that the new device is safe and effective and performs as intended, similar to the predicate. The reported "performance" is that the device met these standards.

Therefore, I cannot provide the requested table or details related to AI/ML device evaluation. The information in the provided text pertains to the substantial equivalence of a medical consumable (sterile water) based on physical, chemical, and biological properties, not an AI/ML algorithm.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo includes the Department of Health & Human Services logo on the left. To the right of that is the FDA logo in blue. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

August 3, 2023

Hometa Inc Raza Mohammed Director QA/RA 300 Great Oaks Blvd. Suite 325 Albany, New York 12203

Re: K223551

Trade/Device Name: Sterile Water for Inhalation in 1L Flexoval bottles. Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory gas humidifier Regulatory Class: Class II Product Code: BTT Dated: June 30, 2023 Received: July 3, 2023

Dear Raza Mohammed:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/ofdocs/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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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).

Sincerely,

James J. Lee -S

for Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223551

Device Name Sterile Water for Inhalation Flexoval® Bottle

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)

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510(k) Summary

APPLICANT:

Company Name: Hometa Inc Company Address: 300 Great Oaks Blvd, Suite 325, Albany, NY, 12203 Company Phone: +1 4435545486 Company Fax: +1 5189925044 Company e-mail: raza.mohammed@pisa-biopharm.com

Official Contact for Correspondence: Raza Mohammed Title: Global QA/RA Director Phone: +1 4435545486 E-mail: raza.mohammed@pisa-biopharm.com

Date Summary Prepared: Aug 3rd , 2023

DEVICE IDENTIFICATION:

Device Trade Name: Sterile Water for Inhalation in 1L Flexoval® Bottles Device Classification Name: Respiratory Gas Humidifier Generic/Common Name: Sterile Water for Inhalation Device Regulation Number : 21 CFR 868.5450, Class II Product Code: BTT Panel: Anesthesiology

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PREDICATE DEVICES

Hometa identified the following legally marketed device as substantially equivalent:

Predicate Device	Applicant	510(k) No
Sterile Water for Inhalation Flex Bag, USP	Cardinal Health Inc	K090915

DEVICE DESCRIPTION

The device is sold sterile and cannot be re-used: it is discarded after use. The device is intended for use by qualified staff.

INDICATIONS FOR USE

The Sterile Water for Inhalation is intended for use in all patient populations including adults, pediatrics, infants and neonates.

DISCUSSION OF NON CLINICAL TESTS

Functional Testing: Functional Testing per ISO 15747 performed on both in process and finished devices shows that the device works as intended and to support substantial equivalence.

Resistance to Temperature, Pressure and Leakage
Penetration Ability of the Insertion Point
Adhesion strength of the infusion device and impermeability of the insertion point
Transparency

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Resistance to Dropping
Hanger

Physicochemical and Biological Testing: Physicochemical testing were performed on both in process and finished product shows that the device works as intended and supports substantial equivalence. Testing was performed based on USP methods and , internal validated methods. The following tests were performed on the subject device.

Total Organic Carbon
Conductivity
Oxidizable Substances
Process Bioburden
Sterility
Bacterial Endotoxins

Sterilization Validation: The sterilization process performed in accordance with ISO 17665 Sterilization of Health Care Products- Moist Heat (Established Category A) was qualified and is considered robust to inactive the biological indicators. The Sterile Water for Inhalation in 1L Flexoval Bottles was validated for sterilization using moist heat to achieve a Sterility Assurance Level (SAL) of 10 . The product was sterilized at 108°C for a period of 265 minutes. Geobacillus stearothermophilus, which is the most heat resistant bacteria, was used as a biological indicator and was inactivated during sterilization. Samples were tested for sterility to achieve confidence level of 95% with 90% reliability.

Biocompatibility: Biocompatibility testing performed in accordance with ISO 10993 Biological Evaluation of Medical Devices 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:

-Extractable/leachables testing per ISO 10993-18: Biological evaluation of medical devices - Part 18: Chemical characterization of materials

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-Toxicological risk assessment conducted per ISO 10993- 17: Biological Evaluation of Medical Devices - Part 17: Establishment of allowable limits for leachable substances on the detected chemicals within the extract.
-Cytotoxicity Testing: MEM Elution test
-Sensitization Testing: Guinea Pig Maximization Test
Intracutaneous Reactivity Test -
Material Mediated Pyrogenicity: Test for Systemic toxicity. -

SUBSTANTIAL EQUIVALENCE

The side by side comparison between the subject and the predicate device shows that the two devices are same in indications for use use i.e. they provide a supply of sterile water for inhalation to humidifier chambers. The devices have same BTT classification. The devices are manufactured using the same sterile water as primary material and is packaged in disposable plastic containers. Both the devices are similar in design and technological characteristics. Various physicochemical, functional and biological testing has shown that the differences in primary packing and sterilization temperatures do not pose any significant issues and the subject device works as intended..

The following Substantial Equivalence Comparison Table summarizes the key features of the subject device compared to its predicate device.

Section	Sterile Water forInhalation in Flex BagsUSP (Predicate Device)	Sterile Water for Inhalation(Proposed Device)	Conclusion
K Number	K090915	K223551
ProprietaryName	Airlife, Sterile Water forInhalation	Sterile Water for Inhalation in1L Flexoval ® Bottles
Manufacturer	Cardinal Health	Hometa Inc
CFR Section	868.5450	868.5450	Substantially Equivalent
Product Code	BTT	BTT	Substantially Equivalent
ClassificationName	Humidifier Respiratory Gas	Humidifier Respiratory Gas	Substantially Equivalent
Indications forUse	The Sterile Water forInhalation Flex Bag USPbag is intended to provide asupply of sterile water tounfilled respiratoryhumidifier chambers It isintended to be used ininstitutional and non-institutional care settings	The Sterile Water for InhalationFlexoval® Bottle is intended toprovide a supply of sterile waterto unfilled respiratoryhumidifier chambers. It isintended to be used ininstitutional and non-institutional care settings byqualified staff.The Sterile Water for Inhalationis intended for use in all patientpopulations including adults,pediatrics, infants and neonates.	The predicate deviceand proposed devicehave the sameindications for use.
PrimaryPackagingMaterial	PVC	LDPE	Difference in primarypackaging material doesnot impact thefunctionality of thedevice. The subjectdevice works asintended due to similardesign as predicate.Extensivebiocompatibility,functional,physicochemical andbiological testing
			eliminate the risk of anyadditional concerns.
Design	The predicate device is aflexible plastic bag made ofPVC. The bag is prefilledwith sterile water. It has asingle port at the base totransfer the sterile waterfrom the bag to thehumidifier chambers usingtubular sets. It has a hangerso suspend the productduring use.	The subject device is a flexiblebottle made of LDPE. Thebottle is prefilled with samesterile water as the predicate. Ithas a spikeable rubber disc thatis used to transfer the sterilewater to the humidifierchambers using tubular sets. Italso has an integrated hangerthat is used to suspend theproduct during usage.	Substantially equivalent.Both the devices havesimilar design and workas intended. Bothdevices have a singlespike port for transfersets. Both devices havea hanger to suspend thedevice during usage.Both the devices arecollapsible.
Biocompatibility	Meets the requirements ofISO 10993	Meets the requirements of ISO10993	Substantially equivalent
Spike Access	Special Twist off	Universal Rubber Disc	Substantially equivalent
Hanger	1 Standard Hanger	1 standard hanger	Substantially equivalent
ContainerClarity	Clear	Clear	Substantially equivalent
TamperEvidence	Yes	Yes	Substantially equivalent
Compounding	Water for the compoundingis produced from drinkingwater that is purified in itsfinal stage by distillation orother equivalent or superiortechnology thatdemonstrates the eliminationof chemicals,	Water for the compounding isproduced from drinking waterthat is purified in its final stageby distillation or otherequivalent or superiortechnology that demonstratesthe elimination of chemicals,microorganisms and endotoxins	Substantially equivalent

microorganisms and	and does not contain any added
endotoxins and does not	substances.
contain any added	Sterile water is filled in
substances.	compounding tanks at 70°C and
Sterile water is filled in	filled via BFS into bottles.
compounding tanks at 70°C
and filled in bags.

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CONCLUSION

Based on the available information, Hometa concludes that Sterile Water for Inhalation in 1L Flexoval® bottle is substantially equivalent in indications for use, design and function to the existing legally marketed devices under 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).