Who is the manufacturer of AMSure Sterile Water, and Sterile Normal Saline for Wound Flush?

Amsino International, Inc. filed the 510(k) submission for AMSure Sterile Water, and Sterile Normal Saline for Wound Flush (K181423).

What is the FDA product code for AMSure Sterile Water, and Sterile Normal Saline for Wound Flush?

FRO. as a Class U device in the SU panel.

What is the regulatory pathway for AMSure Sterile Water, and Sterile Normal Saline for Wound Flush?

510(k) clearance (submission type: Traditional).

What are the predicate devices for AMSure Sterile Water, and Sterile Normal Saline for Wound Flush?

Anexa Wound Flush, Sterile Water and Sterile Normal Saline (K172486); Wound Flush, Sterile Water and Sterile Normal Saline (K083042).

Who can help prepare an FDA 510(k) submission like AMSure Sterile Water, and Sterile Normal Saline for Wound Flush?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

AMSure Sterile Water, and Sterile Normal Saline for Wound Flush

K181423 · Amsino International, Inc. · FRO · Sep 7, 2018 · SU

Device Facts

Record ID	K181423
Device Name	AMSure Sterile Water, and Sterile Normal Saline for Wound Flush
Applicant	Amsino International, Inc.
Product Code	FRO · SU
Decision Date	Sep 7, 2018
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

AMSure® Sterile Water, and Sterile Normal Saline for Wound Flush - For over-the-counter use: For moistening absorbent wound dressing and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. - For prescription use: For moistening absorbent wound dressing and for moistening, debriding 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.

Device Story

Device consists of USP-grade sterile water or 0.9% sterile normal saline in 100mL HDPE bottles with foil induction seals. Used in clinical or home care settings by clinicians or patients. Principle of operation is mechanical action of fluid flow across wound or device surface to remove foreign objects, dirt, and debris. Output is the irrigation fluid itself. Benefits include effective wound debridement and cleaning of dermal lesions or medical devices.

Clinical Evidence

Bench testing only. Biocompatibility testing (ISO 10993) confirmed non-cytotoxic, non-irritating, and non-sensitizing properties. Performance testing verified compliance with USP standards for sterile saline and sterile water. Stability testing conducted via accelerated aging to support labeling.

Technological Characteristics

Materials: HDPE bottle, foil induction seal. Contents: USP-grade sterile water or 0.9% sterile normal saline. Form factor: 100mL bottle. Sterilization: Gamma sterilization. Principle: Mechanical irrigation. No antimicrobial or other additives.

Indications for Use

Indicated for OTC use to moisten absorbent wound dressings and clean minor cuts, burns, superficial abrasions, and skin irritations. Indicated for prescription use to moisten absorbent wound dressings; moisten, debride, and clean acute/chronic dermal lesions (Stage I-IV pressure ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first/second-degree burns, cuts, abrasions, minor skin irritations); and for device irrigation.

Predicate Devices

Anexa Wound Flush, Sterile Water and Sterile Normal Saline (K172486)
Wound Flush, Sterile Water and Sterile Normal Saline (K083042)

Related Devices

K173276 — Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP · Medline Industries, Inc. · Jul 2, 2018
K243001 — Sterile Water USP and Sterile 0.9% Normal Saline USP · Laboratorios Biogalenic S.A. DE C.V. · Mar 6, 2025
K172486 — Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 100mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 250mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 500mL bottle · Anexa Biomedical, Inc. · Sep 21, 2017
K170270 — Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline · Ls Scientific Inc. D.B.A. Kse Scientific · Jun 23, 2017
K161658 — Anexa Wound Flush, Sterile Water & Sterile Normal Saline · Anexa Biomedical, Inc. · Sep 14, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font. September 7, 2018 Amsino International Inc. Jane Gao VP of R&D 708 Corporate Center Drive Pomona, California 91768 Re: K181423 Trade/Device Name: AMSure Sterile Water, and Sterile Normal Saline for Wound Flush Regulatory Class: Unclassified Product Code: FRO Dated: July 9, 2018 Received: July 11, 2018 Dear Jane Gao: 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/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. 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 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. 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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # David Krause -S for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K181423 #### Device Name AMSure® Sterile Water, and Sterile Normal Saline for Wound Flush Indications for Use (Describe) AMSure® Sterile Water, and Sterile Normal Saline for Wound Flush - For over the-counter use: For moistening absorbent wound dressing and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. - For prescription use: For moistening absorbent wound dressing and for moistening, debriding and cleaning acute and chronic dermal lesions, such as Stage I-IV pressure 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) | ☑ 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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for AMSINO, a company that advances healthcare worldwide. The logo is in blue and white, with the word "AMSINO" in large, bold letters. Below the company name is the tagline "Advancing Healthcare Worldwide" in a smaller font. The logo is simple and professional, and it conveys the company's mission to improve healthcare around the world. ## Section 5: 510(k) Summary (K181423) ### a) Submitter Information: | Submitter: | Amsino International Inc. 708 Corporate Center Drive Pomona, CA 91768 Phone: +1 (909)626-5888 Fax: +1 (909)626-3888 | |------------------|-----------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Jane Gao Vice President of R&D, Amsino International Inc. Cell phone: +86 - 139 -1614 - 7664 E-mail: Jane_gao@amsino.com | | Date of Summary: | August 30, 2018 | #### b) Device Information: | Trade or Proprietary Name: | AMSure ® Sterile Water, and Sterile Normal Saline for Wound Flush | |----------------------------|-----------------------------------------------------------------------------| | Common or Usual Name: | Sterile Water and Sterile Saline for Wound flush | | Regulatory Class: | Unclassified, pre-amendment device | | Product Code: | FRO | ### c) Identification of Legally Marketed Device(s): - K172486: Anexa Wound Flush, Sterile Water and Sterile Normal Saline - K083042: Wound Flush, Sterile Water and Sterile Normal Saline #### d) Device Description: AMSure® Sterile Water, and Sterile Normal Saline for Wound Flush devices are wound and device cleaning solutions that are intended for moistening and debriding of dermal wounds and for device irrigation. Sterile Water and sterile normal saline for wound flush are intended to be used in clinical or home care and should only be used by clinicians familiar with the treatment of possible complications. The solution is either sterile water or sterile normal saline for irrigation and meets the requirements of USP<40>. The bottle and cap are made by HDPE, the inner induction sealed film is foil. The devices are offered in 100mL bottles. #### e) Statement of Device Intended Use: AMSure® Sterile Water, and Sterile Normal Saline for Wound Flush Amsino International Inc. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for AMSINO, a healthcare company. The logo features the company name in large, bold, blue letters above a blue line. Below the line, the company's slogan, "Advancing Healthcare Worldwide," is written in a smaller font. - For over-the-counter use: For moistening absorbent wound dressing and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. - For prescription use: For moistening absorbent wound dressing and for moistening, debriding 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. #### f) Substantial Equivalence Discussion: - Technological Characteristics: The proposed device has the same technological characteristics and provide the same mechanism of action as the predicates' devices. - Intended Use: The proposed device also labeled as same intended use as the predicates' devices. - Material: The proposed device use same USP grade saline and water, same type of resin for the container. The biocompatibility testing of proposed device has been conducted and has been proof as non-cytotoxic, non-irritating and non-sensitizing with ISO10993 standard. Comparison table between proposed device and Predicate Devices: #### Table 5-1 | | Subject | Predicate 1 | Predicate 2 | Results | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Manufacturer | Amsino International Inc. | Anexa Biomedical, Inc. | Nurse Assist, Inc. | | | K Number | K181423 | K172486 | K083042 | | | Classification | Unclassified Pre-amendment | Unclassified Pre-amendment | Unclassified Pre-amendment | Same | | Product Code | FRO | FRO | FRO | Same | | Indications for Use | 1. For OTC 2. For Rx | 1. For OTC 2. For Rx | 1. For OTC 2. For Rx | Same | | Principle of Operation | Mechanical action of fluid moving across the wound or device aids in the removal of foreign objects such as dirt and debris. | Mechanical action of fluid moving across the wound or device aids in the removal of foreign objects such as dirt and debris. | Mechanical action of fluid moving across the wound or device aids in the removal of foreign objects such as dirt and debris. | Same | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the AMSINO logo. The logo is in blue and white. Below the logo is the text "Advancing Healthcare Worldwide". | Chemical composition | 0.9% sterile saline or sterile water, no antimicrobial or other substance added | 0.9% sterile saline or sterile water, no antimicrobial or other substance added | 0.9% sterile saline or sterile water, no antimicrobial or other substance added | Same | | |-------------------------|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|----------------------| | Models | AS398 100mL USP Normal Saline AS399 100mL USP Sterile Water | 8100-100mL USP Sterile water 9100- 100mL USP Sterile Saline 8250- 250mL USP Sterile Water 9250- 250mL USP Sterile Saline 8500- 500mL USP Sterile Water 9500- 500mL USP Sterile Saline 8120- 120mL USP Sterile Water 9120- 120mL USP Sterile saline | 6250- 100mL USP Sterile Water 6240- 100mL USP sterile Saline 6260- 250mL USP Sterile Water 6270- 250mL USP Sterile Saline 6290- 500mL USP Sterile Water 6280- 500mL USP Sterile Saline 6210-120mL USP Sterile Water 6220- 120mL USP Sterile Saline | Similar | | | | Sterility | Gamma Sterilization | Unsure | Gamma Sterilization | Same with K083042 | | | Single Use/Reusable | Single Use | Single Use | Single Use | Same | #### Conclusion: Sterile water and sterile normal saline have the same technological characteristics and provide the same mechanism of action as the predicates' devices. According to the above analysis, there's no major difference between the proposed devices and the predicated devices would impact the effectiveness and safety. The AMSure® Sterile Water, and Sterile Normal Saline for Wound Flush devices are therefore considered to be substantially equivalent to the above-mentioned predicates' devices. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the AMSINO logo. The logo is in blue and white. The text "AMSINO" is in large, bold letters, and the text "Advancing Healthcare Worldwide" is in smaller letters below. ### g) Nonclinical Testing (Bench): The following performance testing was conducted on the proposed device: - Biocompatibility testing has demonstrated the biological safety of the proposed devices which may directly or indirectly contact the patients. - Performance testing has demonstrated the proposed devices which meet the standard on USP Sterile Saline and USP Sterile Water. - Stability testing evaluated the properties of the AMSure® Sterile Water, and Sterile Saline for Wound Flush after accelerated aging in support of the labeling. Performance testing conclusion: The results of the performance evaluation tests showed the AMSure® sterile water, and sterile normal saline for wound flush passed all acceptance criteria. #### h) Conclusions: The information provided within this pre-market notification demonstrates that AMSure® Sterile Water, and Sterile Normal Saline for Wound Flush has no difference that would affect the safety or effectiveness of the devices as compared to the predicate device and provide reasonable assurance of the safety and effectiveness of the devices to demonstrate substantial equivalency.