(99 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of sterile water and saline solutions for wound cleaning, with no mention of AI or ML.
No
The device is a wound and device cleaning solution used for moistening, debriding, and cleaning dermal wounds and for device irrigation, which are supportive functions for healing, not direct therapeutic action itself.
No
This device is described as a wound and device cleaning solution for moistening, debriding, and cleaning dermal wounds and for device irrigation. Its function is therapeutic/cleaning, not diagnostic (identifying or characterizing a medical condition).
No
The device is a physical product (sterile water/saline in a bottle) and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Intended Use: The intended use of AMSure® Sterile Water and Sterile Normal Saline for Wound Flush is for cleaning and moistening wounds and for device irrigation. This is a topical application and irrigation, not the analysis of a specimen taken from the body.
- Device Description: The description confirms it's a cleaning solution for wounds and devices.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, diagnostic purposes, or any of the typical components or processes associated with IVD devices (like reagents, assays, or analytical instruments).
Therefore, this device falls under the category of a wound care product and irrigation solution, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations and for device irrigation.
Product codes (comma separated list FDA assigned to the subject device)
FRO
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. The bottle and cap are made by HDPE, the inner induction sealed film is foil. The devices are offered in 100mL bottles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
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) |
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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. 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.
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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 |
- For Rx | 1. For OTC
- For Rx | 1. For OTC
- 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 |
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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.
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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.