(35 days)
Not Found
No
The device description and intended use are for sterile water and saline solutions for wound cleaning and irrigation, with no mention of AI/ML capabilities or data processing.
No.
Therapeutic devices are generally defined as those that treat, cure, or prevent a disease or condition. This device is described as a "wound and device cleaning solution" used for "moistening and debriding of dermal wounds and for device irrigation," which are supportive care functions rather than direct therapeutic actions. It aids in the healing process by preparing the wound, but it doesn't intrinsically alter the disease process itself.
No
The device is described as a wound and device cleaning solution for moistening and debriding dermal wounds and for device irrigation, not for diagnosing medical conditions.
No
The device description clearly states the device is a solution offered in bottles and cups, indicating a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin" (OTC) and "moistening, debriding and cleaning acute and chronic dermal lesions... and for device irrigation" (Prescription). These are all applications directly on or in contact with the body or medical devices, not for testing samples taken from the body.
- Device Description: The device is described as "wound and device cleaning solutions." This aligns with its intended use for external application and irrigation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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, 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.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
The Sterile Water and Sterile Normal Saline devices are wound and device cleaning solutions that are intended for moistening and debriding of dermal wounds and for device irrigation. The solution is either sterile water or sterile normal saline for irrigation and meets the requirements of USP. The devices are offered in 100mL, 250mL, and 500mL bottles, and 120mL cups.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin, dermal lesions (Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-the-Counter Use; Prescription Use
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)
Biocompatibility testing of Sterile Water and Sterile Normal Saline has been conducted.
The devices were found to be non-cytotoxic, non-irritating and non-sensitizing in ISO 10993 standard tests; results which are similar to those reported for the predicates' devices.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle, there is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, flowing line style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 21, 2017
Anexa Biomedical, Inc. Ms. Shelly Budloo, J.D. Executive Management/Quality Manager 40423 Air Time Avenue Zephyrhills, Florida 33542
Re: K172486
Trade/Device Name: Anexa Wound Flush, Sterile Water and Sterile Normal Saline Regulatory Class: Unclassified Product Code: FRO Dated: August 4, 2017 Received: August 17, 2017
Dear Ms. Budloo:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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) K172486
Device Name
Anexa Wound Flush, Sterile Water and Sterile Normal Saline
Indications for Use (Describe)
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, 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.
| 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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3
510(k) Summary
(As per CFR Title 21 Part 807.92)
A. Administrative
Submitter:
Anexa Biomedical, Inc. 40423 Air Time Ave. Zephyrhills, FL 33542 813-780-7927
Contact Person:
Shelly Budloo, J.D. - Executive Management/QA Manager
Date of Preparation:
August 4, 2017
B. Device
Device Name:
Sterile Water and Sterile Normal Saline
Proprietary Name:
Anexa Wound Flush, Sterile Water, and Sterile Normal Saline
Common/Usual Name:
Sterile Water and Sterile Normal Salinc
Classification:
Unclassified, pre-amendment device
Classification Name:
Dressing, Wound, Drug
Product Code:
FRO
4
C. Predicates' Devices
Predicates' Devices Names:
Sterile Water and Sterile Normal Saline; Strukmyer Medical, LLC- K161311
Wound Flush, Sterile Water & Sterile Normal Saline; Nurse Assist, Inc .- K083042
D. Device Description and Intended Use
Device Description:
The Sterile Water and Sterile Normal Saline devices are wound and device cleaning solutions that are intended for moistening and debriding of dermal wounds and for device irrigation. The solution is either sterile water or sterile normal saline for irrigation and meets the requirements of USP. The devices are offered in 100mL, 250mL, and 500mL bottles, and 120mL cups.
Statement of Device Intended 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, debriding and cleaning acute and chronic dermal Icsions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations, and for device irrigation.
E. Device Comparison to Predicates and Discussion of Tests Submitted
Comparison to Predicates' Devices:
Sterile Water and Sterile Normal Saline have the same technological characteristics and provide the same mechanism of action as the predicates' devices, i.e., the mechanical action of fluid moving across the wound or device aids in the removal of foreign objects such as dirt and debris. They are labeled for the same intended uses and are supplied sterile in containers of identical composition.
5
Discussion of Tests Submitted:
Biocompatibility testing of Sterile Water and Sterile Normal Saline has been conducted.
The devices were found to be non-cytotoxic, non-irritating and non-sensitizing in ISO 10993 standard tests; results which are similar to those reported for the predicates' devices.
F. Conclusion
Based on a comparison of composition, technological characteristics, intended use, and biocompatibility test results, we conclude that Sterile Water and Sterile Normal Saline perform at least as well as the predicates' devices. Sterile Water and Sterile Normal Saline are therefore considered to be substantially equivalent to the above- mentioned predicates' devices.
Predicates' Devices Comparison Chart
| | Subject | Predicate | Predicate | Predicate | Similarities &
Differences |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Submitter/holder | Anexa Biomedical,
Inc. | Strukmyer Medical,
LLC | Nurse Assist, Inc. | Anexa
Biomedical, Inc. | |
| K Number | K172486 | K161311 | K083042 | K161658 | |
| Device/Trade/
Brand Name | Anexa Wound Flush,
Sterile Water and
Sterile Normal Saline | Sterile Water and
Sterile Normal Saline | Wound Flush, Sterile
Water and Sterile
Normal Saline | Wound Flush,
Sterile Water and
Normal Saline | Same |
| Classification | Unclassified,
pre-amendment | Unclassified,
pre-amendment | Unclassified,
pre-amendment | Unclassified,
pre-amendment | Same |
| Product Code | FRO | FRO | FRO | FRO | Same |
| 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 Over-the-Counter
Use:
For moistening
absorbent wound
dressings and
cleaning minor cuts,
minor burns,
superficial abrasions
and minor irritations
of the skin. | For Over-the-Counter
Use:
For moistening
absorbent wound
dressings and cleaning
minor cuts, minor
burns, superficial
abrasions and minor
irritations of the skin. | Not for Over-
the-Counter Use | Same
K172486
K161311
K083042
Different
K161658 |
| | For Prescription Use:
For moistening | For Prescription Use:
For moistening | For Prescription Use:
For moistening | For Prescription
Use: | |
| | absorbent wound
dressings and for
moistening, debriding
and cleaning acute
and chronic dermal
lesions, such as Stage
I-IV pressure ulcers,
stasis ulcers, diabetic
ulcers, foot ulcers,
post-surgical wounds,
first and second-
degree burns, cuts,
abrasions and minor
skin irritations and
for device irrigation. | absorbent wound
dressings and for
moistening, debriding
and cleaning acute
and chronic dermal
lesions, such as Stage
I-IV pressure ulcers,
stasis ulcers, diabetic
ulcers, foot ulcers,
post-surgical wounds,
first and second-
degree burns, cuts,
abrasions and minor
skin irritations and
for device irrigation. | absorbent wound
dressings and for
moistening, debriding
and cleaning acute and
chronic dermal
lesions, such as Stage
I-IV pressure ulcers,
stasis ulcers, diabetic
ulcers, foot ulcers,
post-surgical wounds,
first and second-
degree burns, cuts,
abrasions and minor
skin irritations and for
device irrigation. | For moistening
of absorbent
wound dressings
and irrigation to
remove loose
debris and dirt
from the wound. | Same
K172486
K161311
K083042
Different
K161658 |
| 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. | Mechanical
action of fluid
moving across
the wound or
device aids in the
removal of
foreign objects
such as dirt and
debris. | Same |
| 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 | 0.9% Sterile
Saline or Sterile
Water; no
antimicrobial or
other substance
added | Same |
| Models | 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 | Model Numbers Unknown
but sizes are the same:
100mL USP Sterile Water
100mL USP Sterile Saline
120mL USP Sterile Water
120mL USP Sterile Saline
250mL USP Sterile Water
250mL USP Sterile Saline
500mL USP Sterile Water
500mL 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 | 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 | Same |
6
The Indications for Use of the Anexa Wound Flush, Sterile Water & Sterile Normal Saline are identical to the predicates' devices.
The technological characteristics (Design and Materials) of the Anexa Wound Flush, Sterile Water & Sterile Normal Saline are identical to the predicates' devices.
7
Non-Clinical Testing
| ASTM F1980-07 (Reapproved 2011) |
|---|
| AATNU / ANSI/ ISO 11607-1:2006/(R)2010 |
| AAMI / ANSI / ISO 11607-2:2006/(R)2010 |
| AAMI / ANSI / ISO 11607-2:2006/(R)2010 |
| AAMI / ANSI / ISO 11137-1:2006/(R)2010 |
| AAMI / ANSI / ISO 11137-2:2013 |
| AAMI / ANSI / ISO 11737-1:2006 (R)2011 |
| AAMI / ANSI / ISO 11737-2:2009/(R)2014 |
| AAMI / ANSI / ISO 10993-1:2009/(R) 2013 |
| AAMI / ANSI / ISO 10993-5:2009/(R) 2014 |
| ISO 10993-10 Third Edition 2010-08-01 |
| AAMI / ANSI / ISO 10993-11:2006/(R)2010 |
| AAMI TIR 22:2007 |
| AAMI TIR 33:2005 |
| AAMI/ANSI/ISO TIR 13004:2013 |
Substantial Equivalence
To cstablish substantial equivalence to the predicates' devices, Ancxa cvaluated the indications for use, material, technology, and specifications of the device. Through safety and performance testing, Anexa has concluded that the device does not introduce any significant questions of safety and efficacy and is substantially equivalent to the predicates' devices.