(35 days)
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.
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<40>. The devices are offered in 100mL, 250mL, and 500mL bottles, and 120mL cups.
The provided document describes a 510(k) premarket notification for the "Anexa Wound Flush, Sterile Water and Sterile Normal Saline" device. This is a medical device clearance, not an AI/ML device approval, therefore, many of the requested criteria related to AI/ML device evaluation are not applicable.
Based on the information provided in the document:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Criteria/Tests (as per document) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993 standard tests for: | Found to be non-cytotoxic |
| - Cytotoxicity | Found to be non-irritating | |
| - Irritation | Found to be non-sensitizing | |
| Material/Composition | 0.9% Sterile Saline or Sterile Water | Meets USP <40> requirements |
| No antimicrobial or other substance added | Confirmed | |
| Sterility | (Implied by "Sterile Water" and "Sterile Normal Saline", and adherence to ISO standards like AAMI / ANSI / ISO 11137-1:2006/(R)2010 for Sterilization) | Not explicitly detailed in performance column, but clearance implies compliance |
| Shelf Life/Stability | ASTM F1980-07 (Reapproved 2011) - Accelerated Aging | Not explicitly detailed in performance column, but implied by testing |
| Packaging Integrity | AATNU / ANSI/ ISO 11607-1:2006/(R)2010 | Not explicitly detailed in performance column, but implied by testing |
| Packaging Processes | AAMI / ANSI / ISO 11607-2:2006/(R)2010 | Not explicitly detailed in performance column, but implied by testing |
| Biocontamination Control | AAMI / ANSI / ISO 11737-1:2006 (R)2011 (Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products) | Not explicitly detailed in performance column, but implied by testing |
| Bacterial Endotoxins Testing | AAMI / ANSI / ISO 11737-2:2009/(R)2014 (Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process) | Not explicitly detailed in performance column, but implied by testing |
The document concludes that "Sterile Water and Sterile Normal Saline perform at least as well as the predicates' devices" and are "substantially equivalent" based on these comparisons and tests.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This document does not specify a "test set" in the context of an AI/ML algorithm. The tests conducted (biocompatibility, sterility, etc.) are standard material and device performance tests, not AI model evaluations. Therefore, information about sample size, country of origin, or retrospective/prospective nature of data for an AI/ML test set is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. This device is not an AI/ML algorithm that requires expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This device is not an AI/ML algorithm that requires an adjudication method for a test set.
5. 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 a wound flush solution, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a wound flush solution, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" for this device would be its chemical composition, sterility, and biocompatibility, which are verified through laboratory testing against established physical, chemical, and biological standards (e.g., USP <40>, ISO 10993 standards). This is not equivalent to ground truth in the context of AI/ML.
8. The sample size for the training set:
Not applicable. This device is a wound flush solution, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set for an AI/ML algorithm, no ground truth needs to be established for it.
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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
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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<40>. 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. | AnexaBiomedical, Inc. | |
| K Number | K172486 | K161311 | K083042 | K161658 | |
| Device/Trade/Brand Name | Anexa Wound Flush,Sterile Water andSterile Normal Saline | Sterile Water andSterile Normal Saline | Wound Flush, SterileWater and SterileNormal Saline | Wound Flush,Sterile Water andNormal Saline | Same |
| Classification | Unclassified,pre-amendment | Unclassified,pre-amendment | Unclassified,pre-amendment | Unclassified,pre-amendment | Same |
| Product Code | FRO | FRO | FRO | FRO | Same |
| Indications forUse | For Over-the-CounterUse:For moisteningabsorbent wounddressings andcleaning minor cuts,minor burns,superficial abrasionsand minor irritationsof the skin. | For Over-the-CounterUse:For moisteningabsorbent wounddressings andcleaning minor cuts,minor burns,superficial abrasionsand minor irritationsof the skin. | For Over-the-CounterUse:For moisteningabsorbent wounddressings and cleaningminor cuts, minorburns, superficialabrasions and minorirritations of the skin. | Not for Over-the-Counter Use | SameK172486K161311K083042DifferentK161658 |
| For Prescription Use:For moistening | For Prescription Use:For moistening | For Prescription Use:For moistening | For PrescriptionUse: | ||
| absorbent wounddressings and formoistening, debridingand cleaning acuteand chronic dermallesions, such as StageI-IV pressure ulcers,stasis ulcers, diabeticulcers, foot ulcers,post-surgical wounds,first and second-degree burns, cuts,abrasions and minorskin irritations andfor device irrigation. | absorbent wounddressings and formoistening, debridingand cleaning acuteand chronic dermallesions, such as StageI-IV pressure ulcers,stasis ulcers, diabeticulcers, foot ulcers,post-surgical wounds,first and second-degree burns, cuts,abrasions and minorskin irritations andfor device irrigation. | absorbent wounddressings and formoistening, debridingand cleaning acute andchronic dermallesions, such as StageI-IV pressure ulcers,stasis ulcers, diabeticulcers, foot ulcers,post-surgical wounds,first and second-degree burns, cuts,abrasions and minorskin irritations and fordevice irrigation. | For moisteningof absorbentwound dressingsand irrigation toremove loosedebris and dirtfrom the wound. | SameK172486K161311K083042DifferentK161658 | |
| Principleof Operation | Mechanical action offluid moving acrossthe wound or deviceaids in the removal offoreign objects suchas dirt and debris. | Mechanical action offluid moving acrossthe wound or deviceaids in the removal offoreign objects suchas dirt and debris. | Mechanical action offluid moving acrossthe wound or deviceaids in the removal offoreign objects such asdirt and debris. | Mechanicalaction of fluidmoving acrossthe wound ordevice aids in theremoval offoreign objectssuch as dirt anddebris. | Same |
| ChemicalComposition | 0.9% Sterile Saline orSterile Water; noantimicrobial or othersubstance added | 0.9% Sterile Saline orSterile Water; noantimicrobial or othersubstance added | 0.9% Sterile Saline orSterile Water; noantimicrobial or othersubstance added | 0.9% SterileSaline or SterileWater; noantimicrobial orother substanceadded | Same |
| Models | 8100 - 100mL USP SterileWater9100 - 100mL USP SterileSaline8250 - 250mL USP SterileWater9250 - 250mL USP SterileSaline8500 - 500mL USP SterileWater9500 - 500mL USP SterileSaline8120 - 120mL USP SterileWater9120 - 120mL USPSterile Saline | Model Numbers Unknownbut sizes are the same:100mL USP Sterile Water100mL USP Sterile Saline120mL USP Sterile Water120mL USP Sterile Saline250mL USP Sterile Water250mL USP Sterile Saline500mL USP Sterile Water500mL USP Sterile Saline | 6250 - 100mL USP SterileWater6240 - 100mL USP SterileSaline6260 - 250mL USP SterileWater6270 - 250mL USP SterileSaline6290 - 500mL USP SterileWater6280 - 500mL USP SterileSaline6210 - 120mL USP SterileWater6220 - 120mL USPSterile Saline | 8100 - 100mL USPSterile Water9100 - 100mL USPSterile Saline8250 - 250mL USPSterile Water9250 - 250mL USPSterile Saline8500 - 500mL USPSterile Water9500 - 500mL USPSterile Saline8120 - 120mL USPSterile Water9120 - 120mL USPSterile Saline | Same |
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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.
N/A