(90 days)
For moistening of absorbent wound dressings and irrigation to remove loose debris and dirt from the wound.
The Wound Flush, Sterile Water & Sterile Normal Saline device can be used 1) for moistening a dry sterile dressing for wound cleansing and 2) irrigation to remove loose debris and dirt from the wound. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of loose foreign material such as dirt and debris. The product has a shelf life of 2-years.
The solution is available as sterile saline for irrigation and is gamma sterilized. The subject device is offered in various bottle sizes of 100ml, 250ml, and 500ml and cup sizes of 120ml.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Anexa Wound Flush, Sterile Water & Sterile Normal Saline device:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a table of "acceptance criteria" in the traditional sense of performance metrics for a medical device (e.g., sensitivity, specificity, accuracy). Instead, it describes a substantial equivalence (SE) determination based on a comparison to a predicate device and a series of non-clinical tests. The "performance" is demonstrated by passing these tests and showing similarity to the predicate.
| Acceptance Criteria (Demonstrated by) | Reported Device Performance (as stated in the document) |
|---|---|
| Substantial Equivalence to Predicate Device (K083042) | The device is substantially equivalent to the legally marketed predicate device (Nurse Assist, Inc. Wound Flush, Sterile Water & Sterile Normal Saline). Similarities noted include: - Same Regulatory Product Code (FRO) - Same Classification (Pre-amendment) - Similar Indications for Use - Similar Principle of Operation (mechanical action removing foreign objects) - Same Chemical Composition (0.9% Sterile Saline or Sterile Water; no additives) - Uses same materials and container designs - Same method of sterilization (gamma) |
| Biocompatibility Testing | Anexa conducted and passed the following biocompatibility tests: - Cytotoxicity - Dermal Sensitization - Intracutaneous test (direct injection) - Acute Systemic Toxicity - Bacterial Endotoxin Test |
| Compliance with Recognized Standards (Non-Clinical Testing) | Anexa conducted and passed tests according to the following standards: - ASTM F1980-07 (Reapproved 2011) - AAMI/ANSI/ISO 11607-1:2006/(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 |
| Device Stability / Shelf-life | Product has a shelf life of 2-years. This implies successful testing to demonstrate this. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical testing and a comparison to a predicate device, not a "test set" in the context of clinical performance evaluation (e.g., for an AI algorithm). The sample sizes for the specific non-clinical tests (biocompatibility, shelf-life, etc.) are not provided in this summary. The data provenance is also not explicitly stated beyond being part of Anexa Biomedical, Inc.'s internal testing records.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the document describes non-clinical testing for a wound flush solution, not a diagnostic device requiring expert interpretation or ground truth establishment in a clinical setting.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as #3.
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
This information is not applicable. The device is a wound flush solution, not an AI-powered diagnostic tool. An MRMC study is explicitly designed for evaluating the impact of AI on human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a wound flush solution, not an algorithm.
7. The Type of Ground Truth Used
For the non-clinical tests (biocompatibility, sterility, shelf-life), the "ground truth" would be established by:
- Reference Standards/Controls: For biocompatibility, comparisons are made to established safe materials and adverse reactions are assessed.
- Scientific Methods and Measurements: For sterility, microbiological testing to confirm absence of microorganisms. For shelf-life, stability studies measuring chemical and physical properties over time.
- Compliance with Recognized Standards: Meeting the pass/fail criteria outlined in the referenced ASTM, AAMI/ANSI/ISO standards.
For the substantial equivalence claim, the "ground truth" is the legally marketed predicate device and its established safety and effectiveness profile.
8. The Sample Size for the Training Set
This information is not applicable as the device is not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reasons as #8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked one behind the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 14, 2016
Anexa Biomedical, Inc. % Ms. Yolanda Smith Smith Associates 1468 Harwell Avenue Crofton, MD 21114
Re: K161658
Trade/Device Name: Anexa Wound Flush, Sterile Water & Sterile Normal Saline Regulatory Class: Unclassified Product Code: FRO Dated: June 14, 2016 Received: June 16, 2016
Dear Ms. Smith:
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.
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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
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K161658
Device Name
Wound Flush, Sterile Water & Normal Saline
Indications for Use (Describe)
For moistening of absorbent wound dressings and irrigation to remove loose debris and dirt from the wound.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary K161658 (As Per 21 CFR 807.92)
SPONSOR CompanyName: Anexa Biomedical, Inc. Company Address: 40423 Air Time Ave Zephyrhills, Florida 33542 Telephone: 813-780-7927 813-780-7930 Fax: ContactPerson: Lenny Budloo SummaryPrepared September 12, 2016 TradeName: Anexa Sterile Water, Normal Saline Sterile Water, Normal Saline, Wound Common/UsualName: Flush Solution Classification Name: Dressing, Wound, Drug Product Code: FRO Device Class: Unclassified Regulation Number: Predicate Device Company Product 510(k)# Nurse Assist, Inc. Wound Flush, Sterile Water
& Sterile Normal Saline
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Device Description
The Wound Flush, Sterile Water & Sterile Normal Saline device can be used 1) for moistening a dry sterile dressing for wound cleansing and 2) irrigation to remove loose debris and dirt from the wound. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of loose foreign material such as dirt and debris. The product has a shelf life of 2-years.
The solution is available as sterile saline for irrigation and is gamma sterilized. The subject device is offered in various bottle sizes of 100ml, 250ml, and 500ml and cup sizes of 120ml.
Indications for Use
For moistening of absorbent wound dressings and irrigation to remove loose debris and dirt from the wound.
Comparison of Technological Characteristics
| Subject | PredicateNurse Assist, Inc. | SimilaritiesandDifference | |
|---|---|---|---|
| K Number | K083042 | ||
| Brand Name | Anexa Wound Flush, Sterile Water& Sterile Normal Saline | Nurse Assist Wound Flush, SterileWater & Sterile Normal Saline | |
| ClassificationProduct Code | FRO | FRO | Same |
| Classification | Pre-amendment | Pre-amendment | Same |
| Indicationsfor Use | For moistening of absorbent wounddressings and irrigation to removeloose debris and dirt from thewound. | Over the counter UseFor moistening absorbent wounddressings and cleaning minor cuts,minor burns, superficial abrasionsand minor irritations of the skin.For Prescription UseFor moistening absorbent wounddressings and for moistening,debriding and cleaning acute andchronic dermal lesions, such asStage I-IV pressure ulcers, stasisulcers, diabetic ulcers, foot ulcers,post-surgical wounds, first andsecond degree burns, cuts,abrasions and minor skin irritationsand for device irrigation. | Similar |
| Principle ofOperation | Mechanical action of fluid movingacross the wound or device aidsin the removal of foreign objectssuch as loose dirt and debris | Mechanical action of fluid movingacross the wound or device aidsin the removal of foreign objectssuch as dirt and debris | Similar |
| ChemicalComposition | 0.9% Sterile Saline or SterileWater; no antimicrobial or othersubstance added | 0.9% Sterile Saline or SterileWater; no antimicrobial or othersubstance added | Same |
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| Models | 8100 100 mL Sterile Water | 6210 120 mL Sterile Water | Same |
|---|---|---|---|
| 9100 100 mL Sterile Saline | 6220 120 mL Normal Saline | ||
| 8250 250 mL Sterile Water | 6240 100 mL Normal Saline | ||
| 9250 250 mL Sterile Saline | 6250 100 mL Sterile Water | ||
| 8500 500 mL Sterile Water | 6260 250 mL Sterile Water | ||
| 9500 500 mL Sterile Saline | 6270 250 mL Normal Saline | ||
| 8120 120 mL Sterile Water | 6280 500 mL Normal Saline | ||
| 9120 120 mL Sterile Saline | 6290 500 mL Sterile Water |
Discussion of Technological Differences
The subject device and the predicate have similar indications for use and intended use. Both offer bottles with induction sealed pull tab with screw cap closure and high impact polystyrene cups with heat sealed foil lid. The mechanical action is the same for both the subject device and the predicate, as it relates to Sterile Water and Normal Saline bottles and cups. The materials and methods used in the manufacturing and sterilization (gamma) are the same for both devices.
Non Clinical Testing
| ASTM F1980-07 (Reapproved 2011) |
|---|
| AAMI/ANSI/ISO 11607-1:2006/(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 |
Anexa conducted and passed the following biocompatibility tests; cytotoxicity, dermal sensitization, intracutaneous test (direct injection), acute systemic toxicity and bacterial endotoxin test.
Substantial Equivalence Conclusion
The Anexa products passed all the referenced biocompatibility tests, uses the same materials and container designs, same method of sterilization, same principle of operation, and the same intended use(s). Through safety and performance testing, Anexa Biomedical has concluded that the device does not introduce any significant new questions of safety and is substantially equivalent to the predicate device.
N/A