(263 days)
Not Found
No
The device description explicitly states the device functions by "mechanical action" and is a simple sterile saline solution for irrigation and moistening. There is no mention of any computational or analytical capabilities that would suggest AI/ML.
Yes
The device is used for moistening absorbent wound dressings, cleaning minor burns, superficial abrasions, and minor irritations of the skin, and for moisturizing, debridement, and irrigation of acute and chronic dermal lesions, all of which are therapeutic actions.
No.
The device description and intended use clearly state that the device functions by mechanical action for moistening, debridement, and irrigation of wounds and surfaces. It does not mention any diagnostic capabilities or the ability to identify or characterize medical conditions.
No
The device description clearly states it is a physical product (bottles of sterile saline) and its function is based on mechanical action, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for moistening wound dressings, cleaning wounds, and device irrigation. This is a direct application to the body or a medical device, not for examining specimens in vitro (outside the body) to provide information about a physiological state, health, or disease.
- Device Description: The device is sterile saline solution in a bottle, used for mechanical action (flushing, moistening). This is a physical action, not a diagnostic test performed on a sample.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
- Performance Studies: The performance studies focus on safety, biocompatibility, and functionality related to its use for wound care and irrigation, not on diagnostic accuracy.
IVD devices are specifically designed to perform tests on samples taken from the human body to diagnose or monitor medical conditions. This device's function is entirely external and mechanical.
N/A
Intended Use / Indications for Use
For Over-the-Counter Use: For moistening absorbent wound dressings and cleaning minor burns, superficial abrasions and minor irritations of the skin.
For Prescription Use: For moistening absorbent wound dressings and for moistening acute and chronic dernal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic 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 subject devices are 100 mL, 250 mL or 500 mL sterile normal saline (0.9% Sodium Chloride). The design of these single-use devices incorporates clear, high density polyethylene (HDPE) bottles filled and sealed with a sterile, preservative-free, clear, colorless, aqueous solution, as labeled for device irrigation and wound debridement (not for injection). The subject device will function by means of mechanical action; specifically, by the mechanical mechanism of action associated with applying and moving an aqueous solution across a wound or device surface, which facilitates the moisturizing, debridement and irrigation of these surfaces.
The chemical composition of its aqueous solution is either sterile saline (0.9% Sodium Chloride in sterile water) for irrigation, which have been substantiated to each meet their respective USP monograph criteria, and its formulation contains no additives. The components of the subject device's container and closure system, made from polyethylene (PE) resins and an induction-heat seal and liner, meet the requirements of the Agency's food additive regulations.
Medline Sterile Water USP and Sterile 0.9% Normal Saline USP are available in the following configurations:
- Medline Sterile Water, USP - 100 mL
- Medline Sterile Water, USP - 250 mL
- Medline Sterile Water, USP - 500 mL
- Medline Sterile 0.9% Normal Saline, USP - 100 mL
- Medline Sterile 0.9% Normal Saline, USP - 250 mL
- Medline Sterile 0.9% Normal Saline, USP - 500 mL
All six of these configurations are designed to consist of either sterile water USP or sterile normal saline (0.9% Sodium Chloride) USP, packaged and sealed in HDPE bottles and terminally sterilized using gamma irradiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin (for wound dressings, cleaning minor cuts, minor burns, superficial abrasions, minor irritations, acute and chronic dermal lesions, Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Summary of Non-Clinical Testing: Non-clinical verification of Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP has been conducted to evaluate its safety, performance and functionality. The results of these tests have demonstrated the overall safety of the proposed device and ultimately support a substantial equivalence determination.
Biocompatibility Evaluation: Conducted in accordance with ANSI/AAMI/ISO 10993-1:2009. The device is classified as a surface device with a limited duration of contact ( Pyrogen Test Procedure, Material-Mediated Rabbit Pyrogen Testing
Performance Testing (Bench): Non-clinical verification of Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP has been conducted to evaluate the safety, performance and functionality of the proposed device. The results of these tests have demonstrated the overall safety of the proposed device and ultimately support a substantial equivalence determination.
Summary of Clinical Testing: Not applicable. No clinical testing was done on the proposed device.
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). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, which features a stylized depiction of human figures. To the right of this symbol, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a larger, bolder font, while "U.S. FOOD & DRUG" is in a slightly smaller font, and "ADMINISTRATION" is in an even smaller font below.
Medline Industries, Inc. Claire Pigman Senior Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093
Re: K173276
Trade/Device Name: Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP Regulatory Class: Unclassified Product Code: FRO Dated: June 1, 2018 Received: June 5, 2018
Dear Claire Pigman:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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
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 mediation-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, Neil R Oaden -5 For Binita S. Ashar, M.D., M.B.A., F.A.C 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) K173276
Device Name
Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP
Indications for Use (Describe)
For Over-the-Counter Use:
For moistening absorbent wound dressings and cleaning minor burns, superficial abrasions and minor irritations of the skin.
For Prescription Use:
For moistening absorbent wound dressings and for mostening acute and chronic dernal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic 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)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the Medline logo. The logo features the word "MEDLINE" in white, bold, sans-serif font, positioned to the left of a white, stylized starburst symbol. The background is a solid dark blue color. The logo is simple, clean, and professional, reflecting the company's focus on medical supplies and services.
Medline Industries, Inc.
Three Lakes Drive
Northfield, IL 60093
SECTION 5 510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)]
Submitter / 510(k) Sponsor
Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 Registration Number: 1417592
Contact Person
Claire Pigman Sr. Regulatory Affairs Specialist Phone: 847-643-4071 Email: cpigman@medline.com
Summary Preparation Date October 9, 2017
Type of 510(k) Submission Traditional
Device Name / Classification
Name of Device: Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP Device Common Name: Sterile Water and Sterile Saline Classification Name: Dressing, Wound, Drug Product Code: FRO Classification Panel: General and Plastic Surgery Devices Device Classification: Unclassified Regulation Number: Pre-Amendment
Predicate Device
Predicate Device Name: Wound Flush, Sterile Water and Sterile Normal Saline Predicate Device Sponsor: Nurse Assist, Inc. Predicate Device K Number: K083042
Device Description
The subject devices are 100 mL, 250 mL or 500 mL sterile normal saline (0.9% Sodium Chloride). The design of these single-use devices incorporates clear, high density polyethylene (HDPE)
4
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edline Industries. hree Lakes Drive Northfield II 60093
bottles filled and sealed with a sterile, preservative-free, clear, colorless, aqueous solution, as labeled for device irrigation and wound debridement (not for injection). The subject device will function by means of mechanical action; specifically, by the mechanical mechanism of action associated with applying and moving an aqueous solution across a wound or device surface, which facilitates the moisturizing, debridement and irrigation of these surfaces.
The chemical composition of its aqueous solution is either sterile saline (0.9% Sodium Chloride in sterile water) for irrigation, which have been substantiated to each meet their respective USP monograph criteria, and its formulation contains no additives. The components of the subject device's container and closure system, made from polyethylene (PE) resins and an induction-heat seal and liner, meet the requirements of the Agency's food additive regulations. Medline Sterile Water USP and Sterile 0.9% Normal Saline USP are available in the following configurations:
| Medline Item Number | Description |
|---|---|
| RDI30295 | Medline Sterile Water, USP - 100 mL |
| PCS1550 | Medline Sterile Water, USP - 250 mL |
| DYND500MLW | Medline Sterile Water, USP - 500 mL |
| RDI30296 | Medline Sterile 0.9% Normal Saline, USP - 100 mL |
| PCS1650 | Medline Sterile 0.9% Normal Saline, USP - 250 mL |
| DYND500MLS | Medline Sterile 0.9% Normal Saline, USP - 500 mL |
Please note that all six of these configurations are designed to consist of either sterile water USP or sterile normal saline (0.9% Sodium Chloride) USP, packaged and sealed in HDPE bottles and terminally sterilized using gamma irradiation. Please refer to Section 11 of this Premarket Notification for a more comprehensive description of this device.
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.
Summary of Technological Characteristics
Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP are single-use devices and their design incorporates clear, high density polyethylene (HDPE) bottles filled and sealed with a sterile, preservative-free, clear, colorless, aqueous solution, as labeled for device irrigation and wound debridement (not for injection). The chemical composition of its aqueous solution is either sterile water
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ledline Industries, Inc. Three Lakes Drive Northfield. IL 60093
or sterile saline (0.9% Sodium Chloride) for irrigation, which have been substantiated to each meet their respective USP monograph criteria, and its formulation contains no additives.
In addition, the subject device is similar in design, intended use and function to the predicate device, Nurse Assist Wound Flush, Sterile Water and Sterile Normal Saline, cleared under K083042. The table below provides a side-by-side comparison of the proposed and predicate devices. Please refer to Section 12 for a further discussion of the similarities and differences between the two devices.
6
Table 1: Comparison of Proposed and Predicate Devices
| Device
Characteristic | Proposed Device | Predicate Device | Comparison
Analysis | | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|------|
| Product Name | Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline
USP | Nurse Assist Wound Flush, Sterile Water and Sterile Normal
Saline | N/A | | |
| 510(k) Reference | K173276 | K083042 | N/A | | |
| Product Owner | Medline Industries, Inc. | Nurse Assist Incorporated | N/A | | |
| Product Code | FRO | FRO | Same | | |
| Indication for Use | Over-the-Counter Use: For moistening absorbent wound dressings
and cleaning minor cuts, minor burns, superficial abrasions and
minor irritations of the skin | Over-the-Counter Use: For moistening absorbent wound dressings
and cleaning minor cuts, minor burns, superficial abrasions and
minor irritations of the skin. | Same | | |
| | 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, 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 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, stasis ulcers,
diabetic ulcers, foot ulcers, post-surgical wounds, first and second
degree burns, cuts, abrasions and minor skin irritations and for
device irrigation. | Same | | |
| Regulation Number | Pre-Amendment | Pre-Amendment | Same | | |
| Technological
Characteristics: | Principle mechanism of action is through the mechanical action
associated with the application and movement of fluid (either Sterile
Water or Saline) across a wound or device surface to facilitate the
moisturizing, debridement and irrigation of these surfaces. | Mechanical action of fluid moving across the wound or device
provides for the mechanism of action and aids in the removal of
foreign objects such as dirt and debris. | Same | | |
| Chemical
Composition | Sterile Saline (0.9% Sodium Chloride) or Sterile Water for irrigation
substantiated to meet USP; no antimicrobial or other substance
added. | Sterile Saline (0.9% Sodium Chloride) or Sterile Water for
irrigation substantiated to meet USP; no antimicrobial or other
substance added. | Same | | |
| Design
Configurations | CONTENTS
100 mL Sterile Water, USP
250 mL Sterile Water, USP
100 mL Normal Saline, USP
250 mL Normal Saline, USP
500 mL Sterile Water, USP
500 mL Normal Saline, USP | CONTAINER
HDPE Bottles made from
polyethylene (PE) resin.
Include an induction-heat
seal and liner with a
polypropylene (PP) screw
cap closure | CONTENTS
100 mL USP Sterile Water
250 mL USP Sterile Water
100 mL USP Normal Saline
250 mL USP Normal Saline | Similar | |
| | | | CONTAINER
HDPE Bottles made from
polyethylene (PE) resin.
Include an induction sealed
inner pull tab with a
polypropylene (PP) screw cap
closure | | |
| | | | 120 mL USP Sterile Water
120 mL USP Normal Saline
210 mL USP Normal Saline | White polypropylene (PP) cup
with heat sealed foil lid
Nitrogen pressurized
aluminum bottle with latex-
free inner bag | |
| Performance
Specifications | The sterile water and sterile saline is manufactured from Water for
Irrigation that is designed, tested and operated in accordance with
the USP monograph for Water for Irrigation, as specified in USP
General Chapter: Water for Pharmaceutical Purposes | | The sterile water and sterile saline is manufactured from Water for
Irrigation that is designed, tested and operated in accordance with
the USP monograph for Water for Irrigation, as specified in USP
General Chapter: Water for Pharmaceutical Purposes | | Same |
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Table 1: Comparison of Proposed and Predicate Devices
| Device
Characteristic | Proposed Device | Predicate Device | Comparison
Analysis |
|-----------------------------------|----------------------------|----------------------------|------------------------|
| Prescription vs. OTC | Prescription Use & OTC Use | Prescription Use & OTC Use | Similar |
| Contact Durations | Pyrogen Test Procedure, Material-Mediated Rabbit Pyrogen Testing ●
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Medline Industries, Inc.
Three Lakes Drive
Northfield, IL 60093
Performance Testing (Bench)
Non-clinical verification of Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP has been conducted to evaluate the safety, performance and functionality of the proposed device. The results of these tests have demonstrated the overall safety of the proposed device and ultimately support a substantial equivalence determination.
Summary of Clinical Testing
Not applicable. No clinical testing was done on the proposed device.
Conclusion
In accordance with 21 CFR Part 807. and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP are as safe and as effective for their intended use as the predicate device Nurse Assist Wound Flush, Sterile Water and Sterile Normal Saline (K083042).