(116 days)
No
The summary describes a chemical decontamination lotion and its applicator, with no mention of AI or ML technology.
Yes
The device is intended to remove or neutralize chemical warfare agents and toxins from the skin, which is a therapeutic function.
No
The device is a lotion intended to remove or neutralize chemical warfare agents and T-2 toxin from the skin. It is used for decontamination, not for diagnosing a condition.
No
The device description clearly states it is a lotion pre-impregnated in a foam sponge applicator pad, which are physical components, 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 to remove or neutralize chemical warfare agents and T-2 toxin from the skin. This is a direct application to the body surface for decontamination, not for testing a sample taken from the body.
- Device Description: The device is a lotion pre-impregnated in a sponge applicator. This is a topical application device.
- Anatomical Site: The anatomical site is the skin. IVDs typically analyze samples like blood, urine, tissue, etc., which are taken from the body.
- Performance Studies: The performance studies focus on biocompatibility, safety, and efficacy in removing/neutralizing agents from the skin. There is no mention of analyzing biological samples.
IVDs are devices intended for use in vitro for the examination of 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
The Reactive Skin Decontamination Lotion is intended to remove or neutralize chemical warfare agents and T-2 toxin from the skin.
Product codes
MAC
Device Description
The RSDL lotion is pre-impregnated in a 2 x 3.9 x 0.4 inch, or 3.9 x 3.9 x 0.4 inch foam sponge applicator pad. Each applicator pad is packaged as a single unit in a heat-sealed polyethylene-lined aluminum foil pouch. The foil pouch is covered by a kraft paper outer layer to facilitate coloring of the finished package and to make opening the package possible when wearing CW protective clothing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
military personnel
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 RSDL was subjected to a number of biocompatibility and safety tests and from the results of those tests, it can be concluded the RSDL is safe for its intended use.
The RSDL was also tested for efficacy in removing and/or neutralizing groups of chemical warfare agents and T-2 toxin. RSDL performed significantly better than the predicate device against the agents tested.
In tests evaluating the compatibility of RSDL with other agents military personnel would apply to the skin, RSDL was demonstrated to be compatible with all agents tested.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K894455, U.S. Department of the Army, Decontaminating Kit, Skin: M291
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4014 Nonresorbable gauze/sponge for external use.
(a)
Identification. A nonresorbable gauze/sponge for external use is a sterile or nonsterile device intended for medical purposes, such as to be placed directly on a patient's wound to absorb exudate. It consists of a strip, piece, or pad made from open woven or nonwoven mesh cotton cellulose or a simple chemical derivative of cellulose. This classification does not include a nonresorbable gauze/sponge for external use that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9.
0
MAR 2 5 2003
Applicant:
U.S. Department of the Army
Reactive Skin Decontamination Lotion
Traditional 510(k) Premarket Notification
1 of 2
510(k) SUMMARY
Reactive Skin Decontamination Lotion (RSDL)
| Submitter Name: | U.S. Department of the Army |
|---|---|
| Submitter Address: | 64 Thomas Johnson Drive |
| Fort Detrick, Maryland 21702 | |
| Contact Person: | Ronald E. Clawson, Ph.D. |
| Phone Number: | 301-619-2016 |
| Fax Number: | 301-619-7230 |
| Date Prepared: | November 22, 2002 |
| Device Trade Name: | Reactive Skin Decontamination Lotion (RSDL) |
| Device Common Name: | Kit, Decontamination |
| Classification Name: | MAC |
| Predicate Device: | K894455, U.S. Department of the Army, Decontaminating Kit, |
| Skin: M291 | |
| Device Description: | The RSDL lotion is pre-impregnated in a 2 x 3.9 x 0.4 inch, or 3.9 |
| x 3.9 x 0.4 inch foam sponge applicator pad. Each applicator pad | |
| is packaged as a single unit in a heat-sealed polyethylene-lined | |
| aluminum foil pouch. The foil pouch is covered by a kraft paper | |
| outer layer to facilitate coloring of the finished package and to | |
| make opening the package possible when wearing CW protective | |
| clothing. | |
| Intended Use: | The Reactive Skin Decontamination Lotion is intended to remove |
| or neutralize chemical warfare agents and T-2 toxin from the skin. | |
| Discussion of tests and | |
| test results: | The RSDL was subjected to a number of biocompatibility and |
| safety tests and from the results of those tests, it can be | |
| concluded the RSDL is safe for its intended use. | |
| The RSDL was also tested for efficacy in removing and/or | |
| neutralizing groups of chemical warfare agents and T-2 toxin. | |
| RSDL performed significantly better than the predicate device | |
| against the agents tested. | |
| In tests evaluating the compatibility of RSDL with other agents | |
| military personnel would apply to the skin, RSDL was | |
| demonstrated to be compatible with all agents tested. | |
| Conclusion: | This device, with respect to material composition, device |
| characteristics and intended use, has been demonstrated to be | |
| safe and effective as a skin decontaminant, and is substantially | |
| equivalent to the predicate device. |
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000036
2
Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines above two wavy lines.
MAR 2 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Department of the Army C/O Mr. Ronald E. Clawson Department of Defense Chemical-Biological Mgt. Office 64 Thomas Johnson Drive Fort Detrick, Maryland 21702
Re: K023969
Trade/Device Name: Reactive Skin Decontamination Lotion Regulatory Class: II Product Code: MAC Dated: November 26, 2002 Received: November 29, 2002
Dear Mr. Clawson:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Mr. Clawson
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Panov
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Applicant: U.S. Department of the Army
023969
510(k) Number (if known):
Device Name:
Reactive Skin Decontamination Lotion
Indications for Use:
The Reactive Skin Decontamination Lotion is intended to remove or neutralize chemical warfare agents and T-2 toxin from the skin.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED),
| Concurrence of CDRH; Office of Device Evaluation (ODE) | |||
|---|---|---|---|
| Prescription | |||
| Use | |||
| (Per 21 CFR 801.109) | OR | Over-The-Counter | |
| Use | X |
| | (Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices | | (Optional Format 1-2-96) |
|----------------|-----------------------------------------------------------------------------------------------------------|--|--------------------------|
| 510(k) Number: | K023969 | | |
Section 4.0
| 000018 | |||
|---|---|---|---|
| -- | -- | -- | -------- |