REACTIVE SKIN DECONTAMINATION LOTION

K023969 · Dept. of the Army · MAC · Mar 25, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K023969
• Device Name: REACTIVE SKIN DECONTAMINATION LOTION
• Applicant: Dept. of the Army
• Product Code: MAC · General, Plastic Surgery
• Decision Date: Mar 25, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4014
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Reactive Skin Decontamination Lotion is intended to remove or neutralize chemical warfare agents and T-2 toxin from the skin.

Device Story

Reactive Skin Decontamination Lotion (RSDL) consists of a lotion pre-impregnated into a foam sponge applicator pad; packaged in a heat-sealed polyethylene-lined aluminum foil pouch with a kraft paper outer layer. Designed for use by military personnel to remove or neutralize chemical warfare agents and T-2 toxin from skin. Applicator design facilitates opening while wearing chemical warfare protective clothing. RSDL provides improved efficacy in agent removal/neutralization compared to the M291 predicate device. Biocompatibility and safety testing confirmed suitability for skin application; demonstrated compatibility with other military-use skin agents.

Clinical Evidence

Bench testing only. Biocompatibility and safety testing performed. Efficacy testing demonstrated RSDL performed significantly better than the predicate device in removing and/or neutralizing chemical warfare agents and T-2 toxin. Compatibility testing confirmed RSDL is compatible with other agents applied to the skin by military personnel.

Technological Characteristics

Lotion pre-impregnated in foam sponge applicator pad. Dimensions: 2 x 3.9 x 0.4 inches or 3.9 x 3.9 x 0.4 inches. Packaging: heat-sealed polyethylene-lined aluminum foil pouch with kraft paper outer layer. No electronic, software, or energy-based components.

Indications for Use

Indicated for the removal or neutralization of chemical warfare agents and T-2 toxin from the skin.

Regulatory Classification

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.

Predicate Devices

• Decontaminating Kit, Skin: M291 (K894455)

Submission Summary (Full Text)

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MAR 2 5 2003

Applicant:
**U.S. Department of the Army**

Reactive Skin Decontamination Lotion
Traditional 510(k) Premarket Notification

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## 510(k) SUMMARY

### Reactive Skin Decontamination Lotion (RSDL)

| Submitter Name: | U.S. Department of the Army |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 64 Thomas Johnson Drive<br>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,<br>Skin: M291 |
| Device Description: | The RSDL lotion is pre-impregnated in a 2 x 3.9 x 0.4 inch, or 3.9<br>x 3.9 x 0.4 inch foam sponge applicator pad. Each applicator pad<br>is packaged as a single unit in a heat-sealed polyethylene-lined<br>aluminum foil pouch. The foil pouch is covered by a kraft paper<br>outer layer to facilitate coloring of the finished package and to<br>make opening the package possible when wearing CW protective<br>clothing. |
| Intended Use: | The Reactive Skin Decontamination Lotion is intended to remove<br>or neutralize chemical warfare agents and T-2 toxin from the skin. |
| Discussion of tests and<br>test results: | The RSDL was subjected to a number of biocompatibility and<br>safety tests and from the results of those tests, it can be<br>concluded the RSDL is safe for its intended use. |
| | The RSDL was also tested for efficacy in removing and/or<br>neutralizing groups of chemical warfare agents and T-2 toxin.<br>RSDL performed significantly better than the predicate device<br>against the agents tested. |
| | In tests evaluating the compatibility of RSDL with other agents<br>military personnel would apply to the skin, RSDL was<br>demonstrated to be compatible with all agents tested. |
| Conclusion: | This device, with respect to material composition, device<br>characteristics and intended use, has been demonstrated to be<br>safe and effective as a skin decontaminant, and is substantially<br>equivalent to the predicate device. |

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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.

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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 [phone]. 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 [phone] or [phone] 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

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#### 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<br>Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter<br>Use | X |

| | (Division Sign-Off)<br>Division of Anesthesiology, General Hospital,<br>Infection Control, Dental Devices | | (Optional Format 1-2-96) |
|----------------|-----------------------------------------------------------------------------------------------------------|--|--------------------------|
| 510(k) Number: | K023969 | | |

Section 4.0

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