HY-CHLO(TM)WOUND SCRUB

K113312 · Patrin Pharma · FQH · Aug 21, 2012 · General Hospital

Device Facts

• Record ID: K113312
• Device Name: HY-CHLO(TM)WOUND SCRUB
• Applicant: Patrin Pharma
• Product Code: FQH · General Hospital
• Decision Date: Aug 21, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5475
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OTC HyChlo™ Wound Solution is intended for removal of foreign objects such as dirt, for cleansing of minor cuts, lacerations, abrasions and wounds. Professional Use HyChlo™ Wound Solution is intended to be used under the supervision of healthcare professional in cleansing of acute, chronic and/or open wounds such as Stage I-IV pressure ulcers, diabetic foot and leg ulcers, surgical wounds, first and second degree burns and grafted and donor sites.

Device Story

Hy-Chlo™ Wound Solution is an aqueous, clear, colorless solution containing 0.125% sodium hypochlorite (preservative) and sodium bicarbonate (pH modifier). Supplied in HDPE bottles, the solution is dispensed to provide a mechanical lavage force of 8.0 psi to remove foreign objects and debris from wounds. Used in clinical settings (hospitals, nursing homes, surgery centers, wound clinics) by healthcare professionals or as an OTC product for minor wounds. The solution acts as a cleanser; the mechanical force facilitates debris removal. Benefits include effective wound cleansing without inhibiting the natural healing process, as demonstrated in porcine models. The device is intended for external use only.

Clinical Evidence

No human clinical trials provided. Evidence consists of bench and animal studies. In vitro: ISO 10993-5 cytotoxicity testing showed moderate reactivity. In vivo: Porcine dermal abrasion study (n=unspecified) over 14 days showed no inhibition of healing compared to untreated sites. Rabbit dermal irritation study (4h/24h exposure) showed minimal irritation clearing within 72 hours. Guinea pig sensitization study showed no sensitization. Preservative efficacy testing (USP protocol) confirmed effectiveness against S. aureus, E. coli, P. aeruginosa, C. albicans, MRSA, and A. Brasiliensis. Mechanical force testing confirmed 8.0 psi (SD 0.7) output.

Technological Characteristics

Aqueous solution; Ingredients: Purified Water, Sodium Bicarbonate, Sodium Hydroxide, Sodium Hypochlorite (0.125% w/v). pH 9-11. Packaging: Heat-sealed, impervious, mold-extruded HDPE bottles. Mechanical principle: Jet lavage (force 8.0 psi). Manufacturing: cGMP and GLP compliant. Testing per USP standards.

Indications for Use

Indicated for removal of foreign objects (dirt) and cleansing of minor cuts, lacerations, abrasions, and wounds (OTC). Indicated for professional use in cleansing acute, chronic, and open wounds including Stage I-IV pressure ulcers, diabetic foot/leg ulcers, surgical wounds, first/second degree burns, and grafted/donor sites.

Regulatory Classification

Identification

A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

Submission Summary (Full Text)

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## 510 (K) Summary of Hy-Chlo™ Wound Solution

AUG 2 1 2012

| 510(K) Summary | This summary of 510(K) safety and effectiveness information<br>is being submitted in accordance with the requirements of 21<br>CFR §807.92. |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Company | Patrin Pharma, Inc<br>P.O. Box 1481<br>7817 Babb Avenue, Suite 103<br>Skokie, IL 60076-1481 |
| Contact | Jay S. Trivedi<br>Director, New Products<br>Tel: [phone]<br>Fax: [phone]<br>Email: |
| Date Prepared | November 8th, 2011 |
| Device Trade/Brand Name | Hy-Chlo™ Wound Solution |
| Device Common Name | Wound Solution, |
| Classification Name | Dressing, Wound, Drug |
| Device Classification | Jet Lavage |
| Product Code Proposed | FQH |
| Device Description | Hy-Chlo™ Wound Solution is an aqueous, clear, colorless<br>solution that cleans open wounds. The solution delivers<br>sodium hypochlorite as a preservative with sodium<br>bicarbonate as a pH modifier. Hy-Chlo™ Wound Solution<br>will be supplied in heat sealed, impervious, mold extruded<br>HDPE bottles. A permanent affixed label will be on each<br>bottle. |
| Indications for Use | |
| OTC | Hy-Chlo™ Wound Solution is intended for removal of foreign<br>objects such as dirt, for cleansing of minor cuts, lacerations,<br>abrasions and wounds. |
| Professional Use | Hy-Chlo™ Wound Solution is intended to be used under the<br>supervision of healthcare professional in the cleansing of<br>acute, chronic and/or open wounds such as Stage I-IV<br>pressure ulcers, diabetic foot and leg ulcers, surgical wounds,<br>first and second degree burns and grafted and donor sites. |
| General use conditions | Hy-Chlo™ Wound Solution is to be used for patients with<br>acute or chronic wounds generally in an attended healthcare<br>setting such as acute and non-acute care hospitals, nursing<br>homes, surgery centers, emergency rooms and wound clinics |
| Manufacturing and<br>Performance Testing | Hy-Chlo™ Wound Solution will be manufactured in USA in<br>an FDA inspected facility inspected as recently as 2011. The<br>manufacturing and testing will be performed under cGMP<br>(Current Good Manufacturing Practices) and Good<br>Laboratory Practices (GLP) guidance and according to |

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Laboratory Practices (GLP) guidance and according to specifications set per current United States Pharmacopia (USP). Manufacturing practices incorporate a QbD (quality by design) analysis that addresses all critical parameters for consistent and measurable product quality that meets or exceeds established specifications. A testing regimen and associated release specifications have been established per USP (United States Pharmacopeia) to meet Hy-Chlo™ Solution testings. All production batches are tested prior to release to insure product meets established specifications and is safe and effective for its intended use. Pre-marketing stability studies have been performed to demonstrate continued stability and efficacy of the product for the claimed shelf life. Ongoing performance and stability studies are planned for continued monitoring.

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## Device Description

. .

| | Proposed |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Devices | Hy-Chlo™ Wound Solution |
| Indications of<br>Use | OTC: Hy-Chlo™ Wound Solution is intended for removal of foreign<br>objects such as dirt and for cleaning of minor cuts, lacerations,<br>abrasions and wounds. |
| | Professional Use:<br>Hy-Chlo™ Wound Solution is intended to be used under the supervision<br>of healthcare professional for removal of foreign objects such as dirt and<br>for cleaning of minor cuts, lacerations and abrasions. |
| Dispensing | OTC |
| General Use<br>Conditions | Patients with acute or chronic wounds generally in an attended<br>healthcare setting such as acute and non-acute care hospitals, nursing<br>homes, surgery centers, emergency rooms and wound clinics |
| Ingredients | Purified Water, Sodium Bicarbonate, Sodium Hydroxide, Sodium<br>Hypochlorite 0.125% weight/volume |
| pH | 9-11 |
| Organoleptic<br>properties | Mild Chlorine odor; colorless |
| Non-Clinical<br>Performance | Shelf life- 1 year and will be extended up to 2 years with real time data. |
| Manufacturing | Manufacturing under cGMP in a FDA inspected plant and testing<br>performed under GLP. |
| Warnings | • For External Use Only<br>• Keep out of reach of children<br>• If swallowed, contact Poison Center or seek immediate medical<br>attention<br>• If redness, swelling, irritation or pain appears or increases, contact<br>doctor immediately<br>• Do not use if sensitive to chlorine |

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#### Testing Summary:

Overall, in vivo studies conducted demonstrate that Hy-Chlo™ wound solution (0.125% sodium hypochlorite) is safe, non-irritant and non- sensitizer and did not inhibit the healing process. Hy-Chlo wound solution is also effective mold, yeast and S. aureus, E. coli, P. aeruginosa, C. albicans, S. aureus (MRSA), A. Brasiliensis. Testing also confirmed that Hy-Chlo™ wound solution delivers the required force to remove dirt and foreign objects from the wound.

In-vitro study was conducted under ISO 10993 with Mammalian cell line (L-929) with Hv-Chlo Wound solution, 0.125%. Based on the grading criteria in ANSI/AAMI/ISO 10993-5:2009, Hy-Chlo™ Wound solution, 0.125% had a moderate reactivity for cytotoxicity per qualitative evaluation of the cells exposed. However, a follow up in vivo study conducted to study wound healing in young adult pigs, the results clearly show that Patrin Pharma's Sodium Hypochlorite solution, 0.125% did not inhibit the normal healing process (see below).

In vivo, acute dermal abrasion study was conducted in the dorsal area of voung adult pigs over 14 days. Each animal wound was treated every day with 1 ml of Hy-Chlo™ Wound Solution (0.125% Sodium Hypochlorite solution) for 14 days. Each animal was observed every day for healing process and compared with the untreated site. Daily treatment of the abraded sites with Sodium Hypochlorite solution (0.125%) did not inhibit the healing process when compared with untreated abrasion sites. Local infection was not observed.

In-vivo study was conducted in rabbits for dermal irritation with Hy-Chlo wound solution for 4 hours and 24 hours exposure. The results indicated that with 4 hour contact exposure in abraided skin, there was minimal irritation with the irritation clearing within 24 hours. For 24 hours of contact exposure to abraded skin, there was minimal irritation with the irritation clearing up within 72 hours. No skin irritation reactions were observed in the unabraded sites. Thus, in accordance with the OPPTS Guidelines, Hy-Chlo™ Wound Solution, 0.125% would not be considered to be a dermal irritant.

In-vivo study conducted in guinea pigs for sensitization clearly demonstrated that sensitization of naïve group was not significantly different indicating that there was no sensitization.

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Preservative testing was conducted for Hy-Chlo™ Wound Solution (0.125%) using USP protocol. The microorganisms tested were S. aureus, E. coli, P. aeruginosa, C. albicans, S. aureus (MRSA), A. Brasiliensis, mold and yeast. Results clearly indicate that Hy-Chlo™ wound Solution is effective against all of the organisms.

Hy-Chlo™ wound solution was used to estimate the maximum force at the site of administration. The purpose of the study was to measure the forces and estimate the maximum pressure exerted at the site of contact by a plume of Hy-Chlo wound solution that is expelled from the container. It is important that force generated is sufficient to be able to remove dirt and foreign objects from the wound. The results indicate that force generated was 8.0 psi (sd 0.7). The force is well within the typical ranges of 4-15 psi for such applicators.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Patrin Pharma, Incorporated % Mr. Jay S. Trivedi Director of New Products P.O. Box 1481 Skokie, Illinois 60076

AUG 2 1 2012

Re: K113312

Trade/Device Name: HyChlo™ Wound Solution Regulation Number: 21 CFR 880.5475 Regulation Name: Jet Lavage Regulatory Class: Class II Product Code: FOH Dated: July 30, 2012 Received: August 6, 2012

Dear Mr. Trivedi:

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

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#### Page 2 - Mr. Jay S. Trivedi

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 4. Indications for Use Statement

#### 510(k) Number: K113312

### Device Name: HyChlo™ Wound Solution

Indications for Use:

OTC

HyChlo™ Wound Solution is intended for removal of foreign objects such as dirt, for cleansing of minor cuts, lacerations, abrasions and wounds.

Professional Use

HyChlo™ Wound Solution is intended to be used under the supervision of healthcare professional in cleansing of acute, chronic and/or open wounds such as Stage I-IV pressure ulcers, diabetic foot and leg ulcers, surgical wounds, first and second degree burns and grafted and donor sites.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE OM:ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krane for MM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K113312