Professional Use: Hy-Chlo™ Wound Solution is intended to be used under the supervision of healthcare professional in the 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 Description

Hy-Chlo™ Wound Solution is an aqueous, clear, colorless solution that cleans open wounds. The solution delivers sodium hypochlorite as a preservative with sodium bicarbonate as a pH modifier. Hy-Chlo™ Wound Solution will be supplied in heat sealed, impervious, mold extruded HDPE bottles. A permanent affixed label will be on each bottle.

AI/ML Overview

This document describes the 510(k) summary for the Hy-Chlo™ Wound Solution, a medical device for wound cleansing.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for Hy-Chlo™ Wound Solution appear to be demonstrated through various tests evaluating safety, efficacy in wound healing, antimicrobial properties, and physical characteristics. While explicit numerical acceptance criteria are not always stated, the reported performance indicates that the device met the implied safety and effectiveness standards for its intended use.

Acceptance Criteria Category	Specific Test/Parameter	Acceptance Criteria (Implied/Explicit)	Reported Device Performance
Safety - Biocompatibility	Cytotoxicity (In-vitro)	No or minimal cytotoxicity (based on ANSI/AAMI/ISO 10993-5:2009 grading criteria)	Moderate reactivity for cytotoxicity per qualitative evaluation of cells exposed in an in-vitro study with Mammalian cell line (L-929). However, a follow-up in-vivo study showed no inhibition of normal healing.
Safety - Wound Healing	Inhibition of normal healing (In-vivo)	No inhibition of the normal healing process	In an in-vivo acute dermal abrasion study in young adult pigs (14 days), daily treatment with Hy-Chlo™ did not inhibit the healing process compared to untreated sites. Local infection was not observed.
Safety - Dermal Irritation	Dermal irritation (In-vivo)	Not considered a dermal irritant (in accordance with OPPTS Guidelines)	In an in-vivo study in rabbits, 4-hour contact exposure to abraded skin resulted in minimal irritation clearing within 24 hours. 24-hour contact exposure to abraded skin resulted in minimal irritation clearing within 72 hours. No skin irritation reactions were observed in unabraded sites. Concluded not to be a dermal irritant.
Safety - Sensitization	Dermal sensitization (In-vivo)	No sensitization	An in-vivo study in guinea pigs clearly demonstrated that sensitization of the naïve group was not significantly different, indicating no sensitization.
Efficacy - Antimicrobial	Preservative effectiveness against specified organisms	Effective against specified microorganisms (S. aureus, E. coli, P. aeruginosa, C. albicans, S. aureus (MRSA), A. Brasiliensis, mold, yeast)	Preservative testing using USP protocol indicated Hy-Chlo™ Wound Solution was effective against all tested organisms: S. aureus, E. coli, P. aeruginosa, C. albicans, S. aureus (MRSA), A. Brasiliensis, mold, and yeast.
Efficacy - Wound Cleansing	Force generation for foreign object removal	Sufficient force to remove dirt and foreign objects from the wound (typical ranges of 4-15 psi for similar applicators)	The force generated at the site of administration was measured at 8.0 psi (sd 0.7). This force is reported to be well within the typical ranges of 4-15 psi for such applicators, indicating sufficiency for dirt and foreign object removal.
Product Stability	Shelf life	1 year initially, with potential extension to 2 years with real-time data	Pre-marketing stability studies demonstrated continued stability and efficacy for the claimed shelf life of 1 year, with plans for extension to 2 years with real-time data.

2. Sample Sizes Used for Test Set and Data Provenance

Due to the nature of the device (wound solution) and the pre-clinical nature of the studies, the "test set" does not refer to a dataset in the typical AI context but rather to the animal models and in-vitro samples used for various biological and physical tests.

Animal Studies:
- Wound Healing Study (Pigs): "young adult pigs" (specific number not provided). Provenance: Not specified (likely laboratory animal studies).
- Dermal Irritation Study (Rabbits): "rabbits" (specific number not provided). Provenance: Not specified (likely laboratory animal studies).
- Sensitization Study (Guinea Pigs): "guinea pigs" (specific number not provided). Provenance: Not specified (likely laboratory animal studies).
In-vitro Studies:
- Cytotoxicity: Mammalian cell line (L-929). Provenance: Laboratory (in-vitro).
- Preservative Testing: Specific microbial cultures (S. aureus, E. coli, P. aeruginosa, C. albicans, S. aureus (MRSA), A. Brasiliensis, mold, yeast). Provenance: Laboratory (in-vitro).
Physical Testing:
- Force Measurement: Not specified, but involved measuring force from the container. Provenance: Laboratory.

All studies appear to be prospective in nature, as they were specifically conducted for the purpose of demonstrating device safety and effectiveness.

3. Number of Experts and Qualifications for Ground Truth

This document does not describe studies that require expert adjudication or establishing "ground truth" in the context of medical imaging or diagnostic algorithms. The studies performed were pre-clinical (in-vivo animal studies, in-vitro laboratory tests, and physical testing). The assessment of outcomes (e.g., irritation, healing, microbial growth) would have been performed by trained laboratory personnel/scientists/veterinarians, but a specific number or qualification of "experts" for ground truth establishment for a test set, as might be found in an AI/imaging study, is not applicable here.

4. Adjudication Method for the Test Set

Not applicable. As described in point 3, the studies are not of a type that would involve adjudication by experts on a test set in the conventional sense for AI devices. Outcomes were determined by direct observation, laboratory measurements, and standard testing protocols.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is typically performed for diagnostic or screening devices, especially those involving human interpretation of medical images, to assess the impact of an AI system on human reader performance. The Hy-Chlo™ Wound Solution is a topical wound cleansing solution, not an imaging or diagnostic device requiring human-in-the-loop performance evaluation in that manner.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The Hy-Chlo™ Wound Solution is a physical chemical solution, not a software algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this device. Its performance is inherent in its chemical composition and physical properties.

7. Type of Ground Truth Used

The "ground truth" for the performance of Hy-Chlo™ Wound Solution was established by:

Direct Observation of Biological Responses: In-vivo studies (e.g., wound healing, dermal irritation, sensitization) provided direct evidence of the device's effect on living tissues.
Laboratory Assay Results: In-vitro cytotoxicity and preservative effectiveness studies yielded quantitative and qualitative results from established laboratory protocols.
Physical Measurements: Measurement of force generated by the spray mechanism.
Adherence to Standards: Compliance with USP protocols for preservative testing and ISO 10993 for biocompatibility, as well as OPPTS Guidelines for dermal irritation, constitute the benchmarks against which performance was measured.

8. Sample Size for the Training Set

Not applicable. This device is a chemical solution, not an AI/ML algorithm that requires a training set. The safety and effectiveness were demonstrated through pre-clinical laboratory and animal studies, not through machine learning.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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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 informationis being submitted in accordance with the requirements of 21CFR §807.92.
Submitter Company	Patrin Pharma, IncP.O. Box 14817817 Babb Avenue, Suite 103Skokie, IL 60076-1481
Contact	Jay S. TrivediDirector, New ProductsTel: (847) 644-1321Fax: 800-936-3088Email:
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, colorlesssolution that cleans open wounds. The solution deliverssodium hypochlorite as a preservative with sodiumbicarbonate as a pH modifier. Hy-Chlo™ Wound Solutionwill be supplied in heat sealed, impervious, mold extrudedHDPE bottles. A permanent affixed label will be on eachbottle.
Indications for Use
OTC	Hy-Chlo™ Wound Solution is intended for removal of foreignobjects such as dirt, for cleansing of minor cuts, lacerations,abrasions and wounds.
Professional Use	Hy-Chlo™ Wound Solution is intended to be used under thesupervision of healthcare professional in the cleansing ofacute, chronic and/or open wounds such as Stage I-IVpressure ulcers, diabetic foot and leg ulcers, surgical wounds,first and second degree burns and grafted and donor sites.
General use conditions	Hy-Chlo™ Wound Solution is to be used for patients withacute or chronic wounds generally in an attended healthcaresetting such as acute and non-acute care hospitals, nursinghomes, surgery centers, emergency rooms and wound clinics
Manufacturing andPerformance Testing	Hy-Chlo™ Wound Solution will be manufactured in USA inan FDA inspected facility inspected as recently as 2011. Themanufacturing and testing will be performed under cGMP(Current Good Manufacturing Practices) and GoodLaboratory 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 ofUse	OTC: Hy-Chlo™ Wound Solution is intended for removal of foreignobjects such as dirt and for cleaning of minor cuts, lacerations,abrasions and wounds.
	Professional Use:Hy-Chlo™ Wound Solution is intended to be used under the supervisionof healthcare professional for removal of foreign objects such as dirt andfor cleaning of minor cuts, lacerations and abrasions.
Dispensing	OTC
General UseConditions	Patients with acute or chronic wounds generally in an attendedhealthcare setting such as acute and non-acute care hospitals, nursinghomes, surgery centers, emergency rooms and wound clinics
Ingredients	Purified Water, Sodium Bicarbonate, Sodium Hydroxide, SodiumHypochlorite 0.125% weight/volume
pH	9-11
Organolepticproperties	Mild Chlorine odor; colorless
Non-ClinicalPerformance	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 testingperformed under GLP.
Warnings	• For External Use Only• Keep out of reach of children• If swallowed, contact Poison Center or seek immediate medicalattention• If redness, swelling, irritation or pain appears or increases, contactdoctor immediately• 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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

Page 1 of

510(k) Number K113312

Regulation Number and Section

§ 880.5475 Jet lavage.

(a)
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.(b)
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.