(538 days)
Not Found
No
The device description and performance studies focus on the chemical composition and biological effects of a wound cleanser, with no mention of AI or ML technologies.
Yes.
The device is intended for cleansing and debriding various types of wounds, including chronic and open wounds, which is a therapeutic function aimed at promoting healing and managing the wound environment.
No
Explanation: The device is a wound cleanser intended for cleansing and debriding wounds, not for diagnosis. Its description and intended use clearly state its function is for wound care, and there is no mention of diagnostic capabilities, image processing, or AI/ML.
No
The device is a liquid solution packaged in bottles, clearly indicating it is a physical product and 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 cleansing and debriding wounds on the human body. This is a direct application to the patient for therapeutic or cleansing purposes.
- Device Description: The device is a solution applied externally to the wound.
- Lack of In Vitro Testing: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. This device is applied to the body.
- Performance Studies: The performance studies focus on biocompatibility and wound healing in a live animal model, which are relevant for a topical wound care product, not an IVD.
IVD devices are typically used in laboratories or point-of-care settings to diagnose, monitor, or screen for diseases or conditions by analyzing biological samples. This device's function is entirely external and related to wound management on the patient's body.
N/A
Intended Use / Indications for Use
Dakin's Skin and Wound Cleanser is intended for cleansing of acute, chronic and 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.
OTC: Dakin's Skin and Wound Cleanser is intended for cleansing of minor cuts, minor lacerations, minor abrasions and minor wounds, and for removal of foreign objects such as dirt and debris.
Professional Use: Dakin's Skin and Wound Cleanser is intended for cleansing of acute, chronic and 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.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
The Dakin's Skin and Wound Cleanser, Sodium Hypochlorite 0.125% is an aqueous, clear, colorless solution with mild chlorine odor, modified with sodium bicarbonate, used as a solution to cleanse and debride wounds. Sodium hypochlorite is used as a solution preservative, and sodium bicarbonate is used as a pH modifier.
Dakin's Skin and Wound Cleanser is packaged in amber HDPE (High Density PolyEthylene) bottles and induction sealed caps. A permanently affixed label, lot number and expiration date will be on each bottle of the Dakin's Skin and Wound Cleanser.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Environment of Use: Hospitals, nursing homes, wound clinics and pre and post hospitals
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)
Preclinical Wound Healing Study in Yucatan miniature swine: Daily treatment of the abraded site with either Dakin's Skin and Wound Cleanser or Predicate did not inhibit the healing process when compared with untreated sites.
Antimicrobial (preservative testing): Multi-microbial challenge testing meets the criteria in the USP Antimicrobial Effectiveness Testing.
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.
Patrin Pharma, Inc. – Hy-Chlo Wound Solution – K113312
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/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 a stylized image of three human profiles facing to the right, overlapping to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 21, 2016
Century Pharmaceuticals, Inc. Mr. Stephen Deardorff Vice President 10377 Hague Road Indianapolis, IN 46256
Re: K150208
Trade/Device Name: Dakin's Skin and Wound Cleanser Regulatory Class: Unclassified Product Code: FRO Dated: June 2, 2016 Received: June 8, 2016
Dear Mr. Deardorff:
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 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K150208
Device Name Dakin's Skin and Wound Cleanser
Indications for Use (Describe)
Dakin's Skin and Wound Cleanser is intended for cleansing of acute, chronic and 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K150208
Device Name Dakin's Skin and Wound Cleanser
Indications for Use (Describe)
Dakin's Skin and Wound Cleanser is intended for cleansing of minor lacerations, minor abrasions and minor wounds, and for removal of foreign objects such as dirt and debris.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary Page 1 of 4 19-Jul-16
| Century Pharmaceuticals, Inc.
10377 Hague Road
Indianapolis, IN 46256 | Tel (317) 849-4210
Fax (317) 849-4263 |
|-----------------------------------------------------------------------------|----------------------------------------------------------|
| Official Contact: | Stephen Deardorff – Vice President |
| Proprietary or Trade Name: | Dakin's Skin and Wound Cleanser |
| Common/Usual Name: | Wound cleanser |
| Classification Name/Code: | FRO - DRESSING, WOUND, DRUG |
| Device: | Dakin's Skin and Wound Cleanser, Quarter Strength 0.125% |
| Predicate Device: | Patrin Pharma, Inc. – Hy-Chlo Wound Solution – K113312 |
Device Description:
The Dakin's Skin and Wound Cleanser, Sodium Hypochlorite 0.125% is an aqueous, clear, colorless solution with mild chlorine odor, modified with sodium bicarbonate, used as a solution to cleanse and debride wounds. Sodium hypochlorite is used as a solution preservative, and sodium bicarbonate is used as a pH modifier.
Dakin's Skin and Wound Cleanser is packaged in amber HDPE (High Density PolyEthylene) bottles and induction sealed caps. A permanently affixed label, lot number and expiration date will be on each bottle of the Dakin's Skin and Wound Cleanser.
Indications for Use:
OTC: Dakin's Skin and Wound Cleanser is intended for cleansing of minor cuts, minor
lacerations, minor abrasions and minor wounds, and for removal of foreign objects such as dirt and debris.
Professional Use: Dakin's Skin and Wound Cleanser is intended for cleansing of acute, chronic and 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.
Patient Population: Patients with acute or chronic wounds.
Environment of Use: Hospitals, nursing homes, wound clinics and pre and post hospitals
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K150208 Page 2 of 4
510(k) Summary
Summary of substantial equivalence
| Predicate | Proposed | |
|---|---|---|
| Patrin Pharma – Hy-Chlo | Dakin's Skin and Wound Cleanser, | |
| Quarter Strength 0.125% | ||
| K113312 | ||
| Indications for Use | OTC: Hy-chlo Wound Solution is intended for removal | |
| of foreign objects such as dirt, for cleansing of minor | ||
| cuts, lacerations, abrasions and wounds. | ||
| Professional Use: Hy-chlo 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. | OTC: Dakin's Skin and Wound Cleanser is intended for | |
| cleansing of minor cuts, minor lacerations, minor | ||
| abrasions and minor wounds, and for removal of foreign | ||
| objects such as dirt and debris. | ||
| Professional Use: Dakin's Skin and Wound Cleanser is | ||
| intended for cleansing of acute, chronic and 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. | ||
| OTC | OTC | OTC |
| Prescriptive (Professional use) | Prescriptive (Professional use) | |
| Prescriptive | ||
| Environments of use | Attended healthcare setting such as acute and non-acute | |
| care hospitals, nursing homes, surgery centers, | ||
| emergency rooms and wound clinics. | Hospitals, nursing homes, wound clinics and pre and | |
| post hospitals |
6
K150208
Page 3 of 4
510(k) Summary
| | Predicate
Patrin Pharma – Hy-Chlo
K113312 | Proposed
Dakin's Skin and Wound Cleanser,
Quarter Strength 0.125% |
|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Ingredients | Purified Water
Sodium bicarbonate
Sodium Hydroxide
Sodium Hypochlorite concentration:
0.125% weight/volume | Purified Water
Sodium bicarbonate
Sodium Hydroxide
Sodium Hypochlorite concentration:
0.125% weight/volume |
| Non-clinical Performance
Biocompatibility | Tested as stated in 510(k) Summary | Cytotoxicity
Sensitization
Dermal Irritation |
| Preclinical Wound Healing
Study in Yucatan
miniature swine | Daily treatment did not inhibit the healing process when compared with untreated sites. | Daily treatment of the abraded site with either Dakin's Skin and Wound Cleanser or Predicate did not inhibit the healing process when compared with untreated sites. |
| Antimicrobial
(preservative testing) | S. aureus, E.Coli, P. aeruginosa, C. albicans, S.aureus (MRSA), A. Brasiliensis, mold and yeast. | Multi-microbial challenge testing meets the criteria in the USP Antimicrobial Effectiveness Testing |
| Contraindications and
Warnings | Warnings: | Warnings: |
| | For external use only Keep out of reach of children If swallowed, contact Poison Center or seek immediate medical attention If redness, irritation, swelling or pain appears or increases, contact doctor immediately Do not use if sensitive to chlorine | For external use only Stop use and ask a doctor if redness, irritation, swelling or pain persists or increases. Do not use if sensitive to any of the compounds Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away |
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510(k) Summary Page 4 of 4 19-Jul-16
The Dakin's Skin and Wound Cleanser, Quarter Strength 0.125% is viewed as substantially equivalent to the predicate device because:
Indications
- . Identical to predicate - Patrin Pharma - Hy-Chlo - K113312
Formulation / Technology
- Similar formulation / technology used to predicate Patrin Pharma Hy-Chlo . - K113312
Materials
- The materials in patient contact are identical to predicate device, Patrin Pharma . – Hy-Chlo – K113312
Environment of Use
- Identical to predicate Patrin Pharma– Hy-Chlo K113312 .
Differences
- No significant differences between the proposed device and the predicate device, and do ● not introduce any new patient safety issues.