(207 days)
Curaline Polyurethane Foam Dressings are intended for the management of partial and full thickness wounds; pressure ulcers (Stage I-IV); diabetic ulcers; acute and chronic venous stasis ulcers; arterial ulcers; skin grafts, donor and recipient sites; burns (1" and 2nd degree); skin tears and avulsions; abrasions; tube, catheter, and IV sites; dermatologic disorders: under compression bandages and wraps; traumatic wounds; acute and chronic wounds: and minimal, moderate, and heavily exuding wounds.
The Curaline Polyurethane Foam Dressing is composed of a hydrophilic polyurethane matrix backed with a semipermeable polyurethane film which limits oxygen and moisture vapor permeability and is a barrier to liquids. The dressing contains a cleanser (F68 surfactant), a moisturizer (glycerin), and an absorbing agent (superabsorbent polymer), all in the polyurethane matrix. Both F68 and glycerin are soluble in wound fluid or skin moisture. The superabsorbent polymer contained in the dressing draws and absorbs moisture from wound fluid.
The provided text is a 510(k) summary for the Curaline Polyurethane Foam Dressing. It describes the device, its intended use, and claims substantial equivalency to legally marketed predicate devices. The document details studies conducted to prove the device's safety through biocompatibility tests. However, it does not contain the type of AI-specific acceptance criteria, performance data, or study designs (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies) that your request outlines.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as these items are not present in the provided text.
The closest relevant information from the document is related to the biocompatibility studies, which are a type of acceptance criteria for medical devices, albeit not AI-specific performance criteria.
Here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance (Biocompatibility)
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Cytotoxicity: Agar Diffusion Test - ISO 10993-5 guidelines | Product is non-cytotoxic and meets the requirements. |
| Primary Skin Irritation Test: ISO Direct Contact (single topical 4-hour application to New Zealand White rabbits) | Considered a negligible irritant. No signs of Erythema or edema noted at any observation period. |
| Buehler Sensitization Test: ISO Direct Contact | Not considered a skin sensitizer. No reactions observed in the negative control group. |
| Overall Conclusion (from biocompatibility tests) | Consistent in indicating the product is safe for use in absorbing exudates and providing a moist environment for the wound site. |
2. Sample size(s) used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified for biocompatibility studies beyond "New Zealand White rabbits" for skin irritation.
- Data Provenance: Not explicitly stated, but these are in vitro and animal safety studies. Country of origin is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not specified. Biocompatibility tests rely on standardized laboratory protocols and observations rather than expert human interpretation of complex data for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. As above, these are lab tests with defined endpoints, not subjective human assessments requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a medical dressing, not an AI diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a medical dressing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For biocompatibility: Standardized assay results (e.g., cell viability for cytotoxicity, visual assessment of skin reactions for irritation/sensitization) in accordance with ISO standards.
8. The sample size for the training set
- Not applicable. This is not an AI device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI device.
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Image /page/0/Picture/0 description: The image shows the logo for CURALINE. The logo consists of a stylized black graphic to the left of the word "CURALINE" in a bold, sans-serif font. Below the word "CURALINE" is the tagline "The Future of Wound Care" in a smaller, italicized font. The overall design is simple and modern.
5. 510(k) Summary
510(k) SUMMARY
NOV 3 0 2012
Curaline Polyurethane Foam DRESSING
-
- Submitters Name: Curaline, Inc., USA.
(262) 422 -7423 Telephone:
- Submitters Name: Curaline, Inc., USA.
Email: info@curaline.com
-
- Regulatory Contact Person at Curaline, Inc .: Mr. Haitham Matloub
-
- Date that 510(K) Summary was Prepared: September 28, 2012
-
- Name of the Medical Device: Curaline Polyurethane Foam Dressing
- ર્ડ. Legally Marketed Devices to which Substantial Equivalency is Claimed
ર્. Description of the Device:
The Curaline Polyurethane Foam Dressing is composed of a hydrophilic polyurethane matrix backed with a semipermeable polyurethane film which limits oxygen and moisture vapor permeability and is a barrier to liquids. The dressing contains a cleanser (F68 surfactant), a moisturizer (glycerin), and an absorbing agent (superabsorbent polymer), all in the polyurethane matrix. Both F68 and glycerin are soluble in wound fluid or skin moisture. The superabsorbent polymer contained in the dressing draws and absorbs moisture from wound fluid.
7. Intended Use of the Device:
Curaline Polyurethane Foam Dressings are intended for the management of partial and full thickness wounds; pressure ulcers (Stage I-IV); diabetic ulcers; acute and chronic venous stasis ulcers; arterial ulcers; skin grafts, donor and recipient sites; burns (1" and
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K121361
p2/2
2nd degree); skin tears and avulsions; abrasions; tube, catheter, and IV sites; dermatologic disorders: under compression bandages and wraps; traumatic wounds; acute and chronic wounds: and minimal, moderate, and heavily exuding wounds.
Rx only; Federal law restricts this device to sale by or on the order of a physician or other licensed healthcare professional.
Technological Comparison between Subject and Predicate Devices: 8.
Curaline Polyurethane Foam Dressings are sterile, conformable foam wound dressings and are made in various sizes and configurations to conform to the requirements of wound management protocol. The Curaline Polyurethane Foam Dressing is chemically and physically equivalent to the principal predicate and substantially equivalent to the reference predicate wound dressing devices.
9. Summary of Studies and Conclusions from Biocompatibility Tests:
Curaline Polyurethane Foam Dressings were evaluated through in-vitro and animal safety studies. All of these results are consistent in indicating that this product is safe for use in absorbing exudates and providing a moist environment for the wound site.
Safety tests and the conclusions drawn for the test articles:
- . Cytotoxicity: Agar Diffusion Test - ISO: Product is non-cytotoxic and meets the requirements of the Agar Diffusion Test defined in ISO 10993-5 guidelines.
- Primary Skin Irritation Test ISO Direct Contact: Product is considered a ● negligible irritant after a single topical 4 hour application to the skin of New Zealand White rabbits. No signs of Erythema or edema were noted at any observation period.
- Buehler Sensitization Test ISO Direct Contact: The product is not considered to . ● be a skin sensitizer; no reactions were observed in the negative control group.
16W235 830 Street Ste.E, Burr Ridge, IL 60527
Tel.: (262) 422 -7423
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Curaline, Incorporated % Mr Haitham Matloub President 10554 North Washington Port Road Mequon, Wisconsin 53092
November 30, 2012
Re: K121361
· Trade/Device Name: Curaline Polyurethane Foam Dressing Regulation Name: Unclassified Product Code: FRO Dated: October 31, 2012 Received: November 06, 2012
Dear Mr. Matloub:
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.
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Page 2 - Mr Haitham Matloub
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,
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for CURALINE, a company focused on wound care. The logo features a stylized graphic to the left of the company name, "CURALINE," which is written in bold, sans-serif font. Below the company name is the tagline "The Future of Wound Care" in a smaller, italicized font.
4. Indications for Use Statement
Page 1 of 1
Indications for Use
510(k) NUMBER (IF KNOWN): K121361
DEVICE NAME: Curaline Polyurethane Foam Dressing
INDICATIONS FOR USE:
Curaline Polyurethane Foam Dressing is indicated for use in the management of:
- · Partial and full thickness wounds
- · Pressure ulcers (Stage I-IV)
- · Diabetic ulcers
- · Acute and chronic venous stasis ulcers
- · Arterial ulcers
- · Skin grafts; donor and recipient sites
- · Burns (1st and 2nd degree)
- Skin tears and avulsions
- · Abrasions
- · Surgical wounds
- · Tube, catheter, drain and I.V. sites
- · Dermatologic disorders
- · Under compression bandages/wraps
- · Traumatic wounds
- · Acute and Chronic wounds
- · Minimal, moderate and heavily exuding wounds
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
OR Over-the-Counter-Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Jiyoung Dang
(Division Sign-Off) Division of Surgical Devices 510(k) Number K121361
16W235 83" Street Ste.E, Burr Ridge, IL 60527
Tel.: (262) 422 -7423 Email: info@curaline.com
N/A