(65 days)
Not Found
No
The summary describes a physical silicone dressing that provides stress shielding and protection, with no mention of software, algorithms, or AI/ML terms.
Yes
The device is intended for the management of scars, indicating a therapeutic purpose in affecting the body's structure or function.
No
The device description and intended use indicate that the Neodyne Dressing is used for the management and protection of scars, not for diagnosing new conditions or diseases.
No
The device description clearly states it is an "adhesive silicone sheet," indicating it is a physical, hardware-based medical device, not software.
Based on the provided information, the Neodyne Dressing is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of closed hyperproliferative scars. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a physical dressing applied to the skin. It does not involve testing samples of bodily fluids or tissues in vitro (outside the body) to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, assays, or analysis of biological samples.
IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Neodyne Dressing's function is to physically protect and manage a scar on the body.
N/A
Intended Use / Indications for Use
The Neodyne Dressing is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.
Product codes
MDA
Device Description
The Neodyne Dressing is a non-sterile, single use adhesive silicone sheet to be used to protect and manage a newly formed, closed scar. The Dressing is pre-strained prior to application and applied over the new scar. The silicone sheeting protects and stress shields the scar.
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
Not Found
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)
Results of safety and performance testing demonstrate that the Neodyne Dressing is substantially equivalent to the predicate devices. The performance of the Neodyne Dressing is due to both its materials (silicone sheeting) and the stress shielding provided by the pre-strained dressing. Bench testing confirmed that the Neodyne Dressing provided the intended strain relief and functioned as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4025 Silicone sheeting.
(a)
Identification. Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
0
Attachment 2
5.0 510(k) Summary
page K112131 1/2
Submitters Name and Address
Neodyne Biosciences, Inc. 127 Independence Drive Menlo Park CA 94025
SEP 2 9 2011
Contact Person Peggy McLaughlin Consulting Vice President, Clinical & Regulatory Affairs Neodyne Biosciences, Inc. 127 Independence Drive Menlo Park CA 94025 Telephone: 650 504-8501 Facsimile: 650 543-7104 Email: PMcLaughlin@NeodyneBio.com
Date Prepared 25 July 2011
Name of Medical Device Device Classification Name: Silicone Sheeting Device Classification Number: 21 CFR 878.4025 Device Class: Class 1 Proprietary Name: Neodyne Dressing
Predicate Devices Biodermis Corporation Epi-Derm Silicone Sheeting (K003948) 3M Company Steri-Strip Antimicrobial Skin Closures (K813265)
Intended Use
The Neodyne Dressing is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.
Device Description
The Neodyne Dressing is a non-sterile, single use adhesive silicone sheet to be used to protect and manage a newly formed, closed scar. The Dressing is pre-strained prior to application and applied over the new scar. The silicone sheeting protects and stress shields the scar.
1
Attachment 2
9 Sep 2011 revised section for K112131
K112131 Pago
2/2
Safety and Performance
Results of safety and performance testing demonstrate that the Neodyne Dressing is substantially equivalent to the predicate devices. The performance of the Neodyne Dressing is due to both its materials (silicone sheeting) and the stress shielding provided by the pre-strained dressing. Bench testing confirmed that the Neodyne Dressing provided the intended strain relief and functioned as intended.
Substantial Equivalence
The Neodyne Dressing is as safe and effective as Steri-Strips and Epi-Derm Silicone Sheeting. The Neodyne Dressing has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Neodyne Dressing and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Neodyne Dressing functions as intended. Thus, based on the indications for use, technological characteristics, and performance data, the Neodyne Dressing has been shown to be substantially equivalent to predicate devices.
2
Image /page/2/Picture/1 description: The image shows a logo with a stylized depiction of three parallel lines that curve and taper towards the right side of the image. The lines are thick and black, and they appear to be stacked on top of each other. The logo is surrounded by a circular border of text, which is difficult to read due to the image quality. The overall impression is of a simple, modern design.
Food and Drag Adminstration. 10063 New Hampshire Avenue Document Control Room Woodsedon) Silver Spring, MD 20993-0002
Neodyne Biosciences, Inc. % Ms. Peggy Mel.aughlin Consulting VP. Clinical & Regulatory Affairs 127 Independence Drive Menlo Park, California 94025
Re: K112131
Trade/Device Name: Neodyne Dressing Regulation Number: 21 CFR 878.4025 Regulation Name: Silicone sheeting Regulatory Class: I Product Code: MDA Dated: September 9, 2011 Received: September 13. 2011
SEP 2 9 2011
Dear Ms. McLaughlm:
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
3
Page 2 - Ms. Peggy McLaughlin
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.
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.html 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 CDRF '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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
E.M. Keith
-----Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment 1
4.0 Indications for Use Statement
Indications for Use Form
510(k) Number: K112131
Device Name: Neodyne Dressing
Indications for Use:
The Neodyne Dressing is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (O
Page 1 of 1
(Division Sign-Off) Division of Surgical. Orthopedic, and Restorative Devices
510(k) Number K|1|2|3|