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.

AI/ML Overview

The Neodyne Dressing is intended for the management of closed hyperproliferative (hypertrophic and keloid) scars. The device's performance relies on both its silicone sheeting material and the stress shielding provided by the pre-strained dressing.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to predicate devices (Epi-Derm Silicone Sheeting (K003948) and 3M Steri-Strip (K813265))	The Neodyne Dressing is claimed to be as safe and effective as Steri-Strips and Epi-Derm Silicone Sheeting. It shares the same intended uses, similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences are stated not to raise new issues of safety or effectiveness. Performance data demonstrates that the Neodyne Dressing functions as intended by providing intended strain relief and stress shielding. This conclusion is based on comparing "technological characteristics, and principles of operation" and "performance data" with predicates. The FDA concurred with this assessment, granting 510(k) clearance based on substantial equivalence.
Provide intended strain relief	Bench testing confirmed that the Neodyne Dressing provided the intended strain relief.
Function as intended (stress shielding)	Bench testing confirmed that the Neodyne Dressing functioned as intended by providing stress shielding.

Sample size used for the test set and the data provenance:
The document does not specify a test set sample size or data provenance (e.g., country of origin, retrospective/prospective clinical study details) for a clinical trial evaluating the Neodyne Dressing's effectiveness in scar management. The assessment primarily relies on bench testing results regarding strain relief and stress shielding, and a comparison of technological characteristics with predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The submission hinges on bench testing and comparison to predicate devices, not on a clinical ground truth established by experts.
Adjudication method for the test set:
This information is not provided as no clinical test set for evaluating the device's clinical efficacy in scar management is described.
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:
This device is a physical medical dressing, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not conducted.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This device is a physical medical dressing, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and was not done.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the bench testing, the ground truth was likely established by engineering measurements and specifications for strain relief and stress shielding. For the substantial equivalence argument, the "ground truth" was largely based on a comparison of technological characteristics and intended uses against legally marketed predicate devices, supported by bench test data. There is no mention of clinical outcomes data or pathology as primary ground truth for this 510(k) submission.
The sample size for the training set:
This information is not applicable as the device is not an AI algorithm that requires a training set. The "design" or "development" of the dressing would not typically involve a "training set" in the context of machine learning.
How the ground truth for the training set was established:
This information is not applicable as the device is not an AI algorithm that requires a training set and corresponding ground truth.

Summary

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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

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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.

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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

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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

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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|

Regulation Number and Section

§ 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.