Dynarex Xeroform Petrolatum Dressing is intended for use as a primary contact layer in dressing wounds such as lacerations, skin graft recipient sites, newly sutured wounds, abrasions, and minor or partial thickness burns. It may also be used as an initial layer in dressing surgical wounds with light exudate.

Device Description

The Dynarex Xeroform Petrolatum Dressing is a sterile, single use, non-adherent dressing consisting of non-woven absorbent gauze saturated with Xeroform with 3% Bismuth Tribromophenate in a petrolatum blend. Packaged in paper metalized chevron pouches and available in Sizes: 2" x 2" ( Item #: 3051), 1" x 8" ( Item #: 3052), 4" x 4" ( Item #: 3053), 5" x 9" ( Item #: 3054). Dynarex Xeroform Petrolatum Dressing gauze is a type of medical dressing and has ingredients finely wovens mesh medical gauze infused with a blend of petrolatum and 3% Bismuth Tribromophenate.

AI/ML Overview

This document is a 510(k) premarket notification for the Dynarex Xeroform Petrolatum Dressing, claiming substantial equivalence to a predicate device. This type of submission generally focuses on demonstrating similarity to an existing device rather than presenting a novel clinical study with acceptance criteria in the typical sense for algorithm performance.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/algorithm, cannot be fully provided from this document. The document describes the device's physical and biological properties and compares them to a predicate device to establish substantial equivalence.

However, I can extract information related to "acceptance criteria" and "studies" from the perspective of demonstrating the device's safety and effectiveness compared to a predicate device, as required for a 510(k).

Here's an interpretation based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" largely refer to demonstrating the new device's characteristics are similar to or meet the performance of a legally marketed predicate device. The performance is reported by showing that the new device meets established standards or has similar characteristics.

Characteristic	Acceptance Criteria (Predicate Performance)	Reported Device Performance (Dynarex Xeroform Petrolatum Dressing)
Indications for Use	Intended for use as a primary contact layer in dressing wounds such as lacerations, skin graft recipient sites, newly sutured wounds, abrasions, and minor or partial thickness burns. May also be used as an initial layer in dressing surgical wounds with light exudate where mild medication and deodorization are desired (from predicate).	Intended for use as a primary contact layer in dressing wounds such as lacerations, skin graft recipient sites, newly sutured wounds, abrasions, and minor or partial thickness burns. It may also be used as an initial layer in dressing surgical wounds with light exudate (from Dynarex device).
Device Materials	- Substrate: Cotton Gauze - Material 1: 3% Bismuth Tribromophenate - Material 2: Petrolatum	- Substrate: Cotton Gauze - Material 1: 3% Bismuth Tribromophenate - Material 2: Petrolatum
Single Use	Yes	Yes
Color	Yellowish	Yellowish
Dimensions	1x8"/2x2"/4x4"/5x9"/4"x3yds	1x8"/2x2"/4x4"/5x9"
Sterility	Sterile ISO 11137-2: 2013 to a 10^6^ SAL	Sterile ISO 11137-2: 2013 to a 10^6^ SAL
Pouch Packaging	Metalized chevron pouches	PET / ALPET / PE (implicitly demonstrating equivalence or acceptable difference)
Biocompatibility	Meets all applicable requirements per ISO 10993-3, -4, -5, -10, -11 (as implied for the predicate device to be legally marketed).	Meets all of the requirements, as applicable, to ISO 10993-3: 2014 Genotoxicity, ISO 10993-4: 2006 / ASTM F756: Hemolysis, ISO 10993-5:2009 Cytotoxicity, ISO 10993-10: 2010 Skin Sensitization and Primary Skin Irritation. ISO 10993-11: 2006 Systemic Toxicity.

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable in the context of an AI model's test set. The submission focuses on device characteristics and compliance with standards. For biocompatibility, the sample sizes are determined by the specific ISO 10993 tests (e.g., cell cultures for cytotoxicity, animal models for systemic toxicity), but these details are not provided in this summary.
Data Provenance: Not applicable for an AI model. The data relates to material testing and standard compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as this is a medical device (petrolatum dressing), not an AI/algorithmic device that requires expert-established ground truth for performance evaluation in a clinical setting. Standard testing is done in labs.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable for this type of medical device submission.

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

Not applicable as this is not an AI/algorithmic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable as this is not an AI/algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the aspects tested (biocompatibility, sterility, physical properties), the "ground truth" is established by:
- International Standards: e.g., ISO 10993 series for biocompatibility, ISO 11137-2 for sterilization.
- Material Specifications: Chemical composition (3% Bismuth Tribromophenate, petrolatum), physical forms (cotton gauze).
- Validated Test Methods: Procedures for inspecting appearance, coating, cutting edges, size, heat sealing, weight, and count (as described in Quality Assurance Testing).

8. The sample size for the training set

Not applicable as this is not an AI/algorithmic device.

9. How the ground truth for the training set was established

Not applicable as this is not an AI/algorithmic device.

Studies that prove the device meets the "acceptance criteria" (i.e., demonstrates substantial equivalence):

The document explicitly states the studies and standards used to prove the device's characteristics and performance are comparable to the predicate device, thereby demonstrating it meets the "acceptance criteria" for substantial equivalence:

Biocompatibility Testing (Section 18):
- Standards Used: ISO 10993-3: 2014 Genotoxicity, ISO 10993-4: 2006 / ASTM F756: Hemolysis, ISO 10993-5:2009 Cytotoxicity, ISO 10993-10: 2010 Skin Sensitization and Primary Skin Irritation, ISO 10993-11: 2006 Systemic Toxicity.
- Result: "The device meets all of the requirements, as applicable, to [these ISO standards]." This demonstrates the device is acceptably biocompatible.
Sterilization Validation (Section 17):
- Standard Used: ISO 11137-2: 2013.
- Result: The dressing is sterilized via gamma radiation to a 10^6^ SAL (Sterility Assurance Level), complying with the standard.
Quality Assurance Testing (Section 15):
- Methods: "Documented testing procedures are in place." Initial inspection includes visual characteristics (appearance, coating, cutting edges, size, heat sealing). Final inspection includes these tests plus weight and count inspection.
- Results: These tests "demonstrate the device meets its defined specifications."
Physical Properties (Section 14):
- Proof: "Certificates of Analysis showing the standards / testing referenced by the manufacturer which would define the physical properties of the petrolatum and 3% bismuth tribromophenate used in the device manufacturing are attached." (These certificates are referenced but not included in the provided text).

The overarching "study" is the compilation of these tests and their results, which collectively aim to demonstrate that the Dynarex Xeroform Petrolatum Dressing is substantially equivalent to the Kendall Xeroform Petrolatum Wound Dressing, based on their similar intended use, design, materials, and performance, as summarized in the "Table of Comparison" (Table 1) and confirmed by compliance with relevant standards.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 3, 2016

Dynarex Corporation Mr. James Hurlman Manager Regulatory Affair 10 Glenshaw Street Orangeburg, New York 10962

Re: K152970

Trade/Device Name: Dynarex Xeroform Petrolatum Dressing Regulatory Class: Unclassified Product Code: FRO Dated: August 29, 2016 Received: September 2, 2016

Dear Mr. Hurlman:

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 of medical devicerelated 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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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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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

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Indications for Use

510(k) Number (if known) K152970

Device Name Dynarex Xeroform Petrolatum Dressing

Indications for Use (Describe)

Dynarex Xeroform Petrolatum Dressing is intended for use as a primary contact layer in dressing wounds such as lacerations, skin graft recipient sites, newly sutured wounds, abrasions, and minor and partial thickness burns. It may also be used as an initial layer in dressing surgical wounds with light exudate.

Type of Use (Select one or both, as applicable)

|X Prescription Use {Part 21 CFR 801 Subpart D}

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Form Approved: OMB No, 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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September 23, 2016

Food and Drug Administration Center for Devices and Radiological Health Document Control Center - WO66-G609 10903 New Hampshire Avenue Silver Spring, Maryland 20993-0002

Re: 510 (k) Notification - Traditional

Dear Sir / Madam:

In accordance with Section 510(k) of the Federal Food, Drug and Cosmetic Act, and in conformance with 21 CFR Part 807, pre-market notification is hereby given of the intention of Dynarex Corporation to intorstate commerce for commercial distribution a sterile Xeroform Petrolatum Dressing.

The following is being submitted in conformance with 21 CFR Part 807.87:

1. Applicant	Dynarex Corporation10 Glenshaw StreetOrangeburg, NY 10962USA
2. Initial Importer	Dynarex Corporation10 Glenshaw StreetOrangeburg, NY 10962USA
Registration No.	2431014
3. Contact Person	James HurlmanOfficial Correspondent / Dynarex Corp10 Glenshaw StreetOrangeburg, NY 10962PH: 845-365-8200 Ext 6616Fax: 845-680-6717E-mail: j.hurlman@dynarex.com
Alternate Only	Mr. Zalman TenenbaumPresident / CEO / Dynarex Corp10 Glenshaw StreetOrangeburg, NY 10962PH: 845-365-8200 Ext 6425Fax: 845-365-8201E-mail: z.tenenbaum@dynarex.com

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Device Proprietary Trade Name Dynarex Xeroform Petrolatum Dressing 4.
న్. Manufacturer

Roosin Medical Co. Ltd No. 8 Yuandong Road, Kouan Town Gaogang, Taizhou, Jiangsu, China 225321

1. Factory Address Same as Manufacturer.
1. Listing & Registration Information Roosin Medical Co. Ltd Reg. No .: 3007124979
1. Device Class
1. Classification No.

Product Code: FRO

structive Surgery Devices

Unclassified, Div. Surg. Devices Plastic and Recon-

10. Identification of Equivalent Marketed Device

Dynarex would like to claim substantial equivalence to the following device already being marketed in interstate commerce:

Description: Classification Name: Unclassified Common or Usual Name: Xeroform Petrolatum Wound Dressing

Product Code	510(k) Number	Trade Name	Manufacturer
FRO	K973507	Kendall XeroformPetrolatum WoundDressing	Kendall Healthcare ProductsCompany

Statement of Similarities and / or Differences with Marketed Device.

Dynarex Xeroform Petrolatum Dressing is substantially equivalent in safety and effectiveness to Kendall Healthcare Products Company Kendall Xeroform Petrolatum Wound Dressing.

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11. Indications for Use Statement

12. 510(k) Summary

This document serves as our "510(k) Summary", our summary of safety and effectiveness information upon which our equivalence determination is based.

13. Description of Product

a) Classification: FDA's Division of Surgical Devices (DSD) Plastic and Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2) devices as Unclassified -Pre-Amendment, General and Plastic Surgery, Classification Code FRO.
b) Device Description: The Dynarex Xeroform Petrolatum Dressing is a sterile, single use, non-adherent dressing consisting of non-woven absorbent gauze saturated with Xeroform with 3% Bismuth Tribromophenate in a petrolatum blend. Packaged in paper metalized chevron pouches and available in Sizes: 2" x 2" ( Item #: 3051), 1" x 8" ( Item #: 3052), 4" x 4" ( Item #: 3053), 5" x 9" ( Item #: 3054)

c) Principal of Operation and Conditions of Use:

Dynarex Xeroform Petrolatum Dressing gauze is a type of medical dressing and has ingredients finely wovens mesh medical gauze infused with a blend of petrolatum and 3% Bismuth Tribromophenate. Dynarex Xeroform Petrolatum Dressing use is as a primary contact layer in dressing wounds such as lacerations, skin graft recipient sites, newly sutured wounds, abrasions, and minor or partial thickness burns.

Gauze saturated with a moist or wet ointment is normally used to maintain a healthy and hydrated wound bed so that wounds can heal effectively and dressings can be changed without causing unnecessary discomfort. One of the substances the Dynarex Xeroform Dressing is saturated with is the petroleum-derived, gelatinous substance petrolatum.

When applied to a non-draining or lightly draining wound, Dynarex Xeroform Petrolatum Dressing provides a moist environment, conducive to wound healing.

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14. Description of Specific Standards Used for the Dynarex Xeroform Petrolatum Dressing Which Describe the Physical Properties of the dressing.

Standard methods for the manufacture of the Dynarex Xeroform Petrolatum Dressing are utilized by the manufacturer. The Certificates of Analysis showing the standards / testing referenced by the manufacturer which would define the physical properties of the petrolatum and 3% bismuth tribromophenate used in the device manufacturing are attached.

15. Quality Assurance Testing

The quality system is operated and maintained under FDA/QSR CFR21 Part 820 and ISO 13485 guidelines. Documented testing procedures are in place. Initial inspection has visual characteristics such as appearance of mixed ingredients, coating, cutting edges and size and heat sealing testing. Final inspection includes these tests and additional weight and count inspection testing on the finished device to demonstrate the device meets its defined specifications. Dynarex Corporation additionally inspects the product upon arrival for final release.

Standards used:

AAMI/ANSI/ISO 10993-1 Biological Evaluation of Medical Devices - Part 1 Evaluation and Testing Parts 3, 4, 5, 10, 11 2009 (R) 2013

ISO 11137-2 Sterilization of Healthcare Products - Radiation - Part 2 - Dose Method 1 2013

16. Standard Operating Procedures as Applied to the Manufacture of the Dynarex Xeroform Petrolatum Dressing

Standard operating procedures (SOP's) are in place for the manufacturing and assembly portions of the manufacturing such as Machine Set-Up, Process Control, Initial Testing, On-line visual testing (Roaming Inspector) and final inspection.

17. Sterilization Validation / Routine Processing

The dressing is a sterile device via gamma radiation per ISO 11137-2: 2013 to a 106 SAL.

18. Dynarex Xeroform Petrolatum Dressing Biocompatibility

Biocompatibility Testing Matrix: Surface Device, Prolonged [≤ 24 hrs to ≤30 days], Breached / Compromised.

Biocompatibility The device meets all of the requirements, as applicable, to ISO 10993-3: 2014 Genotoxicity ISO 10993-4: 2006 / ASTM F756: Hemolysis, ISO 10993-5:2009 Cytotoxicity, ISO 10993-10: 2010 Skin Sensitization and Primary Skin Irritation. ISO 10993-11: 2006 Systemic Toxicity,

19. Shelf Life / Expiration Dating

Dynarex is claiming a 3 year shelf life / expiration dating.

20. Labeling / Special Labeling Claims

Labeling samples for the device pouch, box and insert are attached.

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CORPORATION

10 Glenshaw Street, Orangeburg, N.Y. 10962

It is understood from the predicate devices 510k letter of substantial equivalence that the Dynarex Xeroform Petrolatum Dressing product has the following limitations;

1. This device may not be labeled for use on 3rd degree burns.
1. This device may not be labeled as having an accelerating effect on the rate of wound healing or epithelization.
1. This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
1. This device may not be labeled as a treatment or a cure for any type of wound.

Table 1

TABLE OF COMPARISON

CHARACTERISTIC		APPLICANT DEVICEDYNAREX XEROFORMPETROLATUM DRESSING	PREDICATE DEVICEKENDALL XEROFORMPETROLATUM DRESSING
Indication for Use		Dynarex Xeroform Petrolatum Dressing isintended for use as a primary contact layerin dressing wounds such as lacerations,skin graft recipient sites, newly suturedwounds, abrasions, and minor or partialthickness burns. It may also be used as aninitial layer in dressing surgical woundswith light exudate.	Is intended for use as a primary contactlayer in dressing wounds such aslacerations, skin graft recipient sites,newly sutured wounds, abrasions, andminor or partial thickness burns. It mayalso be used as an initial layer in dressingsurgical wounds with light exudate wheremild medication and deodorization aredesired.
DeviceMaterials	Substrate	Cotton Gauze	Cotton Gauze
	Material 1	3% Bismuth Tribromophenate	3% Bismuth Tribromophenate
	Material 2	Petrolatum	Petrolatum
Single Use		Yes	Yes
Color		Yellowish	Yellowish
Dimensions		1x8"/2x2"/4x4"/5x9"	1x8"/2x2"/4x4"/5x9"/4"x3yds
Sterility		Sterile ISO 11137-2: 2013 to a 106 SAL	Sterile ISO 11137-2: 2013 to a 106 SAL
Pouch Packaging		PET / ALPET / PE	Metalized chevron pouches

In summary. Dynarex Xeroform Petrolatum Dressing meets the same biocompatibility requirements per ISO 10993-3. ISO 10993-4, ISO 10993-5, ISO 10993-10 and ISO 10993-11 as our predicate device. Also, it's physical and performance meets requirements of it's pre-defined acceptance criteria for intended uses as the predicate device. All dressings are sterilized by radiation using conditions validated following ISO 11137-2: 2013 to a 10°SAL as the predicate device.

21. Substantial Equivalent Statement

Based on the comparisons stated above of the intended use, design, materials and performance, our Dynarex Xeroform Petrolatum Dressing is substantially equivalent to its predicate device.

Regulation Number and Section

N/A