(465 days)
Not Found
No
The device description and intended use clearly define a passive wound dressing with no mention of computational or analytical capabilities, let alone AI/ML.
No.
A therapeutic device is one that treats or prevents a disease or condition. This device is a dressing that acts as a primary contact layer for wounds and does not actively treat or prevent a disease or condition.
No
This device is a wound dressing, intended for use as a primary contact layer to cover and protect wounds. It does not perform any diagnostic function.
No
The device is a physical wound dressing made of gauze and petrolatum, not software.
Based on the provided information, the Roosin Xeroform Petrolatum Dressing is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for dressing wounds on the body (lacerations, burns, etc.). This is a topical application for wound care, not for testing samples taken from the body to diagnose a condition.
- Device Description: The description details a wound dressing made of gauze and petrolatum with an added ingredient. This aligns with a medical device for wound management, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Roosin Xeroform Petrolatum Dressing does not fit this description.
N/A
Intended Use / Indications for Use
Roosin 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.
Product codes
FRO
Device Description
Roosin Xeroform Petrolatum Dressing is a type of wound dressing and has ingredients of finely woven mesh gauze infused with a blend of petrolatum and 3% Bismuth Tribromophenate. It is a sterile, single use dressing. This is a combination product. Roosin Xeroform Petrolatum Dressing is used as a primary contact layer in dressing for wounds such as lacerations, skin graft recipient sites, newly sutured wounds, abrasions, and minor or partial thickness burns. The dressing has a yellow appearance and is available in the form of pad and in four different sizes (2" x 2", 1" x 8", 4" x 4", 5" x 9"), packaged in pouches. All dressings are sterilized by gamma radiation using conditions validated following ISO 11137-2: 2013.
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)
Performance tests were conducted following in house procedures, and results for Roosin Xeroform Petrolatum Dressing met all relevant requirements, and are comparable to the predicate devices. Biocompatibility was evaluated per ISO 19993-1: 2009, and it was found that the subject device is as biocompatible as the predicate device.
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
N/A
0
September 13, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The FDA part is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
Roosin Medical Co., Ltd % Charles Shen Director Manton Business and Technology Services LLC 37 Winding Ridge Oakland. New Jersey 07436
Re: K181478
Trade/Device Name: Roosin Xeroform Petrolatum Dressing Regulatory Class: Unclassified Product Code: FRO Dated: August 11, 2019 Received: August 13, 2019
Dear Charles Shen:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Cynthia Chang, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K181478
Device Name Roosin Xeroform Petrolatum Dressing
Indications for Use (Describe)
Roosin 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.
| 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) |
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3
510(k) Summary:
Submitter & Foreign Manufacturer Identification
Roosin Medical Co., Ltd. 8 Yuandong Road, KouAn Town, Gaogang, Taizhou, Jiangsu Province, China 225321 Tel: (086) 523-86908085 Submitter's FDA Registration Number: 3007124979
US Agent and Contact Person
Charles Shen Manton Business and Technology Services 37 Winding Ridge 07436 Oakland, NJ Tel: 608-217-9358 Email: cyshen@aol.com
Date of Summary: September 12. 2019
Device Name:
| Trade Name: | Roosin Xeroform Petrolatum Dressing |
|---|---|
| Common Name: | Wound Dressing |
| Classification Name: | Dressing, wound, Drug |
| Product Code: | FRO |
| Regulation Number: | Unclassified |
| Review Panel: | General & Plastic Surgery |
Predicate Device Information:
- K152970: "Dynarex Xeroform Petrolatum Dressing", manufactured by "Dynarex (1) Corporation" located in Orangeburg, New York, USA
Device description:
Roosin Xeroform Petrolatum Dressing is a type of wound dressing and has ingredients of finely woven mesh gauze infused with a blend of petrolatum and 3% Bismuth Tribromophenate. It is a sterile, single use dressing. This is a combination product.
Roosin Xeroform Petrolatum Dressing is used as a primary contact layer in dressing for wounds such as lacerations, skin graft recipient sites, newly sutured wounds, abrasions, and minor or partial thickness burns.
4
The dressing has a yellow appearance and is available in the form of pad and in four different sizes (2" x 2", 1" x 8", 4" x 4", 5" x 9"), packaged in pouches.
All dressings are sterilized by gamma radiation using conditions validated following ISO 11137-2: 2013.
Indications for Use:
Roosin 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.
Comparison to Predicate Devices
"Roosin Xeroform Petrolatum Dressing" described in this premarket notification is compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance.
- (1) K152970: "Dynarex Xeroform Petrolatum Dressing", manufactured by "Dynarex Corporation" located in Orangeburg, New York, USA
The following table shows similarities and differences between our device and the predicate device.
| Description | Subject Device | Predicate Device (K152970) |
|---|---|---|
| Indication for | ||
| Use | Roosin 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. | 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. | ||
| Prescription/ | ||
| OTC | Prescription | Same |
| Mechanism | Maintains a moist wound environment | Same |
| Design/ | ||
| Material | Cotton Gauze, 3% Bismuth | |
| Tribromophenate, and Petrolatum | Same | |
| Color | Light Yellow | Same |
Table 5.1: Comparison of Intended Use, Design, and Material
5
| Single Use | Yes | Yes |
|---|---|---|
| Sterile | Sterile to 106 SAL | Same |
Roosin Xeroform Petrolatum Dressing and its predicate devices are made from same materials, utilize same principles of operation, and have same indications for use.
Performance tests were conducted following in house procedures, and results for Roosin Xeroform Petrolatum Dressing met all relevant requirements, and are comparable to the predicate devices.
Biocompatibility was evaluated per ISO 19993-1: 2009, and it was found that the subject device is as biocompatible as the predicate device.
Substantial Equivalent Statement
Based on the comparison of intended use, design, materials, and performance, our Roosin Xeroform Petrolatum Dressing is substantial equivalent to its predicate device.