(262 days)
Not Found
No
The summary describes a wound dressing with silver sulfate and does not mention any AI or ML components or functionalities.
No.
While the device is used in a healthcare setting to treat wounds, its primary function, as described, is to create a physical barrier and reduce bacteria, not to directly treat or cure a disease or medical condition in the way a therapeutic device might (e.g., providing therapy, diagnosing, or mitigating disease). It aids in the healing process by managing the wound environment.
No
This device is a wound dressing designed to cover wounds and provide an antibacterial barrier. It does not perform any diagnostic functions by detecting or identifying a medical condition or disease.
No
The device description clearly states it is a "nonwoven dressing that contains (8mg/gm of dressing) of silver sulfate," indicating it is a physical medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a wound dressing applied directly to the wound on a patient's body. This is a topical application for therapeutic purposes.
- Device Description: The description details a physical dressing material containing silver sulfate, designed to be placed on a wound.
- Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not involve the analysis of bodily specimens.
- Performance Studies: The performance studies mentioned are related to the dressing's properties (antibacterial effectiveness, silver release, absorbency, etc.) and its substantial equivalence to a predicate wound dressing, not diagnostic performance metrics.
Therefore, this device is a wound dressing, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Under the supervision of a health care professional, this dressing may be used as a primary wound dressing over:
- abrasions
- ulcers
- trauma wounds
- · surgical wounds
- · first and second degree burns
- donor sites
This product is not designed, sold or intended for use except as indicated.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
Agem® Ag Mesh Dressing with Silver is a nonwoven dressing that contains (8mg/gm of dressing) of silver sulfate. The soft, absorbent dressing is supplied sterile and may be custom cut to fit the wound. The porous, non-occlusive dressing conforms to the wound base. The dressing creates an effective barrier and silver ions from the silver sulfate have been demonstrated in vitro to reduce the number of bacteria and yeast in the dressing.
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
health care professional
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)
Non-clinical tests were conducted to verify that the proposed device met all design specification as was substantially equivalent(SE) to predicate device. Non-clinical test data was used to support the substantial equivalency.
Biocompatibility
A standard battery of of biocompatibility studies was conducted:Cytotoxicity, Intracutaneous irritation in rabbits, and skin sensitization in Guinea Pig. No deleterious effects were observed with Agem® Ag Mesh Dressing with Silver.
They have the same biocompatibility performance and the equivalent safety in biocompatibility.
Performance testing
Agem® Ag Mesh Dressing with Silver has been evaluated for in in vitro reduction studies against a known number of microorganisms, such as gram negative and gram-positive bacteria and yeast and mold, the antibacterial effective barrier for seven days, silver sulfate, pH value, rate of moisture, fracture strength, absorbency, Minimum Effective Concentration (MEC) and silver release.
These characteristics, as well as the results of safety studies and effectiveness show the two products to be substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, layered on top of each other. The profiles are connected and form a single, abstract shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 23, 2016
Shenzhen Yuanxing Nano-Pharma Co., Ltd. Mr. Long Yang Shenzhen Hlongmed Biotech Company R15-08, East Building, Yihai Plaza, Chuangye Road, Nanshan District Shenzhen, Guangdong, P.R. China 518057
Re: K152544
Trade/Device Name: Agem Ag Mesh Dressing with Silver Regulatory Class: Unclassified Product Code: FRO Dated: April 14, 2016 Received: April 21, 2016
Dear Mr. Yang:
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. Iisting 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.
1
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/Resourcesfor You/Industry/default.htm. 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 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,
Jennifer R. Stevenson -A
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K152544
Device Name
Agem® Ag Mesh Dressing with Silver
Model & Specification: 5cm ×5cm, 10cm×12cm, 10cm×20cm, 20cm×20cm
Indications for Use (Describe)
Under the supervision of a health care professional, this dressing may be used as a primary wound dressing over:
- abrasions
- ulcers
- trauma wounds
- · surgical wounds
- · first and second degree burns
- donor sites
This product is not designed, sold or intended for use except as indicated.
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
(as required by 807.92(c))
The assigned 510(K) number is: K152544
Date of Summary: May 23,2016
1. Submitter information
Manufacturer Name: Shenzhen Yuanxing Pharmaceutical Co., Ltd
Address: Room 1001, Resources-Tech-Building, No1, Songpingshan Rd., Hi-Tech
Industrial Park, Nanshan District, 518057 Shenzhen, China
Contact Person and Title: LIU Longqing/ Administrative representative
Tel: 0086-755-26740339
Fax: 0086-755-26968906
Email: 11q(@thyx.com
2. Contact person
2.1 Primary Contact Person
Long Yang (COO) Shenzhen Hlongmed Biotech Company R1508, East Building, Yihai Plaza, Chuangye Road, Nanshan District, Shenzhen, P.R. China Tel: 0086-755-86664986 Fax: 0086-755-86664933 E-mail: yanglong@hlongmed.com
2.2 Secondary Contact Person
LIU Longqing( Administrative representative) Shenzhen Yuanxing Pharmaceutical Co., Ltd Tel: 0086-755-26740339
3. Device Information
4
| Shenzhen Yuanxing Pharmaceutical Co., Ltd | |||
|---|---|---|---|
| -- | -- | ------------------------------------------- | -- |
| Trade/Device Name | Agem ® Ag Mesh Dressing with Silver |
|---|---|
| Model & Specification | 5cm ×5cm, 10cm×12cm, 10cm×20cm, 20cm×20cm |
| Common Name | Dressing with silver |
| Classification Name | Dressing, Wound, Drug |
| Regulatory Class | Unclassified |
| Unclassified Reason | Pre-Amendment |
| Classification regulation | Not applicable |
| Review Panel | General & Plastic Surgery |
| Product Code | FRO |
4. Predicative Device
| 510(k) number | K053256 |
|---|---|
| Trade/Proprietary name | 3MTM TegadermTM Silver Nonwoven Dressing Also |
| called 3MTM TegadermTM Ag Mesh Dressing with Silver | |
| Sponsor | 3M Health Care |
| Product Code | FRO |
| Regulatory Class | Unclassified |
| Classification regulation | Not applicable |
5. Intended Use
Under the supervision of a health care professional, this dressing may be used as a primary wound dressing over:
- Abrasions ●
- Ulcers
- Trauma wounds ●
- Surgical wounds
- First and second degree burns ●
- Donor sites
This product is not designed, sold or intended for use except as indicated.
6. Device Description
Agem® Ag Mesh Dressing with Silver is a nonwoven dressing that contains (8mg/gm of dressing) of silver sulfate. The soft, absorbent dressing is supplied sterile and may be custom cut to fit the wound. The porous, non-occlusive dressing conforms to the wound
5
base. The dressing creates an effective barrier and silver ions from the silver sulfate have been demonstrated in vitro to reduce the number of bacteria and yeast in the dressing.
7. Summary of non-clinical data
Non-clinical tests were conducted to verify that the proposed device met all design specification as was substantially equivalent(SE) to predicate device. Non-clinical test data was used to support the substantial equivalency.
7.1 Biocompatibility
Agem® Ag Mesh Dressing with Silver is identical to 3MTM Tegaderm™ Silver Nonwoven Dressing from 3M Health Care cleared in K053256, in material and physical proprieties and has the identical type and duration of patient contact.
A standard battery of of biocompatibility studies was conducted:Cytotoxicity, Intracutaneous irritation in rabbits, and skin sensitization in Guinea Pig. No deleterious effects were observed with Agem® Ag Mesh Dressing with Silver.
They have the same biocompatibility performance and the equivalent safety in biocompatibility.
7.2 Performance testing
Agem® Ag Mesh Dressing with Silver has been evaluated for in in vitro reduction studies against a known number of microorganisms, such as gram negative and gram-positive bacteria and yeast and mold, the antibacterial effective barrier for seven days, silver sulfate, pH value, rate of moisture, fracture strength, absorbency, Minimum Effective Concentration (MEC) and silver release.
These characteristics, as well as the results of safety studies and effectiveness show the two products to be substantially equivalent.
8. Comparison to Predicate Device
The Agem® Ag Mesh Dressing with Silver submitted in this 510(k) file is substantially equivalent to the cleared 3M™ Tegaderm™ Silver Nonwoven Dressing which is the
6
| Item | Proposed Device | Predicate Device--K053256 | S/D |
|---|---|---|---|
| Trade Name | Agem® Ag Mesh Dressing with | ||
| Silver | 3MTM TegadermTM Silver | ||
| Nonwoven Dressing | S | ||
| 510(K) Number | ---------- | K053256 | S |
| Classification | |||
| Code | FRO | FRO | S |
| Indications for | |||
| Use | is indicated for use as a primary | ||
| wound dressing over: | |||
| ● Abrasions | |||
| ● Ulcers | |||
| ● Trauma wounds | |||
| ● Surgical wounds | |||
| ● First and second degree burns | |||
| ● Donor sites | is indicated for use as a primary | ||
| wound dressing over: | |||
| ● Abrasions | |||
| ● Ulcers | |||
| ● Trauma wounds | |||
| ● Surgical wounds | |||
| ● First and second degree burns | |||
| ● Donor sites | S | ||
| Contraindications | should not be used on individuals | ||
| that have a known hypersensitivity | |||
| to silver or cotton. This product is | |||
| not indicated for use as a surgical | |||
| sponge or for use on third degree | |||
| burns. | should not be used on individuals | ||
| that have a known hypersensitivity | |||
| to silver or cotton. This product is | |||
| not indicated for use as a surgical | |||
| sponge or for use on third degree | |||
| burns. | S | ||
| silver sulfate | 8 mg/g | 8 mg/g | S |
| Antibacterial | |||
| duration | 7 days | 7 days | S |
| Patient | |||
| Contacting | |||
| Material | cotton nonwoven | cotton nonwoven | S |
| Sterilization | 60Co Irradiation Sterilization | 60Co Irradiation Sterilization | S |
subject of K053256.
Note: S/D : Same /Different
9. Conclusion
The results of the above comparison and discussion about the Agem® Ag Mesh Dressing
7
with Silver demonstrate that the device is safe and effective as the legally marketed predicate devices.