Agem Ag Mesh Dressing with Silver

K152544 · Shenzhen Yuanxing Nano-Pharma Co., Ltd. · FRO · May 23, 2016 · SU

Device Facts

• Record ID: K152544
• Device Name: Agem Ag Mesh Dressing with Silver
• Applicant: Shenzhen Yuanxing Nano-Pharma Co., Ltd.
• Product Code: FRO · SU
• Decision Date: May 23, 2016
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

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.

Device Story

Agem Ag Mesh Dressing with Silver is a sterile, nonwoven, absorbent wound dressing containing 8mg/g silver sulfate. Used as a primary dressing over various wound types (abrasions, ulcers, burns, etc.) under healthcare professional supervision. Dressing is porous, non-occlusive, and conforms to wound base. Silver ions released from silver sulfate provide an antimicrobial barrier within the dressing to reduce bacteria and yeast. Benefits include effective barrier protection for up to seven days, aiding wound management.

Clinical Evidence

Bench testing only. No clinical data provided. Performance supported by in vitro studies including antimicrobial reduction (gram-negative/positive bacteria, yeast, mold), silver release, moisture rate, fracture strength, and absorbency. Biocompatibility testing (cytotoxicity, irritation, sensitization) showed no deleterious effects.

Technological Characteristics

Nonwoven cotton dressing containing 8mg/g silver sulfate. Form factor: porous, non-occlusive mesh in various sizes (5x5cm to 20x20cm). Sterilization: 60Co irradiation. Antimicrobial mechanism: silver ion release.

Indications for Use

Indicated for use as a primary wound dressing for patients with abrasions, ulcers, trauma wounds, surgical wounds, first and second degree burns, and donor sites. Contraindicated for individuals with known hypersensitivity to silver or cotton; not for use as a surgical sponge or on third degree burns.

Predicate Devices

• 3M Tegaderm Silver Nonwoven Dressing (K053256)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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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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# 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: [phone]

Fax: [phone]

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: [phone] Fax: [phone] E-mail: [e-mail]

## 2.2 Secondary Contact Person

LIU Longqing( Administrative representative) Shenzhen Yuanxing Pharmaceutical Co., Ltd Tel: [phone]

## 3. Device Information

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| | | 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<br>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

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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

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| Item | Proposed Device | Predicate Device--K053256 | S/D |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Trade Name | Agem® Ag Mesh Dressing with<br>Silver | 3MTM TegadermTM Silver<br>Nonwoven Dressing | S |
| 510(K) Number | ---------- | K053256 | S |
| Classification<br>Code | FRO | FRO | S |
| Indications for<br>Use | is indicated for use as a primary<br>wound dressing over:<br>● Abrasions<br>● Ulcers<br>● Trauma wounds<br>● Surgical wounds<br>● First and second degree burns<br>● Donor sites | is indicated for use as a primary<br>wound dressing over:<br>● Abrasions<br>● Ulcers<br>● Trauma wounds<br>● Surgical wounds<br>● First and second degree burns<br>● Donor sites | S |
| Contraindications | should not be used on individuals<br>that have a known hypersensitivity<br>to silver or cotton. This product is<br>not indicated for use as a surgical<br>sponge or for use on third degree<br>burns. | should not be used on individuals<br>that have a known hypersensitivity<br>to silver or cotton. This product is<br>not indicated for use as a surgical<br>sponge or for use on third degree<br>burns. | S |
| silver sulfate | 8 mg/g | 8 mg/g | S |
| Antibacterial<br>duration | 7 days | 7 days | S |
| Patient<br>Contacting<br>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

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with Silver demonstrate that the device is safe and effective as the legally marketed predicate devices.