(262 days)
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.
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.
This document describes the premarket notification for the Agem® Ag Mesh Dressing with Silver. It seeks to prove substantial equivalence to a predicate device (3M™ Tegaderm™ Silver Nonwoven Dressing, K053256) rather than establishing independent acceptance criteria and proving the device meets them through a study.
Therefore, many of the requested elements are not directly applicable in the format of a standalone performance study. However, I can extract and infer information relevant to the substantial equivalence claim.
Acceptance Criteria and Reported Device Performance
The core of this submission is to demonstrate that the Agem® Ag Mesh Dressing with Silver is substantially equivalent (SE) to the predicate device in terms of safety and effectiveness. This implies that the proposed device must meet the same performance characteristics as the predicate.
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Agem® Ag Mesh Dressing with Silver) |
|---|---|
| Biocompatibility (Cytotoxicity, irritation, sensitization) | No deleterious effects observed; same biocompatibility performance as predicate. |
| In vitro reduction against microorganisms (Gram-negative, Gram-positive bacteria, yeast, mold) | Evaluated and demonstrated antibacterial effective barrier. |
| Antibacterial duration | 7 days |
| Silver Sulfate concentration | 8 mg/g |
| pH value | Evaluated |
| Rate of moisture | Evaluated |
| Fracture strength | Evaluated |
| Absorbency | Evaluated |
| Minimum Effective Concentration (MEC) | Evaluated |
| Silver release | Evaluated |
| Material (Patient contacting) | Cotton nonwoven |
| Sterilization method | 60Co Irradiation Sterilization |
| Indications for Use | Abrasions, Ulcers, Trauma wounds, Surgical wounds, First and second degree burns, Donor sites |
| Contraindications | Hypersensitivity to silver or cotton; not for surgical sponge or third-degree burns. |
Study Details Based on Substantial Equivalence Claim:
Given this is a 510(k) submission based on substantial equivalence, the "study" proving the device meets acceptance criteria is an analysis demonstrating similarity to a legally marketed predicate device, backed by non-clinical testing.
1. Sample size used for the test set and the data provenance:
* Test Set: The document does not describe a "test set" in the context of a clinical trial or a large-scale performance study. Instead, non-clinical tests were performed on the Agem® Ag Mesh Dressing with Silver. The sample size for each specific non-clinical test (biocompatibility, performance testing) is not explicitly stated.
* Data Provenance: The data is generated internally/by contractors for the submitting company, Shenzhen Yuanxing Nano-Pharma Co., Ltd., based in Shenzhen, China. It is retrospective in the sense that the testing was performed to support a pre-market submission, not as part of an ongoing clinical trial.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* This is not applicable as there is no "ground truth" derived from expert consensus on a clinical test set in this document. The "ground truth" for the non-clinical tests would be established by standard laboratory methods and validated protocols.
3. Adjudication method for the test set:
* Not applicable, as there is no clinical test set requiring expert adjudication.
4. 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. This is a medical device (wound dressing) submission, not an AI/software as a medical device (SaMD) submission. No human reader or AI component is involved in its function or evaluation as described here.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This is a medical device (wound dressing) submission, not an AI/SaMD submission.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* The "ground truth" for the non-clinical tests would be based on laboratory standards and validated test procedures (e.g., standard microbiological methods for antibacterial efficacy, ISO standards for biocompatibility).
7. The sample size for the training set:
* Not applicable. This is a medical device (wound dressing) submission, not an AI/SaMD submission, so there is no "training set."
8. How the ground truth for the training set was established:
* Not applicable.
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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.
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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/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
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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: 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
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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 Alsocalled 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
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| Item | Proposed Device | Predicate Device--K053256 | S/D |
|---|---|---|---|
| Trade Name | Agem® Ag Mesh Dressing withSilver | 3MTM TegadermTM SilverNonwoven Dressing | S |
| 510(K) Number | ---------- | K053256 | S |
| ClassificationCode | FRO | FRO | S |
| Indications forUse | is indicated for use as a primarywound dressing over:● Abrasions● Ulcers● Trauma wounds● Surgical wounds● First and second degree burns● Donor sites | is indicated for use as a primarywound dressing over:● Abrasions● Ulcers● Trauma wounds● Surgical wounds● First and second degree burns● Donor sites | S |
| Contraindications | should not be used on individualsthat have a known hypersensitivityto silver or cotton. This product isnot indicated for use as a surgicalsponge or for use on third degreeburns. | should not be used on individualsthat have a known hypersensitivityto silver or cotton. This product isnot indicated for use as a surgicalsponge or for use on third degreeburns. | S |
| silver sulfate | 8 mg/g | 8 mg/g | S |
| Antibacterialduration | 7 days | 7 days | S |
| PatientContactingMaterial | 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.
N/A