(682 days)
No
The device description and performance studies focus on the material properties and physical mechanisms of the dressing, with no mention of AI or ML.
Yes
The device is described as a "Hemostatic Dressing" intended for "temporary control of severely bleeding wounds" and "to stop bleeding of minor wounds, minor cuts and minor abrasions." It functions by quickly absorbing blood, turning into a gel to seal the wound, and promoting coagulation, all of which are therapeutic actions aimed at treating a health condition (bleeding wounds).
No
The device is a hemostatic dressing intended to control bleeding, which is a therapeutic function, not a diagnostic one.
No
The device is a physical dressing made of fabric and fiber, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the external, temporary control of bleeding from wounds. This is a direct therapeutic action on the body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a dressing that absorbs blood and forms a gel to seal the wound and promote coagulation. This is a physical and chemical interaction with the wound itself, not a test to detect or measure substances in a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.
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. This device does not fit that description.
N/A
Intended Use / Indications for Use
Indications for Use (Rx): Hemostatic Dressing is intended for the external, temporary control of severely bleeding wounds.
Indications for Use (OTC): Hemostatic Dressing is intended for temporary external use to stop bleeding of minor wounds, minor cuts and minor abrasions.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
Hemostatic Dressing is a sterile non-woven fabric dressing composed of hydrophilic fiber (a mixture of chitosan and chitosan derivative). When applied directly over a wound with pressure, this soft and highly absorbent dressing quickly absorbs blood and turns into a gel to seal the wound. It promotes control of wound bleeding and exudates absorption and promotes coagulation.
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)
To verify that the Hemostatic dressing is as safe and effective as the predicate device, representative samples of Hemostatic dressing were underwent a series of tests including bench testing (absorbency, gelling characteristics, pH, loss on drying, residue on ignition, heavy metals, bacterial endotoxins, packaging sealing, and sterility), biocompatibility testing (cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, subacute toxicity, hemolysis), in-vivo hemostatic, sterilization validation testing, and real-time shelf life stability testing.
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.
HemCon ChitoGauze™ (K090026)
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.
SURECELL® Gelling Fiber Wound Dressing (K173005)
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
September 1, 2023
Jiangsu NewValue Medical Products Co., Ltd. Lu Wang Vice Manager Building G35.the east of KouTai Road and the north of XinYang Road.CMC. TaiZhou. Jiangsu 225300 China
Re: K213413
Trade/Device Name: Hemostatic Dressing Regulatory Class: Unclassified Product Code: FRO Dated: March 22, 2023 Received: April 7, 2023
Dear Lu Wang:
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 medical devices and radiation-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,
David Krause -S
David Krause, Ph.D. Deputy Director OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Section 4
Indications for Use Statement
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name Hemostatic Dressing
Indications for Use (Describe)
Indications for Use (Rx): Hemostatic Dressing is intended for the external, temporary control of severely bleeding wounds.
Indications for Use (OTC):
Hemostatic Dressing is intended for temporary external use to stop bleeding of minor wounds, minor cuts and minor
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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FORM FDA 3881 (6/20)
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510(k) Summary
SUBMITTER: I.
Jiangsu NewValue Medical Products Co., Ltd. Building G35, No.1 Avenue, China Medical City, Taizhou, Jiangsu, 225300, China Contact Person: Lu Wang Title: Vice Manager Tel: 86-015951155167 Email: wanglu@new-value.cn
Summary prepared: 08/29/2023
II. DEVICE
Name of Device: Hemostatic Dressing (K213413) Common Name: Dressing, Wound, Drug Regulatory Class: II Product Code: FRO
III. PREDICATE DEVICE
Primary predicate device: HemCon ChitoGauze™ (K090026)
IV. REFERENCE DEVICE
Reference Device: SURECELL® Gelling Fiber Wound Dressing (K173005)
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V. DEVICE DESCRIPTION
Hemostatic Dressing is a sterile non-woven fabric dressing composed of hydrophilic fiber (a mixture of chitosan and chitosan derivative). When applied directly over a wound with pressure, this soft and highly absorbent dressing quickly absorbs blood and turns into a gel to seal the wound. It promotes control of wound bleeding and exudates absorption and promotes coagulation.
VI. INDICATIONS FOR USE
Hemostatic Dressing is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
Hemostatic dressing Over-the-Counter is indicated for temporary external use to stop bleeding of minor wounds, minor cuts and minor abrasions.
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Hemostatic dressing is compared with the predicate device (HemCon ChitoGauze™ (K090026)). The results are shown below in the Technological Characteristics Comparison Table:
| Item | Subject Device
Hemostatic Dressing | Predicate Device
ChitoGauze™
(HemCon Medical
Technologies, Inc.) | Reference Device
SURECELL® Gelling
Fiber Wound Dressing |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K213413 | K090026 | K173005 |
| Classification | Unclassified | Unclassified | Unclassified |
| Product Code | FRO | FRO | FRO |
| Common name | Dressing, Wound, Drug | Dressing, Wound, Drug | Dressing, Wound,
Drug |
| Intended use | External hemostatic | External hemostatic | Wound dressing |
| Indications for use | Indications for Use (Rx
Only): Hemostatic
Dressing is a hemostatic
dressing for the external,
temporary control of
severely bleeding wounds. | Indications for Use (Rx
Only): ChitoGauze is a
hemostatic dressing for
the external, temporary
control of severely
bleeding wounds. | Indications for Use (Rx
Only): Under professional
medical care,
SURECELL™
Gelling Fiber Wound Dressing
may
be used for the |
| Indications for Use (OTC):
Hemostatic
Dressing is intended for
temporary external use to
stop bleeding of minor
wounds, minor cuts and
minor abrasions. | Indications for Use (OTC): ChitoGauze is
intended for temporary
external use to stop
bleeding of minor
wounds, minor cuts and
minor abrasions. | management of leg ulcers
(Stage I-IV), pressure ulcers,
diabetic ulcers, surgical
wounds (e.g. post-operative,
donor sites, dermatological),
Burns (1st and 2nd degree),
surgical or traumatic wounds
which have been left to heal
by secondary
intention. SURECELLTM
Gelling Fiber Wound
Dressing
maintains a moist wound
environment.
SURECELLTM Gelling Fiber
Wound Dressing may also be
used for the local
management of wounds such a
wounds that have been
surgically or mechanically
debrided, donor sites,
and traumatic wounds.
Indications for Use
(OTC): SURECELLTM
Gelling Fiber Wound
Dressing
Over-the-Counter is
indicated for
minor Burns, minor abrasions
and minor Lacerations, minor
superficial cuts.
SURECELLTM Gelling Fiber
Wound Dressing is
intended for the maintenance of
a moist wound environment. | |
| Duration of Use | Temporary | Temporary | Prolonged exposure |
| Physical
Composition | Single layer needle
punched chitosan
nonwoven fabric dressing | polyester/rayon blend
non-woven medical gauze
that is coated with
chitosan | Single layer needle
punched chitosan
nonwoven fabric
dressing |
| Hemostatic
Material | A mixture of chitosan and
chitosan derivatives | Chitosan | A mixture of
chitosan and
chitosan derivatives |
| Mechanism of
Action | Hemostatic Dressing will
turn into a gel-like
condition to absorb the
blood and seal the wound.
It promotes control of
wound bleeding and
exudates absorption and
promotes coagulation. | ChitoGauze™ will turn
into a gel-like condition to
absorb the blood. It
promotes control of
wound bleeding and
exudates absorption and
promotes coagulation. | SURECELL™
Gelling Fiber
Wound Dressing
vertically absorbs
wound exudate and
creates a
comfortable clear
gel, helps reduce
the risk of
periwound
maceration,
maintains a moist
environment for
optimal wound
healing, and
removes dead and
damaged tissue
from wound
without damaging
newly formed
tissue. |
| Chitosan Form | Needle punched chitosan
nonwoven fabric dressing | Chitosan coated on gauze | Needle punched
chitosan nonwoven
fabric dressing |
| Single Use | Single Use | Single Use | Single Use |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible |
| Sterilization | Gamma radiation | Gamma radiation | Gamma radiation |
| Sterility | SAL 10-6 | SAL 10-6 | SAL 10-6 |
| Primary
Packaging | Foil pouch | Foil pouch | Paper-plastic pouch |
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Image /page/6/Picture/0 description: The image shows the logo for New Value. The logo consists of the letters 'NV' in a stylized font, with the 'N' in blue and the 'V' in orange. To the right of the letters is the word 'NewValue' in blue, with the letters connected in a cursive style.
K213413
7
Image /page/7/Picture/0 description: The image contains the logo for NewValue. The logo consists of the letters "NV" in a stylized font, with the first "N" in blue and the "V" in orange. To the right of the letters, the word "NewValue" is written in blue, in a font that is similar to the "NV" letters.
8
Image /page/8/Picture/0 description: The image contains the logo for New Value. The logo consists of the letters 'NV' in a stylized font, with the 'N' in blue and the 'V' in orange. To the right of the letters is the text 'New Value' in a blue, sans-serif font. The text is slightly smaller than the letters 'NV'.
NONCLINICAL DATA VIII.
To verify that the Hemostatic dressing is as safe and effective as the predicate device, representative samples of Hemostatic dressing were underwent a series of tests including bench testing (absorbency, gelling characteristics, pH, loss on drying, residue on ignition, heavy metals, bacterial endotoxins, packaging sealing, and sterility), biocompatibility testing (cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, subacute toxicity, hemolysis), in-vivo hemostatic, sterilization validation testing, and real-time shelf life stability testing.
IX. CONCLUSION
JIANGSU NEWVALUE Medical PRODUCTS CO.,LTD. considers Hemostatic dressing to be equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in intended use, design, mechanisms of action, technology and materials. The slight differences between Hemostatic dressing and the predicate devices do not raise any questions of safety and effectiveness.