(682 days)
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.
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.
The provided text describes a 510(k) premarket notification for a medical device called "Hemostatic Dressing." This document is from the FDA and focuses on demonstrating substantial equivalence to predicate devices, rather than a study proving the device meets specific performance criteria against a predefined acceptance table for a diagnostic or AI-driven device.
Therefore, many of the requested criteria for a study proving a device meets acceptance criteria, such as details on sample sizes for test and training sets, expert adjudication, MRMC studies, or ground truth establishment relevant to an AI/diagnostic device, are not applicable to this document. This document is a regulatory submission for a physical medical product (a dressing).
However, I can extract the information that is present and explain why other information is not included.
Here's an attempt to answer the questions based only on the provided text, recognizing its limitations for the requested specifics:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with specific quantitative performance metrics like sensitivity, specificity, or response times, which are typical for diagnostic or AI devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device. The "performance" is demonstrated through a series of nonclinical tests to show safety and effectiveness comparable to the predicate.
Below is information regarding the types of tests conducted, which imply certain performance expectations, but not a direct acceptance criteria table with reported quantitative results.
| Acceptance Criterion (Implied by Test Type) | Reported Device Performance (Summary) |
|---|---|
| Safety - Biocompatibility | Successfully underwent biocompatibility testing (cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, subacute toxicity, hemolysis) and is "Biocompatible." |
| Safety - Sterility | Achieved SAL 10-6 (Sterility Assurance Level). Sterilization validated by Gamma radiation. |
| Safety - Absence of harmful substances | Tested for heavy metals and bacterial endotoxins. (Results not explicitly quantified but implied to meet standards). |
| Physical Performance - Absorbency | Tested for absorbency and gelling characteristics. Described as "soft and highly absorbent dressing quickly absorbs blood and turns into a gel to seal the wound." |
| Physical Performance - pH Level | Tested for pH. (Result not explicitly quantified but implied to meet standards). |
| Physical Performance - Loss on Drying | Tested for loss on drying. (Result not explicitly quantified but implied to meet standards). |
| Physical Performance - Residue on Ignition | Tested for residue on ignition. (Result not explicitly quantified but implied to meet standards). |
| Retention of Sterility - Packaging Integrity | Successfully tested for packaging sealing. |
| Shelf Life Stability | Underwent real-time shelf life stability testing. (Implied to be stable for specified shelf life, though not stated). |
| Clinical Efficacy (Hemostasis) | Underwent in-vivo hemostatic testing. Described indications for use: "control of wound bleeding and exudates absorption and promotes coagulation." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for the "test set" in terms readily comparable to an AI/diagnostic study (e.g., number of images or patient cases). It refers to "representative samples of Hemostatic dressing" for nonclinical tests.
- Sample Size: Not specified quantitatively (e.g., number of units, number of animal subjects for in-vivo). The text only states "representative samples."
- Data Provenance: Not explicitly stated (country, retrospective/prospective). The manufacturer is Jiangsu NewValue Medical Products Co., Ltd. in China, implying testing was likely conducted in China or by contracted labs. The tests are nonclinical, focusing on material properties and in-vitro/in-vivo animal models, not human patient data in the context of an AI study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a material hemostatic dressing, not a diagnostic or AI device that requires expert-established ground truth from images or clinical data. "Ground truth" for this device would relate to validated laboratory testing methods and established material standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for subjective interpretations by multiple experts, typically in diagnostic imaging or clinical assessment studies. This document describes physical, chemical, and biological performance tests, which are objective and do not involve human adjudication in that sense.
5. 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 hemostatic dressing, not an AI-assisted diagnostic device. Therefore, no MRMC study involving human readers or AI assistance would be conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this type of device, "ground truth" is established through:
- Standardized laboratory assays: For biocompatibility, sterility, pH, absorbency, etc.
- Validated animal models: For in-vivo hemostatic performance.
- Material and chemical property standards: Industry and regulatory standards for composition and purity.
No expert consensus, pathology, or outcomes data from human clinical trials is detailed in this 510(k) summary directly, as the primary goal is substantial equivalence through nonclinical data.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI model, this question does not apply.
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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
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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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Image /page/2/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 a darker shade and the 'V' in a lighter shade. To the right of the letters is the word 'NewValue' in a cursive font.
Section 4
Indications for Use Statement
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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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Image /page/4/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 dark blue and the 'V' in orange. To the right of the letters is the word 'NewValue' in dark blue.
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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Image /page/5/Picture/0 description: The image shows the logo for New Value. The logo consists of the letters "NV" in blue and orange, followed by the words "New Value" in blue. The "N" in "NV" is blue, and the "V" is orange. The words "New Value" are in a sans-serif font.
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 DeviceHemostatic Dressing | Predicate DeviceChitoGauze™(HemCon MedicalTechnologies, Inc.) | Reference DeviceSURECELL® GellingFiber 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 (RxOnly): HemostaticDressing is a hemostaticdressing for the external,temporary control ofseverely bleeding wounds. | Indications for Use (RxOnly): ChitoGauze is ahemostatic dressing forthe external, temporarycontrol of severelybleeding wounds. | Indications for Use (RxOnly): Under professionalmedical care,SURECELL™Gelling Fiber Wound Dressingmaybe used for the |
| Indications for Use (OTC):HemostaticDressing is intended fortemporary external use tostop bleeding of minorwounds, minor cuts andminor abrasions. | Indications for Use (OTC): ChitoGauze isintended for temporaryexternal use to stopbleeding of minorwounds, minor cuts andminor abrasions. | management of leg ulcers(Stage I-IV), pressure ulcers,diabetic ulcers, surgicalwounds (e.g. post-operative,donor sites, dermatological),Burns (1st and 2nd degree),surgical or traumatic woundswhich have been left to healby secondaryintention. SURECELLTMGelling Fiber WoundDressingmaintains a moist woundenvironment.SURECELLTM Gelling FiberWound Dressing may also beused for the localmanagement of wounds such awounds that have beensurgically or mechanicallydebrided, donor sites,and traumatic wounds.Indications for Use(OTC): SURECELLTMGelling Fiber WoundDressingOver-the-Counter isindicated forminor Burns, minor abrasionsand minor Lacerations, minorsuperficial cuts.SURECELLTM Gelling FiberWound Dressing isintended for the maintenance ofa moist wound environment. | |
| Duration of Use | Temporary | Temporary | Prolonged exposure |
| PhysicalComposition | Single layer needlepunched chitosannonwoven fabric dressing | polyester/rayon blendnon-woven medical gauzethat is coated withchitosan | Single layer needlepunched chitosannonwoven fabricdressing |
| HemostaticMaterial | A mixture of chitosan andchitosan derivatives | Chitosan | A mixture ofchitosan andchitosan derivatives |
| Mechanism ofAction | Hemostatic Dressing willturn into a gel-likecondition to absorb theblood and seal the wound.It promotes control ofwound bleeding andexudates absorption andpromotes coagulation. | ChitoGauze™ will turninto a gel-like condition toabsorb the blood. Itpromotes control ofwound bleeding andexudates absorption andpromotes coagulation. | SURECELL™Gelling FiberWound Dressingvertically absorbswound exudate andcreates acomfortable cleargel, helps reducethe risk ofperiwoundmaceration,maintains a moistenvironment foroptimal woundhealing, andremoves dead anddamaged tissuefrom woundwithout damagingnewly formedtissue. |
| Chitosan Form | Needle punched chitosannonwoven fabric dressing | Chitosan coated on gauze | Needle punchedchitosan nonwovenfabric 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 |
| PrimaryPackaging | 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
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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.
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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.
N/A