(265 days)
No
The device description and performance studies focus on the physical and chemical properties of the gauze and zeolite, with no mention of AI or ML.
Yes
The device is intended to control traumatic bleeding and stop bleeding of superficial wounds, minor cuts, and abrasions, which are direct therapeutic actions.
No
The Zeolite Hemostatic Gauze is intended for temporary external use to control traumatic bleeding and stop bleeding of superficial wounds, minor cuts, and abrasions, which are therapeutic functions, not diagnostic ones.
No
The device description clearly states that the device consists of "zeolite and gauze" and is provided in a "sterile dressing format." This indicates a physical, hardware-based medical device, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for controlling traumatic bleeding and stopping bleeding of superficial wounds, minor cuts, and abrasions. This is a direct therapeutic action on the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a hemostatic gauze, a physical dressing applied externally to a wound.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.) or providing diagnostic information about a patient's condition.
- Anatomical Site: The device is for "External use," which aligns with a topical treatment rather than an in vitro diagnostic test.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such a function.
N/A
Intended Use / Indications for Use
Prescription Use: Zeolite Hemostatic Gauze is intended for temporary external use to control traumatic bleeding.
Over-The-Counter Use: Zeolite Hemostatic Gauze is intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions.
Product codes
QSY
Device Description
The Zeolite Hemostatic Gauze consists of zeolite and gauze. Zeolite Hemostatic Gauze is provided in a sterile dressing format that conforms readily to the wound. It is available in four types, which are P (Sheet), J (Rolled), Z (Folded) and L (Cubed). The difference between each type is the dressing shape. Each type is available in a range of different sizes.
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
- ASTM F1886/F1886M: 2016 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection;
- ASTM F88/F88M: 2015 Standard Test Method for Seal Strength of Flexible Barrier Materials;
- ASTM F1929: 2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dve Penetration:
- ASTM F1980: 2016 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ASTM F3039: 2015 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration;
- ASTM D3078-02 (Reapproved 2021)el Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
- USP Bacterial Endotoxins Test
- USP Pyrogen Test (USP Rabbit Test)
- ISO 10993-5: 2009 Biological Evaluation of Medical Devices-Part 5: Tests for in Vitro Cytotoxicity;
- ISO 10993-10: 2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization;
- ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
Physical performance testing: Three discrete batches of subject device were tested for water absorption, zeolite content, and heat release. The water absorption of the devices is ≥300% and the hydration temperature rise is ≤1.0℃. The maximum exothermic temperature of the propose device is 0.5℃. The zeolite amount of the proposed device is ≥10%. The physical performance test results all meet the requirements of the acceptance criteria.
Sterile barrier packaging testing: Visual inspection (ASTM F1886/F1886M-16), seal strength (ASTM F88/F88M-15), dye penetration test (ASTM F1929-15/F3039-15), vacuum leak (ASTM D3078-02(2013)) and packaging resistance bacteria performance (DIN 58953-6-2010) were performed. The test result showed that the device package can maintain its integrity.
Sterilization and shelf life testing: Endotoxin limit did not exceed 20EU/device. Shelf life test result showed that the device can maintain its performance during the claimed shelf life.
Biocompatibility testing: The proposed device was evaluated for Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Pyrogen testing. The results for the biocompatibility testing showed that the proposed device is biocompatible.
Animal Study: In the animal study conducted, 16 animals were selected for hemostatic testing, 8 for testing of the subject device, 8 for predicate device. A in vivo testing using pig as a model is conducted on the subject device and predicate device to supports the indications for use of the subject device.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' in blue, with 'ADMINISTRATION' written below in a smaller font.
Hangzhou Zeo-Innov Life Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O.box 120-119 Shanghai, 200120 China
April 21, 2023
Re: K211570 Trade/Device Name: Zeolite Hemostatic Gauze Regulatory Class: Unclassified Product Code: QSY
Dear Diana Hong:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 10, 2022. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSY.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov.
Sincerely,
Julie A. Morabito -S
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right of it is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
February 10, 2022
Hangzhou Zeo-Innov Life Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O.box 120-119 Shanghai, 200120 China
Re: K211570
Trade/Device Name: Zeolite Hemostatic Gauze Regulatory Class: Unclassified Product Code: FRO Dated: January 10, 2022 Received: January 11, 2022
Dear Diana Hong:
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 mav, 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
2
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 mediation-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,
Julie A. Morabito -S
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number K211570
Device Name
Zeolite Hemostatic Gauze
Indications for Use (Describe)
Prescription Use: Zeolite Hemostatic Gauze is intended for temporary external use to control traumatic bleeding. Over-The-Counter Use: Zeolite Hemostatic Gauze is intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K211570
-
- Date of Preparation: 02/08/2022
-
- Sponsor Identification
Hangzhou Zeo-Innov Life Technology Co., Ltd. R101, building 2, No.291, Fucheng Road, HEDA, Hangzhou, Zhejiang, 310018, China
Establishment Registration Number: Not yet registered
Contact Person: Lijuan Zhao Position: Chief executive officer Tel: +86- 571-86651470 Fax: +86- 571-86651470 Email: zhaolj@zeo-innov.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Tingting Su (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
5
4. Identification of Proposed Device
Trade Name: Zeolite Hemostatic Gauze Common Name: Hemostatic Gauze
Regulatory Information Product code: FRO Classification Name: Dressing, Wound, Drug; Classification: Unclassified; Review Panel: General & Plastic Surgery;
Indication for Use:
Prescription Use: Zeolite Hemostatic Gauze is intended for temporary external use to control traumatic bleeding.
Over-The-Counter Use: Zeolite Hemostatic Gauze is intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions.
Device Description
The Zeolite Hemostatic Gauze consists of zeolite and gauze. Zeolite Hemostatic Gauze is provided in a sterile dressing format that conforms readily to the wound. It is available in four types, which are P (Sheet), J (Rolled), Z (Folded) and L (Cubed). The difference between each type is the dressing shape. Each type is available in a range of different sizes.
-
- Identification of Predicate Device and Reference Device
Predicate device: 510(k) number: K072474 Product Name: QuikClot® eXTM
- Identification of Predicate Device and Reference Device
Reference device: 510(k) number: K013390 Product Name: QuikClot
-
- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
-
ASTM F1886/F1886M: 2016 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection;
6
- A ASTM F88/F88M: 2015 Standard Test Method for Seal Strength of Flexible Barrier Materials;
-
ASTM F1929: 2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dve Penetration:
-
ASTM F1980: 2016 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
-
ASTM F3039: 2015 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration;
-
ASTM D3078-02 (Reapproved 2021)el Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
-
USP Bacterial Endotoxins Test
-
USP Pyrogen Test (USP Rabbit Test)
- ISO 10993-5: 2009 Biological Evaluation of Medical Devices-Part 5: Tests for in Vitro > Cytotoxicity;
- A ISO 10993-10: 2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization;
-
ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
The following performance data were provided in support of the substantial equivalence determination.
Physical performance testing
Three discrete batches of subject device were tested for water absorption, zeolite content, and heat release. The water absorption of the devices is ≥300% and the hydration temperature rise is ≤1.0℃. The maximum exothermic temperature of the propose device is 0.5℃. The zeolite amount of the proposed device is ≥10%. The physical performance test results all meet the requirements of the acceptance criteria.
Sterile barrier packaging testing were performed on the proposed device, which include visual inspection (ASTM F1886/F1886M-16), seal strength (ASTM F88/F88M-15), dye penetration test (ASTM F1929-15/F3039-15), vacuum leak (ASTM D3078-02(2013)) and packaging resistance bacteria performance (DIN 58953-6-2010). The test result showed that the device package can maintain its integrity.
Sterilization and shelf life testing listed in following table were performed on the proposed device. Endotoxin limit did not exceed 20EU/device. Shelf life test result showed that the device can maintain its performance during the claimed shelf life.
| Bacteria Endotoxin Limit | USP |
|---|---|
| Shelf Life Evaluation | Water absorption, zeolite content, and heat release, package tests were performed on aging samples to verify the claimed shelf life of the |
7
device
Biocompatibility testing
The contact level of the proposed device is breached or compromised surfaces, and the contact duration is limited contact (≤24 hours). The proposed device was evaluated for the following tests. The results for the biocompatibility testing showed that the proposed device is biocompatible.
-
Cytotoxicity,
-
Sensitization,
- A Irritation,
-
Systemic toxicity,
-
Pyrogen testing.
Animal Study
In the animal study conducted, 16 animals were selected for hemostatic testing, 8 for testing of the subject device, 8 for predicate device. A in vivo testing using pig as a model is conducted on the subject device and predicate device to supports the indications for use of the subject device.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
8
8. Substantially Equivalent (SE) Comparison
| Item | Proposed Device | Predicate Device | Reference Device | / |
|---|---|---|---|---|
| Product Code | K211570 | K072474 | K013390 | Same |
| Class | Unclassified | Unclassified | Unclassified | Same |
| Indication for Use | Prescription Use: Zeolite Hemostatic Gauze is intended for temporary external use to control traumatic bleeding. | Prescription Use: QuikClot® eXTM is intended for temporary external use to control traumatic bleeding. | QuikClot is intended for emergency use only as an external temporary traumatic wound treatment to achieve hemostasis for moderate to severe bleeding. | Same |
| Over-The-Counter Use: Zeolite Hemostatic Gauze is intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions. | Over-The-Counter Use: QuikClot® eXTM is intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions. | |||
| Material | Gauze | |||
| Zeolite | Gauze | |||
| Clay Mineral (Kaolin) | Zeolite | Analysis 1 | ||
| Single Use | Yes | Yes | Yes | Same |
| Size | P-2cm×2cm-2, | |||
| P-2cm×2cm-4, | ||||
| P-3cm×25cm-2, | ||||
| P-3cm×25cm-4, | ||||
| P-5cm×5cm-4, | ||||
| P-5cm×5cm-8, | ||||
| P-5cm×5cm-12, | ||||
| P-8cm×8cm-4, | ||||
| P-8cm×8cm-8, | ||||
| P-8cm×8cm-12, | ||||
| P-8cm×8cm-16, | ||||
| P-8cm×8cm-24, | ||||
| P-9cm×10cm-4, | ||||
| P-9cm×10cm-8, | ||||
| P-9cm×10cm-12, | ||||
| P-9cm×10cm-16, | ||||
| P-9cm×10cm-24 | 4 in × 4 in | Unknown | Analysis 2 |
Table 1 Comparison of Technology Characteristics
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| P-10cm×15cm-8, | ||
|---|---|---|
| P-10cm×15cm-12, | ||
| P-10cm×15cm-16, | ||
| P-10cm×15cm-24, | ||
| P-12cm×12cm-4, | ||
| P-12cm×12cm-8, | ||
| P-12cm×12cm-12, | ||
| P-12cm×12cm-16, | ||
| P-12cm×12cm-24, | ||
| P-15cm×15cm-4, | ||
| P-15cm×15cm-8, | ||
| P-15cm×15cm-12, | ||
| P-15cm×15cm-16, | ||
| P-15cm×15cm-24, | ||
| P-20cm×20cm-4, | ||
| P-20cm×20cm-8, | ||
| P-20cm×20cm-12, | ||
| P-20cm×20cm-16, | ||
| P-20cm×20cm-24, | ||
| P-30cm×30cm-4, | ||
| P-30cm×30cm-8, | ||
| P-30cm×30cm-12, | ||
| P-30cm×30cm-16, | ||
| P-30cm×30cm-24; | ||
| J-5cm×150cm, | ||
| J-5cm×300cm, | ||
| J-8cm×150cm, | ||
| J-8cm×300cm, | ||
| J-10cm×150cm, | ||
| J-10cm×300cm; | ||
| Z-5cm×150cm×4cm, | ||
| Z-5cm×150cm×6cm, | ||
| Z-5cm×150cm×8cm, | ||
| Z-5cm×350cm×6cm, | ||
| Z-5cm×350cm×8cm, | ||
| Z-8cm×150cm×4cm, | ||
| Z-8cm×150cm×6cm, | ||
| Z-8cm×150cm×8cm, | ||
| Z-8cm×150cm×10cm, | ||
| Z-8cm×150cm×12cm, |
10
| Z-8cm×350cm×4cm, | |||||
|---|---|---|---|---|---|
| Z-8cm×350cm×6cm, | |||||
| Z-8cm×350cm×8cm, | |||||
| Z-8cm×350cm×10cm, | |||||
| Z-8cm×350cm×12cm, | |||||
| Z-10cm×150cm×4cm, | |||||
| Z-10cm×150cm×6cm, | |||||
| Z-10cm×150cm×8cm, | |||||
| Z-10cm×150cm×10cm, | |||||
| Z-10cm×150cm×12cm, | |||||
| Z-10cm×350cm×4cm, | |||||
| Z-10cm×350cm×6cm, | |||||
| Z-10cm×350cm×8cm, | |||||
| Z-10cm×350cm×10cm, | |||||
| Z-10cm×350cm×12cm; | |||||
| L-0.8cm×3.8cm, | |||||
| L-1cm×3.8cm, | |||||
| L-1.2cm×3.8cm, | |||||
| L-1.5cm×3.0cm, | |||||
| L-1.8cm×3.0cm, | |||||
| L-2cm×2.5cm | |||||
| No Cytotoxicity | Analysis | ||||
| 3 | |||||
| Biocompatibility | No intracutaneous | ||||
| reactivity | Comply with ISO 10993 | ||||
| standards requirements | Comply with ISO 10993 | ||||
| standards | |||||
| requirements | |||||
| No Sensitization | Comply with ISO 10993 standards requirements | ||||
| No Acute Systemic | |||||
| Toxicity | |||||
| No pyrogen | |||||
| Sterilization | Co60 Radiation | ||||
| sterilization | Radiation sterilization | Unknown | Analysis | ||
| 4 | |||||
| SAL | 10-6 | 10-6 | Unknown | ||
| Label and | |||||
| Labeling | Conform with 21CFR Part | ||||
| 801 | Conform with 21CFR | ||||
| Part 801 | Conform with | ||||
| 21CFR Part 801 | Same |
Analysis 1- Material
The material for the proposed device is different from the predicate device. The proposed device material is gauze and zeolite, the predicate device material is gauze and clay mineral (Kaolin). Zeolite is also a kind of clay mineral, which is similar to Kaolin.
Analysis 2- Size
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The size for the proposed device is different from the predicate device. Different size can be selected by different condition.With respect to materials, the subject device demonstrates substantial equivalence to the predicate device.
Analysis 3- Biocompatibility
The biocompatibility test were performance on the predicate device. The contact level of the proposed device is breached or compromised surfaces, and the contact duration is limited contact (≤24 hours). So, the proposed device has been tested for cytotoxicity, sensitization, systemic toxicity, pyrogen testing. The results for the biocompatibility testing showed that the proposed device is biocompatible. With respect to materials, the subject device demonstrates substantial equivalence to the predicate device.
Analysis 4-Sterilization and SAL
The sterilization method of the predicate device and the proposed device both are radiation sterilization. The proposed device is radiation of Co60, while the radiation sterilization type of the predicate device is unknown. However, the performance testing of the proposed device has been conducted on the final product and the test results show that the proposed device meets the acceptance criteria.
-
- Substantially Equivalent (SE) Conclusion
The conclusion drawn from the non-clinical tests demonstrates that the subject device in 510(k) submission, Zeolite Hemostatic Gauze, demonstrates substantial equivalence to the device cleared under K072474.
- Substantially Equivalent (SE) Conclusion