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.

AI/ML Overview

This FDA 510(k) summary provides information for a medical device called "Zeolite Hemostatic Gauze" (K211570). The document asserts substantial equivalence to a predicate device, QuikClot® eXTM (K072474), and references another device, QuikClot (K013390).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from various standards and internal specifications, as indicated by the non-clinical test conclusions. The reported device performance is presented as meeting these requirements.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Physical Performance	Water Absorption ≥ 300%	Water absorption ≥300%
	Hydration Temperature Rise ≤ 1.0°C	Hydration temperature rise ≤1.0°C. Maximum exothermic temperature of the proposed device is 0.5℃.
	Zeolite Content ≥ 10%	Zeolite amount ≥10%
Sterile Barrier Packaging	Integrity of Seals (ASTM F1886/F1886M: 2016)	Test result showed that the device package can maintain its integrity.
	Seal Strength (ASTM F88/F88M: 2015)	Test result showed that the device package can maintain its integrity.
	Dye Penetration (ASTM F1929: 2015 / F3039: 2015)	Test result showed that the device package can maintain its integrity.
	Leak Detection by Bubble Emission/Vacuum Leak (ASTM D3078-02 (Reapproved 2021)el)	Test result showed that the device package can maintain its integrity.
	Packaging Resistance Bacteria Performance (DIN 58953-6-2010)	Test result showed that the device package can maintain its integrity.
Sterilization & Shelf Life	Bacterial Endotoxins Test (USP <85>). Endotoxin limit did not exceed 20 EU/device.	Endotoxin limit did not exceed 20EU/device.
	Shelf Life Evaluation (Water absorption, zeolite content, and heat release, package tests on aging samples)	Shelf life test result showed that the device can maintain its performance during the claimed shelf life.
Biocompatibility	Cytotoxicity (ISO 10993-5: 2009)	The results for the biocompatibility testing showed that the proposed device is biocompatible (No Cytotoxicity, No intracutaneous reactivity, No Sensitization, No Acute Systemic Toxicity, No pyrogen).
	Sensitization (ISO 10993-10: 2010)	The results for the biocompatibility testing showed that the proposed device is biocompatible.
	Irritation (ISO 10993-10: 2010)	The results for the biocompatibility testing showed that the proposed device is biocompatible.
	Systemic Toxicity (ISO 10993-11: 2017)	The results for the biocompatibility testing showed that the proposed device is biocompatible.
	Pyrogen Test (USP <151>)	The results for the biocompatibility testing showed that the proposed device is biocompatible.
Hemostatic Effectiveness	In vivo testing to support the indications for use. (No specific quantitative acceptance criteria are provided in the summary, but the predicate device serves as the benchmark for substantial equivalence in effectiveness).	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.

Study Details Proving Device Meets Acceptance Criteria

Sample Size used for the test set and the data provenance:
- Physical performance testing: "Three discrete batches of subject device were tested." No further details on the number of units per batch or the provenance (country, retrospective/prospective) are provided beyond the manufacturer being in China.
- Sterile barrier packaging testing: No specific sample size is provided beyond stating "sterile barrier packaging testing were performed." Provenance is assumed to be from the manufacturer in China.
- Sterilization and shelf life testing: No specific sample size is provided for these tests, except for "aging samples" for shelf life. Provenance is assumed to be from the manufacturer in China.
- Biocompatibility testing: No specific sample sizes for in vitro tests (cytotoxicity, sensitization, irritation, systemic toxicity) are provided. Provenance is assumed to be from the manufacturer in China.
- Animal Study: 16 animals were selected for hemostatic testing: 8 for the subject device and 8 for the predicate device. The model used was a pig. Provenance is not specified beyond the manufacturer being in China, implying the study was conducted there. The study is prospective in nature as it involves active testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For physical performance, sterile barrier packaging, sterilization, shelf life, and biocompatibility, the acceptance criteria are based on established international and national standards (e.g., ASTM, ISO, USP, DIN). The "ground truth" here is the adherence to these standard specifications demonstrated through validated test methods, rather than expert interpretation of data. No external experts are mentioned for establishing ground truth for these tests.
- For the animal study, the "ground truth" for hemostatic effectiveness is the measured outcome in the pig model. The document does not specify if external experts were used to establish the ground truth (e.g., blinded assessment of bleeding time/volume) or the qualifications of those who evaluated the results.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- No adjudication method is mentioned for any of the non-clinical tests or the animal study. Test results are reported directly against the specified standards or internal criteria.
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:
- No MRMC or human reader study was mentioned. This device is a passive hemostatic gauze, not an AI-assisted diagnostic or therapeutic device that would involve human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable as the device is a physical hemostatic gauze, not an algorithm. Performance testing (physical, biocompatibility, sterilization, and animal study) represents the "standalone" performance of the physical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Physical Performance, Sterile Barrier, Sterilization, Shelf-life: Ground truth is defined by published industry standards and specifications (e.g., ASTM, ISO, USP, DIN) and the results obtained from validated testing methods.
- Biocompatibility: Ground truth is established by the results of tests conducted according to ISO 10993 series and USP standards, indicating the absence of adverse biological responses.
- Animal Study: The ground truth for hemostatic efficacy is derived from direct observation and measurement of bleeding control in a live animal model (pig). This is a form of outcomes data within the controlled environment of an animal study.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set. The device is a physical product whose performance is evaluated through conventional non-clinical and pre-clinical testing.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.

Summary

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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

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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

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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

Enclosure

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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

1. Date of Preparation: 02/08/2022
1. 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

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Tingting Su (Alternative Contact Person)

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

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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

1. Identification of Predicate Device and Reference Device
  Predicate device: 510(k) number: K072474 Product Name: QuikClot® eXTM

Reference device: 510(k) number: K013390 Product Name: QuikClot

1. 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:
ASTM F1886/F1886M: 2016 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection;

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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 <85> Bacterial Endotoxins Test
USP <151> 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 <85>
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

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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.

1. Clinical Test Conclusion
  No clinical study is included in this submission.

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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	GauzeZeolite	GauzeClay 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,

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	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		Analysis3
Biocompatibility	No intracutaneousreactivity	Comply with ISO 10993standards requirements	Comply with ISO 10993standardsrequirements
	No Sensitization	Comply with ISO 10993 standards requirements
	No Acute SystemicToxicity

	No pyrogen
Sterilization	Co60 Radiationsterilization	Radiation sterilization	Unknown	Analysis4

SAL	10-6	10-6	Unknown
Label andLabeling	Conform with 21CFR Part801	Conform with 21CFRPart 801	Conform with21CFR 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.

1. 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.

Regulation Number and Section

N/A