(162 days)
Not Found
No
The device description and performance studies focus on the physical and biological properties of the zeolite and cotton material for hemostasis, with no mention of AI or ML technology.
Yes
The device is intended to control/stop bleeding from wounds, which directly treats a physiological condition (hemorrhage) and restores function (hemostasis).
No
The device, named "Zeolite Hemostatic Cotton," is intended for controlling and stopping bleeding from traumatic and superficial wounds. Its purpose is to physically manage bleeding, not to diagnose a condition or illness.
No
The device description clearly states that the device consists of "zeolite and cotton" and is provided in a "sterile dressing format," indicating it is a physical product, 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 "temporary external use to control traumatic bleeding" and "to stop bleeding of superficial wounds, minor cuts, and abrasions." This describes a device used directly on the body to treat a physical condition (bleeding).
- Device Description: The device is a "sterile dressing format that conforms readily to the wound." This is consistent with a topical hemostatic device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (on the body) to control bleeding.
N/A
Intended Use / Indications for Use
Prescription Use: Zeolite Hemostatic Cotton is intended for temporary external use to control traumatic bleeding.
Over-The-Counter Use: Zeolite Hemostatic Cotton is intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
The Zeolite Hemostatic Cotton consists of zeolite and cotton. It is provided in a sterile dressing format that conforms readily to the wound. There are 15 models of Zeolite Hemostatic Cotton, and the size ranges from 0.1g to 10g. The difference between each model is weight.
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 A Flexible Packaging by Visual Inspection
- A ASTM F88/F88M: 2021 Standard Test Method for Seal Strength of Flexible Barrier Materials
- ASTM F1980: 2021 Standard Guide for Accelerated Aging of Sterile Barrier Systems for A Medical Devices
-
ASTM F3039: 2015 Standard Test Method for Leakage of Nonporous Packaging or Flexible Barrier Materials by Dye Penetration
- A ASTM D3078:2002 (Reapproved 2021)e1 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
-
ISO 11737-2:2019 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- 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 Cytotoxicitv
- ISO 10993-10: 2021 Biological Evaluation of Medical Devices-Part 10: Tests for Skin A Sensitization
-
ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
-
ISO 10993-23: 2021 Biological evaluation of medical devices - Part 23: Tests for irritation
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 ≥10g, and the hydration temperature rise is ≤3.0℃. The Zeolite amount of the proposed device is not less than 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: 2016), seal strength (ASTM F88/F88M: 2021), dye penetration test (ASTM F3039: 2015), vacuum leak (ASTM D3078:2002 (Reapproved 2021)e1) and sterility (ISO 11737-2:2019 ). The test result showed that the device package can maintain its integrity during a shelf life of 3 years.
Sterilization and shelf-life testing: Endotoxin limit did not exceed 20EU/10g. Accelerated stability test results showed that the device can maintain its performance meet the acceptance criteria during a shelf life of 3 years.
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.
- A Cytotoxicity,
-
Sensitization,
-
Intracutaneous Reactivity,
-
Acute Systemic Toxicity,
-
Pyrogen 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.
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.
Not Found
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 2, 2023
Hangzhou Zeo-Innov Life Technology Co., Ltd Zhao Lijuan Chief Executive Officer 101, Building 2, No.291 Fucheng Road Hangzhou, Zhejiang 310018 China
Re: K223495
Trade/Device Name: Zeolite Hemostatic Cotton Regulatory Class: Unclassified Product Code: FRO Dated: March 31, 2023 Received: March 31, 2023
Dear Zhao Lijuan:
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
1
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 A. 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223495
Device Name Zeolite Hemostatic Cotton
Indications for Use (Describe)
Prescription Use: Zeolite Hemostatic Cotton is intended for temporary external use to control traumatic bleeding.
Over-The-Counter Use: Zeolite Hemostatic Cotton 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) |
|---|
| ☑ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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: K223495
1. Date of Preparation: 04/24/2023
2. Sponsor Identification
Hangzhou Zeo-Innov Life Technology Co., Ltd.
101, building 2, No.291, Fucheng Road, Hangzhou, 310018, China
Establishment Registration Number: 600558
Contact Person: Lijuan Zhao Position: Chief Executive Officer Tel: +86- 571-86651470 Fax: +86- 571-86651470 Email: zhaolj@zeo-innov.com
3. Identification of Proposed Device
Trade Name: Zeolite Hemostatic Cotton Common Name: Hemostatic Cotton
Regulatory Information Product code: FRO Classification Name: Dressing, Wound, Drug Classification: Unclassified;
Review Panel: General and Plastic Surgery
Indication for Use:
Prescription Use: Zeolite Hemostatic Cotton is intended for temporary external use to control traumatic bleeding.
Over-The-Counter Use: Zeolite Hemostatic Cotton is intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions.
Device Description
The Zeolite Hemostatic Cotton consists of zeolite and cotton. It is provided in a sterile dressing format that conforms readily to the wound. There are 15 models of Zeolite Hemostatic Cotton, and the size ranges from 0.1g to 10g. The difference between each model is weight.
4. Identification of Predicate Device
510(k) number: K211570 Product Name: Zeolite Hemostatic Gauze
4
5. 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 A Flexible Packaging by Visual Inspection
- A ASTM F88/F88M: 2021 Standard Test Method for Seal Strength of Flexible Barrier Materials
- ASTM F1980: 2021 Standard Guide for Accelerated Aging of Sterile Barrier Systems for A Medical Devices
-
ASTM F3039: 2015 Standard Test Method for Leakage of Nonporous Packaging or Flexible Barrier Materials by Dye Penetration
- A ASTM D3078:2002 (Reapproved 2021)e1 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
-
ISO 11737-2:2019 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- 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 Cytotoxicitv
- ISO 10993-10: 2021 Biological Evaluation of Medical Devices-Part 10: Tests for Skin A Sensitization
-
ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
-
ISO 10993-23: 2021 Biological evaluation of medical devices - Part 23: Tests for irritation
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 ≥10g, and the hydration temperature rise is ≤3.0℃. The Zeolite amount of the proposed device is not less than 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: 2016), seal strength (ASTM F88/F88M: 2021), dye penetration test (ASTM F3039: 2015), vacuum leak (ASTM D3078:2002 (Reapproved 2021)e1) and sterility (ISO 11737-2:2019 ). The test result showed that the device package can maintain its integrity during a shelf life of 3 years.
5
Sterilization and shelf-life testing listed in following table were performed on the proposed device. Endotoxin limit did not exceed 20EU/10g. Accelerated stability test results showed that the device can maintain its performance meet the acceptance criteria during a shelf life of 3 years.
| Bacteria Endotoxin Limit | USP |
|---|---|
| Shelf-Life Evaluation | Appearance, water absorption, Zeolite content, |
| heat release, and package integrity tests were | |
| performed on samples of after accelerated aging | |
| to verify the claimed shelf life of the 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.
- A Cytotoxicity,
-
Sensitization,
-
Intracutaneous Reactivity,
-
Acute Systemic Toxicity,
-
Pyrogen testing.
6. Clinical Test
No clinical study is included in this submission.
7. Substantially Equivalent (SE) Comparison
| Table 1 Comparison of Technology Characteristics | ||
|---|---|---|
| Item | Proposed Device | Predicate Device | Comparison |
|---|---|---|---|
| K223495 | K211570 | ||
| Product Code | FRO | FRO | Same |
| Class | Unclassified | Unclassified | Same |
| Indication for Use | Prescription Use: | ||
| Zeolite Hemostatic Cotton is | |||
| intended for temporary external | |||
| use to control traumatic bleeding. |
Over-The-Counter Use:
Zeolite Hemostatic Cotton is
intended for temporary external
use to stop bleeding of superficial | 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 | Same |
6
| | wounds, minor cuts, and
abrasions. | wounds, minor cuts, and
abrasions. | |
|------------|---------------------------------------|---------------------------------------|------------|
| Material | Cotton
Zeolite | Gauze
Zeolite | Analysis 1 |
| Single Use | Yes | Yes | Same |
| Size | | P-2cm×2cm-2, | Analysis 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, | |
| | 0.1g, | P-8cm×8cm-4, | |
| | 0.2g, | P-8cm×8cm-8, | |
| | 0.3g, | P-8cm×8cm-12, | |
| | 0.4g, | P-8cm×8cm-16, | |
| | 0.5g, | P-8cm×8cm-24, | |
| | 0.6g, | P-9cm×10cm-4, | |
| | 0.7g, | P-9cm×10cm-8, | |
| | 0.8g, | P-9cm×10cm-12, | |
| | 0.9g, | P-9cm×10cm-16, | |
| | 1.0g, | P-9cm×10cm-24, | |
| | 1.2g, | P-10cm×15cm-4, | |
| | 1.5g, | P-10cm×15cm-8, | |
| | 3g, | P-10cm×15cm-12, | |
| | 5g, | P-10cm×15cm-16, | |
| | 10g | 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, | |
7
| 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, |
| 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, |
8
| | | 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 | |
|------------------------------|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | Same |
| Pyrogen | No Pyrogen | No Pyrogen | Same |
| Sensitization | No Sensitization | No Sensitization | Same |
| Intracutaneous
Reactivity | No Intracutaneous Reactivity | No Intracutaneous Reactivity | Same |
| Acute Systemic
Toxicity | No Acute Systemic Toxicity | No Acute Systemic Toxicity | Same |
| Sterilization | Co60 Radiation sterilization | Co60 Radiation sterilization | Same |
| SAL | 10-6 | 10-6 | Same |
| Label and Labeling | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Same |
Analysis 1-Material
The hemostatic material of the proposed device is the predicate device. The proposed device materials are cotton and Zeolite, and the predicate device materials are gauze and Zeolite. The gauze is also composed of cotton fiber.
Analysis 2-Size
The configuration of the subject device and the predicate device are different in representation; the subject device is shown in mass, whereas the predicate device is shown based on length, width, and height. The mass of the subject device is similar to the predicate device, and the amount of Zeolite is the same, ≥10% by weight.
8. Substantially Equivalent Conclusion
The conclusion drawn from the non-clinical tests demonstrate that the proposed device in 510(k) submission, Zeolite Hemostatic Cotton, substantial equivalence to the device cleared under K211570, Zeolite Hemostatic Gauze.