(337 days)
Not Found
No
The summary describes a physical hemostatic dressing and its performance in non-clinical and in vivo studies. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The device is described as a "hemostatic dressing for the external, temporary control of severely bleeding wounds," which indicates its use in treating a medical condition.
No
The device is described as a hemostatic dressing for controlling bleeding wounds, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "Hemostatic xerogel sponge," which is a physical dressing, not software. The performance studies also focus on physical and biological properties of the sponge and its packaging.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "a hemostatic dressing for the external, temporary control of severely bleeding wounds." This describes a device that is applied directly to a wound on the body to stop bleeding.
- Device Description: The description talks about a "sponge" and "dressing," which are physical devices used externally.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide diagnostic information. IVDs are used to diagnose diseases or conditions based on tests performed on these specimens.
The device described is a therapeutic device used for wound management, not a diagnostic device used for testing specimens.
N/A
Intended Use / Indications for Use
The Hemostatic Xerogel Sponge is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
Product codes
QSY, FRO
Device Description
The proposed device, Hemostatic xerogel sponge, is available in three models for different size.
The Hemostatic Xerogel Sponge is a irradiation sterilized, single used device, and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 2 years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
External wounds
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
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device.
Physical testing listed in following table were performed on the proposed device. The test results show that the device meets the requirements of related standards.
Item: Water Absorption
Brief description: The samples were placed in glass dishes, and purified water was slowly added to the surface of the samples. After the samples were completely gelated, they were stabilized for 5min. Pour the purified water spilled in the glass dish and weigh it. Calculate the hydroscopicity.
Purpose and objective: Test the subject device's absorbtion ability.
Acceptance criteria: The liquid absorption amount of each sample is not less than 20 times of the weight of the sample before liquid absorption.
Conclusions: The water absorption of Hemostatic Xerogel Sponge meets the acceptance criteria of this test item.
Item: Density Test
Brief description: Cut a piece of sample of a certain size, weigh it with an electronic balance and record it. After weighing it, measure its length, width and thickness with a vernier caliper, and calculate the density.
Purpose and objective: Test the subject device's density.
Acceptance criteria: Product density >= 0.2 g/ cm³ which is specified based on the product technique requirements
Conclusions: The density of Hemostatic Xerogel Sponge meets the acceptance criteria of this test item.
The package test methods include simulated distribution (ASTM D4169:2016) and associated package integrity testing (ASTM F88/F88-15 seal stength test and ASTM F1929-15 dye penetration test), as well as accelerated aging and associated package integrity testing, to validate package integrity and shelf life claims.
Sterilization testing listed in following table were performed on the proposed device. EO ECH residue did not exceed the limit of ISO 10993-7. Endotoxin limit did not exceed 20EU/device.
Item: EO residue, Standard: ISO 10993-7:2008
Item: ECH residue, Standard: ISO 10993-7:2008
Item: Bacteria Endotoxin Limit, Standard: USP
Animal Study
A new in vivo testing using swine femoral artery as a model is conducted one the subject device and predicate device to supports the indications for use of the subject device. The test results demonstrate that the subject device is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows 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, and the FDA logo is on the right. The FDA logo is in blue and includes the letters "FDA" and the words "U.S. Food & Drug Administration".
Solaplus Biotech Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai Shanghai, 200120 China
April 21, 2023
Re: K192671 Trade/Device Name: Hemostatic Xerogel Sponge 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 August 28, 2020. 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 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 ADMINISTRATION' in blue text.
August 28, 2020
Solaplus Biotech Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai Shanghai, 200120 Cn
Re: K192671
Trade/Device Name: Hemostatic Xerogel Sponge Regulatory Class: Unclassified Product Code: FRO Dated: July 29, 2020 Received: July 29, 2020
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 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
2
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 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(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Anjana Jain -S
Anjana Jain, Ph.D. Acting 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
Indications for Use
510(k) Number (if known) K192671
Device Name Hemostatic Xerogel Sponge
Indications for Use (Describe)
The Hemostatic Xerogel Sponge is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K192671
-
- Date of Preparation: 08/28/2020
-
- Sponsor Identification
Solaplus biotech co., ltd.
No.75 Feng Fang Road, Ouhai Economic Development Zone, Wenzhou, China Registration number: not registered yet
Contact Person: Xiangui Shen Position: General manager Tel: +86-0577-88597999 Fax: +86-0577-88597999 Email: 435121306@qq.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (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 Subject Device
Trade Name: Hemostatic Xerogel Sponge Common Name: Chitosan Wound Dressing Models: XLJ-I, XLJ-I-1 and XLJ-I-4
Regulatory Information
Classification Name: Dressing, Wound, Drug Classification: Unclassified Product Code: FRO Review Panel: General & Plastic Surgery
Indications for Use
The Hemostatic Xerogel Sponge is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
Device Description:
The proposed device, Hemostatic xerogel sponge, is available in three models for different size.
The Hemostatic Xerogel Sponge is a irradiation sterilized, single used device, and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 2 years.
న్. Identification of Predicate Device
Predicate Device 510(k) Number: K153582 Product Name: Prometheus ChitoGauze® XR PRO Manufacturer: HemCon Medical Technologies, Inc.
-
- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device.
- Non-Clinical Test Conclusion
Physical testing listed in following table were performed on the proposed device. The test results show that the device meets the requirements of related standards.
6
| Item | Water Absorption | Density Test |
|---|---|---|
| Brief description | The samples were placed in glass dishes, and purified water was slowly added to the surface of the samples. | |
| After the samples were completely gelated, they were stabilized for 5min. | ||
| Pour the purified water spilled in the glass dish and weigh it. Calculate the hydroscopicity. | Cut a piece of sample of a certain size, weigh it with an electronic balance and record it. After weighing it, measure its length, width and thickness with a vernier caliper, and calculate the density. | |
| Purpose and | ||
| objective | Test the subject device's absorbtion ability. | Test the subject device's density. |
| Acceptance criteria | The liquid absorption amount of each sample is not less than 20 times of the weight of the sample before liquid absorption. | Product density $\geq$ 0.2 g/ cm³ which is specified based on the product technique requirements |
| Conclusions | The water absorption of Hemostatic Xerogel Sponge meets the acceptance criteria of this test item. | The density of Hemostatic Xerogel Sponge meets the acceptance criteria of this test item. |
The package test methods include simulated distribution (ASTM D4169:2016) and associated package integrity testing (ASTM F88/F88-15 seal stength test and ASTM F1929-15 dye penetration test), as well as accelerated aging and associated package integrity testing, to validate package integrity and shelf life claims.
Sterilization testing listed in following table were performed on the proposed device. EO ECH residue did not exceed the limit of ISO 10993-7. Endotoxin limit did not exceed 20EU/device.
| Item | Standard |
|---|---|
| EO residue | ISO 10993-7:2008 |
| ECH residue | ISO 10993-7:2008 |
| Bacteria Endotoxin Limit | USP |
Animal Sutdy
A new in vivo testing using swine femoral artery as a model is conducted one the subject device and predicate device to supports the indications for use of the subject device. The test results demonstrate that the subject device is substantially equivalent to the predicate device.
7
7. Substantially Equivalent (SE) Comparison
| Item | Proposed Device | Predicate Device
K153582 | Remark |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Product Code | FRO | FRO | SE |
| Indication for
use | The Hemostatic Xerogel Sponge
is a hemostatic dressing for the
external, temporary control of
severely bleeding wounds. | Prometheus ChitoGauze ®
XP PRO is a hemostatic
dressing for the external,
temporary control
of
severely bleeding wounds. | SE |
| Models/ size | XLJ-I: 80×60x5mm
XLJ-I-1: 40×30×5mm
XLJ-I-4: 120×80×5mm | 4 inch by 4 inch
2 inch by 2 inch | SE
Analysis 1 |
| Product
structure/
Material | a porous sodium
polyacrylate-grafted chitosan
sponge | Polyester/rayon blend
non-woven gauze coated
with chitosan | SE
Analysis 2 |
| Single Use | Yes | Yes | SE |
| Biocompatibility | Breached or compromised
surface contact | Breached or compromised
surface contact | SE |
| | cytotoxicity,
sensitization,
irritation,
systemic toxicity,
material-mediated pyrogenicity | cytotoxicity,
sensitization,
irritation,
systemic toxicity | SE |
| Sterilization | Gamma irradiation | Gamma irradiation | SE |
| | 10-6 SAL | 10-6 SAL | SE |
| Labeling | complies with Title 21, CFR
Section 801 labeling | complies with Title 21, CFR
Section 801 labeling | SE |
| Table 1 Comparison of Technology Characteristic | |||
|---|---|---|---|
SE Analysis 1- Model/Size
The size of proposed device and predicate devices is different. The size will not affect the function and performance of the product. And the model of proposed device is listed in user manual, user can select appropriate model per requirement. Therefore, this difference is considered not to affect the Substantially Equivalency (SE) between the proposed and predicate device.
SE Analysis 2- Product structure/Material
The proposed device and predicate device have different product structure. The proposed device is a porous sponge, while the predicate device is a non-woven gauze. But they have the same main
8
material (chitosan) to control blood bleeding. In addition, biocompatibility test has been conducted on the propose device and the test result does not show any adverse effect. Based on above analysis, we think the difference on the Product structure/Material will not affect the Substantially Equivalency (SE) between the proposed and predicate device
- Substantially Equivalent (SE) Conclusion 8.
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.