(337 days)
The Hemostatic Xerogel Sponge is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
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.
The document describes non-clinical performance data for the Hemostatic Xerogel Sponge to demonstrate substantial equivalence to a predicate device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Testing | ||
| Water Absorption | Not less than 20 times the weight of the sample before liquid absorption. | Meets the acceptance criteria. |
| Density | Product density ≥ 0.2 g/cm³ (specified based on product technique requirements) | Meets the acceptance criteria. |
| Package Integrity | (Implicitly meets criteria through successful testing for shelf-life claims) | |
| Simulated Distribution | Verified through ASTM D4169:2016 and associated integrity testing. | Successfully performed. |
| Package Integrity (Seal) | Verified through ASTM F88/F88-15 seal strength test. | Successfully performed. |
| Package Integrity (Dye) | Verified through ASTM F1929-15 dye penetration test. | Successfully performed. |
| Accelerated Aging | Verified through associated package integrity testing for shelf-life claims. | Successfully performed. |
| Sterilization Testing | ||
| EO Residue | Not to exceed the limit of ISO 10993-7. | Did not exceed the limit of ISO 10993-7. |
| ECH Residue | Not to exceed the limit of ISO 10993-7. | Did not exceed the limit of ISO 10993-7. |
| Endotoxin Limit | Not to exceed 20 EU/device (USP <85>). | Did not exceed 20 EU/device. |
| Animal Study (In Vivo) | Demonstrates substantial equivalence to the predicate device in hemostatic function. | Subject device demonstrated substantial equivalence to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- For physical testing (water absorption, density), the document does not specify the exact number of samples tested, only referring to "samples" and "each sample."
- For package integrity testing, the document does not specify the number of packages or tests performed.
- For sterilization testing (EO/ECH residue, endotoxin), the document does not specify the number of devices tested.
- For the animal study, the document does not explicitly state the number of animals used, only that "A new in vivo testing using swine femoral artery as a model is conducted."
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that the manufacturer is Solaplus Biotech Co., Ltd. located in Wenzhou, China, and the designated submission correspondent is Mid-Link Consulting Co., Ltd in Shanghai, China, it is reasonable to infer the studies were conducted in China, likely prospectively for the purpose of this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The studies described are non-clinical engineering and animal studies, not human clinical trials or expert-adjudicated performance evaluations in the context of diagnostic accuracy.
4. Adjudication Method for the Test Set
- This information is not applicable as the studies are non-clinical and do not involve human interpretation or adjudication for establishing ground truth.
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
- No, an MRMC comparative effectiveness study was not done. The device is a physical medical device (hemostatic sponge), not an AI diagnostic or assistive technology for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a physical medical device, not an algorithm.
7. The type of ground truth used
- For physical testing (water absorption, density): The ground truth is based on direct measurement against predefined quantitative physical property specifications.
- For package integrity testing: The ground truth is based on established engineering standards for package performance (e.g., seal strength, dye penetration).
- For sterilization testing: The ground truth is based on chemical residue limits (ISO 10993-7) and biological contamination limits (USP <85>).
- For the animal study: The ground truth for effectiveness is the direct observation of hemostasis in the swine femoral artery model, compared to the performance of the predicate device.
8. The sample size for the training set
- This information is not applicable. The document describes the performance of a physical device, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- This information is not applicable for the same reason as above.
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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
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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
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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 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
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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)
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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
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- 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
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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.
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- 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.
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| 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 andobjective | 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 <85> |
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.
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7. Substantially Equivalent (SE) Comparison
| Item | Proposed Device | Predicate DeviceK153582 | Remark |
|---|---|---|---|
| Product Code | FRO | FRO | SE |
| Indication foruse | The Hemostatic Xerogel Spongeis a hemostatic dressing for theexternal, temporary control ofseverely bleeding wounds. | Prometheus ChitoGauze ®XP PRO is a hemostaticdressing for the external,temporary controlofseverely bleeding wounds. | SE |
| Models/ size | XLJ-I: 80×60x5mmXLJ-I-1: 40×30×5mmXLJ-I-4: 120×80×5mm | 4 inch by 4 inch2 inch by 2 inch | SEAnalysis 1 |
| Productstructure/Material | a porous sodiumpolyacrylate-grafted chitosansponge | Polyester/rayon blendnon-woven gauze coatedwith chitosan | SEAnalysis 2 |
| Single Use | Yes | Yes | SE |
| Biocompatibility | Breached or compromisedsurface contact | Breached or compromisedsurface 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, CFRSection 801 labeling | complies with Title 21, CFRSection 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
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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.
N/A