(259 days)
Bios King Biocellulose Film is indicated as a topical dressing to manage pressure sores, diabetic ulcers, 1st to 2nd degree burns and skin donor sites.
Bios King Biocellulose Film is made of bacterial synthesized cellulose mesh with a selectively permeable structure allowing water evaporation, and thus provides a moist but not damp environment for wound healing. Bios King Biocellulose Film is resistible to the tensile force generated from the wound handing. It can adhere to wound beds without fixation devices.
The provided document is a 510(k) summary for the Bios King Biocellulose Film, a topical wound dressing. It details the device's characteristics and its substantial equivalence to predicate devices, focusing primarily on non-clinical tests.
However, the document does not contain information about a study proving the device meets acceptance criteria related to typical clinical performance metrics for AI/ML medical devices, such as sensitivity, specificity, or reader performance in diagnostic tasks. The "device performance" described here refers to physical and biological properties of the wound dressing, not diagnostic accuracy.
Therefore, many of the requested fields cannot be answered from the provided text as they pertain to clinical studies involving AI in diagnostics.
Here's the information that can be extracted or deduced from the document regarding the device's non-clinical performance and acceptance criteria:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Sterilization validation test (ISO 11137-1, -2: 2006) | Sterile to 10⁻⁶ SAL after 25kGy gamma radiation |
| Shelf-life test (ASTM F1980-02) | 5 years after manufacturing |
| Endotoxin test (USP <85>, USP <161>) | Lower than 20 EU/device; will not cause endotoxin hazard |
| Cytotoxicity test (ISO 10993-5:1999) | No cytotoxicity; will not cause cytotoxicity hazard |
| Intracutaneous reactivity test (ISO 10993-10: 2002, ISO 10993-12:2012) | No skin irritation; will not cause skin irritation hazard |
| Skin sensitization test (ISO 10993-10: 2010, ISO 10993-12:2012) | No skin sensitization; will not cause skin sensitization hazard |
| Heavy metal residue test (ICP-AES analysis) | Arsenic, cadmium, copper, mercury undetectable; lead < 5 ppm |
| Moisture vapor transmission rate (EN 13726-2 (2002), ASTM E96-95) | Over 800 g/m² x 24 hr; water vapor transmissible |
| Mechanical strength (Internal protocol of Taiwan Textile Research Institute) | Tensile strength > 1000 g/25 mm (tensile resistant) |
Regarding the Study (Non-clinical Tests):
The document describes several non-clinical tests conducted to validate the safety and efficacy of the Bios King Biocellulose Film. These are in-vitro or in-vivo animal/material tests, not human clinical trials for diagnostic performance.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for each individual test. The tests are general biocompatibility, physical property, and sterility tests, often requiring specific numbers of samples or subjects (e.g., animals for skin irritation) as per the referenced ISO or ASTM standards, but these numbers are not detailed in the summary.
- Data Provenance: The document does not specify the country of origin for the test data, though the submitting company is from Taiwan. The tests are non-clinical in nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. Ground truth in the context of expert consensus is not relevant for these types of non-clinical tests. Standards like ISO 10993 define methodologies and criteria for chemical, biological, and physical properties, often determined by laboratory analysis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically used in clinical studies for diagnostic accuracy, not for non-clinical material property or biocompatibility tests.
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
- Not applicable. This device is a topical wound dressing, not an AI/ML diagnostic algorithm. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical tests is established by the specific methodologies and quantifiable outcomes defined in the referenced international standards (e.g., ISO 11137 for sterility, ISO 10993 for biocompatibility, ASTM E96-95 for moisture vapor transmission). These typically involve laboratory analyses, physical measurements, and biological assays against defined thresholds.
8. The sample size for the training set
- Not applicable. This is not an AI/ML algorithm; there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. No training set exists.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a symbol of three stylized human profiles facing right. The profiles are stacked on top of each other, creating a sense of depth and unity. The seal is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 10, 2015
CoreLeader Biotech Company, Ltd. Dr. Ya-Wen Kuo Manager, Regulatory Affairs 19F, Building B, Number 100, Section 1, Xintai 5th Road, Xizhi District New Taipei City 22102 Taiwan
Re: K141382
Trade/Device Name: Bios King Biocellulose Film Regulatory Class: Unclassified Product Code: FRO Dated: January 14, 2015 Received: January 16, 2015
Dear Dr. Kuo:
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. 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 801); medical device reporting (reporting of medical
{1}------------------------------------------------
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use Statement
510(k) Number (if known): K141382
Device Name: Bios King Biocellulose Film
Indications for Use:
Bios King Biocellulose Film is indicated as a topical dressing to manage pressure sores, diabetic ulcers, 1st to 2nd degree burns and skin donor sites.
Prescription Use __X ___ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of _ 1 _
{3}------------------------------------------------
510(k) Summarv
| Submitted by: | CoreLeader Biotech Co., Ltd. |
|---|---|
| 19F, No. 100, Sec. 1, Xintai 5th Rd., Xizhi Dist., New Taipei City, | |
| Taiwan, R.O.C. 22102 | |
| Phone: +886-2-26968880 FAX: +886-2-26968882 | |
| Contact Person: | Ya-Wen Kuo |
| Date Prepared: | 2014/04/19 |
| Proprietary Name: | Bios King Biocellulose Film |
| Common Name: | Topical wound dressing |
| Classification: | Unclassified |
| Classification Name: | Dressing, Wound, Drug |
| Predicate Device: | 1. BioFill Biocellulose Dressing Sterile (The Purdue Frederick Co.)K950621 |
| 2. X-CELL Wound Dressing (Xylos Corporation): K974251 |
Device Description:
Bios King Biocellulose Film is made of bacterial synthesized cellulose mesh with a selectively permeable structure allowing water evaporation, and thus provides a moist but not damp environment for wound healing. Bios King Biocellulose Film is resistible to the tensile force generated from the wound handing. It can adhere to wound beds without fixation devices.
Indications for Use:
Bios King Biocellulose Film is indicated as a topical dressing to manage pressure sores, diabetic ulcers, 1st to 2nd degree burns and skin donor sites.
Technological Characteristics:
Bios King Biocellulose Film is made of biocellulose mesh synthesized by a gram-negative bacteria strain called acetobacter xylinum, which secrets a large quantity of organized and twisted cellulose microfibrils. The pores within the Bios King Biocellulose Film permit water vapor transportation. Bios King Biocellulose Film is removed of water content through lyophilization process. After that, it barely absorbs water. Bios King Biocellulose Film passes endotoxin test, skin irritation test and maximized skin sensitivity test following ISO 10993 protocols. Bios King Biocellulose Film biocellulose film encompasses tensile strength and readily conforms to irregular wound shapes.
Substantial equivalence:
The safety and efficacy of Bios King Biocellulose Film are substantially equivalent to the predicate devices, including BioFill Biocellulose Dressing Sterile (K950621) and X-CELL Wound
{4}------------------------------------------------
Chapter 5 510(k) Summery
Dressing (K974251) in the aspect of indications for use, materials, mode of action, sterility, biocompatibility, water vapor transmission, and directions to use.
- Indications for use: Similar to the predicate devices, Bios King Biocellulose Film is intended 1 to be used as a topical dressing to manage pressure sores, diabetic ulcers, 18 to 200 degree burns and skin donor sites.
- Mode of action: Similar to the predicate devices, the selectivity of substance transportation 2 though Bios King Biocellulose Film is determined by the fine pores within the film constructed by layers of biocellulose micro fibrils. The pores are small that they allow the entry of water vapor.
- ന Materials: Similar to the predicate devices, Bios King Biocellulose Film is made of biocellulose micro fibrils synthesized by a gram-negative bacteria strain called acetobacter xylinum. Biocellulose film is fabricated through a week of exclusive fermentation process and removed of endotoxcity origins through alkine treatment. The water within the biocellulose film is removed though lyophilization process.
4 Non-clinical tests
- 4.1 Sterility: Similar to the predicate devices, Bios King Biocellulose Film is sterilized to 10 ° SAL using gamma ray. The sterilization validation tests meet the criteria of ISO 11137-1, -2: 2006: Sterilization of health care product radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices; Part 2: Establishing the sterilization dose.
- 4.2 Shelf life: The shelf life of Bios King Biocellulose Film is 5 years when the product is stored at room temperature without sun light exposure. The shelf life is determined through the stability test using accelerated aging model.
- 4.3 Biocompatibility: Bios King Biocellulose Film is as biocompatible as the predicate devices.
- Endotoxin Test: The endotoxin level of Bios King Biocellulose Film is lower than 20 4.3.1 EU/device.
- Cytotoxicity: Bios King Biocellulose Film passes in vitro cytotoxicity test required in 4.3.2 ISO 10993-5.
- 4.3.3 Intracutaneous reactivity: Bios King Biocellulose Film passes the intracutaneous reactivity test required in ISO 10993-10.
- Skin sensitization: Bios King Biocellulose Film passes skin sensitization test required 4.3.4 in ISO 10993-10.
- 4.3.5 Heavy metal test: CoreLeader Bios King is free of heavy metal contamination, including arsentic, cadmium, copper, lead, and mercury.
ഗ Performance:
- 5.1 Moisture vapor transmission rate: Bios King Biocellulose Film is water vapor permeable. The moisture vapor transmission rate is greater than 800 g/m² x 24hr. The test follows protocols of ASTM E96-95: Standard Test Method for Water Vapor Transmission of Materials and EN 13726-2 (2002): Test methods for primary wound dressings-Part 2: Moisture vapor transmission rate of permeable film dressings
{5}------------------------------------------------
- 5.2 Mechanical strength: The tensile strength of Bios King Biocellulose Film larger than 1000 g/25mm.
The results and references of non-clinical tests of Bios King Biocellulose Film are listed in Table 1. According to the results of the aforementioned non-clinical tests, the substantial equivalences of Bios King Biocellulose Film to the predicate devices are summarized in Table 2
| Table 1. The list of non-clinical tests conducted to validate the safety and efficacy of Bios King | ||
|---|---|---|
| Biocellulose Film to achieve the indications as claimed. | ||
| Test | Conclusion | Guidance |
| Sterilizationvalidation test | Bios King Biocellulose Film is sterile to10-6 SAL after 25kGy gamma radiation. | ISO 11137-1, -2: 2006 |
| Shelf life test report | Bios King Biocellulose Film is expired 5years after manufacturing. | ASTM F1980-02 |
| Endotoxin test | Bios King Biocellulose Film will notcause endotoxin hazard as a skin wounddressing. | USP <85>USP <161> |
| Cytotoxicity test | Bios King Biocellulose Film will notcause cytotoxicity hazard as a skin wounddressing. | ISO 10993-5:1999 |
| Intracutaneousreactivity test | Bios King Biocellulose Film will notcause skin irritation hazard as a skinwound dressing. | ISO 10993-10: 2002.ISO 10993-12:2012. |
| Skin sensitizationtest | Bios King Biocellulose Film will notcause skin sensitization hazard as a skinwound dressing. | ISO 10993-10: 2010.ISO 10993-12:2012. |
| Heavy metal residuetest | The arsenic, cadmium, copper, mercuryare undetectable. The lead is lower than 5 ppm | ICP-AES analysis |
| Moisture vaportransmission test | Moisture vapor rate is over 800 g/m2 x 24 hr | EN 13726-2 (2002)ASTM E96-95 |
| Tensile strength | Bios King Biocellulose Film is tensileresistant with tensile strength larger than1000 g/25 mm. | Internal protocol of TaiwanTextile Research Institute |
Table 2. Substantial equivalence comparison with the predicate devices.
| Proposed device | Predicate device | ||
|---|---|---|---|
| CoreLeader Bios KingBiocellulose | X-CELL WoundDressing | BIOFILLBiocellulose DressingSterile |
{6}------------------------------------------------
| Indications | Bios King BiocelluloseFilm is intended to beused as a topicaldressing to managepressure sores, diabeticulcers, 1st to 2nd degreeburns and skin donorsites. | X-CELL WoundDressing is intendedto cover a wound orburn on a patient'sskin to absorb woundexudates, and protectagainst abrasion,friction, or externalcontamination. | Chronic wounds |
|---|---|---|---|
| Ingredient | Bacterial cellulose | Bacterial cellulose | Bacterial cellulose |
| Mode of action | Substancetransportation thoughBios King BiocelluloseFilm is determined bythe pore size ofcellulose dressing. | Substancetransportation isdetermined byinternal pore size ofdressing. | Substancetransportation isdetermined byinternal pore size ofdressing. |
| Sterilization | 25kGy gamma radiationto reach 10-6 SAL | Sterile | Sterile |
| Shelf life | 5 years | 3 years | 3 years |
| Endotoxin test | Lower than 20EU/device | pass | pass |
| In vitro cytotoxicitytest | No cytotoxicity | No cytotoxicity | No cytotoxicity |
| In vivo rabbit skinirritation test | No skin irritation | No skin irritation | No skin irritation |
| In vivo guinea pigskin sensitizationtest | No skin sensitization | No skin sensitization | No skin sensitization |
| Heavy metal test | No heavy metalcontamination | No heavy metalcontamination | No heavy metalcontamination |
| Moisture vaportransmission test | Moisture vaportransmissible | Yes | Yes |
N/A