(268 days)
No
The device description and performance studies focus on the material properties and biological compatibility of a collagen wound dressing. There is no mention of AI, ML, or any computational analysis of data.
Yes.
The device is applied to oral wounds and sores to manage and protect them, facilitating healing.
No
The device is a wound dressing designed for the management of oral wounds and sores, not for diagnosing medical conditions.
No
The device description clearly states it is a physical collagen wound dressing fabricated from bovine Achilles tendons, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of oral wounds and sores. This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a wound dressing made of collagen. It is applied directly to the wound to protect it. This is a physical barrier and healing aid, not a tool for analyzing biological samples.
- Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze any substances or characteristics in a biological sample (like blood, saliva, tissue, etc.) to provide diagnostic information.
- Performance Studies: The performance studies focus on biocompatibility, degradation, viral inactivation, and shelf life. These are relevant to a therapeutic device, not an IVD. IVD performance studies would typically involve metrics like sensitivity, specificity, accuracy, etc., related to the diagnostic capability.
In summary, the HealiAid® Dental Collagen Wound Dressing is a therapeutic device intended to aid in the healing of oral wounds, not a diagnostic device used to analyze biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
HealiAid® Dental Collagen Wound Dressing is indicated for the management of oral wounds and sores, including:
- Denture sores
- Oral ulcers (non-infected or viral)
- Periodontal surgical wounds
- Extraction sites
- Surgical wounds.
- Traumatic wounds
Product codes
OLR
Device Description
The subject device is HealiAid® Dental Collagen Wound Dressing (HealiAid Dental) that is a white, porous, pliable and absorbable collagen wound dressing. HealiAid Dental is fabricated by fibrous collagen matrix purified from bovine Achilles tendons. HealiAid Dental is pliable and can be applied easily to oral wounds to protect the wound bed. The product is supplied in a sterile, nonpyrogenic package, and is indicated for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral cavity
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 studies:
HealiAid Dental has been subjected to extensive pre-clinical testing to assess the biocompatibility of the device. Biocompatibility evaluations include cytotoxicity, genotoxicity, systemic toxicity, irritation, sensitization, implantation in accordance with ISO 10993-1: 2018. The results verified that HealiAid Dental comply with the corresponding requirements.
| Study | Test Method / Model | Results |
|---|---|---|
| Cytotoxicity | L929 MEM Elution, ISO 10993-5 | Non-cytotoxic. |
| Genotoxicity | Salmonella Typhimurium Reverse Mutation Assay Ames test, ISO 10993-3 | Non-genotoxic. |
| In Vitro Mammalian Cell Gene Mutation Test Using Mouse Lymphoma (L5178Y) Cells, ISO 10993-3 | Non-genotoxic. | |
| In Vivo Mammalian Erythrocyte Micronucleus Test, ISO 10993-3 | Non-genotoxic. | |
| Systemic toxicity | Acute systemic toxicity | Acute Systemic Toxicity Study in Mice, ISO 10993-11. No acute systemic toxicity. |
| Subchronic systemic toxicity | A Dual Route Subchronic Systemic Toxicity Study in Rats, ISO 10993-11. No subchronic systemic toxicity. | |
| Irritation | Intracutaneous reactivity in Rabbits, ISO 10993-23 | Non-irritant. |
| Sensitization | Guinea Pig Maximization, ISO 10993-10 | Non-sensitizing. |
| Implantation | Implantation Study in Porcine gingiva. ISO 10993-6 | Very slight or non-tissue reaction. |
| Material mediated pyrogenicity | Pyrogen Study in Rabbits, USP 151 | Non-pyrogenic |
The pre-clinical evaluations have demonstrated the substantial equivalence with the predicate device, including collagen content, carbohydrate analysis, in vitro/in vivo degradation test, pH value analysis, thermal stability analysis, microstructure analysis, moisture content analysis and water absorption measurement etc. In comparative testing in the porcine gingiva model, the subject device, HealiAid® Dental, exhibited a similar timecourse of degradation compared to the predicate device, neoTape®/neoPlug®/ neoCote®.
The validation of shelf life, sterilization, and devices containing animal-derived material, were also conducted in the following laboratory studies:
- Viral Inactivation. The control on sourcing and collection of bovine tendon and the viral clearance validation study was in compliance with the ISO 22442 standard series.
- Expiration dating / Three-year shelf life. Packaging for terminally sterilized medical devices via gamma irradiation and shelf life testing were conducted on device properties, including dimension, thermal stability (DSC), water absorption, moisture content, collagen content and sterility test. The three years of shelf life for product stability and packaging stability has been confirmed by real-time aging.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 22, 2023
Maxigen Biotech Inc. Cheng-Han Zhou Regulatory Affairs No.88, Keji 1st Rd., Guishan Dist. Taoyuan, 33383 TAIWAN
Re: K230529
Trade/Device Name: HealiAid ® Dental Collagen Wound Dressing Regulatory Class: Unclassified Product Code: OLR Dated: October 30, 2023 Received: October 31, 2023
Dear Cheng-Han Zhou:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/medical
2
devices/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,
Sherrill Lathrop Blitzer
for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K230529
Device Name HealiAid® Dental Collagen Wound Dressing
Indications for Use (Describe)
HealiAid® Dental Collagen Wound Dressing is indicated for the management of oral wounds and sores, including:
- Denture sores
-
- Oral ulcers (non-infected or viral)
-
- Periodontal surgical wounds
-
- Extraction sites
-
- Surgical wounds.
-
- Traumatic wounds
| 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)
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."
FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740
20th November, 2023
4
Image /page/4/Picture/0 description: The image shows the logo for Maxigen Biotech Inc. The logo consists of the letters "MBI" in bold, with the "I" being a red vertical line with a red dot on top. To the right of the letters are the Chinese characters for "Maxigen Biotech Inc." in blue. Below the Chinese characters is the English translation of the company name, also in blue.
510(k) Summary (K230529)
Date of revised: November 22, 2023
1 Submitter
Maxigen Biotech Inc. Name: No.88, Keji 18t Rd., Guishan Dist., Taoyuan City, Taiwan Address: Telephone: (03)328-7222 #1251 Fax: (03) 328-7333 Contact: Cheng-Han Zhou / RA
- 2 Device Name:
| Trade name: | HealiAid® Dental Dental Collagen Wound Dressing |
|---|---|
| Classification Name: | Oral Wound Dressing |
| Common Name: | Dental Collagen Wound Dressing |
| Product Code: | OLR |
| Regulation Number: | NA |
| Class: | Unclassified |
| Review Panel: | Dental |
- 3 Legally marketed to which substantial equivalence is claimed
Inc.
Predicate devices: neoTape/neoPlug/neoCote Collagen Dental Wound Dressing (K152600) marketed by Collagen Matrix Inc. Reference devices: SurgiAid/HealiAid® Dental Collagen Wound Dressing (K100927) marketed by Maxigen Biotech
Device Description 4
The subject device is HealiAid® Dental Collagen Wound Dressing (HealiAid Dental) that is a white, porous, pliable and absorbable collagen wound dressing. HealiAid Dental is fabricated by fibrous collagen matrix purified from bovine
5
Image /page/5/Picture/0 description: The image shows the logo for MBI Maxigen Biotech Inc. The logo has the letters "MBI" in bold, with the "M" in black, the "B" in red, and the "I" in black with a red line going through it. To the right of the letters is the company name in blue, written in both Chinese and English.
Achilles tendons. HealiAid Dental is pliable and can be applied easily to oral wounds to protect the wound bed. The product is supplied in a sterile, nonpyrogenic package, and is indicated for single use only.
5 Intended Use
HealiAid® Dental Collagen Wound Dressing is indicated for the management of oral wounds and sores, including:
- · Denture sores
- Oral ulcers (non-infected or viral)
- Periodontal surgical wounds
- Extraction sites
- Surgical wounds
- Traumatic wounds
- 6 Comparison of technical characteristics and substantial equivalence discussion
The following tables provide a summary of substantial equivalence between the subject device and predicate device, neoTape/neoPlug/neoCote Collagen Dental Wound Dressing (K152600) manufactured by Collagen Matrix Inc. Tthe technological characteristics of HealiAid Dental and neoTape/neoplug/neoCote are similar in terms of instruction for use, composition, collagen source, sterilization method, etc. HealiAid Dental exhibited substantially equivalent characteristics to the predicate device that do not raise significant concern about substantial equivalence.
HealiAid Dental applied in oral cavity is submitted to obtain the clearance for new indication from a previously FDA-cleared device, SurgiAid/HealiAid Collagen Wound Dressing (SurgiAid) (K100927) manufactured by Maxigen Biotech Inc. HealiAid Dental is identical to the SurgiAid in the composition, manufacturing process, sterilization, packaging materials and acceptance criteria of final inspections, geometry and technical characteristics.
6
Image /page/6/Picture/0 description: The image shows the logo for Maxigen Biotech Inc. The logo consists of the letters "MBI" in large, bold font, with the "M" in black, the "B" in red, and the "I" in black with a red vertical line running through it. To the right of "MBI" are the Chinese characters for "Maxigen Biotech Inc." in blue, followed by the English translation "Maxigen Biotech Inc." in blue.
Table 1. Comparison of Technical Characteristics.
| Subject Device | Predicate Device | Reference device | |
|---|---|---|---|
| Product | HealiAid® Dental | ||
| Collagen Wound Dressing | neoTape®/neoPlug®/ | ||
| neoCote® | |||
| Collagen Dental Wound | |||
| Dressing | SurgiAid® | ||
| Collagen Wound Dressing | |||
| Manufacturer | Maxigen Biotech Inc. | Collagen Matrix, Inc. | Maxigen Biotech Inc. |
| K number | K230529 | K152600 | K100927 |
| Classification | |||
| Product Code | OLR | KGN | KGN |
| Indications for Use | intended for the | ||
| management of wounds | |||
| including: |
- Denture sores
- Oral ulcers
(non-infected or viral) - Periodontal surgical
wounds - Extraction sites
- Surgical wounds
- Traumatic wounds | intended for the
management of wounds
including: - Denture sores
- Oral ulcers
(non-infected or viral) - Periodontal surgical
wounds - Suture sites
- Burns
- Extraction sites
- Surgical wounds
Traumatic wounds | intended for the
management of wounds
including: - Surgical wounds
- Donor/sites/grafts
podiatric wounds - Wound dehiscence
- Traumatic wounds
- Abrasions
- Lacerations
- Partial thickness burns
- Skin tears
Wounds with depth less
than 0.3 cm |
| Material | Purified collagen | Purified collagen | Purified collagen |
| Collagen source | Bovine | Bovine | Bovine |
| Form | Porous collagen sponge | Porous collagen sponge | Porous collagen sponge |
| Color | White to light-yellow | White to light-yellow | White to light-yellow |
| Shapes | Rectangular sheet and
plug type | Rectangular sheet and
plug type | Rectangular sheet and
plug type |
| Absorbency | Absorbs local wound
fluids upon application | Absorbs local wound
fluids upon application | Absorbs local wound
fluids upon application |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible |
| Pyrogenicity | Non-Pyrogenic | Non-Pyrogenic | Non-Pyrogenic |
| Sterilization | Gamma irradiation,
SAL 10-6 | Gamma irradiation,
SAL 10-6 | Gamma irradiation,
SAL 10-6 |
| Packaging | Sheet: double barrier
Plug: Single barrier
(Blister tray and Tyvek) | Single barrier
(Blister tray and Tyvek) | Sheet: double barrier
Plug: Single barrier
(Blister tray and Tyvek) |
| Storage | Subject device should be
stored at room
temperature. | Predicate device should be
stored at 15-30 °C. | Reference device should
be stored at room
temperature. |
| Single use / Reuse | Single use only. | Single use only. | Single use only. |
| Implantation duration
and timecourse of
degradation | It degrades within 30 days
and is implanted for a
maximum of 30 days in
oral cavity. | It degrades within 30 days
and is implanted for a
maximum of 30 days in
oral cavity. | Not applicable. |
7
Image /page/7/Picture/0 description: The image shows the logo for Maxigen Biotech Inc. The logo consists of the letters "MBI" in black and red, with the "i" in red and having a curved line extending from the top. To the right of the letters are the company's name in both Chinese and English. The Chinese characters are above the English name.
7 Performance data
- 7.1 Non-clinical studies
HealiAid Dental has been subjected to extensive pre-clinical testing to assess the biocompatibility of the device. Biocompatibility evaluations include cytotoxicity, genotoxicity, systemic toxicity, irritation, sensitization, implantation in accordance with ISO 10993-1: 2018. The results verified that HealiAid Dental comply with the corresponding requirements.
| Study | Test Method / Model | Results | |
|---|---|---|---|
| Cytotoxicity | L929 MEM Elution, | ||
| ISO 10993-5 | Non-cytotoxic. | ||
| Genotoxicity | Salmonella Typhimurium | ||
| Reverse Mutation Assay Ames | |||
| test, | |||
| ISO 10993-3 | Non-genotoxic. | ||
| In Vitro Mammalian Cell Gene | |||
| Mutation Test Using Mouse | |||
| Lymphoma (L5178Y) Cells, | |||
| ISO 10993-3 | Non-genotoxic. | ||
| In Vivo Mammalian | |||
| Erythrocyte Micronucleus Test, | |||
| ISO 10993-3 | Non-genotoxic. | ||
| Systemic | |||
| toxicity | Acute | ||
| systemic | |||
| toxicity | Acute Systemic Toxicity Study | ||
| in Mice, | |||
| ISO 10993-11 | No acute systemic | ||
| toxicity. | |||
| Subchronic | |||
| systemic | |||
| toxicity | A Dual Route Subchronic | ||
| Systemic Toxicity Study in | |||
| Rats, | |||
| ISO 10993-11 | No subchronic | ||
| systemic toxicity. | |||
| Irritation | Intracutaneous reactivity in | ||
| Rabbits, | |||
| ISO 10993-23 | Non-irritant. |
8
Image /page/8/Picture/0 description: The image shows the logo for Maxigen Biotech Inc. The logo consists of the letters "MBI" in black and red, with a red dot above the "i". To the right of the letters is the company's name in Chinese and English. The English name is "Maxigen Biotech Inc."
| Sensitization | Guinea Pig Maximazation,
ISO 10993-10 | Non-sensitizing. |
|--------------------------------------|----------------------------------------------------------|-----------------------------------------|
| Implantation | Implantation Study in Porcine
gingiva.
ISO 10993-6 | Very slight or non-
tissue reaction. |
| Material
mediated
pyrogenicity | Pyrogen Study in Rabbits, USP
151 | Non-pyrogenic |
The pre-clinical evaluations have demonstrated the substantial equivalence with the predicate device, including collagen content, carbohydrate analysis, in vitro/in vivo degradation test, pH value analysis, thermal stability analysis, microstructure analysis, moisture content analysis and water absorption measurement etc. In comparative testing in the porcine gingiva model, the subject device, HealiAid® Dental, exhibited a similar timecourse of degradation compared to the predicate device, neoTape®/neoPlug®/ neoCote®.
The validation of shelf life, sterilization, and devices containing animal-derived material, were also conducted in the following laboratory studies:
-
Viral Inactivation.
The control on sourcing and collection of bovine tendon and the viral clearance validation study was in compliance with the ISO 22442 standard series. -
Expiration dating / Three-year shelf life.
Packaging for terminally sterilized medical devices via gamma irradiation and shelf life testing were conducted on device properties, including dimension, thermal stability (DSC), water absorption, moisture content, collagen content and sterility test. The three years of shelf life for product stability and packaging stability has been confirmed by real-time aging. -
- Conclusion
HealiAid Dental is identical with the reference device in composition and manufacturing process, and is substantially equivalent to the predicate devices with respect to technical characteristics, biocompatibility and intended use.
- Conclusion
9
Image /page/9/Picture/0 description: The image shows the logo for Maxigen Biotech Inc. The logo consists of the letters "MBI" in large, bold font, with the "M" in black, the "B" in red, and the "I" in black with a red dot above it. To the right of "MBI" is the company name in Chinese characters, followed by "Maxigen Biotech Inc." in English.
Therefore, HealiAid Dental is substantially equivalent to the predicate devices and reference device.