(268 days)
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
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.
The provided text describes the regulatory clearance (510(k)) for the HealiAid® Dental Collagen Wound Dressing. This is a medical device, not an AI/ML software device, and therefore the concepts of acceptance criteria for AI performance metrics (like sensitivity, specificity, AUC), sample size for test sets, ground truth establishment by experts, adjudication methods, MRMC studies, or training sets are not applicable here.
Instead, the acceptance criteria for this medical device are related to its physical and biological properties, and its performance in pre-clinical studies to demonstrate substantial equivalence to a legally marketed predicate device.
Here's a breakdown of the information provided, framed to address the prompt's categories where applicable for a medical device without AI/ML components:
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices like wound dressings, "acceptance criteria" are typically defined by demonstrating compliance with established standards (like ISO 10993 for biocompatibility) and exhibiting comparable performance to predicate devices in pre-clinical tests.
| Acceptance Criteria Category | Specific Test / Property | Reported Device Performance (HealiAid® Dental) |
|---|---|---|
| Biocompatibility | Cytotoxicity (ISO 10993-5) | Non-cytotoxic |
| Genotoxicity (Ames test, Mammalian Cell Gene Mutation, Micronucleus Test - ISO 10993-3) | Non-genotoxic | |
| Systemic Toxicity (Acute & Subchronic - ISO 10993-11) | No acute/subchronic systemic toxicity | |
| Irritation (Intracutaneous reactivity - ISO 10993-23) | Non-irritant | |
| Sensitization (Guinea Pig Maximization - ISO 10993-10) | Non-sensitizing | |
| Implantation (in porcine gingiva - ISO 10993-6) | Very slight or non-tissue reaction | |
| Material-mediated pyrogenicity (USP 151) | Non-pyrogenic | |
| Physical/Chemical Properties | Collagen content | Demonstrated substantial equivalence |
| Carbohydrate analysis | Demonstrated substantial equivalence | |
| pH value analysis | Demonstrated substantial equivalence | |
| Thermal stability analysis | Demonstrated substantial equivalence | |
| Microstructure analysis | Demonstrated substantial equivalence | |
| Moisture content analysis | Demonstrated substantial equivalence | |
| Water absorption measurement | Demonstrated substantial equivalence | |
| Degradation | In vitro/in vivo degradation test | Similar timecourse of degradation to predicate (within 30 days in oral cavity) |
| Sterility & Shelf Life | Sterilization (Gamma irradiation, SAL 10-6) | Confirmed by testing |
| Viral Inactivation (ISO 22442 series compliance) | Compliant with ISO 22442 | |
| Shelf life (3-year stability) | Confirmed by real-time aging |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Pre-clinical Studies): The document does not specify exact sample sizes for each pre-clinical test (e.g., number of animals for toxicity or implantation studies). These studies are typically conducted according to standardized protocols outlined in documents like ISO 10993, which define appropriate sample sizes for each test type.
- Data Provenance: The studies were pre-clinical (laboratory and animal studies) rather than human clinical trials. The bovine Achilles tendons are the source material.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This is not applicable as the "ground truth" for this type of device is established through standardized laboratory tests and animal models, adhering to recognized international standards (e.g., ISO 10993, USP 151, ISO 22442). These tests have defined endpoints and criteria, and their interpretation is generally performed by qualified laboratory personnel following strict protocols, rather than a consensus of human "experts" evaluating an outcome like an image.
4. Adjudication Method for the Test Set
- Not applicable. The pre-clinical tests have objective measurements and pass/fail criteria based on established standards, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- Not applicable. MRMC studies are specific to diagnostic devices (often imaging-based AI) where multiple human readers interpret cases, and their performance is compared with and without AI assistance. The HealiAid® Dental Collagen Wound Dressing is a therapeutic/wound management device, not a diagnostic one.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical wound dressing and does not involve an algorithm or AI functionality.
7. The Type of Ground Truth Used
- For the pre-clinical studies, the "ground truth" is established by the objective results of standardized biological and chemical tests (e.g., cell viability in cytotoxicity, presence/absence of mutagenic activity in genotoxicity, tissue reactions in implantation, absorption values, degradation rates). These are verifiable scientific outcomes, not interpretations of medical images or pathology.
8. The Sample Size for the Training Set
- Not applicable. This device does not use AI/ML and therefore does not have a "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable for the same reason as above.
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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.
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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
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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
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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)
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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
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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.
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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® DentalCollagen Wound Dressing | neoTape®/neoPlug®/neoCote®Collagen Dental WoundDressing | SurgiAid®Collagen Wound Dressing |
| Manufacturer | Maxigen Biotech Inc. | Collagen Matrix, Inc. | Maxigen Biotech Inc. |
| K number | K230529 | K152600 | K100927 |
| ClassificationProduct Code | OLR | KGN | KGN |
| Indications for Use | intended for themanagement of woundsincluding:1. Denture sores2. Oral ulcers(non-infected or viral)3. Periodontal surgicalwounds4. Extraction sites5. Surgical wounds6. Traumatic wounds | intended for themanagement of woundsincluding:1. Denture sores2. Oral ulcers(non-infected or viral)3. Periodontal surgicalwounds4. Suture sites5. Burns6. Extraction sites7. Surgical woundsTraumatic wounds | intended for themanagement of woundsincluding:1. Surgical wounds2. Donor/sites/graftspodiatric wounds3. Wound dehiscence4. Traumatic wounds5. Abrasions6. Lacerations7. Partial thickness burns8. Skin tearsWounds with depth lessthan 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 andplug type | Rectangular sheet andplug type | Rectangular sheet andplug type |
| Absorbency | Absorbs local woundfluids upon application | Absorbs local woundfluids upon application | Absorbs local woundfluids 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 barrierPlug: Single barrier(Blister tray and Tyvek) | Single barrier(Blister tray and Tyvek) | Sheet: double barrierPlug: Single barrier(Blister tray and Tyvek) |
| Storage | Subject device should bestored at roomtemperature. | Predicate device should bestored at 15-30 °C. | Reference device shouldbe stored at roomtemperature. |
| Single use / Reuse | Single use only. | Single use only. | Single use only. |
| Implantation durationand timecourse ofdegradation | It degrades within 30 daysand is implanted for amaximum of 30 days inoral cavity. | It degrades within 30 daysand is implanted for amaximum of 30 days inoral cavity. | Not applicable. |
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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 TyphimuriumReverse Mutation Assay Amestest,ISO 10993-3 | Non-genotoxic. | |
| In Vitro Mammalian Cell GeneMutation Test Using MouseLymphoma (L5178Y) Cells,ISO 10993-3 | Non-genotoxic. | ||
| In Vivo MammalianErythrocyte Micronucleus Test,ISO 10993-3 | Non-genotoxic. | ||
| Systemictoxicity | Acutesystemictoxicity | Acute Systemic Toxicity Studyin Mice,ISO 10993-11 | No acute systemictoxicity. |
| Subchronicsystemictoxicity | A Dual Route SubchronicSystemic Toxicity Study inRats,ISO 10993-11 | No subchronicsystemic toxicity. | |
| Irritation | Intracutaneous reactivity inRabbits,ISO 10993-23 | Non-irritant. |
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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 Porcinegingiva.ISO 10993-6 | Very slight or non-tissue reaction. |
| Materialmediatedpyrogenicity | Pyrogen Study in Rabbits, USP151 | 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
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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.
N/A