(373 days)
SurgiAid® Collagen Wound Dressing is indicated for use in patients who have surgical wounds, donor sites/grafts, podiatric wound, wound dehiscence, traumatic wounds, abrasions, lacerations, partial thickness burns or skin tears. SurgiAid® Collagen Wound Dressing can be applied to wounds with depth less than 0.3 cm.
SurgiAid Collagen Wound Dressing (SurgiAid) is white, porous pliable and absorbable collagen wound dressing. It is fabricated by fibrous collagen matrix which is purified from bovine Achilles tendon. SurgiAid is pliable and can be applied easily to clean wound. The product is supplied in sterile, non-pyrogenic package, and is indicated for single use only.
The provided text describes a 510(k) submission for a medical device called "SurgiAid® Collagen Wound Dressing" (K223126). This submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than a de novo approval requiring extensive clinical efficacy studies. Therefore, the "study" described and the "acceptance criteria" are primarily related to non-clinical performance data and comparison to the predicate device.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document provides a comparison table (Table 1) between the subject device (K223126), the predicate device (K100927), and a reference device (K122325). The acceptance criteria are implied by the "Comparison" column, which states "Identical to Predicate Device" or similar, indicating that the subject device's performance should match that of the predicate. For specifications (dimensions), the acceptance is that the new sizes "fall within the size range of the reference device."
| Item / Acceptance Criteria | Reported Device Performance (Subject Device K223126) |
|---|---|
| Manufacturer (Identical to Predicate Device) | MAXIGEN BIOTECH INC. (Identical to Predicate Device) |
| Product Code (Identical) | KGN (Identical) |
| Classification name (Identical) | Collagen Wound Dressing (Identical) |
| Indications for use (Identical to Predicate Device) | SurgiAid® Collagen Wound Dressing is indicated for use in patients who have surgical wounds, donor sites/grafts, podiatric wound, wound dehiscence, traumatic wounds, abrasions, lacerations, partial thickness burns or skin tears. SurgiAid® Collagen Wound Dressing can be applied to wounds with depth less than 0.3 cm. (Identical to Predicate Device) |
| Materials (Identical to Predicate Device) | Bovine (Achilles) tendon type I collagen (Identical to Predicate Device) |
| Form (Identical) | Sheet (Identical) |
| Specifications (Dimensions) (New dimensions fall within the size range of the reference device) | 15mm x 20mm x 0.5mm20mm x 30mm x 0.5mm25mm x 30mm x 0.5mm30mm x 40mm x 0.5mm100mm x 100mm x 0.5mm20mm x 40mm x 3.0mm30mm x 30mm x 3.0mm40mm x 50mm x 3.0mm50mm x 50mm x 3.0mm100mm x 100mm x 3.0mm (These new dimensions are stated to fall within the size range of the reference device - SkinTemp II Dressing, which has sizes 2"x2", 3"x4", 8"x12") |
| Usage type (Identical) | Single use only (Identical) |
| Sterilization (Identical to Predicate Device) | By gamma irradiation (Identical to Predicate Device) |
| Design (Identical to Predicate Device) | White, porous, pliable, absorbable, sterile, non-pyrogenic package collagen wound dressing and it is indicated for single use only. (Identical to Predicate Device) |
| Biocompatibility (Identical) | All biocompatibility evaluations of SurgiAid were conforms to the requirements specified in ISO10993 (Identical to Predicate Device, all results acceptable based on non-clinical data section). |
| Shelf life (Identical to Predicate Device) | Three years (Identical to Predicate Device) |
| Sterile Barrier Packaging (Identical to Predicate Device) | Double blister tray as Sterile Barrier System (Identical to Predicate Device) |
| Storage condition (Identical to Predicate Device) | Store in a dry place below 25°C (Identical to Predicate Device) |
| Performance (Water absorption, Porosity, Density) (Identical to Predicate Device) | Water absorption (>25 fold); Porosity (>80%); Density (About 37 mg/cm³) (Identical to Predicate Device, confirmed in non-clinical data section that "All tests were met acceptance criteria in according with related standards.") |
The Study that Proves the Device Meets the Acceptance Criteria:
The "study" here is a series of non-clinical tests and a comparison to the predicate device to demonstrate substantial equivalence, rather than a clinical trial.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily discusses non-clinical performance and material characteristics.
- Sample size: The specific sample sizes for each non-clinical test (e.g., how many dressings were tested for water absorption, porosity, sterilization validation, etc.) are not explicitly provided in the summary.
- Data provenance: The document states the manufacturer is Maxigen Biotech Inc. in Taoyuan City, Taiwan. The non-clinical tests would have been conducted by or for this manufacturer. It does not specify whether these tests were performed in Taiwan or elsewhere. The data is "retrospective" in the sense that the new device's characteristics were compared to already established characteristics of the predicate and reference devices, and tested against established standards (ISO10993, etc.). These are typically laboratory tests, not patient data trials.
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)
This question is not applicable to this type of submission. The "ground truth" for non-clinical performance data (e.g., water absorption, porosity, biocompatibility) is established according to recognized international standards (e.g., ISO 10993 for biocompatibility) and validated laboratory methods. It does not involve expert consensus on medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are typically used in clinical trials involving subjective interpretation of data (like imaging studies where multiple readers agree/disagree on a finding). For non-clinical tests, results are typically quantitative and objective measurements against predefined criteria/standards.
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
This question is not applicable. An MRMC study is relevant for diagnostic devices, especially those incorporating AI, where human readers interpret medical images. This document describes a collagen wound dressing, which is a therapeutic device, and does not mention any AI component or diagnostic function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical wound dressing, not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests:
- Standards/Specifications: The "ground truth" for characteristics like water absorption, porosity, density, sterilization, packaging integrity, and biocompatibility is based on established international standards (e.g., ISO10993-1:2018) and predefined acceptance criteria derived from the predicate device's performance and general recognized medical device safety and efficacy principles.
- Predicate Device Data: The performance of the predicate device (K100927) serves as a key "ground truth" for comparison to establish substantial equivalence.
8. The sample size for the training set
This question is not applicable. There is no "training set" in the context of this 510(k) submission for a wound dressing. Training sets are used in machine learning for AI algorithms.
9. How the ground truth for the training set was established
This question is not applicable as there is no training set.
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October 11, 2023
Maxigen Biotech, Inc. Cheng-Han Chou Regulatory Affairs No. 88, Keji 1st Rd., Guishan District Taoyuan City, 333411 Taiwan
Re: K223126
Trade/Device Name: SurgiAid® Collagen Wound Dressing Regulatory Class: Unclassified Product Code: KGN Dated: July 12, 2023 Received: July 13, 2023
Dear Cheng-Han Chou:
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.
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).
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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/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@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Yu-chieh Chiu -S
Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive 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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Indications for Use
510(k) Number (if known) K223126
Device Name SurgiAid Collagen Wound Dressing
Indications for Use (Describe)
SurgiAid Collagen Wound Dressing is indicated for use in patients who have surgical wounds, donor sites/grafts, podiatric wound, wound dehiscence, traumatic wounds, abrasions, partial thickness burns or skin tears. SurgiAid Collagen Wound Dressing can be applied to wounds with depth less than 0.3 cm.
| 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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510(K) Summary (K223126)
Date of Summary revised: October 11, 2023
SUBMITTER TYPE INFORMATION : 1.
Name: Maxigen Biotech Inc. Address:No.88, Keji 1st Rd., Guishan Dist., Taoyuan City 333, Taiwan (R.O.C.) Phone:886-3-3287222 Fax:886-3-3287333 Contact:Cheng Han, Chou
2. DEVICE :
Name: SurgiAid Collagen Wound Dressing Common Name : Collagen Wound Dressing Classification Regulation/Class:Unclassified Product Code:KGN Panel:General & Plastic Surgery
PREDICATE DEVICE : 3.
Predicate device: SurgiAid Collagen Wound Dressing (K100927) Reference device: SkinTemp II Dressing (K122325)
4. DEVICE DESCRIPTION :
SurgiAid Collagen Wound Dressing (SurgiAid) is white, porous pliable and absorbable collagen wound dressing. It is fabricated by fibrous collagen matrix which is purified from bovine Achilles tendon. SurgiAid is pliable and can be applied easily to clean wound. The product is supplied in sterile, non-pyrogenic package, and is indicated for single use only.
INDICATIONS FOR USE : 5.
SurgiAid® Collagen Wound Dressing is indicated for use in patients who have surgical wounds, donor sites/grafts, podiatric wound, wound dehiscence, traumatic wounds, abrasions, lacerations, partial thickness burns or skin tears. SurgiAid® Collagen Wound Dressing can be applied to wounds with depth less than 0.3 cm.
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COMPARISION OF TECHNOLOGICAL CHARACTERISTICS 6.
The subject device has the same characteristics as the predicate device in terms of raw materials, nature of sterile barrier system as well as sealing process, sterilization method, shelf-life, indication for use, operation and thickness of device. The different is identified in dimension of device and addition of eight new size in this submission. Please refer to Table 1 for comparison of the subject device and predicate device. The introduction of new dimensions in SurgiAid does not affect the intended use, performance test and fundamental scientific technology of the device.
| Item | Subject Device | Predicate Device | Reference Device | Comparison |
|---|---|---|---|---|
| Manufacturer | MAXIGENBIOTECH INC. | MAXIGENBIOTECH INC. | HumanBiosciences,Inc. | Identical toPredicate Device |
| 510(k) No. | K223126 | K100927 | K122325 | N/A |
| Product Code | KGN | KGN | KGN | Identical |
| Classificationname | Collagen WoundDressing | Collagen WoundDressing | Collagen WoundDressing | Identical |
| Indications foruse | SurgiAid® CollagenWound Dressing isindicated for use inpatients who havesurgical wounds,donor sites/grafts,podiatric wound,wound dehiscence,traumatic wounds,abrasions, lacerations,partial thickness burnsor skin tears.SurgiAid® CollagenWound Dressing canbe applied to woundswith depth less than0.3 cm | SurgiAid® CollagenWound Dressing isindicated for use inpatients who havesurgical wounds,donor sites/grafts,podiatric wound,wound dehiscence,traumatic wounds,abrasions, lacerations,partial thickness burnsor skin tears.SurgiAid® CollagenWound Dressing canbe applied to woundswith depth less than0.3 cm | The HBSSkinTemp IIDressing isindicated for themanagement ofburns, sores,blisters, scrapes,ulcers, and otherwounds. | Identical toPredicate Device |
| Materials | Bovine (Achilles)tendon type I collagen | Bovine (Achilles)tendon type I collagen | Type I bovinecollagen | Identical toPredicate Device |
| Form | Sheet | Sheet | Sheet | Identical |
| Specifications | 15mm x 20mm x 0.5mm | 20mm x 40mm x 3.0mm | 2" x 2" | The sizes ofthe subjectdevicefall within thesizerange of thereference device |
| 20mm x 30mm x 0.5mm | 20mm x 30mm x 3.0mm | 3" x 4" | ||
| 25mm x 30mm x 0.5mm | 8" x 12" | |||
| 30mm x 40mm x 0.5mm | ||||
| 100mm x 100mm x 0.5mm | ||||
| 20mm x 40mm x 3.0mm | ||||
| 30mm x 30mm x 3.0mm | ||||
| 40mm x 50mm x 3.0mm | ||||
| 50mm x 50mm x 3.0mm | ||||
| 100mm x 100mm x 3.0mm | ||||
| Usage type | Single use only | Single use only | Single patients use | Identical |
| Sterilization | By gamma irradiation | By gamma irradiation | Each dressing issterilized usingElectron BeamSterilization | Identical toPredicate Device |
| Design | White, porous, pliable,absorbable, sterile,non-pyrogenicpackage collagenwound dressing and itis indicated for singleuse only. | White, porous, pliable,absorbable, sterile,non-pyrogenicpackage collagenwound dressing and itis indicated for singleuse only. | Soft, sterile,disposable,absorbent &confirmable singleuse wound dressingwith non-adherentbacking | Identical toPredicate Device |
| Biocompatibility | All biocompatibilityevaluations ofSurgiAid wereconforms to therequirements specifiedin ISO10993 | All biocompatibilityevaluations ofSurgiAid wereconforms to therequirements specifiedin ISO10993 | All testing wasperformed as perFDAbiocompatibilityguidance onISO10993 | Identical |
| Shelf life | Three years | Three years | Five years | Identical toPredicate Device |
| Sterile BarrierPackaging | Double blister tray asSterile Barrier System | Double blister tray asSterile Barrier System | It is packed inprimary packagingin the form of aTyvek pouch(1050B) and is then | Identical toPredicate Device |
| packed insecondary packingfor additionalprotection | ||||
| Storagecondition | Store in a dry placebelow 25°C | Store in a dry placebelow 25°C | Store in a cool anddry place | Identical toPredicate Device |
| Performance | ● Water absorption(>25 fold) | ● Water absorption(>25 fold) | NA | Identical toPredicate Devic |
| ● Porosity (>80%) | ● Porosity (>80%) | |||
| ● Density (About 37mg/cm³) | ● Density (About 37mg/cm³) |
Table 1. Substantial Equivalence Comparison of SurgiAid Collagen Wound Dressing of the predicate device.
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7. NON-CLINICAL PERFORMANCE DATA:
The subject device is technically identical to the predicate device regarding materials, indications for use, form, sterilization, packaging and storage conditions. The only difference is the addition of new dimension. Any potential new risks raised with the new dimension have been identified and addressed with verification and validation activities to ensure that substantial equivalence is still established in technological characteristics.
The following non-clinical performance test evaluation associated with physicochemical and microbial properties, biocompatibility, sterilization, packaging and stability were conducted on SurgiAid Collagen Wound Dressing (subject device). The subject device is comprised of the same materials and undergo the same manufacturing process as the predicate device but different in dimensions simply caused by physical cutting.
The Biocompatibility evaluations including cytotoxicity, genotoxicity, acute systemic toxicity, sub chronic systemic toxicity, irritation reactivity, sensitization and pyrogen for the subject device were in accordance with ISO10993-1:2018. All results were acceptable. Moreover, the evaluation of sterilization, product/packaging stability (packaging- burst test, creep test, seal strength, dye penetration and sterility) and product characteristics testing (dimension, bioburden, endotoxin, thermal characteristics, collagenase resistance heavy metal value, lipid, carbohydrate, pepsin resistance and pH) has been completed and these results were leveraged to demonstrate the substantial equivalence between the subject device and predicated device. All tests were met acceptance criteria in according with related standards.
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Conclusion 8.
SurgiAid Collagen Wound Dressing (subject device) has the same fundamental scientific technology and indications for use as the originally cleared SurgiAid (predicate device) in terms of product's designs, biocompatibility, raw material used, manufacturing process, primary composition, performance, packaging and sterilization method based on declaration of conformity to pre-established design control requirements and on a risk assessment of the changes to predicate device. The only modification for the subject device is the addition of new dimensions to the predicate device that is also derived from the same component material. Existing biocompatibility, sterilization validation and stability test performed on predicated device could be leveraged without affecting safety and efficacy of subject device. No additional new risk with respect to safety and efficacy of subject device is identified in the course of introduction of new dimensions. Consequently, SugiAid Collagen Wound Dressing (subject device) is substantially equivalent to the predicate SurgiAid cleared under K100927.
N/A