(723 days)
The Maxiocel Chitosan Wound Dressing is indicated for the management of moderately to heavily exuding chronic and acute wounds and to provide a barrier against bacterial penetration. Under medical supervision, the Maxiocel Chitosan Wound Dressing may be used for the management of the following wounds: Pressure sores, Diabetic ulcers, Leg ulcers, Donor sites and graft sites, Surgical wounds, Skin abrasions and lacerations, 1st and 2nd degree burns, Trauma wounds. Over-the-counter use: The Maxiocel Chitosan Wound Dressing is indicated for the management of Minor cuts, Minor scalds and 1st-degree burns, Abrasions, Lacerations and to provide a barrier against bacterial penetration.
The Maxiocel Chitosan Wound Dressing is a soft, sterile, single-use absorbent gelling wound dressing used for absorption of wound exudate. The Maxiocel Chitosan Wound Dressing helps in maintaining a moist, optimal wound healing environment, helps in autolytic debridement, and is easy to remove. The Maxiocel Chitosan Wound Dressing is provided both in prescription (Rx) and over-the-counter (OTC) forms. The Maxiocel Chitosan Wound Dressing can be kept on the wound site for up to 7 days. Dressings are individually packed in moisture-proof pouches and terminally sterilized using gamma radiation to achieve a SAL 10t. The Maxiocel Chitosan Wound Dressing can be manufactured in different sizes and are currently available in the following sizes. 18" x 18" (45 cm x 45 cm), 8"x 12" (20 cm x 30cm), 6" x 6" (15 cm x 15 cm), 4" x 4" (10 cm x 10 cm), 2" x 4" (5 cm x 10 cm), 2"x 2" (5 cm x 5cm), 1"x2" (2.5 cm x 5cm), 1"x1" (2.5 cm x 2.5 cm), 1" x 12" (2.5 cm x 30 cm).
The provided text describes information about the Maxiocel Chitosan Wound Dressing, but does not contain information related to acceptance criteria, device performance in terms of specific metrics like sensitivity or specificity, or the methodology of a study proving such performance against acceptance criteria.
The document is a 510(k) summary for an FDA submission, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific clinical performance acceptance criteria using metrics typically associated with AI/algorithm performance (like sensitivity, specificity, or AUC).
Therefore, I cannot fulfill the request as it asks for information not present in the provided text, specifically:
- A table of acceptance criteria and the reported device performance: No such table or metrics are provided. The "performance data" section details bench tests, biocompatibility tests, and bacterial barrier tests, but these are not presented as acceptance criteria with numerical performance results against them.
- Sample sized used for the test set and the data provenance: Not mentioned, as it's not an AI/algorithm performance study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not mentioned for this type of device submission.
- Adjudication method: Not applicable/not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is a physical wound dressing, not an algorithm.
- The type of ground truth used: Not applicable/not mentioned in the context of AI/algorithm performance. The ground truth for the non-clinical tests is the established scientific methods and standards used for those specific tests.
- The sample size for the training set: Not applicable, as this is not an AI/algorithm.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/algorithm.
The document primarily focuses on:
- Biocompatibility testing: Passed, indicating non-cytotoxic, non-sensitizer, non-irritant, non-toxic, and compliant with bacterial endotoxin limits.
- Heavy metal testing: Met USP-232 limits.
- Bench performance testing: Mentioned tests like Appearance, Moisture Content, Absorbency, pH, Dispersion Test, Fluid Retention Test, and Tensile Strength. No specific numerical results or acceptance criteria are given for these, only that the "Subject Device performs as intended."
- Bacterial Barrier Testing: Demonstrated capacity to act as a barrier to bacterial penetration by showing "No bacterial growth was observed in the plates containing the Maxiocel Chitosan Wound Dressing" compared to control plates with cotton gauze that showed bacterial growth. The sample size was n=3 for test samples and n=3 for control samples.
- Sterilization and Packaging validation: Gamma radiation per ISO 11137-2, sterility assurance level (SAL) of 10^-6, and validated 3-year shelf life through real-time stability studies including seal strength, dye penetration, sterility, bacterial endotoxin, and bench performance tests.
In summary, the provided document does not contain the specific information requested about acceptance criteria and study details for an AI/algorithm-based device. It details non-clinical safety and performance testing for a wound dressing.
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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-USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
August 24, 2023
Advamedica Inc. % Alan Donald President Matrix Medical Consulting, INC. 8880 Rio San Diego Drive Suite 800 San Diego, California 92108
Re: K212766
Trade/Device Name: Maxiocel Chitosan Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: April 26, 2023 Received: April 27, 2023
Dear Alan Donald:
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
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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 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 (OS) 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@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Krause -S
David Krause, Ph.D. Deputy Director 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) K212766
Device Name Maxiocel Chitosan Wound Dressing
Indications for Use (Describe)
The Maxiocel Chitosan Wound Dressing is indicated for the management of moderately to heavily exuding chronic and acute wounds and to provide a barrier against bacterial penetration.
Under medical supervision, the Maxiocel Chitosan Wound Dressing may be used for the management of the following wounds:
- Pressure sores
- Diabetic ulcers
- Leg ulcers
- · Donor sites and graft sites
- · Surgical wounds
- · Skin abrasions and lacerations
- 1st and 2nd degree bums
- · Trauma wounds
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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SECTION 05 510(k) Summary
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510(k) SUMMARY
MAXIOCEL CHITOSAN WOUND DRESSING
1. ADMINISTRATIVE INFORMATION
| a. Date of preparation : | 07/08/2023 |
|---|---|
| b. Submitter : | Advamedica Inc. |
| Harvard Square, 1 Mifflin Place, | |
| Suite 400, Cambridge, | |
| Massachusetts 02138, USA. | |
| Phone: +1 973-718-7575 | |
| Fax: +1 888-584-8237 | |
| c. Contact Person : | Mr. Leo Mavely, |
| President, Advamedica Inc. | |
| Email: office@advamedica.com | |
| Web: www.advamedica.com | |
| d.Prepared By : | Mr. Leo Mavely, |
2. DEVICE NAME AND CLASSIFICATION
| a. Trade/ Proprietary Name | : | Maxiocel Chitosan Wound Dressing |
|---|---|---|
| b. Common Name | : | Wound dressing |
| c. Classification Name | : | Dressing, Wound, Drug, |
| d. Regulatory Class | : | Unclassified |
| e. Product code | : | FRO |
| f. Classification Panel | : | General and Plastic Surgery |
President, Advamedica, Inc.
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IDENTIFICATION OF PREDICATE DEVICE 3.
| Primary Predicate Device | Secondary Predicate Device | |
|---|---|---|
| Proprietary/Tradename | KA01 Chitosan WoundDressing | AQUANOVA Super-AbsorbentDressing |
| Manufacturer | Foshan United MedicalTechnologies LTD | Medtrade Products Ltd.Crewe Business ParkCrewe, Cheshire CWI 6GLUnited Kingdom |
| Decision Date | 26/01/2015 | 25/07/2007 |
| Classification Name | Unclassified | Unclassified |
| Device Class | Dressing, Wound, Drug | Dressing, Wound, Drug |
| Product Code | FRO | FRO |
| Panel | General & Plastic Surgery | General & Plastic Surgery |
| 510(k) Number | K143124 | K070175 |
Table.1-Predicate Device Details
4. IDENTIFICATION OF REFERENCE DEVICE
| Table 2: Reference device details | |||
|---|---|---|---|
| -- | ----------------------------------- | -- | -- |
| Reference Device | |
|---|---|
| Proprietary/Trade name | Axiostat Patch |
| Manufacturer | Advamedica Inc. |
| Decision Date | 15/04/2021 |
| Classification Name | Unclassified |
| Device Class | Unclassified |
| Product Code | FRO |
| Panel | General & Plastic Surgery |
| 510(k) Number | K202830 |
5. DEVICE DESCRIPTION
Advamedica Inc.
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The Maxiocel Chitosan Wound Dressing is a soft, sterile, single-use absorbent gelling wound dressing used for absorption of wound exudate. The Maxiocel Chitosan Wound Dressing helps in maintaining a moist, optimal wound healing environment, helps in autolytic debridement, and is easy to remove. The Maxiocel Chitosan Wound Dressing is provided both in prescription (Rx) and over-the-counter (OTC) forms.
The Maxiocel Chitosan Wound Dressing can be kept on the wound site for up to 7 days. Dressings are individually packed in moisture-proof pouches and terminally sterilized using gamma radiation to achieve a SAL 10t. The Maxiocel Chitosan Wound Dressing can be manufactured in different sizes and are currently available in the following sizes.
- 18" x 18" (45 cm x 45 cm)
- 8"x 12" (20 cm x 30cm) ●
- 6" x 6" (15 cm x 15 cm) ●
- . 4" x 4" (10 cm x 10 cm)
- 2" x 4" (5 cm x 10 cm) ●
- 2"x 2" (5 cm x 5cm)
- 1"x2" (2.5 cm x 5cm) ●
- 1"x1" (2.5 cm x 2.5 cm)
- 1" x 12" (2.5 cm x 30 cm)
INDICATIONS FOR USE 6.
6.1. Prescription Use
The Maxiocel Chitosan Wound Dressing is indicated for the management of moderately to heavily exuding chronic and acute wounds and to provide a barrier against bacterial penetration.
The Maxiocel Chitosan Wound Dressing can be used in the control of minor bleeding.
Under medical supervision, the Maxiocel Chitosan Wound Dressing may be used for the management of the following wounds:
- Pressure sores ●
- Diabetic ulcers ●
- Leg ulcers ●
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- . Donor sites and graft sites
- Surgical wounds ●
- Skin abrasions and lacerations ●
- 1st and 2nd degree partial thickness burns ●
- Trauma wounds
6.2. Over the Counter Use
The Maxiocel Chitosan Wound Dressing is indicated for the management of
- Minor cuts .
- Minor scalds and 1st-degree burns .
- Abrasions .
- Lacerations .
and to provide a barrier against bacterial penetration.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS OF SUBJECT AND 7. PREDICATE DEVICES
| Subject Device | Predicate Device 1 | Predicate Device 2 | Similarity | |
|---|---|---|---|---|
| Manufacturer | Advamedica Inc. | Foshan UnitedMedicalTechnologiesLTD | MedtradeProducts Ltd.Crewe BusinessParkCrewe, CheshireCW1 6GLUnited Kingdom | - |
| Model/TradeName | Maxiocel ChitosanWound Dressing | KA01 ChitosanWoundDressing | AQUANOVASuper-AbsorbentDressing | - |
| 510k Number | To be issued | K143124 | K070175 | - |
| Product Code | FRO | FRO | FRO | Same |
| CommonName | Wound Dressing | Wound Dressing | Wound Dressing | Same |
| Classification | Unclassified | Unclassified | Unclassified | Same |
| PrimaryMaterial | Chitosan | Chitosan | Chitosan | Same |
| Indicationsfor Use | Prescription use:The MaxiocelChitosan WoundDressing is indicatedfor the managementof moderately toheavily exudingchronic and acutewounds and toprovide a barrieragainst bacterialpenetration.The MaxiocelChitosan WoundDressing can be usedin the control ofminor bleeding. | Prescription use:The KA01Chitosan WoundDressing isindicated for themanagement ofmoderately toheavily exudingchronicwounds and acutewounds. | Prescription use:Under thesupervision of ahealthcareprofessionalAQUANOVAmay be used forwounds such asleg ulcers (StagesI - IV), diabeticulcers, surgicalwounds (post -operative, donorsites,dermatologicalburns (first andsecond degree),and themanagement of | Same. See Note 1 |
| Under medicalsupervision, theMaxiocel ChitosanWound Dressing maybe used for themanagement of thefollowing wounds:• Pressure sores• Diabeticulcers• Leg ulcers• Donor sitesand graft sites• Surgicalwounds• Skin abrasionsandlacerations• 1st and 2nddegree partialthicknessburns• Trauma | Under medicalsupervision, theKA01 ChitosanWound Dressingmay be used forthemanagement of:• Pressure sores• Diabetic ulcers• Leg ulcers• Donor sites andgraft sites• Surgicalwounds• Skin abrasionsandLacerations• 1st and2nd-degree burns• Trauma wounds | surgical ortraumatic woundswhich have beenleft to heal bysecondaryintention.AQUANOVAmay also be usedfor the localmanagement ofwounds that areprone to bleedingsuch as woundsthat have beensurgically ormechanicallydebrided, donorsites, andtraumaticwounds.AQUANOVA canbe used in thecontrol of minor | ||
| wounds | bleeding. | |||
| Over-the-counteruse:The MaxiocelChitosan WoundDressing is indicatedfor the managementof• Minor cuts• Minor scaldsand 1st degreeburns• Abrasions• Lacerationsand to provide abarrier againstbacterial penetration. | Over-the-counter use:The KA01Chitosan WoundDressing may beused for themanagement of:• Minor cuts• Minor scalds and1st-degree burns• Abrasions• Lacerations | Over-the-counter use:AQUANOVASuper-AbsorbentOTC is indicatedfor minor burns,superficial cuts,lacerations andabrasions, andminor irritationsof the skin. | ||
| AnatomicalSite | Surface wounds | Surface wounds | Surface wounds | Same |
| OTC | Yes | Yes | Yes | Yes |
| Prescription | Yes | Yes | Yes | Yes |
| Contactduration | The MaxiocelChitosanWound Dressing canremain on-site for upto 7 days, dependingon the level ofexudate. | The KA01Chitosan wounddressing canremain in situ forup to 7 days,dependingon the level ofexudate. | Not provided | Same. See Note 2 |
| Mechanism ofAction | Conformable, highlyabsorbent dressingthat forms a soft cleargel on contact withwound exudate whichmaintains a moistenvironment foroptimal woundhealing, provides | Conformable,highly absorbentdressing thatforms a soft cleargel on contactwith woundexudate whichmaintains a moistenvironment for | It is a soft padthat gels in thepresence of fluidsto absorb largequantities ofexudate andproduce a moistwound healingenvironment. | Same |
| patient comfort andallows painlessremoval. | optimal woundhealing providespatient comfortand allowspainless intactremoval. | |||
| Biocompatibility(ISO 10993) | Yes | Yes | Yes | Same. See Note 3 |
| Sterilization | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation | Same |
| Single-Use | Yes | Yes | Yes | Same |
| Shelf Life | 3 years | Not included | Not included | See Note 4 |
Table.3- Comparison of technological characteristics of Subject and Predicate devices
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Note 1:
Both the Maxiocel Chitosan Wound Dressing and the predicate devices form a gel when they contact the wound exudate, which maintains a moist environment for optimal wound healing.
Additionally, both the Maxiocel Chitosan Wound Dressing and the reference device form a gel when they contact the wound exudate, which provides a barrier against bacteria.
This difference in Subject Device holding an additional claim, however, does not raise questions on safety and effectiveness due to proven test results (Barrier to Bacteria Testing).
As a result, the addition of minor bleeding and barrier to bacterial claims in the Maxiocel Chitosan Wound Dressing do not raise any concerns about its safety and efficacy.
Note 2:
The contact duration of AQUANOVA Super-Absorbent Dressing is not provided in the 510(k) summary.
Note 3:
The biocompatibility testing of AQUANOVA Super-Absorbent Dressing is not provided in the 510(k) summary.
Note 4:
The shelf life of the KA01 and AQUANOVA Super-Absorbent Dressing is not provided in the 510(k) summary.
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8. PERFORMANCE DATA
The performance testing demonstrates that the Subject Device performs as intended under anticipated conditions of use. The Subject Device has been evaluated through a series of nonclinical studies to determine whether it meets the acceptance criteria for its intended applications. These tests are summarized below.
8.1. Biocompatibility testing
Biocompatibility tests have been performed per the requirements of ISO 10993-1:2018, under the section "Surface devices used on breached or compromised surfaces" with "limited contact duration (24 hours ≤ 30 days)". The following tests have been carried out as per these requirements.
| S.No. | Biocompatibility test | Standard followed | Outcome |
|---|---|---|---|
| 1 | Cytotoxicity | ISO 10993-5 | Non-cytotoxic |
| 2 | Skin Sensitization | ISO 10993-10 | Non-sensitizer |
| 3 | Skin irritation | ISO 10993-10 | Non-irritant |
| 4 | Acute Systemic Toxicity | ISO 10993-11 | Non-toxic |
| 5 | Bacterial Endotoxin Test | USP 85 & USP 161 | Complies |
Table.5- Summary of Biocompatibility Tests
8.2. Heavy metal testing
The Subject Device was tested for heavy metal contamination in the finished sterilized product, which met USP-232 limits [(232) ELEMENTAL IMPURITIES-LIMITS].
8.3. Bench performance testing
The Subject Device was evaluated through the following bench tests.
Table.6- Bench performance testing
| S. No | Test | Test Method |
|---|---|---|
| ------- | ------ | ------------- |
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| 1. | Appearance | In house protocol |
|---|---|---|
| 2. | Moisture Content | ASTM E 1868-10 |
| 3. | Absorbency | BS EN 13726-1:2002 |
| 4. | pH | BS EN 13726-1:2002 |
| 5. | Dispersion Test | BS EN 13726-1:2002 |
| 6. | Fluid Retention Test | BS EN 13726-1:2002 |
| 7. | Tensile strength | EN 29073-3 and ISO9073-18 |
9. BACTERIAL BARRIER TESTING
This study was performed to evaluate the barrier to bacteria property of the Maxiocel Chitosan Wound Dressing. In this test, the Maxiocel Chitosan Wound Dressing (n=3) was used as a test sample and a similarly-sized gauze (n=3) was used as a control samples were challenged with 106 cells of three gram-positive and three gram-negative bacterial species. After challenging for 24 hrs, the dressings were removed. Then the plates without the dressing were incubated to observe for the presence/absence of bacterial growth. The following organisms were used.
- Staphylococcus aureus (ATCC 29737) ●
- Staphylococcus epidermidis (ATCC 12228) ●
- Micrococcus luteus (ATCC 9341)
- Pseudomonas aeruginosa (ATCC 9027) ●
- Escherichia coli (ATCC 14169)
- Proteus mirabilis (ATCC 12453) .
No bacterial growth was observed in the plates containing the Maxiocel Chitosan Wound Dressing, whereas all plates containing cotton gauze showed bacterial growth. These results demonstrate the capacity of the Maxiocel Chitosan Wound Dressing to act as a barrier to bacterial penetration through the device
STERILIZATION AND PACKAGING 10.
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The Maxiocel Chitosan Wound Dressing is packed in a moisture-proof pack. The product is terminally sterilized using gamma radiation ensuring a sterility assurance level (SAL) of 10°. The dose of gamma radiation has been optimized and validated per ISO 11137-2.
Following gamma sterilization, the package integrity was subjected to sterile barrier testing to validate a shelf life of 3 years. The stability and effectiveness of packaging of the sterilized product during the shelf-life was confirmed by real-time (to support 3-year shelf life) stability studies.
The following tests were performed periodically in the validation of the 3-year shelf life.
- Seal strength test as per ASTM F88. .
- Dye penetration test as per ASTM F1929-15. .
- Sterility test as per US Pharmacopeia <71>.
- Bacterial Endotoxin Test as per US Pharmacopeia <85> and Medical devices Bacterial . Endotoxin and Pyrogen Tests as per USP <161>
- Bench performance tests to validate the shelf-life of the product. .
- i. Appearance
- ii. Moisture Content
- iii. Absorbency
- iv. pH Test
- Dispersion Test V.
- Fluid Retention vi.
- vii. Tensile Strength
11. CONCLUSION
The Maxiocel Chitosan Wound Dressing is substantially equivalent to the Predicate Devices with respect to intended use, indications for use, design, material, sterilization, and biocompatibility and the reference device in terms of barrier against bacterial penetration, material, sterilization and biocompatibility. The non-clinical testing data provided support the safety and performance of the device for the claimed indications for use statement. Hence the minor difference between the Subject and Predicate Device do not raise any different device safety or performance issues.
N/A