(723 days)
No
The summary describes a physical wound dressing and its material properties and performance, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is indicated for the management of various wounds, including acute and chronic wounds, and helps in maintaining a moist, optimal wound healing environment. These functions directly contribute to the healing and treatment of injuries, thus classifying it as a therapeutic device.
No
Explanation: The Maxiocel Chitosan Wound Dressing is a treatment device, specifically a wound dressing, used for the management and healing of wounds. It does not provide diagnostic information or identify medical conditions.
No
The device description clearly states it is a physical wound dressing made of chitosan, a material, and describes its physical properties and packaging. There is no mention of software components.
Based on the provided information, the Maxiocel Chitosan Wound Dressing is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for the management of wounds by providing absorption of exudate and a bacterial barrier. This is a therapeutic function applied directly to the body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a physical wound dressing designed to absorb fluid and maintain a moist environment. This aligns with a medical device used for treatment, not for diagnosing a condition.
- Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze substances in a sample (like blood, urine, or tissue) to provide diagnostic information.
- Performance Studies: The performance studies focus on biocompatibility, physical properties (absorbency, tensile strength), and bacterial barrier function. These are relevant to the safety and efficacy of a wound dressing, not to the accuracy of a diagnostic test.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Maxiocel Chitosan Wound Dressing does not fit this definition.
N/A
Intended Use / Indications for 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.
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
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
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)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Surface wounds
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D), Over-The-Counter Use (21 CFR 801 Subpart C)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Biocompatibility testing: Tests performed per ISO 10993-1:2018 for "Surface devices used on breached or compromised surfaces" with "limited contact duration (24 hours ≤ 30 days)".
- Cytotoxicity (ISO 10993-5): Non-cytotoxic
- Skin Sensitization (ISO 10993-10): Non-sensitizer
- Skin irritation (ISO 10993-10): Non-irritant
- Acute Systemic Toxicity (ISO 10993-11): Non-toxic
- Bacterial Endotoxin Test (USP 85 & USP 161): Complies
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].
Bench performance testing:
- Appearance (In house protocol)
- Moisture Content (ASTM E 1868-10)
- Absorbency (BS EN 13726-1:2002)
- pH (BS EN 13726-1:2002)
- Dispersion Test (BS EN 13726-1:2002)
- Fluid Retention Test (BS EN 13726-1:2002)
- Tensile strength (EN 29073-3 and ISO 9073-18)
Bacterial Barrier Testing: This study was performed to evaluate the barrier to bacteria property of the Maxiocel Chitosan Wound Dressing. Maxiocel Chitosan Wound Dressing (n=3) as test sample and gauze (n=3) as control were challenged with 10^6 cells of three gram-positive (Staphylococcus aureus (ATCC 29737), Staphylococcus epidermidis (ATCC 12228), Micrococcus luteus (ATCC 9341)) and three gram-negative (Pseudomonas aeruginosa (ATCC 9027), Escherichia coli (ATCC 14169), Proteus mirabilis (ATCC 12453)) bacterial species for 24 hours.
- Results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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-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
1
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
2
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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3
SECTION 05 510(k) Summary
4
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.
5
IDENTIFICATION OF PREDICATE DEVICE 3.
| Primary Predicate Device | Secondary Predicate Device | |
|---|---|---|
| Proprietary/Trade | ||
| name | KA01 Chitosan Wound | |
| Dressing | AQUANOVA Super-Absorbent | |
| Dressing | ||
| Manufacturer | Foshan United Medical | |
| Technologies LTD | Medtrade Products Ltd. | |
| Crewe Business Park | ||
| Crewe, Cheshire CWI 6GL | ||
| United 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.
6
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 ●
7
- . 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 United | ||
| Medical | ||||
| Technologies | ||||
| LTD | Medtrade | |||
| Products Ltd. | ||||
| Crewe Business | ||||
| Park | ||||
| Crewe, Cheshire | ||||
| CW1 6GL | ||||
| United Kingdom | - | |||
| Model/Trade | ||||
| Name | Maxiocel Chitosan | |||
| Wound Dressing | KA01 Chitosan | |||
| Wound | ||||
| Dressing | AQUANOVA | |||
| Super-Absorbent | ||||
| Dressing | - | |||
| 510k Number | To be issued | K143124 | K070175 | - |
| Product Code | FRO | FRO | FRO | Same |
| Common | ||||
| Name | Wound Dressing | Wound Dressing | Wound Dressing | Same |
| Classification | Unclassified | Unclassified | Unclassified | Same |
| Primary | ||||
| Material | Chitosan | Chitosan | Chitosan | Same |
| Indications | ||||
| for Use | 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. | Prescription use: | |||
| The KA01 | ||||
| Chitosan Wound | ||||
| Dressing is | ||||
| indicated for the | ||||
| management of | ||||
| moderately to | ||||
| heavily exuding | ||||
| chronic | ||||
| wounds and acute | ||||
| wounds. | Prescription use: | |||
| Under the | ||||
| supervision of a | ||||
| healthcare | ||||
| professional | ||||
| AQUANOVA | ||||
| may be used for | ||||
| wounds such as | ||||
| leg ulcers (Stages | ||||
| I - IV), diabetic | ||||
| ulcers, surgical | ||||
| wounds (post - | ||||
| operative, donor | ||||
| sites, | ||||
| dermatological | ||||
| burns (first and | ||||
| second degree), | ||||
| and the | ||||
| management of | Same. See Note 1 | |||
| 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 partial | ||||
| thickness | ||||
| burns | ||||
| • Trauma | Under medical | |||
| supervision, the | ||||
| KA01 Chitosan | ||||
| Wound Dressing | ||||
| may be used for | ||||
| the | ||||
| management of: | ||||
| • Pressure sores | ||||
| • Diabetic ulcers | ||||
| • Leg ulcers | ||||
| • Donor sites and | ||||
| graft sites | ||||
| • Surgical | ||||
| wounds | ||||
| • Skin abrasions | ||||
| and | ||||
| Lacerations | ||||
| • 1st and | ||||
| 2nd-degree burns | ||||
| • Trauma wounds | surgical or | |||
| traumatic wounds | ||||
| which have been | ||||
| left to heal by | ||||
| secondary | ||||
| intention. | ||||
| AQUANOVA | ||||
| may also be used | ||||
| for the local | ||||
| management of | ||||
| wounds that are | ||||
| prone to bleeding | ||||
| such as wounds | ||||
| that have been | ||||
| surgically or | ||||
| mechanically | ||||
| debrided, donor | ||||
| sites, and | ||||
| traumatic | ||||
| wounds. | ||||
| AQUANOVA can | ||||
| be used in the | ||||
| control of minor | ||||
| wounds | bleeding. | |||
| 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. | Over-the-counte | |||
| r use: | ||||
| The KA01 | ||||
| Chitosan Wound | ||||
| Dressing may be | ||||
| used for the | ||||
| management of: | ||||
| • Minor cuts | ||||
| • Minor scalds and | ||||
| 1st-degree burns | ||||
| • Abrasions | ||||
| • Lacerations | Over-the-counte | |||
| r use: | ||||
| AQUANOVA | ||||
| Super-Absorbent | ||||
| OTC is indicated | ||||
| for minor burns, | ||||
| superficial cuts, | ||||
| lacerations and | ||||
| abrasions, and | ||||
| minor irritations | ||||
| of the skin. | ||||
| Anatomical | ||||
| Site | Surface wounds | Surface wounds | Surface wounds | Same |
| OTC | Yes | Yes | Yes | Yes |
| Prescription | Yes | Yes | Yes | Yes |
| Contact | ||||
| duration | The Maxiocel | |||
| Chitosan | ||||
| Wound Dressing can | ||||
| remain on-site for up | ||||
| to 7 days, depending | ||||
| on the level of | ||||
| exudate. | The KA01 | |||
| Chitosan wound | ||||
| dressing can | ||||
| remain in situ for | ||||
| up to 7 days, | ||||
| depending | ||||
| on the level of | ||||
| exudate. | Not provided | Same. See Note 2 | ||
| Mechanism of | ||||
| Action | Conformable, highly | |||
| absorbent dressing | ||||
| that forms a soft clear | ||||
| gel on contact with | ||||
| wound exudate which | ||||
| maintains a moist | ||||
| environment for | ||||
| optimal wound | ||||
| healing, provides | Conformable, | |||
| highly absorbent | ||||
| dressing that | ||||
| forms a soft clear | ||||
| gel on contact | ||||
| with wound | ||||
| exudate which | ||||
| maintains a moist | ||||
| environment for | It is a soft pad | |||
| that gels in the | ||||
| presence of fluids | ||||
| to absorb large | ||||
| quantities of | ||||
| exudate and | ||||
| produce a moist | ||||
| wound healing | ||||
| environment. | Same | |||
| patient comfort and | ||||
| allows painless | ||||
| removal. | optimal wound | |||
| healing provides | ||||
| patient comfort | ||||
| and allows | ||||
| painless intact | ||||
| removal. | ||||
| 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
8
9
10
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.
11
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 |
|---|---|---|
| ------- | ------ | ------------- |
12
| 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 ISO |
| 9073-18 |
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 .
- Bacterial Endotoxin Test as per US Pharmacopeia and Medical devices Bacterial . Endotoxin and Pyrogen Tests as per USP
- 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.