(175 days)
Not Found
No
The device is a sterilization wrap, a passive material used for packaging. There is no mention of any computational or analytical capabilities that would involve AI/ML.
No.
The device is a sterilization wrap intended to enclose other medical devices for sterilization and maintain their sterility, not to provide a therapeutic effect on a patient.
No
The device is a sterilization wrap used to maintain sterility of other medical devices, not to diagnose a condition or disease.
No
The device description clearly states the device is made of "blue nonwoven Polypropylene fabric" and is a "sterilization wrap," indicating it is a physical product, not software.
Based on the provided text, the Dukal SMS sterilization wraps are not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Dukal SMS Sterilization Wrap's Intended Use: The intended use clearly states that the wraps are used to enclose another medical device for sterilization and to maintain sterility. They are not used to analyze human specimens.
- Device Description: The description details the material composition of the wraps, which is consistent with packaging materials, not diagnostic reagents or instruments.
The function of the Dukal SMS sterilization wraps is to facilitate the sterilization process of other medical devices and maintain their sterility, which falls under the category of sterilization packaging, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Dukal SMS sterilization wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using:
· In a steam sterilization pre-vacuum cycle at 270°F / 132°C for 4 minutes
o Models 100, 200 and 300 were validated for dry times of 20 minutes: models 400, 500 and 600 were validated for dry times of 30 minutes.
· In 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F / 55°C and 40-80% relative humidity for 60 minutes.
o The wrap was validated for aeration times for EO sterilization of 16 hours at 40.0 ℃.
Dukal SMS sterilization wraps are intended to allow sterilization of the enclosed medical device(s), and also to maintain sterility of the enclosed device(s) for 6 months or until opened. The devices are intended for over-the-counter use and are single use disposable sterilization wraps.
Test results validated that the Dukal SMS sterilization wraps allowed sterilization of the enclosed medical device(s) by ethylene oxide sterilization and by pre-vacuum cycles.
These models of the Dukal SMS sterilization wrap have been validated for use with the ethylene oxide and pre-vacuum cycles listed in below table:
Product codes (comma separated list FDA assigned to the subject device)
FRG
Device Description
Models 100, 200, 300, 400, 500 and 600
Available in one or two sheets of blue nonwoven Polypropylene fabric. Each sheet of fabric is composed of three thermally- bonded layers consisting of a Meltblown polypropylene layer surrounded by Spunbond polypropylene layers (SMS).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare provider
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)
Non-Clinical Test Results:
The subject sterilization wraps were tested and found conformance with the following standards:
- ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals
- ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests for in Vitro Cytotoxicity
- ISO 10993-10:2021 Biological Evaluation of Medical Devices-Part 10: Tests for Skin Sensitization
- ISO 10993-23: 2021 Biological Evaluation of Medical Devices-Part 23: Tests for Irritation
- ISO 6588-2:2021 Paper, board and pulps—Determination of pH of Aqueous Extracts—Part 2: Hot Extraction
- ASTM F1980: 2021- Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
- ISO 11607-1: 2019 Packaging for Terminally Sterilized Medical Devices Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems
- AAMI TIR12:2020 Designing, Testing, and Labeling Medical Devices Intended For Processing By Health Care Facilities: A Guide for Device Manufacturers
- ANSI/AAMI ST79:2017/(R)2022 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities
- ASTM D3776/D3776M-20 Standard Test Method for Mass Per Unit Area (Weight) of Fabric
- ASTM D1683/D1683M-22 Standard Test Method for Failure in Sewn Seams of Woven Fabrics
- ASTM D5034-21 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
- ASTM D5587-15(2019) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
- ASTM D257-14 (Reapproved 2021) Standard Test Methods for DC Resistance or Conductance of Insulating Materials
- ASTM D3786/D3786M-18 Standard Test Method for Bursting Strength of Textile Fabrics-Diaphragm Bursting Strength Tester Method
- ISO 9073-10:2003 Textiles-Test methods for nonwovens -Part 10 Lint and other particles generation in the dry state
- 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles
- AATCC TM193(2017) Test Method for Aqueous Liquid Repellency: Water/Alcohol Solution Resistance
- ASTM F2101-23 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- AATCC Test Method 127-2018 Water Resistance: Hydrostatic Pressure Test
- ASTM D737-18 Standard Test Method for Air Permeability of Textile Fabrics
- ASTM D4966-22 Standard Test Method for Abrasion Resistance of Textile Fabrics (Martindale Abrasion Tester Method)
- USP-NF 2022 Sterility test
- ASTM F1608-21 Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
Summary for Non-Clinical Testing:
Basis Weight: Meets requirement.
Seam Strength: ≥20N, Meets requirement.
Breaking Strength and Elongation: Breaking Strength MD≥45N, CD≥30N; Elongation MD≥20%, CD≥20%, Meets requirement.
Tearing Strength: MD≥10N, CD≥7N, Meets requirement.
Surface Resistance: ≤ 2*10^12 Ω, Meets requirement.
Bursting Strength: ≥80 kPa, Meets requirement.
Lint Generation: 1.0~4.0 (Log 10), Meets requirement.
Flammability: Class 1, Meets requirement.
Aqueous Liquid Repellency: Grade 3 or above, Meets requirement.
Bacterial Filtration Efficiency (BFE): ≥50%, Meets requirement.
Hydrostatic Pressure: ≥20 cmH2O, Meets requirement.
Air Permeability: ≥20 ft^3/min/ ft^2, Meets requirement.
Abrasion Resistance: Grade 3 or above, Meets requirement.
Sterilant penetration- BI incubation: BI result: Negative, Meets requirement.
Maintenance of Package Sterility- Sterility Test: No growth, Meets requirement.
Maintenance of Package Sterility- Microbial Aerosol Challenge: Average Spore Retained: ≥60%, Meets requirement.
Biocompatibility- Cytotoxicity, Irritation and Sensitization: Under the conditions of the study, the device did not show cytotoxicity potential. Under the conditions of the study, the irritation response category of the device was classified as Negligible. Under the conditions of the study, the device showed no significant evidence of causing delayed dermal contact sensitization. Meets requirement.
EO Sterilization Residual: Meet requirements of ISO 10993-7, Meets requirement.
pH Value: Non-Aged - Extract Appearance: Neither of the extracts shows blue color - pH: Meets acceptance criteria. Aged 30 days - Extract Appearance: Neither of the extracts shows blue color - pH: Meets acceptance criteria. Meets requirement.
Summary for Clinical Testing: Not Applicable
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.
Not Found
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
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 22, 2024
Dukal LLC Megan Quevedo Supervisor of Ouality and Regulatory Affairs 2 Fleetwood Court Ronkonkoma, New York 11779
Re: K233262
Trade/Device Name: Dukal SMS Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: February 23, 2024 Received: February 23, 2024
Dear Megan Quevedo:
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"
1
(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 OS 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.
Image /page/1/Picture/7 description: The image shows the text "Stephen A. Anisko -S" in a large, sans-serif font. The text is arranged in two lines, with "Stephen A." on the first line and "Anisko -S" on the second line. The text is black, and the background is white.
Digitally signed by Stephen A. Anisko -S Date: 2024.03.22 09:06:46 -04'00'
for Christopher Dugard Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices
2
OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233262
Device Name Dukal SMS Sterilization Wrap
Indications for Use (Describe)
The Dukal SMS sterilization wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using:
· In a steam sterilization pre-vacuum cycle at 270°F / 132°C for 4 minutes
o Models 100, 200 and 300 were validated for dry times of 20 minutes: models 400, 500 and 600 were validated for dry times of 30 minutes.
· In 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F / 55°C and 40-80% relative humidity for 60 minutes.
o The wrap was validated for aeration times for EO sterilization of 16 hours at 40.0 ℃.
Dukal SMS sterilization wraps are intended to allow sterilization of the enclosed medical device(s), and also to maintain sterility of the enclosed device(s) for 6 months or until opened. The devices are intended for over-the-counter use and are single use disposable sterilization wraps.
Test results validated that the Dukal SMS sterilization wraps allowed sterilization of the enclosed medical device(s) by ethylene oxide sterilization and by pre-vacuum cycles.
These models of the Dukal SMS sterilization wrap have been validated for use with the ethylene oxide and pre-vacuum cycles listed in below table:
| 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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4
Dukal SMS Sterilization Wrap Recommendations for Use with the Pre-Vacuum Steam or Ethylene Oxide¹
| Dukal SMS
Sterilization Wrap
Models | Intended Loads | Maximum Wrapped
Package Content
Weights Used in
Sterility Maintenance
Validation Study² | Descriptions of Loads
Used in Sterility
Maintenance Validation
Study² |
|-------------------------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model 100 | Very Light Weight Package
(for example: towel packs
or batteries) | 3 lbs. | Pre-Vacuum Steam and
EO:
20 huck towels (17"x26") |
| Model 200 | Light Weight Package (for
example: standard linen
packs or telescope with
light cord) | 6lbs. | Pre-Vacuum Steam and
EO:
2 huck towels (17"x26")
2 fluid resistant U-drapes
(68"x109")
1 fluid resistant universal
bar drape (70"x108") |
| Model 300 | Light to Moderate Weight
Package (for example:
general use medical
instruments) | 9 lbs. | Pre-Vacuum Steam:
15 huck towels (17"x26")
1 small fluid resistant
drape (60"x76")
5 lbs. of metal mass
EO:
16 huck towels
2 fluid resistant large
drapes (76"x 100")
1 fluid resistant small
drape (76"x60")
1 fluid resistant table
cover (60" x 90") |
| Model 4003 | Moderate to Heavy Weight
Package (for example:
general use medical
instruments) | 13 lbs. | Pre-Vacuum Steam and
EO:
4 tray liners 20"x25"
stacked
10"x10"x2 1/2" tray
containing 11 lbs. of
metal mass |
| Model 5003 | Heavyweight Package (for
example: general use
medical instruments) | 17 lbs. | Pre-Vacuum Steam and
EO:
4 tray liners 20"x25"
stacked
10"x10"x2 1/2" tray
containing 15 lbs. of
metal mass |
| Model 6003 | Very Heavy Weight
Package (for example:
general use medical
instruments) | 25 lbs. | Pre-Vacuum Steam and
EO: |
| | | | 4 tray liners 20"x25"
stacked
10"x10"x2 1/2" tray
containing 23 lbs. of
metal mass |
5
1 Individual results may differ due to factors such as variations in handling practices, wrapping techniques, and folding methods. Results may also differ due to the use of irregularly shaped contents, which may put added stress on the wrap. Each healthcare facility should determine for itself which wrap model is most appropriate for each intended use.
² It is recommended to not exceed the maximum wrapped package content weights indicated for each wrap model. Furthermore, it is recommended to not exceed the number, weight, and size of individual content types that were validated for the Sterilization Wraps (i.e.: the number and size of the fluid resistant linens or the weight of the metal mass).
3 The 400, 500 and 600 model wraps were validated for sterilant penetration with 3 lbs. of non-fluid resistant linen, and it is recommended to not exceed 3 lbs. of non-fluid resistant linen in sterilization cycles with these models. It is recommended that the user not include fluid-resistant linens in 400, 500 and 600 model wraps, as use of such fluid resistant materials has not been evaluated with these models.
Note: The loads used in each Sterility Validation Study corresponded to the maximum wrapped package content weights in above table.
Note: The trays used for the pre-vacuum studies were not the same as those used for the EO validation. Therefore, different amounts of metal mass were used in each study to achieve the maximum recommended wrapped package content weights for each wrap model.
6
K233262 510(k) SUMMARY 510(k) Premarket Notification for Dukal SMS Sterilization Wrap
| 1. Submitter: | Dukal LLC
2 Fleetwood Court
Ronkonkoma NY 11779
Phone: 631-656-3800
Fax: 631-656-3810 |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. FDA Registration Number: | 2435946 |
| 3. Regulatory Affairs Contact: | Megan Quevedo
Quality and Regulatory Affairs Supervisor
2 Fleetwood Court
Ronkonkoma NY 11779
Telephone Number: 631-656-3800 ext. 133
Fax Number: 631-656-3810 |
| 4. Date Summary Prepared: | February 22, 2024 |
| 5. Name of Device: | Dukal SMS Sterilization Wrap |
| 6. Trade Name: | Dukal SMS Sterilization Wrap |
| 7. Common/Classification Name: | Sterilization Wrap |
| 8. Regulation Number: | 21 CFR 880.6850 |
| 9. Device Class: | Class II |
| 10. Regulation Name: | Sterilization Wrap |
| 11. Product Code: | ERG |
12. Predicate Device:
- o Kimguard Sterilization wrap, models KC100, KC300, KC300, KC400, KC500 and KC600
- . K082554
- . Cleared: 05/01/2009
- Kimguard One-Step Sterilization Wrap
- K143053 .
- . Cleared: 04/03/2015
7
| 13. Device Description: | Models 100, 200, 300, 400, 500 and 600
Available in one or two sheets of blue nonwoven
Polypropylene fabric. Each sheet of fabric is composed
of three thermally- bonded layers consisting of a
Meltblown polypropylene layer surrounded by
Spunbond polypropylene layers (SMS). |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 14. Packaging: | The packaging material of the inner bag consists of
transparent polyethylene (PE). |
15. Indications for Use:
The Dukal SMS Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using:
- . In a steam sterilization pre-vacuum cycle at 270°F / 132°C for 4 minutes
- Models 100, 200 and 300 were validated for dry times of 20 minutes; models 400, 500 O and 600 were validated for dry times of 30 minutes.
- . In 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F / 55°C and 40-80% relative humidity for 60 minutes.
- o The wrap was validated for aeration times for EO sterilization of 16 hours at 40.0 °C.
Dukal SMS sterilization wraps are intended to allow sterilization of the enclosed medical device(s), and also to maintain sterility of the enclosed device(s) for 6 months or until opened. The devices are intended for over-the- counter use and are single use disposable sterilization wraps.
Test results validated that the Dukal SMS sterilization wraps allowed sterilization of the enclosed medical device(s) by ethylene oxide sterilization and by pre-vacuum cycles.
These models of the Dukal SMS sterilization wrap have been validated for use with the ethylene oxide and pre-vacuum cycles listed in below table:
Dukal SMS Sterilization Wrap Recommendations for Use with the Pre-Vacuum Steam or Ethylene Oxide¹
| Dukal SMS
Sterilization Wrap
Models | Intended Loads | Maximum Wrapped
Package Content
Weights Used in
Sterility Maintenance
Validation Study2 | Descriptions of Loads
Used in Sterility
Maintenance Validation
Study2 |
|-------------------------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model 100 | Very Light Weight Package
(for example: towel packs
or batteries) | 3 lbs. | Pre-Vacuum Steam and
EO:
20 huck towels (17"x26") |
| Model 200 | Light Weight Package (for
example: standard linen
packs or telescope with
light cord) | 6 lbs. | Pre-Vacuum Steam and
EO:
2 huck towels (17"x26") |
| | | | |
| Model 300 | Light to Moderate Weight
Package (for example:
general use medical
instruments) | 9 lbs. | 2 fluid resistant U-drapes
(68"x109")
1 fluid resistant universal
bar drape (70"x108")
Pre-Vacuum Steam:
15 huck towels (17"x26")
1 small fluid resistant
drape (60"x76")
5 lbs. of metal mass |
| | | | EO:
16 huck towels
2 fluid resistant large
drapes (76"x 100")
1 fluid resistant small
drape (76"x60")
1 fluid resistant table
cover (60" x 90") |
| Model 4003 | Moderate to Heavy Weight
Package (for example:
general use medical
instruments) | 13 lbs. | Pre-Vacuum Steam and
EO:
4 tray liners 20"x25"
stacked
10"x10"x2 1/2" tray
containing 11 lbs. of
metal mass |
| Model 5003 | Heavyweight Package (for
example: general use
medical instruments) | 17 lbs. | Pre-Vacuum Steam and
EO:
4 tray liners 20"x25"
stacked
10"x10"x2 1/2" tray
containing 15 lbs. of
metal mass |
| Model 6003 | Very Heavy Weight
Package (for example:
general use medical
instruments) | 25 lbs. | Pre-Vacuum Steam and
EO:
4 tray liners 20"x25"
stacked
10"x10"x2 1/2" tray
containing 23 lbs. of
metal mass |
8
¹ Individual results may differ due to factors such as variations in handling practices, wrapping techniques, and folding methods. Results may also differ due to the use of irregularly shaped contents, which may put added stress on the wrap. Each healthcare facility should determine for itself which wrap model is most appropriate for each intended use.
9
² It is recommended to not exceed the maximum wrapped package content weights indicated for each wrap model. Furthermore, it is recommended to not exceed the number, weight, and size of individual content types that were validated for the Sterilization Wraps (i.e.: the number and size of the fluid resistant linens or the weight of the metal mass).
3 The 400, 500 and 600 model wraps were validated for sterilant penetration with 3 lbs. of non-fluid resistant linen, and it is recommended to not exceed 3 lbs. of non-fluid resistant linen in sterilization cycles with these models. It is recommended that the user not include fluid-resistant linens in 400, 500 and 600 model wraps, as use of such fluid resistant materials has not been evaluated with these models.
Note: The loads used in each Sterility Validation Study corresponded to the maximum wrapped package content weights in above table.
Note: The trays used for the pre-vacuum studies were not the same as those used for the EO validation. Therefore, different amounts of metal mass were used in each study to achieve the maximum recommended wrapped package content weights for each wrap model.
16. Comparison of Technological Characteristics with the Predicate Devices:
| Element of
Comparison | Predicate Device-
K082554 Kimguard
Sterilization wrap | Predicate Device-
K143053 Kimguard
One-Step Sterilization
Wrap | Subject Device-Dukal SMS
Sterilization Wrap | Comparison | | until opened. The
wrap was validated
for aeration times for
EtO sterilization of 8
hours at 55°C or 12
hours at 43.3 °C. The
wrap was validated
for dry times of 20
minutes for Models
100, 200, and 300 and
for dry times of 30
minutes for models
400, 500, and 600.
KIMGUARD
Sterilization Wrap is
not indicated for use
for gravity steam
sterilization. | 55°C and 40-80%
relative humidity for
60 minutes. The wrap
was validated for
aeration times for EtO
sterilization of 8 hours
at 55˚C or 12 hours at
43.3°C for Models
KC100, and KC200.
KIMGUARD One-Step
Sterilization Wrap
(KC100, KC200) are
intended to allow
sterilization of the
enclosed medical
device(s), and also to
maintain sterility of
the enclosed device(s)
until opened.
Test results validated
that the KIMGUARD
One-Step Sterilization
Wraps (KC100,KC200)
allowed sterilization
of the enclosed
devices by ethylene
oxide sterilization and
by pre-vacuum cycles. | The wrap was validated
for aeration times for EO
sterilization of 16 hours at
40.0°C.
Dukal SMS sterilization
wraps are intended to
allow sterilization of the
enclosed medical
device(s), and also to
maintain sterility of the
enclosed device(s) until
opened. The devices are
intended for over-the-
counter use and are single
use disposable sterilization
wraps.
Test results validated that
the Dukal SMS sterilization
wraps allowed sterilization
of the enclosed medical
device(s) by ethylene
oxide sterilization and by
pre-vacuum cycles. | |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Indications
for Use | KIMGUARD
Sterilization Wrap is
intended to be used
to enclose another
medical device that is
to be sterilized by a
healthcare provider by
pre-vacuum steam at
270°F / 132°C for 4
minutes or by 100%
ethylene oxide (EtO)
with a concentration
of 725-735 mg/L at
131°F / 55°C and 40-
80% relative humidity
for 60 minutes. The
wrap is intended to
allow sterilization of
the enclosed medical
device(s), and also to
maintain sterility of
the enclosed device(s) | KIMGUARD One-Step
Sterilization Wrap
(KC100, KC200) are
intended to be used
to enclose another
medical device that is
to be sterilized by a
healthcare provider
using:
-Pre-vacuum steam at
270°F / 132°C for 4
minutes. The wrap
was validated for dry
times of 20 minutes
for Models KC100,
and KC200.
-100% ethylene oxide
(EO) with a
concentration of 725-
735 mg/L at 131°F / | The Dukal SMS sterilization
wraps are intended to be
used to enclose another
medical device that is to
be sterilized by a
healthcare provider using:
In a steam sterilization
pre-vacuum cycle at 270°F
/ 132°C for 4 minutes
-Models 100, 200 and 300
were validated for dry
times of 20 minutes;
models 400, 500 and 600
were validated for dry
times of 30 minutes
In 100% ethylene oxide
(EO) with a concentration
of 725-735 mg/L at 131°F/
55°C and 40-80% relative
humidity for 60 minutes. | Similar | Regulation,
Classification
, Product
Code | Regulation Number:
21 CFR 880.6850
Classification/Commo
n Name: Sterilization
Wrap
Regulatory Class: II
Product Code: FRG | Regulation Number:
21 CFR 880.6850
Classification/Commo
n Name: Sterilization
Wrap
Regulatory Class: II
Product Code: FRG | Regulation Number: 21
CFR 880.6850
Classification/Common
Name: Sterilization Wrap
Regulatory Class: II
Product Code: FRG | Same |
| Device
Design | Two sheets of
medium blue
nonwoven
Polypropylene fabric.
Each sheet of fabric
is composed of three
thermally- bonded
layers consisting of a
Meltblown | Two sheets of
medium blue
nonwoven
Polypropylene fabric.
Each sheet of fabric
is composed of three
thermally- bonded
layers consisting of a
Meltblown | Available in one or two
sheets of blue nonwoven
Polypropylene fabric. Each
sheet of fabric is
composed of three
thermally-bonded layers
consisting of a Meltblown
polypropylene layer
surrounded by Spunbond | Similar | | | | | |
10
11
| Method for
bonding
SMS layers | polypropylene layer
surrounded by
Spunbond
polypropylene layers
(SMS). | polypropylene layer
surrounded by
Spunbond
polypropylene layers
(SMS). | polypropylene layers
(SMS). | Similar |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| | Thermal bonding with
round pin, hexagonal,
triangle bond pattern
("daisy" pattern) | Thermal bonding with
round pin, hexagonal,
triangle bond pattern
("daisy" pattern) | Thermal bonding with line
of one square inch pattern | |
| Materials | Polypropylene with
blue and white
pigments and
antistatic treatment | Polypropylene with
blue and white
pigments and
antistatic treatment | Polypropylene and
polyethylene with blue
and violet pigments. | Similar |
| Models | 6 basis weights
models- Models
KC100, KC200, KC300,
KC400, KC500 and
KC600 | 2 basis weights
models- Models
KC100 and KC200.
KIMGUARD ONE-STEP
Sterilization Wrap is
comprised of two
sheets of KIMGUARD
Sterilization Wrap
ultrasonically seamed
on two edges. This
allows for convenient
wrapping with
two sheets
simultaneously. | 6 basis weights models-
Models 100, 200, 300, 400,
500 and 600
Dukal One-Step SMS
Sterilization Wrap is
comprised of two sheets
of Dukal SMS Sterilization
Wrap ultrasonically
seamed on two edges. This
allows for convenient
wrapping with two sheets
simultaneously. | Similar |
| Product
Color and
Sizes | Blue and white fabric,
9x9", 12x12", 15x15",
18x18", 20x20",
24x24", 30x30",
36x36", 40x40",
45x45", 48x48",
54x54", 54x72",
60x60" | Blue and white fabric,
9x9", 12x12", 15x15",
18x18", 20x20",
24x24", 30x30",
36x36", 40x40",
45x45", 48x48",
54x54", 54x72",
60x60" | Blue fabric, 9x9", 12x12",
15x15", 18x18", 20x20",
24x24", 30x30", 36x36",
40x40", 45x45", 48x48",
54x54", 54x72", 54x90",
60x60" | Similar |
| Prescription
vs OTC | OTC | OTC | OTC | Same |
| Single Use
vs. Reusable | Single use only | Single use only | Single use only | Same |
| Biocompatibi
lity | Applicable parts of ISO
10993 ">– Biological
evaluation of medical
devices | Applicable parts of
ISO 10993 – Biological
evaluation of medical
devices | Applicable parts of ISO
10993 – Biological
evaluation of medical
devices | Same |
| Maintenance
of
Package
Sterility | Real-time testing
following sterilization
using pre-vacuum
steam or Ethylene
Oxide supports
maintenance of
package sterility for
30 days. | Real-time testing
following sterilization
using
pre-vacuum steam or
Ethylene Oxide
supports maintenance
of package sterility for
365 days. | Accelerated aging testing
following sterilization
using pre-vacuum steam
or Ethylene Oxide supports
maintenance of package
sterility for 6 months. | Similar |
12
Comparison Summary of Non-Clinical Testing Results
| Test | Predicate Device-
K082554 Kimguard
Sterilization wrap | Predicate Device-
K143053 Kimguard
One-Step Sterilization
Wrap | Subject Device-
Dukal SMS
Sterilization Wrap | Comparison |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Material
Compatibility, ISO
11607) &
Premarket
Notification 510(k)
Submissions for
Medical Sterilization
Packaging Systems in
Health Care Facilities;
Draft Guidance for
Industry and FDA, -
- Basis weight,
ASTM
D3776/D3776M - Air permeability,
ASTM D737
Compatible - Material burst
strength, ASTM
D3786 - Grab Tensile
strength, ASTM
D5034 - Trapezoidal Tear
strength, ASTM
D5587 | Compatible | Compatible | Compatible | Same |
| - Hydrosta°c Pressure,
AATC127 | | | | |
| Sterilant Penetra on
(BI incubation) | BI result: Negative | BI result: Negative | BI result: Negative | Same |
| Maintenance of
Package Sterility
(ASTM F1608 & USP
) | No growth
Real-time testing
following
sterilization
using pre-vacuum
steam or Ethylene
Oxide supports
maintenance of
package sterility for
30 days. | No growth
Real-time testing
following sterilization
using
pre-vacuum steam or
Ethylene Oxide
supports maintenance
of package sterility for
365 days. | No growth
Accelerated aging
testing following
sterilization using
pre-vacuum steam
or Ethylene Oxide
supports
maintenance of
package sterility
for 6 months. | Similar |
| Biocompatibility-
Cytotoxicity (ISO 10993-
5), Irritation &
Sensitization (ISO
10993-10) | Under the
conditions of the
study, the device did
not show
cytotoxicity
potential.
Under the
conditions of the
study, the irritation
response category
of the device was
classified as
Negligible.
Under the
conditions of the
study, the device
showed no
significant evidence
of causing delayed
dermal contact
sensitization. | Under the conditions
of the study, the
device did not show
cytotoxicity potential.
Under the conditions
of the study, the
irritation response
category of the device
was classified as
Negligible.
Under the conditions
of the study, the
device showed no
significant evidence of
causing delayed
dermal contact
sensitization. | Under the
conditions of the
study, the device
did not show
cytotoxicity
potential.
Under the
conditions of the
study, the
irritation response
category of the
device was
classified as
Negligible.
Under the
conditions of the
study, the device
showed no
significant
evidence of
causing delayed
dermal contact
sensitization. | Same |
| EO Sterilization
Residual (ISO 10993-7) | Meet requirements
of ISO 10993-7 | Meet requirements of
ISO 10993-7 | Meet
requirements of
ISO 10993-7 | Same |
13
14
Non-Clinical Test Results:
The subject sterilization wraps were tested and found conformance with the following standards:
- ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals
- . ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests for in Vitro Cytotoxicity
- . ISO 10993-10:2021 Biological Evaluation of Medical Devices-Part 10: Tests for Skin Sensitization
- ISO 10993-23: 2021 Biological Evaluation of Medical Devices-Part 23: Tests for Irritation
- ISO 6588-2:2021 Paper, board and pulps—Determination of pH of Aqueous Extracts—Part 2: Hot Extraction
- . ASTM F1980: 2021- Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
- ISO 11607-1: 2019 Packaging for Terminally Sterilized Medical Devices Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems
- . AAMI TIR12:2020 Designing, Testing, and Labeling Medical Devices Intended For Processing By Health Care Facilities: A Guide for Device Manufacturers
- . ANSI/AAMI ST79:2017/(R)2022 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities
- ASTM D3776/D3776M-20 Standard Test Method for Mass Per Unit Area (Weight) of Fabric
- ASTM D1683/D1683M-22 Standard Test Method for Failure in Sewn Seams of Woven Fabrics
- . ASTM D5034-21 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
- ASTM D5587-15(2019) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
- . ASTM D257-14 (Reapproved 2021) Standard Test Methods for DC Resistance or Conductance of Insulating Materials
- . ASTM D3786/D3786M-18 Standard Test Method for Bursting Strength of Textile Fabrics-Diaphragm Bursting Strength Tester Method
- . ISO 9073-10:2003 Textiles-Test methods for nonwovens -Part 10 Lint and other particles generation in the dry state
- 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles
- . AATCC TM193(2017) Test Method for Aqueous Liquid Repellency: Water/Alcohol Solution Resistance
- . ASTM F2101-23 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- AATCC Test Method 127-2018 Water Resistance: Hydrostatic Pressure Test
- ASTM D737-18 Standard Test Method for Air Permeability of Textile Fabrics
- ASTM D4966-22 Standard Test Method for Abrasion Resistance of Textile Fabrics (Martindale Abrasion Tester Method)
15
- . USP-NF 2022 Sterility test
- . ASTM F1608-21 Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
Summary for Non-Clinical Testing:
| Test Item | Test
Standard
Methods | Test Requirements | Test Results of Subject
Device-Dukal SMS
Sterilization Wrap | Remark |
|------------------------------------------------------------------------|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Basis Weight | ASTM
D3776/
D3776M-20 | 100: 35gsm(±2gsm)
200: 45gsm (±2gsm)
300: 52gsm(±2gsm)
400: 60gsm(±2gsm)
500 70gsm(±2gsm)
600:75gsm(±2gsm) | 100: 35gsm(±2gsm)
200: 45gsm (±2gsm)
300: 52gsm(±2gsm)
400: 60gsm(±2gsm)
500 70gsm(±2gsm)
600:75gsm(±2gsm) | Meets
requirement |
| Seam Strength | ASTM
D1683/D168
3M-22 | ≥20N | ≥20N | Meets
requirement |
| Breaking Strength
and Elongation | ASTM D5034-
21 | Breaking Strength
MD≥45N
CD≥30N
Elongation
MD≥20%
CD≥20% | Breaking Strength
MD≥45N
CD≥30N
Elongation
MD≥20%
CD≥20% | Meets
requirement |
| Tearing Strength | ASTM D5587-
15(2019) | MD≥10N
CD≥7N | MD≥10N
CD≥7N | Meets
requirement |
| Surface Resistance | ASTM D257-
14
(Reapproved
2021) | ≤ 210^12 Ω | ≤ 210^12 Ω | Meets
requirement |
| Bursting Strength | ASTM
D3786/D378
6M-18 | ≥80 kPa | ≥80 kPa | Meets
requirement |
| Lint Generation | ISO 9073-
10:2003 | 1.04.04.0
(Log 10) | 1.0
(Log 10) | Meets
requirement |
| Flammability | 16 CFR Part
1610 | Class 1 | Class 1 | Meets
requirement |
| Aqueous Liquid
Repellency | AATCC
TM193(2017) | Grade 3 or above | Grade 3 or above | Meets
requirement |
| Bacterial Filtration
Efficiency (BFE) | ASTM F2101-
23 | ≥50% | ≥50% | Meets
requirement |
| Hydrostatic Pressure | AATCC Test
Method 127-
2018 | ≥20 cmH2O | ≥20 cmH2O | Meets
requirement |
| Air Permeability | ASTM D737-
18 | ≥20 ft^3/min/ ft^2 | ≥20 ft^3/min/ ft^2 | Meets
requirement |
| Abrasion Resistance | ASTM D4966-
22 | Grade 3 or above | Grade 3 or above | Meets
requirement |
| Sterilant penetra�on-
BI incubation | BI incubation | Bl result: Negative | BI result: Negative | Meets
requirement |
| Maintenance of
Package Sterility-
Sterility Test | USP-NF 2022
| No growth | No growth | Meets
requirement |
| Maintenance of
Package Sterility-
Microbial Aerosol
Challenge | ASTM F1608-
21 | Average Spore
Retained: ≥60% | Average Spore
Retained: ≥60% | Meets
requirement |
| Biocompatibility-
Cytotoxicity, Irritation
and Sensitization | ISO 10993-
5:2009, ISO
10993-23:
2021, ISO
10993-
10:2021 | Under the conditions
of the study, the
device did not show
cytotoxicity potential.
Under the conditions
of the study, the
irritation response
category of the device
was classified as
Negligible.
Under the conditions
of the study, the
device showed no
significant evidence of
causing delayed | Under the conditions of
the study, the device
did not show
cytotoxicity potential.
Under the conditions of
the study, the irritation
response category of
the device was
classified as Negligible.
Under the conditions of
the study, the device
showed no significant
evidence of causing
delayed dermal contact
sensitization. | Meets
requirement |
| | | dermal contact
sensitization. | | |
| EO Sterilization
Residual | ISO 10993-
7:2008 | Meet requirements of
ISO 10993-7 | Meet requirements of
ISO 10993-7 | Meets
requirement |
| pH Value | ISO 6588-
2:2021 | Non-Aged
- Extract
Appearance: Neither
of the extracts shows
blue color - pH: Meets
acceptance criteria
Aged 30 days
- Extract
Appearance: Neither
of the extracts shows
blue color - pH: Meets
acceptance criteria | Non-Aged - Extract
Appearance: Neither of
the extracts shows blue
color - pH: Meets acceptance
criteria
Aged 30 days
- Extract
Appearance: Neither of
the extracts shows blue
color - pH: Meets acceptance
criteria | Meets
requirement |
16
17
Summary for Clinical Testing: Not Applicable
Conclusions: The conclusion drawn from the 510(k) from the nonclinical tests shall demonstrate that the subject devices included in the 510(k) submission, Dukal SMS sterilization wraps, are as safe, as effective, and perform as well as or better than the legally marketed predicate device cleared under K082554 (Kimguard Sterilization wrap, models KC100, KC300, KC400, KC500 and KC600) and K143053 (Kimguard One-Step Sterilization Wrap).