(175 days)
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:
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).
The provided document is a 510(k) Premarket Notification for a medical device, specifically Dukal SMS Sterilization Wrap. It details the device's technical characteristics, indications for use, and a comparison to predicate devices, along with non-clinical test results.
However, this document does not describe a study involving an AI/software device or human-in-the-loop performance. The "device" in this context is a physical sterilization wrap, not an AI or software algorithm. Therefore, many of the requested criteria related to AI/software performance, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are not applicable to this submission.
The acceptance criteria provided in the document are for the physical properties and performance of the sterilization wrap itself (e.g., burst strength, air permeability, sterility maintenance) and its biological compatibility. The "study that proves the device meets the acceptance criteria" refers to the non-clinical testing performed on the physical wrap.
Here's a breakdown based on the provided document, addressing the applicable criteria for a physical medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Test Standard Methods | Test Requirements | Reported Device Performance (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/D1683M-22 | ≥20N | ≥20N | Meets requirement |
| Breaking Strength and Elongation | ASTM D5034-21 | Breaking Strength MD≥45N, CD≥30NElongation MD≥20%, CD≥20% | Breaking Strength MD≥45N, CD≥30NElongation 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) | ≤ 2*10^12 Ω | ≤ 2*10^12 Ω | Meets requirement |
| Bursting Strength | ASTM D3786/D3786M-18 | ≥80 kPa | ≥80 kPa | Meets requirement |
| Lint Generation | ISO 9073-10:2003 | 1.0~4.0 (Log 10) | 1.0~4.0 (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 penetration - BI incubation | BI incubation | BI result: Negative | BI result: Negative | Meets requirement |
| Maintenance of Package Sterility - Sterility Test | USP-NF 2022 <71> | 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 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. | Meets requirement |
| 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 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state sample sizes for each specific test. However, it references numerous ASTM, ISO, AATCC, and USP standards for non-clinical testing. These standards typically define the number of samples required for robust testing. For example, specific test procedures for tensile strength or burst strength would involve testing a statistically relevant number of samples.
- Data Provenance: The document does not specify the country of origin of the data. The tests are "non-clinical," implying laboratory testing of the material. There is no indication of retrospective or prospective data as this refers to patient data collection, which is irrelevant for a physical device like a sterilization wrap.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physical product (sterilization wrap), not an AI/software. Ground truth is established by objective physical and chemical testing methods as per international standards, not by human expert interpretation of images or clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication of human interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/software device, so MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this physical device, the "ground truth" is defined by the validated and established performance requirements outlined in the referenced national and international standards (e.g., ASTM, ISO, AATCC, USP). These standards define the quantitative and qualitative criteria for material properties, sterilization efficacy, and biocompatibility. For example:
- Sterilant Penetration/Sterility Maintenance: Demonstrated by "BI result: Negative" (Biological Indicator) and "No growth" in sterility tests, which are objective microbiological tests.
- Material Properties: Measured objectively (e.g., in grams per square meter for basis weight, Pascals for bursting strength, Newtons for tearing strength).
- Biocompatibility: Determined by laboratory tests for cytotoxicity, irritation, and sensitization against established biological thresholds.
8. The sample size for the training set
Not applicable. This is not an AI/software device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/software device requiring a training set or ground truth for training.
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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"
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(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
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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) 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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Dukal SMS Sterilization Wrap Recommendations for Use with the Pre-Vacuum Steam or Ethylene Oxide¹
| Dukal SMSSterilization WrapModels | Intended Loads | Maximum WrappedPackage ContentWeights Used inSterility MaintenanceValidation Study² | Descriptions of LoadsUsed in SterilityMaintenance ValidationStudy² |
|---|---|---|---|
| Model 100 | Very Light Weight Package(for example: towel packsor batteries) | 3 lbs. | Pre-Vacuum Steam andEO:20 huck towels (17"x26") |
| Model 200 | Light Weight Package (forexample: standard linenpacks or telescope withlight cord) | 6lbs. | Pre-Vacuum Steam andEO:2 huck towels (17"x26")2 fluid resistant U-drapes(68"x109")1 fluid resistant universalbar drape (70"x108") |
| Model 300 | Light to Moderate WeightPackage (for example:general use medicalinstruments) | 9 lbs. | Pre-Vacuum Steam:15 huck towels (17"x26")1 small fluid resistantdrape (60"x76")5 lbs. of metal massEO:16 huck towels2 fluid resistant largedrapes (76"x 100")1 fluid resistant smalldrape (76"x60")1 fluid resistant tablecover (60" x 90") |
| Model 4003 | Moderate to Heavy WeightPackage (for example:general use medicalinstruments) | 13 lbs. | Pre-Vacuum Steam andEO:4 tray liners 20"x25"stacked10"x10"x2 1/2" traycontaining 11 lbs. ofmetal mass |
| Model 5003 | Heavyweight Package (forexample: general usemedical instruments) | 17 lbs. | Pre-Vacuum Steam andEO:4 tray liners 20"x25"stacked10"x10"x2 1/2" traycontaining 15 lbs. ofmetal mass |
| Model 6003 | Very Heavy WeightPackage (for example:general use medicalinstruments) | 25 lbs. | Pre-Vacuum Steam andEO: |
| 4 tray liners 20"x25"stacked10"x10"x2 1/2" traycontaining 23 lbs. ofmetal mass |
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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.
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K233262 510(k) SUMMARY 510(k) Premarket Notification for Dukal SMS Sterilization Wrap
| 1. Submitter: | Dukal LLC2 Fleetwood CourtRonkonkoma NY 11779Phone: 631-656-3800Fax: 631-656-3810 |
|---|---|
| 2. FDA Registration Number: | 2435946 |
| 3. Regulatory Affairs Contact: | Megan QuevedoQuality and Regulatory Affairs Supervisor2 Fleetwood CourtRonkonkoma NY 11779Telephone Number: 631-656-3800 ext. 133Fax 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
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| 13. Device Description: | Models 100, 200, 300, 400, 500 and 600Available in one or two sheets of blue nonwovenPolypropylene fabric. Each sheet of fabric is composedof three thermally- bonded layers consisting of aMeltblown polypropylene layer surrounded bySpunbond polypropylene layers (SMS). |
|---|---|
| 14. Packaging: | The packaging material of the inner bag consists oftransparent 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 SMSSterilization WrapModels | Intended Loads | Maximum WrappedPackage ContentWeights Used inSterility MaintenanceValidation Study2 | Descriptions of LoadsUsed in SterilityMaintenance ValidationStudy2 |
|---|---|---|---|
| Model 100 | Very Light Weight Package(for example: towel packsor batteries) | 3 lbs. | Pre-Vacuum Steam andEO:20 huck towels (17"x26") |
| Model 200 | Light Weight Package (forexample: standard linenpacks or telescope withlight cord) | 6 lbs. | Pre-Vacuum Steam andEO:2 huck towels (17"x26") |
| Model 300 | Light to Moderate WeightPackage (for example:general use medicalinstruments) | 9 lbs. | 2 fluid resistant U-drapes(68"x109")1 fluid resistant universalbar drape (70"x108")Pre-Vacuum Steam:15 huck towels (17"x26")1 small fluid resistantdrape (60"x76")5 lbs. of metal mass |
| EO:16 huck towels2 fluid resistant largedrapes (76"x 100")1 fluid resistant smalldrape (76"x60")1 fluid resistant tablecover (60" x 90") | |||
| Model 4003 | Moderate to Heavy WeightPackage (for example:general use medicalinstruments) | 13 lbs. | Pre-Vacuum Steam andEO:4 tray liners 20"x25"stacked10"x10"x2 1/2" traycontaining 11 lbs. ofmetal mass |
| Model 5003 | Heavyweight Package (forexample: general usemedical instruments) | 17 lbs. | Pre-Vacuum Steam andEO:4 tray liners 20"x25"stacked10"x10"x2 1/2" traycontaining 15 lbs. ofmetal mass |
| Model 6003 | Very Heavy WeightPackage (for example:general use medicalinstruments) | 25 lbs. | Pre-Vacuum Steam andEO:4 tray liners 20"x25"stacked10"x10"x2 1/2" traycontaining 23 lbs. ofmetal mass |
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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.
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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 ofComparison | Predicate Device-K082554 KimguardSterilization wrap | Predicate Device-K143053 KimguardOne-Step SterilizationWrap | Subject Device-Dukal SMSSterilization Wrap | Comparison | until opened. Thewrap was validatedfor aeration times forEtO sterilization of 8hours at 55°C or 12hours at 43.3 °C. Thewrap was validatedfor dry times of 20minutes for Models100, 200, and 300 andfor dry times of 30minutes for models400, 500, and 600.KIMGUARDSterilization Wrap isnot indicated for usefor gravity steamsterilization. | 55°C and 40-80%relative humidity for60 minutes. The wrapwas validated foraeration times for EtOsterilization of 8 hoursat 55˚C or 12 hours at43.3°C for ModelsKC100, and KC200.KIMGUARD One-StepSterilization Wrap(KC100, KC200) areintended to allowsterilization of theenclosed medicaldevice(s), and also tomaintain sterility ofthe enclosed device(s)until opened.Test results validatedthat the KIMGUARDOne-Step SterilizationWraps (KC100,KC200)allowed sterilizationof the encloseddevices by ethyleneoxide sterilization andby pre-vacuum cycles. | The wrap was validatedfor aeration times for EOsterilization of 16 hours at40.0°C.Dukal SMS sterilizationwraps are intended toallow sterilization of theenclosed medicaldevice(s), and also tomaintain sterility of theenclosed device(s) untilopened. The devices areintended for over-the-counter use and are singleuse disposable sterilizationwraps.Test results validated thatthe Dukal SMS sterilizationwraps allowed sterilizationof the enclosed medicaldevice(s) by ethyleneoxide sterilization and bypre-vacuum cycles. | ||
|---|---|---|---|---|---|---|---|---|---|
| Indicationsfor Use | KIMGUARDSterilization Wrap isintended to be usedto enclose anothermedical device that isto be sterilized by ahealthcare provider bypre-vacuum steam at270°F / 132°C for 4minutes or by 100%ethylene oxide (EtO)with a concentrationof 725-735 mg/L at131°F / 55°C and 40-80% relative humidityfor 60 minutes. Thewrap is intended toallow sterilization ofthe enclosed medicaldevice(s), and also tomaintain sterility ofthe enclosed device(s) | KIMGUARD One-StepSterilization Wrap(KC100, KC200) areintended to be usedto enclose anothermedical device that isto be sterilized by ahealthcare providerusing:-Pre-vacuum steam at270°F / 132°C for 4minutes. The wrapwas validated for drytimes of 20 minutesfor Models KC100,and KC200.-100% ethylene oxide(EO) with aconcentration of 725-735 mg/L at 131°F / | The Dukal SMS sterilizationwraps are intended to beused to enclose anothermedical device that is tobe sterilized by ahealthcare provider using:In a steam sterilizationpre-vacuum cycle at 270°F/ 132°C for 4 minutes-Models 100, 200 and 300were validated for drytimes of 20 minutes;models 400, 500 and 600were validated for drytimes of 30 minutesIn 100% ethylene oxide(EO) with a concentrationof 725-735 mg/L at 131°F/55°C and 40-80% relativehumidity for 60 minutes. | Similar | Regulation,Classification, ProductCode | Regulation Number:21 CFR 880.6850Classification/Common Name: SterilizationWrapRegulatory Class: IIProduct Code: FRG | Regulation Number:21 CFR 880.6850Classification/Common Name: SterilizationWrapRegulatory Class: IIProduct Code: FRG | Regulation Number: 21CFR 880.6850Classification/CommonName: Sterilization WrapRegulatory Class: IIProduct Code: FRG | Same |
| DeviceDesign | Two sheets ofmedium bluenonwovenPolypropylene fabric.Each sheet of fabricis composed of threethermally- bondedlayers consisting of aMeltblown | Two sheets ofmedium bluenonwovenPolypropylene fabric.Each sheet of fabricis composed of threethermally- bondedlayers consisting of aMeltblown | Available in one or twosheets of blue nonwovenPolypropylene fabric. Eachsheet of fabric iscomposed of threethermally-bonded layersconsisting of a Meltblownpolypropylene layersurrounded by Spunbond | Similar |
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| Method forbondingSMS layers | polypropylene layersurrounded bySpunbondpolypropylene layers(SMS). | polypropylene layersurrounded bySpunbondpolypropylene layers(SMS). | polypropylene layers(SMS). | Similar |
|---|---|---|---|---|
| Thermal bonding withround pin, hexagonal,triangle bond pattern("daisy" pattern) | Thermal bonding withround pin, hexagonal,triangle bond pattern("daisy" pattern) | Thermal bonding with lineof one square inch pattern | ||
| Materials | Polypropylene withblue and whitepigments andantistatic treatment | Polypropylene withblue and whitepigments andantistatic treatment | Polypropylene andpolyethylene with blueand violet pigments. | Similar |
| Models | 6 basis weightsmodels- ModelsKC100, KC200, KC300,KC400, KC500 andKC600 | 2 basis weightsmodels- ModelsKC100 and KC200.KIMGUARD ONE-STEPSterilization Wrap iscomprised of twosheets of KIMGUARDSterilization Wrapultrasonically seamedon two edges. Thisallows for convenientwrapping withtwo sheetssimultaneously. | 6 basis weights models-Models 100, 200, 300, 400,500 and 600Dukal One-Step SMSSterilization Wrap iscomprised of two sheetsof Dukal SMS SterilizationWrap ultrasonicallyseamed on two edges. Thisallows for convenientwrapping with two sheetssimultaneously. | Similar |
| ProductColor andSizes | 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 |
| Prescriptionvs OTC | OTC | OTC | OTC | Same |
| Single Usevs. Reusable | Single use only | Single use only | Single use only | Same |
| Biocompatibility | Applicable parts of ISO10993 ">– Biologicalevaluation of medicaldevices | Applicable parts ofISO 10993 – Biologicalevaluation of medicaldevices | Applicable parts of ISO10993 – Biologicalevaluation of medicaldevices | Same |
| MaintenanceofPackageSterility | Real-time testingfollowing sterilizationusing pre-vacuumsteam or EthyleneOxide supportsmaintenance ofpackage sterility for30 days. | Real-time testingfollowing sterilizationusingpre-vacuum steam orEthylene Oxidesupports maintenanceof package sterility for365 days. | Accelerated aging testingfollowing sterilizationusing pre-vacuum steamor Ethylene Oxide supportsmaintenance of packagesterility for 6 months. | Similar |
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Comparison Summary of Non-Clinical Testing Results
| Test | Predicate Device-K082554 KimguardSterilization wrap | Predicate Device-K143053 KimguardOne-Step SterilizationWrap | Subject Device-Dukal SMSSterilization Wrap | Comparison |
|---|---|---|---|---|
| MaterialCompatibility, ISO11607) &PremarketNotification 510(k)Submissions forMedical SterilizationPackaging Systems inHealth Care Facilities;Draft Guidance forIndustry and FDA, -- Basis weight,ASTMD3776/D3776M- Air permeability,ASTM D737Compatible- Material burststrength, ASTMD3786- Grab Tensilestrength, ASTMD5034- Trapezoidal Tearstrength, ASTMD5587 | Compatible | Compatible | Compatible | Same |
| - Hydrosta°c Pressure,AATC127 | ||||
| Sterilant Penetra on(BI incubation) | BI result: Negative | BI result: Negative | BI result: Negative | Same |
| Maintenance ofPackage Sterility(ASTM F1608 & USP<71>) | No growthReal-time testingfollowingsterilizationusing pre-vacuumsteam or EthyleneOxide supportsmaintenance ofpackage sterility for30 days. | No growthReal-time testingfollowing sterilizationusingpre-vacuum steam orEthylene Oxidesupports maintenanceof package sterility for365 days. | No growthAccelerated agingtesting followingsterilization usingpre-vacuum steamor Ethylene Oxidesupportsmaintenance ofpackage sterilityfor 6 months. | Similar |
| Biocompatibility-Cytotoxicity (ISO 10993-5), Irritation &Sensitization (ISO10993-10) | Under theconditions of thestudy, the device didnot showcytotoxicitypotential.Under theconditions of thestudy, the irritationresponse categoryof the device wasclassified asNegligible.Under theconditions of thestudy, the deviceshowed nosignificant evidenceof causing delayeddermal contactsensitization. | Under the conditionsof the study, thedevice did not showcytotoxicity potential.Under the conditionsof the study, theirritation responsecategory of the devicewas classified asNegligible.Under the conditionsof the study, thedevice showed nosignificant evidence ofcausing delayeddermal contactsensitization. | Under theconditions of thestudy, the devicedid not showcytotoxicitypotential.Under theconditions of thestudy, theirritation responsecategory of thedevice wasclassified asNegligible.Under theconditions of thestudy, the deviceshowed nosignificantevidence ofcausing delayeddermal contactsensitization. | Same |
| EO SterilizationResidual (ISO 10993-7) | Meet requirementsof ISO 10993-7 | Meet requirements ofISO 10993-7 | Meetrequirements ofISO 10993-7 | Same |
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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)
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- . USP-NF 2022 <71> 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 | TestStandardMethods | Test Requirements | Test Results of SubjectDevice-Dukal SMSSterilization Wrap | Remark |
|---|---|---|---|---|
| Basis Weight | ASTMD3776/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) | Meetsrequirement |
| Seam Strength | ASTMD1683/D1683M-22 | ≥20N | ≥20N | Meetsrequirement |
| Breaking Strengthand Elongation | ASTM D5034-21 | Breaking StrengthMD≥45NCD≥30NElongationMD≥20%CD≥20% | Breaking StrengthMD≥45NCD≥30NElongationMD≥20%CD≥20% | Meetsrequirement |
| Tearing Strength | ASTM D5587-15(2019) | MD≥10NCD≥7N | MD≥10NCD≥7N | Meetsrequirement |
| Surface Resistance | ASTM D257-14(Reapproved2021) | ≤ 2*10^12 Ω | ≤ 2*10^12 Ω | Meetsrequirement |
| Bursting Strength | ASTMD3786/D3786M-18 | ≥80 kPa | ≥80 kPa | Meetsrequirement |
| Lint Generation | ISO 9073-10:2003 | 1.0~4.0(Log 10) | 1.0~4.0(Log 10) | Meetsrequirement |
| Flammability | 16 CFR Part1610 | Class 1 | Class 1 | Meetsrequirement |
| Aqueous LiquidRepellency | AATCCTM193(2017) | Grade 3 or above | Grade 3 or above | Meetsrequirement |
| Bacterial FiltrationEfficiency (BFE) | ASTM F2101-23 | ≥50% | ≥50% | Meetsrequirement |
| Hydrostatic Pressure | AATCC TestMethod 127-2018 | ≥20 cmH2O | ≥20 cmH2O | Meetsrequirement |
| Air Permeability | ASTM D737-18 | ≥20 ft^3/min/ ft^2 | ≥20 ft^3/min/ ft^2 | Meetsrequirement |
| Abrasion Resistance | ASTM D4966-22 | Grade 3 or above | Grade 3 or above | Meetsrequirement |
| Sterilant penetra�on-BI incubation | BI incubation | Bl result: Negative | BI result: Negative | Meetsrequirement |
| Maintenance ofPackage Sterility-Sterility Test | USP-NF 2022<71> | No growth | No growth | Meetsrequirement |
| Maintenance ofPackage Sterility-Microbial AerosolChallenge | ASTM F1608-21 | Average SporeRetained: ≥60% | Average SporeRetained: ≥60% | Meetsrequirement |
| Biocompatibility-Cytotoxicity, Irritationand Sensitization | ISO 10993-5:2009, ISO10993-23:2021, ISO10993-10:2021 | Under the conditionsof the study, thedevice did not showcytotoxicity potential.Under the conditionsof the study, theirritation responsecategory of the devicewas classified asNegligible.Under the conditionsof the study, thedevice showed nosignificant evidence ofcausing delayed | Under the conditions ofthe study, the devicedid not showcytotoxicity potential.Under the conditions ofthe study, the irritationresponse category ofthe device wasclassified as Negligible.Under the conditions ofthe study, the deviceshowed no significantevidence of causingdelayed dermal contactsensitization. | Meetsrequirement |
| dermal contactsensitization. | ||||
| EO SterilizationResidual | ISO 10993-7:2008 | Meet requirements ofISO 10993-7 | Meet requirements ofISO 10993-7 | Meetsrequirement |
| pH Value | ISO 6588-2:2021 | Non-Aged- ExtractAppearance: Neitherof the extracts showsblue color- pH: Meetsacceptance criteriaAged 30 days- ExtractAppearance: Neitherof the extracts showsblue color- pH: Meetsacceptance criteria | Non-Aged- ExtractAppearance: Neither ofthe extracts shows bluecolor- pH: Meets acceptancecriteriaAged 30 days- ExtractAppearance: Neither ofthe extracts shows bluecolor- pH: Meets acceptancecriteria | Meetsrequirement |
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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).
§ 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).