(302 days)
Gemini Sterilization Wraps are 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 such content until used. Gemini Sterilization Wrap is validated for use in steam or STERRAD sterilization processes in the following sterilization modes and cycles:
TABLE 1: Pre-vacuum team at 270°F/132°C for 4 minutes with the following dry times by weight
TABLE 2: Gravity steam at 250°F/121°C for 30 minutes with the following dry times by weight
TABLE 3: STERRAD® Sterilization
Gemini Sterilization Wrap is offered to the marketplace as bulk packages of single ply sheets for use by customers in accordance with standard hospital practices which require that two sheets are used each time a medical device or collection of medical devices are wrapped.
Gemini Sterilization Wrap items are square or rectangular sheets of fabric produced using a five-layer SSMMS (spunbond-spunbond-meltblown-meltblown-spunbond) process.
The standard blue wrap fabric is made of polypropylene with the addition of less than 2% of phthalocyanine blue pigmentation and less than 0.35% titanium dioxide white pigmentation. The wrap allows for aseptic opening of the sterilized package.
Gemini Sterilization Wrap is available in sizes ranging from 12"x12" to 54"x90" across the five different material weights/models.
Below is a summary of the acceptance criteria and study information for the Gemini Sterilization Wrap based on the provided FDA 510(k) summary (K152564).
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with numerical thresholds for performance. Instead, it describes performance testing conducted and states whether the device "Passed" each test. The acceptance criteria are implicitly met by passing these tests, demonstrating substantial equivalence to the predicate device and suitability for its intended use.
| Study Description | Acceptance Criterion (Implicitly "Pass") | Reported Device Performance |
|---|---|---|
| Maintenance of Sterility (Package Integrity) - Steam Pre-Vacuum & Steam Gravity Cycles (Real Time Event Related) | Maintain sterility for two years after steam sterilization. | Passed |
| Maintenance of Sterility (Package Integrity) - STERRAD® (Real Time Event Related) | Maintain sterility for 180 days after STERRAD® sterilization. | Passed |
| Pre-Vacuum Steam and Gravity Sterilant Penetration | Allow sterilant penetration for pre-vacuum steam (270°F/132°C for 4 minutes with specified dry times) and gravity steam (250°F/121°C for 30 minutes with specified dry times) cycles, ensuring effective sterilization of enclosed medical devices. | Passed |
| STERRAD® 50 Cycle, STERRAD® 200 S Cycle and STERRAD® 100NX™ DUO Cycle Sterilant Penetration | Allow sterilant penetration for STERRAD® 50, 200S, and 100NX™ DUO cycles, ensuring effective sterilization of enclosed medical devices. | Passed |
| Post Sterilization Biocompatibility Testing (Primary Skin Irritation Testing - ISO 10993-10) | Demonstrate biocompatibility, specifically primary skin irritation, after sterilization. | Passed |
| Air permeability (per ASTM D737-04 R2012) | Meet established standards for air permeability. | Passed (Implied) |
| Basis weight (per ASTM D3776) | Meet established standards for basis weight. | Passed (Implied) |
| Material burst strength (per ASTM D3786) | Meet established standards for material burst strength. | Passed (Implied) |
| Resistance to water penetration (per AATCC127) | Meet established standards for resistance to water penetration. | Passed (Implied) |
| Tensile strength and elongation (per ASTM D5034) | Meet established standards for tensile strength and elongation. | Passed (Implied) |
| Tear strength (per ASTM D5587) | Meet established standards for tear strength. | Passed (Implied) |
Note: For the material characteristic tests (Air permeability, Basis weight, etc.), the document states these tests were conducted and then concludes "The safety and effectiveness...is adequately supported..." which implies they passed relevant acceptance criteria for those standards.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific numerical sample sizes used for each test. It refers to "real time stability studies" for shelf life and other performance tests.
- Sample Size for Test Set: Not explicitly stated as specific numbers of wraps or sterilization cycles.
- Data Provenance: The document does not specify the country of origin. The studies are described as "real time stability studies" and "performance testing," which implies prospective testing conducted for the purpose of the 510(k) submission. There is no indication of retrospective data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the evaluation of a sterilization wrap. The performance evaluation relies on objective physical and microbial barrier testing in controlled laboratory environments, not subjective expert assessment of images or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable, as this is related to expert review of subjective data, which is not relevant for this device's testing.
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 a medical device (sterilization wrap), not an AI-powered diagnostic or interpretive tool that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for the performance of the Gemini Sterilization Wrap is established through standardized physical tests and challenge tests (e.g., sterilization penetration, package integrity, material properties, biocompatibility) designed to objectively evaluate the device's ability to maintain sterility and withstand sterilization processes. This is based on established scientific principles and industry standards (e.g., ASTM, AATCC, ISO 10993-10).
8. The Sample Size for the Training Set
Not applicable. There is no AI component or machine learning model that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no AI component or machine learning model.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other, representing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 7, 2016
Medline Industries, Inc. Ms. Jennifer Mason Senior Regulatory Affairs Specialist 1 Medline Place Mundelein, IL 60060
Re: K152564 Trade/Device Name: Gemini Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization wrap Regulatory Class: Class II Product Code: FRG Dated: May 31, 2016 Received: June 1. 2016
Dear Ms. Jennifer Mason:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
{1}------------------------------------------------
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152564
Device Name Gemini Sterilization Wrap
Indications for Use (Describe)
Gemini Sterilization Wraps are 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 such content until used. Gemini Sterilization Wrap is validated for use in steam or STERRAD sterilization processes in the following sterilization modes and cycles:
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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| Gemini Wrap Model | Gemini Wrap Weight | Dry Time |
|---|---|---|
| GEM11XX | Lightweight | 20 Minutes |
| GEM21XX | Regular Weight | 20 Minutes |
| GEM31XX | Medium Weight | 20 Minutes |
| GEM41XX | Heavyweight | 30 Minutes |
| GEM51XX | Super Heavyweight | 30 Minutes |
TABLE 1: Pre-vacuum team at 270°F/132°C for 4 minutes with the following dry times by weight
TABLE 2: Gravity steam at 250°F/121°C for 30 minutes with the following dry times by weight
| Gemini Wrap Model | Gemini Wrap Weight | Dry Time |
|---|---|---|
| GEM11XX | Lightweight | 20 Minutes |
| GEM21XX | Regular Weight | 20 Minutes |
| GEM31XX | Medium Weight | 20 Minutes |
| GEM41XX | Heavyweight | 30 Minutes |
| GEM51XX | Super Heavyweight | 30 Minutes |
TABLE 3: STERRAD® Sterilization
| Gemini Wrap Model | Gemini Wrap Weight | STERRAD® Cycles |
|---|---|---|
| GEM11XX | Lightweight | STERRAD® 50, 200S and 100NXTM DUO Cycles |
| GEM21XX | Regular Weight | STERRAD® 50, 200S and 100NXTM DUO Cycles |
| GEM31XX | Medium Weight | STERRAD® 50, 200S and 100NXTM DUO Cycles |
| GEM41XX | Heavyweight | STERRAD® 50, 200S and 100NXTM DUO Cycles |
| GEM51XX | Super Heavyweight | STERRAD® 50, 200S and 100NXTM DUO Cycles |
The Gemini Sterilization Wrap intended loads with pre-vacuum steam sterilization, gravity steam sterilization and the Advanced Sterilization Products STERRAD® Sterilization systems are provided in Table 4.
The Gemini Sterilization Wrap Recommendations for use with Pre-vacuum steam cycles, Gravity steam cycles, and the Advanced Sterilization Products STERRAD® Sterilization systems are provided in Table 5.
| TABLE 4: Validated Pre-Vacuum Steam, Gravity Steam, and Advanced Sterilization Product | ||
|---|---|---|
| STERRAD® 50, 200S and STERRAD® 100 NXTM DUO Cycles |
| Cycle | MaximumrecommendedChamber Load | Intended Load | |
|---|---|---|---|
| Pre-VacuumSteam &Gravity SteamCycles | Lightweight | 6 lbs. | 2 huck towels (17 in. x 29 in.), 3 fluid-resistant drapes (108 in. x72 in.) |
| RegularWeight | 9 lbs. | 16 huck towels (17 in. x 29 in.), 1 fluid resistant table cover (90in. x 60 in.). 5 lbs. of metal mass. | |
| MediumWeight | 13 lbs. | 4 tray liners (20 in. x 25 in.) stacked 23 in. x 11 in. x 3.5 in. traycontaining 11 lbs. of metal mass. | |
| Heavyweight | 17 lbs. | 4 tray liners (20 in. x 25 in.) stacked 23 in. x 11 in. x 3.5 in. tray containing 15 lbs. of metal mass. | |
| SuperHeavyweight | 25 lbs. | 4 tray liners (20 in. x 25 in.) stacked 23in. x 11in. x 3.5 in. tray containing 20 lbs. of metal mass. | |
| STERRAD®50 | 10.7 lbs. | Reusable metal and non-metal medical devices, including up to10 lumens of the following dimensions per chamber load:An inside diameter of 1 mm or larger and a length of 125 mm or shorter of single-channel stainless steel lumens. An inside diameter of 2 mm or larger and a length of 250 mm or shorter of single-channel stainless steel lumens. An inside diameter of 3mm or larger and length of 400 mm or shorter of single-channel stainless steel lumens An inside diameter of 6 mm or larger and a length of 310 mm or shorter of single-channel Teflon-Polyethylene lumens. Refer to the STERRAD® 50 Sterilizer User's Guide for complete instructions on load(s) and cycle(s), including chamber loading instructions (i.e., 10 lumens per load). | |
| STERRAD®200S | 10.7 lbs. | Reusable metal and non-metal medical devices, including up to12 lumens of the following dimensions per chamber load:An inside diameter of 1 mm or larger and a length of 125 mm or shorter of single-channel stainless steel lumens. An inside diameter of 2 mm or larger and a length of 250 mm or shorter of single-channel stainless steel lumens. An inside diameter of 3mm or larger and length of 400 mm or shorter of single-channel stainless steel lumens An inside diameter of 6 mm or larger and a length of 310 mm or shorter of single-channel Teflon-Polyethylene lumens. Refer to the STERRAD® 200 Sterilizer User's Guide for complete instructions on load(s) and cycle(s), including chamber loading instructions (i.e., 36.48 lbs. per load). | |
| STERRAD®100NXTMDUO cycle | 10.7 lbs. | One or two single-channel Flexible Endoscope with accessory devices that are normally connected to it, with or without a silicone mat. The flexible endoscope may contain:A single-channel Teflon®/Polyethylene lumen with an inside diameter of 1 mm or larger and a length of 850 mm or shorter. Accessory devices that are normally connected to a flexible endoscope during use. Flexible endoscopes without lumens. Refer to the STERRAD® 100NXTM Sterilizer User's Guide for | |
| complete instructions on load(s) and cycle(s), including chamber | |||
| loading instructions (i.e., 13.2 lbs. per load). |
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TABLE 5: Wrap Model Recommendations for Use with Pre-vacuum steam cycles, Gravity steam cycles, and the Advanced Sterilization Products STERRAD® Sterilization Systems
| Gemini WrapWeight | GeminiWrapModel | Intended Load | Pre-Vacuum,Gravity, and EO | Maximum Recommended WrappedPackage Content2ASP STERRAD®50, 200S and100NX™ DUOCycles |
|---|---|---|---|---|
| Light Weight | GEM11XX | Light weight package (forexample: standard linenpacks) | 6 lbs. | 10.7 lbs. |
| RegularWeight | GEM21XX | Light to moderate weightpackage (for example:general use medicalinstruments) | 9 lbs. | 10.7 lbs. |
| MediumWeight | GEM31XX | Moderate to heavy weightpackage (for example:general use medicalinstruments) | 13 lbs. | 10.7 lbs. |
| Heavy Weight | GEM41XX | Heavy weight package(for example: general usemedical instruments) | 17 lbs. | 10.7 lbs. |
| Super HeavyWeight | GEM51XX | Very heavy weightpackage (for example:general use medicalinstruments) | 25 lbs. | 10.7 lbs. |
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 Gemini Sterilization Wraps (i.e .: the weight of the metal mass).
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Image /page/6/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is in white, sans-serif font, and it is positioned to the left of a white, stylized star shape. The star shape has four points, with the top and bottom points being longer than the side points.
K152564 510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)]
Submitter / 510(k) Sponsor
Medline Industries, Inc. 1 Medline Place Mundelein, IL 60060
Registration Number: 1417592
Contact Person
Jennifer Mason Senior Regulatory Affairs Specialist Phone: 847-643-3652 Email: jamason@medline.com
Summary Preparation Date July 7, 2016
Type of 510(k) Submission Traditional
Device Name / Classification
Name of Device: Gemini Sterilization Wrap Proprietary Name: Gemini Sterilization Wrap Common Name: Sterilization Wrap Classification Name: Wrap, Sterilization Product Code: FRG Classification Panel: General Hospital Regulation: 21 CFR 880.6850
Predicate Device
Gemini Sterilization Wrap K113353
Device Description
There have been no changes to the Gemini Sterilization Wrap. The materials of construction, colorants, sizes and product specifications have not changed and are identical to what was cleared under K113353.
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Image /page/7/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in a sans-serif font, with a white starburst symbol behind the text. The background of the logo is a solid dark blue color. There is a small gray rectangle in the upper right corner of the image.
Medline Industries, Inc.
One Medline Place
Mundelein, IL 60060
As previously described in K113353, Gemini Sterilization Wrap is offered to the marketplace as bulk packages of single ply sheets for use by customers in accordance with standard hospital practices which require that two sheets are used each time a medical device or collection of medical devices are wrapped.
Gemini Sterilization Wrap items are square or rectangular sheets of fabric produced using a five-layer SSMMS (spunbond-spunbond-meltblown-meltblown-spunbond) process.
The standard blue wrap fabric is made of polypropylene with the addition of less than 2% of phthalocyanine blue pigmentation and less than 0.35% titanium dioxide white pigmentation. The wrap allows for aseptic opening of the sterilized package.
Gemini Sterilization Wrap is available in sizes ranging from 12"x12" to 54"x90" across the five different material weights/models.
Indications for Use
Gemini Sterilization Wrap is 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 such content until used. Gemini Sterilization Wrap is validated for use in steam or STERRAD® sterilization processes in the following sterilization modes and cycles:
| Gemini Wrap Model | Gemini Wrap Weight | Dry Time |
|---|---|---|
| GEM11XX | Lightweight | 20 Minutes |
| GEM21XX | Regular Weight | 20 Minutes |
| GEM31XX | Medium Weight | 20 Minutes |
| GEM41XX | Heavyweight | 30 Minutes |
| GEM51XX | Super Heavyweight | 30 Minutes |
TABLE 1: Pre-vacuum steam at 270°F/132°C for 4 minutes with the following dry times by weight
TABLE 2: Gravity steam at 250°F/121°C for 30 minutes with the following dry times by weight
| Gemini Wrap Model | Gemini Wrap Weight | Dry Time |
|---|---|---|
| GEM11XX | Lightweight | 20 Minutes |
| GEM21XX | Regular Weight | 20 Minutes |
| GEM31XX | Medium Weight | 20 Minutes |
| GEM41XX | Heavyweight | 30 Minutes |
| GEM51XX | Super Heavyweight | 30 Minutes |
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Image /page/8/Picture/0 description: The image is a logo for Medline. The logo is set against a blue square background. The word "MEDLINE" is written in white, block letters on the left side of the square. To the right of the word is a white symbol that looks like a stylized cross or star.
TABLE 3: STERRAD® Sterilization
| Gemini Wrap Model | Gemini Wrap Weight | STERRAD® Cycles |
|---|---|---|
| GEM11XX | Lightweight | STERRAD® 50, 200 S and100NX™ DUO Cycles |
| GEM21XX | Regular Weight | STERRAD® 50, 200 S and100NX™ DUO Cycles |
| GEM31XX | Medium Weight | STERRAD® 50, 200 S and100NX™ DUO Cycles |
| GEM41XX | Heavyweight | STERRAD® 50, 200 S and100NX™ DUO Cycles |
| GEM51XX | Super Heavyweight | STERRAD® 50, 200 S and100NX™ DUO Cycles |
The Gemini Sterilization Wrap intended loads with pre-vacuum steam sterilization, gravity steam sterilization and the Advanced Sterilization Products STERRAD® Sterilization systems are provided in Table 4.
The Gemini Sterilization Wrap Recommendations for use with Pre-vacuum steam cycles, Gravity steam cycles, and the Advanced Sterilization Products STERRAD® Sterilization systems are provided in Table 5.
| 200S, 100NX™ DUO Cycles | ||
|---|---|---|
| Cycle | Maximum recommendedChamber Load | Intended Load |
| Pre-VacuumSteam & GravitySteam Cycles | Lightweight6 lbs. | 2 huck towels (17 in. x 29 in.), 3 fluid-resistant drapes (108 in. x 72 in.) |
| Regular Weight9 lbs. | 16 huck towels (17 in. x 29 in.), 1 fluid resistant table cover (90 in. x 60 in.). 5 lbs. of metal mass. | |
| Medium Weight13 lbs. | 4 tray liners (20 in. x 25 in.) stacked 23 in. x 11 in. x 3.5 in. tray containing11 lbs. of metal mass. | |
| Heavyweight17 lbs. | 4 tray liners (20 in. x 25 in.) stacked 23 in. x 11 in. x 3.5 in. tray containing15 lbs. of metal mass. | |
| SuperHeavyweight25 lbs. | 4 tray liners (20 in. x 25 in.) stacked 23in. x 11in. x 3.5 in. tray containing20 lbs. of metal mass. | |
| STERRAD® 50 | 10.7 lbs. | Reusable metal and non-metal medical devices, including up to 10 lumensof the following dimensions per chamber load: |
| • An inside diameter of 1mm or larger and a length of 125 mm orshorter of single-channel stainless steel lumens. | ||
| • An inside diameter of 2 mm or larger and a length of 250 mm orshorter of single-channel stainless steel lumens. |
| TABLE 4: Validated Pre-Vacuum Steam, Gravity Steam, and Advanced Sterilization Products STERRAD® 50, | |
|---|---|
| 200S, 100NXTM DUO Cycles |
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Image /page/9/Picture/0 description: The image features the logo of Medline, a healthcare company. The logo is set against a blue square background. A white, stylized star-like symbol is prominently displayed, with the word "MEDLINE" horizontally aligned and superimposed on the star. The font is sans-serif and appears to be in bold.
| An inside diameter of 3mm or larger and length of 400 mm or shorter of single-channel stainless steel lumens An inside diameter of 6 mm or larger and a length of 310 mm or shorter of single-channel Teflon-Polyethylene lumens. Refer to the STERRAD® 50 Sterilizer User's Guide for complete instructions on load(s) and cycle(s), including chamber loading instructions (i.e., 10 lumens per load). | ||
|---|---|---|
| STERRAD® 200 S | 10.7 lbs. | Reusable metal and non-metal medical devices, including up to 12 lumens of the following dimensions per chamber load: An inside diameter of 1mm or larger and a length of 125 mm or shorter of single-channel stainless steel lumens. An inside diameter of 2 mm or larger and a length of 250 mm or shorter of single-channel stainless steel lumens. An inside diameter of 3mm or larger and length of 400 mm or shorter of single-channel stainless steel lumens An inside diameter of 6 mm or larger and a length of 310 mm or shorter of single-channel Teflon-Polyethylene lumens. Refer to the STERRAD® 200 Sterilizer User's Guide for complete instructions on load(s) and cycle(s), including chamber loading instructions (i.e., 36.48 lbs. per load). |
| STERRAD® 100NXTM DUO cycle | 10.7 lbs. | One or two single-channel Flexible Endoscope with accessory devices that are normally connected to it, with or without a silicone mat. The flexible endoscope may contain: A single-channel Teflon®/Polyethylene lumen with an inside diameter of 1 mm or larger and a length of 850 mm or shorter. Accessory devices that are normally connected to a flexible endoscope during use. Flexible endoscopes without lumens. Refer to the STERRAD® 100NXTM Sterilizer User's Guide for complete instructions on load(s) and cycle(s), including chamber loading instructions (i.e., 13.2 lbs. per load). |
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Image /page/10/Picture/0 description: The image is a logo for Medline. The logo is a blue square with the word "MEDLINE" in white letters on the left side of the square. To the right of the word is a white symbol that looks like a compass. The compass is pointing in four directions.
TABLE 5: Wrap Model Recommendations for Use with Pre-vacuum steam cycles, Gravity steam cycles, and the Advanced Sterilization Products STERRAD® Sterilization Systems
| Gemini WrapWeight | GeminiWrapModel | Intended Load | Maximum Recommended WrappedPackage Content2 | |
|---|---|---|---|---|
| Light Weight | GEM11XX | Light weight package (forexample: standard linenpacks) | 6 lbs. | ASP STERRAD®50, 200 S and100NXTM DUOCycles |
| RegularWeight | GEM21XX | Light to moderate weightpackage (for example:general use medicalinstruments) | 9 lbs. | 10.7 lbs. |
| MediumWeight | GEM31XX | Moderate to heavy weightpackage (for example:general use medicalinstruments) | 13 lbs. | 10.7 lbs. |
| Heavy Weight | GEM41XX | Heavy weight package(for example: general usemedical instruments) | 17 lbs. | 10.7 lbs. |
| Super HeavyWeight | GEM51XX | Very heavy weightpackage (for example:general use medicalinstruments) | 25 lbs. | 10.7 lbs. |
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.
4 It is recommended to not exceed the maximum wapped 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 Gemini Sterilization Wraps (i.e.: the weight of the metal mass).
Maintenance of Sterility (Shelf Life)
The Gemini Sterilization Wrap has a shelf life of two years following steam sterilization and 180 days following STERRAD® sterilization.
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Image /page/11/Picture/0 description: The image features the Medline logo set against a blue background. The logo consists of the word "MEDLINE" in a sans-serif font, positioned to the left of a white, stylized starburst or cross-like symbol. The symbol is composed of four triangular shapes converging at a central point. A small portion of a gray rectangle is visible in the upper right corner of the image.
Validated Sterilization Cycles
Gemini Sterilization Wrap is validated for use in steam or STERRAD® sterilization processes in the following sterilization modes and cycles:
TABLE 6: Pre-vacuum steam at 270°F/132°C for 4 minutes with the following dry times by weight (cleared under K113353)
| Gemini Wrap Model | Gemini Wrap Weight | Dry Time |
|---|---|---|
| GEM11XX | Lightweight | 20 Minutes |
| GEM21XX | Regular Weight | 20 Minutes |
| GEM31XX | Medium Weight | 20 Minutes |
| GEM41XX | Heavyweight | 30 Minutes |
| GEM51XX | Super Heavyweight | 30 Minutes |
TABLE 7: Gravity steam at 250°F/121°C for 30 minutes with the following dry times by weight (cleared under K113353)
| Gemini Wrap Model | Gemini Wrap Weight | Dry Time |
|---|---|---|
| GEM11XX | Lightweight | 20 Minutes |
| GEM21XX | Regular Weight | 20 Minutes |
| GEM31XX | Medium Weight | 20 Minutes |
| GEM41XX | Heavyweight | 30 Minutes |
| GEM51XX | Super Heavyweight | 30 Minutes |
Advanced Sterilization Products STERRAD® Sterilization System
- STERRAD® 50, 200 S and 100NX™ DUO Subject of this 510(k) .
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Image /page/12/Picture/0 description: The image shows the logo for Medline, a healthcare company. The logo features the word "MEDLINE" in a bold, sans-serif font, placed to the left of a stylized starburst symbol. The starburst is white, and the background is a solid dark blue. The overall design is clean and professional, conveying a sense of trust and reliability.
Summary of Technological Characteristics
TABLE 8: COMPARISON OF PROPOSED AND PREDICATE DEVICES
| Device Characteristic | Proposed Device | Predicate Device | ComparisonAnalysis |
|---|---|---|---|
| Product Name | Gemini Sterilization Wrap | Gemini Sterilization Wrap | Same |
| 510(k) Reference | K113353 | Same | |
| Product Owner | Medline Industries, Inc. | Medline Industries, Inc. | Same |
| Product Code | FRG | FRG | Same |
| Intended Use | Gemini Sterilization Wrap isintended to be used to encloseanother medical device that isto be sterilized by a healthcare provider. It is intended toallow sterilization of theenclosed medical device andalso to maintain sterility ofsuch content. | Gemini Sterilization Wrap isintended to be used to encloseanother medical device that isto be sterilized by a health careprovider. It is intended toallow sterilization of theenclosed medical device andalso to maintain sterility ofsuch content. | Same |
| Regulation Number | 21 CFR 880.6850 | 21 CFR 880.6850 | Same |
| Design Features | Square or rectangular sheetsmfd. by spunbond-meltblownprocess | Square or rectangular sheetsmfd. by spunbond-meltblownprocess | Same |
| Design Configurations | 12 in. x 12 in. to 54 in. x 90 in. | 12 in. x 12 in. to 54 in. x 90 in. | Same |
| Materials | Polypropylene withphthalocyanine blue andtitanium dioxide | Polypropylene withphthalocyanine blue andtitanium dioxide | Same |
| Wrapping Technique | Sequential/simultaneousdouble wrapping | Sequential/simultaneousdouble wrapping | Same |
| Prescription vs. OTC | OTC | OTC | Same |
| Sterilization | Pre-Vacuum Steam Cycle: 4Minutes Exposure at270°F/132C° with minimum20 minutes dry timeGravity Steam Cycle: 30Minutes Exposure at250°F/121°C with minimum20 minutes dry timeSTERRAD® 50, 200 S and100NXTM DUO cycle | Pre-Vacuum Steam Cycle: 4Minutes Exposure at270°F/132C° with minimum20 minutes dry timeGravity Steam Cycle: 30Minutes Exposure at250°F/121°C with minimum20 minutes dry timeN/A | SameDifferent |
| STERRAD® NXTM,(Standard Cycle, AdvancedCycle) | STERRAD® NXTM,(Standard Cycle, AdvancedCycle) | Same | |
| STERRAD® 100S,Standard Cycle | STERRAD® 100S,Standard Cycle | Same | |
| STERRAD® 100NXTM,(Standard Cycle, Flex Cycle,EXPRESS Cycle) | STERRAD® 100NXTM,(Standard Cycle, Flex Cycle,EXPRESS Cycle) | Same | |
| Maintenance of Sterility(Shelf Life) | Steam – 2 years | Steam – 180 days | Different |
| Single Use vs. Reusable | STERRAD® – 180 days | STERRAD® – 180 days | Same |
| Single Use | Single Use | Same |
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Discussion of Similarities and Differences
The proposed Gemini Sterilization Wrap is substantially equivalent in intended use, materials, device features / specifications and function in comparison to the predicate (K113353) Gemini Sterilization Wrap. As noted in the table above, these characteristic comparisons render the devices identical. The difference between subject/predicate devices is related to:
- Maintenance of Sterility (Shelf Life): Extending the maintenance of sterility from 180 days to two years for steam sterilization based on real time stability studies. The completed stability studies were identical to the in-process stability studies described within K113353.
- Addition of STERRAD® Systems: STERRAD® 50 Cycle, STERRAD® 200 S Cycle and STERRAD® 100NX™ Duo Cycle.
This product modification involving the subject and predicate devices does not significantly alter the Gemini Sterilization Wrap or raise questions regarding safety or effectiveness.
Information within this Premarket Notification demonstrates that there are no significant differences in technological characteristics between Medline's Gemini Sterilization Wrap and the cited predicate device K113353.
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ne Medline Place Mundelein II 60060
Summary of Non-Clinical Testing
TABLE 9: Summary of Performance Testing
| Study | Performance Results | |
|---|---|---|
| Maintenance ofSterility ( PackageIntegrity) | Steam Pre-Vacuum & Steam Gravity Cycles(Real Time Event Related Two Years ShelfLife) | Passed |
| STERRAD® (Real Time Event Related 180Days Shelf Life) | Passed | |
| Pre-Vacuum Steam and Gravity Sterilant Penetration | Passed | |
| STERRAD® 50 Cycle, STERRAD® 200 S Cycle andSTERRAD® 100NX™ DUO Cycle) Sterilant Penetration | Passed | |
| Post Sterilization Biocompatibility Testing (Primary Skin IrritationTesting - ISO 10993-10) | Passed |
The following performance testing was conducted on the lightest weight and the heaviest weight Gemini Sterilization Wrap both pre-sterilization and after exposure to a STERRAD® 100NX™ DUO cycle.
Air permeability - per ASTM D737-04 R2012 Basis weight - per ASTM D3776 Material burst strength - per ASTM D3786 Resistance to water penetration - per AATCC127 Tensile strength and elongation - per ASTM D5034 Tear strength - per ASTM D5587
The safety and effectiveness of Medline's Gemini Sterilization Wrap is adequately supported by the substantial equivalence information, materials information, and Design Control activities referenced within this Premarket Notification.
Summary of Clinical Testing
Not applicable.
Basis for Determination of Substantial Equivalence/Conclusion
Based on the intended use, technological characteristics, performance data, and nonclinical tests performed, the subject Gemini Sterilization Wrap are substantially equivalent to, and are as safe and as effective as, the legally marketed predicate device, Gemini Sterilization Wrap, cleared under K113353 under regulation 21 CFR 880.6850, product code FRG.
§ 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).