Gemini Sterilization Wrap
Device Facts
| Record ID | K150698 |
|---|---|
| Device Name | Gemini Sterilization Wrap |
| Applicant | Medline Industries, Inc. |
| Product Code | FRG · General Hospital |
| Decision Date | Nov 20, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6850 |
| Device Class | Class 2 |
Indications for Use
The Gemini Single Ply and Bonded Sterilization Wraps are intended to allow sterilization of the enclosed medical devices(s) and also maintain sterility of the enclosed medical device(s) within the period of time for which performance data demonstrating maintenance of sterility has been provided. The Gemini Single Ply and Bonded Sterilization Wraps have been validated for use with Lumen, and Flexible Cycles by the STERIS Amsco® V-PRO™ 1. Amsco® V-PRO™ 1 Plus, and Amsco® V-PRO™ maX Low Temperature Sterilization Systems.
Device Story
Gemini Sterilization Wrap consists of single or two-ply bonded polypropylene sheets; manufactured via five-layer SSMMS (spunbond-spunbond-meltblown-meltblown-spunbond) process. Used by healthcare facility staff to wrap medical instruments prior to sterilization in STERIS Amsco V-PRO low-temperature systems. Wrap allows sterilization of enclosed devices and maintains sterility post-process. Available in five weights/models; sizes range from 12"x12" to 54"x72". Healthcare providers select appropriate wrap model based on package weight and content type. Output is a sterile-wrapped package; facilitates aseptic opening. Benefits include maintenance of device sterility until point of use.
Clinical Evidence
No clinical data. Bench testing only. Performance evaluated via tensile breaking strength/elongation (ASTM D5034), tearing strength (ASTM D5587), hydrostatic pressure (AATCC 127), and air permeability (ASTM D737). Biocompatibility assessed per ISO 10993-1:2009 (irritation, sensitization, and leachable analysis via ICP-MS/HPLC-MS).
Technological Characteristics
Material: Polypropylene SSMMS nonwoven fabric with phthalocyanine blue pigment (<2%) and titanium dioxide (<0.35%). Design: Single ply or ultrasonically seamed bonded sheets. Dimensions: 12"x12" to 54"x72". Sterilization: Compatible with STERIS Amsco V-PRO 1, 1 Plus, and maX systems. Standards: ASTM D5034 (tensile), ASTM D5587 (tear), AATCC 127 (hydrostatic), ASTM D737 (air permeability), ISO 10993-1 (biocompatibility).
Indications for Use
Indicated for use by healthcare providers to enclose medical devices for sterilization in STERIS Amsco V-PRO 1, 1 Plus, and maX low-temperature systems; maintains sterility of enclosed devices until use.
Regulatory Classification
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.
Predicate Devices
- KIMGUARD ONE-STEP Sterilization Wrap (K112805)
Submission Summary (Full Text)
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 20, 2015
Medline Industries. Inc. Ms. Jennifer Mason Senior Regulatory Affairs Specialist 1 Medline Place Mundelein, IL 60060
Re: K150698
Trade/Device Name: Gemini Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: October 16, 2015 Received: October 19, 2015
Dear Ms. 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
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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 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 Small Manufacturers. International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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,
# Erin | Keith -S
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)
Device Name Gemini Sterilization Wrap
#### Indications for Use (Describe)
The Gemini Single Ply and Bonded Sterilization Wraps are intended to allow sterilization of the enclosed medical devices(s) and also maintain sterility of the enclosed medical device(s) within the period of time for which performance data demonstrating maintenance of sterility has been provided.
The Gemini Single Ply and Bonded Sterilization Wraps have been validated for use with Lumen, and Flexible Cycles by the STERIS Amsco® V-PRO™ 1. Amsco® V-PRO™ 1 Plus, and Amsco® V-PRO™ maX Low Temperature Sterilization Systems.
Table 1 provides a listing of validated sterilization cycles
Table 2 provides recommended weights for each wrap model
Table 3 provides maintenance of package sterility recommendations
| 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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| Table 1 - Validated STERIS Amsco® V-PRO™ Cycles | | |
|-------------------------------------------------|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Amsco® V-PRO™ Cycle | Maximum Recommended Chamber Load | Intended Load |
| Lumen Cycle | 19.65 lbs. | Reusable metal and non-metal medical devices, including up to 20 lumens of the following dimensions per chamber load:<br>• An inside diameter of 1 mm or larger and a length of 125 mm or shorter<br>• An inside diameter of 2 mm or larger and a length of 250 mm or shorter<br>• An inside diameter of 3 mm or larger and a length of 400 mm or shorter |
| Non Lumen Cycle | 19.65 lbs. | Non-lumened reusable metal and non-metal medical devices |
| Flexible Cycle | 24 lbs. | Single or dual lumen surgical flexible endoscopes and bronchoscopes in either of two load configurations:<br>1. Two trays, each containing a flexible endoscope with a light cord (if not integral to endoscope) and mat with no additional load<br>2. One tray containing a flexible endoscope with a light cord (if not integral to endoscope) and mat and an additional tray containing non-lumened medical devices<br>The flexible endoscopes(s) may contain either:<br>• A single lumen with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter<br>• Two lumens, with one lumen having an inside diameter of 1 mm or larger and length of 998 mm or shorter and the other lumen having an inside diameter of 1 mm or larger and a length of 850 mm or shorter |
#### Table 1 – Validated STERIS Amsco® V-PRO™ Cycles
Gemini Single Ply and Bonded Sterilization Wraps Recommendations for Use with the STERIS Amsco® V-PRO™ 1, Amsco® V-PRO™ 1 Plus, and Amsco® V-PRO™ maX Low Temperature Sterilization Systems are provided in Table 3.
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| Gemini Wrap<br>Weight | Item Number<br>Series | Intended Load | Maximum<br>Recommended<br>Wrapped Package<br>Content | Description of Loads Used in<br>Sterility Maintenance Validation<br>Study² |
|-----------------------|-----------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------|--------------------------------------------------------------------------------|
| Light Weight | GEM1XXX<br>GEM11XXS | Light Weight<br>Package (for<br>example:<br>telescope with<br>light cord) | 6.5 lbs. | 2.5 lbs. metal mass<br>6 forceps<br>V-PRO tray (17" x 10" x 3 ½") at<br>4 lbs. |
| Regular Weight | GEM2XXX<br>GEM21XXS | Light to Moderate<br>Weight Package<br>(for example:<br>general use<br>medical<br>instruments) | 9 lbs. | 5 lbs. metal mass<br>6 forceps<br>V-PRO tray (17" x 10" x 3 ½") at<br>4 lbs. |
| Medium Weight | GEM3XXX<br>GEM31XXS | Moderate to<br>Heavy Weight<br>Package (for<br>example: general<br>use medical<br>instruments) | 10 lbs. | 6 lbs. metal mass<br>6 forceps<br>V-PRO tray (17" x 10" x 3 ½") at<br>4 lbs. |
| Heavyweight | GEM4XXX<br>GEM41XXS | Heavyweight<br>Package (for<br>example: general<br>use medical<br>instruments) | 10 lbs. | 5 lbs. metal mass<br>6 forceps<br>V-PRO tray (17" x 10" x 3 ½") at<br>5 lbs. |
| Super<br>Heavyweight | GEM5XXX<br>GEM51XXS | Very<br>Heavyweight<br>Package (for<br>example: general<br>use medical<br>instruments) | 10 lbs. | 5 lbs. metal mass<br>6 forceps<br>V-PRO tray (17" x 10" x 3 ½") at<br>5 lbs. |
Table 2 – Wrap Model Recommendations for STERIS Amsco® V-PRO™ 1, Amsco® V-PRO™ 1 Plus, and
Amsco® V-PRO" maX Low Temperature Sterilization'
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.
if 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 Single Ply and Bonded Sterilization Wraps (i.e.: the weight of the metal mass).
| | | Table 3 - Maintenance of Package Sterility Recommendations |
|--|--|------------------------------------------------------------|
| | | |
| Models | V-PRO Cycles |
|--------------------------------------------------|--------------|
| Gemini Sterilization Wrap Single Play and Bonded | 30 days |
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Image /page/5/Picture/0 description: The image features the Medline logo against a blue background. The logo consists of the word "MEDLINE" in white, bold sans-serif font, positioned to the left of a stylized white starburst or cross-like symbol. The starburst is oriented vertically, with its points extending upwards and downwards from the center. A small portion of a gray rectangle is visible on the right edge of the image.
# 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 November 19, 2015
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: Sterilization Wrap Product Code: FRG Classification Panel: General Hospital
Predicate Device KIMGUARD ONE-STEP Sterilization Wrap PREDICATE DEVICE K112805
#### Device Description
Gemini Sterilization Wraps are offered to the market place as bulk packages of single and two ply bonded sheets of wrap for use by customers in accordance with standard hospital practices which require that two sheets are used each time a medical device or collections of medical devices are wrapped. The bonded wrap is comprised of two sheets of the Gemini Sterilization Wrap ultrasonically seamed on two
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Image /page/6/Picture/0 description: The image is a logo for Medline. The logo consists of the word "MEDLINE" in a sans-serif font, with a white cross-like symbol behind the text. The background is a solid dark blue color. The logo is simple and clean, with a professional look.
ne Medline Place
parallel sides. This allows for convenient wrapping with two sheets simultaneously. The wrap allows for aseptic opening of the sterilized package.
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 wraps are offered in 5 different shades of blue that vary in the amount of phthalocyanine blue pigmentation depending on the weight of the wrap. The lightest weight wrap has the least amount of blue pigment and the super heavy weight has the highest amount. Also, some wraps contain titanium dioxide and others do not.
Gemini Sterilization Wrap is available in sizes ranging from 12"x12" to 54"x72" across five different material weights/models.
#### Indications for Use
The Gemini Single Ply and Bonded Sterilization Wraps are intended to allow sterilization of the enclosed medical devices(s) and also maintain sterility of the enclosed medical device(s) within the period of time for which performance data demonstrating maintenance of sterility has been provided.
The Gemini Single Ply and Bonded Sterilization Wraps have been validated for use with Lumen. Non Lumen, and Flexible Cycles by the STERIS Amsco® V-PRO™ 1, Amsco® V-PRO™ 1 Plus, and Amsco® V-PRO™ maX Low Temperature Sterilization Systems.
Table 1 provides a listing of validated sterilization cycles
Table 2 provides recommended weights for each wrap model
Table 3 provides maintenance of package sterility recommendations
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Image /page/7/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, stacked vertically, and placed to the left of a white starburst-like symbol. The background is a solid dark blue color. The logo is simple and clean, with a focus on the company name and a recognizable symbol.
# Table 1 – Validated STERIS Amsco® V-PRO™ Cycles
| Amsco® V-PROTM<br>Cycle | Maximum<br>Recommended<br>Chamber Load | Intended Load |
|-------------------------|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Lumen Cycle | 19.65 lbs. | Reusable metal and non-metal medical devices, including up to 20 lumens of the following dimensions per chamber load:<br>• An inside diameter of 1 mm or larger and a length of 125 mm or shorter<br>• An inside diameter of 2 mm or larger and a length of 250 mm or shorter<br>• An inside diameter of 3 mm or larger and a length of 400 mm or shorter |
| Non Lumen Cycle | 19.65 lbs. | Non-lumened reusable metal and non-metal medical devices |
| Flexible Cycle | 24 lbs. | Single or dual lumen surgical flexible endoscopes and bronchoscopes in either of two load configurations:<br>1. Two trays, each containing a flexible endoscope with a light cord (if not integral to endoscope) and mat with no additional load<br>2. One tray containing a flexible endoscope with a light cord (if not integral to endoscope) and mat and an additional tray containing non-lumened medical devices<br>The flexible endoscopes(s) may contain either:<br>• A single lumen with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter<br>• Two lumens, with one lumen having an inside diameter of 1 mm or larger and length of 998 mm or shorter and the other lumen having an inside diameter of 1 mm or larger and a length of 850 mm or shorter |
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Image /page/8/Picture/0 description: The image shows the Medline logo, which features the word "MEDLINE" in white, bold, sans-serif font. The word is positioned diagonally across a white, stylized starburst symbol. The background is a solid dark blue color, and there is a small gray rectangle in the upper right corner of the image.
Gemini Single Ply and Bonded Sterilization Wraps Recommendations for Use with the STERIS Amsco® V-PRO™1, Amsco® V-PRO™ 1 Plus, and Amsco® V-PRO™ maX Low Temperature Sterilization systems are provided in Table 3.
Table 2 - Wrap Model Recommendations for STERIS Amsco® V-PRO™ 1, Amsco® V-PRO™ 1 Plus, and Amsco® V-PRO™ maX Low Temperature Sterilization1
| Gemini<br>Wrap<br>Weight | Item<br>Number<br>Series | Intended<br>Load | Maximum<br>Recommended<br>Wrapped<br>Package<br>Content | Description of Loads Used in<br>Sterility Maintenance Validation<br>Study2 |
|--------------------------|--------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------|-----------------------------------------------------------------------------|
| Light Weight | GEM11XX<br>GEM11XXS | Light Weight<br>Package (for<br>example:<br>telescope with<br>light cord) | 6.5 lbs. | 2.5 lbs. metal mass<br>6 forceps<br>V-PRO tray (17" x 10" x 3 ½") at 4 lbs. |
| Regular<br>Weight | GEM21XX<br>GEM21XXS | Light to<br>Moderate<br>Weight Package<br>(for example:<br>general use<br>medical<br>instruments) | 9 lbs. | 5 lbs. metal mass<br>6 forceps<br>V-PRO tray (17" x 10" x 3 ½") at 4 lbs. |
| Medium<br>Weight | GEM31XX<br>GEM31XXS | Moderate to<br>Heavy Weight<br>Package (for<br>example: general<br>use medical<br>instruments) | 10 lbs. | 6 lbs. metal mass<br>6 forceps<br>V-PRO tray (17" x 10" x 3 ½") at 4 lbs. |
| Heavyweight | GEM41XX<br>GEM41XXS | Heavyweight<br>Package (for<br>example: general<br>use medical<br>instruments) | 10 lbs. | 5 lbs. metal mass<br>6 forceps<br>V-PRO tray (17" x 10" x 3 ½") at 5 lbs. |
| Super<br>Heavyweight | GEM51XX<br>GEM51XXS | Very<br>Heavyweight<br>Package (for<br>example: general<br>use medical<br>instruments | 10 lbs. | 5 lbs. metal mass<br>6 forceps<br>V-PRO tray (17" x 10" x 3 ½") at 5 lbs. |
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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Image /page/9/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in a sans-serif font, with the letters stacked vertically. To the right of the word is a white starburst symbol. The background of the logo is a dark blue square.
## Table 3 - Maintenance of Package Sterility Recommendations
| Models | V-PRO Cycles |
|--------------------------------------------------|--------------|
| Gemini Sterilization Wrap Single Play and Bonded | 30 days |
# Summary of Technological Characteristics
#### Comparison of Proposed and Predicate Devices
| Device<br>Characteristic | Proposed Device | Predicate Device | Comparison<br>Analysis |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Gemini Sterilization Wrap | KIMGUARD ONE-STEP<br>Sterilization Wrap | |
| 510(k) Reference | | K112805 | |
| Product Owner | Medline Industries, Inc | Kimberly Clark | |
| Product Code | FRG | FRG | Same |
| Intended Use | The Gemini Single Ply<br>and Bonded<br>Sterilization Wraps are<br>intended to enclose<br>another medical device<br>that is to be sterilized<br>by a health care<br>provider using:<br>• Lumen, Non<br>Lumen, and<br>Flexible<br>Cycles by the<br>STERIS<br>Amsco V-<br>PRO, Amsco<br>V-PRO 1 Plu,<br>and amsco V-<br>PRO maX<br>Low<br>Temperature<br>Sterilization<br>Systems. | KIMGUARD ONE-STEP*<br>Sterilization Wrap is intended to<br>be used to enclose another<br>medical device that is to be<br>sterilized by a healthcare<br>provider in the Amsco® V-<br>PRO™ 1 Low Temperature<br>Sterilization System's Cycle,<br>The Amsco® V-PRO™ 1 Plus<br>Low Temperature Sterilization<br>System's Lumen (Identical to<br>the V-PRO™ 1 Cycle), and<br>Non Lumen Cycles, and The V-<br>PRO™ Low Temperature<br>Sterilization System's Flexible<br>Cycle. The wrap is intended to<br>maintain sterility of the<br>enclosed device(s) until opened<br>within the period of time for<br>which performance data<br>demonstrating maintenance of<br>sterility has been provided. | Similar |
| sterilization of the<br>enclosed medical<br>device(s) and also<br>maintain sterility of the<br>enclosed device(s)<br>until used, which<br>complies with 21 CFR<br>880.6850. "A<br>sterilization wrap<br>(pack, sterilization<br>wrapper, bag, or<br>accessories) is a device<br>intended to be used to<br>enclose another<br>medical device that is<br>to sterilized by a<br>healthcare provider. It<br>is intended to allow<br>sterilization of the<br>enclosed medical<br>device and also to<br>maintain sterility of the<br>enclosed device until<br>used." | | | |
| Regulation Number | 21 CFR 880.6850 | 21 CFR 880.6850 | Same |
| Design Features | Single Ply and Bonded with an<br>ultrasonic seam | Bonded with an ultrasonic seam | Similar |
| Sizes | 12"x12" to 54"x72" | 12"x12" to 54"x72" | Same |
| Materials | Polypropylene Spunbond-<br>Spunbond-meltblown-<br>meltblown-spunbond nonwoven<br>fabric | Polypropylene Spunbond-<br>meltblown-spunbond (SMS0<br>Trilaminate nonwoven fabric | Similar |
| Prescription vs. OTC | OTC | OTC | Same |
| Sterilization | Lumen, Non Lumen, and<br>Flexible Cycles by the STERIS<br>Amsco V-PRO1, AMSCO V-<br>PRO 1 Plus, and Amsco V-PRO<br>maX Low Temperature<br>Sterilization Systems | Lumen, Non Lumen, and<br>Flexible Cycle in the Amsco V-<br>Pro 1, Amsco V-PRO 1 Plus,<br>and Amsco V-PRO maX Low<br>Temperature Sterilization<br>Systems | Same |
| Wrapping Technique | Sequential/simultaneous double<br>wrapping | Simultaneous double wrapping | Similar |
| Disposable vs. Non-<br>Disposable | Disposable | Disposable | Same |
| Single Use vs. Reusable | Single Use | Single Use | Same |
| Biocompatibility<br>Testing | Pass | Pass | Same |
| Event Related<br>Maintenance of<br>Package Sterility | Pass | Pass | Same |
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Image /page/10/Picture/0 description: The image features the logo of Medline, a healthcare company. The logo consists of the word "MEDLINE" in bold, sans-serif font, positioned to the left of a stylized, four-pointed star-like symbol. The background is a solid, dark blue color, providing a strong contrast to the white text and symbol. The overall design is clean and professional, reflecting the company's focus on healthcare solutions.
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Image /page/11/Picture/0 description: The image shows the logo for Medline. The logo features the word "MEDLINE" in white, bold, sans-serif font, stacked above a white, stylized starburst symbol. The background is a solid dark blue color. A small portion of a gray rectangle is visible on the right side of the image.
#### Summary of Non-Clinical Testing
#### Biocompatibility Testing
The biocompatibility evaluation for Gemini Sterilization Wrap was conducted in accordance with ANSI/AAMI/ISO 10993-1:2009 Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing Within a Risk Management Process, as recognized by FDA. Gemini Sterilization Wrap is classified as non-patient contacting devices. Specific biocompatibility tests were selected under the guidance of ISO 10993-1:2009 Annex A.
The following tests were performed to evaluate the biocompatibility of Gemini Sterilization Wrap:
- ISO 10993-10: Irritation Intracutaneous reactivity; and ●
- . ISO 10993-10: Delayed-Type Hypersensitivity (Sensitization) – Guinea Pig Maximization Test
A study was performed on the Gemini Sterilization Wrap by analysis of semi-volatile and elemental leachables utilizing inductively coupled plasma-mass spectrometry (ICP-MS) and highperformance liquid chromatography (HPLC-MS).
#### Performance Testing (Bench)
Medline Gemini Wraps were evaluated through a series of performance tests including tensile breaking strength and elongation (ASTM D5034), tearing strength (ASTM D5587), hydrostatic pressure (AATCC 127), and air permeability (ASTM D737).
#### Summary of Clinical Testing
Not applicable.
#### Conclusion
In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the Gemini Sterilization Wraps are as safe and as effective and substantially equivalent to the predicate KIMGUARD ONE-STEP Sterilization Wrap (K112805)] as described herein.
