(247 days)
Not Found
No
The device description and performance studies focus on the physical properties and sterilization efficacy of the wrap material, with no mention of AI or ML technologies.
No
The device is a sterilization wrap used to maintain the sterility of medical devices, not to treat or diagnose patients.
No
Explanation: The device is a sterilization wrap intended to maintain the sterility of medical devices, not to diagnose any condition or disease.
No
The device description clearly indicates it is a physical product (sterilization wraps made of fabric) and does not mention any software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to allow sterilization of medical devices and maintain their sterility. This is a function related to the preparation and storage of medical devices, not the diagnosis of a disease or condition using in vitro methods.
- Device Description: The device is a sterilization wrap made of fabric. This is a physical barrier and material used in the sterilization process.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
- Performance Studies: The performance studies focus on the physical properties of the wrap (tensile strength, tearing strength, etc.) and biocompatibility, which are relevant to its function as a sterilization wrap, not an IVD.
- Predicate Device: The predicate device is also a sterilization wrap, further indicating that this device falls under the category of sterilization accessories, not IVDs.
In summary, the Gemini Single Ply and Bonded Sterilization Wraps are medical devices used in the sterilization process, not for in vitro diagnostic purposes.
N/A
Intended Use / 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.
Product codes
FRG
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare provider / hospital practices
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
Key Results: Pass
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).
Key Results: Event Related Maintenance of Package Sterility: Pass
Summary of Clinical Testing:
Not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).
0
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
1
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
2
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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3
| 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: |
| • An inside diameter of 1 mm or larger and a length of 125 mm or shorter | ||
| • An inside diameter of 2 mm or larger and a length of 250 mm or shorter | ||
| • 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: |
- Two trays, each containing a flexible endoscope with a light cord (if not integral to endoscope) and mat with no additional load
- 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
The flexible endoscopes(s) may contain either:
• A single lumen with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter
• 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.
4
| Gemini Wrap
Weight | Item Number
Series | Intended Load | Maximum
Recommended
Wrapped Package
Content | Description of Loads Used in
Sterility Maintenance Validation
Study² |
|-----------------------|-----------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------|--------------------------------------------------------------------------------|
| Light Weight | GEM1XXX
GEM11XXS | Light Weight
Package (for
example:
telescope with
light cord) | 6.5 lbs. | 2.5 lbs. metal mass
6 forceps
V-PRO tray (17" x 10" x 3 ½") at
4 lbs. |
| Regular Weight | GEM2XXX
GEM21XXS | Light to Moderate
Weight Package
(for example:
general use
medical
instruments) | 9 lbs. | 5 lbs. metal mass
6 forceps
V-PRO tray (17" x 10" x 3 ½") at
4 lbs. |
| Medium Weight | GEM3XXX
GEM31XXS | Moderate to
Heavy Weight
Package (for
example: general
use medical
instruments) | 10 lbs. | 6 lbs. metal mass
6 forceps
V-PRO tray (17" x 10" x 3 ½") at
4 lbs. |
| Heavyweight | GEM4XXX
GEM41XXS | Heavyweight
Package (for
example: general
use medical
instruments) | 10 lbs. | 5 lbs. metal mass
6 forceps
V-PRO tray (17" x 10" x 3 ½") at
5 lbs. |
| Super
Heavyweight | GEM5XXX
GEM51XXS | Very
Heavyweight
Package (for
example: general
use medical
instruments) | 10 lbs. | 5 lbs. metal mass
6 forceps
V-PRO tray (17" x 10" x 3 ½") at
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 |
5
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
6
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
7
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
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:
• An inside diameter of 1 mm or larger and a length of 125 mm or shorter
• An inside diameter of 2 mm or larger and a length of 250 mm or shorter
• 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:
- Two trays, each containing a flexible endoscope with a light cord (if not integral to endoscope) and mat with no additional load
- 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
The flexible endoscopes(s) may contain either:
• A single lumen with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter
• 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 |
8
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
Wrap
Weight | Item
Number
Series | Intended
Load | Maximum
Recommended
Wrapped
Package
Content | Description of Loads Used in
Sterility Maintenance Validation
Study2 |
|--------------------------|--------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------|-----------------------------------------------------------------------------|
| Light Weight | GEM11XX
GEM11XXS | Light Weight
Package (for
example:
telescope with
light cord) | 6.5 lbs. | 2.5 lbs. metal mass
6 forceps
V-PRO tray (17" x 10" x 3 ½") at 4 lbs. |
| Regular
Weight | GEM21XX
GEM21XXS | Light to
Moderate
Weight Package
(for example:
general use
medical
instruments) | 9 lbs. | 5 lbs. metal mass
6 forceps
V-PRO tray (17" x 10" x 3 ½") at 4 lbs. |
| Medium
Weight | GEM31XX
GEM31XXS | Moderate to
Heavy Weight
Package (for
example: general
use medical
instruments) | 10 lbs. | 6 lbs. metal mass
6 forceps
V-PRO tray (17" x 10" x 3 ½") at 4 lbs. |
| Heavyweight | GEM41XX
GEM41XXS | Heavyweight
Package (for
example: general
use medical
instruments) | 10 lbs. | 5 lbs. metal mass
6 forceps
V-PRO tray (17" x 10" x 3 ½") at 5 lbs. |
| Super
Heavyweight | GEM51XX
GEM51XXS | Very
Heavyweight
Package (for
example: general
use medical
instruments | 10 lbs. | 5 lbs. metal mass
6 forceps
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.
9
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
Characteristic | Proposed Device | Predicate Device | Comparison
Analysis |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Gemini Sterilization Wrap | KIMGUARD ONE-STEP
Sterilization Wrap | |
| 510(k) Reference | | K112805 | |
| Product Owner | Medline Industries, Inc | Kimberly Clark | |
| Product Code | FRG | FRG | Same |
| Intended Use | The Gemini Single Ply
and Bonded
Sterilization Wraps are
intended to enclose
another medical device
that is to be sterilized
by a health care
provider using:
• Lumen, Non
Lumen, and
Flexible
Cycles by the
STERIS
Amsco V-
PRO, Amsco
V-PRO 1 Plu,
and amsco V-
PRO maX
Low
Temperature
Sterilization
Systems. | KIMGUARD ONE-STEP*
Sterilization Wrap is intended to
be used to enclose another
medical device that is to be
sterilized by a healthcare
provider in the Amsco® V-
PRO™ 1 Low Temperature
Sterilization System's Cycle,
The Amsco® V-PRO™ 1 Plus
Low Temperature Sterilization
System's Lumen (Identical to
the V-PRO™ 1 Cycle), and
Non Lumen Cycles, and The V-
PRO™ Low Temperature
Sterilization System's Flexible
Cycle. The wrap is intended to
maintain sterility of the
enclosed device(s) until opened
within the period of time for
which performance data
demonstrating maintenance of
sterility has been provided. | Similar |
| sterilization of the
enclosed medical
device(s) and also
maintain sterility of the
enclosed device(s)
until used, which
complies with 21 CFR
880.6850. "A
sterilization wrap
(pack, sterilization
wrapper, bag, or
accessories) is a device
intended to be used to
enclose another
medical device that is
to sterilized by a
healthcare provider. It
is intended to allow
sterilization of the
enclosed medical
device and also to
maintain sterility of the
enclosed device until
used." | | | |
| Regulation Number | 21 CFR 880.6850 | 21 CFR 880.6850 | Same |
| Design Features | Single Ply and Bonded with an
ultrasonic seam | Bonded with an ultrasonic seam | Similar |
| Sizes | 12"x12" to 54"x72" | 12"x12" to 54"x72" | Same |
| Materials | Polypropylene Spunbond-
Spunbond-meltblown-
meltblown-spunbond nonwoven
fabric | Polypropylene Spunbond-
meltblown-spunbond (SMS0
Trilaminate nonwoven fabric | Similar |
| Prescription vs. OTC | OTC | OTC | Same |
| Sterilization | Lumen, Non Lumen, and
Flexible Cycles by the STERIS
Amsco V-PRO1, AMSCO V-
PRO 1 Plus, and Amsco V-PRO
maX Low Temperature
Sterilization Systems | Lumen, Non Lumen, and
Flexible Cycle in the Amsco V-
Pro 1, Amsco V-PRO 1 Plus,
and Amsco V-PRO maX Low
Temperature Sterilization
Systems | Same |
| Wrapping Technique | Sequential/simultaneous double
wrapping | Simultaneous double wrapping | Similar |
| Disposable vs. Non-
Disposable | Disposable | Disposable | Same |
| Single Use vs. Reusable | Single Use | Single Use | Same |
| Biocompatibility
Testing | Pass | Pass | Same |
| Event Related
Maintenance of
Package Sterility | Pass | Pass | Same |
10
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.
11
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.