(278 days)
Not Found
No
The device is a physical sterilization wrap and the description focuses on its material properties and performance in sterilization processes. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a sterilization wrap intended to maintain sterility of medical devices, not to treat or diagnose a disease.
No
This device is a sterilization wrap used to maintain the sterility of other medical devices. It does not perform any diagnostic function.
No
The device is a physical sterilization wrap made of fabric, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to enclose medical devices for sterilization and maintain their sterility. This is a function related to the preparation and storage of medical devices, not the diagnosis of diseases or conditions using samples from the human body.
- Device Description: The device is a fabric wrap made of polypropylene. This material and its function are consistent with sterilization packaging, not diagnostic reagents or instruments.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases
The device is clearly intended for use in a healthcare setting for the sterilization and storage of other medical devices.
N/A
Intended Use / Indications for Use
Gemini Bonded 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 Bonded 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
Product codes (comma separated list FDA assigned to the subject device)
FRG
Device Description
There have been no changes to the Gemini Bonded Sterilization Wrap. The materials of construction, colorants, sizes and product specifications have not changed and are identical to what was cleared under K143147.
As previously described in K143147. Gemini Bonded Sterilization Wrap is offered to the marketplace as bulk packages of two ply sheets which are ultrasonically bonded together 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. The Gemini Bonded Sterilization Wrap provides the protection of double-wrapping in an efficient manner; cutting wrap/unwrap time in half, compared to traditional doublewrapping methods.
Gemini Bonded Sterilization Wrap 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.
The two-tone blue/pink wrap fabric is made of polypropylene with the addition of less than 2% of phthalocyanine blue pigmentation, less than 0.5% of titanium dioxide white pigmentation and less than 2% of disazocondensation red pigmentation. The wrap allows for aseptic opening of the sterilized package.
Gemini Bonded Sterilization Wrap is available in sizes ranging from 12"x12" across the 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
health care provider
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
TABLE 8: Summary of Performance Testing
Study: Maintenance of Sterility (Package integrity). Performance Results: Passed.
Steam Pre-Vacuum & Steam Gravity Cycles (Real Time Event Related Two Years Shelf Life)
STERRAD® (Real Time Event Related 180 Days Shelf Life)
Study: Pre-Vacuum Steam and Gravity Sterilant Penetration. Performance Results: Passed.
Study: STERRAD® 50 Cycle, STERRAD® 200S Cycle and STERRAD® 100NXTM DUO Cycle) Sterilant Penetration. Performance Results: Passed.
Study: Post Sterilization Biocompatibility Testing (Primary Skin Irritation Testing - ISO 10993-10). Performance Results: Passed.
The following performance testing was conducted on the lightest weight and the heaviest weight Gemini Bonded Sterilization Wrap both pre-sterilization and after exposure to a STERRAD 100NX 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 Bonded Sterilization Wrap is adequately supported by the substantial equivalence information, materials information, and Design Control activities referenced within this Premarket Notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three profiles forming its body, symbolizing the department's focus on people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 1, 2016
Medline Industries, Inc. Ms. Jennifer Mason Senior Regulatory Affairs Specialist 1 Medline Place Mundelein, IL 60060
Re: K152458 Trade/Device Name: Gemini Bonded Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization wrap Regulatory Class: Class II Product Code: FRG Dated: May 4, 2016 Received: May 5, 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.
1
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 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,
Susan Runno DDS, MA
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) K152458
Device Name Gemini Bonded Sterilization Wrap
Indications for Use (Describe)
Gemini Bonded 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 Bonded 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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3
| Gemini Wrap Model | Gemini Wrap Weight | Dry Time |
|---|---|---|
| GEM11XXS / GEM11XXT | Lightweight | 20 Minutes |
| GEM21XXS / GEM21XXT | Regular Weight | 20 Minutes |
| GEM31XXS / GEM31XXT | Medium Weight | 20 Minutes |
| GEM41XXS / GEM41XXT | Heavyweight | 30 Minutes |
| GEM51XXS / GEM51XXT | 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 |
|---|---|---|
| GEM11XXS / GEM11XXT | Lightweight | 20 Minutes |
| GEM21XXS / GEM21XXT | Regular Weight | 20 Minutes |
| GEM31XXS / GEM31XXT | Medium Weight | 20 Minutes |
| GEM41XXS / GEM41XXT | Heavyweight | 30 Minutes |
| GEM51XXS / GEM51XXT | Super Heavyweight | 30 Minutes |
TABLE 3: STERRAD® Sterilization
| Gemini Wrap Model | Gemini Wrap Weight | STERRAD® Cycles |
|---|---|---|
| GEM11XXS / GEM11XXT | Lightweight | STERRAD® 50, 200S and |
| 100NX™ DUO Cycles | ||
| GEM21XXS / GEM21XXT | Regular Weight | STERRAD® 50, 200S and |
| 100NX™ DUO Cycles | ||
| GEM31XXS / GEM31XXT | Medium Weight | STERRAD® 50, 200S and |
| 100NX™ DUO Cycles | ||
| GEM41XXS / GEM41XXT | Heavyweight | STERRAD® 50, 200S and |
| 100NX™ DUO Cycles | ||
| GEM51XXS / GEM51XXT | Super Heavyweight | STERRAD® 50, 200S and |
| 100NX™ DUO Cycles |
The Gemini Bonded 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 Bonded 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 Products |
|---|
| STERRAD® 50, 200S and STERRAD® 100 NX™ Cycles |
| Cycle | Maximum
recommended
Chamber Load | Intended Load | |
|--------------------------------------------------|----------------------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pre-Vacuum
Steam &
Gravity Steam
Cycles | Lightweight | 2 huck towels (17 in. x 29 in.), 3 fluid-resistant drapes (108 in. x 72 in.) | |
| | Regular
Weight | 16 huck towels (17 in. x 29 in.), 1 fluid resistant table cover (90 in. x 60 in.). 5 lbs. of metal mass. | |
| | Medium
Weight | 4 tray liners (20 in. x 25 in.) stacked 23 in. x 11 in. x 3.5 in. tray containing 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. |
| STERRAD®
50 | Super
Heavyweight | 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.
Reusable metal and non-metal medical devices, including up to
10 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® 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 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® 100NX™ Sterilizer User's Guide for |
4
5
| | complete instructions on load(s) and cycle(s), including chamber
loading instructions (i.e., 13.2 lbs. per load). |
| -- | ---------------------------------------------------------------------------------------------------------------------- |
|---|
TABLE 5: Wrap Model Recommendations for Use with Pre-vacuum steam cycles, Gravity steam cycles, and the Advanced Sterilization Products STERRAD® Sterilization Systems
| Gemini Wrap
Weight | Gemini
Wrap
Model | Intended Load | Maximum Recommended Wrapped
Package Content2 | |
|-----------------------|-------------------------|------------------------------------------------------------------------------------------|-------------------------------------------------|------------------------------------------------|
| | | | Pre-Vacuum,
Gravity, and EO | ASP STERRAD®
50, 200S and
100NXTM Cycles |
| Light Weight | GEM11XX | Light weight package (for
example: standard linen
packs) | 6 lbs. | 10.7 lbs. |
| Regular
Weight | GEM21XX | Light to moderate weight
package (for example:
general use medical
instruments) | 9 lbs. | 10.7 lbs. |
| Medium
Weight | GEM31XX | Moderate to heavy weight
package (for example:
general use medical
instruments) | 13 lbs. | 10.7 lbs. |
| Heavy Weight | GEM41XX | Heavy weight package
(for example: general use
medical instruments) | 17 lbs. | 10.7 lbs. |
| Super Heavy
Weight | GEM51XX | Very heavy weight
package (for example:
general use medical
instruments) | 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 healtheare 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 Bonded Sterilization Wraps (i.e .: the weight of the metal mass).
6
Image /page/6/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in a sans-serif font, with a stylized starburst symbol above and below the text. The background is a solid dark blue color. The logo is simple and modern, and the colors are professional and trustworthy.
Medline Industries, Inc. One Medline Place Mundelein. IL 60060
510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)]
K152458
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
May 4, 2016
Type of 510(k) Submission Traditional
Device Name / Classification
Name of Device: Gemini Bonded Sterilization Wrap Proprietary Name: Gemini Bonded Sterilization Wrap Common Name: Sterilization Wrap Classification Name: Wrap, Sterilization Product Code: FRG Classification: 21 CFR 880.6850 Device Class: Class II Classification Panel: General Hospital
Predicate Device
Gemini Bonded Sterilization Wrap K143147
Device Description
There have been no changes to the Gemini Bonded Sterilization Wrap. The materials of construction, colorants, sizes and product specifications have not changed and are identical to what was cleared under K143147.
7
Image /page/7/Picture/0 description: The image shows the Medline logo. The logo is white and is set against a blue background. The logo consists of the word "MEDLINE" in a sans-serif font, with a stylized starburst symbol above it. The starburst symbol has four points, with the top and bottom points being longer than the side points.
One Medline Place Mundelein. II 60060
As previously described in K143147. Gemini Bonded Sterilization Wrap is offered to the marketplace as bulk packages of two ply sheets which are ultrasonically bonded together 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. The Gemini Bonded Sterilization Wrap provides the protection of double-wrapping in an efficient manner; cutting wrap/unwrap time in half, compared to traditional doublewrapping methods.
Gemini Bonded Sterilization Wrap 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.
The two-tone blue/pink wrap fabric is made of polypropylene with the addition of less than 2% of phthalocyanine blue pigmentation, less than 0.5% of titanium dioxide white pigmentation and less than 2% of disazocondensation red pigmentation. The wrap allows for aseptic opening of the sterilized package.
Gemini Bonded Sterilization Wrap is available in sizes ranging from 12"x12" across the five different material weights/models.
Indications for Use
Gemini Bonded 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:
| TABLE 1: Pre-vacuum steam at 270°F/132°C for 4 minutes with the following dry times by weight | ||
|---|---|---|
| Gemini Wrap Model | Gemini Wrap Weight | Dry Time |
| GEM11XXS / GEM11XXT | Lightweight | 20 Minutes |
| GEM21XXS / GEM21XXT | Regular Weight | 20 Minutes |
| GEM31XXS / GEM31XXT | Medium Weight | 20 Minutes |
| GEM41XXS / GEM41XXT | Heavyweight | 30 Minutes |
| GEM51XXS / GEM51XXT | Super Heavyweight | 30 Minutes |
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 |
|---|---|---|
| GEM11XXS / GEM11XXT | Lightweight | 20 Minutes |
| GEM21XXS / GEM21XXT | Regular Weight | 20 Minutes |
| GEM31XXS / GEM31XXT | Medium Weight | 20 Minutes |
| GEM41XXS / GEM41XXT | Heavyweight | 30 Minutes |
| GEM51XXS / GEM51XXT | Super Heavyweight | 30 Minutes |
8
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, and a white star-like symbol is above the word. The symbol has four points, with the top and bottom points being longer than the side points.
Medline Industries, Inc. One Medline Place Mundelein, IL 60060
TABLE 3: STERRAD® Sterilization
| Gemini Wrap Model | Gemini Wrap Weight | STERRAD® Cycles |
|---|---|---|
| GEM11XXS / GEM11XXT | Lightweight | STERRAD® 50, 200S and |
| 100NXTM Cycles | ||
| GEM21XXS / GEM21XXT | Regular Weight | STERRAD® 50, 200S and |
| 100NXTM Cycles | ||
| GEM31XXS / GEM31XXT | Medium Weight | STERRAD® 50, 200S and |
| 100NXTM Cycles | ||
| GEM41XXS / GEM41XXT | Heavyweight | STERRAD® 50, 200S and |
| 100NXTM Cycles | ||
| GEM51XXS / GEM51XXT | Super Heavyweight | STERRAD® 50, 200S and |
| 100NXTM Cycles |
The Gemini Bonded 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 Bonded 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 Products STERRAD® 50, | |
|---|---|
| 200S, 100NXTM DUO Cycles |
| Cycle | Maximum recommended
Chamber Load | Intended Load |
|-----------------------------------------------|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pre-Vacuum
Steam & Gravity
Steam Cycles | Lightweight
6 lbs. | 2 huck towels (17 in. x 29 in.), 3 fluid-resistant drapes (108 in. x 72 in.) |
| | Regular Weight
9 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 Weight
13 lbs. | 4 tray liners (20 in. x 25 in.) stacked 23 in. x 11 in. x 3.5 in. tray containing 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. |
| | Super
Heavyweight
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 to 10 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. |
9
Image /page/9/Picture/0 description: The image features the logo of Medline, a healthcare company. The logo consists of the word "MEDLINE" in bold, white letters, positioned to the left of a stylized white starburst symbol. The background is a solid, dark blue color, providing a strong contrast that makes the logo elements stand out. The overall design is clean and professional, reflecting the company's focus on healthcare solutions.
Medline Industries, Inc. One Medline Place Mundelein, IL 60060
| STERRAD® 200 S | 10.7 lbs. | 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 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® 100NX™ 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® 100NX™ Sterilizer User's Guide for complete instructions on load(s) and cycle(s), including chamber loading instructions (i.e., 13.2 lbs. per load). |
10
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 stylized cross or star. The symbol is made up of four triangles that point towards the center of the square.
Medline Industries. Inc One Medline Place Mundelein. IL 60060
TABLE 5: Wrap Model Recommendations for Use with Pre-vacuum steam cycles, Gravity steam cycles, and the Advanced Sterilization Products STERRAD® Sterilization Systems
| Gemini Wrap
Weight | Gemini
Wrap
Model | Intended Load | Maximum Recommended Wrapped
Package Content2 | |
|-----------------------|-------------------------|------------------------------------------------------------------------------------------|-------------------------------------------------|------------------------------------------------|
| | | | Pre-Vacuum,
Gravity, and EO | ASP STERRAD®
50, 200S and
100NXTM Cycles |
| Light Weight | GEM11XX | Light weight package (for
example: standard linen
packs) | 6 lbs. | 10.7 lbs. |
| Regular
Weight | GEM21XX | Light to moderate weight
package (for example:
general use medical
instruments) | 9 lbs. | 10.7 lbs. |
| Medium
Weight | GEM31XX | Moderate to heavy weight
package (for example:
general use medical
instruments) | 13 lbs. | 10.7 lbs. |
| Heavy Weight | GEM41XX | Heavy weight package
(for example: general use
medical instruments) | 17 lbs. | 10.7 lbs. |
| Super Heavy
Weight | GEM51XX | Very heavy weight
package (for example:
general use medical
instruments) | 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 healtheare facility should determine for itself which wrap model is most appropriate for each intended use.
1 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 Bonded Sterilization Wraps (i.e.: the weight of the metal mass).
Maintenance of Sterility (Shelf Life)
Validation performance data for the Gemini Bonded Sterilization Wrap is listed below in Table 6.
TABLE 6: Maintenance of Sterility
| Sterilization Modality | Shelf Life |
|---|---|
| Pre-Vacuum & Gravity Steam | 2 years |
| STERRAD® 50, 200S and 100NX™ Cycles | 180 days |
11
Image /page/11/Picture/0 description: The image is a logo for Medline. The logo features the word "MEDLINE" in a sans-serif font, with a stylized starburst symbol behind the text. The background of the logo is a solid blue color. The starburst symbol is white, and the text is a lighter shade of blue.
Medline Industries, Inc. One Medline Place Mundelein, IL 60060
Summary of Technological Characteristics
TABLE 7: COMPARISON OF PROPOSED AND PREDICATE DEVICES
| Device Characteristic | Proposed Device | Predicate Device | Comparison
Analysis |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Gemini Bonded Sterilization
Wrap | Gemini Bonded Sterilization
Wrap | Same |
| 510(k) Reference | | K143147 | |
| Product Owner | Medline Industries, Inc. | Medline Industries, Inc. | Same |
| Product Code | FRG | FRG | Same |
| Intended Use | Gemini Bonded 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. | Gemini Bonded 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. | Same |
| Regulation Number | 21 CFR 880.6850 | 21 CFF 880.6850 | Same |
| Design Features | Square or rectangular sheets
mfd. by spunbond-meltblown
process | Square or rectangular sheets
mfd. by spunbond-meltblown
process | 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 with
phthalocyanine blue, titanium
dioxide and
disazocondensation red | Polypropylene with
phthalocyanine blue, titanium
dioxide and
disazocondensation red | Same |
| Wrapping Technique | Sequential/simultaneous
double wrapping | Sequential/simultaneous
double wrapping | Same |
| Bonding Material | Ultrasonically seamed in a
dotted line pattern along two
sides | Ultrasonically seamed in a
dotted line pattern along two
sides | Same |
| Prescription vs. OTC | OTC | OTC | Same |
| Sterilization | Pre-Vacuum Steam Cycle: 4
Minutes Exposure at
270°F/132C° with minimum
20 minutes dry time | Pre-Vacuum Steam Cycle: 4
Minutes Exposure at
270°F/132C° with minimum
20 minutes dry time | Same |
| | Gravity Steam Cycle: 30
Minutes Exposure at
250°F/121°C with minimum | Gravity Steam Cycle: 30
Minutes Exposure at
250°F/121°C with minimum | Same |
| | 20 minutes dry time | 20 minutes dry time | |
| | STERRAD® 50, 200S and | N/A | Different |
| | 100NXTM DUO | | |
| | STERRAD® NXTM, | STERRAD® NXTM. | Same |
| | (Standard Cycle, Advanced | (Standard Cycle, Advanced | |
| | Cycle) | Cycle) | |
| | STERRAD® 100S. | STERRAD® 100S. | Same |
| | Standard Cycle | Standard Cycle | |
| | STERRAD® 100NX™. | STERRAD® 100NX™, | Same |
| | (Standard Cycle, Flex Cycle, | (Standard Cycle, Flex Cycle, | |
| | EXPRESS Cycle) | EXPRESS Cycle) | |
| Maintenance of Sterilitv | Steam - 2 years | Steam - 180 days | Different |
| (Shelf Life) | STERRAD® – 180 days | STERRAD® – 180 days | Same |
| Single Use vs. Reusable | Single Use | Single Use | Same |
12
Image /page/12/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 symbol. The starburst has four points, creating a visual effect of radiating light or energy. The overall design is clean and corporate, conveying a sense of professionalism and reliability.
ledline Industries, Inc One Medline Place Mundelein. IL 60060
Discussion of Similarities and Differences
The proposed Gemini Bonded Sterilization Wrap is substantially equivalent in intended use, materials, device features / specifications and function to the predicate (K143147) Gemini Bonded Sterlization 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 K143147.
- Addition of STERRAD® Systems: STERRAD® 50 Cycle, STERRAD® 200S Cycle and STERRAD® ● 100NXTM Duo Cycle.
This product modification involving the subject and predicate devices does not significantly alter the Gemini Bonded 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 Bonded Sterilization Wrap and the cited predicate device K143147.
13
Image /page/13/Picture/0 description: The image features the Medline logo, set against a blue background. The logo consists of the word "MEDLINE" in a bold, sans-serif font, positioned to the left of a stylized white cross-like symbol. The cross is formed by two intersecting lines, with the vertical line extending further down than the horizontal one, creating a distinctive visual element.
edline Industries. ne Medline Place Mundelein. II 60060
Summary of Non-Clinical Testing
TABLE 8: Summary of Performance Testing
| Study | Performance Results | |
|---|---|---|
| Maintenance of | ||
| Sterility (Package | ||
| integrity) | Steam Pre-Vacuum & Steam Gravity Cycles | |
| (Real Time Event Related Two Years Shelf Life) | ||
| STERRAD® (Real Time Event Related 180 | ||
| Days Shelf Life) | Passed | |
| Pre-Vacuum Steam and Gravity Sterilant Penetration | Passed | |
| STERRAD® 50 Cycle, STERRAD® 200S Cycle and STERRAD® | ||
| 100NXTM DUO Cycle) Sterilant Penetration | Passed | |
| Post Sterilization Biocompatibility Testing (Primary Skin Irritation | ||
| Testing - ISO 10993-10) | Passed |
The following performance testing was conducted on the lightest weight and the heaviest weight Gemini Bonded Sterilization Wrap both pre-sterilization and after exposure to a STERRAD 100NX 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 Bonded 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.
Conclusion
Based on the intended use, technological characteristics, performance data, and nonclinical tests performed, the subject Gemini Bonded Sterilization Wrap are substantially equivalent to, and are as safe and as effective as, the legally marketed predicate device, Gemini Bonded Sterilization Wrap cleared under K143147.