(185 days)
Not Found
No
The device description and intended use clearly describe a physical sterilization wrap made of fabric, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No.
The device is a sterilization wrap used to maintain sterility of medical devices, not to treat or diagnose a disease or condition in a patient.
No
The device, Gemini Bonded Sterilization Wrap, is intended to enclose medical devices for sterilization and maintain their sterility. It does not perform any diagnostic function.
No
The device description clearly states it is a physical product made of fabric (polypropylene) and is used to enclose other medical devices for sterilization. It is a tangible item, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Gemini Bonded Sterilization Wrap is used to enclose another medical device for sterilization and maintain its sterility. This is a function related to the preparation and storage of medical devices, not the diagnosis of diseases or conditions.
- Device Description: The description details the physical characteristics and material composition of the wrap, which is designed for packaging and sterilization. It does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic information about a patient's health status
- Use in a laboratory setting for diagnostic purposes
The device's function is purely related to the sterilization and sterile storage of other medical devices.
N/A
Intended Use / 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 for 180 days following sterilization. Gemini Bonded Sterilization Wrap is validated for use in steam or STERRAD® sterilization processes in the following sterilization modes and cycles.
- Pre-vacuum steam cycles
- Minimum 4 Minutes Exposure at 270°F/132°C with minimum 20 minutes dry time
- Gravity steam cycles
- Maximum 30 Minutes Exposure at 250°F/121°C with minimum 20 minutes dry time
- STERRAD® Sterilization
- STERRAD® 100NX, Flex cycle
- STERRAD® 100NX, Standard cycle
- STERRAD® 100NX, Express cycle
- STERRAD® 100S. Standard cycle
- STERRAD® NX, Advanced cycle
- STERRAD® NX, Standard cycle
The Gemini Bonded Sterilization Wrap intended loads with pre-vacuum steam sterilization, gravity steam sterilization, and the Advanced Sterilization Products (ASP) STERRAD® 100S, and STERRAD® 100S, and STERRAD® NX cycles are provided in Table 1.
The Gemini Bonded Sterilization Wrap Recommendations for Use with Pre-vacuum steam cycles. and the Advanced Sterilization Products STERRAD® Sterilization Systems are provide in Table 2.
Product codes (comma separated list FDA assigned to the subject device)
FRG
Device Description
Gemini Bonded Sterilization Wrap is comprised of two ply sheets 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 collections of medical devices are wrapped. The Gemini Bonded Sterilization Wrap provides the protection of double-wrapping in an efficient manner; reducing wrapping/unwrapping time significantly compared to traditional double-wrapping methods. Gemini Bonded Sterilization Wrap items are square or rectangular sheets of fabric produced using a five-layer SSMMS (spunbondspunbond-meltblown-meltblown-spunbond) process. The standard blue wrap fabric is made of polypropylene with the addition of blue and 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 blue, white and red pigmentation. The wrap allows for aseptic opening of the sterilized package. 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
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 1 - Summary of Performance Testing
Primary Skin Irritation Testing – Testing Standards: ISO 10993-10, Performance Results: Meets ISO Requirements
Microbial Barrier Properties – Testing Standards: ISO 11607-1, ASTM F1980, Performance Results: Meets ISO and ASTM Requirements
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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, each head facing a different direction. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 7, 2015
Medline Industries, Inc. Mr. Matt Clausen Senior Regulatory Affairs Specialist One Medline Place Mundelein, IL 60060
Re: K143147
Trade/Device Name: Gemini Bonded Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: April 15, 2015 Received: April 17, 2015
Dear Mr. Clausen:
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
Page 2 - Mr. Clausen
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 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,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K143147
Device Name Gemini Bonded Sterilization Wrap
Indications for Use (Describe)
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 for 180 days following sterilization. Gemini Bonded Sterilization Wrap is validated for use in steam or STERRAD® sterilization processes in the following sterilization modes and cycles.
- Pre-vacuum steam cycles
-
- Minimum 4 Minutes Exposure at 270°F/132°C with minimum 20 minutes dry time
-
· Gravity steam cycles
-
- Maximum 30 Minutes Exposure at 250°F/121°C with minimum 20 minutes dry time
· STERRAD® Sterilization
-
- STERRAD® 100NX, Flex cycle
-
- STERRAD® 100NX, Standard cycle
-
- STERRAD® 100NX, Express cycle
-
- STERRAD® 100S. Standard cycle
-
- STERRAD® NX, Advanced cycle
-
- STERRAD® NX, Standard cycle
The Gemini Bonded Sterilization Wrap intended loads with pre-vacuum steam sterilization, gravity steam sterilization, and the Advanced Sterilization Products (ASP) STERRAD® 100S, and STERRAD® 100S, and STERRAD® NX cycles are provided in Table 1.
The Gemini Bonded Sterilization Wrap Recommendations for Use with Pre-vacuum steam cycles. and the Advanced Sterilization Products STERRAD® Sterilization Systems are provide in Table 2.
(tables 1 and 2 are on a separate attachment. SEE ATTACHMENT)
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
V | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Number: K143147
Device Name: Gemini Bonded Sterilization Wrap
Table 1 – Validated Advanced Sterilization Products STERRAD® 100S, and STERRAD® NX 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® 100NX,
Flex Cycle | 10.7 lbs. | One or two single-channel Flexible Endoscope with or without a silicone mat and no additional load. 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. (A maximum of two flexible endoscope, one per tray per sterilization cycle.) |
| STERRAD® 100NX,
Standard Cycle | 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 0.7 mm or larger and a length of 500 mm or shorter of single-channel stainless steel lumens. (A maximum of two flexible endoscopes, one per tray per sterilization cycle.) |
| STERRAD® 100NX,
EXPRESS Cycle | 10.7 lbs. | Non-lumened reusable metal and non-metal devices requiring surface sterilization, and sterilization of diffusion-restricted spaces such as the hinged portions of forceps and scissors, and rigid or semi-rigid endoscopes without lumens. |
5
| STERRAD® 100S,
Standard Cycle | Light Weight | 6
lbs. | Reusable metal and non-metal medical devices, including
up to 10 lumens of the following dimensions per chamber |
|----------------------------------|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| | Regular Weight | | load: |
| | Medium Weight | | • An inside diameter of 1mm or larger and a length of |
| | Heavyweight | | 125 mm or shorter of single-channel stainless steel |
| | Super Heavyweight | | lumens. |
| | | 10.7
lbs. | • An inside diameter OF 2 mm or larger and length of |
| | | | 250 mm or shorter of single-channel stainless steel
lumens. |
| | | | • An inside diameter of 3 mm or larger and a length of |
| | | | 400 mm or shorter of single-channel stainless lumens. |
| | | | • An inside diameter of 6 mm or larger and a length of |
| | | | 310 mm or shorter of single-channel
Teflon/Polyethylene lumens. |
| | | | |
| STERRAD® NX,
Advanced Cycle | 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 of larger and a length of 500 mm | |
| | | or shorter of single-channel stainless steel lumens | |
| | | Or | |
| | | One single-channel Flexible Endoscope with or without a silicone | |
| | | mat and no additional load. 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. | |
| STERRAD® NX,
Standard Cycle | 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 of larger and a length of 150 mm | |
| | | or shorter of single-channel stainless steel lumens. | |
| | | • An inside diameter of 2 mm or larger and a length of 400 mm | |
| | | or shorter of single-channel stainless steel lumens. | |
| | | | |
Table 2 – Wrap Model Recommendations for Use with Pre-vacuum steam cycles, Gravity steam cycles, and the Advanced Sterilization Products STERRAD® Sterilization Systems
| | | | Maximum Wrapped Package
Content Weights Based on Validated Sterility
Cycle | | |
|-----------------------|-----------------------|------------------------------------------------------|----------------------------------------------------------------------------------|--------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Gemini Wrap
Weight | Item Number
Series | Intended Load | Pre-Vacuum
Steam &
Gravity
Steam | Advanced
Sterilization
Products
(ASP)
STERRAD®
100S | Advanced
Sterilization
Products
(ASP)
STERRAD®
NX and
100NX |
| Light Weight | GEM11XX
GEM11XXS | Light weight package (for
example: standard linen | 6 lbs | 6 lbs | 10.7 lbs |
6
| GEM11XXT | packs) | ||||
|---|---|---|---|---|---|
| Regular Weight | GEM21XX | ||||
| GEM21XXS | |||||
| GEM21XXT | Light to moderate weight | ||||
| package (for example: | |||||
| general use medical | |||||
| instruments) | 9 lbs | 9.7 lbs | 10.7 lbs | ||
| Medium Weight | GEM31XX | ||||
| GEM31XXS | |||||
| GEM31XXT | Moderate to heavy | ||||
| weight package (for | |||||
| example: general use | |||||
| medical instruments) | 13 lbs | 9.7 lbs | 10.7 lbs | ||
| Heavyweight | GEM41XX | ||||
| GEM41XXS | |||||
| GEM41XXT | Heavyweight package (for | ||||
| example: general use | |||||
| medical instruments) | 17 lbs | 9.7 lbs | 10.7 lbs | ||
| Super | |||||
| Heavyweight | GEM51XX | ||||
| GEM51XXS | |||||
| GEM51XXT | Very heavyweight | ||||
| package (for example: | |||||
| general use medical | |||||
| instruments) | 25 lbs | 9.7 lbs | 10.7 lbs |
The following loads were used in the pre-vacuum steam and gravity steam Sterility Validation Studies:
- Light Weight: 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 Ibs of metal mass.
- o Heavyweight: 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: 4 tray liners (20 in. x 25 in.) stacked 23in. x 11in. x 3.5 in. tray containing 20 lbs of metal mass.
The following loads were used in the Advanced Sterilization Products (ASP) STERRAD 100S Sterility Validation Studies:
- Light Weight: 15 in. x 10 in. x 1.2 in. tray containing metal instruments.
- Regular Weight: 15 in. x 10 in. x 1.2 in. tray containing metal instruments.
- . Medium Weight: 15 in. x 10 in. x 1.2 in. tray containing metal instruments.
- Heavyweight: 15 in. x 10 in. x 1.2 in. tray containing metal instruments.
- Super Heavyweight: 15 in. x 10 in. x 1.2 in. tray containing metal instruments.
7
The following loads were used in the Advanced Sterilization Products (ASP) STERRAD NX and STERRAD 100NX Sterility Validation Studies:
- Light Weight: 23 in. x 11 in. x 4 in tray containing metal instruments. ●
- Regular Weight: 23 in. x 11 in. x 4 in tray containing metal instruments.
- Medium Weight: 23 in. x 11 in. x 4 in tray containing metal instruments.
- Heavyweight: 23 in. x 11 in. x 4 in tray containing metal instruments. .
- . Super Heavyweight: 23 in. x 11 in. x 4 in tray containing metal instruments.
8
Image /page/8/Picture/0 description: The image shows the logo for Medline. The word "MEDLINE" is written in blue, stylized, sans-serif font. Below the text is a blue, four-pointed star-like shape, with the bottom point extending further down than the other three. The logo is simple and clean, using only the color blue.
510(k) Summary (as required per 21 CFR 807.92)
Summary Preparation Date
May 7, 2015
Submitter / 510(k) Sponsor
Medline Industries, Inc. One Medline Place Mundelein, IL 60060
Contact Person
Matt Clausen Sr. Regulatory Affairs Specialist Phone: 847-643-4785 Fax: 847-643-4482
Device Name / Classification
Device Name: Gemini Bonded Sterilization Wrap Proprietary Name: Medline's Gemini Bonded Sterilization Wrap Common Name: Sterilization Wrap Classification Name: Sterilization Wrap (21 CRF 880.6850, product code - FRG)
Predicate Device
Gemini Sterilization Wrap - K113353
Device Description
Gemini Bonded Sterilization Wrap is comprised of two ply sheets 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 collections of medical devices are wrapped. The Gemini Bonded Sterilization Wrap provides the protection of double-wrapping in an efficient manner; reducing wrapping/unwrapping time significantly compared to traditional double-wrapping methods. Gemini Bonded Sterilization Wrap items are square or rectangular sheets of fabric produced using a five-layer SSMMS (spunbondspunbond-meltblown-meltblown-spunbond) process. The standard blue wrap fabric is made of polypropylene with the addition of blue and 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 blue, white and red pigmentation. The wrap allows for aseptic opening of the sterilized package. Gemini sterilization wrap is available in sizes ranging from 12"x12" to 54"x72" across five different material weights/models.
9
Image /page/9/Picture/0 description: The image shows the logo for Medline. The logo is blue and consists of the word "MEDLINE" in a sans-serif font, with a stylized starburst symbol below it. The starburst has four points and a curved line connecting the bottom two points.
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 the enclosed device until opened. Gemini Bonded Sterilization Wrap is validated for use in steam or STERRAD® sterilization processes in the following sterilization modes and cycles.
- Pre-vacuum steam cycles
- Minimum 4 Minutes Exposure at 270°F/132°C with minimum 20 minutes dry time o
- Gravity steam cycles
- Maximum 30 Minutes Exposure at 250°F/121°C with minimum 20 minutes dry time o
- STERRAD® Sterilization ●
- STERRAD® 100NX, Flex cycle o
- STERRAD® 100NX, Standard cycle o
- STERRAD® 100NX, Express cycle o
- STERRAD® 100S, Standard cycle O
- STERRAD® NX, Advanced cycle o
- STERRAD®NX, Standard cycle O
The Gemini Bonded Sterilization Wrap intended loads with pre-vacuum steam sterilization, gravity steam sterilization, and the Advanced Sterilization Products (ASP) STERRAD® 100NX, STERRAD® 100S, and STERRAD® NX cycles are provided in Table 1.
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 2.
10
Image /page/10/Picture/0 description: The image shows the word "MEDLINE" in blue, with a stylized star symbol to the right of the word. The word is in a bold, italicized font, and the star symbol has four points. The star symbol is also in blue and appears to be connected to the word "MEDLINE".
Table 1 – Validated Advanced Sterilization Products STERRAD® 100NX, STERRAD® 100S, and STERRAD® NX 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® 100NX, Flex Cycle | 10.7 lbs. | One or two single-channel Flexible Endoscope with or without a silicone mat and no additional load. 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. (A maximum of two flexible endoscope, one per tray per sterilization cycle.) | ||
| STERRAD® 100NX, Standard Cycle | 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 0.7 mm or larger and a length of 500 mm or shorter of single-channel stainless steel lumens. (A maximum of two flexible endoscopes, one per tray per sterilization cycle.) | ||
| STERRAD® 100NX, EXPRESS Cycle | 10.7 lbs. | Non-lumened reusable metal and non-metal devices requiring surface sterilization, and sterilization of diffusion-restricted spaces such as the hinged portions of forceps and scissors, and rigid or semi-rigid endoscopes without lumens. |
| STERRAD® 100S, Standard Cycle | Light Weight 6 lbs. | Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load: |
| Regular Weight | 10.7 | |
| Medium Weight | ||
| Heavyweight | ||
| Super Heavyweight | lbs. | |
| 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 length of 250 mm or shorter of single-channel stainless steel lumens. An inside diameter of 3 mm or larger and a length of 400 mm or shorter of single-channel stainless lumens. An inside diameter of 6 mm or larger and a length of 310 mm or shorter of single-channel Teflon/Polyethylene lumens. | ||
| STERRAD® | ||
| NX, Advanced | ||
| Cycle | 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 of larger and a length of 500 mm or shorter of single-channel stainless steel lumens Or |
| One single-channel Flexible Endoscope with or without a silicone mat and no additional load. 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. | ||
| STERRAD® | ||
| NX, Standard | ||
| Cycle | 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 of larger and a length of 150 mm or shorter of single-channel stainless steel lumens. An inside diameter of 2 mm or larger and a length of 400 mm or shorter of single-channel stainless steel lumens. |
11
Image /page/11/Picture/0 description: The image shows the logo for Medline. The logo consists of the word "MEDLINE" in blue, with a stylized blue starburst symbol below it. The starburst has four points, with the bottom point extending downwards.
Medline Industries, Inc. One Medline Place Mundelein, IL 60060-4486
12
Image /page/12/Picture/0 description: The image shows the word "MEDLINE" in blue, with a star-like symbol below it. The word is written in a bold, italicized font. The star symbol has four points, with the bottom point being longer than the other three. The image is set against a white background.
Table 2 – Wrap Model Recommendations for Use with Pre-vacuum steam cycles, Gravity steam cycles, and the Advanced Sterilization Products STERRAD® Sterilization Systems
| | Item Number
Series | | Maximum Wrapped Package
Content Weights Based on Validated
Sterility Cycle | | |
|-----------------------|---------------------------------|------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Gemini Wrap
Weight | | Intended Load | Pre-
Vacuum
Steam &
Gravity
Steam | Advanced
Sterilizatio
n Products
(ASP)
STERRAD
® 100S | Advanced
Sterilizatio
n Products
(ASP)
STERRAD
® NX and
100NX |
| Light Weight | GEM11XX
GEM11XXS
GEM11XXT | Light weight package
(for example: standard
linen packs) | 6 lbs | 6 lbs | 10.7 lbs |
| Regular
Weight | GEM21XX
GEM21XXS
GEM21XXT | Light to moderate
weight package (for
example: general use
medical instruments) | 9 lbs | 9.7 lbs | 10.7 lbs |
| Medium
Weight | GEM31XX
GEM31XXS
GEM31XXT | Moderate to heavy
weight package (for
example: general use
medical instruments) | 13 lbs | 9.7 lbs | 10.7 lbs |
| Heavyweight | GEM41XX
GEM41XXS
GEM41XXT | Heavyweight package
(for example: general
use medical
instruments) | 17 lbs | 9.7 lbs | 10.7 lbs |
| Super
Heavyweight | GEM51XX
GEM51XXS
GEM51XXT | Very heavyweight
package (for example:
general use medical
instruments) | 25 lbs | 9.7 lbs | 10.7 lbs |
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Image /page/13/Picture/0 description: The image shows the logo for Medline. The word "MEDLINE" is in blue, block letters. Below the word is a blue star-like shape with four points. The bottom point of the star is elongated.
Summary of Technological Characteristics
Comparison of Subject and Predicate Devices
| Characteristic | Subject Device | Predicate Device | Compariso
n |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| 510(k) | TBD | K113353 | n/a |
| Product Code | FRG | FRG | Same |
| Regulation No. | 21 CRF 880.6850 | 21 CRF 880.6850 | Same |
| Class | II | II | 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
for 180 days following
sterilization. Gemini Bonded
Sterilization Wrap is validated for
use in steam or STERRAD®
sterilization processes. | Gemini Sterilization Wrap is
intended to be used to enclose
another medical device that is to
be sterilized by a health care
provider. It is intended to allow
sterilization of the enclosed
medical device and also to
maintain sterility of such content
for 180 days following
sterilization. Gemini Sterilization
Wrap is validated for use in steam
or STERRAD® sterilization
processes. | Same |
| OTC / single
use | Yes | Yes | Same |
| Device
materials | Polypropylene w/ blue and pink
pigmentation | Polypropylene w/ blue and pink
pigmentation | Same |
| Device features | Square or rectangular sheets mfd.
by spunbond-meltblown process | Square or rectangular sheets mfd.
by spunbond-meltblown process | Same |
| Sizes | 12"x12" to 54"x72" | 12"x12" to 54"x72" | Same |
| Wrapping
technique | Sequential/simultaneous double
wrapping | Sequential/simultaneous double
wrapping | Same |
| Bonding
method | Ultrasonically seamed in a dotted
line pattern along two sides | Unbonded | Different |
| Sterilization | Pre-Vacuum Steam Cycle: 4
Minutes Exposure at
270°F/132C° with minimum
20 minutes dry time
Gravity Steam Cycle: 30 | Pre-Vacuum Steam Cycle: 4
Minutes Exposure at
270°F/132C° with minimum
20 minutes dry time
Gravity Steam Cycle: 30 | Same |
| | Minutes Exposure at
250°F/121°C with minimum
20 minutes dry time | | Minutes Exposure at
250°F/121°C with minimum
20 minutes dry time |
| - | STERRAD® 100NX (Flex,
Standard, and Express
Cycles) | - | STERRAD® 100NX (Flex,
Standard, and Express
Cycles) |
| - | STERRAD® 100S,
Standard Cycle | - | STERRAD® 100S,
Standard Cycle |
| - | STERRAD® NX (Advance
and Standard Cycles) | - | STERRAD® NX (Advance
and Standard Cycles) |
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Image /page/14/Picture/0 description: The image shows the Medline logo. The logo is blue and consists of the word "MEDLINE" in a stylized font, with a star-like symbol to the right of the word. The star symbol has four points, and there is a curved shape below the star.
Medline Industries. Inc. One Medline Place Mundelein, IL 60060-4486
This table illustrates the identical nature of the subject/predicate devices across all but one of the comparative features. The singular difference of ultrasonic bonding is the reason for this Special 510(k) submission.
Discussion of similarities and differences:
The proposed Gemini Bonded Sterilization Wrap is substantially equivalent in intended use, materials, device features / specifications and function in comparison to the predicate Gemini Sterilization Wrap. As noted in the table above, these characteristic comparisons render the devices identical. The difference between subject/predicate devices is related to:
- . Bonding Method: The process involves the ultrasonic bonding on two single ply sheets of Gemini Sterilization Wrap. High-frequency ultrasonic acoustic vibrations and pressure fuse bond the layers together in a three-dotted line pattern along two open sides. There is no adhesive or other materials introduced to facilitate the bonding operation - strictly ultrasonic acoustic vibration and pressure.
Once the bonding process is completed, the predicate Gemini Wrap is converted into the proposed Gemini Bonded Wrap.
The following responses to FDA's 510(k) "Substantial Equivalence" Decision-Making Process (Overview) flow chart demonstrate substantial equivalence in terms of indications for use and technological characteristics.
Does the New Device Have the Same Intended Use?
Yes, the subject and predicate (K113353) have the same intended uses.
Does the New Device Have Technological Characteristics That Raise New Types of Safety and Effectiveness Ouestions?
There are no new technology characteristics. The Gemini Bonded Sterilization Wrap incorporates the same design features and principles of operation found in currently marketed product.
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Image /page/15/Picture/0 description: The image shows the Medline logo and address. The logo is a blue star with the word "MEDLINE" in blue letters. The address is "Medline Industries, Inc., One Medline Place, Mundelein, IL 60060-4486".
This product modification involving the subject and predicate devices does not significantly alter the Gemini 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.
Summary of Non-Clinical Testing
Table 1 - Summary of Performance Testing
| Test Objective | Testing Standards | Performance Results |
|---|---|---|
| Primary Skin Irritation Testing | ISO 10993-10 | Meets ISO Requirements |
| Microbial Barrier Properties | ISO 11607-1 | |
| ASTM F1980 | Meets ISO and ASTM | |
| Requirements |
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
In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the Gemini Bonded Sterilization Wrap is as safe, as effective, and performs as well as the predicate device [Gemini Sterilization Wrap (K113353)].