(239 days)
No
The device is a physical sterilization wrap and the summary describes its material properties and intended use in standard sterilization processes. There is no mention of any 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 other medical devices, not to provide therapeutic care directly to a patient.
No.
The device is a sterilization wrap intended to enclose other medical devices for sterilization and maintain their sterility, not to diagnose a condition.
No
The device description clearly states it is a physical product made of non-woven fabric (polypropylene) and describes its physical characteristics, including size, material composition, and pigmentation. It is a tangible wrap used for sterilization, not a software program.
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 wraps are used to enclose other 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 disease or other conditions.
- Device Description: The description details the physical characteristics and materials of the wraps, which are designed for packaging and sterilization processes. There is no mention of 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 substances in biological samples
- Providing information for diagnosis, monitoring, or screening
- Reagents, calibrators, or controls
The function of Gemini Sterilization Wraps is to facilitate the sterilization and storage of other medical devices, which falls under the category of general medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Gemini Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of such content until used. Gemini Sterilization Wrap is validated for use in the following sterilization processes modes and cycles:
TABLE 1: STERIS V-PRO® Low Temperature Sterilization Systems. The wrap was validated to be effectively aerated during the pre-programmed cycles
Gemini Wrap Model: GEM11XX/GEM11XXS/GEM11XXT (Lightweight), STERIS V-PRO® Low Temperature Sterilization Cycles: STERIS V-PRO® 60 (Lumen, Non-Lumen and Flexible Cycles)
Gemini Wrap Model: GEM21XX/GEM11XXS/GEM11XXT (Regular Weight), STERIS V-PRO® Low Temperature Sterilization Cycles: STERIS V-PRO® 1 (Lumen Cycle) (per K150698)
Gemini Wrap Model: GEM31XX/GEM31XXS/GEM31XXT (Medium Weight), STERIS V-PRO® Low Temperature Sterilization Cycles: STERIS V-PRO® 1 Plus (Lumen and Non-Lumen Cycle) (per K150698)
Gemini Wrap Model: GEM41XX/GEM41XXS/GEM41XXT (Heavyweight), STERIS V-PRO® Low Temperature Sterilization Cycles: STERIS V-PRO® maX (Lumen, Non-Lumen, and Flexible Cycle)(per K150698)
Gemini Wrap Model: GEM51XX/GEM51XXS/GEM51XXT (Super Heavyweight)
TABLE 2: STERIZONE® VP4 Sterilization System
Gemini Wrap Model: GEM11XX/GEM11XXS/GEM11XXT (Lightweight), STERIZONE® VP4 Sterilization System: STERIZONE® VP4 Sterilizer single preset sterilization cycle
Gemini Wrap Model: GEM21XX/GEM21XXS/GEM21XXT (Regular Weight)
Gemini Wrap Model: GEM31XX/GEM31XXS/GEM31XXT (Medium Weight)
Gemini Wrap Model: GEM41XX/GEM41XXS/GEM41XXT (Heavyweight)
Gemini Wrap Model: GEM51XX/GEM51XXS/GEM51XXT (Super Heavyweight)
Product codes (comma separated list FDA assigned to the subject device)
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 Gemini Sterilization Wrap ultrasonically seamed on two parallel sides. This allows for convenient wrapping with two sheets simultaneously.
Gemini Sterilization Wrap items are square or rectangular sheets of non-woven 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 3 different shades of blue that vary in the amount of phthalocyanine blue pigmentation depending on the weight of the wrap. Also, some wraps contain titanium dioxide and others do not. A detailed description of material composition can be found in the Device Description section.
The two-tone blue/pink wrap fabric is made of polypropylene with the addition of less than 2% phthalocyanine blue pigmentation, less than 0.5% of titanium dioxide white pigmentation and less than 2% of disazocondensation red pigmentation. The two-tone blue/pink wraps are offered in 3 different shades of blue and pink that vary in the amount of phthalocyanine, disazocondensation red and titanium dioxide depending on the weight of the wrap. A detailed description of material composition can be found in the Device Description section.
Gemini Sterilization Wrap is available in sizes ranging from 12" x 72" across five different material weights/models listed below. Photos showing the different material weights are listed in Figure 2 below. Additional product and size information is provided in Table 1 below. The material composition of the Gemini Sterilization Wrap is listed in Table 2. Details on the product variations and composition are also provided with Appendix B.
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 4: Summary of Performance Testing V-PRO® 60
Performance Study: Maintenance of Sterility, Performance Results: Passed
Performance Study: Sterilant Penetration, Performance Results: Passed
Performance Study: Tensile breaking strength and elongation (ASTM D5034), Performance Results: Passed
Performance Study: Tear Strength (ASTM D5587), Performance Results: Passed
Performance Study: Hydrostatic Pressure (AATCC 127), Performance Results: Passed
Performance Study: Burst Pressure (ASTM D3786), Performance Results: Passed
Performance Study: Air Permeability (ASTM D737), Performance Results: Passed
Performance Study: Post Sterilization Biocompatibility (Cytotoxicity – ISO 10993-5, Performance Results: Passed
Performance Study: Post Sterilization Biocompatibility (Primary Skin Irritation Testing- ISO 10993-10), Performance Results: Passed
TABLE 5: Summary of Performance Testing Sterizone VP4
Performance Study: Maintenance of Sterility, Performance Results: Passed
Performance Study: Sterilant Penetration, Performance Results: Passed
Performance Study: Tensile breaking strength and elongation (ASTM D5034), Performance Results: Passed
Performance Study: Tear Strength (ASTM D5587), Performance Results: Passed
Performance Study: Hydrostatic pressure (AATCC 127), Performance Results: Passed
Performance Study: Air Permeability (ASTM D737), Performance Results: Passed
Performance Study: Post Sterilization Biocompatibility (Cytotoxicity – ISO 10993-5, Performance Results: Passed
Performance Study: Post Sterilization Biocompatibility (Primary Skin Irritation Testing- ISO 10993-10), Performance Results: Passed
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.
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three overlapping human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 23, 2017
Medline Industries, Inc. Jennifer Mason Senior Regulatory Affairs Specialist One Medline Place Mundelein, Illinois 60060
Re: K162993
Trade/Device Name: Gemini Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: May 16, 2017 Received: June 25, 2017
Dear Jennifer Mason:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.
1
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Lori A. Wiggins -S6
Lori A. Wiggins, MPT, CLT Acting 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
Expiration Date: January 31, 2017 See PRA Statement below.
Form Approved: OMB No. 0910-0120
510(k) Number (if known) K162993
Device Name Gemini Sterilization Wrap
Indications for Use (Describe)
Gemini Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of such content until used. Gemini Sterilization Wrap is validated for use in the following sterilization processes 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"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."
3
TABLE 1: STERIS V-PRO® Low Temperature Sterilization Systems. The wrap was validated to be effectively aerated during the pre-programmed cycles
| Gemini Wrap Model | Gemini
Wrap
Weight | STERIS V-PRO® Low
Temperature Sterilization
Cycles |
|---------------------------|--------------------------|--------------------------------------------------------------------------------|
| GEM11XX/GEM11XXS/GEM11XXT | Lightweight | ■ STERIS V-PRO® 60 (Lumen, Non-
Lumen and Flexible Cycles) |
| GEM21XX/GEM11XXS/GEM11XXT | Regular Weight | ■ STERIS V-PRO® 1 (Lumen Cycle)
(per K150698) |
| GEM31XX/GEM31XXS/GEM31XXT | Medium Weight | ■ STERIS V-PRO® 1 Plus (Lumen and
Non-Lumen Cycle) (per K150698) |
| GEM41XX/GEM41XXS/GEM41XXT | Heavyweight | ■ STERIS V-PRO® maX (Lumen, Non-
Lumen, and Flexible Cycle)(per
K150698) |
| GEM51XX/GEM51XXS/GEM51XXT | Super Heavyweight | |
TABLE 2: STERIZONE® VP4 Sterilization System
| Gemini Wrap Model | Gemini
Wrap
Weight | STERIZONE® VP4
Sterilization System |
|---------------------------|--------------------------|----------------------------------------|
| GEM11XX/GEM11XXS/GEM11XXT | Lightweight | • STERIZONE® VP4 Sterilizer single |
| GEM21XX/GEM21XXS/GEM21XXT | Regular Weight | preset sterilization cycle |
| GEM31XX/GEM31XXS/GEM31XXT | Medium Weight | |
| GEM41XX/GEM41XXS/GEM41XXT | Heavyweight | |
| GEM51XX/GEM51XXS/GEM51XXT | Super Heavyweight | |
TABLE 3: Wrap Model Recommendations1
| Gemini Wrap
Weight | Gemini
Wrap
Model | Intended Load | Maximum Recommended Wrapped Package
Content2
STERIS V-
PRO® 1,
1Plus, maX | STERIS V-
PRO 60® | STERIZONE®
VP4 Sterilizer |
|-----------------------|-------------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|----------------------|------------------------------|
| Light Weight | GEM1 | Light weight
package (for
example: standard
linen packs) | 6.5 lbs. | 6 lbs. | 6 lbs. |
| Regular
Weight | GEM2 | Light to moderate
weight package (for
example: general
use medical
instruments) | 9 lbs. | 9 lbs. | 9 lbs. |
| Medium
Weight | GEM3 | Moderate to heavy
weight package (for
example: general
use medical
instruments) | 10 lbs. | 13 lbs. | 13 lbs. |
| Heavy Weight | GEM4 | Heavy weight
package (for | 10 lbs. | 17 lbs. | 17 lbs. |
4
| | | example: general
use medical
instruments) | | | |
|-----------------------|------|--------------------------------------------------------------------------------------|---------|---------|---------|
| Super Heavy
Weight | GEM5 | Very heavy weight
package (for
example: general
use medical
instruments) | 10 lbs. | 25 lbs. | 25 lbs. |
The following loads were used in STERIS V-PRO® 1, 1Plus, maX Sterility Maintenance Validation Studies:
- GEM1: 2.5 lbs. metal mass, 6 forceps, STERIS V-PRO® Tray (17 in. x 10 in. x 3.5 in.) at 4 los. ●
- GEM2: 5 lbs. metal mass, 6 forceps, STERIS V-PRO® Tray (17 in. x 10 in. x 3.5 in.) at 4 lbs. ●
- GEM3: 6 lbs. metal mass, 6 forceps, STERIS V-PRO® Tray (17 in. x 10 in. x 3.5 in.) at 4 lbs. ●
- GEM4: 5 lbs. metal mass, 6 forceps, STERIS V-PRO® Tray (21 in. x 10 in. x 3.5 in.) at 5 lbs. ●
- GEM5: 5 lbs. metal mass, 6 forceps, STERIS V-PRO® Tray (21 in. x 10 in. x 3.5 in.) at 5 lbs. ●
The following loads were used in STERIS V-PRO® 60 Sterility Maintenance Validation Studies:
-
GEM1 GEM5: V-PRO® Tray (10 in. x 21 in. x 3.5 in.), metal mass to make final total weight tested ● above, and 6 forceps.
The follow loads were used in STERIZONE® VP4 Sterility Maintenance Validation Studies: -
GEM1-GEM2: Symmetry Medical MicroPack® Plastic Tray (15 in. x 1.5 in.), metal and non-● metal instruments to make final total weight recommended above.
-
GEM3-GEM5: SteriPack Metal Tray (23 in. x 11 in. x 5 in.), metal and non-metal instruments to make . final total weight tested recommended above.
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 aded stress on the wrap. Each healthcare facility should determine for itself which wrap model is most appropriate for each intended use.
2 It is recommended to not exceed the maximum wrapped package content weights indicated for each wrap model. Furthermore it is recommended to not exceed the number, weight and sizes of individual content types that were validated for the Gemini Sterilization Wrap (i.e.: the weight of the metal mass)
5
Image /page/5/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 starburst symbol. The starburst is white and appears to be composed of several elongated triangles converging at a central point, creating a dynamic and modern design.
SECTION 5 510(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 June 21, 2017
Type of 510(k) Submission Traditional
Device Name / Classification
Name of Device: Gemini Sterilization Wrap Proprietary Name: Sterilization Wrap Common Name: Sterilization Wrap Classification Name: Wrap, Sterilization Product Code: FRG Classification Panel: Regulatory Class: II Regulation #: 21 CFR 880.6850
Predicate Device
Gemini Sterilization Wrap K150698
Reference Devices
Gemini Sterilization Wrap K152564
6
Image /page/6/Picture/0 description: The image shows the Medline logo. The logo is set against a blue square background. The word "MEDLINE" is written in white, block letters on the left side of the square. To the right of the word is a white, stylized star shape. A small gray rectangle is in the upper right corner of the image.
Gemini Bonded Sterilization Wrap K152458
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 Gemini Sterilization Wrap ultrasonically seamed on two parallel sides. This allows for convenient wrapping with two sheets simultaneously.
Gemini Sterilization Wrap items are square or rectangular sheets of non-woven 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 3 different shades of blue that vary in the amount of phthalocyanine blue pigmentation depending on the weight of the wrap. Also, some wraps contain titanium dioxide and others do not. A detailed description of material composition can be found in the Device Description section.
The two-tone blue/pink wrap fabric is made of polypropylene with the addition of less than 2% phthalocyanine blue pigmentation, less than 0.5% of titanium dioxide white pigmentation and less than 2% of disazocondensation red pigmentation. The two-tone blue/pink wraps are offered in 3 different shades of blue and pink that vary in the amount of phthalocyanine, disazocondensation red and titanium dioxide depending on the weight of the wrap. A detailed description of material composition can be found in the Device Description section.
Gemini Sterilization Wrap is available in sizes ranging from 12" x 72" across five different material weights/models listed below. Photos showing the different material weights are listed in Figure 2 below. Additional product and size information is provided in Table 1 below. The material composition of the Gemini Sterilization Wrap is listed in Table 2. Details on the product variations and composition are also provided with Appendix B.
Indications for Use
Gemini Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of such content until used. Gemini Sterilization Wrap is validated for use in the following sterilization processes modes and cycles:
7
Image /page/7/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, bold, sans-serif font, stacked on top of a white stylized cross. The background is a solid dark blue color. The logo is simple and clean, with a focus on the company name and a symbol that suggests healthcare.
TABLE 1: STERIS V-PRO® Low Temperature Sterilization Systems. The wrap was validated to be effectively aerated during the pre-programmed cycles
| Gemini Wrap Model | Gemini
Wrap
Weight | STERIS V-PRO® Low
Temperature Sterilization
Cycles |
|---------------------------|--------------------------|--------------------------------------------------------------------------------|
| GEM11XX/GEM11XXS/GEM11XXT | Lightweight | ■ STERIS V-PRO® 60 (Lumen, Non-
Lumen and Flexible Cycles) |
| GEM21XX/GEM11XXS/GEM11XXT | Regular Weight | |
| GEM31XX/GEM31XXS/GEM31XXT | Medium Weight | ■ STERIS V-PRO® 1 (Lumen Cycle)
(per K150698) |
| GEM41XX/GEM41XXS/GEM41XXT | Heavyweight | |
| GEM51XX/GEM51XXS/GEM51XXT | Super Heavyweight | ■ STERIS V-PRO® 1 Plus (Lumen and
Non-Lumen Cycle) (per K150698) |
| | | ■ STERIS V-PRO® maX (Lumen, Non-
Lumen, and Flexible Cycle)(per
K150698) |
TABLE 2: STERIZONE® VP4 Sterilization System
| Gemini Wrap Model | Gemini
Wrap
Weight | STERIZONE® VP4
Sterilization System |
|---------------------------|--------------------------|------------------------------------------------------------------|
| GEM11XX/GEM11XXS/GEM11XXT | Lightweight | • STERIZONE® VP4 Sterilizer single
preset sterilization cycle |
| GEM21XX/GEM11XXS/GEM11XXT | Regular Weight | |
| GEM31XX/GEM31XXS/GEM31XXT | Medium Weight | |
| GEM41XX/GEM41XXS/GEM41XXT | Heavyweight | |
| GEM51XX/GEM51XXS/GEM51XXT | Super Heavyweight | |
TABLE 3: Wrap Model Recommendations1
| Gemini
Wrap
Weight | Gemini
Wrap
Model | Intended Load | Maximum Recommended Wrapped Package Content2 | | |
|--------------------------|-------------------------|------------------------------------------------------------------------------------------|----------------------------------------------|----------------------|------------------------------|
| | | | STERIS V-
PRO® 1,
1Plus, maX | STERIS V-
PRO 60® | STERIZONE® VP4
Sterilizer |
| Light
Weight | GEM1 | Light weight
package (for
example: standard
linen packs) | 6.5 lbs. | 6 lbs. | 6 lbs. |
| Regular
Weight | GEM2 | Light to moderate
weight package (for
example: general use
medical instruments) | 9 lbs. | 9 lbs. | 9 lbs. |
| Medium
Weight | GEM3 | Moderate to heavy
weight package (for | 10 lbs. | 13 lbs. | 13 lbs. |
8
Image /page/8/Picture/0 description: The image features the Medline logo set against a blue background. The logo consists of the word "MEDLINE" in bold, sans-serif font, positioned to the left of a stylized, white starburst symbol. The starburst has four points, with the top and bottom points being more elongated than the side points. A gray bar is visible on the right edge of the image, partially obscuring the blue background.
| | | example: general use
medical instruments) | | | |
|--------------------------|------|-----------------------------------------------------------------------------------|---------|---------|---------|
| Heavy
Weight | GEM4 | Heavy weight
package (for
example: general use
medical instruments) | 10 lbs. | 17 lbs. | 17 lbs. |
| Super
Heavy
Weight | GEM5 | Very heavy weight
package (for
example: general use
medical instruments) | 10 lbs. | 25 lbs. | 25 lbs. |
The following loads were used in STERIS V-PRO® 1, 1Plus, maX Sterility Maintenance Validation Studies:
- GEM1: 2.5 lbs. metal mass, 6 forceps, STERIS V-PRO® Tray (17 in. x 10 in. x 3.5 in.) at 4 lbs. ●
- . GEM2: 5 lbs. metal mass, 6 forceps, STERIS V-PRO® Tray (17 in. x 10 in. x 3.5 in.) at 4 lbs.
- GEM3: 6 lbs. metal mass, 6 forceps, STERIS V-PRO® Tray (17 in. x 10 in. x 3.5 in.) at 4 lbs. ●
- GEM4: 5 lbs. metal mass, 6 forceps, STERIS V-PRO® Tray (21 in. x 10 in. x 3.5 in.) at 5 lbs. ●
- GEM5: 5 lbs. metal mass, 6 forceps, STERIS V-PRO® Tray (21 in. x 10 in. x 3.5 in.) at 5 lbs. ●
The following loads were used in STERIS V-PRO® 60 Sterility Maintenance Validation Studies:
-
GEM1 GEM5: V-PRO® Tray (10 in. x 21 in. x 3.5 in.), metal mass to make final total weight tested ● above, and 6 forceps.
The follow loads were used in STERIZONE® VP4 Sterility Maintenance Validation Studies: -
GEM1-GEM2: Symmetry Medical MicroPack® Plastic Tray (15 in. x 10 in. x 1.5 in.), metal and non-● metal instruments to make final total weight recommended above.
-
. GEM3-GEM5: SteriPack Metal Tray (23 in. x 11 in. x 5 in.), metal and non-metal instruments to make final total weight tested recommended above.
1 Individual results may differ due to factors such as variations in handling practices, wrapping techniques and folding methods. Results may also differ due to the use of irregularly shaped contents, which may put added stress on the wrap. Each healthcare facility should determine for itself which wrap model is most appropriate for each intended use.
2 It is recommended to not exceed the maximum wrapped package content weights indicated for each wrap model. Furthermore it is recommended to not exceed the number, weight and sizes of individual content types that were validated for the Gemini Sterilization Wrap (i.e .: the weight of the metal mass)
9
Image /page/9/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, stacked on top of a white starburst-like shape. The background is a solid dark blue color. The logo is simple and clean, with a focus on the company name and a visual element that suggests energy or innovation.
Summary of Technological Characteristics
TABLE 3: Comparison of Proposed and Predicate Devices
| Device
Characteristic | Proposed Device | Predicate Device | Reference Devices | Comparison
Analysis |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Product Name | Gemini Sterilization
Wrap | Gemini Sterilization
Wrap | Gemini and Gemini
Bonded Sterilization
Wrap | Same |
| 510(k) Reference | | K150698 | K152564
K152458 | N/A |
| Product Owner | Medline Industries, Inc. | Medline Industries, Inc. | Medline Industries, Inc. | Identical |
| Product Code | FRG | FRG | FRG | Identical |
| Intended Use | Gemini Sterilization
Wraps are intended to be
used to enclose another
medical device that is to
be sterilized by a health
care provider. It is
intended to allow
sterilization of the
enclosed medical device
and also to maintain
sterility of such content
until used. | The Gemini Single Ply
and Bonded Wraps are
intended to allow
sterilization of the
enclosed medical
device(s) and also to
maintain sterility of the
enclosed medical
device(s) within the
period of time for which
performance data
demonstrating
maintenance of sterility
has been provided. | Gemini and 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. | Identical to
K152564 and
K152458.
Similar to
K150698. |
| Regulation Number | 21 CFR 880.6850 | 21 CFR 880.6850 | 21 CFR 880.6850 | Identical |
| Design Features | Square or rectangular
sheets manufactured by
spunbond-meltblown
process | Square or rectangular
sheets manufactured by
spunbond-meltblown
process | Square or rectangular
sheets manufactured by
spunbond-meltblown
process | Identical |
| Design
Configurations | 12 in. x 12 in. to 54 in. x
90 in. | 12 in. x 12 in. to 54 in. x
90 in. | 12 in. x 12 in. to 54 in.
x 90 in. | Identical |
| Materials | Polypropylene with
phthalocyanine blue,
titanium dioxide and
disazocondensation red | Polypropylene with
phthalocyanine blue,
titanium dioxide | Polypropylene with
phthalocyanine blue,
titanium dioxide and
disazocondensation red | Similar to
K150698.
Identical to
K152564 and
K152458. |
| Wrapping
Technique | Sequential/simultaneous
double wrapping | Sequential/simultaneous
double wrapping | Sequential/simultaneous
double wrapping | Identical |
| Bonding Material | Ultrasonically seamed in
a dotted line pattern | Ultrasonically seamed in
a dotted line pattern | Ultrasonically seamed
in a dotted line pattern | Identical |
| Prescription vs.
OTC | OTC | OTC | OTC | Identical |
| Sterilization | Sterizone VP4
V-PRO® 60 (Lumen,
Non-Lumen, Flexible)
V-PRO® 1 (Lumen
cycle)
V-PRO® 1 Plus (Lumen,
Non-Lumen)
V-PRO® maX (Lumen,
Non-Lumen, Flexible) | V-PRO® 1 (Lumen
cycle)
V-PRO® 1 Plus (Lumen,
Non-Lumen)
V-PRO® maX (Lumen,
Non-Lumen, Flexible) | Pre-vacuum steam
Gravity steam
STERRAD 50, 200S
and 100NX DUO
Cycles | Different |
| Disposable vs. Non-
Disposable | Disposable | Disposable | Disposable | Identical |
| Single Use vs.
Reusable | Single Use Only | Single Use Only | Single Use Only | Identical |
| Maintenance of
Sterility | V-PRO® 1 – 1 year*
V-PRO® 1 Plus – 1
year*
V-PRO® maX – 1 year*
V-PRO® 60 - 1 year
Sterizone VP4 - 1 year | 30 days | Steam – 2 years
STERRAD – 180 days | Different |
10
Image /page/10/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is written in white, sans-serif font, stacked vertically. A white, stylized starburst symbol is positioned behind the text, with its points extending above and below the word "MEDLINE".
*Sterilization cycles cleared in previous 510(k)'s are included here due to the additional indication for use of maintenance of sterility now being 1 year.
Summary of Non-Clinical Testing
TABLE4: Summary of Performance Testing V-PRO® 60
| Performance Study | Performance Results |
|---|---|
| Maintenance of Sterility | Passed |
| Sterilant Penetration | Passed |
| Tensile breaking strength and elongation (ASTM D5034) | Passed |
| Tear Strength (ASTM D5587) | Passed |
| Hydrostatic Pressure (AATCC 127) | Passed |
| Burst Pressure (ASTM D3786) | Passed |
| Air Permeability (ASTM D737) | Passed |
| Post Sterilization Biocompatibility (Cytotoxicity – ISO 10993-5 | Passed |
| Post Sterilization Biocompatibility (Primary Skin Irritation | |
| Testing- ISO 10993-10) | Passed |
11
Image /page/11/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, set against a blue square background. Above the word, there is a white star-like symbol with four points. To the right of the blue square, there is a gray vertical bar.
TABLE 5: Summary of Performance Testing Sterizone VP4
| Performance Study | Performance Results |
|---|---|
| Maintenance of Sterility | Passed |
| Sterilant Penetration | Passed |
| Tensile breaking strength and elongation (ASTM D5034) | Passed |
| Tear Strength (ASTM D5587) | Passed |
| Hydrostatic pressure (AATCC 127) | Passed |
| Air Permeability (ASTM D737) | Passed |
| Post Sterilization Biocompatibility (Cytotoxicity – ISO 10993-5 | Passed |
| Post Sterilization Biocompatibility (Primary Skin | |
| Irritation Testing- ISO 10993-10) | Passed |
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 Wrap is as safe and as effective for their intended use as the predicate device Gemini Sterilization Wrap (K150698).