(259 days)
No
The device is a sterilization wrap and the description focuses on its material properties and performance in sterilization cycles, with no mention of AI or ML.
No.
The device is a non-woven sterile wrap intended to enclose other medical devices for sterilization and maintain their sterility, not to provide therapeutic treatment itself.
No
Explanation: The device is a sterilization wrap intended to enclose other medical devices for sterilization and maintain their sterility, not to diagnose a condition or disease.
No
The device description clearly states it is a physical, non-woven sterile wrap made of polypropylene, intended to enclose other medical devices for sterilization. This is a hardware component, 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 device is used to enclose another medical device for sterilization. It is not intended to be used in vitro (outside of the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details the material and function of the wrap as a sterile barrier. It does not mention any components or functions related to analyzing biological samples.
- Performance Studies: The performance studies focus on the sterilization process, barrier integrity, and shelf life of the wrap itself. There are no studies related to diagnostic performance or analysis of biological specimens.
An IVD device is specifically designed to perform tests on samples like blood, urine, or tissue to detect diseases, conditions, or infections. This device's purpose is to maintain the sterility of other medical devices after they have been sterilized.
N/A
Intended Use / Indications for Use
JAMBRO Single Core A is intended to be used to enclose another medical device that is to be sterilized by a health care provider using:
- · Gravity steam at 250°F/121°C for 30 minutes
- · Pre-vacuum steam at 270°F/132°C for 4 minutes
Gravity steam and Pre-vacuum steam sterilization: Validated for dry times of 30 minutes for JAMBRO Single Core A
Types of medical devices to be sterilized in the gravity cycle;
· General purpose non-lumened reusable metal and nonmetal devices with stainless steel diffusionrestricted spaces such as the hinged portion of forceps and scissors, as well as other general medical instruments having mated surfaces, knurled areas etc.
Types of medical devices to be sterilized in the pre-vacuum cycle are;
· General purpose reusable metal and nonmetal devices with stainless steel diffusion-restricted spaces such as the hinged portion of forceps and scissors, as well as other general medical instruments having mated surfaces, knurled areas etc.
· Up to 2 single channel stainless steel lumened devices of the following dimensions; An inside diameter of 3 mm or larger and a length of 400 mm or shorter;
Color of wrap: Blue Size of wrap: 48 in x 48 in
The maximum validated weight of load for JAMBRO Single Core A is 25 lbs.
The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until used.
Product codes
FRG
Device Description
JAMBRO Single Core A is a 63gsm, latex-free, 3-layer (SMS) non-woven sterile wrap, manufactured with spun-bonded / meltblown polypropylenem. JAMBRO Single Core A provides a strong barrier which protects against cuts, tears with particularly heavy orthopedic sets. JAMBRO Single Core A is designed to be implemented as an outer sterilization wrap which can be used in combination with Clinipak choice.
The Maximum Recommended Wrapped Package Content Weights for the JAMBRO Single Core A (63g/m²) is 25 lbs.
The Intended Load for the JAMBRO Single Core A (63g/m²) is moderate to heavy weight package (e.g., general use medical instruments) and the JAMBRO Single Core A can maintain sterility of sterilized devices for 90 days.
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: Sterilization Validation - Steam GRAVITY
STANDARDS: ANSI/AAMI ST8:2013 ANSI/AAMI ST77:2013 ANSI/AAMI ST79:2017 ANSI/AAMI/ISO 14937:2009/(R)2013
DESCRIPTION/CRITERIA: A method of steam Sterilization was validated to a sterility assurance level (SAL) of 10-6
RESULTS: Pass
STUDY: Sterilant Penetration - Steam GRAVITY
STANDARDS: ANSI/AAMI ST8:2013 ANSI/AAMI ST77:2013 ANSI/AAMI ST79:2017
DESCRIPTION/CRITERIA: The testing details the methods used in determining the internal temperature profile for wrapped sterilization packs when processed in a steam sterilization gravity cycle at 121° C (250°F) for thirty (30) minutes.
RESULTS: Testing has demonstrated adequate sterilant penetration
STUDY: Validation - Dry Time Study GRAVITY
STANDARDS: ANSI/AAMI ST8:2013 ANSI/AAMI ST77:2013 ANSI/AAMI ST79:2017 BS EN 868-8:2009 BS EN 285:2006+A2:2009
DESCRIPTION/CRITERIA: Determining the proper drying time required
RESULTS: Test samples meet or exceed the minimum criteria for dry time.
STUDY: 90 Day Real Time Maintenance of Sterility Validation - Steam GRAVITY
STANDARDS: ANSI/AAMI ST79:2017 United States Pharmacopeia
DESCRIPTION/CRITERIA: The study details the methods used in verifying the test samples can maintain the integrity of its contents for an extended period of time following exposure to a steam gravity sterilization process.
RESULTS: No growth
STUDY: Sterilization Validation - Steam PREVACUUM
STANDARDS: ANSI/AAMI ST8:2013 ANSI/AAMI ST77:2013 ANSI/AAMI ST79:2017 ANSI/AAMI/ISO 14937:2009/(R)2013
DESCRIPTION/CRITERIA: A method of steam sterilization was validated to a sterility assurance level (SAL) of 10-6
RESULTS: Pass
STUDY: Sterilant Penetration - Steam PREVACUUM
STANDARDS: ANSI/AAMI ST8:2013 ANSI/AAMI ST77:2013 ANSI/AAMI ST79:2017 ANSI/AAMI/ISO 14937:2009/(R)2013
DESCRIPTION/CRITERIA: The testing details the methods used in determining the internal temperature profile for wrapped sterilization packs when processed in a steam sterilization pre-vacuum cycle at 132°C (270°F) for four (4) minutes exposure.
RESULTS: Testing has demonstrated adequate sterilant penetration
STUDY: Validation - Dry Time Study PREVACUUM
STANDARDS: ANSI/AAMI ST8:2013 ANSI/AAMI ST77:2013 ANSI/AAMI ST79:2017 BS EN 868-8:2009 BS EN 285:2006+A2:2009
DESCRIPTION/CRITERIA: Determining the proper drying time required
RESULTS: Test samples meet or exceed the minimum criteria for dry time.
STUDY: 90 Day Real Time Maintenance of Sterility Validation - Steam PREVACUUM
STANDARDS: ANSI/AAMI ST79:2017 United States Pharmacopeia
DESCRIPTION/CRITERIA: The study details the methods used in verifying the test samples can maintain the integrity of its contents for an extended period of time following exposure to a steam sterilization process.
RESULTS: No growth
STUDY: Aerosol Challenge Whole Package Integrity Test - Steam
STANDARDS: ANSI/AAMI ST8:2013 ANSI/AAMI ST77:2013
DESCRIPTION/CRITERIA: The testing details the methods used to challenge the maintaining package integrity following a microbial aerosol challenge test.
RESULTS: The subject wrap, were found to be effective barriers cycle and subjected to a rigorous microbial aerosol challenge.
STUDY: Aerosol Challenge Whole Package Integrity Test - Steam PREVACUUM
STANDARDS: ANSI/AAMI ST8:2013 ANSI/AAMI ST77:2013 ANSI/AAMI ST79:2017
DESCRIPTION/CRITERIA: The testing details the methods used to challenge the effectiveness of the test sample in maintaining package integrity following a microbial aerosol challenge test.
RESULTS: The subject wrap, were found to be effective barriers when processed in a Steam Pre-Vacuum cycle and subjected to a rigorous microbial aerosol challenge.
STUDY: Bacterial Filtration Efficiency (BFE) of Non-Woven Sterilization Wrap When Processed In a Steam Sterilization Cycle
STANDARDS: ASTM F2101-14 EN 14683: 2014 AS4381: 2015
DESCRIPTION/CRITERIA: BFE testing is a type of test used to determine the efficiency of filter materials to provide protection against microbial organisms. It
RESULTS: Pass
STUDY: Physical Integrity
STANDARDS: ISO 11607
DESCRIPTION/CRITERIA: The purpose of the physical properties testing was to demonstrate passing results for the physical properties for the wrap.
RESULTS: The physical properties testing met the acceptance criteria and demonstrated passing results
STUDY: Shelf Life Testing
STANDARDS: ANSI/AAMI ST8:2013 ANSI/AAMI ST77:2013 ANSI/AAMI ST79:2017
DESCRIPTION/CRITERIA: Whole package integrity test of real time shelf life samples
RESULTS: Sterilization Wrap was capable of maintaining sterility and package integrity (when used as a steam sterilization wrapper) following an approximate 18 month period of real time shelf life prior to being sterilized in the steam sterilization cycles
Biocompatibility Assessment:
A biocompatibility test for Cytotoxicity based on ANSI/AAMI/ISO 10993-5 Biological Evaluation of Medical Devices – Part 5: Tests for in vitro Cytotoxicity was performed. The device was found not to be cytotoxic.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 11, 2019
Jiangsu Zhande Medical Supplies Co., Ltd % Jigar Shah Consultant mdi Consultants, Inc. 55 Northern Blvd Great Neck, New York 11021
Re: K182656
Trade/Device Name: JAMBRO Single Core A Sterilization wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: March 12, 2019 Received: March 14, 2019
Dear Jigar Shah:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Elizabeth F. Claverie-Williams. MS Assistant Director, THT4B2: Disinfection Reprocessing and Personal Protection Acting Assistant Director, THT4B1: Sterility Devices DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182656
Device Name
JAMBRO Single Core A Sterilization wrap
Indications for Use (Describe)
JAMBRO Single Core A is intended to be used to enclose another medical device that is to be sterilized by a health care provider using:
- · Gravity steam at 250°F/121°C for 30 minutes
- · Pre-vacuum steam at 270°F/132°C for 4 minutes
Gravity steam and Pre-vacuum steam sterilization: Validated for dry times of 30 minutes for JAMBRO Single Core A
Types of medical devices to be sterilized in the gravity cycle;
· General purpose non-lumened reusable metal and nonmetal devices with stainless steel diffusionrestricted spaces such as the hinged portion of forceps and scissors, as well as other general medical instruments having mated surfaces, knurled areas etc.
Types of medical devices to be sterilized in the pre-vacuum cycle are;
· General purpose reusable metal and nonmetal devices with stainless steel diffusion-restricted spaces such as the hinged portion of forceps and scissors, as well as other general medical instruments having mated surfaces, knurled areas etc.
· Up to 2 single channel stainless steel lumened devices of the following dimensions; An inside diameter of 3 mm or larger and a length of 400 mm or shorter;
Color of wrap: Blue Size of wrap: 48 in x 48 in
The maximum validated weight of load for JAMBRO Single Core A is 25 lbs.
The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until used.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☐ Prescription Use (Part 21 CFR 801 Subpart D) | ☑ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
510(k) SUMMARY
The assigned 510(k) number is K182656
l. SUBMITTER
Jiangsu Zhande Medical Supplies Co., Ltd Nanjing Binjiang Economic Development Park
#719 Shengan Avenue, 1/F Building H1
Jiangsu, Nanjing, China 211178
Date Summary Prepared: June 3, 2019
Contact Person: Ms. Chaniuan Xu
ll. DEVICE
Name of Device: JAMBRO® Single Core A Sterilization wrap Common or Usual Name: Sterilization Wrap Classification Name: Sterilization Wrap Regulatory Class: 21 CFR Part 880.6850 Class II Product Code: FRG
lll. PREDICATE DEVICE
Ahlstrom Nonwovens LLC's Reliance® Solo Sterilization Wrap, Reliance® Tandem Sterilization Wrap, K160755
IV. DEVICE DESCRIPTION
JAMBRO Single Core A is a 63gsm, latex-free, 3-layer (SMS) non-woven sterile wrap, manufactured with spun-bonded / meltblown polypropylenem. JAMBRO Single Core A provides a strong barrier which protects against cuts, tears with particularly heavy orthopedic sets. JAMBRO Single Core A is designed to be implemented as an outer sterilization wrap which can be used in combination with Clinipak choice.
The Maximum Recommended Wrapped Package Content Weights for the JAMBRO Single Core A (63g/m²) is 25 lbs.
The Intended Load for the JAMBRO Single Core A (63g/m²) is moderate to heavy weight package (e.g., general use medical instruments) and the JAMBRO Single Core A can maintain sterility of sterilized devices for 90 days.
5
V. INDICATIONS FOR USE
JAMBRO Single Core A is intended to be used to enclose another medical device that is to be sterilized by a health care provider using:
- . Gravity steam at 250°F/121°C for 30 minutes
- Pre-vacuum steam at 270°F/132°C for 4 minutes ●
Gravity steam and Pre-vacuum steam sterilization: Validated for dry times of 30 minutes for JAMBRO Single Core A
Types of medical devices to be sterilized in the gravity cycle;
-
General purpose non-lumened reusable metal and nonmetal devices . including devices with stainless steel diffusion-restricted spaces such as the hinged portion of forceps and scissors, as well as other general medical instruments having mated surfaces, knurled areas etc.
Types of medical devices to be sterilized in the pre-vacuum cycle are; -
General purpose reusable metal and nonmetal devices including devices ● with stainless steel diffusion-restricted spaces such as the hinged portion of forceps and scissors, as well as other general medical instruments having mated surfaces, knurled areas etc.
-
Up to 2 single channel stainless steel lumened devices of the following . dimensions; An inside diameter of 3 mm or larger and a length of 400 mm or shorter:
Color of wrap: Blue Size of wrap: 48 in x 48 in
The maximum validated weight of load for JAMBRO Single Core A is 25 lbs.
The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until used.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
The JAMBRO Single Core A sterilization wrap is similar to the RELIANCE Solo sterilization wrap, K160755. The following Comparison Chart is outlined:
6
Comparison Chart
| Device
| Characteristic | Proposed Device | Predicate Device | Comparison |
|---|---|---|---|
| Product Name | JAMBRO® Single Core A | ||
| Sterilization wrap | Reliance® Solo Sterilization | ||
| Wrap, Reliance® Tandem | |||
| Sterilization Wrap | |||
| 510(k) Reference | K182656 | K160755 | |
| Product Owner | Jiangsu Zhande Medical | ||
| Supplies Co., Ltd | Ahlstrom Nonwovens LLC | ||
| Product Code | FRG | FRG | Similar |
| Indications for Use | JAMBRO Single Core A is intended to be | ||
| used to enclose another medical device | |||
| that is to be sterilized by a health care | |||
| provider using: | |||
| Gravity steam at 250°F/121°C for 30 | |||
| minutes | |||
| Pre-vacuum steam at 270°F/132°C for 4 | |||
| minutes | |||
| Types of medical devices to be sterilized | |||
| in the gravity cycle; | |||
| General purpose non-lumened reusable | |||
| metal and nonmetal devices including | |||
| devices with stainless steel diffusion- | |||
| restricted spaces such as the hinged | |||
| portion of forceps and scissors, as well | |||
| as other general medical instruments | |||
| having mated surfaces, knurled areas | |||
| etc. | |||
| Types of medical devices to be sterilized | |||
| in the pre-vacuum cycle are; | |||
| General purpose reusable metal and | |||
| nonmetal devices including devices with | |||
| stainless steel diffusion-restricted spaces | |||
| such as the hinged portion of forceps | |||
| and scissors, as well as other eneral | |||
| medical instruments having mated | |||
| surfaces, knurled areas etc. | |||
| Up to 2 single channel stainless steel | |||
| lumened devices of the following | |||
| dimensions; An inside diameter of 3 mm | |||
| or larger and a length of 400 mm or | |||
| shorter; | |||
| Color of wrap: Blue | |||
| Size of wrap: 48 in x 48 in | |||
| The maximum validated weight of load | |||
| for JAMBRO Single Core A is 25 Ibs. | |||
| The wrap is intended to allow sterilization | |||
| of the enclosed medical device(s) and | |||
| also to maintain sterility of the enclosed | |||
| device(s) until used. | Ahlstrom Reliance® Tandem | ||
| and Solo Sterilization Wraps | |||
| are intended to be used to | |||
| enclose another medical | |||
| device that is to be sterilized | |||
| by a healthcare provider via | |||
| the following: | |||
| • Pre-vacuum Steam | |||
| 270°F/132°C for 4 minutes | |||
| • Gravity Steam | |||
| 250°F/121°C for 30 | |||
| minutes | |||
| • 100% Ethylene Oxide (EO) | |||
| with a concentration of 725- | |||
| 735 mg/L @ 131°F/55°C | |||
| and 40%-80% relative | |||
| humidity for 60 minutes | |||
| • Advanced Sterilization | |||
| Products (ASP) | |||
| STERRAD® 100S | |||
| • Advanced Sterilization | |||
| Products (ASP) | |||
| STERRAD® 100NX | |||
| (Standard, Express and | |||
| Flex cycles) | |||
| • STERIS Amsco® V-PRO 1, | |||
| STERIS Amsco® V-PRO 1 | |||
| Plus, STERIS Amsco® V- | |||
| PRO maX Low | |||
| Temperature Sterilization | |||
| Systems (Lumen, Non | |||
| Lumen and Flexible | |||
| Cycles) | |||
| The wrap is intended to allow | Similar | ||
| sterilization of the enclosed | |||
| medical device(s) and | |||
| maintain sterility of the | |||
| enclosed device(s) until used. | |||
| Regulation Number | 21 CFR 880.6850 | 21 CFR 880.6850 | Similar |
| Design Features | The JAMBRO® Single Core | ||
| A Sterilization wrap are | |||
| square nonwoven sheets | |||
| produces using a three-layer | |||
| SMS (spunbond-meltblown- | |||
| spunbond) process. | |||
| • JAMBRO® Single Core A | |||
| Consists of single sheets of | |||
| SMS wrap, where two sheets | |||
| are used together for the | |||
| sequential wrapping of one or | |||
| a collection of medical | |||
| devices that will be sterilized | |||
| following standard healthcare | |||
| practices. | The Reliance® Tandem and | ||
| Solo Sterilization Wraps are | |||
| square or rectangular | |||
| nonwoven sheets produced | |||
| using a three-layer SMS | |||
| (spunbond-meltblown- | |||
| spunbond) process. | |||
| The Reliance® SMS | |||
| Sterilization Wraps are | |||
| separated into two distinct | |||
| product offerings: | |||
| • Reliance® Tandem: | |||
| Consists of single sheets of | |||
| SMS wrap, where two | |||
| sheets are used together for | |||
| the sequential wrapping of | |||
| one or a collection of | |||
| medical devices that will be | |||
| sterilized following standard | |||
| healthcare practices. | |||
| • Reliance® Solo: Consists of | |||
| two sheets of SMS wrap, | |||
| ultrasonically bonded | |||
| together along two edges for | |||
| convenient simultaneous | |||
| wrapping of one or a | |||
| collection of medical devices | |||
| that will be sterilized | |||
| following standard | |||
| healthcare practices. | Similar | ||
| Size and color | 48"X 48" | ||
| Blue | 9"x9" to 54"x90" | ||
| Blue or Green | similar | ||
| Materials | The JAMBRO® Single Core | ||
| A Sterilization wrap are | |||
| composed of polypropylene | |||
| with blue pigments and an | |||
| anti-static treatment. The | |||
| JAMBRO® Single Core A | |||
| Sterilization wrap allows a | |||
| sterilized package of medical | |||
| devices to be opened | |||
| aseptically. | The Reliance® Tandem and | ||
| Solo Sterilization Wraps are | |||
| composed of polypropylene | |||
| with the addition of blue or | |||
| green pigment and an anti- | |||
| static treatment. Reliance® | |||
| Tandem and Solo | |||
| Sterilization Wraps allow a | |||
| sterilized package of medical | |||
| devices to be opened | |||
| aseptically. | Similar | ||
| Prescription vs. OTC | OTC | OTC | Similar |
| Sterilization | pre-vacuum steam at | ||
| 270°F/132°C for 4 minutes Gravity Steam at | |||
| 250°F/121°C for 30 minutes Drying time: 30 minutes | pre-vacuum steam at | ||
| 270°F/132°C for 4 minutes Drying time: Reliance® | |||
| Tandem and Solo Models | |||
| T100/S100, T200/S200, | |||
| T300/S300: 20 minutes | |||
| Reliance® Tandem and | |||
| Solo Models T400/S400, | |||
| T500/S500, T600/S600: | |||
| 30 minutes 100% ethylene oxide (EO) | |||
| with a concentration of | |||
| 725 -735 mg/L at | |||
| 131°F/55°C and 40% - | |||
| 80% relative humidity for | |||
| 60 minutes Gravity Steam at | |||
| 250°F/121°C for 30 | |||
| minutes Advanced Sterilization | Similar | ||
| Wrapping Technique | Sequential | Sequential/simultaneous | |
| double | |||
| wrapping | Similar | ||
| Disposable vs. Non- | |||
| Disposable | Disposable | Disposable | Similar |
7
8
| Single Use vs.
| Reusable | Single Use | Single Use | Similar |
|---|---|---|---|
| Biocompatibility | Cytotoxicity ISO 10993-5 | Cytotoxicity ISO 10993-5 | Similar |
| Maintenance of | |||
| Package | |||
| Sterility | 90 days | 90 days | Similar |
| Shelf Life | 18 months | NA | Similar |
VII. PERFORMANCE DATA
For the sterilization wrap performance testing, the following standards were utilized to demonstrate that the device met the acceptance criteria in the following standards below:
ANSI/ AAMI ST77:2013, Containment devices for reusable medical device sterilization
9
ANSI/ AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities
ANSI/ AAMI/ ISO 14937:2009/(R) 2013, Sterilization of health care products – General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including: Amendment 1 (2014)]
| STUDY | STANDARDS | DESCRIPTION/
CRITERIA | RESULTS |
|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization
Validation - Steam
GRAVITY | ANSI/AAMI ST8:2013
ANSI/AAMI ST77:2013
ANSI/AAMI ST79:2017
ANSI/AAMI/ISO
14937:2009/(R)2013 | A method of steam
Sterilization was
validated to a
sterility assurance
level (SAL) of 10-6 | Pass |
| Sterilant Penetration -
Steam GRAVITY | ANSI/AAMI ST8:2013
ANSI/AAMI ST77:2013
ANSI/AAMI ST79:2017 | The testing details
the methods used
in determining the
internal
temperature profile
for wrapped
sterilization packs
when processed in
a steam
sterilization gravity
cycle at 121° C
(250°F) for thirty
(30) minutes. | Testing has
demonstrated
adequate sterilant
penetration |
| Validation - Dry Time
Study GRAVITY | ANSI/AAMI ST8:2013
ANSI/AAMI ST77:2013
ANSI/AAMI ST79:2017
BS EN 868-8:2009
BS EN
285:2006+A2:2009 | Determining the
proper drying time
required | Test samples
meet or exceed
the minimum
criteria for dry
time. |
| 90 Day Real Time
Maintenance of
Sterility Validation -
Steam GRAVITY | ANSI/AAMI ST79:2017
United States
Pharmacopeia | The study details
the methods used
in verifying the test
samples can
maintain the
integrity of its
contents for an
extended period of | No growth |
| | | | |
| | | time following
exposure to a
steam gravity
sterilization
process. | |
| Sterilization
Validation - Steam
PREVACUUM | ANSI/AAMI ST8:2013
ANSI/AAMI ST77:2013
ANSI/AAMI ST79:2017
ANSI/AAMI/ISO
14937:2009/(R)2013 | A method of steam
sterilization was
validated to a
sterility assurance
level (SAL) of 10-6 | Pass |
| Sterilant Penetration -
Steam PREVACUUM | ANSI/AAMI ST8:2013
ANSI/AAMI ST77:2013
ANSI/AAMI ST79:2017
ANSI/AAMI/ISO
14937:2009/(R)2013 | The testing details
the methods used
in determining the
internal
temperature profile
for wrapped
sterilization packs
when processed in
a steam
sterilization pre-
vacuum cycle at
132°C (270°F) for
four (4) minutes
exposure. | Testing has
demonstrated
adequate sterilant
penetration |
| Validation - Dry Time
Study PREVACUUM | ANSI/AAMI ST8:2013
ANSI/AAMI ST77:2013
ANSI/AAMI ST79:2017
BS EN 868-8:2009
BS EN
285:2006+A2:2009 | Determining the
proper drying time
required | Test samples
meet or exceed
the minimum
criteria for dry
time. |
| 90 Day Real Time
Maintenance of
Sterility Validation -
Steam PREVACUUM | ANSI/AAMI ST79:2017
United States
Pharmacopeia | The study details
the methods used
in verifying the test
samples can
maintain the
integrity of its
contents for an
extended period of
time following
exposure to a
steam sterilization
process. | No growth |
| Aerosol Challenge
Whole Package
Integrity Test - Steam | ANSI/AAMI ST8:2013
ANSI/AAMI ST77:2013 | The testing details
the methods used
to challenge the | The subject wrap,
were found to be
effective barriers |
| Aerosol Challenge
Whole Package
Integrity Test - Steam
PREVACUUM | ANSI/AAMI ST8:2013
ANSI/AAMI ST77:2013
ANSI/AAMI ST79:2017 | maintaining
package integrity
following a
microbial aerosol
challenge test.
The testing details
the methods used
to challenge the
effectiveness of
the test sample in
maintaining
package integrity
following a
microbial aerosol
challenge test. | cycle and
subjected to a
rigorous microbial
aerosol challenge.
The subject wrap,
were found to be
effective barriers
when processed in
a Steam Pre-
Vacuum cycle and
subjected to a
rigorous microbial
aerosol challenge. |
| Bacterial Filtration
Efficiency (BFE) of
Non-Woven
Sterilization Wrap
When Processed In a
Steam Sterilization
Cycle | ASTM F2101-14
EN 14683: 2014
AS4381: 2015 | BFE testing is a
type of test used
to determine the
efficiency of filter
materials to
provide protection
against
microbial
organisms. It | Pass |
| Physical Integrity | ISO 11607 | The purpose of the
physical properties
testing was to
demonstrate
passing results for
the physical
properties for the
wrap. | The physical
properties testing
met the
acceptance criteria
and demonstrated
passing results |
| Shelf Life Testing | ANSI/AAMI ST8:2013
ANSI/AAMI ST77:2013
ANSI/AAMI ST79:2017 | Whole package
integrity test of
real time shelf life
samples | Sterilization Wrap
was capable of
maintaining
sterility and
package integrity
(when
used as a steam
sterilization
wrapper) following
an approximate 18
month period of
real time shelf life
prior to being
sterilized in the
steam sterilization
cycles |
Following testing have been performed:
10
11
12
Biocompatibility Assessment
Cytotoxicity testing is a type of biocompatibility test used to determine whether use of a medical device can have any potentially harmful physiological effects. This involves extracting leachable materials from the device or components and analyzing the leachable extracts for potentially harmful chemicals or cytotoxicity. The materials were exposed to one (1) full sterilization cycle.
- . ANSI/AAMI/ISO 10993-5 Biological Evaluation of Medical Devices – Part 5: Tests for in vitro Cytotoxicity
Based on the conditions of the study the device was found not to be cytotoxic.
VIII. CONCLUSIONS
The conclusion drawn from the non-clinical tests demonstrate that the subject device (K182565) is as safe, as effective and performs as well as or better than the legally marketed predicated device (K160755).