(264 days)
CDB Hospital ® Sterilization Wraps 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
· 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 sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) until used.
Pre-Vacuum Steam Sterilization:
- · Validated for dry time of 30 minutes for 44gsm.
- · Validated for dry time of 30 minutes for 70gsm.
- · Validated maximum weight of 6 lbs for 44 gsm.
- · Validated maximum weight of 15 lbs for 70 gsm.
• All models of CDB Hospital ® Sterilization Wraps validated for pre-vacuum steam sterilization with stainless steel lumens of 3 mm diameter or larger and length 400 mm or shorter as part of the load.
Advanced Sterilization Products (ASP) STERRAD® 100S Sterilization:
All models of CDB Hospital® Sterilization Wraps validated with ASP STERRAD® 100S sterilization with stainless steel lumens as part of the load with a maximum weight of 10.7lbs.
Advanced Sterilization Products (ASP) STERRAD® 100NX Sterilization:
All models of CDB Hospital® Sterilization Wraps validated with ASP STERRAD® 100NX sterilization cycles are detailed below:
VALIDATED ADVANCED STERILIZATION PRODUCTS (ASP) STERRAD® 100NX CYCLES Advanced Sterilization Products (ASP) STERRAD® System and Cycle
Intended Load for 100NX Standard Cycle:
Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load: · An inside diameter of 0.7mm or larger and a length of 200mm or shorter of single channel stainless steel lumens.
Intended Load for 100NX Flex Cycle:
One or two single-channel flexible endoscopes with or without a silicone mat. Flexible endoscope may contain: A single channel Teflon/PE/PTFE lumen with an inside diameter of 1 mm or larger and a length of 850 mm or shorter (a maximum of two flexible endoscopes, one per tray per sterilization cycle).
Intended Load for 100NX Express Cycle:
Non-lumened reusable metal and non-metal medical devices requiring surface sterilization, or sterilization of mated stainless steel and titanium surfaces, and rigid or semi-rigid endoscopes without lumens.
STERIS Amsco® V-PRO 1, STERIS Amsco® V-PRO 1 Plus, STERIS Amsco® V-PRO maX Low Temperature Sterilization Systems:
• All models of CDB Hospital® Sterilization Wraps have been validated for use with STERIS V-PRO® cycles detailed below.
· CDB Hospital® Sterilization Wraps were validated to be effectively aerated during the preprogrammed STERIS Amsco V-PRO® Sterilization Cycles.
VALIDATED STERIS AMSCO® V-PRO CYCLES STERIS Amsco® V-PRO Cycle
Intended Load for Lumen Cycle:
Reusable metal and non-metal medical devices, including up to 20 stainless steel lumens with dimensions of 3.0mm diameter or larger and a length of 400mm or shorter.
Intended Load for Non Lumen Cycle:
Non lumened reusable metal and non-metal medical devices.
Intended Load for Flexible Cycle:
Single lumen surgical flexible endoscopes and bronchoscopes in the following load configuration:
1.) One tray containing a flexible endoscope with a light cord (if not integral to endoscope) and mat. The flexible endoscope having an inside diameter of 3 mm or larger and a length of 450 mm or shorter.
2.) An additional tray containing non-lumened medical devices.
The CDB Hospital ® Sterilization Wraps are square or rectangular nonwoven sheets produced using a three-layer SMS (spunbond-meltblown-spunbond) process. The CDB Hospital ® Sterilization Wraps' SMS fabric is made of 100% polypropylene, blue color, and are separated into two distinct product offerings:
CDB Hospital® Sterilization Wraps, 44gsm: Consist of two sheets of SMS wrap (light blue and dark blue), ultrasonically bonded together along two edges for convenient simultaneous wrapping of one or a collection of medical devices that will be sterilized following standard health care practices.
CDB Hospital® Sterilization Wraps, 70gsm: Consist of two sheets of SMS wrap (light blue and dark blue), 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.
CDB Hospital® Sterilization Wraps are composed of polypropylene with the addition of light blue and dark blue pigment and an antistatic treatment. The CDB Hospital ® Sterilization Wraps allow a sterilized package of medical devices to be opened aseptically. This product is over-the-counter use.
The provided text is a 510(k) summary for a sterilization wrap, not an AI/ML medical device. Therefore, many of the requested categories for AI/ML device studies (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, and ground truth establishment for training set) are not applicable.
Below is a table describing the acceptance criteria and reported device performance from the provided document where information is available.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test Item) | Test Standard Methods | Reported Device Performance |
|---|---|---|
| Basis Weight | ASTM D3776/D3776M-20 | Meets requirement |
| Tearing Strength | ASTM D5587-15(2019) | Meets requirement |
| Lint Generation | ISO 9073-10:2003 | Meets requirement |
| Bacterial Filtration Efficiency (BFE) | ASTM F2101-23 | Meets requirement |
| Hydrostatic Pressure | AATCC Test Method 127-2018 | Meets requirement |
| Air Permeability | ASTM D737-18 | Meets requirement |
| Sterilant penetration - BI incubation | ANSI/AAMI/ISO 11138-7 | Meets requirement |
| Maintenance of Package Sterility - Sterility Test | USP-NF 2022 <71> | Meets requirement |
| Maintenance of Package Sterility - Microbial Aerosol Challenge | ASTM F1608-21 | Meets requirement |
| Biocompatibility - Cytotoxicity and Irritation | ISO 10993-5:2009, ISO 10993-23:2021 | Meets requirement |
| Pre-Vacuum Steam Sterilization (Dry Time 44gsm) | (Implicitly, 30 minutes) | Validated for 30 minutes |
| Pre-Vacuum Steam Sterilization (Dry Time 70gsm) | (Implicitly, 30 minutes) | Validated for 30 minutes |
| Pre-Vacuum Steam Sterilization (Max Weight 44gsm) | (Implicitly, 6 lbs) | Validated for 6 lbs |
| Pre-Vacuum Steam Sterilization (Max Weight 70gsm) | (Implicitly, 15 lbs) | Validated for 15 lbs |
| ASP STERRAD® 100S Sterilization (Max Weight) | (Implicitly, 10.7 lbs) | Validated for 10.7 lbs |
| Maintenance of Sterility | (Implicitly, 180 days) | 180 days |
Study Details:
- 2. Sample size used for the test set and the data provenance: Not explicitly stated for each test, but the document mentions "a series of nonclinical tests." The provenance is internal testing by Comercializadora Brever, S.A. de C.V. as stated: "all testing refers to the same product(s) that are manufactured by Comercializadora Brever, S.A. de C.V."
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a non-clinical device (sterilization wrap), and "ground truth" in the context of expert medical interpretation is not relevant here. The 'ground truth' for these tests would be the established scientific and engineering standards and methods.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical testing of a sterilization wrap.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The 'ground truth' for this type of device is established through documented standard test methods (e.g., ASTM, ISO, AATCC, USP-NF) and validated sterilization cycles.
- 8. The sample size for the training set: Not applicable. This is not an AI/ML device.
- 9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
Additional Information from the "Summary of Non-Clinical Testing":
The study described the performance data for the CDB Hospital Sterilization Wrap, which included a series of nonclinical tests "associated with specific unique codes." These tests were conducted to demonstrate conformance with microbial barrier properties. The testing encompassed:
- Low Temperature Efficacy
- Steam Efficacy
- Shelf Life (up to 180 days under standard conditions)
- Aerosol Challenge
- Biocompatibility / Cytotoxicity (referencing ISO 10993 parts 5 and 23)
The key finding from these tests was that "All results met the defined acceptance criteria." The purpose of these tests was to validate the wrap's ability to maintain the sterility of package contents after sterilization, across different sterilization methods and for a specified shelf life.
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Image /page/0/Picture/0 description: The image contains 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.
November 4, 2024
Comercializadora Brever Clarisbeth Flores Lara Regulatory Advisor and Project Manager Omega 102 Local Leon, Guanajuato Mexico
Re: K240438
Trade/Device Name: CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm) Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: January 5, 2024 Received: February 14, 2024
Dear Clarisbeth Flores Lara:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
Image /page/2/Picture/3 description: The image contains the text "Stephen A. Anisko -S". The text is arranged in two lines, with "Stephen A." on the first line and "Anisko -S" on the second line. The text is black and the background is white with a blue design on the right side.
Digitally signed by Stephen A. Anisko -S Date: 2024.11.04 17:24:33 -05'00'
for: Christopher K. Dugard, M.S. Assistant Director DHT4C: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K240438
Device Name
CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital @ Sterilization Wrap (44 gsm)
Indications for Use (Describe)
CDB Hospital ® Sterilization Wraps 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
· 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 sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) until used.
Pre-Vacuum Steam Sterilization:
- · Validated for dry time of 30 minutes for 44gsm.
- · Validated for dry time of 30 minutes for 70gsm.
- · Validated maximum weight of 6 lbs for 44 gsm.
- · Validated maximum weight of 15 lbs for 70 gsm.
• All models of CDB Hospital ® Sterilization Wraps validated for pre-vacuum steam sterilization with stainless steel lumens of 3 mm diameter or larger and length 400 mm or shorter as part of the load.
Advanced Sterilization Products (ASP) STERRAD® 100S Sterilization:
All models of CDB Hospital® Sterilization Wraps validated with ASP STERRAD® 100S sterilization with stainless steel lumens as part of the load with a maximum weight of 10.7lbs.
Advanced Sterilization Products (ASP) STERRAD® 100NX Sterilization:
All models of CDB Hospital® Sterilization Wraps validated with ASP STERRAD® 100NX sterilization cycles are detailed below:
VALIDATED ADVANCED STERILIZATION PRODUCTS (ASP) STERRAD® 100NX CYCLES Advanced Sterilization Products (ASP) STERRAD® System and Cycle
Intended Load for 100NX Standard Cycle:
Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load: · An inside diameter of 0.7mm or larger and a length of 200mm or shorter of single channel stainless steel lumens.
Intended Load for 100NX Flex Cycle:
One or two single-channel flexible endoscopes with or without a silicone mat. Flexible endoscope may contain: A single channel Teflon/PE/PTFE lumen with an inside diameter of 1 mm or larger and a length of 850 mm or shorter (a maximum of two flexible endoscopes, one per tray per sterilization cycle).
Intended Load for 100NX Express Cycle:
Non-lumened reusable metal and non-metal medical devices requiring surface sterilization, or
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sterilization of mated stainless steel and titanium surfaces, and rigid or semi-rigid endoscopes without lumens.
STERIS Amsco® V-PRO 1, STERIS Amsco® V-PRO 1 Plus, STERIS Amsco® V-PRO maX Low Temperature Sterilization Systems:
• All models of CDB Hospital® Sterilization Wraps have been validated for use with STERIS V-PRO® cycles detailed below.
· CDB Hospital® Sterilization Wraps were validated to be effectively aerated during the preprogrammed STERIS Amsco V-PRO® Sterilization Cycles.
VALIDATED STERIS AMSCO® V-PRO CYCLES STERIS Amsco® V-PRO Cycle
Intended Load for Lumen Cycle:
Reusable metal and non-metal medical devices, including up to 20 stainless steel lumens with dimensions of 3.0mm diameter or larger and a length of 400mm or shorter.
Intended Load for Non Lumen Cycle:
Non lumened reusable metal and non-metal medical devices.
Intended Load for Flexible Cycle:
Single lumen surgical flexible endoscopes and bronchoscopes in the following load configuration:
1.) One tray containing a flexible endoscope with a light cord (if not integral to endoscope) and mat. The flexible endoscope having an inside diameter of 3 mm or larger and a length of 450 mm or shorter.
2.) An additional tray containing non-lumened medical devices.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY (as required by 21 CFR § 807.92) K240438
- l. Submitter: Comercializadora Brever Ms. Clarisbeth Flores Lara Omega 102 Local Leon, Guanajuato Mexico Phone: 477-331-1478 c.flores@cdbhospital.com Date Prepared: 1 November 2024
| II. | Device: | |
|---|---|---|
| Trade Name of Device: | CDB Hospital® Sterilization Wrap (70 gsm); | |
| CDB Hospital® Sterilization Wrap (44 gsm) | ||
| Common or Usual Name: | Sterilization Wrap | |
| Classification Name: | Sterilization Wrap | |
| Regulation Number: | 21 CFR 880.6850 | |
| Device Class: | Class II | |
| Regulation Name: | Sterilization Wrap | |
| Product Code: | FRG |
lll. Predicate Device:
- K171533 Ahlstrom Nonwovens LLC Reliance® Tandem and Reliance® Solo
IV. Device Description:
The CDB Hospital ® Sterilization Wraps are square or rectangular nonwoven sheets produced using a three-layer SMS (spunbond-meltblown-spunbond) process. The CDB Hospital ® Sterilization Wraps' SMS fabric is made of 100% polypropylene, blue color, and are separated into two distinct product offerings:
CDB Hospital® Sterilization Wraps, 44gsm: Consist of two sheets of SMS wrap (light blue and dark blue), ultrasonically bonded together along two edges for convenient simultaneous wrapping of one or a collection of medical devices that will be sterilized following standard health care practices.
CDB Hospital® Sterilization Wraps, 70gsm: Consist of two sheets of SMS wrap (light blue and dark blue), 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.
CDB Hospital® Sterilization Wraps are composed of polypropylene with the addition of light blue and dark blue pigment and an antistatic treatment. The CDB Hospital ® Sterilization Wraps allow a sterilized package of medical devices to be opened aseptically. This product is over-the-counter use.
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V. Indications for Use:
CDB Hospital ® Sterilization Wraps 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
- 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 sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) until used.
Pre-Vacuum Steam Sterilization:
- Validated for dry time of 30 minutes for 44gsm.
- Validated for dry time of 30 minutes for 70gsm. ●
- . Validated maximum weight of 6 lbs for 44 gsm.
- Validated maximum weight of 15 lbs for 70 gsm.
- All models of CDB Hospital ® Sterilization Wraps validated for pre-vacuum steam sterilization with stainless steel lumens of 3 mm diameter or larger and length 400 mm or shorter as part of the load.
Advanced Sterilization Products (ASP) STERRAD® 100S Sterilization:
All models of CDB Hospital® Sterilization Wraps validated with ASP STERRAD® 100S sterilization with stainless steel lumens as part of the load with a maximum weight of 10.7lbs.
Advanced Sterilization Products (ASP) STERRAD® 100NX Sterilization:
All models of CDB Hospital® Sterilization Wraps validated with ASP STERRAD® 100NX sterilization cycles are detailed below:
VALIDATED ADVANCED STERILIZATION PRODUCTS (ASP) STERRAD® 100NX CYCLES
Advanced Sterilization Products (ASP) STERRAD® System and Cycle
Intended Load for 100NX Standard Cycle:
Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load:
- An inside diameter of 0.7mm or larger and a length of 200mm or shorter of single channel . stainless steel lumens.
Intended Load for 100NX Flex Cycle:
One or two single-channel flexible endoscopes with or without a silicone mat. Flexible endoscope may contain:
A single channel Teflon/PE/PTFE lumen with an inside diameter of 1 mm or larger and a length of 850 mm or shorter (a maximum of two flexible endoscopes, one per tray per sterilization cycle).
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Intended Load for 100NX Express Cycle:
Non-lumened reusable metal and non-metal medical devices requiring surface sterilization, or sterilization of mated stainless steel and titanium surfaces, and rigid or semi-rigid endoscopes without lumens.
STERIS Amsco® V-PRO 1, STERIS Amsco® V-PRO 1 Plus, STERIS Amsco® V-PRO maX Low Temperature Sterilization Systems:
- . All models of CDB Hospital® Sterilization Wraps have been validated for use with STERIS V-PRO® cycles detailed below.
- . CDB Hospital® Sterilization Wraps were validated to be effectively aerated during the preprogrammed STERIS Amsco V-PRO® Sterilization Cycles.
VALIDATED STERIS AMSCO® V-PRO CYCLES
STERIS Amsco® V-PRO Cycle
Intended Load for Lumen Cycle:
Reusable metal and non-metal medical devices, including up to 20 stainless steel lumens with dimensions of 3.0mm diameter or larger and a length of 400mm or shorter.
Intended Load for Non Lumen Cycle:
Non lumened reusable metal and non-metal medical devices.
Intended Load for Flexible Cycle:
Single lumen surgical flexible endoscopes and bronchoscopes in the following load configuration:
1.) One tray containing a flexible endoscope with a light cord (if not integral to endoscope) and mat. The flexible endoscope having an inside diameter of 3 mm or larger and a length of 450 mm or shorter.
2.) An additional tray containing non-lumened medical devices.
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VI. Comparison of Technological Characteristics with the Predicate Device:
| Element of Comparison | Predicate Device – K171533RELIANCE® Tandem and Solo Sterilization Wrap | Subject Device – K240438CDB Hospital ® Sterilization Wrap | Comparison |
|---|---|---|---|
| Indications for Use | Ahlstrom Reliance® Tandem and SoloSterilization Wraps are intended to be usedto enclose another medical device that is tobe sterilized by a healthcare provider via thefollowing:Pre-vacuum Steam 270°F/132°C for 4minutes Gravity Steam 250°F/121°C for 30 minutes 100% Ethylene Oxide (EO) with aconcentration of 725-735 mg/L @131°F/55°C and 40% - 80% relative humidityfor 60 minutes Advanced Sterilization Products (ASP)STERRAD® 100S Advanced Sterilization Products (ASP)STERRAD® 100NX (Standard, Express andFlex cycles) STERIS Amsco® V-PRO 1, STERIS Amsco®V-PRO 1 Plus, STERIS Amsco® V-PRO maX LowTemperature Sterilization Systems (Lumen,Non Lumen and Flexible Cycles) The wrap is intended to allow sterilization ofthe enclosed medical device(s) and maintainsterility of the enclosed device(s) until used.Pre-Vacuum Steam Sterilization: Validated for dry time of 20 minutes forModels T100/S100, T200/S200, T300/S300. Validated for dry time of 30 minutes forModels T400/S400, T500/S500, T600/S600. All models of Reliance® Tandem and Solovalidated for pre-vacuum steam sterilizationwith stainless steel lumens as part of theload with a maximum weight of 25lbsdependent on the model. | CDB Hospital® Sterilization Wrapsintended to be used to enclose anothermedical device that is to be sterilized by ahealthcare provider via the following:Pre-vacuum Steam 270°F/132°C for 4minutes Advanced Sterilization Products (ASP)STERRAD® 100S Advanced Sterilization Products (ASP)STERRAD® 100NX (Standard, Express andFlex cycles) STERIS Amsco® V-PRO 1, STERIS Amsco®V-PRO 1 Plus, STERIS Amsco® V-PRO maX LowTemperature Sterilization Systems (Lumen,Non Lumen and Flexible Cycles) The wrap is intended to allow sterilizationof the enclosed medical device(s) andmaintain sterility of the encloseddevice(s) until used.Pre-Vacuum Steam Sterilization: Validated for dry time of 30 minutes for44gsm. Validated for dry time of 30 minutes for70gsm. Validated maximum weight of 6 lbs for44 gsm. Validated maximum weight of 15 lbs for70 gsm. All models of CDB Hospital ® SterilizationWraps validated for pre-vacuum steamsterilization with stainless steel lumens of3 mm diameter or larger and length 400mm or shorter as part of the load. | Similar |
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| Gravity Steam Sterilization:• Validated for dry times of 20 minutes forModels T100/S100, T200/S200,T300/S300.• Validated for dry times of 30 minutes forModels T400/S400.• Models T100/S100, T200/S200,T300/S300, T400/S400 of Reliance®Tandem and Solo validated for gravitysteam sterilization with stainless steellumens as part of the load with amaximum weight of 25lbs dependent onthe model.• Models T500/S500 and T600/S600 arenot validated for use for gravity steamsterilization. | Advanced Sterilization Products (ASP)STERRAD® 100S Sterilization:All models of CDB Hospital® SterilizationWraps validated with ASP STERRAD®100S sterilization with stainless steellumens as part of the load with amaximum weight of 10.7lbs.Advanced Sterilization Products (ASP)STERRAD® 100NX Sterilization:All models of CDB Hospital® SterilizationWraps validated with ASP STERRAD®100NX sterilization cycles are detailedbelow:VALIDATED ADVANCED STERILIZATIONPRODUCTS (ASP) STERRAD® 100NXCYCLESAdvanced Sterilization Products (ASP)STERRAD® System and CycleIntended Load for 100NX Standard Cycle:Reusable metal and non-metal medicaldevices, including up to 10 lumens of thefollowing dimensions per chamber load:• An inside diameter of 0.7mm or largerand a length of 200mm or shorter ofsingle channel stainless steel lumens.Intended Load for 100NX Flex Cycle:One or two single-channel flexibleendoscopes with or without a siliconemat. Flexible endoscope may contain:A single channel Teflon/PE/PTFE lumenwith an inside diameter of 1 mm or largerand alength of 850 mm or shorter (a maximumof two flexible endoscopes, one per trayper sterilization cycle).Intended Load for 100NX Express Cycle:Non-lumened reusable metal and non-metal medical devices requiring surfacesterilization, or sterilization of matedstainless steel and titanium surfaces, andrigid or semi-rigid endoscopes withoutlumens.STERIS Amsco® V-PRO 1, STERIS Amsco®V-PRO 1 Plus, STERIS Amsco® V-PRO maX | |
|---|---|---|
| Ethylene Oxide Sterilization:• Validated for aeration time of 8 hours at550C• All models of Reliance® Tandem and Solovalidated for ethylene oxide sterilizationwith stainless steel lumens as part of theload with a maximum weight of 25lbsdependent on the model. | ||
| Advanced Sterilization Products (ASP)STERRAD® 100S Sterilization• All models of Reliance® Tandem and Solovalidated with ASP STERRAD® 100Ssterilization with stainless steel lumens aspart of the load with a maximum weight of10.7lbs dependent on the model. | ||
| Advanced Sterilization Products (ASP)STERRAD® 100NX Sterilization• All models of Reliance® Tandem and Solovalidated with ASP STERRAD® 100NXsterilization cycles detailed in Table 1. | ||
| Table 1: Validated Advanced Sterilization Products(ASP) STERRAD® 100NX Cycles | ||
| AdvancedSterilization Products(ASP) STERRAD®System and Cycle | Intended Load | |
| 100NX StandardCycle | Reusable metal and non-metal medical devices,including up to 10lumens of the following | |
| dimensions per chamber load:• An inside diameter of0.7mm or larger and alength of 500mm orshorter of single-channelstainless steel lumens. | Low Temperature Sterilization Systems:• All models of CDB Hospital®Sterilization Wraps have been validatedfor use with STERIS V-PRO® cyclesdetailed below. | |
| 100NX Flex Cycle | One or two single-channel flexibleendoscopes with orwithout a silicone mat.Flexible endoscope maycontain:• A single channelTeflon/PE/PTFE lumenwith an inside diameterof 1 mm or larger and alength of 850mm orshorter. (A maximum oftwo flexible endoscopes,one per tray persterilization cycle) | • CDB Hospital® Sterilization Wraps werevalidated to be effectively aeratedduring the preprogrammed STERISAmsco V-PRO® Sterilization Cycles.VALIDATED STERIS AMSCO® V-PRO CYCLESSTERIS Amsco® V-PRO CycleIntended Load for Lumen Cycle:Reusable metal and non-metal medicaldevices, including up to 20 stainless steellumens with dimensions of 3.0mmdiameter or larger and a length of 400mmor shorter. |
| 100NX Express Cycle | Non-lumened reusablemetal and non-metalmedical devicesrequiring surfacesterilization, orsterilization of matedstainless steel andtitanium surfaces, andrigid or semi-rigidendoscopes withoutlumens. | Intended Load for Non Lumen Cycle:Non lumened reusable metal and non-metal medical devices.Intended Load for Flexible Cycle:Single lumen surgical flexible endoscopesand bronchoscopes in the following loadconfiguration:1.) One tray containing a flexibleendoscope with a light cord (if notintegral to endoscope) and mat. Theflexible endoscope having an insidediameter of 3 mm or larger and a lengthof 450 mm or shorter.2.) An additional tray containing non-lumened medical devices. |
| STERIS Amsco® V-PRO 1, STERIS Amsco®V-PRO 1 Plus, STERIS Amsco® V-PRO maXLow Temperature Sterilization Systems• All models of Reliance® Tandem and SoloSterilization Wraps have been validated foruse with STERIS V-PRO® cycles detailed inTable 2.• Reliance® Tandem and Solo SterilizationWraps were validated to be effectivelyaerated during the pre-programmedSTERIS Amsco V-PRO® Sterilization Cycles. | ||
| Table 2: Validated STERIS Amsco® V-PRO Cycles | ||
| STERIS Amsco® V-PRO Cycle | Intended Load | |
| Lumen Cycle | Reusable metal and non-metal medical devices,including up to 20 stainlesssteel lumens with dimensionsof 3.0mm diameter or larger |
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| and a length of 400mm or shorter. | |||||
|---|---|---|---|---|---|
| Non Lumen Cycle | Non lumened reusable metal and non-metal medical devices. | ||||
| Flexible Cycle | Single lumen surgical flexible endoscopes and bronchoscopes in the following load configuration: 1.) One tray containing a flexible endoscope with a light cord (if not integral to endoscope) and mat. The flexible endoscope having an inside diameter of 1 mm or larger and a length of 850 mm or shorter. 2.) An additional tray containing non-lumened medical devices. | ||||
| Regulation,Classification,Product Code | Regulation Number: 21 CFR 880.6850Classification Name: Sterilization WrapRegulatory Class: IIProduct Code: FRG | Regulation Number: 21 CFR 880.6850Classification Name: Sterilization WrapRegulatory Class: IIProduct Code: FRG | Same | ||
| Device Design | Nonwoven sheets produced using a three-layer SMS (spunbond-meltblown-spunbond) process.Reliance® Tandem: One sheet of SMS wrapReliance® Solo: Consists of two sheets of SMS wrap | Two nonwoven sheets of wrap (light blue and dark blue). Each sheet is produced using a three-layer spunbond-meltblown-spunbond (SMS) process. | Similar | ||
| Method forbonding SMSlayers | Reliance® Solo: Consists of two sheets of SMS wrap, ultrasonically bonded together along two edges | two sheets of SMS wrap (light blue and dark blue) are ultrasonically bonded together along two edges. | Similar | ||
| Materials | Polypropylene spunbond-meltblown-spunbond (SMS) fabric | Spunbond-meltblown-spunbond (SMS) nonwoven polypropylene material | Similar | ||
| Models | Reliance® Tandem and Solo Models:T100/S100, T200/S200, T300/S300T400/S400, T500/S500, T600/S600 | 44 gsm70 gsm | Similar | ||
| Product Colorand Dimensions | Blue, Green | Blue | Similar | ||
| 9 x 9 in | 12 x 12 in | 36 x 36 in | |||
| 12 x 12 in | 15 x 15 in | 40 x 40 in | |||
| 15 x 15 in | 18 x 18 in | 45 x 45 in | |||
| 18 x 18 in | 20 x 20 in | 48 x 48 in | |||
| 20 x 20 in | 24 x 24 in | 54 x 54 in | |||
| 24 x 24 in30 x 30 in | 30 x 30 in | 54 x 72 in | |||
| Prescriptionvs OTC | OTC | OTC | Same |
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| Single Usevs. Reusable | Single use only | Single use only | Same |
|---|---|---|---|
| Biocompatibility | Pass | Applicable parts of ISO 10993 -Biological evaluation of medicaldevices | Same |
| Maintenance ofSterility | 180 days | 180 days | Same |
VII. Summary of Non-Clinical Testing:
Performance data for the CDB Hospital Sterilization Wrap included a series of nonclinical tests, each associated with specific unique codes. These tests were conducted to demonstrate continued conformance with the microbial barrier properties. The CDB Hospital Sterilization Wraps underwent a comprehensive range of tests including Low Temperature Efficacy, Steam Efficacy, Shelf Life, Aerosol Challenge, and Biocompatibility / Cytotoxicity. The testing was conducted to validate the wraps' ability to maintain sterility of pack contents after sterilization, assessing different sterilization methods and shelf life durations up to 180 days under standard conditions. All results met the defined acceptance criteria.
Also, please note that all testing refers to the same product(s) that are manufactured by Comercializadora Brever, S.A. de C.V.
| Test Item | Test Standard Methods | Remark |
|---|---|---|
| Basis Weight | ASTM D3776/D3776M-20 | Meets requirement |
| Tearing Strength | ASTM D5587- 15(2019) | Meets requirement |
| Lint Generation | ISO 9073-10:2003 | Meets requirement |
| Bacterial Filtration Efficiency(BFE) | ASTM F2101- 23 | Meets requirement |
| Hydrostatic Pressure | AATCC Test Method 127-2018 | Meets requirement |
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| Air Permeability | ASTM D737- 18 | Meets requirement |
|---|---|---|
| Sterilant penetration- BIincubation | ANSI/AAMI/ISO 11138-7 | Meets requirement |
| Maintenance of PackageSterility- Sterility Test | USP-NF 2022<71> | Meets requirement |
| Maintenance of PackageSterility- Microbial AerosolChallenge | ASTM F1608- 21 | Meets requirement |
| Biocompatibility- Cytotoxicityand Irritation | ISO 10993-5:2009,ISO 10993-23:2021 | Meets requirement |
Summary for Clinical Testing: VIII.
Not Applicable
IX. Conclusions:
The conclusion drawn from the 510(k) from the nonclinical tests shall demonstrate that the subject devices included in the 510(k) submission, CDB Hospital® Sterilization Wrap, are as safe, as effective, and perform as well as or better than the legally marketed predicate device cleared under K171533 (RELIANCE® Tandem and Solo Sterilization Wrap).
§ 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).