Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a physical sterilization wrap and its validation for use with various sterilization methods. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.

Therapeutic

No.
The device is a sterilization wrap intended to enclose other medical devices for sterilization and maintain their sterility, not to treat or diagnose a disease or condition in a patient.

Diagnostic

No

Explanation: The device is a sterilization wrap intended to enclose medical devices for sterilization and maintain their sterility, not to diagnose a condition or disease.

SaMD (Software as a Medical Device)

No

The device is a physical sterilization wrap made of polypropylene, not software. The description details its material, construction, and validation for use with various sterilization methods.

IVD (In Vitro Diagnostic)

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 that is to be sterilized by a healthcare provider". Its purpose is to facilitate sterilization and maintain the sterility of other medical devices.
Device Description: The device is described as "square or rectangular nonwoven sheets produced using a three-layer SMS (spunbond-meltblown-spunbond) process". This is a physical barrier material.
Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.

IVD devices are specifically designed to perform tests on biological samples (like blood, urine, tissue) to provide diagnostic information. This sterilization wrap does not perform any such diagnostic function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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).

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.

Product codes (comma separated list FDA assigned to the subject device)

FRG

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.

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

healthcare 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)

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.

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.

K171533

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

0

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"

1

(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).

2

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

3

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

4

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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5

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.

6

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).

7

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.

8

VI. Comparison of Technological Characteristics with the Predicate Device:

| Element of Comparison | Predicate Device – K171533
RELIANCE® Tandem and Solo Sterilization Wrap | Subject Device – K240438
CDB Hospital ® Sterilization Wrap | Comparison |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for Use | 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 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 20 minutes for
Models T100/S100, T200/S200, T300/S300. Validated for dry time of 30 minutes for
Models T400/S400, T500/S500, T600/S600. All models of Reliance® Tandem and Solo
validated for pre-vacuum steam sterilization
with stainless steel lumens as part of the
load with a maximum weight of 25lbs
dependent on the model. | 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. | Similar |

9

| Gravity Steam Sterilization:
• Validated for dry times of 20 minutes for
Models T100/S100, T200/S200,
T300/S300.
• Validated for dry times of 30 minutes for
Models T400/S400.
• Models T100/S100, T200/S200,
T300/S300, T400/S400 of Reliance®
Tandem and Solo validated for gravity
steam sterilization with stainless steel
lumens as part of the load with a
maximum weight of 25lbs dependent on
the model.
• Models T500/S500 and T600/S600 are
not validated for use for gravity steam
sterilization. | 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 | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Ethylene Oxide Sterilization:
• Validated for aeration time of 8 hours at
550C
• All models of Reliance® Tandem and Solo
validated for ethylene oxide sterilization
with stainless steel lumens as part of the
load with a maximum weight of 25lbs
dependent on the model. | | |
| Advanced Sterilization Products (ASP)
STERRAD® 100S Sterilization
• All models of Reliance® Tandem and Solo
validated with ASP STERRAD® 100S
sterilization with stainless steel lumens as
part of the load with a maximum weight of
10.7lbs dependent on the model. | | |
| Advanced Sterilization Products (ASP)
STERRAD® 100NX Sterilization
• All models of Reliance® Tandem and Solo
validated with ASP STERRAD® 100NX
sterilization cycles detailed in Table 1. | | |
| Table 1: Validated Advanced Sterilization Products
(ASP) STERRAD® 100NX Cycles | | |
| Advanced
Sterilization Products
(ASP) STERRAD®
System and Cycle | Intended Load | |
| 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 500mm or
shorter of single-channel
stainless steel lumens. | Low Temperature Sterilization Systems:
• All models of CDB Hospital®
Sterilization Wraps have been validated
for use with STERIS V-PRO® cycles
detailed below. |
| 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 850mm or
shorter. (A maximum of
two flexible endoscopes,
one per tray per
sterilization cycle) | • 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. |
| 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. | 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. |
| STERIS Amsco® V-PRO 1, STERIS Amsco®
V-PRO 1 Plus, STERIS Amsco® V-PRO maX
Low Temperature Sterilization Systems
• All models of Reliance® Tandem and Solo
Sterilization Wraps have been validated for
use with STERIS V-PRO® cycles detailed in
Table 2.
• Reliance® Tandem and Solo Sterilization
Wraps were validated to be effectively
aerated during the pre-programmed
STERIS 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 stainless
steel lumens with dimensions
of 3.0mm diameter or larger | |

10

11

		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 880.6850
Classification Name: Sterilization Wrap
Regulatory Class: II
Product Code: FRG	Regulation Number: 21 CFR 880.6850
Classification Name: Sterilization Wrap
Regulatory Class: II
Product Code: FRG		Same
Device Design		Nonwoven sheets produced using a three-layer SMS (spunbond-meltblown-spunbond) process.

Reliance® Tandem: One sheet of SMS wrap

Reliance® 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 for
bonding SMS
layers | | 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/S300
T400/S400, T500/S500, T600/S600 | 44 gsm
70 gsm | | Similar |
| Product Color
and 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 in
30 x 30 in | 30 x 30 in | 54 x 72 in | |
| Prescription
vs OTC | | OTC | OTC | | Same |

12

| Single Use

vs. Reusable	Single use only	Single use only	Same
Biocompatibility	Pass	Applicable parts of ISO 10993 -
Biological evaluation of medical
devices	Same
Maintenance of
Sterility	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

13

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

                | 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).