The PRIMED Sterilization wraps are intended to be used to enclose another medical device that is to be sterilized by a health care provider via the following:

Pre-Vacuum Steam at 270°F/ 132°C for 4 minutes. The wrap has been validated for dry time of 20 minutes for P100 and P200 and dry time of 30 minutes for P300, P400, P500 and P600.
100% Ethylene Oxide Sterilization with a concentration of 725-735 mg/L at 131°F/55°C and 40% 80% relative humidity for 60 minutes. Validated for aeration times of 8 hours at 55°C or 12 hours at 43.3°C.
Lumen. Non-Lumen. and Flexible Cycles in the STERIS V-PRO maX/maX2 and STERIS V-PRO 60/s2 low temperature Sterilization Systems.
Advanced Sterilization Products STERRAD 100S system
Advanced Sterilization Products STERRAD NX [Standard Cycle, Advanced Cycle]
Advanced Sterilization Products STERRAD 100 NX [Standard Cycle, Flex Cycle, Express, Duo Cycle]

PRIMED Sterilization wraps are available in 6 models and different sizes ranging from 12" X 12" to 54" X 90" and are intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) for a maximum of 180 days or until used. PRIMED Sterilization wraps are validated for use with above listed sterilization systems with the intended loads as described below.

Device Description

The PRIMED Sterilization wraps are made of SMS (Spunbond) Polypropylene with addition of a master batch pigment for coloration and are available in three separate product offerings:

1- The Fused one colour double layer bonded wrap is comprised of two sheets ultrasonically bonded on two parallel sides. The wrap fabrics are composed of polypropylene with the addition of purple pigment. This product allows convenient simultaneous wrapping of medical devices to be sterilized in accordance with standard healthcare practices.
2- The Fused two colours double layer bonded wrap is comprised of two sheets of purple and blue fabrics ultrasonically bonded on two parallel sides. The wrap fabrics are composed of polypropylene with the addition of purple or blue pigment. This product allows convenient simultaneous wrapping of medical devices to be sterilized in accordance with standard healthcare practices.
3-The Single layer one colour wrap is comprised of a single nonwoven sheet. The standard purple wrap is composed of polypropylene with the addition of a purple pigment. Two sheets are used to sequentially wrap medical devices to be sterilized in accordance with standard healthcare practices.

PRIMED Sterilization wraps are available in various dimensions ranging from 12″ x 12″ x 90″ and six different weights as detailed in table 1.

AI/ML Overview

The provided text describes the acceptance criteria and the comprehensive non-clinical testing performed for the PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) to demonstrate its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Test Performed	Test Method	Acceptance Criteria	Reported Device Performance
Sterilant Penetration	ANSI/AAMI ST79, ANSI/AAMI/ISO 11138-7	All BI test samples should be negative for growth following the minimum incubation period	Pass
Maintenance of Package Integrity	ANSI/AAMI/ISO 11607-1, AAMI TIR12 ANSI, AAMI ST79	Maintain sterility for 180 days	Pass
Maintenance of package sterility	AAMI TIR12 - ANSI/AAMI ST77	No growth in any of the culture vessels containing test coupons after the minimum incubation period	Pass
Residual (Ethylene Oxide)	ISO 10993-7	Less than maximum theoretical residual limits or the tolerable contact limit following a 100% ethylene oxide sterilization process	Pass
Biocompatibility (Cytotoxicity, Irritation, Sensitization)	ISO 10993-5 and ISO 10993-10	non-cytotoxic, non-irritating and non-sensitizing	Pass
Physical and Chemical Properties and Material compatibility with the intended sterilization method (PH value, chloride content, sulphate content, colour fastness, Basis weight, Air permeability, Material burst strength, Grab Tensile strength, Trapezoidal Tear strength, Hydrostatic Pressure, Linting)	ISO 11607-1 and EN 868-2, ASTM D3776, ASTM D737-04, ASTM D3786, ASTM D5034-09, ASTM D5587-15, AATC127-2014, NWSP 160.1	Meets physical and chemical properties, non-sterile and post sterilization	Pass

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample size for each test set. However, it indicates that the testing was non-clinical. This implies that the data provenance is from laboratory testing and not from human patient data. The origin of the data is implicit in the "non-clinical" nature and the use of ISO/ASTM standards for testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this type of device and study. The "ground truth" for sterilization wraps and their performance is established through adherence to recognized international standards (ISO, AAMI, ASTM, EN) and empirical laboratory testing, not through expert consensus from human observation (e.g., radiologists).

4. Adjudication Method for the Test Set

This information is not applicable as the evaluations are based on objective laboratory measurements against predefined technical specifications and standards, not on subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable as the device is a sterilization wrap, not an AI-powered diagnostic or assistive tool for human readers.

6. Standalone Performance Study

Yes, the studies described are standalone performance studies (algorithm only without human-in-the-loop performance), as they focus on the intrinsic properties and performance of the sterilization wrap itself against established technical and biological criteria. The "algorithm" in this context refers to the defined device specifications and its physical/chemical interactions, not a software algorithm.

7. Type of Ground Truth Used

The ground truth used is primarily based on established industry standards and regulatory requirements for medical device sterilization and packaging, including:

Biological indicators (for sterilant penetration and sterility maintenance) which have a known, predictable response.
Physical and chemical property specifications (e.g., burst strength, air permeability, pH, leachable content) that are objectively measurable and defined by standards.
Biocompatibility standards that define acceptable levels of cytotoxicity, irritation, and sensitization.
Package integrity criteria for maintaining a sterile barrier for a specified duration.

8. Sample Size for the Training Set

This information is not applicable. The device is a sterilization wrap, not an AI/ML-based algorithm that requires a "training set" of data. The development and validation process for this device involves material science, engineering, and microbiology, not machine learning.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the reasons stated in point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 7, 2024

PRIMED Medical Products Inc. Mitra Fard Manager, Regulatory Affairs 200. 2003 91 St SW Edmonton, AB T6X0W8 Canada

Re: K242208

Trade/Device Name: PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: July 25, 2024 Received: July 29, 2024

Dear Mitra Fard:

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 is set against a white background. The text appears to be a name.

Digitally signed by Stephen A. Anisko -S
Date: 2024.10.07 11:34:31 -04'00'

for: Christopher Dugard Assistant Director DHT4C: Division of Infection Control 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) K242208

Device Name

PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)

Indications for Use (Describe)

The PRIMED Sterilization wraps are intended to be used to enclose another medical device that is to be sterilized by a health care provider via the following:

Pre-Vacuum Steam at 270°F/ 132°C for 4 minutes. The wrap has been validated for dry time of 20 minutes for P100 and P200 and dry time of 30 minutes for P300, P400, P500 and P600.
100% Ethylene Oxide Sterilization with a concentration of 725-735 mg/L at 131°F/55°C and 40% 80% relative humidity for 60 minutes. Validated for aeration times of 8 hours at 55°C or 12 hours at 43.3°C.
Lumen. Non-Lumen. and Flexible Cycles in the STERIS V-PRO maX/maX2 and STERIS V-PRO 60/s2 low temperature Sterilization Systems.
Advanced Sterilization Products STERRAD 100S system
Advanced Sterilization Products STERRAD NX [Standard Cycle, Advanced Cycle]
Advanced Sterilization Products STERRAD 100 NX [Standard Cycle, Flex Cycle, Express, Duo Cycle]

Model	Intended Load	Maximum Recommended Wrapped Package Content
		Pre-VacuumSteam and EO	ASP STERRAD 100S,100NX and NX	STERIS V-PRO
P100	Very light weight package. For example, light handle covers or towel packs.	3 lbs	3 lbs	3 lbs
P200	Light weight package. For example, standard linen packs	6 lbs	6 lbs	6.5 lbs
P300	Light to moderate weight package. For example, general use medical instruments.	9 lbs	9 lbs	9 lbs
P400	Moderate to heavy weight package. For example, general use medical instruments.	13 lbs	10.7 lbs	12 lbs
P500	Heavy weight package. For example, general use medical instruments	17 lbs	10.7 lbs	12 lbs
P600	Very heavy weight package. For example, general use medical instruments.	25 lbs	10.7 lbs	12 lbs

PRIMED wraps are validated for Pre-Vacuum Steam and EO sterilization with two 3.0mm x 400 mm lumen devices as part of the load.

PRIMED wraps are validated for ASP STERRAD 100 S sterilization with 10 stainless steel lumens (2mm ID x 250 mm length) as part of their load.

PRIMED Sterilization wraps are validated for use with STERIS V-PRO cycles and intended load as listed below:

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V-PRO maX/maX2 Non-Lumen Cycle:

· Non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
· Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes.
V-PRO maX/maX2 Lumen Cycle:
- · Non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
- · Single, dual, or triple channeled stainless steel lumen that are:
  - o ≥ 0.77 mm ID and ≤ 527 mm in length.
  - o ≥ 0.8 mm ID and ≤ 542 mm in length.
  - o ≥0.48 mm ID and ≤ 100 mm in length .
- Dead end lumen that is ≥ 1.3 mm ID and ≤ 73 mm in length
- · Rigid non-metallic lumen that are:
  - o ≥ 3 mm ID and ≤ 298 mm in length.
  - o ≥ 4 mm ID and ≤ 424 mm in length.
V-PRO maX/maX2 Flexible Cycle:
- Non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
- · Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two configurations:
  - o Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. The flexible endoscopes may contain:
    - Single or dual channel lumens that are ≥ 1 mm ID and ≤ 1050 mm in length
  - o One flexible endoscope with a light cord (if not integral to the endoscope) and mat and additional instruments. The flexible endoscope may contain:
    - Single or dual channel lumens that are ≥ 1 mm ID and ≤ 1050 mm in length
    - Additional load, up to 24 lbs (11 kg) can include lumened or non-lumened medical devices:
    - Single, dual, or triple channel stainless steel lumens ≥0.48 mm ID and ≤ 100 mm in length

V-PRO 60/s2 Non-Lumen Cycle:

· Non-lumened instruments and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
· Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes.
V-PRO 60/s2 Lumen Cycle:
- · Non-lumened instruments and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
- · Medical devices (including single, dual, and triple channeled rigid endoscopes) with the following configurations:
  - o Single or dual channeled devices with stainless steel lumens that are:
    - 0.77 mm ID and < 410 mm in length.
    - ≥ 1.8 mm ID and ≤ 542 mm in length.
  - o Triple channeled devices with stainless steel lumens that are either:
    - ≥1.2 mm ID and ≤275 mm in length
    - ->1.8 mm ID and < 310 mm in length or
    - ≥ 2.8 mm ID and ≤317 mm in length

V-PRO 60/s2 Flexible Cycle:

Non-lumened instruments and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
· One surgical flexible endoscope (such as those used in ENT, Urology and Surgical Care) or bronchoscope with light cord (if not integral to the endoscope), mat, and additional load.
- o The flexible endoscope may be a single or dual lumen that are ≥ 1 mm ID and ≤ 990 mm in length.
- o Additional load, up to 11 lb (5 kg) can include stainless steel lumens with the following dimensions:
  - -> 0.76 mm ID and < 233 mm in length
  - ≥ 1.0 mm ID and < 254 mm in length
  - ≥ 1.8 mm ID and ≤ 542 mm in length

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The PRIMED Sterilization wraps are validated with ASP STERRAD 100 NX and ASP STERRAD NX and ASP STERRAD 100s sterilization cycles and intended load detailed below:

STERRAD 100NX Standard cycle:

· Instruments with diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
· Single channel stainless steel lumens with an inside diameter of 0.7 mm or larger and a length of 500 mm or shorter.

(A maximum of ten single channel stainless steel lumens, five per tray per sterilization cycle).

STERRAD 100NX Flex Cycle:

· Instruments with diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
· Medical devices, including most flexible endoscopes, with the following materials and dimensions: o Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1 mm or larger and length of 1065 mm or shorter. (A maximum of two flexible endoscopes, one per tray per sterilization cycle. No additional load)

STERRAD 100NX Express Cycle:

· Instruments surfaces and instruments having diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
· Medical devices, including rigid or semi-rigid endoscopes without lumen.

STERRAD 100NX DUO Cycle:

· Instruments with diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
· Medical devices, including most flexible endoscopes, with the following materials and dimensions:
- o Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1 mm or larger and a length of 875 mm or shorter
  - o Accessory devices that are normally connected to a flexible endoscope during use.
- o Flexible endoscopes without lumens

STERRAD NX Standard cycle:

· Instruments with diffusion-restricted spaces, such as the hinged portion of forceps and up to 10 lumens of followings.
- o Single channel stainless steel lumens with an inside diameter of 1 mm or larger and a length of 150 mm or shorter
- o Single-channel stainless steel lumens with an inside diameter of 2 mm or larger and a length of 400 mm or shorter

STERRAD NX Advanced Cycle:

· Instruments with diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
Single channel stainless steel lumens with an inside diameter of 1 mm or larger and a length of 500 mm or shorter (up to 10 Lumen per load)
· Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscope with an inside diameter of 1 mm or larger and length of 1065 mm or shorter (no additional load)

STERRAD 100s:

· Instruments with diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
· Metal and nonmetal lumened instruments with inside diameter of 6 mm or larger and length of 310 mm or shorter.
· A single stainless steel lumen with an inside diameter of 3 mm or larger and a length of 400 mm or shorter.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

区 Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{7}------------------------------------------------

K242208 - 510(k) Summary

Summary Date:	July 25, 2024
Manufacturer:	PRIMED Medical Products Inc.
Address:	200, 2003-91 St. SW, Edmonton, AB, Canada, T6X 0W8
Phone Number	+1.877.877.4633
Fax Number	+1.780.497.7670
Email	mitra.fard@primed.com
Contact person:	Mitra Fard
Common name of the device	Sterilization Wrap
Trade or Proprietary Name:	PRIMED Sterilization Wrap
Models	P100, P200, P300, P400, P500, P600
Regulation Description	Sterilization Wrap
Review Panel	General Hospital
Regulation number	21 CFR 880.6850
Device Class:	Class II
Product Code:	FRG
Predicate device(s)	PRIMED Sterilization Wrap K233777

Device Description:

The PRIMED Sterilization wraps are made of SMS (Spunbond) Polypropylene with addition of a master batch pigment for coloration and are available in three separate product offerings:

1- The Fused one colour double layer bonded wrap is comprised of two sheets ultrasonically bonded on two parallel sides. The wrap fabrics are composed of polypropylene with the addition of purple pigment. This product allows convenient simultaneous wrapping of medical devices to be sterilized in accordance with standard healthcare practices.
2- The Fused two colours double layer bonded wrap is comprised of two sheets of purple and blue fabrics ultrasonically bonded on two parallel sides. The wrap fabrics are composed of polypropylene with the addition of purple or blue pigment. This product allows convenient simultaneous wrapping of medical devices to be sterilized in accordance with standard healthcare practices.
3-The Single layer one colour wrap is comprised of a single nonwoven sheet. The standard purple wrap is composed of polypropylene with the addition of a purple pigment. Two sheets are used to sequentially wrap medical devices to be sterilized in accordance with standard healthcare practices.

PRIMED Sterilization wraps are available in various dimensions ranging from 12″ x 12″ x 90″ and six different weights as detailed in table 1.

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Model	P100 (40 gsm)			P200 (45 gsm)			P300 (50 gsm)			P400 (65 gsm)			P500 (72 gsm)			P600 (88 gsm)
TypeSize	F1	F2	S	F1	F2	S	F1	F2	S	F1	F2	S	F1	F2	S	F1	F2	S
12" X 12"	✓	✓	✓	✓	✓	✓
15" X 15"	✓	✓	✓	✓		✓
18" X 18"	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓
20" X 20"	✓	✓	✓
24" X 24"	✓	✓	✓		✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓
30" X 30"	✓	✓	✓		✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓
36" X 36"	✓	✓	✓		✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓
40" X 40"	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓				✓	✓
45" X 45"	✓	✓	✓				✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓
48" X 48"	✓	✓	✓			✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓
54" X 54"	✓	✓	✓				✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓
60" X 60"														✓
54" X 72"			✓			✓	✓	✓	✓	✓	✓		✓	✓	✓	✓	✓	✓
54" X 90"	✓	✓					✓	✓					✓	✓		✓	✓

Table 1: Wrap types and size

F1: Fused 1 color double layer wrap,

F2: Fused 2 color double layer wrap and

S: Single layer wrap

Indication for Use

The PRIMED Sterilization wraps are intended to be used to enclose another medical device that is to be sterilized by a health care provider via the following:

-Pre-Vacuum Steam at 270°F/ 132°C for 4 minutes. The wrap has been validated for dry time of 20 minutes for P100 and P200 and dry time of 30 minutes for P300, P400, P500 and P600.
-100% Ethylene Oxide Sterilization with a concentration of 725-735 mg/L at 131°F/55°C and 40% - 80% relative humidity for 60 minutes. Validated for aeration times of 8 hours at 55°C or 12 hours at 43.3°C.
-Lumen, Non-Lumen, and Flexible Cycles in the STERIS V-PRO maX/maX2 and STERIS V-PRO 60/s2 low temperature Sterilization Systems.
Advanced Sterilization Products STERRAD 100S system ・
-Advanced Sterilization Products STERRAD NX [Standard Cycle, Advanced Cycle]
-Advanced Sterilization Products STERRAD 100 NX [Standard Cycle, Flex Cycle, Express, Duo Cycle]

PRIMED Sterilization wraps are validated for use with above listed sterilization systems with the intended loads as described below.

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Table 2: Maximum recommended wrapped package content:

Model	Intended Load	Maximum Recommended Wrapped Package Content
		Pre-Vacuum Steam and EO	ASP STERRAD 100S, 100NX and NX	STERIS V-PRO
P100	Very light weight package. For example, light handle covers or towel packs.	3 lbs	3 lbs	3 lbs
P200	Light weight package. For example, standard linen packs	6 lbs	6 lbs	6.5 lbs
P300	Light to moderate weight package. For example, general use medical instruments.	9 lbs	9 lbs	9 lbs
P400	Moderate to heavy weight package. For example, general use medical instruments.	13 lbs	10.7 lbs	12 lbs
P500	Heavy weight package. For example, general use medical instruments	17 lbs	10.7 lbs	12 lbs
P600	Very heavy weight package. For example, general use medical instruments.	25 lbs	10.7 lbs	12 lbs

PRIMED wraps are validated for Pre-Vacuum Steam and EO sterilization with two 3.0mm x 400 mm lumen devices as part of the load.

PRIMED wraps are validated for ASP STERRAD 100 S sterilization with 10 stainless steel lumens (2mm ID x 250 mm length) as part of their load.

PRIMED Sterilization wraps are validated for use with STERIS V-PRO cycles and intended load as listed below:

V-PRO maX/maX2 Non-Lumen Cycle:

Non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-● rigid and flexible endoscopes.

V-PRO maX/maX2 Lumen Cycle:

Non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
. Single, dual, or triple channelled stainless-steel lumen that are:
- o ≥ 0.77 mm ID and ≤ 527 mm in length.
- 0.8 mm ID and ≤ 542 mm in length. O
- 0.48 mm ID and ≤ 100 mm in length . O
. Dead end lumen that is ≥ 1.3 mm ID and ≤ 73 mm in length
Rigid non-metallic lumen that are: ●
- 3 mm ID and ≤ 298 mm in length. O
- 4 mm ID and ≤ 424 mm in length. o

V-PRO maX/maX2 Flexible Cycle:

. Non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two configurations:

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O Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. The flexible endoscopes may contain:
- Single or dual channel lumens that are ≥ 1 mm ID and ≤ 1050 mm in length 트
O One flexible endoscope with a light cord (if not integral to the endoscope) and mat and additional instruments. The flexible endoscope may contain:
- I Single or dual channel lumens that are ≥ 1 mm ID and ≤ 1050 mm in length
- Additional load, up to 24 lbs (11 kg) can include lumened or non-lumened medical devices:
  - Single, dual, or triple channel stainless steel lumens ≥0.48 mm ID and ≤ 100 mm in length

V-PRO 60/s2 Non-Lumen Cycle:

Non-lumened instruments and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
. Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semirigid and flexible endoscopes.

V-PRO 60/s2 Lumen Cycle:

Non-lumened instruments and instruments with diffusion-restricted spaces such as the hinged portion of ● forceps and scissors.
. Medical devices (including single, dual, and triple channeled rigid endoscopes) with the following configurations:
- Single or dual channeled devices with stainless steel lumens that are: o
  - . > 0.77 mm ID and ≤ 410 mm in length.
  - . > 1.8 mm ID and ≤ 542 mm in length.
- Triple channeled devices with stainless steel lumens that are either: o
  - 1.2 mm ID and ≤275 mm in length
  - . ≥1.8 mm ID and ≤ 310 mm in length or
  - . > 2.8 mm ID and ≤317 mm in length

V-PRO 60/s2 Flexible Cycle:

. Non-lumened instruments and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
One surgical flexible endoscope (such as those used in ENT, Urology and Surgical Care) or bronchoscope with light cord (if not integral to the endoscope), mat, and additional load.
- o The flexible endoscope may be a single or dual lumen device with lumens that are ≥ 1 mm ID and ≤ 990 mm in length.
- o Additional load, up to 11 lb (5 kg) can include stainless steel lumens with the following dimensions:
  - 0.76 mm ID and ≤ 233 mm in length I
  - . ≥ 1.0 mm ID and ≤ 254 mm in length
  - 트 ≥ 1.8 mm ID and ≤ 542 mm in length

The PRIMED Sterilization wraps are validated with ASP STERRAD 100 NX and ASP STERRAD 100s sterilization cycles and intended load detailed below:

STERRAD 100NX Standard cycle:

Instruments with diffusion-restricted spaces, such as the hinged portion of forceps and scissors.

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. Single channel stainless steel lumens with an inside diameter of 0.7 mm or larger and a length of 500 mm or shorter. (A maximum of ten single channel stainless steel lumens, five per tray per sterilization cycle).
STERRAD 100NX Flex Cycle:
Instruments with diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
Medical devices, including most flexible endoscopes, with the following materials and dimensions: ●
- Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside O diameter of 1 mm or larger and length of 1065 mm or shorter. (A maximum of two flexible endoscopes, one per tray per sterilization cycle. No additional load)

STERRAD 100NX Express Cycle:

Instruments surfaces and instruments having diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
Medical devices, including rigid or semi-rigid endoscopes without lumen.

STERRAD 100NX DUO Cycle:

Instruments with diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
Medical devices, including most flexible endoscopes, with the following materials and dimensions:
- O Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1 mm or larger and a length of 875 mm or shorter
- O Accessory devices that are normally connected to a flexible endoscope during use.
- Flexible endoscopes without lumens O

STERRAD NX Standard cycle:

. Instruments with diffusion-restricted spaces, such as the hinged portion of forceps and up to 10 lumens of followings.
- Single channel stainless steel lumens with an inside diameter of 1 mm or larger and a length of 150 O mm or shorter
- о Single-channel stainless steel lumens with an inside diameter of 2 mm or larger and a length of 400 mm or shorter

STERRAD NX Advanced Cycle:

Instruments with diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
. Single channel stainless steel lumens with an inside diameter of 1 mm or larger and a length of 500 mm or shorter (up to 10 Lumen per load)
. Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscope with an inside diameter of 1 mm or larger and length of 1065 mm or shorter (no additional load)

STERRAD 100s:

Instruments with diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
Metal and nonmetal lumened instruments with inside diameter of 6 mm or larger and length of 310 mm or shorter.
. A single stainless steel lumen with an inside diameter of 3 mm or larger and a length of 400 mm or shorter.

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Here below is the summary of the technological characteristics and performance of the proposed device compared to the predicate device.

			Table 3: Comparison of Technological Characteristics with Predicate Device
--	--	--	----------------------------------------------------------------------------	--	--	--

Elements ofComparison	Proposed device	Predicate device	Comparisonto Predicate
PRIMED Sterilization wraps (K242208)	PRIMED Medical Products Inc.	PRIMED Medical Products Inc.	Similar
Regulationnumber	21 CFR 880.6850	21 CFR 880.6850	Similar
Product Code	FRG	FRG	Similar
Commonname	Sterilization Wrap	Sterilization Wrap	Similar
Models/Dimensions	Six basis weights and fourteen sizes	Six basis weights and fourteen sizes	Similar
Intended Use	The PRIMED Sterilization wraps are intended to beused to enclose another medical device that is to besterilized by a health care provider via the following:Pre-Vacuum Steam at 270°F/ 132°C for 4 minutes.The wrap has been validated for dry time of 20minutes for P100 and P200 and dry time of 30minutes for P300, P400, P500 and P600.100% Ethylene Oxide Sterilization with aconcentration of 725-735 mg/L at 131°F/55°C and40% - 80% relativehumidity for 60 minutes. Validated for aerationtimes of 8 hours at 55°C or 12 hours at 43.3°C.Lumen, Non-Lumen, and Flexible Cycles in theSTERIS V-PRO maX/maX2 and STERIS V-PRO 60/s2low temperature Sterilization Systems.Advanced Sterilization Products STERRAD 100SsystemAdvanced Sterilization Products STERRAD NX[Standard Cycle, Advanced Cycle]Advanced Sterilization Products STERRAD 100 NX[Standard Cycle, Flex Cycle, Express, Duo Cycle]PRIMED Sterilization wraps are available in 6 modelsand different sizes ranging from 12" X 12" to 54" X 90"and are intended to allow sterilization of the enclosedmedical device(s) and maintain sterility of the encloseddevice(s) until used.	The PRIMED Sterilization wraps are intended to be usedto enclose another medical device that is to be sterilizedby a health care provider via the following:Pre-Vacuum Steam at 270°F/ 132°C for 4 minutes.The wrap has been validated for dry time of 20minutes for P100 and P200 and dry time of 30minutes for P300, P400, P500 and P600.100% Ethylene Oxide Sterilization with aconcentration of 725-735 mg/L at 131°F/55°C and40% - 80% relativehumidity for 60 minutes. Validated for aerationtimes of 8 hours at 55°C or 12 hours at 43.3°C.Lumen, Non-Lumen, and Flexible Cycles in the STERISV-PRO maX/maX2 and STERIS V-PRO 60/s2 lowtemperature Sterilization Systems.Advanced Sterilization Products STERRAD 100SsystemAdvanced Sterilization Products STERRAD NX[Standard Cycle, Advanced Cycle]Advanced Sterilization Products STERRAD 100 NX[Standard Cycle, Flex Cycle, Express, Duo Cycle]PRIMED Sterilization wraps are available in 6 models anddifferent sizes ranging from 12" X 12" to 54" X 90" andare intended to allow sterilization of the enclosed medicaldevice(s) and maintain sterility of the enclosed device(s)until used.	Similar
Prescriptionvs. OTC	OTC	OTC	Similar
Single use vs.reusable	Single Use Only	Single Use Only	Similar
MaterialComposition	PRIMED wraps are composed of Spunbond MeltblownSpunbond material	PRIMED wraps are composed of Spunbond MeltblownSponbund material	Similar
ChemicalProperties	Polypropylene with blue pigment and antistatictreatment	Polypropylene with blue pigment and antistatic treatmentPolypropylene with purple pigment and antistatictreatment	Similar

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K242208 - 510(k) Summary

Elements ofComparison	Proposed devicePRIMED Sterilization wraps (K242208)			Predicate devicePRIMED Sterilization wraps (K233777)			Comparisonto Predicate
	Polypropylene with purple pigment and antistatictreatment
Device Design	- The Fused one colour double layer bonded wrap iscomprised of two sheets ultrasonically bonded ontwo parallel sides. The wrap fabrics are composed ofpolypropylene with the addition of purple pigment.- The Fused two colours double layer bonded wrap iscomprised of two sheets of purple and blue fabricsultrasonically bonded on two parallel sides. The wrapfabrics are composed of polypropylene with theaddition of purple or blue pigment.- The Single layer one colour wrap is comprised of asingle nonwoven sheet. The standard purple wrap iscomposed of polypropylene with the addition of apurple pigment.			- The Fused one colour double layer bonded wrap iscomprised of two sheets ultrasonically bonded on twoparallel sides. The wrap fabrics are composed ofpolypropylene with the addition of purple pigment.- The Fused two colours double layer bonded wrap iscomprised of two sheets of purple and blue fabricsultrasonically bonded on two parallel sides. The wrapfabrics are composed of polypropylene with theaddition of purple or blue pigment.- The Single layer one colour wrap is comprised of asingle nonwoven sheet. The standard purple wrap iscomposed of polypropylene with the addition of apurple pigment.			Similar
SterilizationParameter	- Pre-vacuum steam at 270°F/132°C for 4 minutes.- 100% ethylene oxide (EO) with a concentration of725-735 mg/l at 131°F/55°C and 40%-80% relativehumidity for 60 minutes.- STERRAD® 100S short and long cycle.- STERRAD® NX, Standard and Advanced Cycles.- STERRAD® 100NX, Standard, Flex, Express and DuoCycles.- Lumen, Non-Lumen, and Flexible Cycles in the STERISV-PRO maX/maX2, V-PRO 60/s2 Low Temperaturesterilization system.			- Pre-vacuum steam at 270°F/132°C for 4 minutes.- 100% ethylene oxide (EO) with a concentration of 725-735 mg/l at 131°F/55°C and 40%-80% relative humidityfor 60 minutes.- STERRAD® 100S short and long cycle.- STERRAD® NX, Standard and Advanced Cycles.- STERRAD® 100NX, Standard, Flex, Express and DuoCycles.- Lumen, Non-Lumen, and Flexible Cycles in the STERIS V-PRO maX/maX2, V-PRO 60/s2 Low Temperaturesterilization system.			Similar
MaximumWrappedpackagecontentweight	Model	Pre-VacuumSteamand EO	ASPSTERRAD100S, 100NXand NX	STERISV-PRO	Model	Pre-VacuumSteam and EO	ASP STERRAD100S, 100NXand NX	STERISV-PRO	Similar
	P100	3 lbs	3 lbs	3 lbs	P100	3 lbs	3 lbs	3 lbs
	P200	6 lbs	6 lbs	6.5 lbs	P200	6 lbs	6 lbs	6.5 lbs
	P300	9 lbs	9 lbs	9 lbs	P300	9 lbs	9 lbs	9 lbs
	P400	13 lbs	10.7 lbs	12 lbs	P400	13 lbs	10.7 lbs	12 lbs
	P500	17 lbs	10.7 lbs	12 lbs	P500	17 lbs	10.7 lbs	12 lbs
	P600	25 lbs	10.7 lbs	12 lbs	P600	25 lbs	10.7 lbs	12 lbs
Maintenanceof PackageIntegrity	180 days				30 days			Different(Note)
SterilantPenetrationand Efficacy	Negative for growth				Negative for growth			Similar
Maintenance ofpackagesterility	Microbial Aerosol Challenge test,Negative for growth				Microbial Aerosol Challenge test,Negative for growth			Similar

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K242208 - 510(k) Summary

Elements ofComparison	Proposed devicePRIMED Sterilization wraps (K242208)	Predicate devicePRIMED Sterilization wraps (K233777)	Comparisonto Predicate
Maintenanceof packageIntegrity	No growth	No growth	Similar
Biocompatibility	PRIMED wraps are tested for Cytotoxicity, Irritationand sensitization and are considered non-cytotoxic,non-irritating and non-sensitizing	PRIMED wraps are tested for Cytotoxicity, Irritation andsensitization and are considered non-cytotoxic, non-irritating and non-sensitizing	Similar
Leachability	Extract prepared as per ISO 6588-2 is colourless, its PH,chloride content, sulphate content meets therequirement of EN 868-2	Extract prepared as per ISO 6588-2 is colourless, its PH,chloride content, sulphate content meets therequirement of EN 868-2	Similar
Residuals, ISO10993- 7	None detected	None detected	Similar
Physical andchemicalpropertiescomparison	Compatible with the requirements ofBasis weight, Air permeability, Material burst strength,Grab Tensile strength, Trapezoidal Tear strength,Hydrostatic Pressure and linting	Compatible with the requirements ofBasis weight, Air permeability, Material burst strength,Grab Tensile strength, Trapezoidal Tear strength,Hydrostatic Pressure and linting	Similar

Note: Testing reports demonstrate that the PRIMED Sterility of the enclosed medical device for 180 days and are safe and effective for their intended use.

Overall Performance Conclusions:

PRIMED Sterilization wraps have been tested for sterilization efficacy, event related maintenance of package integrity, physical properties, and biocompatibility. Testing results demonstrate that the PRIMED Sterilization Wraps allow sterilization of the enclosed medical device and maintain the sterility of the content for 180 days post sterilization after being sterilized with one of following sterilization cycles:

-Pre-Vacuum Steam at 270°F/ 132°C for 4 minutes.
-100% Ethylene Oxide Sterilization with a concentration of 725-735 mg/L at 131°F/55°C and 40% - 80% relative humidity for 60 minutes.
-Lumen, Non-Lumen, and Flexible Cycles in the STERIS V-PRO maX/maX2 and STERIS V-PRO 60/s2 low temperature Sterilization Systems.
Advanced Sterilization Products STERRAD 100S system -
-Advanced Sterilization Products STERRAD NX [Standard Cycle, Advanced Cycle]
-Advanced Sterilization Products STERRAD 100 NX [Standard Cycle, Flex Cycle, Express, Duo Cycle]

The proposed and predicate device in this submission have the same intended use, design, material composition. And they all comply with the applicable requirements. The maintenance of package integrity as demonstrated by the completed tests, do not affect the safety and performance of the proposed device.

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Test Performed	Test Method	Acceptance Criteria	Results (Pass/Fail)
Sterilant Penetration	ANSI/AAMI ST79 ,ANSI/AAMI/ISO 11138-7	All BI test samples should be negativefor growth following the minimumincubation period	Pass
Maintenance of PackageIntegrity	ANSI/AAMI/ISO 11607-1,AAMI TIR12 ANSI, AAMIST79	Maintain sterility for 180 days	Pass
Maintenance of packagesterility	AAMI TIR12 -ANSI/AAMIST77	No growth in any of the culturevessels containing test coupons afterthe minimum incubation period	Pass
Residual	ISO 10993-7	Less than maximum theoreticalresidual limits or the tolerablecontact limit following a 100%ethylene oxide sterilization process	Pass
Biocompatibility	Cytotoxicity, Irritation andSensitization ISO 10993-5and ISO 10993-10	non-cytotoxic, non-irritating andnon-sensitizing	Pass
Physical and ChemicalProperties and Materialcompatibility with theintended sterilizationmethod, PH value, chloridecontent, sulphate content,colour fastness,Basis weight,Air permeability,Material burst strength,Grab Tensile strength,Trapezoidal Tear strength,Hydrostatic Pressure,	ISO 11607-1 and EN 868-2ASTM D3776ASTM D737-04ASTM D3786ASTM D5034-09ASTM D5587-15AATC127-2014NWSP 160.1	Meets physical and chemicalproperties, non-sterile and poststerilization	Pass

Table 4: Summary of the non-clinical testing:

Conclusion:

Based on the non-clinical testing performed, it can be concluded that the subject device, PRIMED Sterilization Wraps (P100, P200, P300, P400, P500, P600) are as safe, as effective and performs as well as or better than the legally marketed predicate device, K233777 class II (21 CFR 880.6850), PRIMED Sterilization Wrap product code FRG.

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).