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) 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 document is a 510(k) Summary for the PRIMED Sterilization Wrap. It outlines the device's technical characteristics, intended use, and a comparison to a predicate device, along with a summary of non-clinical testing.

However, the document does not describe an AI/ML-enabled medical device. It pertains to a physical sterilization wrap. Therefore, the questions related to AI/ML model performance, such as:

Sample sizes for test and training sets
Data provenance
Number and qualifications of experts for ground truth
Adjudication methods
MRMC studies and effect sizes
Standalone AI performance
Type of ground truth

cannot be answered from the provided text. The document focuses on demonstrating substantial equivalence of a physical product to a predicate device through non-clinical testing of its physical, chemical, and functional properties related to sterilization and sterility maintenance.

Here's an analysis of the acceptance criteria and study as presented for this physical device:

1. Table of Acceptance Criteria and Reported Device Performance

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 negative for growth following the minimum incubation period	Pass
Maintenance of Package Integrity	ANSI/AAMI/ISO 11607-1, AAMI TIR12ANSI, AAMI ST79	Maintain sterility for 30 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	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 and 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 the data provenance:

The document refers to "non-clinical testing" and does not specify a "test set" in the context of data for an AI/ML model. Instead, it refers to tests performed on the physical sterilization wraps.
The sample sizes for each specific physical test (e.g., number of wrap samples for sterilant penetration, integrity, etc.) are not provided in this summary.
Data provenance is not applicable in the AI/ML sense; the data is generated from laboratory testing of the physical device. The country of origin for the data (where the tests were conducted) is not specified, but the manufacturer is based in Canada.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable to this device. Ground truth, in this context, refers to established scientific and engineering standards and methods for assessing the performance of sterilization wraps, not expert interpretation of images or clinical data.

4. Adjudication method for the test set:

Not applicable to this device. Testing is based on established laboratory protocols and quantitative or qualitative measurements leading to pass/fail criteria.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

Not applicable. This device is a physical sterilization wrap, not an AI/ML-assisted diagnostic or treatment aid for humans.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm.

7. The type of ground truth used:

For this device, the "ground truth" is established by adherence to recognized international and national standards for medical device sterilization and packaging. These include:
- ANSI/AAMI ST79 (Comprehensive guide to steam sterilization and sterility assurance in health care facilities)
- ANSI/AAMI/ISO 11138-7 (Sterilization of health care products - Biological indicators - Part 7: Biological indicators for ethylene oxide sterilization processes)
- ANSI/AAMI/ISO 11607-1 (Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems)
- AAMI TIR12 (Guidance for establishing product family groupings for sterilization)
- ANSI/AAMI ST77 (Sterilization of health care products - Sterile device packaging - Requirements)
- ISO 10993-5 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity)
- ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)
- EN 868-2 (Packaging for terminally sterilized medical devices - Part 2: Sterilization wraps - Requirements and test methods)
- Various ASTM (American Society for Testing and Materials) standards for fabric properties (D3776, D737-04, D3786, D5034-09, D5587-15)
- AATCC127-2014 (Water Resistance: Hydrostatic Pressure Test)
- NWSP 160.1 (Nonwoven Standard Procedure for linting)
These standards define the methodologies and acceptable performance limits.

8. The sample size for the training set:

Not applicable. This is not an AI/ML model.

9. How the ground truth for the training set was established:

Not applicable.

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 & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

May 24, 2024

PRIMED Medical Products Inc. Mitra Fard 200, 2003-91 St. SW Edmonton, AB T6X 0W8 Canada

Re: K233777

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: November 15, 2023 Received: November 24, 2023

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" (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).

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Your device is also subject to, among other requirements, the Quality System (OS) 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 QS 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.

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).

Sincerelv.

Image /page/1/Picture/7 description: The image shows the name "Stephen A. Anisko -S" in a large, bold font. The name is stacked vertically, with "Stephen A." on the first line and "Anisko -S" on the second line. The text is black against a white background.

Digitally signed by Stephen A. Anisko -S Date: 2024.05.24 14:31:09 -04'00'

for: Christopher K. Dugard, MS Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Enclosure

{3}------------------------------------------------

Indications for Use

510(k) Number (if known) K233777

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

{5}------------------------------------------------

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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

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

K233777- 510(k) Summary

Summary Date:	May 23, 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 (P100, P200, P300, P400, P500, P600)
Models:	P100, P200, P300, P400, P500, P600
Regulation Description:	Sterilization Wrap
Review Panel:	General Hospital
Regulation number:	21 CFR 880.6850
Device Class:	2
Product Code:	FRG
Predicate device(s):	Cardinal Health Sterilization wrap
	K181174

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 available in 6 models and different sizes ranging from 12" X 12" and are intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) until used.

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

{9}------------------------------------------------

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, lighthandle covers or towel packs.	3 lbs	3 lbs	3 lbs
P200	Light weight package. For example, standardlinen packs	6 lbs	6 lbs	6.5 lbs
P300	Light to moderate weight package. Forexample, general use medical instruments.	9 lbs	9 lbs	9 lbs
P400	Moderate to heavy weight package. Forexample, general use medical instruments.	13 lbs	10.7 lbs	12 lbs
P500	Heavy weight package. For example, generaluse 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

Table 2: Maximum recommended wrapped package content:

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, semirigid 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.
- 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:
- o > 3 mm ID and ≤ 298 mm in length.
- 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:
- 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
  - I > 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 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:
- Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside O 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 devicePRIMED Sterilization wraps (K233777)	PredicateCardinal Health Sterilization Wrap (K181174)	Comparisonto Predicate
Manufacturer	PRIMED Medical Products Inc.	Cardinal Health Inc.	---
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 models Fourteen sizes (See Table 8 fordimensions)	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 100Ssystem- 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 modelsand different sizes ranging from 12" X 12" to 54" X 90"and are intended to allow sterilization of theenclosed medical device(s) and maintain sterility ofthe enclosed device(s) until used.	Cardinal Health™ Sterilization Wrap is intended to encloseanother medical device that is to be sterilized by a health careprovider using:• Pre-vacuum steam at 270°F/132°C for 4 minutes• Gravity steam at 250°F/121°C for 30 minutes• 100% ethylene oxide (EO) with a concentration of 725-735mg/L at 131°F/55°C and 40%-80% relative humidity for 60minutes• Advanced Sterilization Products (ASP) STERRAD® 100S System• Advanced Sterilization Products (ASP) STERRAD® 200 System• Advanced Sterilization Products (ASP) STERRAD® NX System,Standard and Advanced Cycles• Advanced Sterilization Products (ASP) STERRAD® 100NX,Standard, Flex, Express, and DUO cycles• Lumen, Non Lumen, and Flexible Cycles by the STERIS V-PRO®1, V-PRO® 1 Plus, V-PRO® maX and V-PRO® 60 Low TemperatureSterilization Systems• TSO3 STERIZONE® VP4 System Cycle 1(Refer to Table 5 forLoad)The wrap is intended to allow sterilization of the enclosedmedical device(s) and to maintain sterility of the encloseddevice(s) until used.	Similar(note 1)
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	Polypropylene fabric using SMS (spunbound-meltdownspunbound) production process	Similar
ChemicalProperties	Polypropylene with blue pigment and antistatictreatment	Polypropylene with blue pigment and antistatic treatmentPolypropylene with green pigment and antistatic treatment	Similar

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K233777- 510(k) Summary

Elements of	Proposed device				Predicate	Comparison
Comparison	PRIMED Sterilization wraps (K233777)				Cardinal Health Sterilization Wrap (K181174)	to 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. Thewrap fabrics are composed of polypropylene withthe addition 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.				Dual layer, fold-over: Double layer wrap comprised of a singlesheet of blue pigmented SMS fabric that has been folded overin half and ultrasonically sealed to itself on the three non-folded edges.Dual Layer: Double layer wrap comprised of two separatesheets of blue pigmented SMS fabric that have beenultrasonically sealed on two opposing edgesSingle Layer: Single layer wrap comprised of a single sheet ofblue pigmented SMS fabricTwo Color: Double layer wrap comprised of one sheet of bluepigmented SMS fabric and one sheet of green pigmented SMSfabric that have been ultrasonically sealed on two opposingedges	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 theSTERIS V-PRO maX/maX2, V-PRO 60/s2 LowTemperature sterilization system.				- Pre-vacuum steam at 270ºF/132ºC for 4 minutes- Gravity steam at 250°F/121°C for 30 minutes 100% ethyleneoxide (EO) with a concentration of 725- 735 mg/L at131ºF/55ºCand 40%- 80% relative humidity for 60 minutes- Advanced Sterilization Products (ASP) STERRAD® 100S System- Advanced Sterilization Products (ASP) STERRAD® 200 System- Advanced Sterilization Products (ASP) STERRAD® NX System,Standard and Advanced Cycles- Advanced Sterilization Products (ASP) STERRAD® 100NX,Standard, Flex, Express, and DUO cycles- Lumen, Non-Lumen, and Flexible Cycles in the STERIS V-PRO®1, V-PRO® 1 Plus, VPRO® maX and VPRO® 60 LowTemperature Sterilization- Systems TSO3 STERIZONE® VP4 System Cycle 1	Similar(note 1)
MaximumWrappedpackagecontentweight	Model	Pre-VacuumSteamand EO	ASPSTERRAD100S, 100NXand NX	STERISV-PRO
	P100	3 lbs	3 lbs	3 lbs	Pre-vacuum Steam: 3 to 25 pounds	Different(note 2)
	P200	6 lbs	6 lbs	6.5 lbs	Gravity Steam: 3 to 25 pounds
	P300	9 lbs	9 lbs	9 lbs	EO: 3 to 25 pounds
	P400	13 lbs	10.7 lbs	12 lbs	STERRAD® 100S: 3 to 9.7 pounds
	P500	17 lbs	10.7 lbs	12 lbs	STERRAD® 200: 9.12 pounds
	P600	25 lbs	10.7 lbs	12 lbs	STERRAD® NX: 10.7 pounds
					STERRAD® 100NX: 10.7 pounds- STERIS V-PRO® 1, VPRO® 1 Plus and VPRO® maX: 3 to 9.1 lbs- STERIS V-PRO® 60: 3 to 12 pounds- STERIZONE® VP4: 3 to 25 pounds
Maintenanceof PackageIntegrity	30 days				Pre vac Steam, Gravity steam, EO = 365 daysSterrad 200 = 30 daysSterrad 100S, Sterrad NX, Sterrad 100NX, VPRO 1, VPRO 1 Plus,VPRO maX = 365 daysVPRO 60, STERIZONE VP4= 365 days	Different(note 3)

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K233777- 510(k) Summary

Elements ofComparison	Proposed devicePRIMED Sterilization wraps (K233777)	PredicateCardinal Health Sterilization Wrap (K181174)	Comparisonto Predicate
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
Event relatedshelf life	No growth	No growth	Similar
Biocompatibility	PRIMED wraps are tested for Cytotoxicity, Irritationand sensitization and are considered non-cytotoxic,non-irritating and non-sensitizing	Negligible irritant	Similar
	Leachability	Extract prepared as per ISO 6588-2 is colourless, itsPH, chloride content, sulphate content meet therequirement of EN 868-2	Non-Aged - Extract Appearance: Clear, free of colour - pH:Comparable to negative control Aged 30 days - ExtractAppearance: Clear, free of colour-pH: Comparable to negativecontrol
Residuals, ISO10993- 7		None detected	None detected
Physical andchemicalpropertiescomparison	Compatible with the requirements ofBasis weight (ASTM D3776), Air permeability (ASTMD737-04), Material burst strength (ASTM D3786), GrabTensile strength (ASTM D5034-09), Trapezoidal Tearstrength (ASTM D5587-15), Hydrostatic Pressure(AATC127-2014) and linting (NWSP 160.1)	Basis weight, ASTM D3776/D3776M-09- Air permeability, ASTM D737-04- Material burst strength, ASTM D3786- Grab Tensile strength, ASTM D5034-09- Trapezoidal Tear strength, ASTM D5587-15- Hydrostatic Pressure, AATC127-2014Compatible	Similar

Note 1: The differences are outside the scope of the PRIMED Sterilization Wraps intended use. The proposed devices are safe and effective for their intended use.

Note 2: Testing reports demonstrate that the PRIMED Sterlization wraps are safe and effective for their intended use and the proposed maximum wrapped package content weight.

Note 3: The testing reports demonstrate the safety and effectiveness of the PRIMED Sterilization Wraps for their intended use within the proposed shelf life.

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 30 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 י 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]

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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 indication for use, maximum content loads, and the maximum shelf life as demonstrated by the completed tests, do not affect the safety and performance of the proposed device.

			Table 4: Summary of the non-clinical testing:
--	--	--	-----------------------------------------------	--

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 TIR12ANSI, AAMIST79	Maintain sterility for 30 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,Linting.	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

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, K181174 class II (21 CFR 880.6850), 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).