K Number

Device Name

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

Manufacturer

PRIMED Medical Products Inc.

Date Cleared

2024-05-24

(182 days)

Product Code

FRG

Regulation Number

880.6850

Intended 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" 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K181174

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use are focused on the physical properties and sterilization compatibility of the wraps, with no mention of AI or ML capabilities.

Therapeutic

No.
The device is a sterilization wrap intended to maintain the sterility of medical devices, not to directly treat a medical condition or perform a therapeutic function on a patient.

Diagnostic

Explanation: The device, PRIMED Sterilization wraps, is intended to enclose medical devices for sterilization and maintain their sterility. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

The device is a physical sterilization wrap made of polypropylene, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, the PRIMED Sterilization wraps are not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: An IVD device is used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
Intended Use: The intended use of the PRIMED Sterilization wraps is to enclose other medical devices for sterilization and maintain their sterility. They are not used to analyze human specimens.
Device Description: The description focuses on the material and construction of the wraps, not on any components or functions related to analyzing biological samples.
Performance Studies: The performance studies described relate to the efficacy of sterilization and maintaining package integrity, not to the accuracy or reliability of diagnostic results.

Therefore, the PRIMED Sterilization wraps fall under the category of a medical device used in the sterilization process, but not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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" 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.
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 channeled stainless steel lumen that are:
- ≥ 0.77 mm ID and ≤ 527 mm in length.
- ≥ 0.8 mm ID and ≤ 542 mm in length.
- ≥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:
- ≥ 3 mm ID and ≤ 298 mm in length.
- ≥ 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:
- 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
- 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:
- Single or dual channeled devices with stainless steel lumens that are:
  - 0.77 mm ID and 0.76 mm ID and

Regulation Number and Section

§ 880.6850 Sterilization wrap.

(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).

Summary

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).

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

Enclosure

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-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 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 1.8 mm ID and 0.76 mm ID and 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."

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.

Model	P100 (40 gsm)			P200 (45 gsm)			P300 (50 gsm)			P400 (65 gsm)			P500 (72 gsm)			P600 (88 gsm)
Type
Size	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.

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

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:

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.

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.

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 of
Comparison | Proposed device
PRIMED Sterilization wraps (K233777) | Predicate
Cardinal Health Sterilization Wrap (K181174) | Comparison
to Predicate |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Manufacturer | PRIMED Medical Products Inc. | Cardinal Health Inc. | --- |
| Regulation
number | 21 CFR 880.6850 | 21 CFR 880.6850 | Similar |
| Product Code | FRG | FRG | Similar |
| Common
name | Sterilization Wrap | Sterilization Wrap | Similar |
| Models/
Dimensions | Six basis weights and fourteen sizes | Six basis weights models Fourteen sizes (See Table 8 for
dimensions) | Similar |
| Intended 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" 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. | Cardinal Health™ Sterilization Wrap is intended to enclose
another medical device that is to be sterilized by a health care
provider 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 725-735
mg/L at 131°F/55°C and 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 by the STERIS V-PRO®
1, V-PRO® 1 Plus, V-PRO® maX and V-PRO® 60 Low Temperature
Sterilization Systems
• TSO3 STERIZONE® VP4 System Cycle 1(Refer to Table 5 for
Load)
The wrap is intended to allow sterilization of the enclosed
medical device(s) and to maintain sterility of the enclosed
device(s) until used. | Similar
(note 1) |
| Prescription
vs. OTC | OTC | OTC | Similar |
| Single use vs.
reusable | Single Use Only | Single Use Only | Similar |
| Material
Composition | PRIMED wraps are composed of Spunbond Meltblown
Spunbond material | Polypropylene fabric using SMS (spunbound-
meltdownspunbound) production process | Similar |
| Chemical
Properties | Polypropylene with blue pigment and antistatic
treatment | Polypropylene with blue pigment and antistatic treatment
Polypropylene with green pigment and antistatic treatment | Similar |

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 antistatic
treatment
Device Design	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.
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.
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.		Dual layer, fold-over: Double layer wrap comprised of a single
sheet of blue pigmented SMS fabric that has been folded over
in half and ultrasonically sealed to itself on the three non-
folded edges.
Dual Layer: Double layer wrap comprised of two separate
sheets of blue pigmented SMS fabric that have been
ultrasonically sealed on two opposing edges
Single Layer: Single layer wrap comprised of a single sheet of
blue pigmented SMS fabric
Two Color: Double layer wrap comprised of one sheet of blue
pigmented SMS fabric and one sheet of green pigmented SMS
fabric that have been ultrasonically sealed on two opposing
edges	Similar
Sterilization
Parameter	- 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
humidity for 60 minutes.
STERRAD® 100S short and long cycle.
STERRAD® NX, Standard and Advanced Cycles.
STERRAD® 100NX, Standard, Flex, Express and Duo
Cycles.
Lumen, Non-Lumen, and Flexible Cycles in the
STERIS V-PRO maX/maX2, V-PRO 60/s2 Low
Temperature sterilization system. | | | | - Pre-vacuum steam at 270ºF/132ºC for 4 minutes
Gravity steam at 250°F/121°C for 30 minutes 100% ethylene
oxide (EO) with a concentration of 725- 735 mg/L at
131ºF/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 Low
Temperature Sterilization
Systems TSO3 STERIZONE® VP4 System Cycle 1 | Similar
(note 1) |
| Maximum
Wrapped
package
content
weight | Model | Pre-
Vacuum
Steam
and EO | ASP
STERRAD
100S, 100NX
and NX | STERIS
V-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 | |
| Maintenance
of Package
Integrity | 30 days | | | | Pre vac Steam, Gravity steam, EO = 365 days
Sterrad 200 = 30 days
Sterrad 100S, Sterrad NX, Sterrad 100NX, VPRO 1, VPRO 1 Plus,
VPRO maX = 365 days
VPRO 60, STERIZONE VP4= 365 days | Different
(note 3) |

K233777- 510(k) Summary

| Elements of
Comparison | Proposed device
PRIMED Sterilization wraps (K233777) | Predicate
Cardinal Health Sterilization Wrap (K181174) | Comparison
to Predicate |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilant
Penetration
and Efficacy | Negative for growth | Negative for growth | Similar |
| Maintenance of
package
sterility | Microbial Aerosol Challenge test,
Negative for growth | Microbial Aerosol Challenge test,
Negative for growth | Similar |
| Event related
shelf life | No growth | No growth | Similar |
| Biocompatibility | PRIMED wraps are tested for Cytotoxicity, Irritation
and sensitization and are considered non-cytotoxic,
non-irritating and non-sensitizing | Negligible irritant | Similar |
| | Leachability | Extract prepared as per ISO 6588-2 is colourless, its
PH, chloride content, sulphate content meet the
requirement of EN 868-2 | Non-Aged - Extract Appearance: Clear, free of colour - pH:
Comparable to negative control Aged 30 days - Extract
Appearance: Clear, free of colour-pH: Comparable to negative
control |
| Residuals, ISO
10993- 7 | | None detected | None detected |
| Physical and
chemical
properties
comparison | Compatible with the requirements of
Basis weight (ASTM D3776), Air permeability (ASTM
D737-04), Material burst strength (ASTM D3786), Grab
Tensile strength (ASTM D5034-09), Trapezoidal Tear
strength (ASTM D5587-15), Hydrostatic Pressure
(AATC127-2014) 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, AATC127-2014
Compatible | 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]

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
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

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.