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

K233777 · Primed Medical Products, Inc. · FRG · May 24, 2024 · General Hospital

Device Facts

• Record ID: K233777
• Device Name: PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
• Applicant: Primed Medical Products, Inc.
• Product Code: FRG · General Hospital
• Decision Date: May 24, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

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.

Device Story

PRIMED Sterilization Wraps are non-woven, SMS (spunbond-meltblown-spunbond) polypropylene sheets used to wrap medical instruments for sterilization. Available in six models (P100-P600) and various sizes, they are used in clinical settings by healthcare staff. The wraps allow sterilant penetration (steam, EO, or low-temp vapor) while maintaining a microbial barrier post-sterilization for up to 30 days. The device is a passive barrier; it does not transform inputs or provide clinical outputs. It benefits patients by ensuring the sterility of surgical instruments, thereby reducing the risk of healthcare-associated infections.

Clinical Evidence

Bench testing only. Testing included sterilization efficacy (BI growth), maintenance of package integrity (microbial aerosol challenge), biocompatibility (cytotoxicity, irritation, sensitization per ISO 10993), and physical/chemical property testing (ASTM D3776, D737-04, D3786, D5034-09, D5587-15, AATC127-2014, NWSP 160.1). All tests passed.

Technological Characteristics

Material: SMS (Spunbond-Meltblown-Spunbond) polypropylene with pigment and antistatic treatment. Dimensions: 12"x12" to 54"x90". Basis weights: 40-88 gsm. Standards: ASTM D3776 (basis weight), ASTM D737-04 (air permeability), ASTM D3786 (burst strength), ASTM D5034-09 (tensile strength), ASTM D5587-15 (tear strength), AATC127-2014 (hydrostatic pressure). Single-use, non-sterile as supplied.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices for sterilization via pre-vacuum steam, 100% ethylene oxide, or specific low-temperature sterilization systems (STERIS V-PRO and ASP STERRAD). Intended to maintain sterility of enclosed devices until use.

Regulatory Classification

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.

Predicate Devices

• Cardinal Health Sterilization wrap (K181174)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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

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## 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]

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.

| Model | Intended Load | Maximum Recommended Wrapped Package Content | | |
|-------|---------------------------------------------------------------------------------|---------------------------------------------|--------------------------------|--------------|
| | | Pre-Vacuum<br>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:

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V-PRO maX/maX2 Non-Lumen Cycle:

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

### V-PRO 60/s2 Non-Lumen Cycle:

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

## V-PRO 60/s2 Flexible Cycle:

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

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

### STERRAD 100NX Standard cycle:

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

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

### STERRAD 100NX Flex Cycle:

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

### STERRAD 100NX Express Cycle:

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

### STERRAD 100NX DUO Cycle:

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

### STERRAD NX Standard cycle:

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

### STERRAD NX Advanced Cycle:

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

### STERRAD 100s:

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

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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### 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: | [e-mail] |
| 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) | | |
|--------------|---------------|----|---|---------------|----|---|---------------|----|---|---------------|----|---|---------------|----|---|---------------|----|---|
| Type<br>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.

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| Model | Intended Load | Maximum Recommended Wrapped Package Content | | |
|-------|------------------------------------------------------------------------------------|---------------------------------------------|-----------------------------------|--------------|
| | | Pre-Vacuum<br>Steam and EO | ASP STERRAD 100S,<br>100NX and NX | STERIS V-PRO |
| P100 | Very light weight package. For example, light<br>handle covers or towel packs. | 3 lbs | 3 lbs | 3 lbs |
| P200 | Light weight package. For example, standard<br>linen packs | 6 lbs | 6 lbs | 6.5 lbs |
| P300 | Light to moderate weight package. For<br>example, general use medical instruments. | 9 lbs | 9 lbs | 9 lbs |
| P400 | Moderate to heavy weight package. For<br>example, general use medical instruments. | 13 lbs | 10.7 lbs | 12 lbs |
| P500 | Heavy weight package. For example, general<br>use medical instruments | 17 lbs | 10.7 lbs | 12 lbs |
| P600 | Very heavy weight package. For example,<br>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 of<br>Comparison | Proposed device<br>PRIMED Sterilization wraps (K233777) | Predicate<br>Cardinal Health Sterilization Wrap (K181174) | Comparison<br>to Predicate |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Manufacturer | PRIMED Medical Products Inc. | Cardinal Health Inc. | --- |
| Regulation<br>number | 21 CFR 880.6850 | 21 CFR 880.6850 | Similar |
| Product Code | FRG | FRG | Similar |
| Common<br>name | Sterilization Wrap | Sterilization Wrap | Similar |
| Models/<br>Dimensions | Six basis weights and fourteen sizes | Six basis weights models Fourteen sizes (See Table 8 for<br>dimensions) | Similar |
| Intended Use | The PRIMED Sterilization wraps are intended to be<br>used to enclose another medical device that is to be<br>sterilized by a health care provider via the following:<br>- Pre-Vacuum Steam at 270°F/ 132°C for 4 minutes.<br>The wrap has been validated for dry time of 20<br>minutes for P100 and P200 and dry time of 30<br>minutes for P300, P400, P500 and P600.<br>- 100% Ethylene Oxide Sterilization with a<br>concentration of 725-735 mg/L at 131°F/55°C and<br>40% - 80% relative<br>humidity for 60 minutes. Validated for aeration<br>times of 8 hours at 55°C or 12 hours at 43.3°C.<br>- Lumen, Non-Lumen, and Flexible Cycles in the<br>STERIS V-PRO maX/maX2 and STERIS V-PRO 60/s2<br>low temperature Sterilization Systems.<br>- Advanced Sterilization Products STERRAD 100S<br>system<br>- Advanced Sterilization Products STERRAD NX<br>[Standard Cycle, Advanced Cycle]<br>- Advanced Sterilization Products STERRAD 100 NX<br>[Standard Cycle, Flex Cycle, Express, Duo Cycle]<br>PRIMED Sterilization wraps are available in 6 models<br>and different sizes ranging from 12" X 12" to 54" X 90"<br>and are intended to allow sterilization of the<br>enclosed medical device(s) and maintain sterility of<br>the enclosed device(s) until used. | Cardinal Health™ Sterilization Wrap is intended to enclose<br>another medical device that is to be sterilized by a health care<br>provider using:<br>• Pre-vacuum steam at 270°F/132°C for 4 minutes<br>• Gravity steam at 250°F/121°C for 30 minutes<br>• 100% ethylene oxide (EO) with a concentration of 725-735<br>mg/L at 131°F/55°C and 40%-80% relative humidity for 60<br>minutes<br>• Advanced Sterilization Products (ASP) STERRAD® 100S System<br>• Advanced Sterilization Products (ASP) STERRAD® 200 System<br>• Advanced Sterilization Products (ASP) STERRAD® NX System,<br>Standard and Advanced Cycles<br>• Advanced Sterilization Products (ASP) STERRAD® 100NX,<br>Standard, Flex, Express, and DUO cycles<br>• Lumen, Non Lumen, and Flexible Cycles by the STERIS V-PRO®<br>1, V-PRO® 1 Plus, V-PRO® maX and V-PRO® 60 Low Temperature<br>Sterilization Systems<br>• TSO3 STERIZONE® VP4 System Cycle 1(Refer to Table 5 for<br>Load)<br>The wrap is intended to allow sterilization of the enclosed<br>medical device(s) and to maintain sterility of the enclosed<br>device(s) until used. | Similar<br>(note 1) |
| Prescription<br>vs. OTC | OTC | OTC | Similar |
| Single use vs.<br>reusable | Single Use Only | Single Use Only | Similar |
| Material<br>Composition | PRIMED wraps are composed of Spunbond Meltblown<br>Spunbond material | Polypropylene fabric using SMS (spunbound-<br>meltdownspunbound) production process | Similar |
| Chemical<br>Properties | Polypropylene with blue pigment and antistatic<br>treatment | Polypropylene with blue pigment and antistatic treatment<br>Polypropylene 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 antistatic<br>treatment | | | | | |
| Device Design | The Fused one colour double layer bonded wrap is<br>comprised of two sheets ultrasonically bonded on<br>two parallel sides. The wrap fabrics are composed of<br>polypropylene with the addition of purple pigment.<br>The Fused two colours double layer bonded wrap is<br>comprised of two sheets of purple and blue fabrics<br>ultrasonically bonded on two parallel sides. The<br>wrap fabrics are composed of polypropylene with<br>the addition of purple or blue pigment.<br>The Single layer one colour wrap is comprised of a<br>single nonwoven sheet. The standard purple wrap is<br>composed of polypropylene with the addition of a<br>purple pigment. | | | | Dual layer, fold-over: Double layer wrap comprised of a single<br>sheet of blue pigmented SMS fabric that has been folded over<br>in half and ultrasonically sealed to itself on the three non-<br>folded edges.<br>Dual Layer: Double layer wrap comprised of two separate<br>sheets of blue pigmented SMS fabric that have been<br>ultrasonically sealed on two opposing edges<br>Single Layer: Single layer wrap comprised of a single sheet of<br>blue pigmented SMS fabric<br>Two Color: Double layer wrap comprised of one sheet of blue<br>pigmented SMS fabric and one sheet of green pigmented SMS<br>fabric that have been ultrasonically sealed on two opposing<br>edges | Similar |
| Sterilization<br>Parameter | - Pre-vacuum steam at 270°F/132°C for 4 minutes.<br>- 100% ethylene oxide (EO) with a concentration of<br>725-735 mg/l at 131°F/55°C and 40%-80% relative<br>humidity for 60 minutes.<br>- STERRAD® 100S short and long cycle.<br>- STERRAD® NX, Standard and Advanced Cycles.<br>- STERRAD® 100NX, Standard, Flex, Express and Duo<br>Cycles.<br>- Lumen, Non-Lumen, and Flexible Cycles in the<br>STERIS V-PRO maX/maX2, V-PRO 60/s2 Low<br>Temperature sterilization system. | | | | - Pre-vacuum steam at 270ºF/132ºC for 4 minutes<br>- Gravity steam at 250°F/121°C for 30 minutes 100% ethylene<br>oxide (EO) with a concentration of 725- 735 mg/L at<br>131ºF/55ºCand 40%- 80% relative humidity for 60 minutes<br>- Advanced Sterilization Products (ASP) STERRAD® 100S System<br>- Advanced Sterilization Products (ASP) STERRAD® 200 System<br>- Advanced Sterilization Products (ASP) STERRAD® NX System,<br>Standard and Advanced Cycles<br>- Advanced Sterilization Products (ASP) STERRAD® 100NX,<br>Standard, Flex, Express, and DUO cycles<br>- Lumen, Non-Lumen, and Flexible Cycles in the STERIS V-PRO®<br>1, V-PRO® 1 Plus, VPRO® maX and VPRO® 60 Low<br>Temperature Sterilization<br>- Systems TSO3 STERIZONE® VP4 System Cycle 1 | Similar<br>(note 1) |
| Maximum<br>Wrapped<br>package<br>content<br>weight | Model | Pre-<br>Vacuum<br>Steam<br>and EO | ASP<br>STERRAD<br>100S, 100NX<br>and NX | STERIS<br>V-PRO | | |
| | P100 | 3 lbs | 3 lbs | 3 lbs | Pre-vacuum Steam: 3 to 25 pounds | Different<br>(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…