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

K242208 · Primed Medical Products, Inc. · FRG · Oct 7, 2024 · General Hospital

Device Facts

• Record ID: K242208
• Device Name: PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
• Applicant: Primed Medical Products, Inc.
• Product Code: FRG · General Hospital
• Decision Date: Oct 7, 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) for a maximum of 180 days or until used.

Device Story

Device consists of SMS (Spunbond-Meltblown-Spunbond) polypropylene sheets, available in six weight-based models (P100-P600) and various sizes. Used by healthcare providers to wrap medical instruments prior to sterilization. Wraps allow sterilant penetration while acting as a microbial barrier to maintain sterility post-process. Available as single-layer or ultrasonically bonded double-layer configurations. After wrapping, packages are processed in validated steam, EO, or low-temperature hydrogen peroxide gas plasma cycles. Once sterilized, wraps maintain package integrity for up to 180 days. Healthcare staff use these to ensure instruments remain sterile until the point of use in clinical settings.

Clinical Evidence

Bench testing only. Testing included sterilization efficacy (ANSI/AAMI ST79, ISO 11138-7), maintenance of package integrity (ISO 11607-1, AAMI TIR12), residual EO levels (ISO 10993-7), biocompatibility (ISO 10993-5/10), and physical/chemical properties (ASTM D3776, D737, D3786, D5034, D5587, AATCC 127, NWSP 160.1). All tests passed.

Technological Characteristics

Material: SMS (Spunbond-Meltblown-Spunbond) polypropylene with pigment and antistatic treatment. Construction: Single-layer or ultrasonically bonded double-layer. Dimensions: 12"x12" to 54"x90". Basis weights: 40-88 gsm. Sterilization compatibility: Pre-vacuum steam, 100% EO, and specific low-temperature hydrogen peroxide gas plasma systems. Standards: ISO 11607-1, EN 868-2, ASTM D3776, ASTM D737-04, ASTM D3786, ASTM D5034-09, ASTM D5587-15, AATCC 127-2014, NWSP 160.1.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices during sterilization via pre-vacuum steam, 100% ethylene oxide, or specific low-temperature hydrogen peroxide gas plasma systems (STERIS V-PRO and ASP STERRAD). Intended to maintain sterility of the enclosed devices for up to 180 days post-sterilization.

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

• PRIMED Sterilization Wrap (K233777)

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

October 7, 2024

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

Re: K242208

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

Dear Mitra Fard:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

Image /page/2/Picture/3 description: The image contains the text "Stephen A. Anisko -S". The text is arranged in two lines, with "Stephen A." on the first line and "Anisko -S" on the second line. The text is black and is set against a white background. The text appears to be a name.

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

for: Christopher Dugard Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K242208

#### Device Name

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

Indications for Use (Describe)

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

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

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

| 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 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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## K242208 - 510(k) Summary

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

#### Device Description:

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

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

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

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| Model | | P100 (40 gsm) | | | P200 (45 gsm) | | | P300 (50 gsm) | | | P400 (65 gsm) | | | P500 (72 gsm) | | | P600 (88 gsm) | | |
|--------------|--|---------------|----|---|---------------|----|---|---------------|----|---|---------------|----|---|---------------|----|---|---------------|----|---|
| 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" to 54" X 90" and are intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) for a maximum of 180 days or until used.

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

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| Table 2: Maximum recommended wrapped package content: | | |
|-------------------------------------------------------|--|--|
| | | |

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

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

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

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

V-PRO maX/maX2 Non-Lumen Cycle:

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

V-PRO maX/maX2 Lumen Cycle:

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

V-PRO maX/maX2 Flexible Cycle:

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

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

V-PRO 60/s2 Non-Lumen Cycle:

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

V-PRO 60/s2 Lumen Cycle:

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

V-PRO 60/s2 Flexible Cycle:

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

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

STERRAD 100NX Standard cycle:

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

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- . Single channel stainless steel lumens with an inside diameter of 0.7 mm or larger and a length of 500 mm or shorter. (A maximum of ten single channel stainless steel lumens, five per tray per sterilization cycle).
STERRAD 100NX Flex Cycle:

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

STERRAD 100NX Express Cycle:

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

STERRAD 100NX DUO Cycle:

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

STERRAD NX Standard cycle:

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

#### STERRAD NX Advanced Cycle:

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

STERRAD 100s:

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

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

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

| Elements of<br>Comparison | Proposed device | Predicate device | Comparison<br>to Predicate |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| PRIMED Sterilization wraps (K242208) | PRIMED Medical Products Inc. | PRIMED Medical Products Inc. | Similar |
| 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 and fourteen sizes | 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><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><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 enclosed<br>medical device(s) and maintain sterility of the enclosed<br>device(s) until used. | The PRIMED Sterilization wraps are intended to be used<br>to enclose another medical device that is to be sterilized<br>by a health care provider via the following:<br><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 STERIS<br>V-PRO maX/maX2 and STERIS V-PRO 60/s2 low<br>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><br>PRIMED Sterilization wraps are available in 6 models and<br>different sizes ranging from 12" X 12" to 54" X 90" and<br>are intended to allow sterilization of the enclosed medical<br>device(s) and maintain sterility of the enclosed device(s)<br>until used. | Similar |
| 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 | PRIMED wraps are composed of Spunbond Meltblown<br>Sponbund material | Similar |
| Chemical<br>Properties | Polypropylene with blue pigment and antistatic<br>treatment | Polypropylene with blue pigment and antistatic treatment<br>Polypropylene with purple pigment and antistatic<br>treatment | Similar |

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# K242208 - 510(k) Summary

| Elements of<br>Comparison | Proposed device<br>PRIMED Sterilization wraps (K242208) | | | Predicate device<br>PRIMED Sterilization wraps (K233777) | | | Comparison<br>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 wrap<br>fabrics are composed of polypropylene with the<br>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. | | | - The Fused one colour double layer bonded wrap is<br>comprised of two sheets ultrasonically bonded on two<br>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 wrap<br>fabrics are composed of polypropylene with the<br>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. | | | 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 STERIS<br>V-PRO maX/maX2, V-PRO 60/s2 Low Temperature<br>sterilization system. | | | - Pre-vacuum steam at 270°F/132°C for 4 minutes.<br>- 100% ethylene oxide (EO) with a concentration of 725-<br>735 mg/l at 131°F/55°C and 40%-80% relative humidity<br>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 STERIS V-<br>PRO maX/maX2, V-PRO 60/s2 Low Temperature<br>sterilization system. | | | Similar | | |
| Maximum<br>Wrapped<br>package<br>content<br>weight | Model | Pre-Vacuum<br>Steam<br>and EO | ASP<br>STERRAD<br>100S, 100NX<br>and NX | STERIS<br>V-PRO | Model | Pre-Vacuum<br>Steam and EO | ASP STERRAD<br>100S, 100NX<br>and NX | STERIS<br>V-PRO | Similar |
| | P100 | 3 lbs | 3 lbs | 3 lbs | P100 | 3 lbs | 3 lbs | 3 lbs | |
| | P200 | 6 lbs | 6 lbs | 6.5 lbs | P200 | 6 lbs | 6 lbs | 6.5 lbs | |
| | P300 | 9 lbs | 9 lbs | 9 lbs | P300 | 9 lbs | 9 lbs | 9 lbs | |
| | P400…