(70 days)
Not Found
No
The device is a physical sterilization wrap and the description focuses on its material properties and compatibility with various sterilization methods. There is no mention of any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a sterilization wrap intended to maintain the sterility of other medical devices, not to provide therapy itself.
No
The device, PRIMED Sterilization wraps, is intended to enclose and maintain the sterility of other medical devices after a sterilization process. It is not used to diagnose any condition or disease.
No
The device is a physical sterilization wrap made of polypropylene, not software.
Based on the provided text, the PRIMED Sterilization wraps are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the wraps are used to "enclose another medical device that is to be sterilized" and "maintain sterility of the enclosed device(s)". This describes a function related to the sterilization and storage of medical devices, not the examination of specimens derived from the human body for diagnostic purposes.
- Device Description: The description focuses on the material (SMS Polypropylene), construction (single or double layer, bonded), and physical properties of the wraps. There is no mention of reagents, calibrators, controls, or any components typically associated with IVD devices.
- Performance Studies: The performance studies described evaluate the wraps' ability to allow sterilant penetration, maintain package integrity and sterility, and their physical and chemical properties. These are relevant to sterilization packaging, not diagnostic performance metrics like sensitivity, specificity, or accuracy in detecting analytes.
- Lack of IVD Characteristics: The text does not mention any of the key characteristics of an IVD, such as:
- Analyzing human specimens (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or treatment decisions based on specimen analysis.
- Using reagents or other components to perform a test on a specimen.
In summary, the PRIMED Sterilization wraps are a medical device intended for the packaging and maintenance of sterility of other medical devices during and after sterilization. Their function is entirely separate from the diagnostic testing of human specimens.
N/A
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) 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.
Product codes (comma separated list FDA assigned to the subject device)
FRG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care provider
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
PRIMED Sterilization wraps have been tested for sterilization efficacy, event related maintenance of package integrity, physical properties, and biocompatibility.
Key Results:
Testing results demonstrate that the PRIMED Sterilization Wraps allow sterilization of the enclosed medical device and maintain the sterility of the content for 180 days post sterilization after being sterilized with one of following sterilization cycles:
- -Pre-Vacuum Steam at 270°F/ 132°C for 4 minutes.
- -100% Ethylene Oxide Sterilization with a concentration of 725-735 mg/L at 131°F/55°C and 40% - 80% relative humidity for 60 minutes.
- -Lumen, Non-Lumen, and Flexible Cycles in the STERIS V-PRO maX/maX2 and STERIS V-PRO 60/s2 low temperature Sterilization Systems.
- Advanced Sterilization Products STERRAD 100S system -
- -Advanced Sterilization Products STERRAD NX [Standard Cycle, Advanced Cycle]
- -Advanced Sterilization Products STERRAD 100 NX [Standard Cycle, Flex Cycle, Express, Duo Cycle]
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
| Test Performed | Acceptance Criteria | Results (Pass/Fail) |
|---|---|---|
| Sterilant Penetration | All BI test samples should be negative for growth following the minimum incubation period | Pass |
| Maintenance of Package Integrity | Maintain sterility for 180 days | Pass |
| Maintenance of package sterility | No growth in any of the culture vessels containing test coupons after the minimum incubation period | Pass |
| Residual | Less than maximum theoretical residual limits or the tolerable contact limit following a 100% ethylene oxide sterilization process | Pass |
| Biocompatibility | 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, | Meets physical and chemical properties, non-sterile and post sterilization | Pass |
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
PRIMED Sterilization Wrap K233777
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
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
3
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 | ||||
| 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:
4
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
- o Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. The flexible endoscopes may contain:
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
-
- o Single or dual channeled devices with stainless steel lumens that are:
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
7
K242208 - 510(k) Summary
| Summary Date: | July 25, 2024 |
|---|---|
| Manufacturer: | PRIMED Medical Products Inc. |
| Address: | 200, 2003-91 St. SW, Edmonton, AB, Canada, T6X 0W8 |
| Phone Number | +1.877.877.4633 |
| Fax Number | +1.780.497.7670 |
| mitra.fard@primed.com | |
| Contact person: | Mitra Fard |
| Common name of the device | Sterilization Wrap |
| Trade or Proprietary Name: | PRIMED Sterilization Wrap |
| Models | P100, P200, P300, P400, P500, P600 |
| Regulation Description | Sterilization Wrap |
| Review Panel | General Hospital |
| Regulation number | 21 CFR 880.6850 |
| Device Class: | Class II |
| Product Code: | FRG |
| Predicate device(s) | PRIMED Sterilization Wrap K233777 |
Device Description:
The PRIMED Sterilization wraps are made of SMS (Spunbond) Polypropylene with addition of a master batch pigment for coloration and are available in three separate product offerings:
- 1- The Fused one colour double layer bonded wrap is comprised of two sheets ultrasonically bonded on two parallel sides. The wrap fabrics are composed of polypropylene with the addition of purple pigment. This product allows convenient simultaneous wrapping of medical devices to be sterilized in accordance with standard healthcare practices.
- 2- The Fused two colours double layer bonded wrap is comprised of two sheets of purple and blue fabrics ultrasonically bonded on two parallel sides. The wrap fabrics are composed of polypropylene with the addition of purple or blue pigment. This product allows convenient simultaneous wrapping of medical devices to be sterilized in accordance with standard healthcare practices.
- 3-The Single layer one colour wrap is comprised of a single nonwoven sheet. The standard purple wrap is composed of polypropylene with the addition of a purple pigment. Two sheets are used to sequentially wrap medical devices to be sterilized in accordance with standard healthcare practices.
PRIMED Sterilization wraps are available in various dimensions ranging from 12″ x 12″ x 90″ and six different weights as detailed in table 1.
8
| 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" 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.
9
| 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:
10
- 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
-
- Single or dual channeled devices with stainless steel lumens that are: o
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.
11
-
. 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.
12
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 | Predicate device | Comparison
to Predicate |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| PRIMED Sterilization wraps (K242208) | PRIMED Medical Products Inc. | PRIMED Medical Products Inc. | Similar |
| 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 and fourteen sizes | 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. | 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. | Similar |
| 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 | PRIMED wraps are composed of Spunbond Meltblown
Sponbund material | Similar |
| Chemical
Properties | Polypropylene with blue pigment and antistatic
treatment | Polypropylene with blue pigment and antistatic treatment
Polypropylene with purple pigment and antistatic
treatment | Similar |
13
K242208 - 510(k) Summary
| Elements of
Comparison | Proposed device
PRIMED Sterilization wraps (K242208) | | | Predicate device
PRIMED Sterilization wraps (K233777) | | | Comparison
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. | | | - 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. | | | 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 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. | | | Similar | | |
| Maximum
Wrapped
package
content
weight | Model | Pre-Vacuum
Steam
and EO | ASP
STERRAD
100S, 100NX
and NX | STERIS
V-PRO | Model | Pre-Vacuum
Steam and EO | ASP STERRAD
100S, 100NX
and NX | STERIS
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 | 13 lbs | 10.7 lbs | 12 lbs | P400 | 13 lbs | 10.7 lbs | 12 lbs | |
| | P500 | 17 lbs | 10.7 lbs | 12 lbs | P500 | 17 lbs | 10.7 lbs | 12 lbs | |
| | P600 | 25 lbs | 10.7 lbs | 12 lbs | P600 | 25 lbs | 10.7 lbs | 12 lbs | |
| Maintenance
of Package
Integrity | 180 days | | | | 30 days | | | Different
(Note) | |
| 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 | |
14
K242208 - 510(k) Summary
| Elements of
Comparison | Proposed device
PRIMED Sterilization wraps (K242208) | Predicate device
PRIMED Sterilization wraps (K233777) | Comparison
to Predicate |
|------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Maintenance
of package
Integrity | 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 | PRIMED wraps are tested for Cytotoxicity, Irritation and
sensitization and are considered non-cytotoxic, non-
irritating and non-sensitizing | Similar |
| Leachability | Extract prepared as per ISO 6588-2 is colourless, its PH,
chloride content, sulphate content meets the
requirement of EN 868-2 | Extract prepared as per ISO 6588-2 is colourless, its PH,
chloride content, sulphate content meets the
requirement of EN 868-2 | Similar |
| Residuals, ISO
10993- 7 | None detected | None detected | Similar |
| Physical and
chemical
properties
comparison | Compatible with the requirements of
Basis weight, Air permeability, Material burst strength,
Grab Tensile strength, Trapezoidal Tear strength,
Hydrostatic Pressure and linting | Compatible with the requirements of
Basis weight, Air permeability, Material burst strength,
Grab Tensile strength, Trapezoidal Tear strength,
Hydrostatic Pressure and linting | Similar |
Note: Testing reports demonstrate that the PRIMED Sterility of the enclosed medical device for 180 days and are safe and effective for their intended use.
Overall Performance Conclusions:
PRIMED Sterilization wraps have been tested for sterilization efficacy, event related maintenance of package integrity, physical properties, and biocompatibility. Testing results demonstrate that the PRIMED Sterilization Wraps allow sterilization of the enclosed medical device and maintain the sterility of the content for 180 days post sterilization after being sterilized with one of following sterilization cycles:
- -Pre-Vacuum Steam at 270°F/ 132°C for 4 minutes.
- -100% Ethylene Oxide Sterilization with a concentration of 725-735 mg/L at 131°F/55°C and 40% - 80% relative humidity for 60 minutes.
- -Lumen, Non-Lumen, and Flexible Cycles in the STERIS V-PRO maX/maX2 and STERIS V-PRO 60/s2 low temperature Sterilization Systems.
- Advanced Sterilization Products STERRAD 100S system -
- -Advanced Sterilization Products STERRAD NX [Standard Cycle, Advanced Cycle]
- -Advanced Sterilization Products STERRAD 100 NX [Standard Cycle, Flex Cycle, Express, Duo Cycle]
The proposed and predicate device in this submission have the same intended use, design, material composition. And they all comply with the applicable requirements. The maintenance of package integrity as demonstrated by the completed tests, do not affect the safety and performance of the proposed device.
15
| Test Performed | Test Method | Acceptance Criteria | Results (Pass/Fail) |
|---|---|---|---|
| Sterilant Penetration | ANSI/AAMI ST79 , | ||
| ANSI/AAMI/ISO 11138-7 | All BI test samples should be negative | ||
| for growth following the minimum | |||
| incubation period | Pass | ||
| Maintenance of Package | |||
| Integrity | ANSI/AAMI/ISO 11607-1, | ||
| AAMI TIR12 ANSI, AAMI | |||
| ST79 | Maintain sterility for 180 days | Pass | |
| Maintenance of package | |||
| sterility | AAMI TIR12 -ANSI/AAMI | ||
| ST77 | No growth in any of the culture | ||
| vessels containing test coupons after | |||
| the minimum incubation period | Pass | ||
| Residual | 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, | 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 |
Table 4: Summary of the non-clinical testing:
Conclusion:
Based on the non-clinical testing performed, it can be concluded that the subject device, PRIMED Sterilization Wraps (P100, P200, P300, P400, P500, P600) are as safe, as effective and performs as well as or better than the legally marketed predicate device, K233777 class II (21 CFR 880.6850), PRIMED Sterilization Wrap product code FRG.