(27 days)
Not Found
No
The device is a sterilization pouch/roll and its description focuses on materials, sealing methods, and compatibility with different sterilization processes. There is no mention of any computational or analytical functions that would involve AI/ML.
No.
The device is a sterilization pouch/roll intended to enclose medical devices for sterilization and maintain their sterility, not to treat or diagnose patients.
No
The device described is a sterilization pouch/roll, which is used to enclose other medical devices for sterilization and maintain their sterility. It contains chemical indicators to show exposure to sterilization processes, but it does not diagnose medical conditions.
No
The device described is a physical product (pouches and rolls) used for sterilization and maintaining sterility of other medical devices. It is not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the pouches and rolls are used to enclose another medical device for sterilization. Their purpose is to facilitate and maintain the sterility of other medical devices, not to perform a diagnostic test on a biological sample.
- Device Description: The description focuses on the materials, construction, and function of the pouches and rolls as sterile barrier systems and indicators of sterilization exposure. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not describe any components or functions typically associated with IVD devices, such as reagents, assays, or the analysis of biological specimens (blood, urine, tissue, etc.).
The device is a sterilization packaging system with integrated chemical indicators, intended for use by healthcare providers to sterilize and maintain the sterility of other medical devices. This falls under the category of general medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Safe Secure Sterilization Pouches and Rolls are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using:
- Gravity steam at 121°C (250°F) for 30 minutes; 25 minutes dry time
- Pre-vacuum steam at 132℃ (270°F) for 4 minutes; 20 minutes dry time
- Pre-vacuum steam at 134℃ (273°F) for 3 minutes; 20 minutes dry time
- Pre-vacuum steam at 135℃ (275°F) for 3 minutes; 16 minutes dry time
- Ethylene Oxide (EO) with a concentration of 735 mg/L at 55℃ (131°F) and 50% relative humidity for 60 minutes. Aeration time of 8 hours at 60℃ (140°F).
- The recommended hydrogen peroxide vapor sterilization cycle is :
- Standard Cycle of STERRAD® 100S
- Standard cycle and Advanced cycle of STERRAD® NX
- Standard cycle, Flex cycle and Express cycle of STERRAD® 100NX
- Non Lumen Cycle, Lumen Cycle and Flexible Cycle of V-PRO® maX
The steam and EO device are not intended and has not been validated for sterilization of devices that contain lumens. The hydrogen peroxide device has been validated for devices that contain a lumen listed below:
- Standard Cycle of STERRAD® 100S
- inside diameter ≥ 1 mm and length ≤ 125 mm
- inside diameter ≥ 2 mm and length ≤ 250 mm
- Standard cycle of STERRAD® NX
- Single channel stainless steel lumens with:
- Inside diameter ≥ 1 mm and length ≤ 150 mm
- Inside diameter ≥ 2 mm and length ≤ 400 mm
- Single channel PE/PTFE tubing with:
- Inside diameter ≥ 1 mm and length ≤ 350 mm
- Single channel stainless steel lumens with:
- Advanced cycle of STERRAD® NX
- Single channel stainless steel lumens with:
- Inside diameter ≥ 1 mm and length ≤ 500 mm
- Single PTFE lumen tubing with:
- Inside diameter ≥ 1 mm and length ≤ 1000 mm
- Single channel PE/PTFE flexible endoscopes with:
- Inside diameter ≥ 1 mm and length ≤ 850 mm
- Single channel stainless steel lumens with:
- Standard cycle of STERRAD® 100NX
- Single channel stainless steel lumens with:
- Inside diameter ≥ 0.7 mm and length ≤ 500 mm
- Single channel PE/PTFE instruments with:
- Inside diameter ≥ 1 mm and length ≤ 1000 mm
- Single channel stainless steel lumens with:
- Flex cycle of STERRAD® 100NX
- Single channel PE/PTFE flexible endoscope with:
- Inside diameter ≥ 1 mm and length ≤ 850 mm
- Single channel PE/PTFE flexible endoscope with:
- Lumen Cycle of V-PRO® maX
- Lumened and non-luments 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 channeled devices with a stainless lumen that is > 0.77mm internal diameter (ID) and
§ 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" below. The logo is simple and professional, reflecting the FDA's role in regulating food and drugs.
October 16, 2024
Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K242839
Trade/Device Name: Safe Secure Sterilization Pouches and Rolls Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization wrap Regulatory Class: Class II Product Code: FRG, JOJ Dated: September 19, 2024 Received: September 19, 2024
Dear Prithul Bom:
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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (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 Rule"). 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-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-regulatory
2
assistance/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).
Sincerely,
PAULO LARANJEIRA -S Digitally signed by PAULO LARANJEIRA -S Date: 2024.10.16 16:18:27 -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) K242839
Device Name
Safe Secure Sterilization Pouches and Rolls
Indications for Use (Describe)
Safe Secure Sterilization Pouches and Rolls are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using:
- · Gravity steam at 121°C (250°F) for 30 minutes; 25 minutes dry time
- Pre-vacuum steam at 132℃ (270°F) for 4 minutes; 20 minutes dry time
- · Pre-vacuum steam at 134℃ (273°F) for 3 minutes; 20 minutes dry time
- Pre-vacuum steam at 135℃ (275°F) for 3 minutes; 16 minutes dry time
- Ethylene Oxide (EO) with a concentration of 735 mg/L at 55℃ (131°F) and 50% relative humidity for 60 minutes. Aeration time of 8 hours at 60℃ (140°F).
- The recommended hydrogen peroxide vapor sterilization cycle is :
- · Standard Cycle of STERRAD® 100S
- Standard cycle and Advanced cycle of STERRAD® NX
- · Standard cycle, Flex cycle and Express cycle of STERRAD® 100NX
- · Non Lumen Cycle, Lumen Cycle and Flexible Cycle of V-PRO® maX
The steam and EO device are not intended and has not been validated for sterilization of devices that contain lumens. The hydrogen peroxide device has been validated for devices that contain a lumen listed below:
- Standard Cycle of STERRAD® 100S
- inside diameter ≥ 1 mm and length ≤ 125 mm
- inside diameter ≥ 2 mm and length ≤ 250 mm
- Standard cycle of STERRAD® NX
- · Single channel stainless steel lumens with:
- Inside diameter ≥ 1 mm and length ≤ 150 mm
- Inside diameter ≥ 2 mm and length ≤ 400 mm
- · Single channel PE/PTFE tubing with:
- Inside diameter ≥ 1 mm and length ≤ 350 mm
- Advanced cycle of STERRAD® NX
- · Single channel stainless steel lumens with:
- Inside diameter ≥ 1 mm and length ≤ 500 mm
- · Single PTFE lumen tubing with:
- Inside diameter ≥ 1 mm and length ≤ 1000 mm
- · Single channel PE/PTFE flexible endoscopes with:
- Inside diameter ≥ 1 mm and length ≤ 850 mm
- Standard cycle of STERRAD® 100NX
- · Single channel stainless steel lumens with:
- Inside diameter ≥ 0.7 mm and length ≤ 500 mm
- Single channel PE/PTFE instruments with:
4
-
Inside diameter ≥ 1 mm and length ≤ 1000 mm
-
Flex cycle of STERRAD® 100NX
-
Single channel PE/PTFE flexible endoscope with:
-
Inside diameter ≥ 1 mm and length ≤ 850 mm
-
Lumen Cycle of V-PRO® maX
△ Lumened and non-luments 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 channeled devices with a stainless lumen that is > 0.77mm internal diameter (ID) and Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
6
K242839 - 510(k) Summary
Submission Sponsor
Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd. 6A01, Block 1, Ahoke Plaza, DaLing Community, Minzhi Street, Longhua District, ShenZhen City, Guangdong Province 518109 China.
Parker Lee Tel: 86-755-27040468 Fax: 86-755-27040488 tse(@anbaopack.com
Date Prepared
October 10, 2024
Device Identification
| Trade/Proprietary Name: | Safe Secure Sterilization Pouches and Rolls |
|---|---|
| Common/Usual Name: | Sterilization Pouch |
| Classification Name: | Sterilization Wrap |
| Classification Regulation: | 21 CFR Part 880.6850 |
| Product Code: | FRG |
| Subsequent Product Code: | JOJ |
| Device Class: | Class II |
| Classification Panel: | General Hospital |
Predicate Device
K180139 - Safe Secure Sterilization Pouches and Rolls
Device Description
The device is made from porous material printed chemical indicator thermally sealed to a plastic film, additionally Self-Seal has medical double side tape.
They are divided according to porous material to paper pouch and Tyvek pouch. Paper Pouch are constructed from uncoated medical paper and plastic film; it can be used with steam and EO sterilization. Tyvek Pouch are constructed from an uncoated Tyvek and plastic film, , it can be used with hydrogen peroxide sterilization.
The device is preformed sterile barrier systems, sealed 2 sides (roll for left and right) or 3 sides(pouch for left, right and top). The remaining edges can be Heat-Sealed or Self-Sealed to form a sealing system. The Self-Seal pouch
7
permits sealing of the pouch without Heat-Sealing equipment, whereas the Heat-Sealable pouches must be Heat-Sealed prior to the cycle.
The pouches and rolls are used to enclose medical devices that are to be sterilized by a healthcare provider following manufacturer's instructions. The medical devices are inserted into Pouches or rolls and sealed.
The devices contain chemical process indicator intended to demonstrate that the device has been exposed to the steam, EO and vapor hydrogen peroxide Sterilization.
Indications for Use
Safe Secure Sterilization Pouches and Rolls are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using:
- Gravity steam at 121℃ (250°F) for 30 minutes; 25 minutes dry time
- Pre-vacuum steam at 132℃ (270°F) for 4 minutes; 20 minutes dry time
- Pre-vacuum steam at 134℃ (273°F) for 3 minutes; 20 minutes dry time
- Pre-vacuum steam at 135℃ (275°F) for 3 minutes; 16 minutes dry time
- Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% to 80% relative humidity for 60 minutes. Aeration time of 8 hours at 60°C (140°F).
- The recommended hydrogen peroxide vapor sterilization cycle is :
- Standard Cycle of STERRAD® 100S
- Standard cycle and Advanced cycle of STERRAD® NX
- Standard cycle, Flex cycle and Express cycle of STERRAD® 100NX
- · Non Lumen Cycle, Lumen Cycle and Flexible Cycle of V-PRO® maX
The steam and EO device are not intended and has not been validated for sterilization of devices that contain lumens. The hydrogen peroxide device has been validated for devices that contain a lumen listed below:
- Standard Cycle of STERRAD® 100S
- inside diameter > 1 mm and length 1 mm and length 0.77mm internal diameter (ID) and ≤ 500mm in length
- Dual channeled devices with stainless steel lumens that are ≥ 0.77mm ID and ≤ 527mm in length
- Triple channeled devices with stainless steel lumens that are
- ≥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
- Flexible Cycle of V-PRO® maX
- △ Two flexible endoscopes with a light cord (if not integral to the endoscope) and mat with no additional load. The flexible endoscopes may contain either:
- A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length
- Or two lumens with:
- One lumen that is ≥ 1 mm ID and ≤ 990 mm in length
- And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length
- △ One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors. The flexible endoscopes my contain either:
- A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length
- Or two lumens with:
9
-
One lumen that is ≥ 1 mm ID and ≤ 990 mm in length
-
And the other lumen that is > 1 mm ID and ≤ 850 mm in length
The external chemical indicators on the pouches/rolls are intended to demonstrate that the device has been exposed to the steam, EO, or hydrogen peroxide sterilization process and to distinguish between processed and unprocessed devices. The chemical indicators change from green to purple or from Pink to Cocoa after exposure to steam, from yellow to brown or from Blue to Brown after exposure to ethylene oxide, and from blue to pink for hydrogen peroxide.
The paper version of the pouch is for Steam and EO. The Tyvek version of the pouch is for hydrogen peroxide sterilization only.
If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 5 years(for paper pouch) and 2 years(for Tyvek pouch) from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility (SAL=106).
The subject device is intended and has been validated to maintain sterility of the enclosed devices for 12 months after steam sterilization and 24 months after EO sterilization(for paper pouch), and, 2 years after hydrogen peroxide sterilization (for Tyvek Pouch).
| Pouch
| Material | Sterilization Method | Size | Model Number |
|---|---|---|---|
| Medical Grade | |||
| Paper | Steam or EO Sterilization Pouch/Roll Products | L: 2" – 30" | |
| W: 2" – 30" | ABSSP | ||
| ABHSP | |||
| ABHRP | |||
| Tyvek | Hydrogen Peroxide Sterilization Pouch/Roll Products | L: 2" – 30" | |
| W: 2" – 30" | ABSST | ||
| ABHST | |||
| ABHRT |
The maximum validated pouch load is 2.64 pounds (1.2kg).
Predicate Technology Comparison
The subject device has the same intended use of the device as its predicate and the same technological characteristics. The primary difference is
- extend the expiry date of Paper pouch to 12 months after steam a) sterilization,
- b) add the indicator printed in Paper pouch intended to demonstrate that the device has been exposed to the steam and EO,
- add application of Tyvek pouch with Standard cycle and Advanced cycle of c) STERRAD® NX, Standard cycle, Flex cycle and Express cycle of
10
STERRAD® 100NX, Non Lumen Cycle, Lumen Cycle and Flexible Cycle of V-PRO® maX, and,
- d) add parameters of rotary sealer
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| 510(k) | |||
| Number | K242839 | K180139 | |
| Product name | Safe Secure Sterilization Pouches | ||
| and Rolls | Safe Secure Sterilization Pouches | ||
| and Rolls | Identical | ||
| Manufacturer | Shenzhen SafeSecure Medical | ||
| Infection Control Tech Co., Ltd. | Shenzhen SafeSecure Medical | ||
| Infection Control Tech Co., Ltd. | Identical | ||
| Classification | II | II | Identical |
| Product Code | FRG | FRG | Identical |
| Regulation | |||
| Number | 21 CFR 880.6850 | 21 CFR 880.6850 | Identical |
| Indications for | |||
| Use | Safe Secure Sterilization Pouches and | ||
| Rolls are intended to be used to enclose | |||
| another medical device, in a single or | |||
| double pouch configuration, that is to be | |||
| sterilized by a health care provider using: | |||
| Gravity steam at 121°C (250°F) for 30 minutes; 25 minutes dry time Pre-vacuum steam at 132°C (270°F) for 4 minutes; 20 minutes dry time Pre-vacuum steam at 134°C (273°F) for 3 minutes; 20 minutes dry time Pre-vacuum steam at 135°C (275°F) for 3 minutes; 16 minutes dry time Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% to 80% relative humidity for 60 minutes. Aeration time of 8 hours at 60°C (140°F). The recommended hydrogen peroxide vapor sterilization cycle is: Standard Cycle of STERRAD® 100S Standard cycle and Advanced cycle of STERRAD® NX Standard cycle, Flex cycle and Express cycle of STERRAD® 100NX Non Lumen Cycle, Lumen Cycle and Flexible Cycle of V-PRO® maX | Safe Secure Sterilization Pouches and | ||
| Rolls are intended to be used to enclose | |||
| another medical device, in a single or | |||
| double pouch configuration, that is to be | |||
| sterilized by a health care provider | |||
| using: | |||
| Gravity steam at 121°C (250°F) for 30 minutes; 25 minutes dry time Pre-vacuum steam at 132°C (270°F) for 4 minutes; 20 minutes dry time Pre-vacuum steam at 134°C (273°F) for 3 minutes; 20 minutes dry time Pre-vacuum steam at 135°C (275°F) for 3 minutes; 16 minutes dry time Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% to 80% relative humidity for 60 minutes. Aeration time of 8 hours at 60°C (140°F). The recommended hydrogen peroxide vapor sterilization cycle is the STERRAD® 100S Standard Cycle. | Similar¹ | ||
| Subject Device | Predicate Device | Comparison | |
| 510(k) | |||
| Number | K242839 | K180139 | |
| Configuration | Pouch or Roll | Pouch or Roll | Identical |
| Design | Adhesive laminated film is a clear, | ||
| high strength material; Uncoated | |||
| Porous material is compatible with | |||
| sterilization, resistant to microbial | |||
| penetration, and resistant to | |||
| puncture | Adhesive laminated film is a clear, | ||
| high strength material; Uncoated | |||
| Porous material is compatible with | |||
| sterilization, resistant to microbial | |||
| penetration, | |||
| and | |||
| resistant | |||
| to | |||
| puncture | Identical | ||
| Primary | |||
| Material | Medical paper & PET/CPP Film or | ||
| Tyvek & PET/SPE Film, | |||
| Medical Double Side Tape (for | |||
| Self-Seal pouches only) | Medical paper & PET/CPP Film or | ||
| Tyvek & PET/SPE Film, | |||
| Medical Double Side Tape (for | |||
| Self-Seal pouches only) | Identical | ||
| Chemical | |||
| Indicator | Steam: green to purple or pink to | ||
| cocoa | |||
| EO: yellow to brown or blue to | |||
| brown | |||
| H2O2: blue to pink | Steam: green to purple EO: yellow | ||
| to brown H2O2: blue to pink | Similar2 | ||
| Seal Strength | |||
| Pre- | |||
| Sterilization, | |||
| ASTM | |||
| F88/F88M | ≥ 2.0N/15mm | ≥ 2.0N/15mm | Identical |
| Seal strength | |||
| Post | |||
| sterilization, | |||
| ASTM | |||
| F88/F88M | Steam: ≥ 1.5N/15mm | ||
| EO: ≥ 1.2N/15mm | |||
| H2O2: ≥ 2.0N/15mm | Steam: ≥ 1.5N/15mm | ||
| EO: ≥ 1.2N/15mm | |||
| H2O2: ≥ 2.0N/15mm | Identical | ||
| Seal Integrity | |||
| Post | |||
| sterilization | Visually examine the seal area | ||
| through the transparent side of the | |||
| package. | |||
| No Channels with Dye penetration. | Visually examine the seal area | ||
| through the transparent side of the | |||
| package. | |||
| No Channels with Dye penetration. | Identical | ||
| Peeling open | Peeling open and visual. | ||
| No broken paper or film. | Peeling open and visual. | ||
| No broken paper or film. | Identical | ||
| Shelf Life | Paper Pouch: 5 years before | ||
| Sterilization, and | |||
| Tyvek Pouch: 2 years before | |||
| Sterilization | Paper Pouch: 5 years before | ||
| Sterilization | |||
| Tyvek Pouch: 2 years before | |||
| Sterilization | Identical | ||
| Subject Device | Predicate Device | Comparison | |
| 510(k) | |||
| Number | K242839 | K180139 | |
| Maintenance | |||
| of package | |||
| integrity | Paper Pouch: 12 months after | ||
| steam sterilization and 24 months | |||
| after EO sterilization | |||
| Tyvek Pouch: 24 months after | |||
| hydrogen peroxide | Paper Pouch: 6 months after | ||
| steam sterilization and 2 years | |||
| after EO sterilization | |||
| Tyvek Pouch: 24 months after | |||
| hydrogen peroxide sterilization. | Identical |
Table 1: Primary Predicate Device Technological Comparison
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1 The testing reports demonstrate the safety and effectiveness of device for their Indications for Use.
2 The testing reports demonstrate the safety and effectiveness of device for their Chemical Indicator.
Summary of Non-Clinical Testing
The predicate and subject devices (pre-formed pouch and roll) in their presterilized final finished form are identical in formulation, processing, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents), with the exception of the steam and EO sterilization chemical process indicator on the exterior of the device.
This section includes a brief discussion of the nonclinical tests submitted, referenced, or relied on in the premarket notification submission to support subject device performance.
| Test | Standard or test method | Acceptance Criteria | Result |
|---|---|---|---|
| Seal Width | Ruler | More than 8mm | Pass |
| Seal Strength | ASTM F88/F88M | Pre sterilization: ≥ 2N/15mm | |
| Post sterilization: | |||
| Steam: ≥ 1.5N/15mm | |||
| EO: ≥ 1.2N/15mm | |||
| H2O2: ≥ 2.0N/15mm | Pass | ||
| Dye penetration | ASTM F1929 | No Channels with Dye penetration. | Pass |
| Peeling open | Peeling open and visual | No broken paper or film | Pass |
| Chemical indicator | |||
| color | ISO 11140-1 | Meets the requirements of Guidance | |
| for Industry and FDA Staff | Pass | ||
| Sterilant | |||
| Penetration | ISO 11138-1, ISO 11737-2, ISO 22441 | ||
| Half cycles were used to validate the | |||
| cycle. | The positive control group had | ||
| bacterial growth, the negative | |||
| control group had no growth, and | |||
| the experimental group had no | |||
| growth. | Pass |
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| Maintenance of
| package integrity | Expiry date Validation Test; | The device performance shall be | |
|---|---|---|---|
| Conducted the expiry date testing as real | meet the requirements of | ||
| time aging method. | maintenance of package integrity. | ||
| Paper Pouch: | |||
| after Steam sterilization: 12 months. | Pass | ||
| after EO sterilization: 24 months. | |||
| Tyvek Pouch: | |||
| after hydrogen peroxide sterilization: | |||
| 24 months. | |||
| Shelf Life | Shelf Life Validation Test; | The device performance shall be | |
| Conducted the shelf life testing as real | meet the requirements of shelf life. | ||
| time aging method. | Pass | ||
| Paper Pouch:5 years before Sterilization | |||
| Tyvek Pouch: 2 years before Sterilization | |||
| Biocompatibility | ISO 10993-5 | Non-cytotoxic. | Pass |
Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device cleared under K180139.