(238 days)
Safe Secure Paper 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% relative humidity for 60 minutes. Aeration time of 8 hours at 60℃ (140°F).
The device is not intended and has not been validated for sterilization of devices that contain lumens.
The external chemical indicators on the pouches/rolls are intended to demonstrate that the device has been exposed to the steam or EO sterilization process and to distinguish between processed devices. The chemical indicators change from green to purple after exposure to steam and from yellow to brown after exposure to ethylene oxide.
The Tyvek version of the pouch is for EO sterilization only.
If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 5 years from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility (SAL=10 4). The subject device is intended and has been validated to maintain sterlity of the enclosed devices for 6 months after steam sterilization and 24 months after EO sterilization.
The maximum validated pouch load is 2.64 pounds (1.2kg).
The Safe Secure Sterilization Pouches are made from either a medical grade porous paper or Tyvek thermally sealed to a plastic film on the left, right, and bottom of the pouch. The top side is open in order to receive the medical device to be sterilized and to seal the pouch. They are available either pre-manufactured self-seal or heat-seal sizes or in a roll of heat-seal tubing for the customer to cut the pouches to their required size.
The base model numbers for the subject device are described as follows, where the last three letters corresponds to the type of material:
- ABSST - Self seal Tyvek
- ABHST Heat seal Tyvek .
- ABHSP Heat seal paper ●
- ABSSP Self seal paper .
The pouches also contain external chemical indicators used to indicate that the pouches have been processed by either a steam or ethylene oxide sterilization process.
The medical grade paper versions can be used in either gravity steam, pre-vacuum steam, or ethylene oxide (EO) sterilization cycles. The Tyvek version is only for EO sterilization.
The document describes the Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators, and its substantial equivalence to a predicate device (K112591). It details the device's indications for use, material composition, and performance testing.
Here's an analysis of the acceptance criteria and the study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria and reported device performance" as a distinct section. However, it provides a "Substantial Equivalence Table" (starting on page 9) that compares various characteristics of the subject device to its predicate. This table implicitly highlights the acceptance criteria by stating how the subject device performs compared to the predicate, often indicating "Same" or "Substantially Equivalent."
Below is a consolidated table based on the information provided in the "Substantial Equivalence Table" and the "Functional Testing" section. The "Acceptance Criteria" column is inferred from the values or descriptions given for the predicate and often directly matched by the subject device. The "Reported Device Performance" column reflects the subject device's characteristics.
| Item No. | Characteristic | Acceptance Criteria (Predicate Device) | Reported Device Performance (Subject Device) |
|---|---|---|---|
| 1 | 510(k) Number | K1125591 | TBD (Assigned K153540 later) |
| 2 | Manufacturer | Safe Secure Packaging (Shenzhen) Co., Ltd | Safe Secure Packaging (Shenzhen) Co., Ltd |
| 3 | Model Numbers | ABHSP, ABSSP | ABHSP, ABSSP, ABHST, ABSST |
| 4 | Classification | Class II | Class II |
| 5 | Product Code | FRG | FRG |
| 6 | Regulation | 21 CFR 880.6850 | 21 CFR 880.6850 |
| 7 | Indications for Use | Sterilization by gravity steam (121°C/30 min) and EO (735mg/L at 55°C/60 min). External chemical indicators change color; maintains sterility (SAL=10^-6). | Sterilization by gravity steam (121°C/30 min), pre-vacuum steam (132°C/4 min, 134°C/3 min, 135°C/3 min), and EO (735mg/L at 55°C/60 min). External chemical indicators change color; maintains sterility (SAL=10^-6), Tyvek for EO only. Max validated pouch load 2.64 lbs (1.2kg). For products without lumens. |
| 8 | Material Composition | Porous paper or Tyvek, PET/CPP high-temperature blue compound film, High temperature adhesive paper, Medical Double Side Tape, EO gas indicator ink, Steam indicator ink. | Porous paper or Tyvek, PET/CPP high-temperature blue compound film, High temperature adhesive paper, Medical Double Side Tape, EO gas indicator ink, Steam indicator ink. |
| 9 | Pouch Dimensions (Nominal) | Length: 2 to 20 inches; Width: 8 to 30 inches | Length: 2 to 20 inches; Width: 8 to 30 inches |
| 10 | Roll Dimensions | Width: 8 to 30 inches | Width: 8 to 30 inches |
| 11 | Air Permeance | Maximum equivalent pore size diameter shall not exceed 50µm. | Maximum equivalent pore size diameter shall not exceed 50µm. |
| 12 | Shelf Life | 5 years before sterilization; 6 months after gravity steam sterilization or 24 months after EO sterilization. | 5 years before sterilization; 6 months after steam sterilization (gravity or pre-vacuum) or 24 months after EO sterilization. |
| 13 | Paper and Film Thickness & Density | Paper: ±2 gm/m²; Film: +0.002 mm; Tyvek: ±2 gm/m² | Paper: ±2 gm/m²; Film: +0.002 mm; Tyvek: ±2 gm/m² |
| 14 | Seal Strength before sterilization | 2.5 to 5.5 N/15mm | 2.5 to 5.5 N/15mm |
| 15 | Seal Strength after steam sterilization | 2.5 to 5.5 N/15mm | > 1.5 N / 15mm |
| 16 | Seal Strength after EO sterilization | 2.5 to 5.5 N/15mm | > 1.5 N / 15mm |
| 17 | Burst Strength | 2.5 to 5.5 N/15mm | 2.5 to 5.5 N/15mm |
| 18 | Peel-Open | No splitting of paper more than 10mm from heat seal lines. | No splitting of paper more than 10mm from heat seal lines. |
| 19 | Tensile Strength | Paper: > 220 N/50mm; Film: > 550 N/50mm; Tyvek: > 250 N/50mm. | Paper: > 220 N/50mm; Film: > 550 N/50mm; Tyvek: > 250 N/50mm. |
| 20 | Seal Integrity | Visual examination of the seal area through the transparent side of the package shows no channels present. | Visual examination of the seal area through the transparent side of the package shows no channels present. |
| 21 | Seal Width | More than 8mm | More than 8mm |
| 22 | Limits for acidity or alkalinity | The PH value of an extract prepared shall be within one PH unit of that of the control fluid. | The PH value of an extract prepared shall be within one PH unit of that of the control fluid. |
| 23 | Limits for extractable metals | Shall not contain greater than a combined total of 5 mg/ml of lead, zinc, or iron. | Shall not contain greater than a combined total of 5 mg/ml of lead, zinc, or iron. |
| 24 | EO Residual Limits | Less than 1 mg/pouch/day | Less than 1 mg/pouch/day |
| 25 | Chemical Process Indicators | For Steam: Green to Purple. For EO: Yellow to Brown. | For Steam: Green to Purple. For EO: Yellow to Brown. |
Summary of Device Performance: The "Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators" generally meets the same criteria as its predicate device. The primary changes in the subject device are the expansion of available model numbers to include Tyvek versions (specifically for EO sterilization) and additional pre-vacuum steam sterilization cycles. For most physical and chemical properties, the acceptance criteria are met by matching the predicate's performance. For "Seal strength after steam sterilization" and "Seal strength after EO sterilization," the acceptance criteria shifted from "2.5 to 5.5 N/15mm" to "> 1.5 N / 15mm", still indicating a performance deemed "Substantially Equivalent."
2. Sample Size Used for the Test Set and Data Provenance
The document states that "testing was conducted in accordance with ASTM and ISO standards relating to sterile packaging of medical devices" and "bench performance tests were performed." However, specific sample sizes for these tests (test sets) are not provided in this summary.
Regarding data provenance:
- Country of Origin of the Data: Not explicitly stated, but the submission sponsor and manufacturer are "Safe Secure Packaging (Shenzhen) Co., Ltd" in China. It is reasonable to infer that the testing data originated from or was managed by this entity, potentially through a testing lab.
- Retrospective or Prospective: The testing described (functional testing, biocompatibility, accelerated aging, validation of sterilization cycles) is typically prospective as it's conducted to demonstrate the performance of the device for regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The tests described are largely objective physical, chemical, and biological tests (e.g., seal strength, air permeance, sterilization indicator function, biological indicator tests) performed against established industry standards (ASTM, ISO). These types of tests typically do not involve human experts establishing a "ground truth" in the same way clinical image analysis would. Instead, their results are measured against predefined specifications or pass/fail criteria derived from these standards.
4. Adjudication Method for the Test Set
Given the nature of the tests (bench performance, physical, chemical, biological tests), an "adjudication method" as typically understood in studies involving human interpretation (e.g., 2+1, 3+1 for clinical reads) is not applicable or mentioned. The results of the tests would be objectively measured and compared against specified acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret data, often with and without AI assistance, to measure changes in reader performance. The "Safe Secure Sterilization Pouch" is a sterilization packaging device, not a diagnostic device involving human interpretation of medical images or data.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the device is a physical sterilization pouch and not an AI algorithm. The performance evaluation focuses on the pouch's physical, chemical, and functional attributes, not on an algorithm's standalone performance.
7. The Type of Ground Truth Used
For the various tests conducted:
- Physical and Chemical Tests (e.g., Seal Strength, Air Permeance, Dimensions, Acidity, Metals, EO Residual): The "ground truth" is established by the specified ISO/ASTM standards and internal specifications derived from these standards. These are objective measurements compared against quantitative limits.
- Sterilization Indicator Test: The "ground truth" is the visually observable color change (Green to Purple for Steam, Yellow to Brown for EO) as specified, which indicates exposure to the sterilization process.
- Biological Indicator Test: The "ground truth" for sterilization effectiveness is typically the absence of microbial growth after exposure to the sterilization process, demonstrating a Sterility Assurance Level (SAL) of 10^-6.
- Shelf-life Tests: The "ground truth" is the maintenance of specified physical, chemical, and sterility properties over the stated shelf-life durations (6 months after steam, 24 months after EO, 5 years before sterilization) as determined by various challenge tests and aging studies.
8. The Sample Size for the Training Set
This question is not applicable as the device is a physical sterilization pouch and does not involve machine learning or a "training set" in the context of AI/algorithms.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as point 8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing design that suggests movement or progress.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 4, 2016
Safe Secure Packaging Co., Ltd % Mr. Brian Edwards Senior Medical Research Manager, Regulatory NAMSA 4050 Olson Memorial Highway Golden Valley, MN 55422
Re: K153540
Trade/Device Name: Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: July 11, 2016 Received: July 12, 2016
Dear Mr. Edwards:
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 (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. 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.
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runne, DDS, MA
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153540
Device Name
Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators
Indications for Use (Describe)
Safe Secure Paper 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% relative humidity for 60 minutes. Aeration time of 8 hours at 60℃ (140°F).
The device is not intended and has not been validated for sterilization of devices that contain lumens.
The external chemical indicators on the pouches/rolls are intended to demonstrate that the device has been exposed to the steam or EO sterilization process and to distinguish between processed devices. The chemical indicators change from green to purple after exposure to steam and from yellow to brown after exposure to ethylene oxide.
The Tyvek version of the pouch is for EO sterilization only.
If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 5 years from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility (SAL=10 4). The subject device is intended and has been validated to maintain sterlity of the enclosed devices for 6 months after steam sterilization and 24 months after EO sterilization.
The maximum validated pouch load is 2.64 pounds (1.2kg).
The following tables list the available model numbers of the Safe Secure Sterilization Pouches and Rolls.
| Model | Type | Sterilization Cycle(s) | Dimensions(mm) | |
|---|---|---|---|---|
| Width (mm) | Length (mm) | |||
| ABHSP100001 | POUCH PAPER HEAT SEAL 3.5X10 | Steam or Ethylene Oxide | 89 | 254 |
| ABHSP100002 | POUCH PAPER HEAT SEAL 7.5X13 | Steam or Ethylene Oxide | 191 | 330 |
| ABHSP100003 | POUCH PAPER HEAT SEAL 6X10 | Steam or Ethylene Oxide | 152 | 254 |
| ABHSP100004 | POUCH PAPER HEAT SEAL 4.5X11 | Steam or Ethylene Oxide | 114 | 279 |
| ABHSP100005 | POUCH PAPER HEAT SEAL 5X15 | Steam or Ethylene Oxide | 127 | 381 |
| ABHSP100006 | POUCH PAPER HEAT SEAL 10X15 | Steam or Ethylene Oxide | 254 | 381 |
| ABHSP100007 | POUCH PAPER HEAT SEAL 18X22 | Steam or Ethylene Oxide | 457 | 559 |
| ABHSP100008 | POUCH PAPER HEAT SEAL 12X18 | Steam or Ethylene Oxide | 305 | 457 |
| ABHSP100009 | POUCH PAPER HEAT SEAL 4X8 | Steam or Ethylene Oxide | 102 | 203 |
| ABHSP100010 | POUCH PAPER HEAT SEAL 3X8 | Steam or Ethylene Oxide | 76 | 203 |
| ABHSP100011 | POUCH PAPER HEAT SEAL 16X16 | Steam or Ethylene Oxide | 406 | 406 |
| ABHSP100012 | POUCH PAPER HEAT SEAL 4X22 | Steam or Ethylene Oxide | 102 | 559 |
| ABHSP100013 | POUCH PAPER HEAT SEAL 13X15 | Steam or Ethylene Oxide | 330 | 381 |
| ABHSP100014 | POUCH PAPER HEAT SEAL 8X10 | Steam or Ethylene Oxide | 203 | 254 |
| ABHSP100015 | POUCH PAPER HEAT SEAL 8X16 | Steam or Ethylene Oxide | 203 | 406 |
| ABHSP110001 | TUBING PAPER 6IN WIDTH 100FT ROLL | Steam or Ethylene Oxide | 151 | 30500 |
Table 1: Safe Secure Medical Grade Paper Sterilization Pouch/Roll Products
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| Model | Type | Sterilization Cycle(s) | Dimensions(mm) | |
|---|---|---|---|---|
| Width (mm) | Length (mm) | |||
| ABHSP110002 | TUBING PAPER 9IN WIDTH 100FT ROLL | Steam or Ethylene Oxide | 228 | 30500 |
| ABHSP110003 | TUBING PAPER 4IN WIDTH 100FT ROLL | Steam or Ethylene Oxide | 101 | 30500 |
| ABHSP110004 | TUBING PAPER 3IN WIDTH 100FT ROLL | Steam or Ethylene Oxide | 75 | 30500 |
| ABHSP110005 | TUBING PAPER 12IN WIDTH 100FTROLL | Steam or Ethylene Oxide | 305 | 30500 |
| ABHSP110006 | TUBING PAPER 2IN WIDTH 100FT ROLL | Steam or Ethylene Oxide | 51 | 30500 |
| ABHSP120001 | POUCH MULTIPLE INNER 8 POUCHESSHEET | Steam or Ethylene Oxide | 230 | 415 |
| ABHSP120002 | POUCH MULTIPLE INNER 4 POUCHESSHEET | Steam or Ethylene Oxide | 230 | 415 |
| ABSSP100001 | POUCH PAPER SELF SEAL 7.5X13 | Steam or Ethylene Oxide | 191 | 353 |
| ABSSP100002 | POUCH PAPER SELF SEAL 5.25X10 | Steam or Ethylene Oxide | 140 | 277 |
| ABSSP100003 | POUCH PAPER SELF SEAL 13X18 | Steam or Ethylene Oxide | 330 | 480 |
| ABSSP100004 | POUCH PAPER SELFSEAL 12X15 | Steam or Ethylene Oxide | 305 | 404 |
| ABSSP100005 | POUCH PAPER SELF SEAL 3.5X8.75 | Steam or Ethylene Oxide | 89 | 245 |
| ABSSP100006 | POUCH PAPER SELF SEAL 5X15 | Steam or Ethylene Oxide | 127 | 404 |
| ABSSP100007 | POUCH PAPER SELF SEAL 3.5X9.875 | Steam or Ethylene Oxide | 89 | 274 |
| ABSSP100008 | POUCH PAPER SELF SEAL 8X16 | Steam or Ethylene Oxide | 203 | 429 |
| ABSSP100009 | POUCH PAPER SELF SEAL 3.5X22 | Steam or Ethylene Oxide | 89 | 582 |
| ABSSP100010 | POUCH PAPER SELF SEAL 9.125X25.5 | Steam or Ethylene Oxide | 232 | 671 |
| ABSSP100011 | POUCH PAPER SELF SEAL 4X11 | Steam or Ethylene Oxide | 102 | 302 |
Table 2: Safe Secure Tyvek Sterilization Pouch/Roll Products
| Model | Type | Sterilization Cycle(s) | Dimensions(mm) | |
|---|---|---|---|---|
| Width (mm) | Length (mm) | |||
| ABSST100001 | POUCH TYVEK SELF SEAL 8X12 | Ethylene Oxide Only | 203 | 345 |
| ABSST100002 | POUCH TYVEK SELF SEAL 6X10 | Ethylene Oxide Only | 152 | 294 |
| ABSST100003 | POUCH TYVEK SELF SEAL 12X18 | Ethylene Oxide Only | 305 | 497 |
| ABSST100004 | POUCH TYVEK SELF SEAL 10X15 | Ethylene Oxide Only | 254 | 421 |
| ABSST100005 | POUCH TYVEK SELF SEAL 4X9 | Ethylene Oxide Only | 102 | 269 |
| ABSST100006 | POUCH TYVEK SELF SEAL 3X7 | Ethylene Oxide Only | 76 | 218 |
| ABSST100007 | POUCH TYVEK SELF SEAL 4X12 | Ethylene Oxide Only | 102 | 345 |
| ABSST100008 | POUCH TYVEK SELF SEAL 4X22 | Ethylene Oxide Only | 102 | 599 |
| ABHST100001 | POUCH TYVEK HEAT SEAL 8X12 | Ethylene Oxide Only | 203 | 305 |
| ABHST100002 | POUCH TYVEK HEAT SEAL 6X10 | Ethylene Oxide Only | 152 | 254 |
| ABHST100003 | POUCH TYVEK HEAT SEAL 10X15 | Ethylene Oxide Only | 254 | 381 |
| ABHST100004 | POUCH TYVEK HEAT SEAL 12X18 | Ethylene Oxide Only | 305 | 457 |
| ABHST100005 | POUCH TYVEK HEAT SEAL 4X12 | Ethylene Oxide Only | 102 | 305 |
| ABHST100006 | POUCH TYVEK HEAT SEAL 4X9 | Ethylene Oxide Only | 102 | 229 |
| ABHST100007 | POUCH TYVEK HEAT SEAL 4X22 | Ethylene Oxide Only | 102 | 559 |
| ABHST100008 | POUCH TYVEK HEAT SEAL 3X7 | Ethylene Oxide Only | 76 | 178 |
| ABHST110001 | TUBING TYVEK 9IN WIDTH 75FT ROLL | Ethylene Oxide Only | 228 | 22900 |
| ABHST110002 | TUBING TYVEK 6IN WIDTH 75FT ROLL | Ethylene Oxide Only | 151 | 22900 |
| ABHST110003 | TUBING TYVEK 4IN WIDTH 75FT ROLL | Ethylene Oxide Only | 101 | 22900 |
| ABHST110004 | TUBING TYVEK 3IN WIDTH 75FT ROLL | Ethylene Oxide Only | 75 | 22900 |
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Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary 5.0
Submission Sponsor 5.1
Safe Secure Packaging (Shenzhen) Co., Ltd No.4 Chengguang Industrial Park Guanlan Street Baoan District, Shenzhen Guangdon Province, 518110 China Tel: 86-755-27040498 Fax: 86-755-27040488 Howard Jia, President howard.jia@anbaopack.com
5.2 Submission Correspondent
NAMSA 4050 Olson Memorial Hwy Suite 450 Minneapolis, MN 55422
Brian J. Edwards Principal Medical Research Manager, Regulatory Phone: +1-763-390-8409 Fax: +1-763-287-3836 bedwards@namsa.com
5.3 Date Prepared
August 1, 2016
5.4 Device Identification
Trade/Proprietary Name: Safe Secure Sterilization Pouches with Steam and Ethylene Oxide Process Indicators Common/Usual Name: Sterilization Pouch Classification Name: Sterilization Wrap Classification Regulation: 21 CFR Part 880.6850 Product Code: FRG Device Class: II Classification Panel: General Hospital Model Numbers: ABHSP, ABSSP, ABHST, ABSST
ર્સ્ડ Predicate Devices
K112591 - Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators
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5.6 Device Description
The Safe Secure Sterilization Pouches are made from either a medical grade porous paper or Tyvek thermally sealed to a plastic film on the left, right, and bottom of the pouch. The top side is open in order to receive the medical device to be sterilized and to seal the pouch. They are available either pre-manufactured self-seal or heat-seal sizes or in a roll of heat-seal tubing for the customer to cut the pouches to their required size.
The base model numbers for the subject device are described as follows, where the last three letters corresponds to the type of material:
- ABSST - Self seal Tyvek
- ABHST Heat seal Tyvek .
- ABHSP Heat seal paper ●
- ABSSP Self seal paper .
The pouches also contain external chemical indicators used to indicate that the pouches have been processed by either a steam or ethylene oxide sterilization process.
The medical grade paper versions can be used in either gravity steam, pre-vacuum steam, or ethylene oxide (EO) sterilization cycles. The Tyvek version is only for EO sterilization.
5.7 Indication for Use
Safe Secure Paper 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 device is not intended and has not been validated for sterilization of devices that contain lumens.
The external chemical indicators on the pouches/rolls are intended to demonstrate that the device has been exposed to the Steam or EO sterilization process and to distinguish between processed and unprocessed devices. The chemical indicators change from green to purple after exposure to steam and from yellow to brown after exposure to ethylene oxide.
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The Tyvek version of the pouch is for EO sterilization only.
If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 5 years from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility (SAL=10 %). The subject device is intended and has been validated to maintain sterility of the enclosed devices for 6 months after steam sterilization and 24 months after EO sterilization.
The maximum validated pouch load is 2.64 pounds (1.2kg).
These products are to be used for medical products without lumens.
The follow table list the available model numbers of the Safe Secure Sterilization Pouches and Rolls.
| Dimensions (mm) | ||||
|---|---|---|---|---|
| Model | Type | Sterilization Cycle(s) | Width(mm) | Length(mm) |
| ABHSP100001 | POUCH PAPER HEAT SEAL 3.5X10 | Steam or Ethylene Oxide | 89 | 254 |
| ABHSP100002 | POUCH PAPER HEAT SEAL 7.5X13 | Steam or Ethylene Oxide | 191 | 330 |
| ABHSP100003 | POUCH PAPER HEAT SEAL 6X10 | Steam or Ethylene Oxide | 152 | 254 |
| ABHSP100004 | POUCH PAPER HEAT SEAL 4.5X11 | Steam or Ethylene Oxide | 114 | 279 |
| ABHSP100005 | POUCH PAPER HEAT SEAL 5X15 | Steam or Ethylene Oxide | 127 | 381 |
| ABHSP100006 | POUCH PAPER HEAT SEAL 10X15 | Steam or Ethylene Oxide | 254 | 381 |
| ABHSP100007 | POUCH PAPER HEAT SEAL 18X22 | Steam or Ethylene Oxide | 457 | 559 |
| ABHSP100008 | POUCH PAPER HEAT SEAL 12X18 | Steam or Ethylene Oxide | 305 | 457 |
| ABHSP100009 | POUCH PAPER HEAT SEAL 4X8 | Steam or Ethylene Oxide | 102 | 203 |
| ABHSP100010 | POUCH PAPER HEAT SEAL 3X8 | Steam or Ethylene Oxide | 76 | 203 |
| ABHSP100011 | POUCH PAPER HEAT SEAL 16X16 | Steam or Ethylene Oxide | 406 | 406 |
| ABHSP100012 | POUCH PAPER HEAT SEAL 4X22 | Steam or Ethylene Oxide | 102 | 559 |
| ABHSP100013 | POUCH PAPER HEAT SEAL 13X15 | Steam or Ethylene Oxide | 330 | 381 |
| ABHSP100014 | POUCH PAPER HEAT SEAL 8X10 | Steam or Ethylene Oxide | 203 | 254 |
| ABHSP100015 | POUCH PAPER HEAT SEAL 8X16 | Steam or Ethylene Oxide | 203 | 406 |
| ABHSP110001 | TUBING PAPER 6IN WIDTH 100FT ROLL | Steam or Ethylene Oxide | 151 | 30500 |
| ABHSP110002 | TUBING PAPER 9IN WIDTH 100FT ROLL | Steam or Ethylene Oxide | 228 | 30500 |
| ABHSP110003 | TUBING PAPER 4IN WIDTH 100FT ROLL | Steam or Ethylene Oxide | 101 | 30500 |
| ABHSP110004 | TUBING PAPER 3IN WIDTH 100FT ROLL | Steam or Ethylene Oxide | 75 | 30500 |
| ABHSP110005 | TUBING PAPER 12IN WIDTH 100FTROLL | Steam or Ethylene Oxide | 305 | 30500 |
Table 1: Safe Secure Medical Grade Paper Sterilization Pouch/Roll Products
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Safe Secure Packaging Co. Ltd.
Sterilization Pouch
| Model | Type | Sterilization Cycle(s) | Dimensions (mm) | |
|---|---|---|---|---|
| Width (mm) | Length (mm) | |||
| ABHSP110006 | TUBING PAPER 2IN WIDTH 100FT ROLL | Steam or Ethylene Oxide | 51 | 30500 |
| ABHSP120001 | POUCH MULTIPLE INNER 8 POUCHESSHEET | Steam or Ethylene Oxide | 230 | 415 |
| ABHSP120001 | POUCH MULTIPLE INNER 4 POUCHESSHEET | Steam or Ethylene Oxide | 230 | 415 |
| ABSSP100001 | POUCH PAPER SELF SEAL 7.5X13 | Steam or Ethylene Oxide | 191 | 353 |
| ABSSP100002 | POUCH PAPER SELF SEAL 5.25X10 | Steam or Ethylene Oxide | 140 | 277 |
| ABSSP100003 | POUCH PAPER SELF SEAL 13X18 | Steam or Ethylene Oxide | 330 | 480 |
| ABSSP100004 | POUCH PAPER SELFSEAL 12X15 | Steam or Ethylene Oxide | 305 | 404 |
| ABSSP100005 | POUCH PAPER SELF SEAL 3.5X8.75 | Steam or Ethylene Oxide | 89 | 245 |
| ABSSP100006 | POUCH PAPER SELF SEAL 5X15 | Steam or Ethylene Oxide | 127 | 404 |
| ABSSP100007 | POUCH PAPER SELF SEAL 3.5X9.875 | Steam or Ethylene Oxide | 89 | 274 |
| ABSSP100008 | POUCH PAPER SELF SEAL 8X16 | Steam or Ethylene Oxide | 203 | 429 |
| ABSSP100009 | POUCH PAPER SELF SEAL 3.5X22 | Steam or Ethylene Oxide | 89 | 582 |
| ABSSP100010 | POUCH PAPER SELF SEAL 9.125X25.5 | Steam or Ethylene Oxide | 232 | 671 |
| ABSSP100011 | POUCH PAPER SELF SEAL 4X11 | Steam or Ethylene Oxide | 102 | 302 |
Table 2: Safe Secure Tyvek Sterilization Pouch/Roll Products
| Model | Type | Sterilization Cycle(s) | Dimensions (mm) | |
|---|---|---|---|---|
| Width (mm) | Length (mm) | |||
| ABSST100001 | POUCH TYVEK SELF SEAL 8X12 | Ethylene Oxide Only | 203 | 345 |
| ABSST100002 | POUCH TYVEK SELF SEAL 6X10 | Ethylene Oxide Only | 152 | 294 |
| ABSST100003 | POUCH TYVEK SELF SEAL 12X18 | Ethylene Oxide Only | 305 | 497 |
| ABSST100004 | POUCH TYVEK SELF SEAL 10X15 | Ethylene Oxide Only | 254 | 421 |
| ABSST100005 | POUCH TYVEK SELF SEAL 4X9 | Ethylene Oxide Only | 102 | 269 |
| ABSST100006 | POUCH TYVEK SELF SEAL 3X7 | Ethylene Oxide Only | 76 | 218 |
| ABSST100007 | POUCH TYVEK SELF SEAL 4X12 | Ethylene Oxide Only | 102 | 345 |
| ABSST100008 | POUCH TYVEK SELF SEAL 4X22 | Ethylene Oxide Only | 102 | 599 |
| ABHST100001 | POUCH TYVEK HEAT SEAL 8X12 | Ethylene Oxide Only | 203 | 305 |
| ABHST100002 | POUCH TYVEK HEAT SEAL 6X10 | Ethylene Oxide Only | 152 | 254 |
| ABHST100003 | POUCH TYVEK HEAT SEAL 10X15 | Ethylene Oxide Only | 254 | 381 |
| ABHST100004 | POUCH TYVEK HEAT SEAL 12X18 | Ethylene Oxide Only | 305 | 457 |
| ABHST100005 | POUCH TYVEK HEAT SEAL 4X12 | Ethylene Oxide Only | 102 | 305 |
| ABHST100006 | POUCH TYVEK HEAT SEAL 4X9 | Ethylene Oxide Only | 102 | 229 |
| ABHST100007 | POUCH TYVEK HEAT SEAL 4X22 | Ethylene Oxide Only | 102 | 559 |
| ABHST100008 | POUCH TYVEK HEAT SEAL 3X7 | Ethylene Oxide Only | 76 | 178 |
| ABHST110001 | TUBING TYVEK 9IN WIDTH 75FT ROLL | Ethylene Oxide Only | 228 | 22900 |
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Safe Secure Packaging Co. Ltd. Sterilization Pouch
| Model | Type | Sterilization Cycle(s) | Dimensions (mm) | |
|---|---|---|---|---|
| Width (mm) | Length (mm) | |||
| ABHST110002 | TUBING TYVEK 6IN WIDTH 75FT ROLL | Ethylene Oxide Only | 151 | 22900 |
| ABHST110003 | TUBING TYVEK 4IN WIDTH 75FT ROLL | Ethylene Oxide Only | 101 | 22900 |
| ABHST110004 | TUBING TYVEK 3IN WIDTH 75FT ROLL | Ethylene Oxide Only | 75 | 22900 |
Comparison to Predicates 5.8
The Safe Secure Sterilization Pouches are substantially equivalent to the previous pouch version cleared under K112591 – Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators.
Safe Secure Sterilization Pouch Substantial Equivalence Table
| Item# | Safe Secure Sterilization Pouch(Predicate Device) | Safe Secure Sterilization Pouch(Subject Device) | ||
|---|---|---|---|---|
| 1 | 510(k) Number | K112591 | TBD | |
| 2 | Manufacturer | Safe Secure Packaging(Shenzhen) Co., LtdNo.4 Chengguang IndustrialPark,Guanlan Street, BaoanDistrict,Shenzhen,518110 China | Safe Secure Packaging(Shenzhen) Co., LtdNo.4 Chengguang IndustrialPark, Guanlan Street, BaoanDistrict,Shenzhen,518110 China | Same |
| 3 | ModelNumbers | ABHSP, ABSSP | ABHSP, ABSSP, ABHST,ABSST | SubstantialEquivalent |
| 4 | Classification | II | II | Same |
| 5 | Product Code | FRG | FRG | Same |
| 6 | Regulation | 21 CFR 880.6850 | 21 CFR 880.6850 | Same |
| Item | Safe Secure Sterilization Pouch(Predicate Device) | Safe Secure Sterilization Pouch(Subject Device) | ||
| # | ||||
| 7 | Indications forUse | Safe Secure Sterilization Pouchwith Steam and Ethylene OxideProcess Indicators (Heat-sealand Self-seal) is intended to beused to enclose another medicaldevice that is to be sterilized by ahealth provider by gravity steamand ethylene oxide (EO). Therecommended steamsterilization cycle parameters is30 minutes at 121°C (250°F).The recommended EO gassterilization cycle is greaterthan or equal to 735mg/L ofethylene oxide (EO) for 1 hour at55°C (130 °F)) and 50% to80%RH. The pouch's externalchemical ink indicators on thepouches are intended todemonstrate that the device hasbeen expose to the steamor EO sterilization process andto distinguish between processedand unprocessed devices. Thepouch is intended to allowsterilization of the enclosedmedical device and also tomaintain sterility (SAL= 10-6) ofthe enclosed device until used. | Safe Secure Paper SterilizationPouches and Rolls are intendedto be used to enclose anothermedical device, in a single ordouble pouch configuration, thatis to be sterilized by a healthcare provider using:• Gravity Steam at 121°C(250°F) for 30 minutes• Pre-vacuum Steam at 132°C(270°F) for 4 minutes• Pre-vacuum Steam at 134°C(273°F) for 3 minutes• Pre-vacuum steam at 135°C(275°F) for 3 minutes• Ethylene Oxide (EO) with aconcentration of 735 mg/L at55°C (131°F) and 50% to 80%relative humidity for 60minutes. Aeration timeof 8 hours at 60°C(140°F).The external chemical indicatorson the pouches/rolls are intendedto demonstrate that the devicehas been exposed to the Steamor EO sterilization process andto distinguish between processedand unprocessed devices.The Tyvek version of the pouchis for EO sterilization only.If stored according to therecommended conditions, theproducts before sterilizationhave a maximum shelf life of 5years from the date ofmanufacture. The pouches areintended to allow sterilization ofthe enclosed medical device(s)and also to maintain sterility(SAL=10-6).The maximum validated pouchload is 2.64 pounds (1.2kg).These products are to be used for | SubstantiallyEquivalent |
| 8 | MaterialComposition | Porous paper or Tyvek,PET/CPP high-temperatureblue compound film, Hightemperature adhesive paper,Medical Double Side Tape, EOgas indicator ink, Steamindicator ink. | Porous paper or Tyvek,PET/CPP high-temperatureblue compound film, Hightemperature adhesive paper,Medical Double Side Tape, EOgas indicator ink, Steamindicator ink. | Same |
| Item | Safe Secure Sterilization Pouch(Predicate Device) | Safe Secure Sterilization Pouch(Subject Device) | ||
| # | ||||
| 9 | PouchDimensions* | Length: 2 to 20 inchesWidth: 8 to 30 inches | Length: 2 to 20 inchesWidth: 8 to 30 inches | Same |
| 10 | RollDimensions | Width: 8 to 30 inches | Width: 8 to 30 inches | Same |
| 11 | Air Permeance | The maximum equivalent poresize diameter shall not exceed50um. | The maximum equivalent poresize diameter shall not exceed50um. | Same |
| 12 | Shelf Life | 5 years before sterilization; 6months after gravity steamsterilization or 24 months afterEOsterilization | 5 years before sterilization; 6months after steam sterilization(gravity or pre-vacuum) or 24months after EOsterilization | Same |
| 13 | Paper and FilmThickness &Density | Paper: ±2 gm/m²Film: +0.002 mmTyvek: ±2 gm/m² | Paper: ±2 gm/m²Film: +0.002 mmTyvek: ±2 gm/m² | Same |
| 14 | Seal Strengthbeforesterilization | 2.5 to 5.5 N/15mm | 2.5 to 5.5 N/15mm | Same |
| 15 | Seal strengthafter steamsterilization | 2.5 to 5.5 N/15mm | > 1.5 N / 15mm | SubstantiallyEquivalent |
| 16 | Seal strengthafter EOsterilization | 2.5 to 5.5 N/15mm | > 1.5 N / 15mm | SubstantiallyEquivalent |
| 17 | Burst Strength | 2.5 to 5.5 N/15mm | 2.5 to 5.5 N/15mm | Same |
| 18 | Peel-Open | No splitting of paper more than10mm from heat seal lines | No splitting of paper more than10mm from heat seal lines | Same |
| 19 | TensileStrength | Paper: > 220 N/50mmFilm: > 550 N/50mmTyvek: > 250 N/50mm | Paper: > 220 N/50mmFilm: > 550 N/50mmTyvek: > 250 N/50mm | Same |
| 20 | Seal Integrity | Visual examination of the sealarea through the transparent sideof the package shows nochannels present. | Visual examination of the sealarea through the transparent sideof the package shows nochannels present. | Same |
| 21 | Seal Width | More than 8mm | More than 8mm | Same |
| 22 | Limits foracidity oralkalinity | The PH value of an extractprepared shall be within one PHunit of that of the control fluid | The PH value of an extractprepared shall be within one PHunit of that of the control fluid | Same |
| 23 | Limits forextractablemetals | Shall not contain greater than acombined total of 5 mg/ml oflead, zinc, or iron | Shall not contain greater than acombined total of 5 mg/ml oflead, zinc, or iron | Same |
| 24 | EO ResidualLimits | Less than 1 mg/pouch/day | Less than 1 mg/pouch/day | Same |
| 25 | ChemicalProcessIndicators | For Steam Sterilization:Green to Purple | For Steam Sterilization:Green to Purple | Same |
| For EO Sterilization:Yellow to Brown | For EO Sterilization:Yellow to Brown |
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Safe Secure Packaging Co. Ltd. Sterilization Pouch
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Safe Secure Packaging Co. Ltd. Sterilization Pouch
*Nominal Length and Width is determined by Product Code ordered.
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5.9 Functional Testing
To verify that the Safe Secure Sterilization Pouches meet the design requirements after exposure to the three new pre-vacuum steam sterilization cycles, and continue to meet the requirements after being exposed to the already cleared gravity steam and ethylene oxide cycles, testing was conducted in accordance with ASTM and ISO standards relating to sterile packaging of medical devices. In addition, biocompatibility and shelf-life stability testing was performed.
The following bench performance tests were performed to support substantial equivalence.
- Visual Appearance
- Seal Integrity ●
- . Dimensional Size
- Seal Width
- . Seal Leak
- Seal Strength
- Sterilization Indicator Test ●
- . Biological Indicator Test
- Accelerated Aging and Shelf-Life Tests
- Half and full cycle sterilization validation using worst case load configurations
- . Dry time validation using worst case load configurations
The following biocompatibility tests were performed to support substantial equivalence.
- Cytotoxicity
- Maximization Sensitization
- . Irritation
In all instances, the addition of the Pre-Vacuum Sterilization Cycles did not affect the pouch performance.
5.10 Conclusion
Based on the intended use, indications for use, technological characteristics, performance data and nonclinical tests performed, the subject device, the Safe Secure Sterilization Pouch with added pre-vacuum sterilization cycles is substantially equivalent and as safe and as effective as the legally marketed predicate devices, K112591, Safe Secure Sterilization pouch.
§ 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).