Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators Models: ABHSP, ABSSP, is intended to be used to enclose another medical device that is to be sterilized by a health provider by gravity steam and ethylene oxide (EtO). The recommended steam sterilization cycle parameters are 30 minutes at 121°C (250 °F). The recommended EtO gas sterilization cycle is 735mg/L of ethylene oxide (EtO) for 1 hour at 55℃ (130 ° F) and 50% to 80%RH. The pouch's external chemical ink indicators on the pouches are intended to demonstrate that the device has been exposed to the steam or EtO sterilization process and to distinguish between processed and unprocessed devices. The pouch is intended to allow sterilization of the enclosed medical device and also to maintain sterility (SAL=109) of the enclosed device until used.

Device Description

These pouches are manufactured from a medical grade paper and plastic film that is aged to are heat sealed on three sides. The fourth side has an addesive tape that is wed to seal the pouch or heat-seated by the heat-seel machine. The modical brade pager conforms to recognized material standards and can be steellized by steam or conforms fo recognized material starkers childreators has the same intended use, Essential Component, Raw material, Sterillzator method, manufacturing mellods and same technological characteristics as these predical testing of Substantial equivalent to the predicate device was established by physical testing of the medical grade paper (pressure drop vs. five and fifthelion officiency) and tilln (thickness, tensile strength and elongation) from non-stermanner of these linished ellygene oxice sterlilzed linished devices, as well as, performance diatribution for devices (seal strength, package burst, dye migralian cride sterfitzalion for steam and ethytene oxide sterlilzabions, ataam and ethylene oxide storibalion of shoum and einytene balde bennizators meet the performance requirements of ANSI/AAMMSO 11140-1:2005 standard entitled "Sterlizztion of health caro products-ANOMANICAL indications- Part 1: General requirements".

The pouches are manufactured from modical grade paper that is the fourth side an to laminated film on the left, right, and bottom of pouch. The fourth side has an edhealve tape that is used to that is used to see to see to section dealers. The pouches heat-seal machine prior to sterlization of the enclosed medical devices were processed contain extennal chemical indicators used to indicato the pouches were processed to via steam or EIO sterilization. See Chatper 10 for a detailed device description via steam or ENO sterility achievement and compatibility with stearn and EIO starilization processes and Bill of Materialis.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a medical device: "Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials with specific acceptance criteria in the way a new drug or high-risk device might.

Therefore, the study outlined here is a substantial equivalence comparison study against predicate devices, rather than a traditional efficacy study with AI components. The "acceptance criteria" are effectively demonstrating that the device performs similarly or identically to the predicate device across various parameters and meets relevant performance standards.

Here's an attempt to extract the information requested within the context of this 510(k) submission:

Acceptance Criteria and Reported Device Performance

The study aims to demonstrate substantial equivalence to predicate devices (Winner Medical USA, Inc. - K062704 and K051242). The "acceptance criteria" are implicitly met if the "Proposed Device" performs at least as well as, or comparably to, the "Predicate Device" in the specified tests and adheres to the relevant standards.

Acceptance Criteria (Demonstrates Substantial Equivalence via)	Reported Device Performance (Summary from Submission)
Sterilant Penetration	Demonstrated substantial equivalence to predicate devices.
Drying Time	Demonstrated substantial equivalence to predicate devices.
Aeration	Demonstrated substantial equivalence to predicate devices.
Biocompatibility	Demonstrated substantial equivalence to predicate devices.
Package Integrity	Demonstrated substantial equivalence to predicate devices.
Material Compatibility	Demonstrated substantial equivalence to predicate devices.
Sterility Maintenance	Demonstrated substantial equivalence to predicate devices.
Chemical Indicator Efficacy (meets ISO 11140-1:2005)	Meets the performance requirements of ANSI/AAMISO 11140-1:2005 standard.
Physical testing of medical grade paper (pressure drop vs. time, filtration efficiency)	Testing established substantial equivalence to the predicate device.
Physical testing of film (thickness, tensile strength, elongation)	Testing established substantial equivalence to the predicate device.
Performance distribution for finished devices (seal strength, package burst, dye migration)	Testing established substantial equivalence to the predicate device.
Sterilization performance (steam and ethylene oxide)	Testing established substantial equivalence to the predicate device; indicators meet performance requirements of ANSI/AAMISO 11140-1:2005.

Study Details

Sample size used for the test set and the data provenance:
- The document does not explicitly state numerical sample sizes for each test (e.g., how many pouches were tested for seal strength or sterilant penetration).
- The data provenance is not specified in terms of country of origin, but the testing was conducted to support a submission to the U.S. FDA (K112591), implying it adheres to U.S. regulatory standards.
- The study is retrospective in the sense that it's a series of laboratory and physical tests comparing a newly manufactured device to existing predicate devices and established standards. It's not a prospective clinical trial.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable in the context of this device and study type. "Ground truth" here refers to the objective measurements of physical properties, performance characteristics (e.g., sterilization indicator color change, seal strength), and adherence to recognized standards (like ISO 11140-1:2005). These are determined by established testing methodologies and equipment, not expert consensus in the same way an image diagnosis might be.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used for subjective assessments or when multiple human readers interpret data, which is not the case for material property or performance testing of a sterilization pouch.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, this is a physical medical device (sterilization pouch) and does not involve AI or human readers in an MRMC study context.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device does not involve an algorithm or AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is based on:
  - Objective physical measurements: (e.g., thickness, tensile strength, elongation of film; pressure drop, filtration efficiency of paper; seal strength, package burst, dye migration of pouches).
  - Standardized chemical indicator response: The indicator's color change proving exposure to sterilant, validated against the requirements of ANSI/AAMISO 11140-1:2005.
  - Material properties and performance parameters defined by recognized industry standards for sterilization packaging.
The sample size for the training set:
- This is not applicable as there is no "training set" in the machine learning sense. The device is a physical product, not an algorithm.
How the ground truth for the training set was established:
- Not applicable.

Summary

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K112591

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FEB - 7 2012

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PREMARKET NOTIFICATION

510(K) Summary

Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators Models: ABHSP,
Indication Pouch De Kanal) Sale Socure (Heat-seal and Self-seal)

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

Submitter's Identification:	Safe Secure Packaging (Shenzhen) Co., Ltd
Address:	Chengguang Industrial Park, No.4, Kukeng PoNew Village, Guanian Town, Baoan District,518110, Shenzhen City P.R.C.
Phone:	+86 755 27040468
Fax:	+86 755 27040488
Contact:	Mr. Garfield Wang
Email:	Wangxuebo_11@hotmail.com
Date	Dec. 01 2010
Device Name:	Safe Secure Sterilization Pouch with Steam and Ethylene Oxide ProcessIndicators Models: ABHSP, ABSSP. (Heat-seal and Self-seal).
Classification Name:	Pack, Sterilization Wrapper, Bag and Accessories
Classification:	Class II
Intended Use:	Safe Secure Sterilization Pouch with Steam and Ethylene Oxide ProcessIndicators Models: ABHSP, ABSSP, is intended to be used to encloseanother medical device that is to be sterilized by a health provider bygravity steam and ethylene oxide (EtO). The recommended steamsterilization cycle parameters are 30 minutes at 121° C (250 °F). Therecommended EtO gas sterilization cycle is 735mg/L of ethylene oxide(EtO) for 1 hour at 55°C (130 ° F) and 50% to 80%RH. The pouch'sexternal chemical ink indicators on the pouches are intended todemonstrate that the device has been exposed to the steam or EtO

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sterilization process and to distinguish between processed and otenized.
unprocessed devices. The pouch is intended to allow sterilization of the anproses .
enclosed medical device and also to maintain sterility (SAL=10+) of the enclosed device until used.

Predicate Device Information:

Company Name:	Winner Medical USA, Inc.
Address:	1900-H Proforma Ave. Ontario, CA 92861
510(k) number:	K062704
Device Name:	STERILIZATION POUCH WITH INDICATORS
Intended Use:	Sterilization Pouch with indicators is intended to be used to encloseanother medical device that is to be sterilized by a health provider bysteam 121oC for 15 minutes or ethylene oxide (EtO). It is intended toallow sterilization of the enclosed medical device and also to maintainsterility of the enclosed device until used.
Company Name:	Winner Medical USA, Inc.
Address:	1900-H Proforma Ave. Ontario, CA 92861
510(k) number:	K051242
Device Name:	WINNER SELF SEAL STERILIZATION POUCH
Intended Use:	Winner Self Seal Sterilization Pouches are intended to be used toenclose another medical device that is to be sterilized by a healthprovider by steam 121oC for 15 minutes or ethylene oxide (EtO). It isintended to allow sterilization of the enclosed medical device and also tomaintain sterility of the enclosed device until used.

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Device Description:

Ref Number	ModelNumber	Description	Dimensions	Packaging
ABHSP100001	ABHSP	Heat-SealSterilization Pouch	Length: 2"-20"Width: 3"-30"	400pcs/cs-6000pcs/cs
ABHSP100002	ABHSP	SterilizationTubing Pouch	Width: 2"-30"	/
ABSSP100001	ABSSP	Self-SealSterilization Pouch	Length: 2"-20"Width: 3"-30"	400pcs/cs-6000pcs/cs

Model numbers of the pouches:

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Device Comparison:

Side by side testing was conducted on the Safe Secure Sterilization Pouch with Side by side testing was conducted on the case of CH WITH INDICATORS,
Indicators and the WINNER STERILLATION POUCH WITH INDICATION Indicators and the WINNER OTERILIZATION POUCH to determine substantial WINNER SELF SEAL STERILIZATION POON to ation, Biocompatibility, Package
equivalence. Sterilant Penetration, Drying Time, Aeration, Biocompatibility, Package equivalence. Stemant Potitity, Sterility Maintenance, and Integrity, Material Compatibility, Stehlic Manterd ISO 11140-1:2005) were the
Chemical Indicator Efficacy (recognized standard ISO 11140-1:2005) were the Chemical Indicator Efficacy (recognized standard 10 - 11 million in the safety and efficacy of the device.

Proposed Labeling:

A comparison with the predicate labeling confirms our claim of substantial equivalence with the predicate.

Conclusion:

Conclusion:
The materials, performance, and functions of both the submitted device and the The materials, performance, and functions of are safe and effective for their predicate devices are substantially equivalorit and are and produced by the manufacturer.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community or interconnectedness. The design is simple and iconic, conveying the department's focus on health and human well-being.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Safe Secure Packaging Company, Limited C/O Ms. Paula Wilkerson Responsible Third Party Official Intertek Testing Services 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

FEB - 7 2012

Re: K112591

Trade/Device Name: Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators Models: ABHSP, ABSSP Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: January 23, 2012 Received: January 24, 2012

Dear Ms. Wilkerson:

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.

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Page 2 - Ms. Wilkerson

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for Anthony D. Watson

Anthony D. Watson, B.S., M.S., M.B.A. . Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): K112591

Device Name: Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators Models: ABHSP. ABSSP.

Indications For Use:

Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators Models: ABHSP, ABSSP, is intended to be used to enclose another medical device that is to be sterilized by a health provider by gravity steam and ethylene oxide (EtO). The recommended steam sterilization cycle parameters are 30 minutes at 121°C (250 °F). The recommended EtO gas sterilization cycle is 735mg/L of ethylene oxide (EtO) for 1 hour at 55℃ (130 ° F) and 50% to The pouch's external chemical ink indicators on the pouches are intended to 80%RH. demonstrate that the device has been exposed to the steam or EtO sterilization process and to distinguish between processed and unprocessed devices. The pouch is intended to allow sterilization of the enclosed medical device and also to maintain sterility (SAL=109) of the enclosed device until used.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Edith S. Clainin-Wall

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 1 of 1

510(k) Number:	K112591
----------------	---------

Regulation Number and Section

§ 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).