The Self Sealing Sterilization Pouches are intended to be used to enclose another medical devices 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.

The Self Sealing Sterilization Pouches are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels).

The intended sterilization cycles are listed below:

Prevacuum steam; 4 minutes at 132 ℃; 10 minute dry time.

Ethylene oxide: 1 hours at 55 ℃; relative humidity between 40%- 80%; 100% ethylene oxide at a concentration of 740 mg/L, 7 day aeration time at 20℃.

The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process.

The Self Sealing sterilization Pouches are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 540g or 1.19 lbs. The sterilization pouch maintains the enclosed devices up until 6 months post sterilization.

The pouches are available in the following sizes:

Model(s): 57 x 102mm, 57 x 130 mm, 70 x 255 mm, 83 x 165 mm, 13 x 191 mm, 133 x 279 mm, 133 x 290 mm, 140 x 280 mm, 140 x 330 mm, 190 x 330 mm, 190 x 360 mm, 255 x 380 mm, 279 x 406 mm, 300 x 400 mm, 300 x 474 mm, 305 x 457 mm;

Device Description

There are 18 models of the Self Sealing Sterilization Pouches in this application with different physical specification.

These pouches are made from a medical grade paper and plastic (CPP/PET) film that are heat sealed on three sides. The forth side has an adhesive strip that is used to seal the pouch. Release paper used in the pouch is a laminated sheet with composing structure of PE/paper/PE. It is a strip to cover the adhesive area and is released before seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam or ethylene oxide gas. The indicators printed on the medical grade paper will exhibit a color change (EtO- Pink to Yellow/Steam- Blue to Dark Green) after the pouch is exposed to steam or ethylene oxide gas. The validated maintenance of sterility period is 6 months.

AI/ML Overview

The provided text describes the acceptance criteria and study results for "Self Sealing Sterilization Pouches" (K162258). However, this document is a 510(k) summary for a medical device that is not an AI/ML device.

The questions you've asked are specifically geared towards the evaluation of AI/ML-driven medical devices, which typically involve performance metrics like sensitivity, specificity, AUC, and studies with human experts establishing ground truth, multi-reader multi-case studies, and details about training/test sets.

Since this device is a physical product (sterilization pouches), the information requested (e.g., number of experts for ground truth, sample size for training set, MRMC study effect size) is not applicable to this type of FDA submission.

Therefore, I cannot provide answers to your specific questions based on the provided document.

Instead, I can extract the acceptance criteria and the types of non-clinical tests performed, as this is relevant to the document you provided.

Acceptance Criteria and Device Performance (Non-AI/ML Device)

The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. The "acceptance criteria" are implied by the successful completion of these tests, demonstrating that the device meets relevant standards and performs as intended.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Test)	Reported Device Performance
Material Properties:
Tensile Properties (ASTM D638-14)	Met acceptance criteria (implied by "test results demonstrated that the subject device met the acceptance criteria")
Thickness Measurement (ASTM F2251-03)	Met acceptance criteria (implied)
Propagation Tear Resistance (ASTM D1922-03)	Met acceptance criteria (implied)
Air Permeance (ISO 5636-3:2013)	The maximum equivalent pore size diameter shall not exceed 50µm (listed as a similarity to predicate, implying conformity for the proposed device).
Internal Pressurization Failure Resistance (ASTM F1140/f1140M-13)	Met acceptance criteria (implied)
Sterilization & Barrier Integrity:
Microbial Ranking of Porous Packaging Materials (ASTM F1608-00)	Used ASTM 1608 method and met the acceptance criteria.
Sterilization Process Validation Test (EO and Steam)	Performed, implying successful validation.
Verification Test of Sterilization Process (EO and Steam)	Performed, implying successful verification.
Chemical Indicator Efficacy (ISO 11140-1:2009)	Changed color: EtO- Pink to Yellow; Steam- Blue to Dark Green (demonstrates functionality).
Material Compatibility (After sterilization)	Materials were not degraded.
Biocompatibility & Safety:
Ethylene Oxide Sterilization residuals (ISO 10993-7:2009)	Met acceptance criteria (implied)
In Vitro Cytotoxicity (ISO 10993-5:2009)	Met acceptance criteria (implied for ISO 10993-1, which covers part 5 and 10).
Irritation and Skin Sensitization (ISO 10993-10:2010)	Met acceptance criteria (implied for ISO 10993-1, which covers part 5 and 10).
Shelf Life & Sterility Maintenance:
Accelerated Aging (ASTM F1980-07) & Shelf Life Validation Test	Performed, validated shelf life performance as real-time aging method. Device maintains sterility for 6 months (longer than predicate's 90 days). Total shelf life is 2 years (longer than predicate's 18 months).
Detecting Seal Leaks (ASTM F1929-12)	Met acceptance criteria (implied)
Other Performance Characteristics:
Sterilization Cycles (Prevacuum steam; Ethylene oxide)	Specific parameters defined (Steam: 4 mins @ 132°C, 10 min dry time; EtO: 1 hr @ 55°C, 40-80% RH, 740 mg/L EtO, 7-day aeration @ 20°C).
Maximum wrapped package weight	540g or 1.19 lbs.
Maintenance of Sterility	Up to 6 months post-sterilization.
Drying Time (Post-steam)	10 minutes.
Aeration Time (Post-EtO)	7 days at 20°C.

Since the device is a physical sterilization pouch and not an AI/ML device, the following points are not applicable (N/A) based on the provided document:

Sample size used for the test set and the data provenance: N/A (No AI model, thus no "test set" in the AI sense. Testing was physical product testing to standards.)
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No "ground truth" establishment by experts in this context; performance assessed against physical standards and functional tests.)
Adjudication method: N/A (Not an AI-based diagnostic/screening device.)
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: N/A (Not an AI-based device for human readers.)
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (No algorithm.)
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A (Ground truth is based on physical/chemical testing standards and functional performance parameters, not clinical outcomes or expert consensus on interpretations.)
The sample size for the training set: N/A (No AI model, thus no "training set.")
How the ground truth for the training set was established: N/A (No AI model, thus no "training set.")

Summary

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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of three faces in profile, stacked on top of each other.

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

April 28, 2017

Tianchang Jiarui Packaging Material Co., Ltd. % Ray Wang General Manager Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, DaFangJu, No. 25 BanBiDian Rd., TongZhou District Beijing, 101121 CN

Re: K162258

Trade/Device Name: Self Sealing Sterilization Pouches Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG, JOJ Dated: March 8, 2017 Received: March 13, 2017

Dear Ray Wang:

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.

Michael J. Ryan -S

for 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K162258

Device Name

Self Sealing Sterilization Pouches

The Self Sealing Sterilization Pouches are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels).

The intended sterilization cvcles are listed below:

Prevacuum steam; 4 minutes at 132 ℃; 10 minute dry time.

Ethylene oxide: 1 hours at 55 ℃; relative humidity between 40%- 80%; 100% ethylene oxide at a concentration of 740 mg/L, 7 day aeration time at 20℃.

The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process.

The pouches are available in the following sizes:

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

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K162258

1. Date of Preparation: 2017-4-24
1. Sponsor Identification

Tianchang Jiarui Packaging Material Co., Ltd. Yeshan Industria Zone, Tianchang City, 239300, Anhui Province of China

Contact Person: Zhang Ruiqing Position: General Manager Tel: +86 550 7981778 Fax: +86 550 7323988 Email: sales@cncarate.com

Designated Submission Correspondent 3.
Mr. Ray Wang

Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd.,

LiYuan Town, TongZhou District, Beijing, 101121, China

Tel: +86-18910677558 Fax: +86-10-52214696 Email: ray.wang@believe-med.com

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4. Identification of Proposed Device

Trade Name: Self Sealing Sterilization Pouches Common Name: Sterilization Pouches

Model(s): 57 x 102mm, 57 x 130 mm, 70 x 255 mm, 83 x 165 mm, 90 x 260 mm, 133 x 191 mm, 133 x 279 mm, 133 x 290 mm, 140 x 280 mm, 140 x 330 mm, 190 x 330 mm, 190 x 360 mm, 255 x 380 mm, 279 x 406 mm, 300 x 400 mm, 300 x 474 mm, 305 x 457 mm;

Regulatory Information

Classification Name: Wrap, Sterilization/Indicator, Physical/Chemical Sterilization Process Classification: 2 Product Code: FRG/JOJ Regulation Number: 21 CFR 880.6850/ 21 CFR 880.2800 Review Panel: General Hospital

Intended Use Statement:

The Self Sealing Sterilization Pouches are intended to enclose another medical devices 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.

The Self Sealing Sterilization Pouches are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels).

The intended sterilization cycles are listed below:

Prevacuum steam; 4 minutes at 132 ℃; 10 minute dry time.

Ethylene oxide: 1 hours at 55 ℃; relative humidity between 40%- 80%; 100% ethylene oxide at a concentration of 740 mg/L, 7 day aeration time at 20℃.

The pouch's external chemical ink indicators are designed to the user that the pouch has undergone either a steam or EtO sterilization process.

Model(s): 57 x 102mm, 57 x 130 mm, 70 x 255 mm, 83 x 165 mm, 90 x 260 mm, 133 x 191 mm, 133 x 279 mm, 133 x 290 mm, 140 x 280 mm, 140 x 330 mm, 190 x 330 mm, 190 x 360 mm. 255 x 380 mm. 279 x 406 mm. 300 x 400 mm. 300 x 474 mm. 305 x 457 mm:

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Device Description

There are 18 models of the Self Sealing Sterilization Pouches in this application with different physical specification.

Identification of Predicate Device(s) న్.
Predicate Device

510(k) Number: K143637 Product Name: Winner Self Seal Sterilization Pouch Model Name: U&U Medical Technology Co., Ltd.

The comparison table is shown in subsection 8.

Non-Clinical Test Conclusion 6.
The proposed device

Non clinical tests were conducted to subject device. The test results demonstrated that the subject device met the acceptance criteria, and the conducted tests listed as below:

ISO 14937:2009 Sterilization of health care products General requirements or A characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical device
ASTM D638-14 Standard Test Method For Tensile Properties of Plastics;
ASTM F2251-03 Standard Test Method for thickness measurement of flexible packaging material;
ASTM D1922-03 Standard Test Method for Propagation tear resistance of plastic film and thin sheeting by pendulum method;
A ISO 5636-3:2013 Paper and board - Determination of air permeance (medium range) - Part 3: Bendtsen method;
A ASTM F1140/f1140M-13 Standard Test Methods for internal pressurization failure resistance of unrestrained package;
ASTM F1608-00 Standard test methods for Microbial Ranking of Porous packaging materials; >

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ISO 10993-7:2009 Biological Evaluation of Medical Device - Part 7: Ethylene Oxide Sterilization residuals:
ISO 11140-1:2009 Sterilization of Health Care Products - Chemical Indicators - Part 1: General Requirements;
ASTM F1980-07 Standard guide for accelerated aging of sterile barrier systems for medical device:
ASTM F1929-12 Standard test methods for detecting seal leaks in porous medical packaging by dye penetration.
ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity;
ISO 10993-10:2010 Biological Evaluation of Medical Devices – Part 10: Tests for irritation and skin sensitization;
Shelf Life Validation Test, validate the shelf life performance to the proposed device as real time aging method.
Sterilization Process Validation Test of Self Sealing Sterilization Pouch for EO and Steam sterilization process
Verification Test of Self Sealing Sterilization Pouch for EO and Steam Sterilization Process
Clinical Test Conclusion 7.

No clinical study is included in this submission.

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Substantially Equivalent (SE) Comparison 8.

ITEM	Proposed Device	Predicate Device	Remark
Indication For Use	The Self Sealing Sterilization Pouches are intended to be used to enclose another medical devices 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.The Self Sealing Sterilization Pouches are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels).The intended sterilization cycles are listed below:Prevacuum steam; 4 minutes at 132 °C; 10 minute dry time.Ethylene oxide: 1 hours at 55 °C; relative humidity between 40%- 80%; 100% ethylene oxide at a concentration of 740 mg/L, 7 day aeration time at 20°C.The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process.The Self Sealing sterilization Pouches are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 540g or 1.19 lbs. The sterilization pouch maintains the enclosed devices up until 6 months post sterilization.The pouches are available in the following sizes:Model(s): 57 x 102mm, 57 x 130 mm, 70	The U&U sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam and Ethylene Oxide (EtO).The recommended gravity steam sterilization cycle parameters are 30 minutes at 121 °C.The recommended EtO sterilization cycle is 4 hours at 55 °C with a relative humidity between 50%- 85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 90Days post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process.	Similar

Table 1 General Comparison

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	x 255 mm, 83 x 165 mm, 90 x 260 mm,133 x 191 mm, 133 x 279 mm, 133 x 290mm, 140 x 280 mm, 140 x 330 mm, 180 x330 mm, 190 x 330 mm, 190 x 360 mm,255 x 380 mm, 279 x 406 mm, 300 x 400mm, 300 x 474 mm, 305 x 457 mm;
MaterialCompostion	Top Web - Medical Porous PaperBottom Web - Medical Plastic film(CPP)Bottom Web - Medical two-sided adhesivetapeEtO gas indicator ink-Process IndicatorsSteam indicator ink-Process Indicators	Top Web - Medical Porous PaperBottom Web - Medical Plastic film(CPP)Bottom Web - Medical two-sided adhesivetapeEtO gas indicator ink-Process Indicatorsclass 1Steam indicator ink-Process Indicatorsclass 1	SE
SterilizationCycles	The recommended gravity steamsterilization cycle parameters isPrevacuum steam 4 minutes at 132 °C; 10minute dry time.The recommended EtO sterilization cycleis 1 hours at 55 °C; relative humiditybetween 40%-80%; 100% ethylene oxideat a concentration of 740 mg/L, 7 dayaeration time at 20°C.	The recommended gravity steamsterilization cycle parameters are 30minutes at 121 °C. Therecommended EtO sterilization cycle is 4hours at 55 °C with a relative humiditybetween 50%-85% and a sterilantconcentration of 600 mg/L.	Similar
Configuration/Dimension	Min. 57 x 102 mmMax. 305 x 457 mm	Width: ±0.1"" Length ± 0.2""	Similar
Air Permeance	The maximum equivalent pore sizediameter shall not exceed 50um.	The maximum equivalent pore sizediameter shall not exceed 50um.	Similar
Microbial BarrierProperties(PackagingIntegrity)	Use ASTM 1608 method, and met theacceptance criteria	Use ASTM 1608 method, and met theacceptance criteria	SE
MaterialCompatibility	After sterilization, the materials were notdegraded	After sterilization, the materials were notdegraded	SE
Biocompatibility	Meet ISO 10993-1	Meet ISO10993-1	SE
Maintenance ofSterility	6 months	90 Days	Similar
Shelf Life	2 years	18 months	Similar
Drying Time	10 minutes	25 minutes	Similar
Aeration Time	7 days at 20°C	8 hours at 60°C	Similar
ChemicalIndicator Efficacy	Changed color EtO- Pink to Yellow;Steam- Blue to Dark Green	Changed color EtO- YELLOW toCOCOA;Steam- GREEN to PURPLE	Similar

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Analysis for difference

The noted differences above do not change the intended use of the device or raise new safety and effectiveness concerns.

1. Substantially Equivalent (SE) Conclusion
  Based on the comparison and analysis above, the subject device is determined to be Substantially Equivalent (SE) to the predicate device.

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).