The Disposable Medical Device Self-seal Sterilization Pouch are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam autoclaves.

The intended sterilization cycles are listed below: Prevacuum steam: 4 minutes at 134 ℃; 10 minute dry time.

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

The Disposable Medical Device Self-seal Sterilization Pouch are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 1600g of metal instruments.

The Disposable Medical Device Sterilization Reel Pouch are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam autoclaves.

The intended sterilization cycles are listed below: Prevacuum steam; 4 minutes at 134 ℃; 10 minute dry time.

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

Device Description

There are 2 models of the Sterilization Pouches in this application with different physical specification. The Disposable Medical Device Seff-seal Sterilization Pouch is made from a medical grade plastic film that is heat sealed on three sides. The forth side has an adhesive strip that is used to seal the pouch. 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 Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam.

The Disposable Medical Device Sterilization Reel Pouch are made from a medical grade paper and plastic (PP/PET) film that are heat sealed on opposite two sides. It will be cut to suitable length and the opened sides will be heat-sealed. The Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device, which is an application to demonstrate substantial equivalence to an existing legally marketed device. It describes the device, its intended use, and the non-clinical tests conducted. However, it does not detail specific acceptance criteria for a study in the way one might expect for a clinical trial or a performance study with numerical thresholds.

Instead, the document primarily focuses on verifying that the proposed device (Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch) meets design specifications and complies with recognized standards and validation tests. The "acceptance criteria" can be inferred from the successful completion of these tests as per the relevant standards.

Here's an attempt to extract the requested information, acknowledging that the document doesn't explicitly present acceptance criteria and reported performance in a table format for a single study, but rather refers to various validation methods.

Acceptance Criteria and Device Performance for Disposable Medical Device Self-seal Sterilization Pouch and Disposable Medical Device Sterilization Reel Pouch

The device's performance is demonstrated through non-clinical testing against various international and ASTM standards. The acceptance criteria are implicit in the successful fulfillment of these standards and validation tests.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from standards and test objectives)	Reported Device Performance
Internal Pressurization Failure Resistance (ASTM F1140/f1140M-13): The package must resist internal pressure without failure.	"Non clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with... ASTM F1140/f1140M-13 Standard Test Methods for internal pressurization failure resistance of unrestrained package." (Implies successful resistance to pressure).
Microbial Ranking of Porous Packaging Materials (ASTM F1608-00): The material must demonstrate microbial barrier properties sufficient for sterilization.	"The test results demonstrated that the proposed device complies with... ASTM F1608-00 Standard test methods for Microbial Ranking of Porous packaging materials." (Implies successful demonstration of microbial barrier).
Chemical Indicators - General Requirements (ISO 11140-1:2009): The external chemical ink indicators must exhibit the specified color change after sterilization.	"The test results demonstrated that the proposed device complies with... ISO 11140-1:2009 Sterilization of Health Care Products – Chemical Indicators – Part 1: General Requirements." Chemical Indicator Efficacy: "Steam Sterilization Indicating Ink Initial Color: Blue -> Signal Color: Ash Black" (Implies successful color change as per standard).
Accelerated Aging of Sterile Barrier Systems (ASTM F1980-07): The device must maintain integrity and function after accelerated aging equivalent to its shelf life.	"The test results demonstrated that the proposed device complies with... ASTM F1980-07 Standard guide for accelerated aging of sterile barrier systems for medical device." Shelf Life: 2 years (validated via accelerated aging).
Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration (ASTM F1929-12): The seals must be free of leaks.	"The test results demonstrated that the proposed device complies with... ASTM F1929-12 Standard test methods for detecting seal leaks in porous medical packaging by dye penetration." (Implies no detectable leaks).
Cytotoxicity (ISO 10993-5:2009): The device must not exhibit cytotoxicity.	"The test results demonstrated that the proposed device complies with... ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity." (Implies acceptable biocompatibility in terms of cytotoxicity).
Irritation and Skin Sensitization (ISO 10993-10:2010): The device must not cause irritation or skin sensitization.	"The test results demonstrated that the proposed device complies with... ISO 10993-10:2010 Biological Evaluation of Medical Devices – Part 10: Tests for irritation and skin sensitization." (Implies acceptable biocompatibility in terms of irritation and sensitization).
Shelf Life Validation (Real-time aging method): The device must perform as intended for its specified shelf life.	"Shelf Life Validation Test, validate the shelf life performance to the proposed device as real time aging method." Maintenance of Sterility: 6 months Shelf Life: 2 years (Supported by real-time aging).
Steam Sterilization Process Validation (Half cycle overkill & Full cycle dry time): - Half cycle overkill: No microbiological growth after half-cycle sterilization. - Dry time validation: Samples free of visible moisture with no significant weight gain after full cycle sterilization and specified dry time.	"Half cycle overkill validation of the claimed steam sterilization cycle: Challenge loads consisted of scalers, hemostatic forceps and tooth probes. No cavities or complex devices. All loads showed no growth at 1/2 cycle." "Dry time validation: Full cycle sterilization testing showed samples to be free of visible moisture with no signification weight gain following sterilization and stated dry time." (Both criteria were met).
Material Compatibility: Materials must not degrade after sterilization.	"After sterilization, the materials were not degraded." (Reported as met for the proposed device, predicate, and reference devices).

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes for each non-clinical test. It lists the standards and types of validation performed. The data provenance is not specified beyond the tests being conducted for submission to the U.S. FDA, likely implying internal company testing or testing by certified labs for the manufacturer (Weihai Xingtai Packaging Products Co., Ltd. from China). The tests are retrospective in the sense that they were performed on manufactured devices to demonstrate compliance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This device is a sterilization packaging material, and its performance is evaluated against engineering, material, microbiological, and chemical standards, not by human interpretation of medical images or diagnoses. Ground truth is established by the specified test methods and criteria within the aforementioned standards.

4. Adjudication Method for the Test Set

Not applicable for this type of non-clinical testing. The outcomes of the tests are objective measurements and observations (e.g., color change, absence of microbial growth, resistance to pressure, absence of leaks, material integrity).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a Class II medical device (sterilization wrap) and the validation is based on non-clinical performance standards. MRMC studies are typically for diagnostic imaging devices where human reader performance is a key metric.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

This concept is not directly applicable. The device itself is not an algorithm. Its performance is inherent in its physical and chemical properties when subjected to sterilization processes. The "standalone" performance here refers to the device's ability to meet its functional requirements (e.g., maintain sterility, indicate sterilization) independent of human variability in the use of the device, assuming proper handling and sterilization procedures are followed. The non-clinical tests validate these inherent properties.

7. Type of Ground Truth Used

The ground truth used for evaluating this device's performance is based on established scientific and engineering standards and validation protocols. This includes:

Physical measurements (e.g., pressure resistance, seal integrity).
Microbiological challenge testing (e.g., absence of growth).
Chemical reactions (e.g., specific color change of indicators).
Biocompatibility assessments (e.g., cytotoxicity, irritation).
Material science evaluations (e.g., material degradation, aging).

8. Sample Size for the Training Set

Not applicable. The device is not an AI/ML algorithm that requires a training set. The "training" for this device comes from its design and manufacturing process, optimized to meet the performance standards.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" below it.

August 19, 2019

Weihai Xingtai Packaging Products Co.,Ltd. % Ray Wang Official Correspondent Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd. FangShan District Beijing, 102401 Cn

Re: K183356

Trade/Device Name: Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch

Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: July 18, 2019 Received: July 22, 2019

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. 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 located 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.

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality 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) K183356

Device Name

Disposable Medical Device Self-seal Sterilization Pouch,Disposable Medical Device Sterilization Reel Pouch

Indications for Use (Describe)

Disposable Medical Device Self-seal Sterilization Pouch

The Disposable Medical Device Self-seal Sterilization Pouch are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam autoclaves.

The intended sterilization cycles are listed below: Prevacuum steam: 4 minutes at 134 ℃; 10 minute dry time.

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

Model(s):

57mm×102mm×130mm×130mm×230mm 83mm×165mm 90mm×260mm 133mm×191mm 133mm×279mm 133mm×290mm 140mm×280mm 140mm×330mm 190mm×330mm 190mm×360mm 255mm×380mm 279mm×406mm 300mm×400mm 300mm×474mm 305mm×455mm

Disposable Medical Device Sterilization Reel Pouch

The Disposable Medical Device Sterilization Reel Pouch are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam autoclaves.

The intended sterilization cycles are listed below: Prevacuum steam; 4 minutes at 134 ℃; 10 minute dry time.

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

Model(s):

100mm×100m 150mm×100m 250mm×100m 300mm×100m 350mm×100m 400mm×100m 50mm×200m 55mm×200m ×200m ×200m 75mm×200m 125mm×200m 150mm×200m 200mm×200m 225mm×200m 250mm×200m 300mm×200m 350mm×200m 400mm×200m

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Type of Use (Select one or both, as applicable)

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

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510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR

Section 807.92.

The assigned 510(k) Number: K183356

1. Date of Preparation: 08/01/2019
1. Sponsor Identification Weihai Xingtai Packaging Products Co., Ltd. Sunjiatan Industrial Zone, Yangting Town, Huancui area, Weihai, Shandong, People's Republic of China Contact Person: Miao Qifen Position:Quality Manager

Tel: +86 631 5674466 Fax: +86 631 5674466 Email: 834166004@qq.com

1. Designated Submission Correspondent
  Mr. Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, BeiJing, China 102401

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

4. Identification of Proposed Device

Trade Name: Disposable Medical Device Self-seal Sterilization Pouch,Disposable Medical Device Sterilization Reel Pouch

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

Predicate devices: 510(k) Number: K162258 Device Name: Self Sealing Sterilization Pouches (primary predicate) 510(k) Number: K102158 Device Name: SIGMA Sterilization Pouch and Roll

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5. Device Description

The design information as mentioned in this section is to provide the clear description for the devices included in the 510(k) submission. Basically the information was provided according to the FDA guidance Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA.

Disposable Medical Device Self-seal Sterilization Pouch Model(s):

57mm×102mm	57mm×130mm	70mm×230mm	83mm×165mm	90mm×260mm
133mm×279mm	133mm×290mm	140mm×280mm	140mm×330mm	180mm×330mm
190mm×330mm	190mm×360mm	255mm×380mm	279mm×406mm	300mm×400mm
300mm×474mm	305mm×455mm

Disposable Medical Device Sterilization Reel Pouch Model(s):

150mm×100m 200mm×100m 250mm×100m 
                                              300mm×100m 350mm× 100m
100mm×100m
400mm×100m
            50mm×200m
                        55mm×200m
                                   60mm×200m
                                               75mm×200m 100mm×200m
125mm×200m
           150mm×200m 200mm×200m 225mm×200m
                                               250mm×200m
300mm×200m
            350mm×200m 400mm×200m

Intended Use Statement:

Disposable Medical Device Self-seal Sterilization Pouch

The Disposable Medical Device Self-seal Sterilization Pouch is intended to provide healthcare workers with an effective method to enclose devices intended for sterilization in steam autoclaves.

The intended sterilization cycle is listed below: Prevacuum steam; 4 minutes at 134℃; 10 minute dry time.

The pouch's external chemical ink indicator is designed to the user that the pouch has undergone a steam sterilization process.

The Disposable Medical Device Self-seal Sterilization Pouch is not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 1600g of metal instruments.

Disposable Medical Device Sterilization Reel Pouch The Disposable Medical Device Sterilization Reel Pouch is intended to provide health care

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workers with an effective method to enclose devices intended for sterilization in steam autoclaves.

The intended sterilization cycle is listed below: Prevacuum steam; 4 minutes at 134℃; 10 minute dry time.

The pouch's external chemical ink indicator is designed to indicate to the user that the pouch has undergone a steam sterilization process.

Technological Characteristics 6.

Predicate Device - 510(k) Number: K162258 Device Name: Self Sealing Sterilization Pouches
Reference Device - 510(k) Number: K102158 Device Name: SIGMA Sterilization Pouch and Roll

Proposed Device: K183356	Predicate Device: K162258	Reference Device: K102158
Indication For Use
Disposable Medical Device Self-sealSterilization PouchThe Disposable Medical Device Self-seal Sterilization Pouch are intended toprovide health care workers with aneffective method to enclose devicesintended for sterilization in steam autoclaves.The intended sterilization cycles are listedbelow:Prevacuum steam; 4 minutes at 134 °C; 10minute dry time.The pouch's external chemical inkindicators are designed to indicate to theuser that the pouch has undergoneeither a steam sterilization process.	The Self Sealing Sterilization Pouches areintended to be used to enclose anothermedical devices that is to be sterilized by ahealth care provider. It is intended to allowsterilization of the enclosed medical deviceand also to maintain sterility of the encloseddevice until used.The Self Sealing Sterilization Pouches areintended for sterilization of dentalinstruments, excluding complex devices(endoscopes and instruments withlumen/channels).The intended sterilization cycles are listedbelow:Prevacuum steam; 4 minutes at 132 °C; 10minute dry time.Ethylene oxide: 1 hours at 55 °C; relativehumidity between 40%- 80%; 100%ethylene oxide at a concentration of 740mg/L, 7 day aeration time at 20°C.The pouch's external chemical ink	The SIGMA sterilization pouch and rollare intended to provide health careworkers with an effective method toenclose devices intended for sterilizationin steam auto claves and via EthyleneOxide (EO). The recommended steamsterilization cycle parameters are 30minutes at 121 °C.The recommended EO sterilization cycleis 4 hours at 55 °C with a relativehumidity between 50%-85% and asterilant concentration of 600 mg/L.Furthermore, the sterilization pouch androll maintains the enclosed devices upuntil 3 years post sterilization. Lastly,the pouch's external chemical inkindicators are designed to indicate to theuser that the pouch has undergone eithera steam or EO sterilization process.
Disposable Medical Device SterilizationReel PouchThe Disposable Medical Device SterilizationReel Pouch are intended to provide healthcare workers with an effective method toenclose devices intended for sterilization in

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steam auto claves.The Disposable Medical Device SterilizationReel Pouch is intended for sterilization ofdental instruments, excluding complexdevices (endoscopes and instruments withlumen/channels). The intended sterilizationcycles are listed below:Prevacuum steam; 4 minutes at 134 °C; 10minute dry time.The pouch's external chemical ink indicatorsare designed to indicate to the user that thepouch has undergone either a steamsterilization process

indicators are designed to indicate to theuser that the pouch has undergone either asteam or EtO sterilization process. TheSelf Sealing sterilization Pouches are notcomplex device. The maximum wrappedpackage weight for each pouch is 540g or1.19 lbs.The sterilization pouch maintains theenclosed devices up until 6 months poststerilization.

Technical Characteristics
ITEM	Proposed Device: K183356	Predicate Device: K162258	Reference Device: K102158
MaterialComposition	Top Web - Medical PorousPaper Bottom Web - MedicalPlastic film(PP) Steamindicator ink-Process Indicators	Top Web - Medical PorousPaper Bottom Web - MedicalPlastic film(CPP) EtO gasindicator ink-Process IndicatorsSteam indicator ink-ProcessIndicators	Self-sealing sterilizationpouches: These pouches aremade from a medical gradeplastic film that is heat sealedon three side. The forth side hasan adhesive strip that is used toseal the pouch .Release paperused in the pouch is laminatedsheet with composing structureof PE/paper/ PE.it is a strip tocover the adhesive area and isrelease before seal the pouch.The medical grade paperconforms to recognizedmaterial standards and can besterilized by steam or EO gas.The process indicator INKprinted on the medical gradepaper will exhibit a colorchange after the pouch isexposed to steam or EO gas
SterilizationCycles	Prevacuum steam; 4 minutes at134 °C; 10 minute dry time.	Prevacuum steam; 4 minutes at132 °C; 10 minute dry time.Ethylene oxide: 1 hours at 55 °C;relative humidity between 40%-80%; 100% ethylene oxide at aconcentration of 740 mg/L, 7day aeration time at 20°C.	The recommended steamsterilization cycle parametersare 30 minutes at 121°C. Therecommended EO sterilizationcycle is 4 hours at 55 t with arelative humidity between50-85% and a sterilantconcentration of 600 mg/L
Configuration/Dimension	Various Sizes	Various Sizes	Various Sizes
Air Permeance	The maximum equivalent poresize diameter shall not exceed50um	The maximum equivalent poresize diameter shall not exceed50um	NA
MaterialCompatibility	After sterilization, the materialswere not degraded	After sterilization, the materialswere not degraded	After sterilization, the materialswere not degraded

Technical Characteristics

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ITEM	Proposed Device: K183356	Predicate Device: K162258	Reference Device: K102158
Maintenance ofSterility	6 months	6 months	1 year
Shelf Life	2 years	2 years	3 years
Drying Time	10 minutes	10 minutes	30 minute
ChemicalIndicatorEfficacy	Steam SterilizationIndicating Ink Initial Color:Blue -> Signal Color: AshBlack	Changed color EtO- Pink toYellow;Steam- Blue to black	Changed color EtO- Yellow;Steam- Black

7. Non-Clinical Testing

Non clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:

A ~ASTM F1140/f1140M-13 Standard Test Methods for internal pressurization failure resistance of unrestrained package;
A ASTM F1608-00 Standard test methods for Microbial Ranking of Porous packaging materials;
ISO 11140-1:2009 Sterilization of Health Care Products – Chemical Indicators – Part 1: General Requirements;
A ASTM F1980-07 Standard guide for accelerated aging of sterile barrier systems for medical device;
A ASTM F1929-12 Standard test methods for detecting seal leaks in porous medical packaging by dye penetration.
A 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.
Steam Sterilization Process Validation and Sterilization test report: A
- . Half cycle overkill validation of the claimed steam sterilization cvcle: Challenge loads consisted of scalers, hemostatic forceps and tooth probes. No cavities or complex devices. All loads showed no growth at 1/2 cycle.
- Dry time validation: Full cycle sterilization testing showed samples to be free of visible moisture with no signification weight gain following sterilization and stated dry time.
1. Clinical Testing:

No clinical study is included in this submission.

9. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the Disposable Medical Device Self-seal Sterilization Pouch,Disposable Medical Device Sterilization Reel Pouch is as safe, as effective, and performs as well as or better than the legally marketed 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).