Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator are intended to be used to enclose medical devices that are to be terminally sterilized in the STERRAD® Sterilization Systems and Cycles, in a single or double pouch configuration, and to indicate, by color change, that the pouch has been exposed to sterilant. After completion of the sterilization process, the pouch/roll maintains sterility until the pouch/roll is used; in the United States, this is for a period of 30 days.

The STERRAD® Sterilization Systems and Cycles that can be used are shown in Table 1. The product codes for all Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator are listed in Table 2.

The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to yellow (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® Sterilization Systems.

Device Description

The proposed pouches are constructed from Tyvek® / plastic films, with the STERRAD® Chemical Indicator printed onto the Tyvek® film. The self-seal pouch permits sealing of the pouch without need of heat-sealing equipment, while the heat sealed pouches and rolls are heat sealed prior to processing in the STERRAD® Sterilization Systems.

The STERRAD® Chemical Indicator offers an additional way to verify processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. STERRAD® Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the hydrogen peroxide. The color of the Chemical Indicator changes from red to yellow (or lighter) when exposed to hydrogen peroxide.

AI/ML Overview

The document provided describes a medical device, the "Tyvek® Pouch/Roll with STERRAD® Chemical Indicator," and its performance testing in comparison to a predicate device. This is a 510(k) premarket notification, which demonstrates substantial equivalence to a legally marketed predicate device, rather than providing extensive de novo clinical trial data as would be expected for novel devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Type	Acceptance Criteria (Implied / Stated)	Reported Device Performance
Sterilant Penetration	- Sterilant penetrates through a "double pouch" configuration under worst-case half-cycle conditions. - A sterility assurance level (SAL) of 10$^{-6}$ is demonstrated. - Sterilant affects Chemical Indicator (CI) color change to endpoint (red to yellow or lighter) under suboptimal conditions.	Passed
Chemical Indicator (CI) Functionality and Endpoint	CI changes from red to yellow (or lighter) when exposed to hydrogen peroxide vapor during processing. The endpoint color is consistent with being processed.	Passed (Explicitly stated CI function in description and endpoint color stability in separate study)
Package Integrity: Seal Strength	Seal strength performance characteristics are maintained for manufactured seal and user-made seal after STERRAD® processing.	Passed
Package Integrity: Microbial Barrier	Contents of pouches are sterile when processed pouches are subjected to the microbial aerosol challenge test.	Passed
Package Integrity: Burst	Ability to withstand internal pressurization is maintained after STERRAD® processing.	Passed
Package Integrity: Peel Open	Peel open characteristics of the Tyvek® Pouch/Roll are maintained after STERRAD® processing.	Passed
Maintenance of Package Integrity	Sterility is maintained in the Tyvek® Pouches/Rolls for 30 days after STERRAD® processing.	Passed
Material Compatibility	Seal strength, microbial barrier properties, burst, and peel open characteristics are maintained after STERRAD® processing. (Tested to demonstrate material compatibility).	Passed
End Point / Post Processing Color Stability	Tyvek® Pouches/Rolls, after STERRAD® processing, maintain the endpoint CI color reaction.	Passed
Shelf Life: CI Functionality	CI functionality (color change from red to yellow or lighter) of processed Tyvek® Pouches/Rolls is verified at the end of shelf life.	Passed
Shelf Life: Seal Strength	Seal strength of the processed Tyvek® Pouches/Rolls is verified at the end of shelf life.	Passed
Biocompatibility	Pouch samples, after STERRAD® processing, meet acceptance criteria per ISO 10993-11 (Systemic Toxicity) and 10993-10 (Irritation and Skin Sensitization) (Implied acceptance criteria from ISO standards).	Passed

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

The document provides a summary of "nonclinical tests." While it lists various performance studies, it does not specify the sample sizes used for the test sets in these studies. The provenance of the data (e.g., country of origin, retrospective or prospective) is also not explicitly stated, but since it's for a US FDA submission, it's presumed to be relevant to US regulatory standards. These are laboratory/engineering tests, not clinical studies with patients.

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

Since this involves chemical indicators and package integrity tests, the "ground truth" is established by the physical and chemical properties of the materials and the functionality of the device under test conditions, as measured by established laboratory methods. There is no mention of "experts" in the context of human interpretation or ground truth establishment for these types of performance tests, as one might find in an imaging AI study.

4. Adjudication Method for the Test Set

As the "ground truth" is determined by objective physical and chemical tests (e.g., color change, sterility assurance level, seal strength measurements), no adjudication method involving human interpretation (like 2+1 or 3+1 consensus) is applicable or mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study was mentioned or performed. This device is a sterilization packaging system with a chemical indicator, not an AI-assisted diagnostic tool that would typically involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable as the device is a physical product (pouch/roll with a chemical indicator), not an algorithm or software. The "performance" of the device itself (e.g., its color change, seal integrity) is what was tested.

7. The Type of Ground Truth Used

The ground truth for these tests is based on:

Physical and Chemical Measurement Standards: Such as predefined sterilant concentrations, specific temperature/pressure conditions in sterilizers, and objective color change definitions for the chemical indicator.
Microbiological Standards: Demonstrated sterility assurance level (SAL) of 10$^{-6}$.
Mechanical Property Standards: For seal strength, burst, and peel-open tests (e.g., ISO or ASTM standards, though not explicitly cited beyond ISO 11140-1:2005 for the CI).
Biocompatibility Standards: ISO 10993-10 and ISO 10993-11 for biological responses.

8. The Sample Size for the Training Set

This device does not involve machine learning or AI, so there is no concept of a "training set."

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

Since there is no training set, this question is not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized emblem featuring three profiles facing to the right, resembling a bird or a symbol of human connection.

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

December 19,2014

Advanced Sterilization Products % Sun Choi Regulatory Affairs Specialist 33 Technology Dr. Irvine, California 92618

Re: K141693

Trade/Device Name: Tyvek® Pouch/Roll with STERRAD® Chemical Indicator Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG, JOJ Dated: November 20, 2014 Received: November 21, 2014

Dear Sun Choi,

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 Runno DDS, MA

Erin Keith, MS 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) K141693

Device Name

Tyvek® Pouch/Roll with STERRAD® Chemical Indicator

Indications for Use (Describe) (Page 1 of 2)

Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator are intended to be used to enclose medical devices that are to be terminally sterilized in the STERRAD® Systems and Cycles, in a single or double pouch configuration, and to indicate, by color change, that the pouch has been exposed to sterilization process, the pouch roll maintains sterility until the pouch/roll is used; in the United States, this is for a period of 30 days.

The STERRAD® Sterilization Systems and Cycles that can be used are shown in Table 1. The product codes for all Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator are listed in Table 2.

STERRAD® / Cycle	Single-channel stainless steel lumens	Other lumens	Load requirements
STERRAD® 100S	≥1 mm ID x ≤125 mm long≥2 mm ID x ≤250 mm long≥3 mm ID x ≤400 mm long	Metal and nonmetal≥6 mm ID x ≤310 mmlong	≤10 lumens per load
STERRAD® 50	≥1 mm ID x ≤125 mm long≥2 mm ID x ≤250 mm long≥3 mm ID x ≤400 mm long	Metal and nonmetal≥6 mm ID x ≤310 mmlong	≤10 lumens per load
STERRAD® 200	≥1 mm ID x ≤125 mm long≥2 mm ID x ≤250 mm long≥3 mm ID x ≤400 mm long	Teflon® andpolyethylene≥6 mm ID x ≤310 mmlong	≤12 lumens per load≤36.48 lbs

Table 1: Indications for Use

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Indications for Use

510(k) Number (if known) K141693

Device Name

Tyvek® Pouch/Roll with STERRAD® Chemical Indicator

Indications for Use (Describe) (Page 2 of 2)

Table 1: Indications for Use (continued)

	STERRAD® / Cycle	Single-channel stainlesssteel lumens	Other lumens	Load requirements
STERRAD®NX®	Standard	≥1 mm ID x ≤150 mm long≥2 mm ID x ≤400 mm long	N/A	≤10 lumens per load≤10.7 lbs
	Advanced	≥1 mm ID x ≤500 mm long	N/A	≤10 lumens per load≤10.7 lbs
STERRAD®100NX®	Standard	≥0.7 mm ID x ≤500 mm long	N/A	≤10 lumens per load≤21.4 lbs
	EXPRESS	N/A	N/A	≤10.7 lbs on bottomshelf only
	DUO	N/A	N/A	Accessory devices(e.g., cameras andlight cords) only2 cameras maximum

Table 2: Product Codes for Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator

Product Type	Product Codes
Tyvek® Self-Seal Pouches withSTERRAD® Chemical Indicator (123XX)	12320, 12326, 12335, 12332, 12342, 12340,12348, 12356
Tyvek® Rolls with STERRAD® ChemicalIndicator (124XX)	12407, 12410, 12415, 12420, 12425, 12435,12442, 12450
Tyvek® Heat-Seal Pouches withSTERRAD® Chemical Indicator (125XX)	12521, 12526, 12532, 12541, 12548

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

| Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

Applicant's Name, Address, Telephone, FAX, Contact Person

Advanced Sterilization Products 33 Technology Drive Irvine, CA 92618

Establishment Registration Number: 2084725

Contact Person

Sun Choi Regulatory Affairs Specialist IV Email: sjchoi@its.jnj.com (949) 453-6378 (Telephone) (949) 789-3900 (Fax)

Date: December 19, 2014

1. CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

Classification Name:	Sterilization WrapSterilization Process Indicator
Common/Usual Name:	Sterilization Pouch / Roll with Chemical Indicator
Product Classification:	Class II
Product Code:	FRG / JOJ
Panel:	General Hospital
Classification Regulation:	21 CFR 880.685021 CFR 880.2800
Proprietary Name:	Tyvek® Pouch/Roll with STERRAD® Chemical Indicator

2. PREDICATE DEVICES

The predicate device [510(k) Notification K112087, cleared October 15, 2012] is the Tyvek® Pouch/Roll with STERRAD® Chemical Indicator, for use in the STERRAD® 100NX® Sterilizer.

3. INTENDED USE

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The STERRAD® Sterilization Systems and Cycles that can be used are shown in Table 1. The product codes for all Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator are listed in Table 2.

	STERRAD® / Cycle	Single-channel stainlesssteel lumens	Other lumens	Load requirements
	STERRAD® 100S	≥1 mm ID x ≤125 mm long≥2 mm ID x ≤250 mm long≥3 mm ID x ≤400 mm long	Metal and nonmetal≥6 mm ID x ≤310 mmlong	<10 lumens per load
	STERRAD® 50	≥1 mm ID x ≤125 mm long>2 mm ID x <250 mm long≥3 mm ID x <400 mm long	Metal and nonmetal≥6 mm ID x ≤310 mmlong	<10 lumens per load
	STERRAD® 200	≥1 mm ID x ≤125 mm long≥2 mm ID x ≤250 mm long≥3 mm ID x ≤400 mm long	Teflon® andpolyethylene≥6 mm ID x ≤310 mmlong	<12 lumens per load<36.48 lbs
	Standard	≥1 mm ID x ≤150 mm long≥2 mm ID x ≤400 mm long	N/A	<10 lumens per load<10.7 lbs
STERRAD®NX®	Advanced	≥1 mm ID x ≤500 mm long	N/A	<10 lumens per load<10.7 lbs
	Standard	≥0.7 mm ID x ≤500 mm long	N/A	<10 lumens per load<21.4 lbs
STERRAD®100NX®	EXPRESS	N/A	N/A	<10.7 lbs on bottomshelf only
	DUO	N/A	N/A	Accessory devices(e.g., cameras andlight cords) only2 cameras maximum

Table 1: Indications for Use

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Product Type	Product Codes
Tyvek® Self-Seal Pouches withSTERRAD® Chemical Indicator (123XX)	12320, 12326, 12335, 12332, 12342, 12340,12348, 12356
Tyvek® Rolls with STERRAD® ChemicalIndicator (124XX)	12407, 12410, 12415, 12420, 12425, 12435,12442, 12450
Tyvek® Heat-Seal Pouches withSTERRAD® Chemical Indicator (125XX)	12521, 12526, 12532, 12541, 12548

Table 2: Product Codes for Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator

4. DESCRIPTION OF DEVICE

	Proposed Device:Tyvek® Pouch/Roll withSTERRAD® ChemicalIndicator	Predicate Device: Tyvek®Pouch/Roll with STERRAD®Chemical Indicator(K112087)	Comparison
	Intended Use	The Tyvek® Pouch/Roll withSTERRAD® ChemicalIndicator is intended to enclosea medical device that is to besterilized in the STERRAD®Sterilization System, and toshow that the pouch/roll hasbeen exposed to hydrogenperoxide during the sterilizationprocess.	The Tyvek® Pouch/Roll withSTERRAD® ChemicalIndicator is intended to enclosea medical device that is to besterilized in the STERRAD®Sterilization System, and toshow that the pouch/roll hasbeen exposed to hydrogenperoxide during the sterilizationprocess.	Same
		Proposed Device:Tyvek® Pouch/Roll withSTERRAD® ChemicalIndicator	Predicate Device: Tyvek®Pouch/Roll with STERRAD®Chemical Indicator(K112087)	Comparison
	Indicationsfor Use	Tyvek® Pouches and Rolls withSTERRAD® ChemicalIndicator are intended to beused to enclose medical devicesthat are to be terminallysterilized in the STERRAD®Sterilization Systems andCycles, in a single or doublepouch configuration, and toindicate, by color change, thatthe pouch has been exposed tosterilant. After completion ofthe sterilization process, thepouch/roll maintains sterilityuntil the pouch/roll is used; inthe United States, this is for aperiod of 30 days.The STERRAD® SterilizationSystems and Cycles that can beused are shown in Table 1. Theproduct codes for all Tyvek®Pouches and Rolls withSTERRAD® ChemicalIndicator are listed in Table 2.The pouches and rolls areprinted with a chemicalindicator bar which is a processindicator (ISO 11140-1:2005)that changes from red to yellow(or lighter) when exposed tohydrogen peroxide vaporduring processing in theSTERRAD® SterilizationSystems.	Tyvek® Pouches and Rolls withSTERRAD® ChemicalIndicator are intended to beused to enclose medical devicesthat are to be terminallysterilized in the STERRAD®100NX® Sterilizer and toindicate, by color change thatthe pouch has been exposed tosterilant. After completion ofthe sterilization process, thepouch/roll maintains sterilityuntil the seal of the pouch/rollis opened; in the United States,this is for a period of 30 days.The pouches and rolls areprinted with a chemicalindicator bar which is a processindicator (ISO 11140-1:2005)that changes from red to yellow(or lighter) when exposed tohydrogen peroxide vaporduring processing in theSTERRAD® SterilizationSystems.	Additionalindicationshave beenincluded intheIndicationsfor Use forthe proposeddevice.Clarificationadded forpackagingconfiguration.
Materials ofConstruction	Tyvek® and transparent plasticfilm	Tyvek® and transparent plasticfilm	Same
	Proposed Device:Tyvek® Pouch/Roll withSTERRAD® ChemicalIndicator	Predicate Device: Tyvek®Pouch/Roll with STERRAD®Chemical Indicator(K112087)	Comparison
Pouch Types	Self Seal Pouch (123XX),Heat-Seal Pouch (125XX), and	Self Seal Pouch (123XX),Heat-Seal Pouch (125XX), and	Same
	Heat-Seal Roll (124XX)	Heat-Seal Roll (124XX)
DesignFeatures	Two films which are heatsealed together on three sides	Two films which are heat sealedtogether on three sides for	Same
	for individual pouches and ontwo sides for roll form pouches.	individual pouches and on twosides for roll form pouches.
	A Chemical Indicator (CI) baris printed onto the Tyvek® side	A Chemical Indicator (CI) bar isprinted onto the Tyvek® side of
	of the pouch. For the self-sealpouch, the CI is printed ontoback surface of the Tyvek®. For	the pouch. For the self-sealpouch, the CI is printed ontoback surface of the Tyvek®. For
	the heat-seal pouch and roll, theCI is printed onto the Tyvek®,	the heat-seal pouch and roll, theCI is printed onto the Tyvek®,
	but is encased in the seam ofthe pouch between the Tyvek®and transparent film.	but is encased in the seam of thepouch between the Tyvek® andtransparent film.
ChemicalIndicator	STERRAD® indicator ink	STERRAD® indicator ink	Same
ChemicalIndicatorDeviceDesign:	Chemical Indicator bar changesfrom red to yellow (or lighter)upon exposure to the sterilant,hydrogen peroxide	Chemical Indicator bar changesfrom red to yellow (or lighter)upon exposure to the sterilant,hydrogen peroxide	Same

Table 3: Comparison Table for Proposed Device vs. Predicate Device

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5. SUMMARY OF NONCLINICAL TESTS

Performance testing was conducted to show that the Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator perform as intended and, anter completion of the
sterilization process in the STERRAD® 100S, STERRAD®200, STERRAD®200, STERRAD® pouch/roll is used. The testing also showed that the STERRAD® Chemical Indicator changes from red to yellow (or lighter) when exposed to hydrogen peroxide. Refer to Table 4 for the summary of performance testing.

Table 4: Pouch/Roll with Chemical Indicator Performance Tests

Study Type	Description	Results
SterilantPenetration	Half-Cycle EfficacyThe sterilant penetrated through the “double pouch” configuration under the worst case half-cycle conditions and the sterility	Passed
Study Type	Description	Results
Chemical Indicator (CI) Functionality and Endpoint	assurance level (SAL) of $10^{-6}$ was demonstrated. The sterilant penetrated through the “double pouch” configuration and affected the CI color change to the endpoint color (from red to yellow or lighter) under the suboptimal conditions.	Passed
Package Integrity	Seal StrengthSeal strength performance characteristics were maintained for the manufactured seal and user made seal after STERRAD® processing.	Passed
	Microbial BarrierThe contents of pouches were sterile when the processed pouches were subjected to the microbial aerosol challenge test.	Passed
	BurstAbility to withstand the internal pressurization was maintained after STERRAD® processing.	Passed
	Peel OpenPeel open characteristics of the Tyvek® Pouch/Roll were maintained after STERRAD® processing.	Passed
Maintenance of Package Integrity	Sterility was maintained in the Tyvek® Pouches/Rolls for 30 days after STERRAD® processing.	Passed
Material Compatibility	Seal strength test, microbial barrier properties, burst test, and peel open test were studied to demonstrate material compatibility characteristics of the Tyvek® Pouches/Rolls after STERRAD® processing.	Passed
End Point / Post Processing Color Stability	Tyvek® Pouches/Rolls, after STERRAD® processing, maintained the endpoint CI color reaction.	Passed
Shelf Life	Chemical Indicator (CI) FunctionalityCI functionality of the processed Tyvek® Pouches/Rolls (CI color change from red to yellow or lighter) was verified at the end of shelf life.	Passed
	Seal StrengthSeal strength of the processed Tyvek® Pouches/Rolls was verified at the end of shelf life.	Passed
Biocompatibility	In vivo testing showed that the pouch samples, after STERRAD® processing, met the acceptance criteria per ISO 10993-11 and 10993-10	Passed

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6. OVERALL PERFORMANCE CONCLUSIONS

The nonclinical studies demonstrate that the Tyvek® Pouch/Roll with STERRAD® Chemical Indicator performs as intended as a sterilization packaging system of medical devices that are being terminally sterilized in STERRAD® Sterilization Systems. The Chemical Indicator performs as intended for differentiating processed from unprocessed packages in the STERRAD® Sterilization Systems. These studies also show that the proposed pouches have the same intended use and met the same criteria as the predicate device (K112087) and are substantially equivalent.

Tyvek® is a registered trademark of DuPont

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).