The AirView™ II Bowie Dick Test Pack is intended for the daily air removal efficacy testing of prevacuum steam sterilizers. It may also be used after sterilizer installation, relocation, after major repairs and after sterilization process failures.

The AirView" II Bowie Dick Test Pack is designed to detect the presence of residual air in prevacuum steam sterilizers operating at 134°C for 3.5 minutes. The indicator sheet within the AirView II Bowie Dick Test Pack will demonstrate a uniform color change from blue to dark brown black when proper sterilization conditions are met and no air is present. If enough air is present to create a 2°C (+1° /-0°C) temperature difference between the center of the towel pack. as identified in ANSVAAMI/ISO 11140-5, and the drain temperature at the beginning of the final one minute of a three and half minute cycle the AirView" II Bowie Dick Test Pack will demonstrate a non-uniform color change.

Device Description

Functionality-The AirView™ II Bowie Dick Test Pack is designed for routine testing of 134°C ' (273°F) prevacuum steam sterilizers. The Bowie Dick test is part of the daily release criteria for any prevacuum steam sterilizer. It may also be used after sterilizer installation, relocation, malfunction, after major repairs and after sterilization process failures. The AirView™M II Bowie Dick Test Pack should always be run in an empty chamber.

Scientific Concepts-The Bowie Dick Test should be run only after the chamber has been preheated. It is a means of detecting air leaks in gaskets or chamber piping, poor air removal and subsequent steam penetration. The AirView™ II Bowie Dick Test Pack has proven safe and effective as a replacement for the standard Bowie Dick Towel Pack through validated performance testing.

Physical Characteristics-The AirView™ II Bowie Dick Test Pack consists of layers of paper with an air removal indicator placed in the center of the stack all placed within an exterior containment box. A process indicator label placed on the containment box alerts users if a pack has been exposed to the sterilization process. The approximate dimensions of the pack are 3-3/4" x 5/8" x 5". The air removal indicator within the AirView™ II Bowie Dick Test Pack should be retained as a permanent record while the remainder of the pack can be discarded with regular waste according to local legislation, recycling land filling or incineration. None of the AirView™ II Bowie Dick Test Packs components are made from lead.

Performance Characteristics-The AirView™ II Bowie Dick Test Pack performs substantially equivalent to the AAMI Standard Towel Pack when tested in conformance with the FDA guidance document for Chemical Indicators and ANSI/AAM1/ISO 11140-5.

AI/ML Overview

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Performance - Pass Cycle	Uniform dark brown/black color when subjected to a 134°C for 3.5 minutes prevacuum steam sterilizer cycle with a complete vacuum air removal phase and temperature limits of 0.5°C or less difference within the test pack compared to drain temperature.	The AirView™ II Bowie Dick Test Pack turns a uniform dark brown/black color when subjected to the standard pass cycle (134°C for 3.5 minutes, complete vacuum, ≤0.5°C temp difference).
Performance - Fail Cycle	Non-uniform color when subjected to a modified air removal phase (fault condition) resulting in residual air entrapped within the test pack, creating a 2-3°C lower temperature in the center of the test pack compared to the drain at the start of the last minute of the exposure phase.	The AirView™ II Bowie Dick Test Pack turns a non-uniform color when subjected to the standard fault condition (modified air removal, 2-3°C lower temperature in pack center). The indicator is sensitive enough to detect when enough air is left to create a 2°C or greater temperature difference in the test pack.
Performance - Dry Heat	Require the presence of steam molecules to turn to specified endpoint color (i.e., no color change in dry heat).	Indicators require the presence of steam molecules to turn to their specified endpoint color. (No color change in dry heat).
Indicator Porosity	Meet predetermined acceptance criteria for indicator material porosity.	Results documented the porosity of the indicator material which meet the predetermined acceptance criteria.
Biocompatibility	Non-toxic (despite being intended for an empty chamber).	Biocompatibility testing concluded the indicators to be non-toxic.
Interfering Substances	Not sensitive to acidic or basic environments (both unprocessed and processed form).	Testing verified that the indicators in their unprocessed form are not sensitive to an acidic or basic environment. Testing verified that the indicators in their processed form are not sensitive to an acidic or basic environment.
Shelf Life	Maintain effectiveness for three (3) years from the date of manufacture.	Maintains a shelf life of three (3) years from the date of manufacture when properly stored.
Post-Processing Stability	Maintain indicator stability for two (2) years or more post-processing.	Post processing indicator stability has been documented to exceed two (2) years when properly stored.

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

The document mentions "multiple lots of indicators" were used for testing. However, it does not explicitly state a specific numerical sample size for the test set.

The provenance is implied to be laboratory-based testing conducted by the manufacturer (SPSmedical Supply Corp.) in the U.S.A., following FDA guidance. It's a prospective study designed to validate the device's performance.

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

Not applicable. This device is a chemical indicator, and its "ground truth" is established through physical and chemical reactions under controlled sterilization conditions, rather than expert interpretation of complex data (like medical images). The "ground truth" for pass/fail cycles is defined by temperature differences and air removal efficacy within the sterilizer, measured by instrumentation, not human experts.

4. Adjudication Method for the Test Set:

Not applicable. The "adjudication" is based on the visual color change of the indicator and objective physical measurements (temperature, vacuum) within the sterilizer during the validation process. The determination of "uniform" vs. "non-uniform" color change for pass/fail conditions is a direct observation of the indicator's performance against predefined criteria, not a consensus among experts.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative devices where human readers are involved (e.g., AI-assisted diagnosis). The AirView™ II Bowie Dick Test Pack is a chemical indicator that produces a direct visual result.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

Yes, the testing described is a standalone performance assessment of the device itself. The chemical indicator operates independently to display a visual outcome (color change) based on environmental conditions within the sterilizer. There is no "human-in-the-loop" component in its direct function, although a human is required to interpret the final visual output.

7. The Type of Ground Truth Used:

The ground truth used is primarily physical and chemical measurements under controlled conditions, established by:

Defined sterilizer cycle parameters (e.g., 134°C for 3.5 minutes).
Objective measurements of air removal and steam penetration (e.g., temperature differences within the test pack and at the drain, vacuum levels).
Compliance with recognized standards (ANSI/AAMI/ISO 11140-5).

Specifically, "pass cycles" and "fail cycles" were experimentally created and defined by these physical conditions.

8. The Sample Size for the Training Set:

Not applicable. This device is a passive chemical indicator, not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" or development of the indicator's chemical formulation would involve laboratory research and development, but not a data-driven training set like those for AI.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as explained in point 8. The "ground truth" for the development of such an indicator would be established through chemical principles and laboratory experiments to ensure the indicator ink responds predictably and accurately to specific sterilization parameters (temperature, steam, air presence).

Summary

{0}------------------------------------------------

K133204

510(k) Summary

MAY 0 5 2014

SUBMITTER INFORMATION:

SPSmedical Supply Corp. Contact: Michael Nolan Research and Development Coordinator a division of Crosstex International . 6789 West Henrietta Road Rush. NY 14543 U.S.A. Phone: (800) 722-1529 Fax: (585) 359-0167 Date of Summary: May 5, 2014

DEVICE INFORMATION:

Device Trade Name:	AirView™ II Bowie Dick Test Pack
Common Name:	Bowie Dick Test Pack
Classification Name:	Indicator, Physical/Chemical Sterilization Process21 CFR § 880.2800
Review Panel:	General Hospital
Product Code:	JOJ
Device Class:	2

PREDICATE DEVICE:

The SPSmedical AirView™ Bowie Dick Test Pack and AirView™ Bowie Dick Indicator Sheets K 130211

DEVICE DESCRIPTION:

INTENDED USE:

{1}------------------------------------------------

510(k) Summary (Continued)

TECHNICAL CHARACTERISTICS:

The outer box and layers of paper within the AirView™ II Bowie Dick Test Pack provide resistance to air removal and subsequent steam penetration of prevacuum steam sterilizers. The air removal indicator sheet within the pack offers clear evidence of sterilizer performance. The external process indicator alerts users when a pack has seen the sterilization process.

RECOMMENDED STORAGE CONDITIONS:

Store in a cool, dry place (15-30℃).

NON-CLINICAI. TESTING:

Validation of the AirView™ II Bowie Dick Test Pack included performance testing in steam and dry heat, porosity of the indicator material, biocompatibility, and interfering substances (acid/base) on multiple lots of indicators. All results from testing meet the predetermined acceptance criteria. All testing followed the FDA Guidance document for Industry and FDA Staff entitled, "Premarket Notification [510(k)] Submissions for Chemical Indicators," issued on December 19, 2003.

Performance Steam - The cycle selected for validation is the commonly used prevacuum Bowie Dick cycle of 134°C for 3.5 minutes exposure. Pass cycles consisted of an air removal phase drawing a complete vacuum. The temperature limits were 0.5℃ or less within the test pack when compared to the drain temperature during the exposure phase. Fail cycles utilized a modified air removal phase as allowed by the FDA guidance document to achieve the standard fault condition. By not completely removing the air from the chamber the residual air becomes entrapped within the test pack and creates a 2-3℃ lower temperature in the center of the test pack when compared to the drain at the start of the last minute of the exposure phase. The results from testing demonstrated that the AirView™ II Bowie Dick Test Pack turns a uniform dark brown/black color when subjected to the standard pass cycle and turns a non-uniform color when subjected to the standard fault condition.

Performance Dry Heat-Results from dry heat testing demonstrated that the indicators require the presence of steam molecules in order to turn to their specified endpoint color.

Indicator Porosity-Results documented the porosity of the indicator material which meet the predetermined acceptance criteria.

Biocompatibility-Although the AirView™ II Bowie Dick Test Pack is intended to be run in an empty chamber SPSmedical and Crosstex International decided to run biocompatibility testing to address concerns of leaching. Biocompatibility testing concluded the indicators to be non-toxic.

Interfering Substances or Conditions-Testing verified that the indicators in their unprocessed form are not sensitive to an acidic or basic environment. Testing verified that the indicators in their processed form are not sensitive to an acidic or basic environment.

Shelf Life-When properly stored the AirView™ II Bowie Dick Test Pack maintains a shelf life of three (3) years from the date of manufacture. The expiration date is located on every pack. Post processing indicator stability has been documented to exceed two (2) years when properly stored.

SUBSTANTIAL EQUIVALENCE DISCUSSION

SPSmedical has identified the AirView™ Bowie Dick Test Pack & AirView™ Bowie Dick Indicator Sheets (K130211) as the (primary) predicate device. We believe the predicate device to be substantially equivalent to the AirView™ II Bowie Dick Test Pack which is the subject of this submission in terms of their intended use and functional characteristics in determining the efficacy of air removal in prevacuum sterilizers. See a comparison of the subject device to the predicate device (K130211) in Table 1.

{2}------------------------------------------------

510(k) Summary (Continued)

PREDICATE I.D .:

Trade Name: ·

SPSmedical AirView™ Bowie Dick Test Pack and AirView™ Bowie Dick Indicator Sheets

Model No.: SBD-030 (for Test Pack) & BDS-050 (for Sheets)

Submitter/holder: .

SPSmedical Supply Corp. 6789 West Henrietta Road Rush, NY 14543 U.S.A. Phone: (585) 359-0130 Fax: (585) 359-0167

510(k) No .: K130211

COMPARISON OF INDICATIONS FOR USE (IFU):

Predicate Device-The AirView™ Bowie Dick Test Pack and AirView™ Bowie Dick indicator sheets are designed to detect the presence of residual air in prevacuum steam sterilizers. When tested in a prevacuum sterilizer operating at 134℃ the indicator will demonstrate a uniform color change from cream or blue to dark brown/black when proper sterilization conditions have been met and no air is detected. It is designed to be used for daily Bowie Dick testing of steam sterilizers as described in ANSI/AAMI ST79.

Subject Device-The AirView" II Bowie Dick Test Pack is designed to detect the presence of residual air in pre-vacuum steam sterilizers operating at 134℃ for 3.5 minutes. The indicator sheet within the AirView" II Bowie Dick Test Pack will demonstrate a uniform color change from blue to dark brown/black when proper sterilization conditions are met and no air is present. If enough air is present to create a 2°C (+1°/-0°C) temperature difference between the center of the towel pack, as identified in ANSI/AAMI/ISO 11140-5, and the drain temperature at the beginning of the final one minute of a three and half minute cycle the AirView™ II Bowie Dick Test Pack will demonstrate a non-uniform color change.

Discussion-When compared to the predicate device the subject device has a similar IFU. They are made of similar package materials, they have the same intended use and they meet the same performance requirements.

DESIGN DIFFERENCES PREDICATE VS. SUBJECT DEVICE:

As stated in Table I both devices are Bowie Dick Test Packs. There are two (2) variations in the design of the packs. First, the subject device is smaller in size than the predicate and secondly, the subject device does not require the use of a foam insert within the pack. These differences do not change the Intended Use of the device.

FUNCTIONAL CHARACTERISTICS:

The AirView™ II Bowie Dick Test Pack is designed to detect the presence of residual air in prevacuum steam sterilizers. The layers of paper within the pack provide resistance to steam penetration and trap residual air which is difficult for marginally performing prevacuum sterilizers to remove. The pack is a reliable tool used for the daily monitoring of air removal in prevacuum steam sterilizers and provides a clear visual indication if residual air was left in the chamber during sterilization. The indicator sheet changes from its initial color (blue or cream) to a uniform dark brown/black signal color under proper sterilization and air removal conditions. A failure would result in a non-uniform color change on the indicator sheet.

{3}------------------------------------------------

510(k) Summary (Continued)

DISCUSSION:

SPSmedical is claiming substantial equivalence for its. AirView™ II Bowie Dick Test Pack to the AirView™ Bowie Dick Test Pack and AirView™ Bowie Dick Indicator Sheets (K130211) based on test data obtained during validation studies.

We have demonstrated with testing that the AirView™ II Bowie Dick Test Pack performs consistently with results which indicate that the indicator is sensitive enough to detect when enough air is left within the sterilizer chamber to create a 2°C or greater temperature difference in the test pack as compared to the sterilizer chamber when running prevacuum Bowie Dick cycles. Under these conditions. the indicator sheet would demonstrate a non-uniform color change. The AirView™M II Bowie Dick Test Pack is also comparable to other commercially available Bowie Dick test packs cleared by the FDA.

SUBSTANTIAL EQUIVALENCE CONCLUSIONS:

The AirView™ II Bowie Dick Test Pack has the same intended use and characteristics as the primary predicate device (K13021). They both provide a visual indication that proper air removal and steam penetration conditions have been met within the sterilizer's chamber. Both products are comprised of paper sheets, a containment box, external chemical indicator label and printed indicator sheet.

Because the ability to perform its intended function has been shown through validated testing, the SPSmedical AirView™ II Bowie Dick Test Pack raises no issues related to safety or effectiveness. See Table I for a substantial equivalence comparison. SPSmedical believes that the SPSmedical AirView™ II Bowie Dick Test Pack is substantially equivalent to the predicate device because it has the same intended use, technical characteristics and performance.

Element	Subject Device	Predicate (K130211)
Intended Use	Air Removal Indicator	Air Removal Indicator
Indications for Use	The AirView™ II Bowie Dick Test Pack isdesigned to detect the presence of residual air inpre-vacuum steam sterilizers operating at 134°C for3.5 minutes. The indicator sheet within theAirView™ II Bowie Dick Test Pack willdemonstrate a uniform color change from blue todark brown/black when proper sterilizationconditions are met and no air is present. If enoughair is present to create a 2°C (+1° /-0°C)temperature difference between the center of thetowel pack, as identified in ANSI/AAMI/ISO11140-5, and the drain temperature at the beginningof the final one minute of a three and half minutecycle the AirView™ II Bowie Dick Test Pack willdemonstrate a non-uniform color change.	The AirView™ Bowie Dick Test Pack andAirView™ Bowie Dick indicator sheets aredesigned to detect the presence of residual air inprevacuum steam sterilizers. When tested in aprevacuum sterilizer operating at 134°C theindicator will demonstrate a uniform color changefrom cream or blue to dark brown/black whenproper sterilization conditions have been met andno air is detected. It is designed to be used for dailyBowie Dick testing of steam sterilizers as describedin ANSI/AAMI ST79.
Device Design	Bowie Dick Test Pack	Bowie Dick Test Pack or Sheet

TABLE 1-COMPARISON OF THE SUBJECT DEVICE TO THE PREDICATE

{4}------------------------------------------------

Package Materials	The AirView™ II Bowie Dick Test Pack consistsof layers of paper with an air removal indicatorplaced in the center of the stack all placed within anexterior containment box. A process indicator labelplaced on the containment box alerts users if a packhas been exposed to the sterilization process. Theapproximate dimensions of the pack are 3-3/4" x5/8" x 5".	The AirView™ Bowie Dick Test Pack consists oflayers of paper, a foam insert and an air removalindicator placed in the center of the stack all placedwithin an exterior containment box. A processindicator label placed on the containment box alertsusers if a pack has been exposed to the sterilizationprocess. The approximate dimensions of the packare 4-5/8" x 7/8" x 6-1/4"
Endpoint Color	Dark Brown/Black	Dark Brown/Black
Indicator Agent	Indicator Ink	Indicator Ink
Sterilization Method	Steam prevacuum	Steam prevacuum
Device Materials	Equivalent	Equivalent
Air Porosity	Equivalent	Equivalent
Performance underComplete reactioncycle	Equivalent	Equivalent
Performance understandard faultcondition	Equivalent	Equivalent
Biocompatibility	Equivalent	Equivalent
Shelf Life	Three (3) years	Three (3) years
Post processingstability	Exceeds two (2) years	Exceeds two (2) years

. .

. . . .

September 19.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO Silver Spring, MI) 20993-0002

May 5. 2014

SPSmedical Supply Corp. Division of Crosstex International Michael Nolan Research and Development Coordinator 6789 West Henrietta Road Rush, NY 14543

Re: K133204

Trade/Device Name: AirView™ II Bowie Dick Test Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Indicator, Physical/Chemical Sterilization Process Regulatory Class: II Product Code: JOJ Dated: March 24. 2014 Received: March 26, 2014

Dear Mr. Nolan:

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.

{6}------------------------------------------------

Page 2 - Mr. Nolan

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 (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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 CDRF'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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Tjadaferl Parolls Smith, M.D.
Clinical Deputy Director
DAGRID/ODE/CDRH

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

Statement of Indications for Use

510(k) Number (if known): K133204 __

AirView™ II Bowie Dick Test Pack Device Trade Name:

INDICATIONS FOR USE:

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

Elizabeth Claverie -

ON:US;o=U.S Government, ou=HHS.
ou=FDA ou= People,
0.9.2342.19200300.100.1.1=1300055864,

che Elizabeth F. Claverle -5
Date: 2014.05.05 17:56:57 -04'00"

Regulation Number and Section

§ 880.2800 Sterilization process indicator.

(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).