(66 days)
Not Found
No
The description focuses on a chemical indicator for steam sterilization and does not mention any computational or learning-based components.
No
This device is designed to test the efficacy of sterilizers, not to treat patients or medical conditions.
No
Explanation: This device is designed to test the efficacy of a steam sterilizer by detecting residual air, not to diagnose a medical condition in a patient. It assesses the performance of equipment, not the health status of an individual.
No
The device description clearly states it is a "disposable device" and a "test pack," indicating a physical, hardware-based product used for testing steam sterilizers. There is no mention of software as the primary component or function.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to detect the presence of residual air in pre-vacuum steam sterilizers. This is a quality control test for a sterilization process, not a test performed on a biological sample from a human or animal to diagnose a condition, monitor treatment, or screen for disease.
- Device Description: The device is a test pack and indicator sheets used within a sterilizer. It does not interact with biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Testing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status
- Being used in a clinical laboratory setting
The device is clearly intended for use in a sterilization process to ensure the effectiveness of that process, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The SPSmedical AirView™ Bowie Dick Test Pack and AirView™ Bowie Dick indicator sheets are designed to detect the presence of residual air in pre-vacuum steam sterilizers operating at 134°C. When tested in a pre-vacuum sterilizer operating at 134°C, the indicator sheet will demonstrate a uniform color change from cream or blue to dark brown/black when proper sterilization conditions have been met and no residual air is present. The BD test pack and indicator sheets are reliable tools used for the daily monitoring of air removal in pre-vacuum processes and provides a visual indication if air removal has occurred in the chamber during sterilization. Its internal indicator sheet changes to a significant and uniform color under proper sterilization and air removal conditions. A failure would result in a non-uniform color change on the indicator sheet.
Product codes (comma separated list FDA assigned to the subject device)
80JOJ
Device Description
The SPSmedical Air View™ Bowie Dick Test Pack (BD Test Pack) is a disposable device which is intended for use as a replacement for the ANSI/AMMI ST46:2002 BD Test Pack. The SPSmedical AirView™ Bowie Dick Indicator Sheets are designed to be used within the ANSI/AMMI ST46:2002 BD Test Pack.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was performed in order to determine the functional equivalency between the SPSmedical Supply Corp's newly developed AirView™ Bowie Dick Test Pack (BD Test Pack) and AirView™ indicator sheets, the 3M Comply Bowie Dick Type Test Pack and the ANSI/AMMI ST46:2002 BD Test Pack. Based on the results of laboratory tests; the SPSmedical AirView™ Bowie Dick Test Pack and AirView™ Bowie Dick indicator sheets are substantially equivalent to the predicate 3M Comply Bowie Dick Type Test Pack and indicator sheets.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
JUN 2 5 2004
510(k) Summary of Safety and Effectiveness
Submitter:
- SPSmedical Supply Corp. . 6789 West Henrietta Road Rush, NY 14543 U.S.A. Phone: (585)-359-0130 Fax: (585)-359-0167
- Establishment FDA Registration No.: 1319130 t
- March 15, 2004 Date Summary was prepared .
- Gary J. Socola . Printed name of person submitting for 510(k) .
- Signature of person submitting for 510(k)
- Director of Quality Assurance . Title of person submitting for 510(k)
Device Name and Classification
| Trade Name: | SPSmedical AirView™ Bowie Dick Test Pack
and AirView™ Bowie Dick Indicator Sheets |
|------------------------|--------------------------------------------------------------------------------------|
| Classification Name: | Physical/Chemical Sterilization Process Indicator |
| Common Name: | Bowie Dick Test Pack and Indicator Sheets |
| Device Classification: | General Hospital - Class II, Regulation Number
880.2800(b) |
| Product Code: | 80JOJ |
| Predicate Device: | 3M Comply Bowie & Dick Test Pack 510(k) no.
841168 |
1
Device Description
The SPSmedical Air View™ Bowie Dick Test Pack (BD Test Pack) is a disposable device which is intended for use as a replacement for the ANSI/AMMI ST46:2002 BD Test Pack. The SPSmedical AirView™ Bowie Dick Indicator Sheets are designed to be used within the ANSI/AMMI ST46:2002 BD Test Pack..
Intended Use
The SPSmedical AirView™ Bowie Dick Test Pack and AirView™ Bowie Dick indicator The SI Sinculcal 7m View - Down Dressence of residual air in pre-vacuum steam sterilizers operating at 134°C. The BD test pack and indicator sheets are reliable tools used for the operating of 194 C. The DD tess pre-vacuum processes and provides a visual indication if montoning of an romover in the chamber during sterilization. Its internal indicator sheet changes to It siguial and was for in the enames and color under proper sterilization and air removal conditions. A failure would result in a non-uniform color change on the indicator sheet.
Technical Characteristics
The layers of paper within the SPSmedical AirView™ Bowie Dick Test Pack provide resistance to steam penetration and also trap air between them which is difficult for marginal performing pre-vacuum sterilizers to remove.
Performance Testing
Testing was performed in order to determine the functional equivalency between the SPSmedical Supply Corp's newly developed AirView™ Bowie Dick Test Pack (BD Test Pack) and AirView™ indicator sheets, the 3M Comply Bowie Dick Type Test Pack and the ANSI/AMMI ST46:2002 BD Test Pack. Based on the results of laboratory tests; the SPSmedical AirView™ Bowie Dick Test Pack and AirView™ Bowie Dick indicator sheets are substantially equivalent to the predicate 3M Comply Bowie Dick Type Test Pack and indicator sheets.
Recommended Storage Conditions
Store in a cool, dry place (15-30℃).
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
The shelf life of the SPSmedical Bowie-Dick Test Pack and indicator sheets shall be 3 years from the date of manufacture, when stored in a cool, dry place (15-30℃).
2
Biocompatibility
A risk analysis was performed concerning the materials used in the manufacturing of the AirView™ Bowie Dick Test Pack and AirView™ indicator sheets as well as on any by
AirView™ Bowie Dick Test Pack and AirView™ indication - Risk analysis AirViewIM Bowle Dick Test Fack and An now occur during sterilization. Risk analysis products created from these materials mar may occur and our associated risk and that the product is safe for its intended use and handling.
Conclusion
Supportive data has demonstrated that the SPSmedical AirView™ Bowie Dick Test Pack and Supportive data has demonstrated in and of envivals to the prodicate device. The AirView™ Bowie Dick Thurcator Silects Pack and AirView™ Bowie Dick indicator sheets
SPSmedical AirView™ Bowie Dick Test Pack and AirView™ Bowie Dick indicator sheets SPSmedical Air View™ Bowle DRK Test rack and therefore should be allowed for market in the United States.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized representation of an eagle, with three curved lines forming its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 5 2004
SPSmedical Supply Corporation C/O Mr. Neil E. Devine Responsible Third Party Official Entela, Incorporated 3033 Madison Avenue, SE Grand Rapids, Michigan 49548
Re: K041017
Ko41017
Trade/Device Name: SPSmedical AirView™ Bowie Dick Test Pack & AirView™ Bowie Dick Indicator Sheets Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: June 9, 2004 Received: June 10, 2004
Dear Mr. Devine:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have to reveal 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 multions for asso barror to May 28, 1976, the enactment date of the Medical Device merslate commerce provises that have been reclassified in accordance with the provisions of Amendinents, or to ac now Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approval appression (she Act. The general controls provisions of the Act include controls provided by annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Mr), it may of suchose of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in firsther announcements concerning your device in the Eederal Register.
4
Page 2 - Mr. Devine
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 mean that I DA mas made a actession and regulations administered by other Federal agencies. of the Act of ally I oderal baker and squirements, including, but not limited to: registration 1 ou inust comply with as a 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 807), labeling systems (QS) regulation (21 CFR Part 820); and if requirences as set form in the quality sion control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anon your of substantial equivalence of your device of your device to a premitset notification. - The PDF results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific acrite for Joiance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may overni ours games games , International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
5
INDICATIONS for USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: AirView™ Bowie Dick Test Pack & AirView™ Bowie Dick Indicator Sheets
Indications For Use:
The SPSmedical AirView™ Bowie Dick Test Pack and AirView™ Bowie Dick indicator sheets The SPSmedical Alf View™ Bowle Dick rest in in nre-vacuum steam stediters. When tested in a are designed to detect the presence of itsidual an in pro-will demonstrate a uniform color change pre-vacuum sterlizer operating at 194 C the nroper sterilizations nave been met and no
f on cream or blue to dark brown/black when proper starilization of steam, sterliizers from cream of blue to daik brownblack which proper sessmeants of steam sterilizers as described in AAMVANSI ST-46.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ × (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kain Mulvey
(Division Sian-Off Division of Anesthesiolo Infection Control, D
510(k) Number: K041017
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