(241 days)
The Verify® 275F Gravity Indicators are chemical integrators which meet ANSVAAMI 1140-1:2005 for emulating indicators intended for use in steam sterilization. The Verify® 275F Gravity Indicators change color from yellow to blue/purple when exposed to 275°F (135°C) and to the appropriate cycle type and duration. The Verify® 275F Indicators models and their cycle types and times are:
| MODEL | TEMPERATURE | STERILIZATION TYPE | TIME |
|---|---|---|---|
| Verify 275F 3-10 | 275°F (135°C) | Gravity flash steam | 3 and 10 minutes |
| Verify 275F 10 | 275°F (135°C) | Gravity steam | 10 minutes |
The proposed Verify® 275F Gravity Indicators consist of:
- A 22 mm x 143 mm polypropylene strip with two 12 mm chemical indicator . ink spots (for Verify® 275F 3-10 Indicator).
- A 22 mm x 143 mm polypropylene strip with one 12 mm chemical indicator . ink spots (for Verify® 275F 10 Indicator).
The indicator ink spots are located on each end of the strip (or one end if it is just one ink spot), adjacent to a reference block exhibiting the endpoint color. The indicator ink on the proposed Verify® 275F Gravity Indicators changes from yellow to blue/purple color when the steam sterilization cycle is complete.
The Verify® 275F Gravity Indicators can be used to monitor 275ºF (135ºC) sterilization cycles as follows:
- The Verify® 275F 3-10 Indicator can be used to monitor a 3 and 10 minute . 275°F (135°C) gravity flash steam sterilization cycle.
- The Verify® 275F 10 Indicator can be used to monitor a 10 minute 2759F . (135℃) gravity steam sterilization cycle.
Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The Verify® 275F Gravity Indicators are chemical indicators intended to meet the requirements for emulating Class 6 chemical steam indicators as defined in ANSI/AAMI/ISO 11140-1:2005. The primary performance criterion is the color change from yellow to blue/purple when exposed to saturated steam at 275°F (135°C) for the specified period of time.
| Criteria (Standard: ANSI/AAMI/ISO 11140-1:2005 for Class 6) | Reported Device Performance |
|---|---|
| Color change from yellow to blue/purple | Achieved |
| Exposure to 275°F (135°C) saturated steam at cycle type and duration | Achieved |
| Verify® 275F 3-10: Monitors 3 and 10 minute 275°F (135°C) gravity flash steam sterilization cycles | Meets requirements |
| Verify® 275F 10: Monitors 10 minute 275°F (135°C) gravity steam sterilization cycles | Meets requirements |
Study Proving Device Meets Acceptance Criteria
1. Sample Size for Test Set and Data Provenance:
The document does not explicitly state the sample size (i.e., number of indicators) used for the performance testing.
The data provenance is not specified beyond "Performance testing was conducted". It is assumed to be an internal laboratory study conducted by STERIS Corporation. There is no information regarding the country of origin of the data or whether it was retrospective or prospective.
2. Number of Experts and Qualifications:
The document does not mention the involvement of human experts for establishing ground truth or evaluating the test set. The evaluation of the chemical indicator's color change is likely objective and based on established color standards.
3. Adjudication Method:
Not applicable as human experts were not involved in establishing ground truth for the test set. The performance is assessed against the instrumental requirements of the standards.
4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative devices where human variability in reading is a factor. For chemical indicators, the assessment is based on a direct chemical reaction and color change, not human interpretation against a complex medical case.
5. Standalone Performance:
Yes, a standalone (algorithm only without human-in-the-loop performance) was effectively done. The performance testing "verified that the proposed Verify® 275F Gravity Indicators meet the requirements for emulating [Class 6] chemical indicators as defined in ANSI/AAMI ISO 11140-1:2005 using a resistometer to ANSI/AAMI ISO 18472." This indicates an objective, instrument-based evaluation of the indicator's performance against the defined standard.
6. Type of Ground Truth Used:
The ground truth is established by the ANSI/AAMI/ISO 11140-1:2005 standard for Class 6 chemical indicators. The device's performance (color change in specific conditions) is directly compared against the engineering and performance specifications outlined in this standard. It's essentially a standards-based ground truth.
7. Sample Size for Training Set:
The document does not specify a separate training set or its sample size. For this type of chemical indicator, there isn't a "training set" in the machine learning sense. The device's formulation and design are developed and then validated against the standard.
8. How Ground Truth for Training Set Was Established:
Not applicable, as there isn't a "training set" in the traditional sense for this chemical indicator. The "ground truth" for the development and validation of such a device is inherently linked to the chemical properties, manufacturing processes, and the performance requirements specified by the and applicable standards (e.g., ANSI/AAMI/ISO 11140-1:2005).
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AUG 0 7 2009
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510(k) Summary For Verify® 275F Gravity Indicators
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459
Contact:
Robert F. Sullivan. Senior Director, FDA Regulatory Affairs
Telephone: 440 392 7695 Fax No: 440 357 9198
Summary Date:
August 5, 2009
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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1. Device Name
Verify® 275F 3-10 Indicator. Verify® 275F 10 Indicator.
Chemical Indicators. Common Name:
Classification Name:
Physical/chemical sterilization process indicators (21 CFR 880.2800 (b), Product Code JOJ).
Predicate Devices 2.
- DANA SteriScan Indicators (K012195)
- SteriTec Integraph [Cardinal Steam Integrators (K960441)] ●
- STERIS Verify Integrators (K002937) ●
3. Device Description
The proposed Verify® 275F Gravity Indicators consist of:
- A 22 mm x 143 mm polypropylene strip with two 12 mm chemical indicator . ink spots (for Verify® 275F 3-10 Indicator).
- A 22 mm x 143 mm polypropylene strip with one 12 mm chemical indicator . ink spots (for Verify® 275F 10 Indicator).
The indicator ink spots are located on each end of the strip (or one end if it is just one ink spot), adjacent to a reference block exhibiting the endpoint color. The indicator ink on the proposed Verify® 275F Gravity Indicators changes from yellow to blue/purple color when the steam sterilization cycle is complete.
The Verify® 275F Gravity Indicators can be used to monitor 275ºF (135ºC) sterilization cycles as follows:
- The Verify® 275F 3-10 Indicator can be used to monitor a 3 and 10 minute . 275°F (135°C) gravity flash steam sterilization cycle.
- The Verify® 275F 10 Indicator can be used to monitor a 10 minute 2759F . (135℃) gravity steam sterilization cycle.
1 Cardinal is a private label brand produced by Steritec under K960441.
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Intended Use 4.
The Verify® 275F Gravity Indicators are chemical indicators intended for use by health care providers to accompany products being sterilized through a sterilization procedure. The indicators change color from yellow to blue/purple when exposed to saturated steam at 275°F for the specified period of time. The performance of the Verify® 275F Gravity Indicators meet the requirements of ANSI/AAMI / ISO 11140-1:2005 for emulating [Class 6] chemical steam indicators.
Description of Safety and Substantial Equivalence న్.
The proposed and predicate devices are all single use indicators for use in steam sterilization cycles. The differences between the proposed Verify® 275F Gravity Indicators and predicate devices are limited to differences in design, material, and parameters of the sterilization cycles these indicators are designed to monitor. These differences do not raise any new issues of safety and efficacy.
Performance Testing 6.
Performance testing was conducted to verify that the proposed Verify® 275F Gravity Indicators meet the requirements for emulating [Class 6] chemical indicators as defined in ANSI/AAMI ISO 11140-1:2005 using a resistometer to ANSI/AAMI ISO 18472.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an abstract human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the figure.
AUG 0 7 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. John R. Scoville Senior Director of FDA Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060-1834
Re: K083643
Trade/Device Name: Verify® 275F Gravity Indicators Regulation Number: 21 CFR 880. 2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: July 9, 2009 Received: July 14, 2009
Dear Mr. Scoville:
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.
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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Page 2 - Mr. Scoville
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 (QS) 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
for
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, 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): K083643
Device Name:
Verify® 275F Gravity Indicators
Indications for Use:
The Verify® 275F Gravity Indicators are chemical integrators which meet ANSVAAMI 1140-1:2005 for emulating indicators intended for use in steam sterilization. The Verify® 275F Gravity Indicators change color from yellow to blue/purple when exposed to 275°F (135°C) and to the appropriate cycle type and duration. The Verify® 275F Indicators models and their cycle types and times are:
| MODEL | TEMPERATURE | STERILIZATION TYPE | TIME |
|---|---|---|---|
| Verify 275F 3-10 | 275°F (135°C) | Gravity flash steam | 3 and 10 minutes |
| Verify 275F 10 | 275°F (135°C) | Gravity steam | 10 minutes |
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 (ODE)
Stink R. Murphy, Ke
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K083643
Page 1 of 1
§ 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).