(28 days)
Not Found
No
The device description and intended use focus on a chemical indicator that changes color based on exposure to steam sterilization parameters. There is no mention of any computational or learning-based technology.
No
The device is described as a 'test pack' used to monitor the effectiveness of steam sterilization cycles, not to directly treat a patient or condition.
No
The device is a chemical indicator used to verify the effectiveness of steam sterilization cycles, not to diagnose a medical condition in a patient.
No
The device description clearly indicates it is a physical product consisting of an emulating indicator and a steam penetration barrier, with color-changing ink and a process indicator. It is not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as being for "use in steam sterilization." This is a process control for sterilization equipment, not a diagnostic test performed on a biological sample from a patient.
- Mechanism: The device works by changing color based on exposure to specific steam sterilization parameters (temperature, type, duration). This is a chemical indicator, not a test that detects or measures substances in a biological sample.
- No Biological Sample: There is no mention of the device being used with or analyzing any biological sample (blood, urine, tissue, etc.).
- No Diagnostic Purpose: The device's purpose is to verify the effectiveness of a sterilization cycle, not to diagnose a disease or condition in a patient.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Verify® Challenge Packs -- Version 2- are chemical indicator test packs intended for use by health care providers to accompany products being sterilized through a sterilization procedure. The indicator sheet within the challenge pack changes color from yellow to blue/purple when exposed to the proper time and temperature of the designated steam sterilization cycle. The performance of the Verify Challenge Packs -- Version 2 - meets the requirements of ANSI/AAMI / ISO 11140-1:2005 for emulating [Class 6] steam indicators.
The Verify® Challenge Packs -Version 2 - are test packs consisting of an emulating indicator surrounded by a steam penetration barrier, intended for use in steam sterilization. The Verify® Challenge Packs indicators change color from yellow to blue/purple when exposed to the appropriate cycle temperature, type, and duration. The challenge pack models and their cycle temperatures, types, and times are:
MODEL: Verify® 270F 4, TEMPERATURE: 270°F (132°C), STERILIZATION TYPE: Pre-vacuum, Steam Flush Pressure Pulse (SFPP), TIME: 4 minutes
MODEL: Verify® 275F 3, TEMPERATURE: 275°F (135°C), STERILIZATION TYPE: Pre-vacuum, TIME: 3 minutes
There is a process indicator outside of the packs which undergoes a visual color change when exposed to steam in a temperature range of 250°F (121°C) to 275°F (135°C).
Product codes (comma separated list FDA assigned to the subject device)
JOJ
Device Description
The proposed Verify® Challenge Packs – Version 2 -consist of an emulating indicator surrounded by a steam penetration barrier. The indicator ink inside the proposed Verify® Challenge Packs changes from yellow to blue/purple color when the steam sterilization cycle is complete:
- The Verify® 270F 4 Challenge Pack -Version 2 can be used to monitor a 4 . minute 270ºF/132ºC Steam-Flush Pressure-Pulse (SFPP) and pre-vacuum steam sterilization cycle.
- The Verify® 275F 3 Challenge Pack -- Version 2 can be used to monitor a 3 . minute 275°F/135°C pre-vacuum steam sterilization cycle.
The process indicator outside of the packs undergoes a visual color change from pink to dark purple when exposed to steam in a temperature range of 250°F (121°C) to 275°F (135°C).
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
health care providers
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)
A risk analysis and the necessary verification and validation activities were performed to demonstrate that the design outputs of the modified device meet the design input requirements.
Performance testing was conducted to verify that the process indicator on the outside of the challenge packs change color from pink to dark purple when exposed to the following full steam sterilization cycles.
- 4 minute 270°F/132°C dynamic air removal steam sterilization cycle. .
- 3 minute 275°F/135°C dynamic air removal steam sterilization cycle. .
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
Image /page/0/Picture/0 description: The image shows the word "STERIS" in all capital letters with the registered trademark symbol. Below the word is a symbol that looks like a series of stacked, wavy lines. Underneath the symbol is the number "K073683" written in a handwritten style.
510(k) Summary For Verify® Challenge Packs – Version 2 -
JAN 25 Cars
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459
Contact:
Richard Bancroft Development and Technical Service Director
Telephone: 011 44 116 2747337 Fax No: 011 44 116 2768639
Submission Date: December 26, 2007
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
1
Device Name 1.
| Indicator Pack Models: | Verify® 270F 4 Challenge Pack
Verify® 275F 3 Challenge Pack |
|------------------------|-----------------------------------------------------------------------------------------------|
| Common Name: | Chemical Indicator |
| Classification Name: | Physical/chemical sterilization process indicator (21
CFR 880.2800 (b), Product Code JOJ). |
2. Predicate Devices
- . Verify® Challenge Packs - K070895.
- Modified Browne Packaging and Label Steam Process Indicator K032801. .
3. Device Description
The proposed Verify® Challenge Packs – Version 2 -consist of an emulating indicator surrounded by a steam penetration barrier. The indicator ink inside the proposed Verify® Challenge Packs changes from yellow to blue/purple color when the steam sterilization cycle is complete:
- The Verify® 270F 4 Challenge Pack -Version 2 can be used to monitor a 4 . minute 270ºF/132ºC Steam-Flush Pressure-Pulse (SFPP) and pre-vacuum steam sterilization cycle.
- The Verify® 275F 3 Challenge Pack -- Version 2 can be used to monitor a 3 . minute 275°F/135°C pre-vacuum steam sterilization cycle.
The process indicator outside of the packs undergoes a visual color change from pink to dark purple when exposed to steam in a temperature range of 250°F (121°C) to 275°F (135°C).
4. Intended Use
The Verify® Challenge Packs -- Version 2- are chemical indicator test packs intended for use by health care providers to accompany products being sterilized through a sterilization procedure. The indicator sheet within the challenge pack changes color from yellow to blue/purple when exposed to the proper time and temperature of the designated steam sterilization cycle. The performance of the Verify Challenge Packs -- Version 2 - meets the requirements of ANSI/AAMI / ISO 11140-1:2005 for emulating [Class 6] steam indicators.
2
The process indicator printed outside of the packs undergoes a visual color change from pink to dark purple when exposed to steam in a temperature range of 250°F (121°C) to 275°F (135°C).
Description of Safety and Substantial Equivalence 5.
The proposed and predicate devices are all single use indicator test packs for use in steam sterilization cycles. The differences between the proposed Verify® Challenge Packs – Version 2 - and the predicate device Verify® Challenge Packs described in K070895 are limited to the presence of an outside pack process indicator identical to the predicate device described in K032801. There are no differences in design, materials, and parameters of the sterilization cycles these indicator test packs are designed to monitor. The addition of the process indicator to the outside of the challenge packs does not raise any new issues of safety and efficacy.
6. Verification and Validation Activities
A risk analysis and the necessary verification and validation activities were performed to demonstrate that the design outputs of the modified device meet the design input requirements.
Performance testing was conducted to verify that the process indicator on the outside of the challenge packs change color from pink to dark purple when exposed to the following full steam sterilization cycles.
- 4 minute 270°F/132°C dynamic air removal steam sterilization cycle. .
- 3 minute 275°F/135°C dynamic air removal steam sterilization cycle. .
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
JAN 25 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John Scoville Fellow, Regulatory Affairs Sterilization Technology STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060-1834
Re: K073683
Trade/Device Name: Verify® Challenge Packs - Versions 2 -Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: December 26, 2007 Received: December 28, 2007
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 such 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.
4
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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), please contact the Office of Compliance at (240) 276-0115. 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 Division of Small Manufacturers, 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/industry/support/index.html.
Sincerely yours.
Clars
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
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name:
Verify® Challenge Packs - Version 2 -
Indications For Use:
The Verify® Challenge Packs -Version 2 - are test packs consisting of an emulating indicator surrounded by a steam penetration barrier, intended for use in steam sterilization. The Verify® Challenge Packs indicators change color from yellow to blue/purple when exposed to the appropriate cycle temperature, type, and duration. The challenge pack models and their cycle temperatures, types, and times are:
| MODEL | TEMPERATURE | STERILIZATION TYPE | TIME |
|---|---|---|---|
| Verify® 270F 4 | 270°F (132°C) | Pre-vacuum, Steam Flush | |
| Pressure Pulse (SFPP) | 4 minutes | ||
| Verify® 275F 3 | 275°F (135°C) | Pre-vacuum | 3 minutes |
There is a process indicator outside of the packs which undergoes a visual color change when exposed to steam in a temperature range of 250°F (121°C) to 275°F (135°C).
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)
Shula H. Murphy, RO
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
Page 1 of 1
December 26, 2007