(4 days)
Not Found
No
The device is a chemical indicator strip that changes color based on a chemical reaction, not through computational analysis or learning.
No.
The device is a chemical indicator used to monitor the peracetic acid dose during an endoscope processing cycle, not to directly treat or diagnose a medical condition.
No
The device is a chemical indicator used to monitor the effectiveness of a peracetic acid dose in an endoscope processing cycle, not to diagnose a disease or condition in a patient.
No
The device is a physical chemical indicator strip that changes color based on exposure to peracetic acid, not a software program.
Based on the provided information, the Reliance PI Process Indicator is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The device is intended to monitor the effectiveness of a chemical process (peracetic acid generation) within the Reliance Endoscope Processing Cycle. While it doesn't directly diagnose a patient condition, it is used in vitro (outside the body) to assess the performance of a process that is critical for patient safety (high-level disinfection of endoscopes).
- Device Description: It's a chemical indicator that reacts to the presence and concentration of a specific chemical (peracetic acid). This type of chemical analysis is a common characteristic of IVD devices used for quality control or process monitoring in healthcare settings.
- Performance Studies: The performance studies focus on the device's ability to accurately detect specific levels of peracetic acid (sensitivity and specificity), which is a key aspect of validating an IVD's analytical performance.
- Predicate Device: The predicate device listed (K921559; STERIS PROCESS Chemical Monitor for the STERIS SYSTEM 1 Processing System) is also a chemical monitor used in a similar processing system, and devices of this nature are typically classified as IVDs.
While it doesn't directly test a biological sample from a patient, its function is to provide information about a critical process used in healthcare to ensure the safety of medical devices used on patients. This falls under the scope of IVD regulation.
N/A
Intended Use / Indications for Use
The Reliance PI Process Indicator is a single use chemical indicator designed to change from the "START" dark pink color to the "ENDPOINT" orange color or lighter upon exposure to an effective dose of peracetic acid generated from Reliance DG Dry Germicide during the Reliance Endoscope Processing Cycle.
The Reliance PI Process Indicator is intended to be used exclusively for the independent monitoring of the Reliance Endoscope Processing Cycle. The Reliance PI Process Indicator is not an indicator of load disinfection or cleaning efficacy.
Product codes
JOJ
Device Description
The Reliance PI Process Indicator is a single use chemical indicator strip that is designed to confirm an effective dose of peracetic acid (PAA), the active ingredient generated from Reliance DG Dry Germicide in the Reliance Endoscope Processor's HLD cycle.
This test strip consists of a 0.2-square inch reagent-containing indicator pad attached to one end of a 0.2 x 3.25-inch polystyrene handle. The indicator pad contains an indicator dye with a background dye that together form a dark pink color.
Upon exposure to the effective dose of PAA generated during the Reliance Endoscope Processing Cycle, the indicator dye only is oxidized by the Reliance DG Dry Germicide use dilution during the Reliance Endoscope Processing Cycle. During the processing cycle, the indicator pad color transitions through a lighter pink color until an orange coloration, based on the background dye, is visible.
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
healthcare 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)
Performance Testing:
- Kinetic Studies validated the Reliance Endoscope Processor's delivery of peracetic acid in concentrations appropriate for PI performance testing. Specially packaged Reliance DG Dry Germicide containers with two targeted PAA generation capacities were used for the majority of Reliance PI Process Indicator performance validation.
- Sensitivity Studies demonstrated that the Reliance PI Process Indicator develops the complete ENDPOINT color (pass) when the dose of PAA is >= 11,500 mg/L PAA min, and fails to reach that color (incomplete endpoint reading, not acceptable) when the PAA dose is = 11,500 mg/L PAA min, and fails to reach that color (incomplete endpoint reading, not acceptable) when the PAA dose is
§ 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
FOR RELIANCE ENDOSCOPE PROCESSING SYSTEM KO 43439888
FOR RELIANCE ENDOSCOPE PROCESSING SYSTEM KO 43439888
ST STERNICE ENDOSCOPE PROCESSING SYSTEM KO 4343988888888888888888888
| Date | July 5, 2006 | ||
|---|---|---|---|
| Submitter | STERIS Corporation | ||
| 5960 Heisley Road | |||
| Mentor Ohio 44060 USA | |||
| Telephone: 440-354-2600 | |||
| Contact | Nancy A. Robinson | ||
| Director, Advanced Sterilization | |||
| STERIS Corporation | |||
| 5960 Heisley Road | |||
| Mentor, OH 44060 USA |
Tel.: 440-392-7742
Fax: 440-392-8955
E-mail: nancy_robinson@steris.com | | |
| Device name | Proprietary Name:
Common Name:
Classification Name: | RelianceTM PI Process Indicator
Physical/Chemical Process Indicator
Physical/Chemical Process Indicator | |
| | The Reliance PI Process Indicator is substantially equivalent to the
STERIS PROCESS Chemical Monitor for the STERIS SYSTEM 1
Processing System (K921559) based on the following comparison: | | |
| | Property | RelianceTM PI
Process Indicator | STERIS PROCESS
Chemical Monitor
(K921559) |
| Legally marketed
devices to which
substantial
equivalence is
claimed | Intended use | The Reliance PI Process
Indicator is a single use
chemical indicator
designed to change from
the "START" dark pink
color to the "ENDPOINT"
orange color or lighter
upon exposure to an
effective dose of peracetic
acid generated from
Reliance DG Dry
Germicide during the
Reliance Endoscope
Processing Cycle. | Intended for use by
healthcare providers for
the detection of
peracetic acid, the
active ingredient of
STERIS 20 Sterilant,
during the STERIS
SYSTEM 1 sterilization
cycle. |
| | Design | 0.20" square, off-white
reagent pad affixed to one
end of a 3.25" x 0.20"
polystyrene strip. | 0.20" square, off-white
reagent pad affixed to
one end of a 3.25" x
0.20" polystyrene strip. |
| | Packaging | Fifty indicator strips per
screw-capped bottle with
desiccant. | Fifty indicator strips per
screw-capped bottle
with desiccant. |
| | Indicator agent | Triphenylmethane dye | Crystal violet |
| Legally marketed
devices to which
substantial
equivalence is
claimed, continued | Property | Reliance™ PI Process
Indicator | STERIS Process
Chemical Monitor
(K921559) |
| | Color change upon
exposure to
appropriate
concentrations of
peracetic acid. | Dark pink starting color to
orange endpoint color or
lighter. | Dark purple starting
color to pale grey or
lighter endpoint color |
| | Mechanism of color
change | Oxidation of indicator dye
by peracetic acid | Oxidation of indicator
dye by peracetic acid |
| | Cycle monitored | The Reliance Process high
level disinfection phase
consists of a 4-minute
generation time and a 6-
minute exposure to the
peracetic acid use dilution
at a temperature of
50 - 57°C. | The STERIS Process
sterilization cycle
consists of a 12-minute
exposure to the
peracetic acid use
dilution at a
temperature of
50 - 56°C. |
| | Endpoint
specifications | When the indicator is
exposed to peracetic acid
(PAA) at a dose ≥ 11,500
mg/L PAA min generated
from Reliance DG Dry
Germicide during the
Reliance Endoscope
Processing Cycle, there
will be a complete change
to endpoint color or lighter
in 100% of the indicator
strips.
When the indicator is
exposed to the minimum
recommended dose of
9000 mg/L PAA min or
less, there will be an
incomplete color change in
100% of the indicator
strips. | When the indicator is
exposed to production
lots of STERIS 20
Sterilant, there should
be a complete color
change to endpoint.
When the indicator is
exposed to a lowered
charge of the STERIS
20 Sterilant, there
should be an
incomplete color
change. |
| | Shelf-life | Based on current testing:
2 years unopened
6 months after opening | 2.5 years unopened
6 months after opening |
L-42
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RELIANCE™ PI PROCESS INDICATORSTRIPS : FOR RELIANCE ENDOSCOPE PROCESSING SYSTEM 510(K) SUMMARY
i
...
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RELIANCE™ PI PROCESS INDICATORSTRIPS FOR RELIANCE ENDOSCOPE PROCESSING SYSTEM 510(K) SUMMARY
| Device description | The Reliance PI Process Indicator is a single use chemical indicator
strip that is designed to confirm an effective dose of peracetic acid
(PAA), the active ingredient generated from Reliance DG Dry Germicide
in the Reliance Endoscope Processor's HLD cycle. | |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Device description | This test strip consists of a 0.2-square inch reagent-containing indicator
pad attached to one end of a 0.2 x 3.25-inch polystyrene handle. The
indicator pad contains an indicator dye with a background dye that
together form a dark pink color. | |
| | Upon exposure to the effective dose of PAA generated during the
Reliance Endoscope Processing Cycle, the indicator dye only is oxidized
by the Reliance DG Dry Germicide use dilution during the Reliance
Endoscope Processing Cycle. During the processing cycle, the indicator
pad color transitions through a lighter pink color until an orange
coloration, based on the background dye, is visible. | |
| Intended use | The Reliance PI Process Indicator is a single use chemical indicator
designed to change from the "START" dark pink color to the
"ENDPOINT" orange color or lighter upon exposure to an effective dose
of peracetic acid generated from Reliance DG Dry Germicide during the
Reliance Endoscope Processing Cycle. | |
| | The Reliance PI Process Indicator is designed to be used exclusively
for the independent monitoring of the Reliance Endoscope Processing
System. The Reliance PI Process Indicator is not an indicator of load
disinfection or cleaning efficacy. | |
| | The Reliance PI Process Indicator was developed and validated in
accordance with FDA's Guidance document: Content and Format of
Premarket Notification [510(k)] Submissions for Liquid Chemical
Sterilants/High Level Disinfectants (2000) | |
| | A summary of this testing follows: | |
| Performance
Testing | Kinetic Studies validated the Reliance Endoscope Processor's delivery
of peracetic acid in concentrations appropriate for PI performance
testing. Specially packaged Reliance DG Dry Germicide containers with
two targeted PAA generation capacities were used for the majority of
Reliance PI Process Indicator performance validation. | |
| | Sensitivity Studies demonstrated that the Reliance PI Process
Indicator develops the complete ENDPOINT color (pass) when the dose
of PAA is >= 11,500 mg/L PAA min, and fails to reach that color
(incomplete endpoint reading, not acceptable) when the PAA dose is