(149 days)
No
The device description and performance studies focus on a physical biological indicator and chemical integrator for monitoring sterilization cycles, with no mention of AI or ML.
No
The device is described as a "single use device designed to assess the effective performance of both gravity displacement and pre-vacuum steam sterilization processes." It is used for monitoring sterilization equipment, not for treating patients.
No
Explanation: The device is used to monitor and qualify steam sterilization processes, not to diagnose a medical condition in a patient. It assesses the performance of a sterilization process, which is a quality control function.
No
The device description clearly states it is a "single use device" consisting of physical components like "layers of paper," a "biological indicator," a "chemical integrator," and an "exterior containment box." This indicates it is a physical medical device, not software-only.
Based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "routine monitoring and sterilizer qualification testing of steam gravity displacement cycles" and "pre-vacuum steam sterilization cycles." This indicates it's used to assess the effectiveness of a sterilization process, which is a critical step in ensuring the safety of medical devices and preventing the transmission of infections.
- Device Description: The device contains a "biological indicator" and a "chemical integrator." Biological indicators, in the context of sterilization monitoring, typically contain spores of a highly resistant microorganism (like Geobacillus stearothermophilus for steam sterilization). The test involves exposing these spores to the sterilization process and then incubating them to see if they grow. Growth indicates a failure of the sterilization process. This process of using a biological agent to assess the effectiveness of a process is characteristic of in vitro diagnostics used for quality control and monitoring in healthcare settings.
- Performance Studies: The performance studies describe testing the device in steam sterilization cycles and evaluating its performance in detecting successful and failed cycles. This further supports its role in assessing the effectiveness of a process.
- Predicate Device: The predicate device is also a "SporView® Plus BI Test Pack," reinforcing that this type of device is categorized as a biological indicator test pack for sterilization monitoring.
While the text doesn't explicitly use the term "in vitro diagnostic," the function and intended use of the device align with the definition of an IVD, particularly those used for quality control and monitoring in healthcare settings to ensure the safety and effectiveness of medical procedures and devices. It's a test performed in vitro (outside the body) to evaluate the effectiveness of a process that directly impacts patient safety.
N/A
Intended Use / Indications for Use
The SPSmedical SporView® Plus Steam BI Test Pack with STEAMPlus Integrator is indicated for use in routine monitoring and sterilizer qualification testing of steam gravity displacement cycles at 121°C/250°F for 30 minutes exposure time and for use in pre-vacuum steam sterilization cycles at 132°C/270°F for 4 minutes exposure time.
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
Description of change to the legally marketed predicate device—The SporView® Plus BI Test Pack cleared under K051173 contained a biological which required 24 hours of incubation time. This submission aims to replace that biological with the Spor View® 10 Steam Self Contained Biological Indicator within the SporView® Plus BI Test Pack.
Functionality-The SporView® Plus BI Test Pack is a single use device designed to assess the effective performance of both gravity displacement and pre-vacuum steam sterilization processes.
Scientific Concepts—The SporView® Plus BI Test Pack provides a defined challenge to the sterilization process that is equal to or greater than the challenge posed by the AAMI reference PCD.
Physical Characteristics-The SporView® Plus BI Test Pack consists of layers of paper with a biological indicator and a load record card with chemical integrator placed in the center and 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 4-5/8" x 7/8" x 6-1/4". The load record card is used to record all the detailed information from the sterilization cycle.
Performance Characteristics-The performance of the SporView® Plus BI Test Pack has been demonstrated to be equivalent to that of the AAMI reference PCD.
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)
Validation of the SporView® Plus BI Test Pack was accomplished with performance testing in steam gravity and prevacuum cycles operating at 250°F/121°C and 270°F/132°C. All results from testing meet the predetermined acceptance criteria. All testing followed the FDA Guidance document for Industry and FDA Staff entitled, "Biological Indicator (BI) Premarket Notification [510(k)] Submissions," issued on October 4, 2007. Testing consisted of running test packs and control packs (predicate) within the same cycles for pass, fail and partial cycles at the end of the product's shelf life of eighteen (18) months.
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.
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/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2014
Crosstex International Mr. Michael Nolan Research and Development Coordinator 6789 West Henrietta Road Rush, NY 14543
Re: K140620
Trade/Device Name: SporView® Plus BI Test Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Biological Sterilization Process Indicator Regulatory Class: II Product Code: FRC July 9, 2014 Dated: Dated: Received: July 11, 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.
1
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 (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 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/Resourcesfor You/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 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Statement of Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K140620
SporView® Plus Steam BI Test Pack Device Trade Name:
INDICATIONS FOR USE:
The SPSmedical SporView® Plus Steam BI Test Pack with STEAMPlus Integrator is indicated for use in routine monitoring and sterilizer qualification testing of steam gravity displacement cycles at 121°C/250°F for 30 minutes exposure time and for use in pre-vacuum steam sterilization cycles at 132°C/270°F for 4 minutes exposure time.
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
Sreekanth Sigland Signaly Signed by Sieckanth Gutala -
Digitally signed by Sreekanth ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=2000 540490, cn=Sreekanth Gutala -S Date: 2014.08.06 11:54:54 -04'00'
3
510(k) Summary
SUBMITTER INFORMATION:
| SPSmedical Supply Corp. | Contact: | Michael G. Nolan |
|---|---|---|
| a division of Crosstex International | Research and Development Coordinator | |
| 6789 West Henrietta Road | Phone: | (800) 722-1529 |
| Rush, NY 14543 U.S.A. | Fax: | (585) 359-0167 |
| Date of Summary: | ||
| August 5, 2014 |
DEVICE INFORMATION:
| Device Trade Name: | SporView® Plus Steam BI Test Pack |
|---|---|
| Common Name: | Biological Test Pack |
| Classification Name: | Biological Sterilization Process Indicator 21 CFR § 880.2800(a) |
| Review Panel: | General Hospital |
| Product Code: | FRC |
| Device Class: | II |
PREDICATE DEVICE:
The SPSmedical SporView® Plus BI Test Pack cleared under K051173.
DEVICE DESCRIPTION:
Description of change to the legally marketed predicate device—The SporView® Plus BI Test Pack cleared under K051173 contained a biological which required 24 hours of incubation time. This submission aims to replace that biological with the Spor View® 10 Steam Self Contained Biological Indicator within the SporView® Plus BI Test Pack.
Functionality-The SporView® Plus BI Test Pack is a single use device designed to assess the effective performance of both gravity displacement and pre-vacuum steam sterilization processes.
Scientific Concepts—The SporView® Plus BI Test Pack provides a defined challenge to the sterilization process that is equal to or greater than the challenge posed by the AAMI reference PCD.
Physical Characteristics-The SporView® Plus BI Test Pack consists of layers of paper with a biological indicator and a load record card with chemical integrator placed in the center and 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 4-5/8" x 7/8" x 6-1/4". The load record card is used to record all the detailed information from the sterilization cycle.
Performance Characteristics-The performance of the SporView® Plus BI Test Pack has been demonstrated to be equivalent to that of the AAMI reference PCD.
INTENDED USE:
NOTE: The intended use of the modified device, as described in the labeling, has not changed as a result of the modification.
The SPSmedical SporView® Plus Steam BI Test Pack is designed to monitor sterilization cycles in both gravity displacement and pre-vacuum steam sterilizers. It is to be used for routine monitoring and qualification testing of steam sterilizers.
TECHNICAL CHARACTERISTICS:
The outer box and layers of paper within the SporView® Plus BI Test Pack provide a significant challenge to air removal and subsequent steam penetration of prevacuum and gravity steam The Load Record Card with STEAMPlus™ Steam Integrator allow for an immediate sterilizers. observation of cycle performance with 10 hour incubation results of the SporView® 10 Steam Self Contained Biological Indicator offers complete assurance of cycle performance. The external process indicator alerts users when a pack has seen the sterilization process.
4
RECOMMENDED STORAGE CONDITIONS:
Store in a cool, dry place (15-30°C).
NON-CLINICAL TESTING:
Validation of the SporView® Plus BI Test Pack was accomplished with performance testing in steam gravity and prevacuum cycles operating at 250°F/121°C and 270°F/132°C. All results from testing meet the predetermined acceptance criteria. All testing followed the FDA Guidance document for Industry and FDA Staff entitled, "Biological Indicator (BI) Premarket Notification [510(k)] Submissions," issued on October 4, 2007. Testing consisted of running test packs and control packs (predicate) within the same cycles for pass, fail and partial cycles at the end of the product's shelf life of eighteen (18) months.
COMPONENTS:
The Spor View® Plus BI Test Pack Components are equivalent to its original filing with the exception of the Spor View® Steam Self Contained Biological Indicator.
- Subject of this change SporView® 10 Steam Self Contained Biological Indicator (K122024)
- Load Record Card with STEAMPlus™ Steam Integrator (K051173) o
- External Process Indicator with lot and expiration information (K051173) ●
- o Outer box and paper inserts (K051173)
SUBSTANTIAL EQUIVALENCE DISCUSSION
SPSmedical has identified the SporView® Plus BI Test Pack (K051173) as the (primary) predicate device. We believe the predicate device to be substantially equivalent to the subject device in terms of their intended use and functional characteristics as they are essentially the same device. See a comparison of the subject device to the predicate device (K051173) in Table 1.
PREDICATE I.D .:
| Trade Name: | SporView® Plus BI Test Pack |
|---|---|
| Model No.: | SBT-025 (25 controls) & SBT-255 (5 controls) |
| 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.: | K051173 |
COMPARISON OF INDICATIONS FOR USE (IFU):
Predicate IFU K051173-The SPSmedical SporView® Plus Steam BI Test Pack with STEAMPlus Integrator is indicated for use in routine and challenge testing of steam gravity displacement cycles at 121°C/250°F for 30 minutes exposure time or longer and for use in pre-vacuum steam sterilization cycles at 132°C/270°F for 4 minutes exposure time or longer.
Subject IFU K140620—The SPSmedical SporView® Plus Steam BI Test Pack with STEAMPlus Integrator is indicated for use in routine monitoring and sterilizer qualification testing of steam gravity displacement cycles at 121°C/250°F for 30 minutes exposure time and for use in pre-vacuum steam sterilization cycles at 132°C/270°F for 4 minutes exposure time.
Compared to the predicate the subject device has changes for clarity but is otherwise the same.
DESIGN DIFFERENCES PREDICATE VS. SUBJECT DEVICE:
The Predicate Device contains the SporView® Steam Self-Contained Biological Indicator which was cleared under K070595. The Subject Device contains the SporView® 10 Steam Self Contained Biological Indicator which was cleared under K122024.
5
FUNCTIONAL CHARACTERISTICS:
The SporView® Plus Steam BI Test Pack is designed to create a significant challenge to air removal and steam penetration. Like the AAMI test pack, the SPSmedical SporView® Plus Steam BI Test Pack provides a significant challenge to the steam sterilization process and is used for routine monitoring and qualification testing of gravity displacement and pre-vacuum steam sterilizers. Both have internal steam monitoring components located within the center of the pack and chemical indicator located on the pack.
DISCUSSION:
SPSmedical is claiming substantial equivalence for its SporView® Plus Steam BI Test Pack to the original SporView® Plus Steam BI Test Pack (K051173) based on test data obtained during validation studies. We have demonstrated with testing that the Spor View® Plus Steam BI Test Pack performs consistently when run in steam gravity and prevacuum cycles operating at 250°F/121°C and 270°F/132°C for pass, fail and partial cycles.
SUBSTANTIAL EQUIVALENCE CONCLUSIONS:
The SporView® Plus Steam BI Test Pack has the same intended use and characteristics as the predicate Spor View® Plus Steam BJ Test Pack. They both provide a significant challenge to the steam sterilization process. Testing data demonstrates the subject device is substantially equivalent to the predicate device.
| Element | Subject Device
(K140620) | Predicate
(K051173) |
|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use: method
of sterilization
process parameters | Steam
250°F/121°C 30 minutes
270°F/132°C 4 minutes | Steam
250°F/121°C 30 minutes
270°F/132°C 4 minutes |
| Indications for Use
(IFU) | The SPSmedical SporView® Plus Steam BI Test
Pack with STEAMPlus Integrator is indicated
for use in routine monitoring and sterilizer
qualification
testing
of steam
gravity
displacement cycles at 121°C/250°F for 30
minutes exposure time and for use in pre-vacuum
steam sterilization cycles at 132°C/270°F for 4
minutes exposure time. | The SPSmedical SporView® Plus Steam BI Test
Pack with STEAMPlus Integrator is indicated
for use in routine and challenge testing of steam
gravity displacement cycles at 121°C/250°F for
30 minutes exposure time or longer and for use
in pre-vacuum steam sterilization cycles at
132°C/270°F for 4 minutes exposure time or
longer. |
| Labeling | Equivalent, except for 10 hour
incubation time | Equivalent, except for 24 hour
incubation time |
| Organism: spore
species
& strain | Geobacillus Stearothermophilus
ATCC 7953 | Geobacillus Stearothermophilus
ATCC 7953 |
| Viable spore
population | $10^5$ or greater | $10^5$ or greater |
| Resistance
characteristics | Equivalent, calculated per USP | Equivalent, calculated per USP |
| Culture Conditions | 55-60°C | 55-60°C |
| Carrier Materials | Whatman Paper | Whatman Paper |
| Packaging: primary &
secondary | Equivalent | Equivalent |
| Storage | Equivalent | Equivalent |
| Shelf Life | Eighteen (18) months | Eighteen (18) months |