(107 days)
No
The device description and performance studies focus on a physical process challenge device and biological/chemical indicators, with no mention of AI or ML.
No
The device is a test pack used for monitoring and validating a sterilizer, not for treating patients.
No
The device is a Process Challenge Device (PCD) designed to monitor the performance of a sterilizer, not to diagnose a disease or condition in a patient. It assesses the effectiveness of a sterilization process.
No
The device description explicitly states that the device is composed of physical components (Self-contained Biological Indicator, syringe, plunger, diffusion restrictor, Chemical Indicator) and is a Process Challenge Device (PCD), which is a physical item used to challenge a sterilization process. There is no mention of software as a component or function of the device.
Based on the provided information, the STERIZONE® VP4 Test Pack is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for monitoring and validating the performance of a sterilizer (STERIZONE® VP4 Sterilizer). This is a quality control function for a medical device (the sterilizer), not a diagnostic test performed on a biological sample from a patient to diagnose a condition or disease.
- Device Description: The device is described as a Process Challenge Device (PCD) designed to simulate products being sterilized and challenge the sterilization process. It contains a biological indicator and a chemical indicator, which are used to assess the effectiveness of the sterilization cycle. This is consistent with a sterilization monitoring device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status
- Being used for diagnosis, monitoring, or screening of diseases
The device's function is to ensure that the sterilization process is effective in killing microorganisms on medical devices, which is a critical step in preventing infections. This falls under the category of sterilization process indicators, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The STERIZONE® VP4 Test Pack is intended to be used for routine monitoring of the STERIZONE® VP4 Sterilizer cycle (Cycle 1) and for the performance validation of the STERIZONE® VP4 Sterilizer system.
Product codes
FRC
Device Description
The STERIZONE® VP4 Test Pack is a Process Challenge Device (PCD) designed to have greater resistance than the worst-case sterilization load of the STERIZONE® VP4 Sterilizer. The STERIZONE® VP4 Test Pack is intended to simulate products to be sterilized and to constitute a defined challenge to the sterilization process and used to assess the effective performance of the process.
The STERIZONE® VP4 Test Pack cleared under K141580 contained a biological indicator (STERIZONE® BI+) which required 18 hours of incubation time. This Traditional 510(k) submission aims to qualify an additional biological indicator -Terragene's Bionova® BT96 (hereinafter referred to as "BT96") within the STERIZONE® VP4 Test Pack (hereinafter referred to as "Test Pack"). BT96 is a rapid biological indicator with 30 mins of incubation time and is cleared under K191021 for monitoring the effectiveness of sterilization processes that use vaporized hydrogen peroxide as the primary sterilant, including the STERIZONE® VP4 Sterilizer. The Test Pack with STERIZONE® BI+ cleared under K141580 will continue to be an option for customers to use.
The STERIZONE® VP4 Test Pack (subject device) is composed of a Self-contained Biological Indicator (the Terragene's Bionova® BT96), a 10 mL syringe and its plunger, and a diffusion restrictor. A STERIZONE® CI+ Chemical Indicator is also added, external to the syringe, to allow differentiating processed from unprocessed test packs. All components of the Test Pack are single-use, disposable items.
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)
The performance of the subject STERIZONE® VP4 Test Pack (using BT96) was evaluated in accordance with FDA guidance document for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions," issued on October 4, 2007. All results from testing meet the predetermined acceptance criteria.
Half-cycle Survivability:
- Test Purpose: Determine if the SCBI, when used within the Test Pack, can provide a resistance to the sterilization process that is equal to or greater than the most difficult item routinely processed in the sterilizer, per ISO 14937, ISO 11138-7 and the Guidance for Industry and Staff – Biological-Indicator (BI) Premarket Notification [510(k)] Submission.
- Test Acceptance Criteria: The SCBI in the Test Pack must show growth at half-cycle in all the limit parameter loads tested.
- Subject Device Test Result: The SCBI in the Test Pack showed growth at half-cycle in all the limit parameter loads tested.
Full cycle inactivation:
- Test Purpose: Determine if the SCBI used within the Test Pack can repeatedly and consistently show an inactivation point in the second half of the sterilization cycle.
- Test Acceptance Criteria: The SCBI in the Test Packs must demonstrate a survival ratio of 0% at least at the full cycle using the worst-case challenge load.
- Subject Device Test Result: The SCBI in the Test Pack shows survival ratio of 0% in the second half of the sterilizer cycle, thus shows total inactivation by the end of a full cycle.
Increased resistance:
- Test Purpose: Determine if the use of the Test Pack provides a greater challenge to the process than the BI itself, per Guidance for Industry and Staff - Biological-Indicator (BI) Premarket Notification [510(k)] Submission.
- Test Acceptance Criteria: The SCBI in the VP4 Test Pack must show a higher survival ratio than its naked counterpart.
- Subject Device Test Result: When exposed to the same partial cycles, the SCBI in the Test Pack showed growth while the naked SCBI was fully inactivated.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.
March 24, 2021
TSO3 Inc., Now a part of Stryker Karan Modi, MS, RAC Staff Regulatory Affairs Specialist 1941. Stryker Wav Portage, Michigan 49002 USA
Re: K203560
Trade/Device Name: STERIZONE VP4 Test Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: February 19, 2021 Received: February 23, 2021
Dear Karan Modi:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Clarence W. Murray, III, PhD. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203560
Device Name STERIZONE® VP4 Test Pack
Indications for Use (Describe)
The STERIZONE® VP4 Test Pack is intended to be used for routine monitoring of the STERIZONE® VP4 Sterilizer cycle (Cycle 1) and for the performance validation of the STERIZONE® VP4 Sterilizer system.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/1 description: The image shows a chemical structure diagram. The diagram includes the letters 'T' and 'S' on the left side. To the right of the letters, there is a chemical structure with an 'O' in the center and a subscript '3' at the bottom right.
1. Submitter
510(k) Owner:
TSO3 Inc., Now a part of Stryker 2505, avenue Dalton Québec (Québec) G1P 3S5 Canada
FDA Establishment Registration Number:
Contact Person:
3004148947
Karan Modi, MS, RAC Staff Regulatory Affairs Specialist Stryker Instruments 1941 Stryker Way Portage, Michigan 49002 USA P 269 888 0305 karan.modi@stryker.com
Date Submitted:
March 24, 2021
Subject Device Name 2.
| Trade Name: | STERIZONE® VP4 Test Pack |
|---|---|
| Common Name: | Biological Indicator (Test Pack) |
| Classification: | Class II |
| Classification Product Code: | FRC |
| Classification Name: | Indicator, Biological Sterilization Process |
| Classification Regulation: | 21CFR 880.2800 |
| Review Panel: | General Hospital |
| Submission Type: | Traditional 510(k) |
4
$$\mathbb{S}^{\mathbb{S}}$$
Legally Marketed Predicate Device 3.
| Predicate Device | |
|---|---|
| STERIZONE® VP4 Test Pack | K141580 |
| Reference Device | |
| Terragene Bionova® SCBI (BT96) | K191021 |
4. Device Description
The STERIZONE® VP4 Test Pack is a Process Challenge Device (PCD) designed to have greater resistance than the worst-case sterilization load of the STERIZONE® VP4 Sterilizer. The STERIZONE® VP4 Test Pack is intended to simulate products to be sterilized and to constitute a defined challenge to the sterilization process and used to assess the effective performance of the process.
The STERIZONE® VP4 Test Pack cleared under K141580 contained a biological indicator (STERIZONE® BI+) which required 18 hours of incubation time. This Traditional 510(k) submission aims to qualify an additional biological indicator -Terragene's Bionova® BT96 (hereinafter referred to as "BT96") within the STERIZONE® VP4 Test Pack (hereinafter referred to as "Test Pack"). BT96 is a rapid biological indicator with 30 mins of incubation time and is cleared under K191021 for monitoring the effectiveness of sterilization processes that use vaporized hydrogen peroxide as the primary sterilant, including the STERIZONE® VP4 Sterilizer. The Test Pack with STERIZONE® BI+ cleared under K141580 will continue to be an option for customers to use.
The STERIZONE® VP4 Test Pack (subject device) is composed of a Self-contained Biological Indicator (the Terragene's Bionova® BT96), a 10 mL syringe and its plunger, and a diffusion restrictor. A STERIZONE® CI+ Chemical Indicator is also added, external to the syringe, to allow differentiating processed from unprocessed test packs. All components of the Test Pack are single-use, disposable items.
5
Image /page/5/Picture/1 description: The image shows a chemical structure diagram. The diagram includes the letters 'T' and 'S' on the left side. To the right of the letters, there is a chemical structure with 'O' and the number '3' at the bottom right.
5. Intended Use/Indications for use
The STERIZONE® VP4 Test Pack is intended to be used for routine monitoring of the STERIZONE® VP4 Sterilizer cycle (Cycle 1) and for the performance validation of the STERIZONE® VP4 Sterilizer system.
Comparison of Technological Characteristics with the Predicate 6. Device
The following table identifies technological characteristics shared between the Predicate and Subject device:
| Features | STERIZONE® VP4 Test Pack
(Predicate Device- K141580) | STERIZONE® VP4 Test Pack (Subject Device) |
|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product description | A Self-contained BI, and a syringe with diffusion restrictor for holding the BI during the sterilization cycle, along with a process chemical indicator. | Same |
| Picture of the device | Image: STERIZONE VP4 Test Pack (Predicate Device- K141580) | Image: STERIZONE VP4 Test Pack (Subject Device) |
| Intended Use | Routine monitoring of the STERIZONE® VP4 Sterilizer cycle and performance validation of the STERIZONE® VP4 Sterilizer system | Same |
| Indications for Use | The STERIZONE® BI+ Self-contained Biological Indicator (SCBI) is intended for routine monitoring of the STERIZONE® VP4 Sterilizer, which offers a single pre-set sterilization cycle (“Cycle 1”). The SCBI should only be used in a Test Pack configuration to monitor Cycle 1. The SCBI placed within the STERIZONE® VP4 Test Pack monitors exposure to both vaporized hydrogen peroxide (H2O2 or VHP) and ozone (O3) which are both used in the STERIZONE® VP4 Sterilizer. The STERIZONE® VP4 Test Pack is intended to have equivalent to greater resistance than worst case devices and loads in any load configuration. | The STERIZONE® VP4 Test Pack is intended to be used for routine monitoring of the STERIZONE® VP4 Sterilizer cycle (Cycle 1) and for the performance validation of the STERIZONE® VP4 Sterilizer system. |
| Features | STERIZONE® VP4 Test Pack
(Predicate Device- K141580) | STERIZONE® VP4 Test
Pack (Subject Device) |
| | The STERIZONE® VP4 Test Pack is a device composed of
the STERIZONE® BI+ Self-contained Biological Indicator
(TSO3 product code 42602, including crusher), a 10 mL
syringe and its plunger, and a diffusion restrictor (sold in the
form of a kit - TSO3 product code: 44020). An external
STERIZONE® CI+ Chemical Indicator (TSO3 product code
43810) is also added to allow differentiating processed from
unprocessed test packs. All components of the Test Pack are
single-use, disposable items.
The STERIZONE® VP4 Test Pack is constructed by first
inserting the STERIZONE® BI+ Self-contained Biological
Indicator inside the syringe, with the SCBI cap facing to the
Luer-lock of the syringe. The plunger is then inserted to the
10 mL mark of the syringe. The diffusion restrictor is
screwed to the Luer-lock of the syringe. The chemical
indicator is then inserted in the opening between the plunger
and the syringe.
The test pack is then placed within the load on the upper
shelf of the STERIZONE® VP4 Sterilizer loading rack.
After processing, the SCBI is retrieved from the test pack.
The SCBI is intended to provide users with a means to
assess spore kill by the STERIZONE® VP4 Sterilizer. A
"no growth" result from the SCBI after 18 hours of
incubation indicates that the process achieved the conditions
necessary to kill at least $1 \times 10^6$ viable spores of Geobacillus
stearothermophilus (6 logs) on the SCBI inoculated stainless
steel carrier. | |
| Contraindication | Do not use in a system other than the STERIZONE® VP4 Sterilizer.Do not reuse any test pack component after it has been processed in the STERIZONE® VP4 Sterilizer. | Same |
| Sterilizer to
be
monitored
by the test
pack | STERIZONE® VP4 Sterilizer | Same |
| Biological
indicator | STERIZONE® BI+ Self-contained Biological Indicator
(K141580) | Terragene Bionova® SCBI
(BT96) (K191021) |
| Features | STERIZONE® VP4 Test Pack
(Predicate Device- K141580) | STERIZONE® VP4 Test
Pack (Subject Device) |
| | Geobacillus stearothermophilus
ATCC 7953 spores | Geobacillus
stearothermophilus ATCC
7953 spores |
| Holder | Syringe and plunger-
10 mL Becton-Dickinson (BD) plastic syringe with Luer-
Lok™ connector and its plunger | Same |
| Diffusion
restrictor | 18 gauge (1.02 mm diameter),
2-inch (50.8 mm) long polytetrafluoroethylene (PTFE)
cannula with Luer-lock attachment | Same |
| Chemical
Indicator | STERIZONE® CI+ Chemical Indicator | Same |
| Resistance
characteristics | Demonstrated to have equivalent or greater resistance than
the worst case devices and loads in any load configuration.
Demonstrated to be more resistant than the half-cycle,
including exposure to hydrogen peroxide and ozone. | Same |
Table 1. Comparison of the subject and the predicate (K141580) STERIZONE® VP4 Test Pack devices
6
TSO₃
7
$$\mathbb{S}^{\mathbb{S}}$$
The intended use of the modified device, as described in the labeling, has not changed as a result of the modification.
The STERIZONE® VP4 Test Pack components are identical to its original filing with the exception of the Self-Contained Biological Indicator.
- Bionova® BT96 Super Rapid Readout Biological Indicator from Terragene -(K191021)
- A diffusion restrictor (same as predicate): PTFE canula of 18 gauge and 2 inches -(5.1 cm) in length (with a Luer-lock connector) (K141580)
- A plastic syringe (same as predicate): A 10 mL Becton Dickinson (BD) plastic syringe with Luer-Lok™ tip (K141580)
- A chemical indicator (same as predicate): STERIZONE® CI+ Chemical Indicator -(K141580 and K141698)
The difference in the self-contained biological indicator between the subject and predicate device was considered in relation to the substantial equivalence determination:
The predicate Test Pack (PCD) contains the STERIZONE® BI+ Self-contained Biological Indicator (BI+) which was cleared under K141580. The subject Test Pack
8
TSO₃
(PCD) contains the Bionova® BT96 Super Rapid Readout Biological Indicator from Terragene. The BT96 biological indicator is cleared for monitoring the effectiveness of STERIZONE® VP4 Sterilizer under K191021 and is therefore used in this submission as a reference device. Similar to the BI+, the BT96 is a self-contained biological indicator inoculated with at least 106 Geobacillus stearothermophilus viable bacterial spores. The qualification of BT96 as a biological challenge device for use within the Test Pack would provide a rapid readout option to the users. The BT96 biological indicator offers rapid readout (30 mins incubation time) compared to 18 hours with the current BI+.
7. Performance Testing - Bench
The performance of the subject STERIZONE® VP4 Test Pack (using BT96) was evaluated in accordance with FDA guidance document for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions," issued on October 4, 2007. All results from testing meet the predetermined acceptance criteria.
The following performance data were provided in support of the substantial equivalence determination:
| Test Name | Test Purpose | Test Acceptance
Criteria | Subject Device Test
Result |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Half-cycle
Survivability | Determine if the SCBI, when used
within the Test Pack, can provide a
resistance to the sterilization process
that is equal to or greater than the most
difficult item routinely processed in the
sterilizer, per ISO 14937, ISO 11138-7
and the Guidance for Industry and Staff
– Biological-Indicator (BI) Premarket
Notification [510(k)] Submission. | The SCBI in the Test
Pack must show
growth at half-cycle
in all the limit
parameter loads
tested. | The SCBI in the Test
Pack showed growth at
half-cycle in all the limit
parameter loads tested. |
| Full cycle
inactivation | Determine if the SCBI used within the
Test Pack can repeatedly and
consistently show an inactivation point
in the second half of the sterilization
cycle. | The SCBI in the Test
Packs must
demonstrate a
survival ratio of 0%
at least at the full
cycle using the worst-
case challenge load. | The SCBI in the Test
Pack shows survival
ratio of 0% in the second
half of the sterilizer
cycle, thus shows total
inactivation by the end
of a full cycle. |
| Increased
resistance | Determine if the use of the Test Pack
provides a greater challenge to the
process than the BI itself, per Guidance
for Industry and Staff - Biological-Indicator (BI) Premarket Notification
[510(k)] Submission. | The SCBI in the VP4
Test Pack must show
a higher survival ratio
than
naked
its
counterpart. | When exposed to the
same partial cycles, the
SCBI in the Test Pack
showed growth while the
naked SCBI was fully
inactivated. |
Table 2. Summary of Nonclinical Testing:
9
Traditional 510(k) – K203560 STERIZONE® VP4 Test Pack
(ປີ
K203560 - 510(k) Summary
Conclusion 8.
The performance testing demonstrates that the subject STERIZONE® VP4 Test Pack is substantially equivalent to the identified predicate STERIZONE® VP4 Test Pack (K141580).