(21 days)
Not Found
No
The document describes a biological indicator test pack for monitoring steam sterilization cycles and does not mention any AI or ML components.
No.
This device is designed for monitoring sterilization cycles, not for treating any medical condition or disease.
No
Explanation: The device is a sterilization process indicator used to monitor the effectiveness of steam sterilization cycles, not to diagnose a medical condition in a patient.
No
The device description clearly states it is a "single use PCD" (Process Challenge Device) and describes physical components like biological indicators and integrators, indicating it is a hardware device used for monitoring sterilization cycles.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "routine and challenge testing of steam gravity displacement cycles" and "pre-vacuum steam sterilization cycles." This describes a quality control or monitoring process for sterilization equipment, not a diagnostic test performed on a biological sample from a patient.
- Device Description: The device is described as a "single use PCD used for the monitoring of both gravity displacement and pre-vacuum steam sterilization cycles." PCD stands for Process Challenge Device, which is used to assess the effectiveness of a sterilization process.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
Therefore, this device falls under the category of a sterilization process indicator or monitor, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SPSmedical SporView®Plus Steam Bl Test pack is designed to monitor sterilization cycles in both gravity displacement and pre-vacuum steam sterilizers. It is to be used for routine and challenge monitoring of steam sterilizers.
The SPSmedical SporView®Plus Steam B1 Test Pack with STEAMPlus Integrator is indicated for use in routine and challenge testing of steam gravity displacement cycles at indication for ace in rouintes 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.
Product codes
80FRC, FRC
Device Description
The SPSmedical modified SporView Plus Steam BI Test pack is a single use PCD used for the monitoring of both gravity displacement and pre-vacuum steam sterilization cycles.
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
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Description of the test set, sample size, data source, and annotation protocol
Testing was performed in a 121°C (250°F) gravity displacement sterilizer and in a pre-vacuum steam sterilizer operating at 132°C (270°F). Three separate lots of biological indicators containing G. stearothermophilus spores were used. The validation study involved preparing AAMI biological indicator test packs as indicated in AAMI standard ST-46:2002, section 7.5.2. A biological indicator and STEAMPlus Integrator were placed within the center of each AAMI biological indicator test pack and within the SporView Plus Steam Bl Test pack. Complete survival, partial survival and complete kill cycles were run in a gravity displacement steam sterilizer at 121°C (250°F) and in a prevacuum steam sterilizer operating at 132°C (270°F).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The biological indicators in the SporView Plus Bl Test packs were found to be equivalent in performance to those located within the AAMI biological indicator test packs. In addition a biological indicator and STEAMPlus Integrator were placed within the center of the predicate test pack and within the SporView Plus Steam Bl Test pack. Complete survival, partial survival and complete kill cycles were run in a gravity displacement steam sterilizer at 121°C (250°F) and in a pre-vacuum steam sterilizer operating at 132°C (270°F). The biological indicators in the SporView®Plus Bl Test packs were found to be equivalent in performance to those located within the predicate test packs.
Conclusion: SPSmedical Sporview Plus Steam Bl Test pack has undergone appropriate validation. For all the foregoing reasons, SPSmedical believes that the SporView Plus Steam BI Test pack is equivalent to the predicate SPSmedical pack when used for routine and challenge monitoring of steam sterilizers and can be safely marketed in the United States.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
MAY 27 2005
K051173
p1of2
510(k) Summary of Safety and Effectiveness
Submitter:
- SPSmedical Supply Corp. . 6789 West Henrietta Road Rush, NY 14543 U.S.A. Phone: (585)-359-0130 Fax: (585)-359-0167
- Establishment FDA Registration No.: 1319130 .
- May 5th, 2005 Date Summary was Prepared .
- Gary J. Socola . Printed name of person submitting for 510(k)
- X Jan ાજીન . Signature of person submitting for 510(k)
- Vice President, Scientific Affairs . Title of person submitting for 510(k)
Device Name and Classification
| Trade Name: | SPSmedical SporView® Plus BI Test Pack |
|---|---|
| Classification Name: | Biological Indicator |
| Common Name: | Biological Test Pack |
| Device Classification: | Class II, Regulation No. 880.2800 |
| Product Code: | 80FRC |
| Predicate Device: | SPSmedical SporView® BI Test Pack (K022706) |
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K051173
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Device Description:
The SPSmedical modified SporView Plus Steam BI Test pack is a single use PCD used for the monitoring of both gravity displacement and pre-vacuum steam sterilization cycles.
Intended Use:
The SPSmedical SporView®Plus Steam Bl Test pack is designed to monitor sterilization cycles in both gravity displacement and pre-vacuum steam sterilizers. It is to be used for routine and challenge monitoring of steam sterilizers.
Statement of Similarity to the Legally Marketed Predicate Device:
- Have the same indicated use .
- Are run in the same sterilization cycles .
- Incorporate the same materials .
- Have the same shelf life .
- Have the same storage conditions .
- Packaged using the same materials and processes .
Non-Clinical Testing:
Testing was performed in a 121°C (250°F) gravity displacement sterilizer and in a pre-vacuum steam sterilizer operating at 132°C (270°F). Three separate lots of biological indicators containing G. stearothermophilus spores were used. The validation study involved preparing AAMI biological indicator test packs as indicated in AAMI standard ST-46:2002, section 7.5.2. A biological indicator and STEAMPlus Integrator were placed within the center of each AAMI biological indicator test pack and within the SporView Plus Steam Bl Test pack. Complete survival, partial survival and complete kill cycles were run in a gravity displacement steam sterilizer at 121°C (250°F) and in a prevacuum steam sterilizer operating at 132°C (270°F). The biological indicators in the SporView Plus Bl Test packs were found to be equivalent in performance to those located within the AAMI biological indicator test packs. In addition a biological indicator and STEAMPlus Integrator were placed within the center of the predicate test pack and within the SporView Plus Steam Bl Test pack. Complete survival, partial survival and complete kill cycles were run in a gravity displacement steam sterilizer at 121°C (250°F) and in a pre-vacuum steam sterilizer operating at 132°C (270°F). The biological indicators in the SporView®Plus Bl Test packs were found to be equivalent in performance to those located within the predicate test packs.
Conclusion:
SPSmedical Sporview Plus Steam Bl Test pack has undergone appropriate validation. For all the foregoing reasons, SPSmedical believes that the SporView Plus Steam BI Test pack is equivalent to the predicate SPSmedical pack when used for routine and challenge monitoring of steam sterilizers and can be safely marketed in the United States.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines extending from its head, representing health, services, and people. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 27 2005
Mr. Gary J. Socola Vice President, Scientific Affairs SPSmedical Supply Corporation 6789 West Henrietta Road Rush, New York 14543
Re: K051173
Trade/Device Name: SporView Plus Steam BI Test Pack Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: May 5, 2005 Received: May 9, 2005
Dear Mr. Socola:
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 Amerade even ar 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 Eederal Register.
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Page 2 - Mr. Socola
Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be act rised that 12 a determination that your device complies with other requirements modifine act or any Federal statutes and regulations administered by other Federal agencies. of the Fet of all , I eachar the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and insting (2) see t forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quadis ion 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 premainer notaries 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), If you dealts 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,
Chiu Lin, Ph.D.
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
4
INDICATIONS for USE STATEMENT
SPSmedical Supply Corp. Applicant: ___________________________________________________________________________________________________________________________________________________________________
KOSI173 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
SporView®Plus Steam Bl Test Pack Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The SPSmedical SporView®Plus Steam B1 Test Pack with STEAMPlus Integrator is indicated for use in routine and challenge testing of steam gravity displacement cycles at indication for ace in rouintes 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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use × (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shule H. Murphy R.S./1/15
Alon Sinn-Off) ം പ nesthesiology, General Hospital, o betor Control. Dental Devices
Number. 1051173
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