(62 days)
Not Found
No
The document describes a biological indicator kit for monitoring sterilization, which is a chemical/biological process, not a technology that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
This device is a biological indicator used to monitor the effectiveness of a sterilization process, not to treat a medical condition.
No
Explanation: This device is for monitoring the effectiveness of a sterilization process, specifically for the STERIS System 1® sterilizer. It uses biological indicators to confirm if sterilization conditions were achieved, rather than diagnosing a medical condition in a patient.
No
The device description clearly indicates physical components like paper strips inoculated with spores, sterile tubes of culture media, and a transfer clip, which are hardware.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended to "provide independent confirmation that sterilization conditions were achieved" by monitoring a sterilization process. This involves testing a sample (the spore strip) in vitro (outside of a living organism) to determine the effectiveness of the sterilization.
- Device Description: The device contains biological indicators (spores) and culture media. The process involves incubating the spores in the media to see if they grow, which indicates a failure in sterilization. This is a classic in vitro diagnostic test for sterilization efficacy.
- Predicate Device: The predicate device, the Castle® SPOR-TEST PA Biological Indicator Kit (K020205), is also a biological indicator for sterilization monitoring, which falls under the category of IVDs.
Therefore, the SPSmedical SporView® PA Culture Set fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SporView® PA Culture Set is only intended to monitor the STERIS System 1® liquid chemical sterilization system using STERIS® 20 sterilant. The SporViews PA Culture Set was qualified using Spor View" Culture Media. The use of the product is restricted to the Sport Views biological indicator spore strip and media only. When tested at 1,000 ppm peracetic acid, 50 ℃ the Spor View PA Culture Set will survive at 41 seconds and will be killed at 6 aminutes.
The SPSmedical SporView® PA Culture Set is intended for use with the STERIS System 1® sterilizer using STERIS® 20 sterilant only. The STERIS System 1® is a liquid chemical sterilization process. The SporView PA Culture Set provides independent confirmation that sterilization conditions were achieved during the STERIS System 1® processing cycle. A reduced incubation time of 24 hours has been validated for the Spor View PA Culture Set using SPSmedical's SporView® culture media.
Product codes (comma separated list FDA assigned to the subject device)
MRB
Device Description
Spor View PA Culture Set is intended to monitor the STERIS System 1® peracetic acid sterilization process using the STERIS® 20 sterilant. The product contains paper strips the are inoculated with G. stearothermophilus spores (formally known as Bacillus stearothermonities) at a nominal population of 1 x 10 per strip. Sterile tubes of Spor View Culture Media mopiditied soybean casein broth) and a transfer clip are included. The product is intended to be uned in en identical manner as the Castle® SPOR-TEST PA Biological Indicator Kit.
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)
Not Found
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
510(k) Summary Statement (043135
| Date Prepared: | November 8, 2004 |
|---|---|
| Submitter's Name/Address: | SPSmedical Supply Corp. |
| 6789 West Henrietta Road | |
| Rush, NY 14543 | |
| Contact Person: | Gary J. Socola, Vice President |
| Phone (585)-624-2419 | |
| Trade Name: | SporView® PA Culture Set |
| Classification: | Sterilization Process Indicator - 21 CFR 880.2800 (a) Class I |
| Predicate Device: | Castle® SPOR-TEST PA Biological Indicator Kit (K020205) |
Device Description:
Spor View PA Culture Set is intended to monitor the STERIS System 1® peracetic acid sterilization process using the STERIS® 20 sterilant. The product contains paper strips the are inoculated with G. stearothermophilus spores (formally known as Bacillus stearothermonities) at a nominal population of 1 x 10 per strip. Sterile tubes of Spor View Culture Media mopiditied soybean casein broth) and a transfer clip are included. The product is intended to be uned in en identical manner as the Castle® SPOR-TEST PA Biological Indicator Kit.
Intended Use:
The SporView® PA Culture Set is only intended to monitor the STERIS System 1® liquid chemical sterilization system using STERIS® 20 sterilant. The SporViews PA Culture Set was qualified using Spor View" Culture Media. The use of the product is restricted to the Sport Views biological indicator spore strip and media only. When tested at 1,000 ppm peracetic acid, 50 ℃ the Spor View PA Culture Set will survive at 41 seconds and will be killed at 6 aminutes.
Comparison to the Predicate Device:
- Both devices are exclusively used to monitor the STERIS System 1® peracetic acid . process.
- Both devices are assessed in process conditions of 1000 parts per million peracetic . acid at 50°C.
- Both devices use a paper carrier inoculated with 105 spores of G. stearothermophilus .
- Both devices are processed in the sterilizer when held by a transfer clip. .
- Both devices are open-loop biological indicators that are recovered in tubes of sterile . growth media.
- Both use a growth medium that is modified with a color change indicator. .
- . Both devices may only monitor sterilization efficacy on exterior surfaces loads processed in the STERIS System 1 peracetic acid process.
Conclusion:
The SporView PA Culture Set is substantially equivalent the Castle® SPOR-TEST PA Biological Indicator Kit for monitoring the STERIS System 19 peracetic acid process.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.
Public Health Service
JAN 1 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gary J. Socola Vice President, Scientific Affairs SPSmedical Supply Corporation 6789 West Henrietta Road Rush, New York 14543
Re: K043135
Trade/Device Name: SporView® Peracetic Acid Culture Set Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: MRB Dated: December 29, 2004 Received: January 3, 2005
Dear Mr. Scola:
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.
2
Page 2 - Mr. Scola
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 (301) 594-0115. 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/dsma/dsmamain.html
Sincerely vours,
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
3
INDICATIONS for USE STATEMENT
Applicant: SPSmedical Supply Corp.
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
SporView® Peracetic Acid Culture Set Device Name:
Indications For Use:
The SPSmedical SporView® PA Culture Set is intended for use with the STERIS System 1® sterilizer using STERIS® 20 sterilant only. The STERIS System 1® is a liquid chemical sterilization process. The SporView PA Culture Set provides independent confirmation that sterilization conditions were achieved during the STERIS System 1® processing cycle. A reduced incubation time of 24 hours has been validated for the Spor View PA Culture Set using SPSmedical's SporView® culture media.
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)
Syute Michie Omd.
(Civision Sign-Off) Orvision of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: _______________________________________________________________________________________________________________________________________________________________ 4043135
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