(28 days)
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No
The document describes a biological indicator and culture media for monitoring sterilization, with no mention of AI or ML technologies.
No
This device, the SporView® PA Culture Set, is a biological indicator intended to monitor the sterilization process of other medical devices, not to treat or diagnose patients itself.
No
The device is a biological indicator used to confirm that sterilization conditions were achieved, rather than to diagnose a medical condition in a patient.
No
The device description clearly indicates the product contains physical components like paper strips with spores, sterile tubes of culture media, and a transfer clip, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to monitor a sterilization process (STERIS System 1) by confirming that sterilization conditions were achieved. This is a quality control or process monitoring function, not a diagnostic test performed on a biological sample from a patient to diagnose a disease or condition.
- Device Description: The device contains spores and culture media used to assess the effectiveness of the sterilization process. It does not involve analyzing human biological samples.
- 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 for the diagnosis, treatment, or prevention of disease
- Measuring analytes in a biological sample
The device is a biological indicator used to validate a sterilization process, which falls under the category of medical device quality control or process monitoring, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The SporView® PA Culture Set is only intended to monitor the STERIS System 19 liquid chemical sterilization system, with STERIS® 20 sterilant. The SporView® PA Culture Set was qualified using SporView® Culture Media. The use of the product is restricted to the SporView® biological indicator spore and media only. SPSmedical's PA Culture Set has been validated for a reduced incubation time of 16 hours,
The SPSmedical SporView® PA Culture Set is intended for use with the STERIS System 1® sterilizer using STERIS® 20 sterilant only. The SporView® PA Culture Set provides independent confirmation that sterilization conditions were achieved during the STERIS System 10 processing cycle. A reduced incubation time of 16 hours has been wallated for the SporView® PA Culture Set using SPSmedical's SporView® culture media.
Product codes (comma separated list FDA assigned to the subject device)
80MRB, MRB
Device Description
SporView® PA Culture Set is intended to monitor the STERIS System 1 sterilization process, with STERIS® 20 sterilant. The product contains paper strips that are process, with G. stearothermophilus spores. Sterile tubes of SporView® Culture Media (modified soybean casein broth) and a transfer clip are included.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was conducted following the FDA guidance for the validation of reduced incubation of biological indicators. Testing was performed for the peracetic acid sterilization process using three lots of biological indicators. All lots were tested using SPSmedical's SporView® Culture Media. All lots tested resulted in a 16 hour reduced incubation time for the peracetic acid sterilization process when using the SPSmedical SporView® PA Culture Set.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
SPSmedical SporView® PA Culture Set (K043135)
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.
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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).
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§ 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
Kori879
510(k) Summary of Safety and Effectiveness
JUL 3 0 2008
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 .
- Date Summary was Prepared July 29th, 2008 .
- Gary J. Socola ● Printed name of person submitting for 510(k)
Gary J. Socola
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® PA Culture Set |
|---|---|
| Classification Name: | Sterilization Process Biological Indicator |
| Common Name: | Peracetic Acid Culture Set |
| Device Classification: | Class II, Regulation Number 880.2800 |
| Product Code: | 80MRB |
| Predicate Device: | SPSmedical SporView® PA Culture Set (K043135) |
1
Device Description:
SporView® PA Culture Set is intended to monitor the STERIS System 1 sterilization process, with STERIS® 20 sterilant. The product contains paper strips that are process, with G. stearothermophilus spores. Sterile tubes of SporView® Culture Media (modified soybean casein broth) and a transfer clip are included.
Intended Use:
The SporView® PA Culture Set is only intended to monitor the STERIS System 19 liquid chemical sterilization system, with STERIS® 20 sterilant. The SporView® PA Culture Set was qualified using SporView® Culture Media. The use of the product is restricted to the SporView® biological indicator spore and media only. SPSmedical's PA Culture Set has been validated for a reduced incubation time of 16 hours,
Statement of Similarity to the Legally Marketed Predicate Device:
- ்டு Have the same indicated use
- Incorporate the same materials []
- Packaged using the same materials and processes П
Non-Clinical Testing:
Testing was conducted following the FDA guidance for the validation of reduced incubation of biological indicators. Testing was performed for the peracetic acid sterilization process using three lots of biological indicators. All lots were tested using SPSmedical's SporView® Culture Media. All lots tested resulted in a 16 hour reduced incubation time for the peracetic acid sterilization process when using the SPSmedical SporView® PA Culture Set.
Conclusion:
Supportive data has demonstrated that the SPSmedical SporView® PA Culture Set is equivalent to the legally marketed predicate device. Results of performance testing validate that the SPSmedical SporView® PA Culture Set provides a 16 hour reduced incubation time when monitoring the peracetic acid sterilization process.
2
Image /page/2/Picture/1 description: The image shows the seal for the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around an emblem. The emblem is a stylized depiction of an eagle with its wings spread, clutching a staff entwined with a serpent, which is a symbol of medicine and healing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gary J. Socola Vice President, Scientific Affairs SPS Medical Supply Corporation 6789 West Henrietta Road Rush, New York 14543
JUL 30 2008
Re: K081879
Trade/Device Name: SPSmedical SporView® Culture Set Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: MRB Dated: July 1, 2008 Received: July 2, 2008
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 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.
3
Page 2 - Mr. Socola
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
signature
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
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INDICATIONS for USE
Applicant: SPSmedical Supply Corp.
510(k) Number (if known): K081879
Device Name: SPSmedical SporView® PA Culture Set
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 SporView® PA Culture Set provides independent confirmation that sterilization conditions were achieved during the STERIS System 10 processing cycle. A reduced incubation time of 16 hours has been wallated for the SporView® 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)
Shiela M Murphy, MD
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
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