(33 days)
Kilit™ (BBL) - Grandfather In, SporView™ (SPSmedical) - K905425
Not Found
No
The device description and performance studies focus on biological and chemical indicators, with no mention of AI or ML technologies.
No
ProSpore® is a biological sterilization process indicator used to monitor the effectiveness of steam sterilization, not to treat any medical condition or directly impact a patient's health.
No
The device is a sterilization process indicator, meaning it monitors the adequacy of sterilization, not a patient's health condition or presence of disease.
No
The device description clearly states it is a self-contained biological indicator with a glass ampoule containing bacterial spores and recovery medium, indicating it is a physical device, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "biological sterilization process indicator" used to "monitor adequacy of sterilization." This monitoring is done in vitro (outside of the human body) on the sterilization process itself, not on a patient.
- Device Description: The device contains bacterial spores and a recovery medium. The process involves incubating the device after sterilization to see if the spores grow, which indicates a failure in the sterilization process. This is a classic in vitro test.
- Mechanism: The device works by detecting the viability of bacterial spores after a sterilization cycle. This is a biological test performed in a laboratory-like setting (incubation) to assess the effectiveness of a process.
While the device is used in a healthcare setting and by healthcare providers, its function is to test the sterilization equipment and process, not to diagnose a condition in a patient. This aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ProSpore® is a biological steritization process indicator for steam sterilization at 121°C is a device intended for use by a health care provider to accompany products being sterilized through a steam sterilization procedure and to monitor adequacy of sterilization.
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
ProSpore is a self-contained biological indicator used for determining the efficacy of a 121°C sterilization cycle. The device is a hermetically sealed glass ampoule containing Bacillus stearothermophilus ATCC#7953 bacterial spores in a recovery medium of Tryptic Soy Broth with Bromocresol Purple pH indicator.
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
health care provider
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
Testing was performed to validate the labeled claims and performance characteristics for Prospore. These included using three separate lots to show stability of resistance characteristics and spore population, recovery of low numbers of injured spores, the effect of the pH indicator on recovery of spores and a reduced incubation period of 48 hours.
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.
Kilit™ (BBL) - Grandfather In, SporView™ (SPSmedical) - K905425
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).
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Summary of "ProSpore Self-contained Biological Indicator" for steam sterilization at 121°C 510(k) # K971432
| Submitter: | Raven Biological Laboratories, Inc. |
|---|---|
| 5017 Leavenworth Street | |
| Omaha, Nebraska 68106 | |
| (402) 556-6690 | |
| (402) 556-4722 FAX | |
| Contact: | Russ Nyberg |
| Production Microbiologist | |
| Prepared on: | 2 April 1997 |
| Device name: | ProSpore Self-contained Biological Indicator |
| Classification: | Class II medical device, General hospital |
| Predicate Devices (legally marketed): | Kilit™ (BBL) |
| SporView™ (SPSmedical) | |
| Predicate Devices 510(k) numbers: | Kilit™ (BBL) - Grandfather In* |
| SporView™ (SPSmedical) - K905425 |
DESCRIPTION:
ProSpore is a self-contained biological indicator used for determining the efficacy of a 121°C sterilization cycle. The device is a hermetically sealed glass ampoule containing Bacillus stearothermophilus ATCC#7953 bacterial spores in a recovery medium of Tryptic Soy Broth with Bromocresol Purple pH indicator.
OPERATIONAL PRINCIPLES
The ProSpore ampoule is placed with a load in the sterilization chamber and subjected to a normal steam sterilization cycle. The ampoule is then removed and cooled to room temperature. The processed ampoule and an unprocessed (control) ampoule are incubated at 55-60°C for 48 hours.
During incubation, the available food supply (Tryptic Soy Broth) and temperature promote growth of any viable spores. As viable spores germinate and consume the nutrients provided nitrogen waste products are released, increasing the acidity of the media which lowers the pH and causes the color to change from purple to yellow.
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Evidence of growth by color change and/or turbidity within 48 hours may be interpreted Evidence of growth by Color change and on one of the sterilization, provided signs of growth are present in the control ampoule.
STATEMENT OF SIMILARITY TO LEGALLY MARKETED PREDICATE DEVICE
ProSpore is similar in composition and function to the "Legally Marketed Predicate Devices" Kilit™ and SporView™.
- Intended for use in monitoring steam sterilization cycles at 121°C
- Intended for use in montoning other of B. stearothermophilus bacterial spore as its organism of choice for steam resistance characteristics
- Combine B. stearcthermophilus spores with a recovery media containing a pH indicator in a flame-sealed glass ampoule
DESCRIPTION OF TESTING
Testing was performed to validate the labeled claims and performance characteristics for Prospore. These included using three separate lots to show stability of resistance characteristics and spore population, recovery of low numbers of injured spores, the effect of the pH indicator on recovery of spores and a reduced incubation period of 48 hours. For all lots tested, the above parameters and overall effectiveness in monitoring routine steam sterilization cycles has been demonstrated.
STATEMENT OF SAFETY AND EFFECTIVENESS
Based on similar claims and design and the results from the above mentioned testing, the ProSpore Biological Indicator has been determined to be substantially equivalent to and therefore, as safe and effective as, the legally marketed devices Kilit™ and SporView™
*Kilit™ (BBL) does not have a 510(k) number. It was marketed under the grandfather clause, which exempts devices in commercial distribution prior to May 28, 1976. We have obtained the results of the Tradesmarkscan search of the U.S. Patent Office trademark filing showing that the product was introduced into commerce on June 8, 1955 (Attachment 10). The FDA number is M452998.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 1997
Mr. Kerrie Groff Quality Assurance Manager Raven Biological laboratories, Incorporated P.O. Box 6408 5017 Leavenworth Street Omaha, Nebraska 68106
K971432 Re : Prospore Trade Name: Requlatory Class: II Product Code: FRC Dated: April 15, 1997 April 17, 1997 Received:
Dear Mr. Groff:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with --the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic ... GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Mr. Groff
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed i 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, uMisbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
L.J. Celtrist
hy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | |
|---|---|
| Device Name: | ProSpore @ |
Indications For Use:
ProSpore® is a biological steritization process indicator for steam sterilization at 121°C is a device intended for use by a health care provider to accompany products being sterilized through a steam sterilization procedure and to monitor adequacy of sterilization.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices 510(k) Number J 5
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use X
(Optional Formal 1-2-96)
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