(458 days)
Attest™
Not Found
No
The device is a biological indicator that relies on the growth of spores in a culture medium to indicate sterilization efficacy. There is no mention of any computational analysis, algorithms, or learning processes.
No
The device is described as a biological sterilization process indicator to monitor the adequacy of sterilization, not to treat a condition or disease.
No
This device is a biological sterilization process indicator used to monitor the adequacy of sterilization, not to diagnose a medical condition in a patient.
No
The device description clearly states it is a physical biological indicator comprised of a plastic tube, cap, glass ampoule of growth media, and a paper spore disc. It is a hardware device used to monitor sterilization efficacy.
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 the adequacy of a sterilization process for products, not to diagnose a condition or disease in a patient.
- Device Description: The device contains spores and growth media to assess the effectiveness of sterilization, not to analyze a biological sample from a patient.
- Lack of Patient Interaction: The device is used to monitor a process applied to products, not to test or interact with a patient directly.
- No Biological Sample Analysis: The device does not analyze a biological sample (like blood, urine, tissue, etc.) from a human body.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. ProSpore2 does not fit this definition. It is a process indicator used in a healthcare setting, but its function is related to equipment and product sterilization, not patient diagnosis.
N/A
Intended Use / Indications for Use
ProSpore2 is a biological sterilization process indicator for EtO (Ethylene Oxide) sterilization. This device is intended for use by a health care provider to accompany products being sterilized through an EtO sterilization procedure and to monitor the adequacy of sterilization. The testing and validations referred to in this document were done using a 10/90 Ethylene Oxide mixture at 600 mg/L, 54°C, and with a relative humidity between 30% and 80%.
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
ProSpore2 is a self-contained biological indicator used for determining the efficacy of an Ethylene Oxide sterilization cycle. ProSpore2 is comprised of a plastic tube housing with a plastic cap. Inside of the tube is a 1.2 - 1.5 ml glass ampoule of growth media consisting of Tryptic Soy Broth (soybean casein digest) and a pH indicator - bromothymol blue. Also inside of the tube housing is a paper spore disc impregnated with a population of 10^6 Bacillus subtilis spores (ATCC #9372).
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
ProSpore2® has been tested for shelf life stability over 18 months. This testing included both D-value stability and Population stability with three separate lots of finished product ProSpore2 vials. The recovery media has been tested to show recovery of 'low numbers' of 'injured spores', 48-hr incubation period, and the stability of the color change when growth occurred.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
For all lots tested, the stability of Resistance Characteristics, Spore Population, Media Recovery, 48-hr incubation, stability of color change and overall effectiveness in monitoring routine Ethylene Oxide sterilization cycles has been demonstrated.
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.
Attest™
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
SUMMARY OF " PROSPORE 2ª SELF CONTAINED BIOLOGICAL VII. INDICATOR" FOR ETHYLENE OXIDE
Submitter:
Raven Biological Laboratories, Inc. 8607 Park Drive Omaha, NE 68127 (402) 593-0781 (402) 593-0921 fax
Contact:
Robert Dwyer President
Wendy Royalty Quality Assurance Manager
Prepared on:
Device name:
Classification:
November 10, 1999
Class II medical device. General hospital
ProSpore2® self-contained biological indicator
Predicate Devices (legally marketed):
Predicate Device 510 (k) number:
DESCRIPTION:
ProSpore2 is a self-contained biological indicator used for determining the efficacy of an Ethylene Oxide sterilization cycle. ProSpore2 is comprised of a plastic tube housing with a plastic cap. Inside of the tube is a 1.2 - 1.5 ml glass ampoule of growth media consisting of Tryptic Soy Broth (soybean casein digest) and a pH indicator - bromothymol blue. Also inside of the tube housing is a paper spore disc impregnated with a population of 106 Bacillus subtilis spores (ATCC #9372).
Attest™
OPERATIONAL PRINCIPLES:
The plastic cap of the ProSpore2® vial has short 'tines' along its lower edge. When placed on the plastic tube body, the space between the tines allows for the passage of Ethylene Oxide into the tube and to the spore disc. A ProSpore2® unit is placed inside of the sterilizer along with a load to be sterilized. If all parameters are met for the cycle (sterilant concentration, relative humidity, exposure time and temperature), the EtO entering the ProSpore2® capsule will be sufficient to deactivate or kill the spores on the paper disc. Once the cycle is finished, the ProSpore2® vial is
1
removed from the sterilizer and sealed by depressing the cap. The sides of the plastic tubes are squeezed which will result in crushing the glass of the media ampoule. With this done, the spore disc is now in contact with the recovery media and the ProSpore2® unit can be placed in an incubator and incubated at 30 to 35°C for 48 hours. If the spores were killed in the sterilization cycle, the color of the recovery media will not change. If the cycle failed to kill the spores, the recovery media will change color from green to yellow, indicating growth, and a failed cycle.
The change in color is the result of 'viable' spores germinating and consuming the nutrients provided in the growth media. This consumption process involves the release of nitrogen waste products. This lowers the pH of the media and increases the acidity, which causes the color to change from green to yellow. Detection of failed EtO sterilization cycles is facilitated by the use of ProSpore2®. The outer label of the ProSpore2® plastic tube body has a chemical indicator on the label which changes color when exposed to EtO thus making it easy to distinguish processed from unprocessed vials.
STATEMENT OF SIMILARITY TO LEGALLY MARKETED PREDICATE DEVICE
ProSpore2® is similar in composition and function to the 'Legally Marketed Predicate Device' -Attest™
- Both devices are intended for use in monitoring Ethylene Oxide sterilization cycles.
- Both devices utilize a USP recommended strain of B. subtilis bacterial spore as its organism of choice for Ethylene Oxide resistance characteristics.
- Both devices use paper as the spore carrier.
- Both devices utilize a plastic vial and cap to house the spore carrier and media capsule.
- Both devices contain a sealed recovery media ampoule made of glass.
- Both devices use a pH indicator in the recovery media that turns from green to yellow in color when growth is present.
- Both devices require that the recovery media ampoule be activated after sterilization by breaking the glass ampoule to release the media to come in contact with the spore carrier.
- Both devices incorporate a 'chemical indicator' on the label, which will change color when exposed to Ethylene Oxide so that exposed vials can be distinguished from unprocessed vials.
DESCRIPTION OF TESTING:
ProSpore2® has been tested for shelf life stability over 18 months. This testing included both D-value stability and Population stability with three separate lots of finished product ProSpore2 vials. The recovery media has been tested to show recovery of "low numbers' of 'injured spores', 48-hr incubation period, and the stability of the color change when growth occurred. For all lots tested, the stability of Resistance Characteristics, Spore Population, Media Recovery, 48-hr incubation, stability of color change and overall effectiveness in monitoring routine Ethylene Oxide sterilization cycles has been demonstrated.
2
CONCLUSION
Raven's ProSpore2® is substantially equivalent in composition and function to the Legally
Marketed predicate device, Attest™, for monitoring Ethylene Oxide sterilization cycl incubation period of 48 hours based on the testing results and analysis of 18-month shelf-life stability data.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 0 2001
Ms. Wendy Royalty Quality Assurance Manager Raven Biological Laboratories, Incorporated 8607 Park Drive Omaha, Nebraska 68127
K994381 Re :
ProSpore2® Self-contained Biological Trade Name: Indicator Regulatory Class : II Product Code: FRC December 27, 2001 Dated: Received: January 5, 2001
Dear Ms. Royalty:
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 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). 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 reqistration, 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. ਬ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:
4
Page 2 - Ms. Royalty
this response to your premarket notification submission does chis response to your pou might have under sections 531 not arrect any obingat for devices under the Electronic Chrough 542 or the nee rol control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as fills recei will areas) premarket notification. The FDA described in your six (i) puivalence of your device to a legally marketed predicate device results in a classification for your marketed predicate as the your device to proceed to the market.
If you desire specific advice for your device on our labeling II you desire bpccirie additionally 809.10 for in regaracton (2) (2) devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on Compriance at (501) 551 ising of your device, please contact 594-4639. Also, please note the Office of Compliance at (301) "Misbranding by reference to the regulation entitled, premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be Information on your responsof Small Manufacturers Assistance oblained from the Drvinies (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
Viktor
Timoth Director
Division of Dental, Infection Control and General Hospital Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) NUMBER: K994381 PRODUCT: PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR 7
I. INDICATION OF USE
ProSpore2 is a biological sterilization process indicator for EtO (Ethylene Oxide) sterilization. This device is intended for use by a health care provider to accompany products being sterilized through an EtO sterilization procedure and to monitor the adequacy of sterilization. The testing and validations referred to in this document were done using a 10/90 Ethylene Oxide mixture at 600 mg/L, 54°C, and with a relative humidity between 30% and 80%.
R.A. Victors
(Division Sign-Off Division of Dental, Infection Control, and General Hospital Dev 510(k) Number _