(79 days)
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Not Found
No
The device description and performance studies focus on traditional biological indicator methods and do not mention any AI or ML components.
No.
The device is a biological indicator used to monitor the efficacy of sterilization cycles, not to treat a disease or condition.
No
Explanation: The device monitors the efficacy of sterilization cycles, not a patient's health condition or disease.
No
The device description clearly states it is a biological indicator consisting of a paper carrier inoculated with bacterial endospores and a primary package made of glassine. This involves physical components, not just software.
Based on the provided information, the ALIBI biological indicator is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "monitor the efficacy of ethylene oxide sterilization cycles." This involves testing a sample (the biological indicator) in vitro (outside of a living organism) to determine the effectiveness of a process (sterilization).
- Device Description: The device consists of a paper carrier inoculated with bacterial spores and a primary package. After exposure to the sterilization cycle, it is incubated in a growth medium. The outcome (growth or no growth) is determined by observing the turbidity of the medium, which is a laboratory test performed in vitro.
- Mechanism of Action: The device works by detecting the viability of bacterial spores after a sterilization process. This is a diagnostic test performed on a sample to assess the effectiveness of the sterilization.
While it doesn't directly diagnose a disease in a patient, it falls under the broader definition of an IVD as it is used to perform a test in vitro to provide information relevant to a medical process (sterilization of medical devices). The fact that it is compared to a "Raven Bacterial Spore Strip," which is a common type of biological indicator used in healthcare settings for sterilization monitoring, further supports its classification as an IVD.
N/A
Intended Use / Indications for Use
The ALIBI biological indicator is used to monitor the efficacy of ethylene oxide sterilization cycles.
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
ALIBI is a biological indicator that complies with the USP XXV:2002 monograph Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier. The ALIBI biological indicator consists of a paper carrier inoculated with of Bacillus subtilis var. niger ATCC 9372 bacterial endospores, and a primary package made of glassine. After exposure to an ethylene oxide sterilization cycle, the biological indicator is incubated in soybean casein digest broth at 30-35°C for 7 days. Growth of biological indicator spores is evidenced by the presence of turbidity in the growth medium. If the sterilization cycle killed all of the biological indicator spores, the growth medium remains clear.
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)
Stability studies on three lots manufactured from three different spore crops are in progress. Each lot is evaluated for population, purity, DEO-value, survival time and kill time. The methods described in USP XXV were used, except for the population test. Here a validated, alternative method is used. Real time data through the 12 months test interval shows that population, purity, and resistance values remain within the acceptance criteria in USP XXV.
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.
Raven Bacterial Spore Strip Pre-amendment device
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).
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
Image /page/0/Picture/0 description: The image shows the logo for Arden Laboratories Incorporated. The text is in a bold, sans-serif font. The words "Arden Laboratories" are stacked on top of each other, and the word "Incorporated" is centered below them. The logo is black and white.
FEB 2 7 2003
SUSAN L. JOHNSON Chief Executive Officer susan@ardenlabs.com
ANGELA STRANTZ, Ph.D. Chief Technical Officer angela@ardenlabs.com
510(k) Summary
| Submitted by: | Arden Laboratories, Inc.
468B Stillwater Road
P.O. Box 486
Willernie, Minnesota 55090-0468 | |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| | Telephone
Fax
E-mail | 651-762-9224
651-762-9226
angela@ardenlabs.com |
| Contact: | Angela Strantz, PhD
Chief Technical Officer | |
| Prepared on: | December 6, 2002 | |
| Trade Name: | ALIBI Biological Indicator | |
| Common Name: | Biological Indicator for Ethylene Oxide, Paper
Carrier | |
| Classification: | II | |
| Predicate Device: | Raven Bacterial Spore Strip
Pre-amendment device | |
| Description: | ALIBI is a biological indicator that complies with the
USP XXV:2002 monograph Biological Indicator for
Ethylene Oxide Sterilization, Paper Carrier. The
ALIBI biological indicator consists of a paper carrier
inoculated with of Bacillus subtilis var. niger ATCC
9372 bacterial endospores, and a primary package
made of glassine. | |
| | After exposure to an ethylene oxide sterilization
cycle, the biological indicator is incubated in | |
soybean casein digest broth at 30-35°C for 7 days.
1
| Description (continues): | Growth of biological indicator spores is evidenced
by the presence of turbidity in the growth medium.
If the sterilization cycle killed all of the biological
indicator spores, the growth medium remains clear. |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use: | The ALIBI biological indicator is used to monitor the
efficacy of ethylene oxide sterilization cycles. |
| Statement of Similarity: | Equivalence of the ALIBI biological indicator is
demonstrated through compliance to the
recognized standard, USP XXV:2002 monograph
Biological Indicator for Ethylene Oxide Sterilization ,
Paper Carrier. |
| Description of Testing | Stability studies on three lots manufactured from
three different spore crops are in progress. Each lot
is evaluated for population, purity, DEO-value,
survival time and kill time. The methods described
in USP XXV were used, except for the population
test. Here a validated, alternative method is used. |
| | Real time data through the 12 months test interval
shows that population, purity, and resistance
values remain within the acceptance criteria in USP
XXV. |
| Conclusion: | The ALIBI biological indicator is appropriate for
monitoring the efficacy of ethylene oxide
sterilization cycles. |
:
.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 7 2003
Dr. Angela Strantz Chief Technical Officer Arden Laboratories, Incorporated 468B Stillwater Road Willernie, Minnesota 55090
Re: K024079
Trade/Device Name: The ALIBI Biological Indicator Regulation Number: 880.2800 (a) Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: December 6, 2002 Received: December 10, 2002
Dear Dr. Strantz:
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 - Dr. Strantz
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) 594-4618. 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 yours,
Susan Runirer
Susan Runner, DDS, MA Interim 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
Page 1
510(k) Number (if known):
Device Name: ALIBI Biological Indicator
Indications for Use:
The ALIBI biological indicator is used to monitor the efficacy of ethylene oxide sterilization cycles.
(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Olin S. Lin
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
r 024079
510(k) Number.__