(79 days)
The ALIBI biological indicator is used to monitor the efficacy of ethylene oxide sterilization cycles.
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.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from USP XXV:2002) | Reported Device Performance (ALIBI Biological Indicator) |
|---|---|
| Population values (number of spores) | "Remain within the acceptance criteria in USP XXV" (through real-time data up to 12 months) |
| Purity values | "Remain within the acceptance criteria in USP XXV" (through real-time data up to 12 months) |
| DEO-value (D-value for Ethylene Oxide) | "Remain within the acceptance criteria in USP XXV" (through real-time data up to 12 months) |
| Survival time | "Each lot is evaluated for... survival time." (No specific value given, but implied to be within criteria due to overall statement) |
| Kill time | "Each lot is evaluated for... kill time." (No specific value given, but implied to be within criteria due to overall statement) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "Stability studies on three lots manufactured from three different spore crops are in progress." This implies a test set of three lots (each from a different spore crop).
- Data Provenance: The study is described as "Real time data through the 12 months test interval." This indicates the data is prospective and collected over time during the stability study. The country of origin is not explicitly stated, but the company (Arden Laboratories, Inc.) is based in Willernie, Minnesota, USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the device is a biological indicator for sterilization, not a medical imaging or diagnostic device requiring expert interpretation. The ground truth is objective (presence or absence of microbial growth).
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as above. The determination of growth or no growth is based on a clear, objective biological outcome (turbidity in the growth medium).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or screening devices where human interpretation is involved. The ALIBI Biological Indicator is a device to monitor sterilization efficacy, not for human interpretation of medical cases.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the evaluation of the ALIBI Biological Indicator is a standalone performance study. The device is used independently to indicate the efficacy of the sterilization cycle without direct human interpretation influencing the end result (turbidity development). The "algorithm" here is the biological process of spore inactivation and subsequent growth/no-growth, which is assessed objectively.
7. The Type of Ground Truth Used
The ground truth used is based on biological outcome:
- Presence of turbidity: Indicates survival of biological indicator spores (sterilization failure).
- Growth medium remains clear: Indicates all biological indicator spores were killed (successful sterilization).
This is an objective, empirical ground truth based on microbial viability.
8. The Sample Size for the Training Set
The document does not explicitly mention a separate "training set" in the context of machine learning or AI. This device is a biological indicator validated against established standards. The "training" in a biological sense would be the development and optimization of the spore crop and manufacturing process to consistently meet the USP XXV criteria, which are not detailed as a distinct 'training set' of data.
9. How the Ground Truth for the Training Set Was Established
Since a "training set" in the AI sense is not applicable, the establishment of ground truth for a training set is also not applicable. The underlying principles of what constitutes a "successful" or "failed" sterilization are predefined by the USP XXV monograph, which serves as the ultimate standard for the biological indicator's performance.
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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 RoadP.O. Box 486Willernie, Minnesota 55090-0468 | |
|---|---|---|
| TelephoneFaxE-mail | 651-762-9224651-762-9226angela@ardenlabs.com | |
| Contact: | Angela Strantz, PhDChief Technical Officer | |
| Prepared on: | December 6, 2002 | |
| Trade Name: | ALIBI Biological Indicator | |
| Common Name: | Biological Indicator for Ethylene Oxide, PaperCarrier | |
| Classification: | II | |
| Predicate Device: | Raven Bacterial Spore StripPre-amendment device | |
| Description: | ALIBI is a biological indicator that complies with theUSP XXV:2002 monograph Biological Indicator forEthylene Oxide Sterilization, Paper Carrier. TheALIBI biological indicator consists of a paper carrierinoculated with of Bacillus subtilis var. niger ATCC9372 bacterial endospores, and a primary packagemade of glassine. | |
| After exposure to an ethylene oxide sterilizationcycle, the biological indicator is incubated in |
soybean casein digest broth at 30-35°C for 7 days.
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| Description (continues): | Growth of biological indicator spores is evidencedby the presence of turbidity in the growth medium.If the sterilization cycle killed all of the biologicalindicator spores, the growth medium remains clear. |
|---|---|
| Intended use: | The ALIBI biological indicator is used to monitor theefficacy of ethylene oxide sterilization cycles. |
| Statement of Similarity: | Equivalence of the ALIBI biological indicator isdemonstrated through compliance to therecognized standard, USP XXV:2002 monographBiological Indicator for Ethylene Oxide Sterilization ,Paper Carrier. |
| Description of Testing | Stability studies on three lots manufactured fromthree different spore crops are in progress. Each lotis evaluated for population, purity, DEO-value,survival time and kill time. The methods describedin USP XXV were used, except for the populationtest. Here a validated, alternative method is used. |
| Real time data through the 12 months test intervalshows that population, purity, and resistancevalues remain within the acceptance criteria in USPXXV. | |
| Conclusion: | The ALIBI biological indicator is appropriate formonitoring the efficacy of ethylene oxidesterilization cycles. |
:
.
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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 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.
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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
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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.__
§ 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).