(230 days)
SteriTec Bowie-Dick Mini Pak is designed to detect the presence of residual air in pre-vacuum steam sterilizers operating at 132° C for 3.5 minutes. The indicator will demonstrate a uniform color change from purple to green when the proper sterilization conditions are met and no air is present. If enough air is present to create a 2° C or greater temperature difference in a standard Bowie-Dick test towel pack, the indicator will demonstrate a non-uniform color change.
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This document is a 510(k) clearance letter from the FDA for a medical device called the "SteriTec Bowie-Dick Mini Pak, Model No. BD 115." It is not a study report or clinical trial. Therefore, it does not contain the detailed information requested regarding acceptance criteria, study methodology, sample sizes, ground truth establishment, or expert involvement for AI device evaluation.
The letter simply states that the FDA has reviewed the manufacturer's premarket notification and determined that the device is "substantially equivalent" to a legally marketed predicate device.
However, based on the "Indications for Use" section, we can infer the intended performance and what would constitute "acceptance" for the device's function:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from "Indications for Use") | Reported Device Performance (Implied by 510(k) Clearance) |
|---|---|
| Detects residual air: The device is designed to detect the presence of residual air in pre-vacuum steam sterilizers operating at 132° C for 3.5 minutes. | The device is considered "substantially equivalent" to predicate devices, implying it effectively detects residual air under the specified conditions. Its performance is expected to be comparable to these legally marketed devices. |
| Uniform color change (purple to green) when proper sterilization conditions met and no air present: Under proper sterilization conditions (132° C for 3.5 minutes) and absence of residual air, the indicator will show a uniform color change from purple to green. | The device is expected to consistently demonstrate a uniform color change from purple to green when proper sterilization conditions are met and no air is present. The FDA clearance suggests this functionality has been demonstrated. |
| Non-uniform color change if sufficient air present: If enough air is present to create a 2° C or greater temperature difference in a standard Bowie-Dick test towel pack, the indicator will demonstrate a non-uniform color change. | The device is expected to reliably demonstrate a non-uniform color change when sufficient residual air (creating a ≥2°C temperature difference in a standard Bowie-Dick test pack) is present. The FDA clearance suggests this functionality has been demonstrated. |
The remaining information requested (sample size, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth, training set specifics) cannot be provided from this document because:
- This is a regulatory clearance, not a scientific study report.
- The device is a chemical indicator (Bowie-Dick Mini Pak), not an AI-powered device, so concepts like "test set," "training set," "ground truth," "experts for ground truth," "MRMC study," or "AI assistance" are not applicable in this context. The "ground truth" for this type of device is the physical condition of the sterilization cycle (presence/absence of air, correct temperature/time).
- The "study" referenced in K024293 would primarily involve laboratory testing to demonstrate the chemical indicator's color change properties under various controlled conditions (e.g., proper sterilization, partial air removal, significant air presence) and comparison to a predicate device, rather than a clinical trial with human readers or image interpretation.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 1 2003
Ms. Linda Nelson Regulatory Affairs Manager SteriTec Products, Incorporated 599 Topeka Way, Suite 700 Castle Rock, Colorado 80109
Re: K024293
Trade/Device Name: SteriTec Bowie-Dick Mini Pak, Model No BD 115 Regulation Number: 880.2800 Regulation Name: Sterilization Process indicator Regulatory Class: II Product Code: JOJ Dated: June 18, 2003 Received: June 19, 2003
Dear Ms. Nelson:
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.
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
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Page 2 -Ms. Nelson
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Burrer
S. Susan Burrer, DDS
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
1224243 510(k) Number (if known):
Device Name: SteriTec Bowie-Dick Mini Pak, Model No. BD 115
Indications For Use:
SteriTec Bowie-Dick Mini Pak is designed to detect the presence of residual air in pre-vacuum steam sterilizers operating at 132° C for 3.5 minutes. The indicator will demonstrate a uniform color change from purple to green when the proper sterilization conditions are met and no air is present. If enough air is present to create a 2° C or greater temperature difference in a standard Bowie-Dick test towel pack, the indicator will demonstrate a non-uniform color change.
Qim S. Win
(Division Sign-Off) Division of Anesthesiology. General Hospital. Infection Control. Denta
510(k) Number: K024293
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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).