(56 days)
The 3M™ Comply™ Bowie-Dick Type Lead Free Test Pack is designed for testing air removal efficiency of 132- 134°C (270- 273°F) dynamic-air-removal steam sterilizers.
The 3M™ Comply™ Bowie-Dick Type Lead Free Test Pack is equivalent in performance to the Bowie-Dick towel pack described in AAMI ST79. The test pack consists of a chemical indicator test sheet positioned within a pack of porous sheets. The test sheet contains a lead-free steam-sensitive chemical indicator ink printed on paper as a yellow-colored pattern. The test sheet will turn a uniform dark brown/black color except when air removal failures such as air leaks occur. An air removal failure is indicated by a lighter-colored area in the indicator ink pattern of an otherwise dark-colored test sheet.
The provided text describes the 3M™ Comply™ Bowie-Dick Type Lead Free Test Pack, which is a sterilization process indicator. However, it does not include detailed acceptance criteria or a study proving the device meets specific acceptance criteria in the format requested (e.g., performance metrics like sensitivity, specificity, accuracy, or associated confidence intervals based on a clinical study).
Instead, the document is a 510(k) summary and the FDA's clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria for a new device.
Here's an attempt to answer the questions based on the available information, noting where information is not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from Substantial Equivalence Goal) | Reported Device Performance |
|---|---|
| Intended Use: For testing air removal efficiency of 132-134°C (270-273°F) dynamic-air-removal steam sterilizers. | The 3M™ Comply™ Bowie-Dick Type Lead Free Test Pack is designed for testing air removal efficiency of 132-134°C (270-273°F) dynamic-air-removal steam sterilizers. (Matches predicate's intended use). |
| Performance: Equivalent to the Bowie-Dick towel pack described in AAMI ST79, specifically in indicating air removal failures (lighter-colored area) vs. successful air removal (uniform dark brown/black color). | The test pack is equivalent in performance to the Bowie-Dick towel pack described in AAMI ST79. An air removal failure is indicated by a lighter-colored area in the indicator ink pattern, while successful removal results in a uniform dark brown/black color. |
| Material/Composition: Lead-free. | Contains a lead-free steam-sensitive chemical indicator ink. |
| Technological Characteristics: Similar to predicate (3M™ Comply™ 1233 Bowie-Dick Type Test Pack). | Information provided in the 510(k) submission shows substantial equivalence to the predicate "in terms of intended use, indications for use, composition, physical properties and technological characteristics." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document states "Comparative Data for Determining Substantial Equivalence," but it does not detail specific study sample sizes (e.g., number of test packs, number of sterilization cycles) or the provenance of this data. The submission focuses on demonstrating equivalence rather than reporting on a new performance study with a defined test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not provided. This type of information is typically part of a clinical performance study involving human assessment. The device is a chemical indicator, which provides a direct visual output, rather than an imaging device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. As stated above, this device provides a direct visual result. Expert adjudication methods are not typically relevant for such chemical indicators.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a chemical sterilization indicator, not a device involving human readers or AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a passive chemical indicator, not an algorithm. Its "standalone" performance is its visual reaction to steam sterilization conditions. The document implies this performance was compared to AAMI ST79 standards and the predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for a Bowie-Dick test pack like this is the physical condition of the sterilizer's air removal efficiency, determined by whether steam penetration was successful or if air pockets remained. The AAMI ST79 standard defines the expected visual outcome (uniform dark coloration) for successful air removal. The "ground truth" against which the new device's performance is measured would be the performance of the predicate device and adherence to the AAMI ST79 standard.
8. The sample size for the training set
- Not applicable/Not provided. This is a physical chemical indicator, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. See point 8.
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5.0 Premarket Notification (510(k)) Summary
Sponsor Information:
DEC - 4 2009
3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
| Contact Person: | Jizhong Jin |
|---|---|
| Regulatory Affairs Specialist | |
| Phone Number: | (651) 733-6655 |
| FAX Number: | (651) 737-5320 |
Date of Summary: October 7, 2009
Device Name and Classification:
Common or Usual Name: Sterilization process indicator
3M™ Comply™ Bowie-Dick Type Lead Free Test Pack Proprietary Name:
Classification Name: Indicator, Physical/Chemical Sterilization Process (21 CFR § 880.2800(b))
Performance Standards: N/A
Predicate Device:
3M™ Comply™ 1233 Bowie-Dick Type Test Pack (ATI Bowie-Dick Test Pack)
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Special 510(k) Premarket Notification for 3MTM Comply TM Bowie-Dick Lead Free Test System
Description of Device:
The 3M™ Comply™ Bowie-Dick Type Lead Free Test Pack is equivalent in performance to the Bowie-Dick towel pack described in AAMI ST79. The test pack consists of a chemical indicator test sheet positioned within a pack of porous sheets. The test sheet contains a lead-free steam-sensitive chemical indicator ink printed on paper as a yellow-colored pattern. The test sheet will turn a uniform dark brown/black color except when air removal failures such as air leaks occur. An air removal failure is indicated by a lighter-colored area in the indicator ink pattern of an otherwise dark-colored test sheet.
Indications for Use:
The 3M™ Comply™ Bowie-Dick Type Lead Free Test Pack is designed for testing air removal efficiency of 132- 134°C (270- 273°F) dynamic-air-removal steam sterilizers.
Comparative Data for Determining Substantial Equivalence of New Device to Predicate Device:
Information provided in this Special 510(k) submission shows that the 3M™ Comply™ Bowie-Dick Type Lead Free Test Pack is substantially equivalent to the predicate device 3M™ Comply™ 1233 Bowie-Dick Type Test Pack (ATI Bowie-Dick Test Pack), cleared under K841168 in terms of intended use, indications for use, composition, physical properties and technological characteristics. There are no new questions of safety or effectiveness.
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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 or bird-like figure with flowing lines, positioned to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird-like figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
DEL - 4 2009
Mr. Jizhong Jin Regulatory Affairs Specialist 3M Company 3M Center, Building 275-5W-06 Saint Paul, Minnesota 55133-3275
Re: K093199
Trade/Device Name: 3M™ Comply™ Bowie-Dick Type Lead Free Test Pack Regulation Number: 21CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: November 10, 2009 Received: November 13, 2009
Dear Mr. Jin:
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 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 Eederal Register.
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Page 2- Mr. Jin
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anten Vimenton
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Special 510(k) Premarket Notification for 3M™ Comply™ Bowie-Dick Lead Free Test Systems
Indications for Use Statement 4.0
Indications for Use
510(k) Number (if known):
Kogzi99
Device Name:
3M™ Comply™ Bowie-Dick Type Lead Free Test Pack
Indications For Use:
The 3M™ Comply™ Bowie-Dick Type Lead Free Test Pack is designed for testing air removal efficiency of 132- 134°C (270- 273°F) dynamic-air-removal steam sterilizers.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizbeth B. Clunie-Willis
(Division Sign-Off) Division of Anesthesiology, General Hoapital nfection Control, Dental Devices
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).