(56 days)
Not Found
No
The device is a chemical indicator test pack that changes color based on steam sterilization conditions. There is no mention of any computational analysis, image processing, or learning algorithms.
No
This device is a test pack designed to evaluate the air removal efficiency of steam sterilizers, not to treat a medical condition or ailment.
No
This device is designed to test the efficiency of steam sterilizers, not to diagnose a medical condition in a patient.
No
The device is a physical test pack consisting of porous sheets and a chemical indicator sheet, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to test the air removal efficiency of steam sterilizers. This is a quality control test for a medical device (the sterilizer), not a test performed on a biological sample from a patient to diagnose a condition or provide information about their health.
- Device Description: The device is a test pack with a chemical indicator that changes color based on steam penetration. It does not interact with biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Testing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient
- Being used in a laboratory setting for patient testing
The device is clearly designed for monitoring the performance of a sterilization process, which falls under the category of sterilization process indicators, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JOJ
Device Description
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.
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
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
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
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)
1
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.
2
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.
3
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
4
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: