(265 days)
Not Found
No
The device description and performance studies focus on the biological and physical properties of a self-contained biological indicator for steam sterilization, with no mention of AI or ML.
No
The device is a self-contained biological indicator used to monitor the effectiveness of steam sterilizers, not to treat a disease or condition in a patient.
No
Explanation: The device is a biological indicator designed to confirm whether sterilization conditions were achieved in steam sterilizers, not to diagnose a medical condition in a patient.
No
The device description explicitly states it consists of a plastic shell containing spores and an ampoule of culture media, indicating it is a physical biological indicator, not software.
Based on the provided text, the Verify® SCBI 275F 3-10 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for monitoring the effectiveness of steam sterilization processes, not for diagnosing a disease or condition in a patient.
- Device Description: The device contains bacterial spores and culture media, which are used to assess the lethality of the sterilization cycle, not to analyze a human specimen for diagnostic purposes.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as analyzing human samples (blood, urine, tissue, etc.), providing diagnostic information about a patient's health, or being used in a clinical laboratory setting for patient testing.
The device is a biological indicator used in the sterilization process of medical devices or other items, ensuring they are free of viable microorganisms. This is a quality control measure for sterilization, not a diagnostic test for a patient.
N/A
Intended Use / Indications for Use
The Verify® SCBI 275F 3-10 is a self-contained biological indicator that may be The Verliy BCDI 2751 - 10 is routine monitoring of steam sterilizers. The used for installation woung andependent confirmation that sterilization conditions were achieved during the following cycles:
| TEMPERATURE | STERILIZATION TYPE | TIME |
|---|---|---|
| 275°F (135°C) | Gravity Flash | 3 minutes |
| 275°F (135°C) | Prevacuum | 3 minutes |
| 275°F (135°C) | Gravity | 10 minute |
| 275°F (135°C) | Gravity Flash | 10 minutes |
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
The proposed Verify® SCBI 275F 3-10 is a self-contained biological indicator The proposed vorily mended for use in mercesses. The proposed Verify® SCBI 275F 3-10 consists of a plastic stellitzation processes: "The proposed it Geobacillus stearothermophilus spores and an ampoule of culture media.
This 510(k) premarket notification was submitted to expand the Indications For Use This 510(K) premarket nonneation in 275°F (135°C) steam sterilization for 3 minute Ior the biological indivator to mentees and 10 minute Gravity and Gravity Flash cycles.
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)
Performance testing was conducted to validate the SCBI for use in the steam Performance testing was conducted to railars section. The results support the use of stentitzandir cyoles institution in the sinces and confirm that the SCBI meets the current requirements of FDA guidance and relevant industry standards.
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
STERIS Additional Information K08366 S001 / Verify SCBI 275F 3-10
ﻨﯽ ﺍ
1083660
SEP - 1 2009
Image /page/0/Picture/13 description: The image shows the STERIS logo. The word "STERIS" is in all capital letters and is located at the top of the image. Below the word is a graphic of several horizontal lines that are slightly curved, resembling waves.
510(k) Summary For Verify® SCBI 275F 3-10
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459
Contact:
John Robert (Jack) Scoville, Jr. Fellow, Regulatory Affairs Telephone: (440) 392-7330 (440) 357-9198 Fax No:
Summary Date:
July 23, 2009
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
1
Device Name 1.
| Trade Name: | Verify® SCBI 275F 3-10 |
|---|---|
| Common/usual Name: | Biological Indicator |
| Classification Name: | Biological Sterilization Process Indicators (21 CFR |
| 880.2800), Product Code FRC |
Predicate Device 2.
- K051056, Verify® Dual Series SCBI cleared as Verify® Self-Contained 트 Biological Indicator
- Blotogroup Increases 1 Robotor, Verry - Deared as Assert™ Biological/Chemical Indicator
- K963841, SGM EZTest Steam BI 체
Description of Device 3.
The proposed Verify® SCBI 275F 3-10 is a self-contained biological indicator The proposed vorily mended for use in mercesses. The proposed Verify® SCBI 275F 3-10 consists of a plastic stellitzation processes: "The proposed it Geobacillus stearothermophilus spores and an ampoule of culture media.
This 510(k) premarket notification was submitted to expand the Indications For Use This 510(K) premarket nonneation in 275°F (135°C) steam sterilization for 3 minute Ior the biological indivator to mentees and 10 minute Gravity and Gravity Flash cycles.
Intended Use 4.
The Verify® SCBI 275F 3-10 is a self-contained biological indicator that may be The Verliy BCDI 2751 - 10 is routine monitoring of steam sterilizers. The used for installation woung andependent confirmation that sterilization conditions were achieved during the following cycles:
| TEMPERATURE | STERILIZATION TYPE | TIME |
|---|---|---|
| 275°F (135°C) | Gravity Flash | 3 minutes |
| 275°F (135°C) | Prevacuum | 3 minutes |
| 275°F (135°C) | Gravity | 10 minute |
| 275°F (135°C) | Gravity Flash | 10 minutes |
2
Description of Safety and Substantial Equivalence 5.
The proposed Verify® SCBI 275F 3-10 is identical in components, design, The proposed Verriy SCDT 2 751 - 15 rot is totalons to the predicates KO5 | 056, Verify - 1
materials, and manufacturing specifications to the predicates K05 | 056, Verify materials, and manafacturing of the predicate to K051056). It has the same cycle temperature as the predicate K963841, SMG EZTest.
Performance testing was conducted to validate the SCBI for use in the steam Performance testing was conducted to railars section. The results support the use of stentitzandir cyoles institution in the sinces and confirm that the SCBI meets the current requirements of FDA guidance and relevant industry standards.
The proposed Verify® SCBI 275F 3-10 does not have any characteristics that would introduce concerns for safety or effectiveness.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. John Robert Scoville, JR Fellow Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060
SEP - 1 2009
Re: K083665
Trade/Device Name: Verify® SCBI 275F 3-10 Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: July 23, 2009 Received: July 28, 2009
Dear Mr. Scoville:
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 Federal Register.
4
Page 2- Mr. Scoville
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/ReportaProblem/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,
Anthony D. Anthon
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infusion Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION Verify® SCBI 275F 3-10
Indications for Use
510(k) Number (if known):
Device Name:
Verify® SCBI 275F 3-10
Indications for Use:
The Verify® SCBI 275F 3-10 is a self-contained biological indicator that may be used for installation testing and routine monitoring of steam sterilizers. The Verify® SCBI 275F 3-10 provides independent confirmation that sterilization conditions were achieved during the following cycles:
| चलाव रिश्वर मिश्री है। | HERE BEAST ON FEY PE | 300 2 2 3 3 3 3 1 4 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 |
|---|---|---|
| 275°F (135°C) | Gravity Flash | 3 minutes |
| 275°F (135°C) | Prevacuum | 3 minutes |
| 275°F (135°C) | Gravity | l () minute |
| 275 F (135 C) | Gravity Flash | 10 minutes |
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (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)
Shula H. Murphy, MD
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
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December 8, 2008