(302 days)
The SteriSafe HP Table-Top Steam Sterilizer is designed to sterilize and flush dental handpieces in a clinical setting. It uses saturated steam at high pressure to effectively kill microorganisms. The unit is intended to sterilize and flush moisture stable handpieces must be suitable for steam sterilization up to 135°C (275°F). The sterilization cycle is as follows:
| CYCLE | TEMPERATURE | STERILIZATION TIMETURNAROUND TIME | LOAD | INTENDED USE |
|---|---|---|---|---|
| Unwrapped | SterilizationTemperature 132°C | 10 minutes / 23 minutes | Maximum Loadis 3 Handpieces | Sterilize & FlushDental Handpieces |
| SterilizationTemperature Control132°C =0° to +3°C | Maximum LoadWeight is 150z |
Not Found
The provided text is a 510(k) premarket notification letter for a steam sterilizer, not an AI/ML medical device. Therefore, it does not contain the information required to answer the questions about acceptance criteria, study design, and ground truth for an AI/ML device.
The document discusses the substantial equivalence of the SteriSafe HP Table-Top Steam Sterilizer to predicate devices. The "acceptance criteria" in this context would typically refer to the device meeting performance standards for sterilization, such as temperature, pressure, and sterilization time, as outlined in the "Indications for Use" section. However, this is for a physical sterilizer, not an AI/ML algorithm.
Therefore, I cannot extract the following information from the provided text:
- Table of acceptance criteria and reported device performance (for an AI/ML device): The document provides operational parameters for the sterilizer (temperature, time, load) but not performance metrics related to AI/ML.
- Sample size used for the test set and data provenance: Not applicable to a physical sterilizer.
- Number of experts used to establish the ground truth and qualifications: Not applicable to a physical sterilizer.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The text focuses on the regulatory approval process for a conventional medical device (a steam sterilizer) based on substantial equivalence, not on the validation of an AI/ML algorithm.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 20, 2015
Milton E Pedrazzi, D.D.S. Inc. Milton E Pedrazzi, D.D.S President 6501 Crown Blvd., Suite 102 San Jose. CA 95120
Re: K140736
Trade/Device Name: SteriSafe HP Table-Top Steam Sterilizer Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: December 19, 2014 Received: December 24, 2014
Dear Dr. Pedrazzi:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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Page 2 - Dr. Pedrazzi
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use Statement
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
SteriSafe HP Table-Top Steam Sterilizer
Indications for Use (Describe)
The SteriSafe HP Table-Top Steam Sterilizer is designed to sterilize and flush dental handpieces in a clinical setting. It uses saturated steam at high pressure to effectively kill microorganisms. The unit is intended to sterilize and flush moisture stable handpieces must be suitable for steam sterilization up to 135°C (275°F). The sterilization cycle is as follows:
| CYCLE | TEMPERATURE | STERILIZATION TIMETURNAROUND TIME | LOAD | INTENDED USE |
|---|---|---|---|---|
| Unwrapped | SterilizationTemperature 132°C | 10 minutes / 23 minutes | Maximum Loadis 3 Handpieces | Sterilize & FlushDental Handpieces |
| SterilizationTemperature Control132°C =0° to +3°C | Maximum LoadWeight is 150z |
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
[ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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FORM FDA 3881 (1/14)
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PSC Publishing Services (301) 443-6740 EF
§ 880.6880 Steam sterilizer.
(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).