(302 days)
Not Found
Not Found
No
The document describes a standard steam sterilizer with defined temperature and time cycles, and there is no mention of AI, ML, or related concepts.
No
The device is a sterilizer for dental instruments, not a device used for treating a disease or condition in a patient.
No
The device is a sterilizer, designed to kill microorganisms on dental handpieces, not to diagnose medical conditions.
No
The device description and intended use clearly describe a physical steam sterilizer, which is a hardware device, not software.
Based on the provided information, the SteriSafe HP Table-Top Steam Sterilizer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. They are used to provide information for diagnosis, monitoring, or screening.
- The SteriSafe HP Table-Top Steam Sterilizer is used to sterilize dental handpieces. This is a process applied to medical devices to render them free of viable microorganisms. It does not involve the examination of human specimens.
The intended use clearly states that the device is designed to "sterilize and flush dental handpieces in a clinical setting." This falls under the category of sterilization equipment for medical devices, not IVD.
N/A
Intended Use / Indications for Use
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: Unwrapped
STERILIZATION TEMPERATURE: 132°C
STERILIZATION TIME / TURNAROUND TIME: 10 minutes / 23 minutes
LOAD: Maximum Load is 3 Handpieces, Maximum Load Weight is 150z
INTENDED USE: Sterilize & Flush Dental Handpieces
Product codes (comma separated list FDA assigned to the subject device)
FLE
Device Description
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).
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
clinical setting
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.
Not Found
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
§ 880.6880 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).
0
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
2
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 TIME
TURNAROUND TIME | LOAD | INTENDED USE |
|-----------|-----------------------------------------------------------|---------------------------------------|---------------------------------|----------------------------------------|
| Unwrapped | Sterilization
Temperature 132°C | 10 minutes / 23 minutes | Maximum Load
is 3 Handpieces | Sterilize & Flush
Dental Handpieces |
| | Sterilization
Temperature Control
132°C =0° to +3°C | | Maximum Load
Weight 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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