(355 days)
Not Found
No
The summary describes a standard steam sterilizer with pre-programmed cycles and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is a sterilizer for medical and dental instruments, not a device used for treating patients.
No
The device is a sterilizer intended for heat and moisture resistant medical and dental instruments, not for diagnosing conditions.
No
The device is described as a gravity table-top steam sterilizer, which is a physical piece of equipment with hardware components like a chamber, compressor, and filter. The description and testing summary clearly indicate it is a hardware device with integrated software for control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as sterilizing medical and dental instruments and cloth packs. This is a process performed on medical devices themselves, not on biological samples from a patient to provide diagnostic information.
- Device Description: The description details a steam sterilizer, which is a piece of equipment used for disinfection/sterilization, not for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health
- Using reagents or assays
Therefore, the iMax 9.5 DS Sterilizer is a medical device used for sterilization, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The iMax 9.5 DS Sterilizer is a gravity table-top steam sterilizer intended for heat and moisture resistant medical and dental (including complex lumened devices such as dental handpieces) instruments and cloth packs for sterilization in healthcare facilities.
Three programmed sterilization cycles are provided with the iMax 9.5 DS Sterilizer (see table below).
| Cycle | Temperature(°C) | Pressure(bar) | Exposure Time (min.) | Drying Time(min.) | Maximum Load (kg) |
|---|---|---|---|---|---|
| Unwrapped instruments* | 134 | 2.14 – 2.21 | 4 | 6 | 4.0 |
| Wrapped instruments** | 134 | 2.14 – 2.21 | 20 | 20 | 4.0 |
| Packs | 121 | 1.10 - 1.17 | 30 | 20 | 1.5 |
- Not indicated for the processing of complex instruments (i.e. containing lumens, hinges, mated surfaces, etc.)
** Dental handpieces can be processed in the Wrapped instruments cycle only
The sterilizer is not intended to sterilize patient-contacting liquids.
Product codes
FLE
Device Description
The iMax 9.5 DS Sterilizer is a gravity table-top steam sterilizer. The iMax 9.5 DS Sterilizer is provided with a diaphragm compressor and HEPA filter that circulates filtered air in the sterilization chamber during the drying phase.
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
healthcare facilities.
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)
Software and performance testing was conducted to determine the safety and effectiveness of the proposed iMax 9.5 DS Sterilizer for its' intended use. The testing included electrical safety testing, electromagnetic compatibility testing and physical testing to ensure that all design requirements were fulfilled. Biological testing was conducted to verify the sterilization efficacy of the preprogrammed process parameters. Additional testing was conducted using both laboratory-inoculated and clinically contaminated dental handpieces to confirm that the iMax 9.5 Sterilizers could be used for the sterilization of complex lumened devices. The results confirm that the iMax 9.5 DS Sterilizer is safe and effective for the sterilization of steam-compatible medical and dental instruments, including dental handpieces.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Delta Steam Sterilizer (K945117), Midmark M9 UltraClave (K023348)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary for iMax 9.5 DS Sterilizer
SEP - 5 2006
SPONSOR 1.
Dental X srl Via Marzotto 11 36031 Dueville Vicenza ITALY
Dr. Marco Nesti Contact Person: 0039-0444-367411 Telephone:
August 17, 2006 Date Prepared:
2. DEVICE NAME
| Proprietary Name: | iMax 9.5 DS Sterilizer |
|---|---|
| Common/Usual Name: | Steam sterilizer |
| Classification Name: | Steam sterilizer |
3. PREDICATE DEVICES
DEVICE DESCRIPTION 4.
The iMax 9.5 DS Sterilizer is a gravity table-top steam sterilizer. The iMax 9.5 DS Sterilizer is provided with a diaphragm compressor and HEPA filter that circulates filtered air in the sterilization chamber during the drying phase.
1
INTENDED USE న.
The iMax 9.5 DS Sterilizer is a gravity table-top steam sterilizer intended for heat and moisture resistant medical and dental (including complex lumened devices such as dental handpieces) instruments and cloth packs for sterilization in healthcare facilities.
Three programmed sterilization cycles are provided with the iMax 9.5 DS Sterilizer (see table below).
| Cycle | Temperature
(°C) | Pressure
(bar) | Exposure Time
(min.) | Drying
Time (min.) | Maximum Load
(kg) |
|---------------------------|---------------------|-------------------|-------------------------|-----------------------|----------------------|
| Unwrapped
instruments* | 134 | 2.14 - 2.21 | 4 | 6 | 4.0 |
| Wrapped
instruments ** | 134 | 2.14 - 2.21 | 20 | 20 | 4.0 |
| Packs | 121 | 1.10 - 1.17 | 30 | 20 | 1.5 |
- Not indicated for the processing of complex instruments (i.e. containing lumens, hinges, mated surfaces, etc.)
**Dental handpieces can be processed in the Wrapped instruments cycle only
The sterilizer is not intended to sterilize patient-contacting liquids.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
Both the proposed and predicate devices are gravity-fed microprocessorcontrolled table top steam sterilizers consisting of a sterilization chamber with a water storage and transport system, heating elements for steam generation, and a valve system for exhausting air and steam for the chamber. Differences in the technical features between the proposed and predicate devices are limited to minor differences in chamber volume, dimensions, etc.
PERFORMANCE TESTING 7.
Software and performance testing was conducted to determine the safety and effectiveness of the proposed iMax 9.5 DS Sterilizer for its' intended use. The testing included electrical safety testing, electromagnetic compatibility testing and physical testing to ensure that all design requirements were fulfilled. Biological testing was conducted to verify the sterilization efficacy of the preprogrammed process parameters. Additional testing was conducted using both laboratoryinoculated and clinically contaminated dental handpieces to confirm that the iMax 9.5 Sterilizers could be used for the sterilization of complex lumened devices. The
2
results confirm that the iMax 9.5 DS Sterilizer is safe and effective for the sterilization of steam-compatible medical and dental instruments, including dental handpieces.
3
Image /page/3/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dental X SRL C/O Cynthia J.M. Nolte Medical Device Consultant, Incorporated 49 Plain Street North Attleboro. Massachusetts 02760
SEP - 5 2006
Re: K052532
Trade/Device Name: iMAX DS 9.5 Sterilizers Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: August 17, 2006 Received: August 17, 2006
Dear Ms. Nolte:
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 such 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 -- Ms. Nolte
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address lttp://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Clue
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): K052532
Device Name: iMax 9.5 DS Sterilizer
Indications for Use:
ﺎ
The iMax 9.5 DS Sterilizer is a gravity table-top steam sterilizer intended for heat and moisture resistant medical and dental (including complex lumened devices such as dental handpieces) instruments and cloth packs for sterilization in healthcare facilities.
Three programmed sterilization cycles are provided with the iMax 9.5 DS Sterilizer (see table below).
| Cycle | Temperature
(°C) | Pressure
(bar) | Exposure
Time (min.) | Drying Time
(min.) | Maximum
Load (kg) |
|---------------------------|---------------------|-------------------|-------------------------|-----------------------|----------------------|
| Unwrapped
instruments* | 134 | 2.14 – 2.21 | 4 | 6 | 4.0 |
| Wrapped
instruments** | 134 | 2.14 – 2.21 | 20 | 20 | 4.0 |
| Packs | 121 | 1.10 - 1.17 | 30 | 20 | 1.5 |
- Not indicated for the processing of complex instruments (i.e. containing lumens, hinges, mated surfaces, etc.)
** Dental handpieces can be processed in the Wrapped instruments cycle only
The sterilizer is not intended to sterilize patient-contacting liquids.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR Over-the-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shuley F. Murphy D 9/1/04
f Anesthesiology, General Hospita ontrol, Dental Device
Number: A052532
Page 1 of 1