(106 days)
Not Found
No
The description focuses on standard steam sterilization technology and does not mention any AI or ML components or functionalities.
No.
The device is an autoclave intended for sterilizing medical and dental instruments, not for providing therapy to patients.
No
The device is an autoclave, used for sterilizing medical and dental instruments, not for diagnosing conditions or diseases.
No
The device is a physical autoclave, which is a hardware device used for sterilization. The description clearly outlines its physical components and function.
Based on the provided information, the STATIM 7000 Cassette Autoclave is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to sterilize medical and dental instruments. This is a process applied to instruments used on patients or in procedures, not a test performed on a sample taken from a patient to diagnose a condition.
- Device Description: The description details a steam autoclave for sterilizing instruments. It does not describe a device that analyzes 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
- Using reagents or assays
- Measuring analytes
The STATIM 7000 is a sterilization device, which is a type of medical device, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The STATIM 7000 Cassette Autoclave is a pressure pulse steam autoclave designed to process medical and dental instruments to achieve successful sterilization in a clinical setting. It utilizes saturated steam at high pressures in order to attain an effective kill of infectious bio-organisms and prevent cross infection.
The unit is intended to sterilize heat and moisture stable medical and dental instruments (including dental handpieces) that are commonly found in medical and dental offices, hospitals, clinics, and other facilities. The instruments must be suitable for steam sterilization at 134°C (273°F) or 121 °C (250°F). The STATIM 7000 Cassette Autoclave is not intended nor recommended for the sterilization of liquids, cloths, text les, biomedical waste and certain rubber and plastic materials specified in the Operator's Manual.
The sterilization cycles as to established times, temperatures and indicated uses for the STATIM 7000 Cassette Autoclave are as follows:
| CYCLE | TEMPERATURE | NO. OF PURGES | STERILIZATION TIME | INTENDED USE |
|---|---|---|---|---|
| UNWRAPPED | 134°C (273°F) | 3 | 3.5 min. | Solid instruments, hinged instruments, dental handpieces, with drying |
| WRAPPED | 134°C (273°F) | 6 | 3.5 min. | Solid, hollow (including dental handpieces) & hinged instruments wrapped in paper/paper or paper/plastic pouches or paper sterilization wrap, with improved drying performance |
| RUBBER & PLASTICS | 121°C (250°F). | 3 | 30 min. | Instruments of rubber & plastic construction (exceptions are listed in the Operator's Manual) with drying |
Product codes (comma separated list FDA assigned to the subject device)
FLE
Device Description
The STAT/M 7000 Cassette Autoclave is a pressure pulse steam autoclave designed to process medical and dental instruments to achieve successful sterilization. The unit utilizes saturated steam at high pressures in order to attain an effective kill of infectious bio-organisms and prevent cross infection. Instruments are placed within the provided cassette, the cassette is placed within the armature, the cycle parameters are selected and the start button depressed. The unit is then fully automatic for the complete sterilizing cycle.
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
hospital or clinical setting such as medical and/or dental surgeries.
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.
STATIM 5000 Cassette Autoclave 510(k) K962179
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
Summary of Safety & Effectiveness Information
| 510(k) Summary: | ||
|---|---|---|
| Submitted by: | SciCan Ltd. | |
| 1440 Don Mills Road | ||
| Toronto, Ontario Canada | ||
| M3B 3P9 | DEC 1 9 2007 | |
| Contact Person: | Teresa Boyce - Senior Regulatory Affairs Specialist | |
| (416) 446-2783 | ||
| Date of Preparation: | August 31, 2007 | |
| Name of Device: | STATIM 7000 Cassette Autoclave | |
| Predicate Device: | STATIM 5000 Cassette Autoclave | |
| 510(k) K962179 |
Description of Device:
The STAT/M 7000 Cassette Autoclave is a pressure pulse steam autoclave designed to process medical and dental instruments to achieve successful sterilization. The unit utilizes saturated steam at high pressures in order to attain an effective kill of infectious bio-organisms and prevent cross infection. Instruments are placed within the provided cassette, the cassette is placed within the armature, the cycle parameters are selected and the start button depressed. The unit is then fully automatic for the complete sterilizing cycle.
Intended use:
The unit is intended to sterilize heat and moisture stable medical and dental instruments (including dental handpieces) within a hospital or clinical setting such as medical and/or dental surgeries. The instruments processed within the STATIM 7000 Cassette Autoclave must be suitable for steam sterilization at 134°C (273°F) or 121°C (250°F).
The sterilization cycles as to established times, temperatures and indicated uses for the STAT/M 7000 Cassette Autoclave are as follows:
| CYCLE | TEMPERATURE | TIME | INTENDED USE |
|---|---|---|---|
| UNWRAPPED | 134°C (273°F) | 3.5 min. | Solid instruments, hinged instruments, dental |
| handpieces, with heated drying | |||
| WRAPPED | 134°C (273°F) | 3.5 min. | Solid, hollow (including dental handpieces) & |
| hinged instruments wrapped in paper/paper or | |||
| paper/plastic pouches or paper sterilization | |||
| wrap, with improved drying performance | |||
| RUBBER & | |||
| PLASTICS | 121°C (250°F) | 30 min. | Instruments of rubber & plastic construction |
| (exceptions are listed in the Operator's | |||
| Manual) with heated drying |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing left and is surrounded by a circular border. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is written around the border of the circle.
Public Health Service
DEC 1 9 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Teresa Boyce Senior Regulatory Affairs Specilist SciCan Limited 1440 Don Mills Road Toronto, Ontario CANADA M3B 3P9
Re: K072466
Trade/Device Name: STATIM 7000 Cassette Autoclave Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: November 28, 2007 Received: November 30, 2007
Dear Ms. Boyce:
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.
2
Page 2 - Ms. Boyce
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 your 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
C. Lin, Ph.D.
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
3
INDICATIONS FOR USE
510(k) Number:
Device Name: STATIM 7000 Cassette Autoclave
Indications for Use: The STATIM 7000 Cassette Autoclave is a pressure pulse steam autoclave designed to process medical and dental instruments to achieve successful sterilization in a clinical setting. It utilizes saturated steam at high pressures in order to attain an effective kill of infectious bio-organisms and prevent cross infection.
The unit is intended to sterilize heat and moisture stable medical and dental instruments (including dental handpieces) that are commonly found in medical and dental offices, hospitals, clinics, and other facilities. The instruments must be suitable for steam sterilization at 134℃ (273%) or 121 °C (250°F). The STATIM 7000 Cassette Autoclave is not intended nor recommended for the sterilization of liquids, cloths, text les, biomedical waste and certain rubber and plastic materials specified in the Operator's Manual.
The sterilization cycles as to established times, temperatures and indicated uses for the STATIM 7000 Cassette Autoclave are as follows:
| CYCLE | TEMPERATURE | NO. OF PURGES | STERILIZATION TIME | INTENDED USE |
|---|---|---|---|---|
| UNWRAPPED | 134°C (273°F) | 3 | 3.5 min. | Solid instruments, hinged |
| instruments, dental handpieces, with | ||||
| drying | ||||
| WRAPPED | 134°C (273°F) | 6 | 3.5 min. | Solid, hollow (including dental |
| handpieces) & hinged instruments | ||||
| wrapped in paper/paper or | ||||
| paper/plastic pouches or paper | ||||
| sterilization wrap, with improved | ||||
| drying performance | ||||
| RUBBER & PLASTICS | 121°C (250°F). | 3 | 30 min. | Instruments of rubber & plastic |
| construction (exceptions are listed in | ||||
| the Operator's Manual) with drying |
Sheila K. Murphy, 52
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K02444
SCICAN STATIM 7000 510(k) 1-5