(284 days)
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Not Found
No
The document describes a steam autoclave for sterilization and does not mention any AI or ML components or functionalities.
No
This device is an autoclave used for sterilizing medical instruments, not for treating patients.
No
The device is an autoclave used for sterilizing medical instruments, not for diagnosing medical conditions.
No
The device description clearly indicates it is a steam autoclave, which is a hardware device used for sterilization. It is not a software-only medical device.
Based on the provided information, the STATIM 2000/5000 G4 Cassette Autoclaves are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is designed for the reprocessing of reusable medical instruments to achieve successful sterilization. This is a process performed on instruments used in patient care, not on biological samples or specimens taken from the body for diagnostic purposes.
- Function: The device uses steam sterilization to kill microorganisms on instruments. This is a method of disinfection/sterilization, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition
- Using reagents or assays
In summary, the STATIM 2000/5000 G4 Cassette Autoclaves are a medical device used for sterilizing instruments, which is a crucial part of infection control in healthcare settings. It does not perform any diagnostic function on biological samples.
N/A
Intended Use / Indications for Use
The STATIM 2000/5000 G4 Cassette Autoclaves are steam flush pressure pulse dynamic air removal steam autoclaves designed for the reprocessing of reusable medical instruments to achieve successful sterilization in a clinical setting. They utilize saturated steam at high pressures in order to attain an effective kill of infectious bio-organisms.
The units are intended to sterilize heat and moisture stable medical instruments (including handpieces) which are commonly found in medical and dental offices, hospitals, clinics, and other frecillies. nancheco) which are vehilization at 134°C (275°F) or 121 °C (250°F). The STATIM 2000/5000 G4 Cassette Autoclaves are only intended for heat stable instruments.
The sterilization cycles as to established times, temperatures and indicated uses for the STATIM 2000 G4 Cassette Autoclave are as follows:
- UNWRAPPED (for Immediate Use): TEMPERATURE 135°C (275°F), STERILIZATION/DRYING TIME 3.5 min. / 60 min., MAX LOAD 1.0 kg (2.2 lbs), INTENDED USE Solid metal instruments, hinged metal instruments, dental and phaco handpieces, with drying.
- WRAPPED: TEMPERATURE 135°C (275°F), STERILIZATION/DRYING TIME 10 min. / 60 min., MAX LOAD 1.0 kg (2.2 lbs), INTENDED USE Solid, hollow (including dental and phaco handpieces) & hinged metal instruments wrapped in paper/paper or paper/plastic pouches that are cleared by FDA for the claimed cycles, with drying.
- RUBBER & PLASTICS: TEMPERATURE 121°C (250°F)., STERILIZATION/DRYING TIME 15 min. / 60 min., MAX LOAD 0.4 kg (0.9 lbs), INTENDED USE Instruments of rubber & plastic construction (exceptions are listed in the Operator's Manual) with drying.
The lumen specifications for STATIM 2000 G4 Cassette Autoclave are as follows:
1Dental Handpieces: 7 handpieces within a 1 kg load
2Phaco Handpieces: 2 handpieces, 2 lumens per handpiece, where the lumens have a minimum inner diameter of 1.5 mm (0.06") and a maximum length of 150 mm (6") or a minimum inner diameter of 2 mm (0.08") and maximum length of 190 mm (7.5")
The sterilization cycles as to established times, temperatures and indicated uses for the STATIM 5000 G4 Cassette Autoclave are as follows:
- UNWRAPPED (for Immediate Use): TEMPERATURE 132°C (270°F), STERILIZATION /DRYING TIME 3.5 min. / 60 min., MAX LOAD 0.5 kg (1.1 lbs), INTENDED USE Solid metal instruments, hinged metal instruments with drying.
- WRAPPED: TEMPERATURE 132°C (270°F), STERILIZATION /DRYING TIME 6 min. / 60 min., MAX LOAD 1.5 kg (3.3 lbs), INTENDED USE Solid, hollow (including dental and phaco handpieces) & hinged metal instruments wrapped in paper/paper or paper/plastic pouches that are cleared by FDA for the claimed cycles, with drying.
- RUBBER & PLASTICS: TEMPERATURE 121°C (250°F), STERILIZATION /DRYING TIME 35 min. / 60 min., MAX LOAD 0.4 kg (0.9 lbs), INTENDED USE Instruments of rubber & plastic construction (exceptions are listed in the Operator's Manual) with drying.
- HEAVY DUTY UNWRAPPED (for Immediate Use): TEMPERATURE 132°C (270°F), STERILIZATION /DRYING TIME 6 min. / 60 min., MAX LOAD 1.5 kg (3.3 lbs), INTENDED USE Solid metal instruments, hinged metal instruments and dental and phaco handpieces with drying. The extended cassette must be used for the processing of longer instruments such as autoclavable rigid endoscopes in this cycle.
The lumen specifications for STATIM 5000 G4 Cassette Autoclave are as follows:
1Dental Handpieces: 8 handpieces within a 1.5 kg load
2Phaco Handpieces: 5 handpieces, 2 lumens per handpiece, where the lumens have a minimum inner diameter of 1.5 mm (0.06") and a maximum length of 150 mm (6") or a minimum inner diameter of 2 mm (0.08") and maximum length of 190 mm (7.5")
3Rigid Endoscopes: 3 scopes, 1 lumen per scope, where the lumens have a minimum inner diameter of 1 mm (0.04") and a maximum length of 490 mm (19")
Product codes
FLE
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical and dental offices, hospitals, clinics, and other frecillies.
Description of the training set, sample size, data source, and annotation protocol
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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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Teresa Boyce Director of Regulatory Affairs SciCan Limited 1440 Don Mills Road Toronto, Ontario CANADA M3B 3P9
JUL 10 2012
Re: K112872
Trade/Device Name: STATIM 2000/5000 G4 Cassette Autoclave Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: June 7, 2012 Received: June 11, 2012
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. 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.
1
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/CentersQffices/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,
For
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE
510(k) Number: K112872
STATIM 2000/5000 G4 Cassette Autoclave Device Name:
Indications for Use:
The STATIM 2000/5000 G4 Cassette Autoclaves are steam flush pressure pulse dynamic air removal steam autoclaves designed for the reprocessing of reusable medical instruments to achieve successful sterilization in a clinical setting. They utilize saturated steam at high pressures in order to attain an effective kill of infectious bio-organisms.
The units are intended to sterilize heat and moisture stable medical instruments (including handpieces) which are commonly found in medical and dental offices, hospitals, clinics, and other frecillies. nancheco) which are vehilization at 134°C (275°F) or 121 °C (250°F). The STATIM 2000/5000 G4 Cassette Autoclaves are only intended for heat stable instruments.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrently of BRANA frice of Device Evaluation (ODE Division of Anesthesiology, General Hospital
SciCan Ltd. K112872
2000 / 5000 G4 510/k)
Infection Control, Dental Devices
510(k) Nugherm
3
INDICATIONS FOR USE - Page 2 of 3
510(k) Number: K112872
The sterilization cycles as to established times, temperatures and indicated uses for the STATIM 2000 G4 Cassette Autoclave are as follows:
| CYCLE | TEMPERATURE | STERILIZATION /
DRYING TIME | MAX
LOAD | INTENDED USE |
|-------------------------------------|----------------|--------------------------------|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| UNWRAPPED
(for Immediate
Use) | 135°C (275°F) | 3.5 min. /
60 min. | 1.0 kg
(2.2 lbs) | Solid metal instruments, hinged
metal instruments, dental¹ and
phaco² handpieces, with drying. |
| WRAPPED | 135°C (275°F) | 10 min. /
60 min. | 1.0 kg
(2.2 lbs) | Solid, hollow (including dental¹ and
phaco² handpieces) & hinged metal
instruments wrapped in paper/paper
or paper/plastic pouches that are
cleared by FDA for the claimed
cycles, with drying. |
| RUBBER &
PLASTICS | 121°C (250°F). | 15 min. /
60 min. | 0.4 kg
(0.9 lbs) | Instruments of rubber & plastic
construction (exceptions are listed in
the Operator's Manual) with drying |
The lumen specifications are as follows:
1Dental Handpieces: 7 handpieces within a 1 kg load
2 handpieces, 2 lumens per handpiece, where the lumens have a minimum inner 2Phaco Handpieces: diameter of 1.5 mm (0.06") and a maximum length of 150 mm (6") or a minimum inner diameter of 2 mm (0.08") and maximum length of 190 mm (7.5")
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | |
|---|---|
| -------------------------------------------------------------------------- | -- |
| El L. H. Adams -NW | |
|---|---|
| -- | -------------------------------------------------------------------- |
Concur(Division Sign Off) Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | SciCan Ltd. K112872 |
|---|---|
| ---------------- | --------------------- |
STATIM 2000 / 5000 G4 510(k)
4
INDICATIONS FOR USE - Page 3 of 3
510(k) Number: K112872
The sterilization cycles as to established times, temperatures and indicated uses for the STATIM 5000 G4 Cassette Autoclave are as follows:
| CYCLE | TEMPERATURE | STERILIZATION /
DRYING TIME | MAX
LOAD | INTENDED USE |
|---------------------------------------------------|---------------|--------------------------------|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| UNWRAPPED
(for Immediate
Use) | 132°C (270°F) | 3.5 min. /
60 min. | 0.5 kg
(1.1 lbs) | Solid metal instruments, hinged metal
instruments with drying. |
| WRAPPED | 132°C (270°F) | 6 min. /
60 min. | 1.5 kg
(3.3 lbs) | Solid, hollow (including dental¹ and
phaco² handpieces) & hinged metal
instruments wrapped in paper/paper or
paper/plastic pouches that are cleared by
FDA for the claimed cycles, with drying. |
| RUBBER &
PLASTICS | 121°C (250°F) | 35 min. /
60 min. | 0.4 kg
(0.9 lbs) | Instruments of rubber & plastic
construction (exceptions are listed in the
Operator's Manual) with drying. |
| HEAVY DUTY
UNWRAPPED
(for Immediate
Use) | 132°C (270°F) | 6 min. /
60 min. | 1.5 kg
(3.3 lbs) | Solid metal instruments, hinged metal
instruments and dental¹ and phaco²
handpieces with drying. The extended
cassette must be used for the processing
of longer instruments such as
autoclavable rigid endoscopes³ in this
cycle. |
The lumen specifications are as follows:
8 handpieces within a 1.5 kg load 1Dental Handpieces:
5 handpieces, 2 lumens per handpiece, where the lumens have a minimum inner 2Phaco Handpieces: diameter of 1.5 mm (0.06") and a maximum length of 150 mm (6") or a minimum inner diameter of 2 mm (0.08") and maximum length of 190 mm (7.5")
3 scopes, 1 lumen per scope, where the lumens have a minimum inner diameter of 1 3Rigid Endoscopes: mm (0.04") and a maximum length of 490 mm (19")
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Elillatt Allع
Concurrence of CDRH, Office of Device Evaluation (ODF)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
SciCan Ltd.
STATIM 2000 / 5000 G4 510(k)
510(k) Number: K112872