(284 days)
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 facilities. The STATIM 2000/5000 G4 Cassette Autoclaves are only intended for heat stable instruments.
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This document is a 510(k) premarket notification from the FDA regarding the STATIM 2000/5000 G4 Cassette Autoclave. It outlines the intended use and sterilization cycles of the device but does not contain information on acceptance criteria for device performance, nor does it describe any study proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information, which typically involves performance metrics like sensitivity, specificity, accuracy, F1-score, AUC, or other statistical measures, and details about a study conducted to validate these metrics.
The document only states the cycles, temperatures, times, and max loads for different types of instruments for sterilization. It confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to a device already on the market and does not raise different questions of safety and effectiveness.
To directly answer your numbered points based only on the provided document:
- A table of acceptance criteria and the reported device performance: Not provided in the document. The tables show intended use parameters (temperature, sterilization/drying time, max load, intended use) for different cycles, not performance metrics or acceptance criteria.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided in the document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not provided in the document.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided in the document.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an autoclave, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is an autoclave, not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided in the document. For a sterilizer, ground truth would typically relate to microbiological inactivation verification (e.g., spore log reduction), but details are absent.
- The sample size for the training set: Not applicable. This device is an autoclave, not an AI model.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory clearance letter acknowledging substantial equivalence for a medical device (autoclave), and as such, it focuses on the device's intended use and regulatory classification rather than detailed performance study results or AI-specific evaluation criteria.
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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.
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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
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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
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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 | MAXLOAD | INTENDED USE |
|---|---|---|---|---|
| UNWRAPPED(for ImmediateUse) | 135°C (275°F) | 3.5 min. /60 min. | 1.0 kg(2.2 lbs) | Solid metal instruments, hingedmetal instruments, dental¹ andphaco² handpieces, with drying. |
| WRAPPED | 135°C (275°F) | 10 min. /60 min. | 1.0 kg(2.2 lbs) | Solid, hollow (including dental¹ andphaco² handpieces) & hinged metalinstruments wrapped in paper/paperor paper/plastic pouches that arecleared by FDA for the claimedcycles, with drying. |
| RUBBER &PLASTICS | 121°C (250°F). | 15 min. /60 min. | 0.4 kg(0.9 lbs) | Instruments of rubber & plasticconstruction (exceptions are listed inthe 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)
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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 | MAXLOAD | INTENDED USE |
|---|---|---|---|---|
| UNWRAPPED(for ImmediateUse) | 132°C (270°F) | 3.5 min. /60 min. | 0.5 kg(1.1 lbs) | Solid metal instruments, hinged metalinstruments with drying. |
| WRAPPED | 132°C (270°F) | 6 min. /60 min. | 1.5 kg(3.3 lbs) | Solid, hollow (including dental¹ andphaco² handpieces) & hinged metalinstruments wrapped in paper/paper orpaper/plastic pouches that are cleared byFDA 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 & plasticconstruction (exceptions are listed in theOperator's Manual) with drying. |
| HEAVY DUTYUNWRAPPED(for ImmediateUse) | 132°C (270°F) | 6 min. /60 min. | 1.5 kg(3.3 lbs) | Solid metal instruments, hinged metalinstruments and dental¹ and phaco²handpieces with drying. The extendedcassette must be used for the processingof longer instruments such asautoclavable rigid endoscopes³ in thiscycle. |
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
§ 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).