(77 days)
The Tuttnauer 2540 EHS Series Table-top Autoclave is intended to provide sterilization of medical and dental instruments (wrapped and unwrapped) including complex lumened devices such as dental handpieces, porous, hollow loads and to sterilize liquids for non-clinical applications. Cycle parameters are as follows:
| Cycle | Ste. Temp & Range(°F) | Press. &Range (Kpa) | Time(min) | Vacuum(kPa.) | Dry Time(min) | LoadConfiguration |
|---|---|---|---|---|---|---|
| 1. Unwrapped273 | 273 (273-279) | 305 (305 - 330) | 3-1/2 | 20 | --- | Single,unwrappedinstrument incenter of lowesttray |
| 2. Wrapped 273(complex/lumened) | 273 (273-279) | 305 (305 - 330) | 8 | 25 | 20 | 4 wrapped traysarranged so thatno instrumentstouching.Approximately80% of areaoccupied. |
| 3. Wrapped 250(for instrumentsonliquida) | 250 (250-256) | 205 (205 - 225) | 30 | 25 | 20 | Instruments4 wrapped traysarranged so thatno instrumentstouching.Approximately80% of areaoccupied. |
| 4. Wrapped 273(non-lumened) | 273 (273-279) | 305 (305 - 330) | 4 | 25 | 20 | 4 wrapped traysarranged so thatno instrumentstouching.Approximately80% of areaoccupied. |
| 5. Bowie-Dick | 273 (273-279) | 305 (305 - 330) | 3-1/2 | 20 | 2 | B-D pack inotherwise emptychamber |
| 6. Liquids | 250 (250-256) | 205 (205-225) | 30 | -- | -- | 6 - 250 ml.Containersmade of heatproof glass,each filled up to2/3 capacity. |
Dental and medical instruments were placed within self-sealing, disposable pouches. The pouches were placed upright in an instrument rack.
The Tuttnauer 2540 EHS Table-top Autoclave is a steam sterilizer that provides an onboard steam generation capability. It is designed for sterilization of medical and dental instruments (wrapped and unwrapped), including complex lumened devices (such as dental handpieces), porous, hollow loads and to sterilize liquids for non-clinical applications. The sterilization medium is steam, which is directly introduced into the sterilization chamber. This eliminates the need to wait for water introduced into the chamber to boil and reach sterilization parameters.
The Tuttnauer EHS Series Electronic Table-top Autoclave is a steam sterilizer that includes as its main components: a pressure vessel with steam jacket, heating elements, a dualchamber water reservoir, a water pump and a vacuum pump. The device is identical to the predicate device, with the exception of the proposed modification to the labeling that would authorize sterilization of wrapped, non-lumened devices at 273° for four (4) minutes.
The provided document describes the Tuttnauer 2540 EHS Series Table-Top Autoclave, a steam sterilizer. The acceptance criteria and the study that proves the device meets the acceptance criteria are outlined below.
1. Table of Acceptance Criteria and Reported Device Performance:
The primary acceptance criterion is successful sterilization. The device performance is reported as meeting this criterion for all tested cycles.
| Cycle | Sterilization Temperature (°F) & Range | Pressure (Kpa) & Range | Time (min) | Vacuum (kPa.) | Dry Time (min) | Load Configuration | Reported Device Performance |
|---|---|---|---|---|---|---|---|
| 1. Unwrapped 273 | 273 (273-279) | 305 (305 - 330) | 3-1/2 | 20 | --- | Single, unwrapped instrument in center of lowest tray | Successful Sterilization |
| 2. Wrapped 273 (complex/lumened) | 273 (273-279) | 305 (305 - 330) | 8 | 25 | 20 | 4 wrapped trays arranged so that no instruments touching. Approximately 80% of area occupied. | Successful Sterilization |
| 3. Wrapped 250 | 250 (250-256) | 205 (205 - 225) | 30 | 25 | 20 | Instruments 4 wrapped trays arranged so that no instruments touching. Approximately 80% of area occupied. | Successful Sterilization |
| 4. Wrapped 273 (non-lumened) | 273 (273-279) | 305 (305 - 330) | 4 | 25 | 20 | 4 wrapped trays arranged so that no instruments touching. Approximately 80% of area occupied. | Successful Sterilization |
| 5. Bowie-Dick | 273 (273-279) | 305 (305 - 330) | 3-1/2 | 20 | 2 | B-D pack in otherwise empty chamber | Successful Sterilization |
| 6. Liquids | 250 (250-256) | 205 (205-225) | 30 | -- | -- | 6 - 250 ml. Containers made of heat proof glass, each filled up to 2/3 capacity. | Successful Sterilization |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample size (i.e., number of sterilization cycles or instruments) used for the test set. However, it indicates that "successful sterilization was accomplished in all tests performed" (Page 3), suggesting a comprehensive testing approach for the defined cycles.
The data provenance is not explicitly mentioned (e.g., country of origin, specific test sites). The studies were non-clinical validation studies described in the submission to the FDA. The nature of the studies ("Non-Clinical Testing") suggests they were conducted in a controlled laboratory environment. The document implies a prospective study design as it describes validation studies conducted to demonstrate the device's performance for specific new and existing cycles.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not mention the use of experts to establish a "ground truth" in the traditional sense of medical image analysis or diagnostic performance. Instead, the ground truth for sterilization efficacy is established through standardized microbiological testing methods (e.g., biological indicators) as dictated by the ANSI/AAMI ST55 standard. Therefore, the "experts" would be the technicians or scientists conducting these validated sterilization efficacy tests, and their qualifications would be expertise in microbiology and sterilization validation protocols.
4. Adjudication Method for the Test Set:
Not applicable. As described above, the determination of successful sterilization is based on objective, standardized microbiological test results, not on subjective expert opinion or adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is a medical device for sterilization, not a diagnostic imaging or AI-assisted system that involves human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. The device is a physical sterilizer and its performance is assessed directly, not through an algorithm's output. The "performance" is the physical sterilization process itself.
7. Type of Ground Truth Used:
The ground truth used is based on the results of sterilization efficacy tests, specifically adhering to the ANSI/AAMI ST55 standard. This standard typically involves using biological indicators (BIs) containing highly resistant bacterial spores (e.g., Geobacillus stearothermophilus). "Successful sterilization" means the complete killing of all spores on the BI, indicating a specific Sterility Assurance Level (SAL).
8. Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a training set. Its performance is based on the physical parameters of steam sterilization.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
{0}------------------------------------------------
JUL 2 5 2002
510(k) Summary
| Submitter: | Tuttnauer USA Co. Ltd.25 Power DriveHauppauge, NY 11788 |
|---|---|
| Phone: 800-624-5836Fax: 516-737-0720 | |
| Contact Name: | Robert R. Basile |
| Date Prepared: | May 9, 2000 |
| Common Name: | Electronic pre-vacuum autoclave, table-top steam sterilizer |
| Trade Name: | Tuttnauer 2540 EHS Series Table-Top Autoclave |
| Classification Name: | Steam SterilizerClass II Device - 21 C.F.R. § 880.6880 |
Substantial Equivalence:
The Tuttnauer 2540 EHS Table-Top Autoclave is substantially equivalent to the following currently marketed device:
| Company | Product Name | 510(k) Clearance Number |
|---|---|---|
| Tuttnauer USA Co. Ltd. | 2540 EHS Table-Top Autoclave | K003470 |
General Description:
The Tuttnauer 2540 EHS Table-top Autoclave is a steam sterilizer that provides an onboard steam generation capability. It is designed for sterilization of medical and dental instruments (wrapped and unwrapped), including complex lumened devices (such as dental handpieces), porous, hollow loads and to sterilize liquids for non-clinical applications. The sterilization medium is steam, which is directly introduced into the sterilization chamber. This eliminates the need to wait for water introduced into the chamber to boil and reach sterilization parameters.
Intended Use:
The Tuttnauer 2540 EHS Series Table-top Autoclave is intended to provide sterilization of medical and dental instruments (wrapped and unwrapped) including complex lumened devices such as dental handpieces, porous, hollow loads and to sterilize liquids for non-clinical applications. Cycle parameters are as follows:
{1}------------------------------------------------
| Cycle | Ste. Temp & Range(°F) | Press. &Range (Kpa) | Time(min) | Vacuum(kPa.) | Dry Time(min) | LoadConfiguration |
|---|---|---|---|---|---|---|
| 1. Unwrapped273 | 273 (273-279) | 305 (305 - 330) | 3-1/2 | 20 | --- | Single,unwrappedinstrument incenter of lowesttray |
| 2. Wrapped 273(complex/lumened) | 273 (273-279) | 305 (305 - 330) | 8 | 25 | 20 | 4 wrapped traysarranged so thatno instrumentstouching.Approximately80% of areaoccupied. |
| 3. Wrapped 250(for instrumentsonliquida) | 250 (250-256) | 205 (205 - 225) | 30 | 25 | 20 | Instruments4 wrapped traysarranged so thatno instrumentstouching.Approximately80% of areaoccupied. |
| 4. Wrapped 273(non-lumened) | 273 (273-279) | 305 (305 - 330) | 4 | 25 | 20 | 4 wrapped traysarranged so thatno instrumentstouching.Approximately80% of areaoccupied. |
| 5. Bowie-Dick | 273 (273-279) | 305 (305 - 330) | 3-1/2 | 20 | 2 | B-D pack inotherwise emptychamber |
| 6. Liquids | 250 (250-256) | 205 (205-225) | 30 | -- | -- | 6 - 250 ml.Containersmade of heatproof glass,each filled up to2/3 capacity. |
Dental and medical instruments were placed within self-sealing, disposable pouches. The pouches were placed upright in an instrument rack.
{2}------------------------------------------------
Technological Characteristics:
The Tuttnauer EHS Series Electronic Table-top Autoclave is a steam sterilizer that includes as its main components: a pressure vessel with steam jacket, heating elements, a dualchamber water reservoir, a water pump and a vacuum pump. The device is identical to the predicate device, with the exception of the proposed modification to the labeling that would authorize sterilization of wrapped, non-lumened devices at 273° for four (4) minutes. The following table contains a comparison of the characteristics of the device and its predicate.
| Characteristic | 2540 EHS (w/newcycle) | 2540 EHS K003470 |
|---|---|---|
| Labeling/IntendedUse | Auto SteamAutoclave | Auto SteamAutoclave |
| Process Parameters | Sterilization cyclesdefined by time, temp.and pressure.Wrapped, non-lumened medicalinstruments sterilizedat 273-279°F for four(4) minutes. Complexlumened devicessterilized at 273-279°F for eight (8)minutes. | Sterilization cyclesdefined by time, temp.and pressure. Allwrapped medicalinstruments, includingcomplex lumeneddevices, sterilized at273-279°F for eight(8) minutes. |
| Process Monitors | Temp. and pressuregauges, digital displayscreen, and printer | Temp. and pressuregauges, digital displayscreen, and printer |
| Pre-Vacuum | Yes | Yes |
| On-Board SteamGeneration | Yes | Yes |
| Control | Cycle time, temp.,pressure, and userinterface controlled bymicroprocessor | Cycle time, temp.,pressure, and userinterface controlled bymicroprocessor |
| Program Comparison | Wrapped, unwrapped,and dry | Wrapped, unwrapped,liquids, and dry |
| Process EquivalentTimes | Sterilization times of3-1/2, 4, 8, 30 minutesdepending uponprogram selected | Sterilization times of3-1/2, 8, 30 minutesdepending uponprogram selected |
{3}------------------------------------------------
Non-Clinical Testing:
Tuttnauer conducted validation studies in accordance with ANSI/AAMI ST55. Successful sterilization was accomplished in all tests performed .
Conclusion:
The Tuttnauer 2540 EHS Series Table-Top Autoclave is substantially equivalent to its predicate device, and can safely and effectively sterilize wrapped, non-lumened medical instruments at 273-279°F for four (4) minutes.
{4}------------------------------------------------
Indications for Use Statement
510(k) Number: KO21504
Device Name: Tuttnauer EHS Series Table-Top Autoclave
Indications For Use: The 2540 EHS Table-Top Autoclave is intended to provide sterilization of medical and dental instruments (wrapped and unwrapped), including complex lumened devices such as dental handpieces, porous, hollow loads, and to sterilize liquids for nonclinical applications. Cycle parameters are as follows:
| Cycle | Ste. Temp & Range (°F) | Press. & Range (Kpa) | Time (min) | Vacuum (kPa.) | Dry Time (min) | Load Configuration |
|---|---|---|---|---|---|---|
| 1. Unwrapped 273 | 273 (273-279) | 305 (305 - 330) | 3-1/2 | 20 | -- | Single, unwrapped instrument in center of lowest tray |
| 2. Wrapped 273 (complex/ lumened) | 273 (273-279) | 305 (305 - 330) | 8 | 25 | 20 | 4 wrapped trays arranged so that no instruments touching.Approximately 80% of area occupied. |
| 3. Wrapped 250 | 250 (250-256) | 205 (205 - 225) | 30 | 25 | 20 | 4 wrapped trays arranged so that no instruments touching.Approximately 80% of area occupied. |
| 4. Wrapped 273 (non-lumened) | 273 (273-279) | 305 (305 - 330) | 4 | 25 | 20 | 4 wrapped trays arranged so that no instruments touching.Approximately 80% of area occupied. |
| 5. Bowie-Dick | 273 (273-279) | 305 (305 - 330) | 3-1/2 | 20 | 2 | B-D pack in otherwise empty chamber |
| 6. Liquids | 250 (250-256) | 205 (205-225) | 30 | -- | -- | 6 - 250 ml.Containers made of heat proof glass, each filled up to 2/3 capacity |
Dental and medical instruments were placed within self-sealing, disposable pouches. The pouches were placed upright in an instrument rack.
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over -The-Counter Use ________________________________________________________________________________________________________________________________________________________ OR
(Per 21 C.F.R. § 801.109)
(Optional Format 1-2-96)
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an inner graphic. The graphic features three stylized human profiles facing right, with three parallel lines above them, resembling a stylized bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 5 2002
Tuttnauer USA Company Limited C/O Mr. Todd H. Halpern Buchanan Ingersoll, P. C. 1776 K Street N.W., Suite 800 Washington, D.C. 20006-2365
Re: K021504
Trade/Device Name: Tuttnauer 2540 EHS Series Table-Top Autoclave Regulation Number: 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: May 9, 2002 Received: May 9, 2002
Dear Mr. Halpern:
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.
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.
{7}------------------------------------------------
Page 2 - Mr. Halpern
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 (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.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Timothy Ulatowski
Timothy Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{8}------------------------------------------------
Indications for Use Statement
510(k) Number:
K02/504f
2540
Device Name:
Tuttnauer EHS Series Table-Top Autoclave
Indications For Use: The 2540 EHS Table-Top Autoclave is intended to provide sterilization of medical and dental instruments (wrapped and unwrapped), including complex lumened devices such as dental handpieces, porous, hollow loads, and to sterilize liquids for nonclinical applications. Cycle parameters are as follows:
| Cycle | Ste. Temp & Range | Press. & | Time | Vacuum | Dry Time | Load |
|---|---|---|---|---|---|---|
| (°F) | Range (Kpa) | (min) | (kPa.) | (min) | Configuration | |
| 1. Unwrapped273 | 273 (273-279) | 305 (305 - 330) | 3-1/2 | 20 | -- | Single,unwrappedinstrument incenter of lowesttray |
| 2. Wrapped 273(complex/lumened) | 273 (273-279) | 305 (305 - 330) | 8 | 25 | 20 | 4 wrapped traysarranged so thatno instrumentstouching.Approximately80% of areaoccupied. |
| 3. Wrapped 250 | 250 (250-256) | 205 (205 - 225) | 30 | 25 | 20 | Instruments4 wrapped traysarranged so thatno instrumentstouching.Approximately80% of areaoccupied. |
| 4. Wrapped 273(non-lumened) | 273 (273-279) | 305 (305 - 330) | 4 | 25 | 20 | 4 wrapped traysarranged so thatno instrumentstouching.Approximately80% of areaoccupied. |
| 5. Bowie-Dick | 273 (273-279) | 305 (305 - 330) | 3-1/2 | 20 | 2 | B-D pack inotherwise emptychamber |
| 6. Liquids | 250 (250-256) | 205 (205-225) | 30 | -- | -- | 6 - 250 ml.Containersmade of heatproof glass,each filled up to2/3 capacity. |
Dental and medical instruments were placed within self-sealing, disposable pouches. The pouches were placed upright in an instrument rack.
{9}------------------------------------------------
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________
OR Over -The-Counter Use ________________________________________________________________________________________________________________________________________________________
(Per 21 C.F.R. § 801.109)
(Optional Format 1-2-96)
$\underset{\text{Division Clerk's Office}}{Passed to Clin}$
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number KO3 1504
§ 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).