(77 days)
Not Found
No
The document describes a standard steam sterilizer with pre-defined cycles and parameters, with no mention of adaptive learning, data analysis for cycle optimization, or any other AI/ML characteristics.
No.
The device is an autoclave intended for sterilizing medical and dental instruments, not for directly treating a disease or condition in a patient.
No
The device is an autoclave, used for sterilizing medical and dental instruments, not for diagnosing medical conditions.
No
The device is a physical autoclave (steam sterilizer) with hardware components like a pressure vessel, heating elements, and pumps, not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the sterilization of medical and dental instruments, porous and hollow loads, and liquids for non-clinical applications. This is a sterilization process for equipment, not a diagnostic test performed on biological samples.
- Device Description: The description details the components and function of a steam sterilizer, which is used to kill microorganisms on instruments. It does not describe a device that analyzes biological samples to provide diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device is a sterilizer, which is a type of medical device used to prepare instruments for use, but it is not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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:
- Unwrapped 273: Ste. Temp & Range (°F) 273 (273-279); Press. & Range (Kpa) 305 (305 - 330); Time (min) 3-1/2; Vacuum (kPa.) 20; Dry Time (min) ---; Load Configuration Single, unwrapped instrument in center of lowest tray.
- Wrapped 273 (complex/lumened): Ste. Temp & Range (°F) 273 (273-279); Press. & Range (Kpa) 305 (305 - 330); Time (min) 8; Vacuum (kPa.) 25; Dry Time (min) 20; Load Configuration 4 wrapped trays arranged so that no instruments touching. Approximately 80% of area occupied.
- Wrapped 250 (for instruments onliquida): Ste. Temp & Range (°F) 250 (250-256); Press. & Range (Kpa) 205 (205 - 225); Time (min) 30; Vacuum (kPa.) 25; Dry Time (min) 20; Load Configuration Instruments 4 wrapped trays arranged so that no instruments touching. Approximately 80% of area occupied.
- Wrapped 273 (non-lumened): Ste. Temp & Range (°F) 273 (273-279); Press. & Range (Kpa) 305 (305 - 330); Time (min) 4; Vacuum (kPa.) 25; Dry Time (min) 20; Load Configuration 4 wrapped trays arranged so that no instruments touching. Approximately 80% of area occupied.
- Bowie-Dick: Ste. Temp & Range (°F) 273 (273-279); Press. & Range (Kpa) 305 (305 - 330); Time (min) 3-1/2; Vacuum (kPa.) 20; Dry Time (min) 2; Load Configuration B-D pack in otherwise empty chamber.
- Liquids: Ste. Temp & Range (°F) 250 (250-256); Press. & Range (Kpa) 205 (205-225); Time (min) 30; Vacuum (kPa.) --; Dry Time (min) --; Load Configuration 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.
Product codes (comma separated list FDA assigned to the subject device)
FLE
Device 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.
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.
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
Not Found
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)
Tuttnauer conducted validation studies in accordance with ANSI/AAMI ST55. Successful sterilization was accomplished in all tests performed.
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.
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
JUL 2 5 2002
510(k) Summary
| Submitter: | Tuttnauer USA Co. Ltd.
25 Power Drive
Hauppauge, NY 11788 |
|----------------------|-----------------------------------------------------------------|
| | |
| | Phone: 800-624-5836
Fax: 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 Sterilizer
Class 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) | 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
(for instruments
onliquida) | 250 (250-256) | 205 (205 - 225) | 30 | 25 | 20 | Instruments
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.
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/new
cycle) | 2540 EHS K003470 |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Labeling/Intended
Use | Auto Steam
Autoclave | Auto Steam
Autoclave |
| Process Parameters | Sterilization cycles
defined by time, temp.
and pressure.
Wrapped, non-
lumened medical
instruments sterilized
at 273-279°F for four
(4) minutes. Complex
lumened devices
sterilized at 273-
279°F for eight (8)
minutes. | Sterilization cycles
defined by time, temp.
and pressure. All
wrapped medical
instruments, including
complex lumened
devices, sterilized at
273-279°F for eight
(8) minutes. |
| Process Monitors | Temp. and pressure
gauges, digital display
screen, and printer | Temp. and pressure
gauges, digital display
screen, and printer |
| Pre-Vacuum | Yes | Yes |
| On-Board Steam
Generation | Yes | Yes |
| Control | Cycle time, temp.,
pressure, and user
interface controlled by
microprocessor | Cycle time, temp.,
pressure, and user
interface controlled by
microprocessor |
| Program Comparison | Wrapped, unwrapped,
and dry | Wrapped, unwrapped,
liquids, and dry |
| Process Equivalent
Times | Sterilization times of
3-1/2, 4, 8, 30 minutes
depending upon
program selected | Sterilization times of
3-1/2, 8, 30 minutes
depending upon
program 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.
5
(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. 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 | Instruments |
| 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.
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