TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540

K021504 · Tuttnauer U.S.A Co, Ltd. · FLE · Jul 25, 2002 · General Hospital

Device Facts

• Record ID: K021504
• Device Name: TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540
• Applicant: Tuttnauer U.S.A Co, Ltd.
• Product Code: FLE · General Hospital
• Decision Date: Jul 25, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6880
• Device Class: Class 2
• Attributes: Therapeutic

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: [Cycle table data omitted for brevity as per instructions to concatenate]

Device Story

Table-top steam sterilizer; provides onboard steam generation. Inputs: medical/dental instruments (wrapped/unwrapped), lumened devices, porous/hollow loads, liquids. Operation: steam introduced directly into chamber; microprocessor controls cycle time, temperature, and pressure. Output: sterilized instruments/liquids. Used in clinical/non-clinical settings; operated by healthcare staff. Monitors include temp/pressure gauges, digital display, and printer. Benefits: eliminates wait time for water boiling; provides validated sterilization cycles for various load configurations.

Clinical Evidence

Bench testing only. Validation studies conducted in accordance with ANSI/AAMI ST55 demonstrated successful sterilization for all tested cycles, including the new 4-minute cycle for wrapped, non-lumened instruments.

Technological Characteristics

Steam sterilizer; components include pressure vessel with steam jacket, heating elements, dual-chamber water reservoir, water pump, and vacuum pump. Microprocessor-controlled cycle parameters (time, temp, pressure). Digital display and printer for monitoring. Connectivity: standalone. Sterilization: steam.

Indications for Use

Indicated for sterilization of medical and dental instruments (wrapped and unwrapped), including complex lumened devices (e.g., dental handpieces), porous, and hollow loads; also indicated for sterilization of liquids for non-clinical applications.

Regulatory Classification

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.

Predicate Devices

• 2540 EHS Table-Top Autoclave (K003470)

Submission Summary (Full Text)

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JUL 2 5 2002

K021504

#### 510(k) Summary

| Submitter: | Tuttnauer USA Co. Ltd.<br>25 Power Drive<br>Hauppauge, NY 11788 |
|----------------------|-----------------------------------------------------------------|
| | |
| | Phone: [phone]<br>Fax: [phone] |
| 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<br>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:

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| Cycle | Ste. Temp & Range<br>(°F) | Press. &<br>Range (Kpa) | Time<br>(min) | Vacuum<br>(kPa.) | Dry Time<br>(min) | Load<br>Configuration |
|--------------------------------------------------|---------------------------|-------------------------|---------------|------------------|-------------------|--------------------------------------------------------------------------------------------------------------------------------|
| 1. Unwrapped<br>273 | 273 (273-279) | 305 (305 - 330) | 3-1/2 | 20 | --- | Single,<br>unwrapped<br>instrument in<br>center of lowest<br>tray |
| 2. Wrapped 273<br>(complex/<br>lumened) | 273 (273-279) | 305 (305 - 330) | 8 | 25 | 20 | 4 wrapped trays<br>arranged so that<br>no instruments<br>touching.<br>Approximately<br>80% of area<br>occupied. |
| 3. Wrapped 250<br>(for instruments<br>onliquida) | 250 (250-256) | 205 (205 - 225) | 30 | 25 | 20 | Instruments<br>4 wrapped trays<br>arranged so that<br>no instruments<br>touching.<br>Approximately<br>80% of area<br>occupied. |
| 4. Wrapped 273<br>(non-lumened) | 273 (273-279) | 305 (305 - 330) | 4 | 25 | 20 | 4 wrapped trays<br>arranged so that<br>no instruments<br>touching.<br>Approximately<br>80% of area<br>occupied. |
| 5. Bowie-Dick | 273 (273-279) | 305 (305 - 330) | 3-1/2 | 20 | 2 | B-D pack in<br>otherwise empty<br>chamber |
| 6. Liquids | 250 (250-256) | 205 (205-225) | 30 | -- | -- | 6 - 250 ml.<br>Containers<br>made of heat<br>proof glass,<br>each filled up to<br>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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### 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<br>cycle) | 2540 EHS K003470 |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Labeling/Intended<br>Use | Auto Steam<br>Autoclave | Auto Steam<br>Autoclave |
| Process Parameters | Sterilization cycles<br>defined by time, temp.<br>and pressure.<br>Wrapped, non-<br>lumened medical<br>instruments sterilized<br>at 273-279°F for four<br>(4) minutes. Complex<br>lumened devices<br>sterilized at 273-<br>279°F for eight (8)<br>minutes. | Sterilization cycles<br>defined by time, temp.<br>and pressure. All<br>wrapped medical<br>instruments, including<br>complex lumened<br>devices, sterilized at<br>273-279°F for eight<br>(8) minutes. |
| Process Monitors | Temp. and pressure<br>gauges, digital display<br>screen, and printer | Temp. and pressure<br>gauges, digital display<br>screen, and printer |
| Pre-Vacuum | Yes | Yes |
| On-Board Steam<br>Generation | Yes | Yes |
| Control | Cycle time, temp.,<br>pressure, and user<br>interface controlled by<br>microprocessor | Cycle time, temp.,<br>pressure, and user<br>interface controlled by<br>microprocessor |
| Program Comparison | Wrapped, unwrapped,<br>and dry | Wrapped, unwrapped,<br>liquids, and dry |
| Process Equivalent<br>Times | Sterilization times of<br>3-1/2, 4, 8, 30 minutes<br>depending upon<br>program selected | Sterilization times of<br>3-1/2, 8, 30 minutes<br>depending upon<br>program selected |

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#### 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.

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## 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.<br>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.<br>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.<br>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.<br>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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…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… 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)

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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.

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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 [phone] . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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### 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<br>273 | 273 (273-279) | 305 (305 - 330) | 3-1/2 | 20 | -- | Single,<br>unwrapped<br>instrument in<br>center of lowest<br>tray |
| 2. Wrapped 273<br>(complex/<br>lumened) | 273 (273-279) | 305 (305 - 330) | 8 | 25 | 20 | 4 wrapped trays<br>arranged so that<br>no instruments<br>touching.<br>Approximately<br>80% of area<br>occupied. |
| 3. Wrapped 250 | 250 (250-256) | 205 (205 - 225) | 30 | 25 | 20 | Instruments<br>4 wrapped trays<br>arranged so that<br>no instruments<br>touching.<br>Approximately<br>80% of area<br>occupied. |
| 4. Wrapped 273<br>(non-lumened) | 273 (273-279) | 305 (305 - 330) | 4 | 25 | 20 | 4 wrapped trays<br>arranged so that<br>no instruments<br>touching.<br>Approximately<br>80% of area<br>occupied. |
| 5. Bowie-Dick | 273 (273-279) | 305 (305 - 330) | 3-1/2 | 20 | 2 | B-D pack in<br>otherwise empty<br>chamber |
| 6. Liquids | 250 (250-256) | 205 (205-225) | 30 | -- | -- | 6 - 250 ml.<br>Containers<br>made of heat<br>proof glass,<br>each filled up to<br>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 _____________________________________________________________________________________________________________________________________________________________

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