MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER

K031259 · Getinge USA, Inc. · FLE · May 12, 2003 · General Hospital

Device Facts

• Record ID: K031259
• Device Name: MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER
• Applicant: Getinge USA, Inc.
• Product Code: FLE · General Hospital
• Decision Date: May 12, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6880
• Device Class: Class 2

Intended Use

The Model 833HC Vacuum/Gravity Steam Sterilizer is intended for use by health care facilities and to be used to sterilize wrapped and unwrapped surgical instruments and linens, by means of pressurized steam.

Device Story

The 833HC Vacuum/Gravity Steam Sterilizer is a large-chamber steam sterilizer for hospital use. It utilizes pressurized steam to sterilize surgical instruments and linens. The device features a large color display for cycle selection, allowing users to rename and re-sequence sterilization cycles. It incorporates the PACS 3000 control system. The device is available in two chamber lengths (42" and 76") and can be pit or floor-mounted. It includes a door lift mechanism for the larger chamber height. Operators select cycles based on load type (wrapped instruments, fabric packs, or test cycles). The device provides automated sterilization cycles, ensuring instruments are processed according to AAMI standards. It benefits patients by ensuring the sterility of surgical equipment, thereby reducing the risk of healthcare-associated infections.

Clinical Evidence

No clinical data required for this device classification submission. Substantial equivalence is supported by nonclinical performance testing and adherence to AAMI ST8:2001 and CSA-Z314.7 standards.

Technological Characteristics

Steam sterilizer with large chamber (672mm x 920mm cross-section; 1067mm or 1930mm length). Features PACS 3000 control system. Operates via vacuum or gravity steam cycles. Includes door lift mechanism for pit/floor mounting. Complies with AAMI ST8 and CSA-Z314.7 standards.

Indications for Use

Indicated for use in health care facilities to sterilize wrapped and unwrapped surgical instruments and linens via pressurized steam.

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

• Model 733HC Vacuum/Gravity Steam Sterilizers (K020590)

Submission Summary (Full Text)

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# 510(k) SUMMARY

# HO31259

## Model 833HC Vacuum/Gravity Steam Sterilizer

| Submitted by: | Getinge Sourcing LLC<br>1777 E Henrietta Road<br>Rochester, NY 14623-3133 |
|------------------------|--------------------------------------------------------------------------------------------------|
| Contact Person: | Frederick R. Catt<br>Senior, Regulatory Engineer<br>Phone: [phone]<br>Fax: [phone] |
| Date prepared: | April 18, 2003 |
| Proprietary Name: | Model 833HC Vacuum/Gravity Steam Sterilizer |
| Common Name: | Steam Sterilizer |
| Device Classification: | Steam Sterilizer (80 FLE)<br>Class II, as listed per 21 CFR 880.6880 |
| Predicate Device: | Model 833HC Vacuum/Gravity Steam Sterilizer [K020590] |

### Description of Device:

The 833HC Vacuum/Gravity Steam Sterilizer is intended for use in hospital and health care facilities. The product incorporates a large sized chamber and has the same control system and offers similar overall features as those on the 733HC Vacuum/Gravity Steam Sterilizers. These include:

- additional functionality .
- . ease of use to the end user
- large color display that will allow the user to choose from the entire list of available ● cycles
- allows renaming and re-sequencing of sterilization cycles. .

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K03i259

April 18, 2003

The full list of available cycles is as follows in Table 1:

#### Model 833HC Vacuum/Gravity Steam Sterilizer Cycle and Load Chart Table 1.

| | Factory<br>Set Cycle<br>P# | Factory Settings | | | Load Configuration2 | |
|-------------------------------|----------------------------|-------------------|------------------|--------------------------------|----------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Cycle Type | | Exposure<br>Temp. | Exposure<br>Time | Dry Time1 | | |
| PREVAC1<br>(vac) | P1-P6 | 275°F<br>(135°C) | 3 min. | 16 min. | Wrapped instrument<br>trays, up to 16 lbs., per<br>tray 42" length - 12 max. 76" length - 24 max. | Fabric packs 42" length - 36 max. 76" length - 72 max. |
| Bowie-Dick Test<br>(vac) | P7 | 273°F<br>(134°C) | 3.5 min | 0 min. | S.M.A.R.T. Pack or equivalent (1 max.) | |
| GRAVITY1<br>(grv) | P8-P10 | 250°F<br>(121°C) | 30 min. | 30 min. | Wrapped instrument<br>trays, up to 16 lbs., per<br>tray 42" length 12 max. 76" length 24 max. | Fabric packs 42" length 36 max. 76" length 72 max. |
| GRAVITY2<br>(grv) | P11-P13 | 275°F<br>(135°C) | 10 min. | 30 min. | Wrapped instrument<br>trays, up to 16 lbs., per<br>tray 42" length 12 max. 76" length 24 max. | Fabric packs 42" length 36 max. 76" length 72 max. |
| Vacuum Leak<br>Test3<br>(lkt) | P14 | 268°F<br>(131°C) | 3 min. | 15 dry +5<br>dwell +15<br>test | Empty chamber | |

#### Notes for Table 1:

Load configurations follow AAMI Standards ST8 Hospital Steam Sterilizers where applicable.

- t. Factory set drying time is the recommended minimum drying time. Extended drying time may be required depending on local conditions.
- 2. Refer to AAMI standards ST46 Good Hospital Practice: Steam Sterilization and Sterility Assurance.
- టు Vacuum leak test cycle parameters are not adjustable.

#### Intended Use:

Model 833HC Vacuum/Gravity Steam Sterilizers are intended for use by health care facilities and to be used to sterilize wrapped and unwrapped surgical instruments and linens by means of pressurized steam.

#### Predicate Device

Model 733HC Vacuum/Gravity Steam Sterilizers [K020590].

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K031259

Getinge Sourcing LLC FDA 510(k) Summary Device: 833HC Vacuum/Gravity Steam Sterilizer

April 18, 2003

#### Nonclinical Comparisons to Predicate Device

The 833HC Vacuum/Gravity Steam Sterilizer is a new model number designation to identify incorporation of our updated sterilizer control system (PACS 3000) with large sterilizer chamber sizes and loads. The chamber cross-section dimensions are 672mm x 920mm (26.5" x 36"). Two lengths are available - 1067mm (42"), and 1930mm (76"). The 833HC sterilizer is similar to the 733HC Steam Sterilizer (predicate device), but with a larger chamber size and volume. Modifications made from the predicate device include:

- The sterilizer chamber height and volumes are increased. .
- The 833HC steam sterilizers can be either pit mounted (with the chamber floor . level to the room floor) or floor mounted.
- Door movements were modified to include a door lift phase that accommodates ● for the increased door height and the need to lift the door from being below floor level, especially for pit mounted sterilizers.
- . Flash and Liquids Cycles are not offered for this larger capacity sterilizer.
- Pipe routing changes were done to integrate with the larger pressure vessel . design where some of the piping is routed to either the left or right side of the vessel, due to limited space beneath the vessel.

#### Clinical Data:

No clinical data is required for this device classification submission.

#### Conclusion:

The 833HC Vacuum/Gravity Steam Sterilizer is a substantially equivalent device to that of the predicate device. There have been no substantial changes in technology, intended use of this device. This steam sterilizer meets the applicable requirements of AAMI ST8:2001, and CSA-Z314.7 performance standards.

Based on the provided information in this premarket notification, it can be concluded that the subject device is substantial equivalent to the predicate device and is safe and effective when used as intended.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 2 2003

Mr. Frederick R. Catt Senior, Regulatory Engineer Getinge Sourcing LLC 1777 E Henrietta Road Rochester, New York 14623-3133

Re: K031259

Trade/Device Name: Model 833HC Vaccuum/Gravity Steam Sterilizer Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: April 18, 2003 Received: April 22, 2003

Dear Mr. Catt:

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.

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Page 2 - Mr. Catt

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); good manufacturing practice requirements as set forth in the quality systems (QS) 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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Susan Ruane

Susan Runner, DDS, MA Interim 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:

K03 1259

833HC Vacuum/Gravity Steam Sterilizer Device Name:

### Indications for Use:

The Model 833HC Vacuum/Gravity Steam Sterilizer is intended for use by health care facilities and to be used to sterilize wrapped and unwrapped surgical instruments and linens, by means of pressurized steam.

| Cycle Type | Factory Set<br>Cycle P# | Exposure<br>Temp. | Exposure<br>Time | Dry Time¹ | Load Configuration² | |
|-------------------------------|-------------------------|-------------------|------------------|-----------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------|
| PREVAC1<br>(vac) | P1-P6 | 275°F<br>(135°C) | 3 min. | 16 min. | Wrapped instrument trays, up to 16 lbs., per tray 42" length – 12 max. 76" length – 24 max. | Fabric packs 42" length – 36 max. 76" length – 72 max. |
| Bowie-Dick Test<br>(vac) | P7 | 273°F<br>(134°C) | 3.5 min | 0 min. | S.M.A.R.T. Pack or equivalent (1 max.) | |
| GRAVITY1<br>(grv) | P8-P10 | 250°F<br>(121°C) | 30 min. | 30 min. | Wrapped instrument trays, up to 16 lbs., per tray 42" length 12 max. 76" length 24 max. | Fabric packs 42" length 36 max. 76" length 72 max. |
| GRAVITY2<br>(grv) | P11-P13 | 275°F<br>(135°C) | 10 min. | 30 min. | Wrapped instrument trays, up to 16 lbs., per tray 42" length 12 max. 76" length 24 max. | Fabric packs 42" length 36 max. 76" length 72 max. |
| Vacuum Leak<br>Test³<br>(lkt) | P14 | 268°F<br>(131°C) | 3 min. | 15 dry +5 dwell<br>+15 test | Empty chamber | |

#### Model 833HC Vacuum/Gravity Steam Sterilizer Cycle and Load Chart Table 1.

Notes for Table 1:

Load configurations follow AAMI Standards ST8 Hospital Steam Sterilizers where applicable.

- 1. Factory set drying time is the recommended minimum drying time. Extended drying time may be required depending on local conditions.
- 2. Refer to AAMI standards ST46 Good Hospital Practice: Steam Sterilization and Sterility Assurance.
- 3. Vacuum leak test cycle parameters are not adjustable.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

4 3 '7

| Prescription Use<br>(Per 21 CFR 801.109) | |
|-----------------------------------------------------------------------------------------------------------|-------------------------|
| | OR Over-The-Counter Use |
| (Division Sign-Off)<br>Division of Anesthesiology, General Hospital,<br>Infection Control, Dental Devices | |
| 510(k) Number | K031259 |