GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER

K070657 · Getinge Sourcing, LLC · FLE · Apr 5, 2007 · General Hospital

Device Facts

• Record ID: K070657
• Device Name: GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER
• Applicant: Getinge Sourcing, LLC
• Product Code: FLE · General Hospital
• Decision Date: Apr 5, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6880
• Device Class: Class 2

Intended Use

The Model 633HC Series Vacuum/Gravity Steam Sterilizer is intended for use by health care facilities and to be used to sterilize wrapped and unwrapped surgical instruments, linens and liquids (liquids not intended for direct patient contact) by means of pressurized steam.

Device Story

The 633HC Series is an intermediate-sized steam sterilizer for hospital/healthcare facility use. It processes wrapped/unwrapped surgical instruments, linens, and non-patient-contact liquids using pressurized steam. The device features a vertical sliding power door driven by a motorized lead screw and an upgraded control system with a color display and soft-key menu navigation. Operators select from preset cycle types (Prevac, Gravity, Flash, Liquids, Vacuum Leak Test) based on load configuration. The system uses a microprocessor to manage cycle parameters (exposure temperature, time, drying time). Output consists of sterilized items; the healthcare provider uses the control panel to monitor cycle status and ensure sterility assurance per AAMI ST8/ST79 standards. The device benefits patients by providing validated sterilization of medical instruments, reducing infection risk.

Clinical Evidence

No clinical data is required for this device classification submission; bench testing only.

Technological Characteristics

Steam sterilizer; vertical sliding power door with motorized lead screw; aluminum extrusion frame; microprocessor-controlled; color display user interface. Vessel materials meet ASME BPVC Section II Part A. Complies with AAMI ST8 and CSA-Z314.7 performance standards. Connectivity/software is embedded firmware.

Indications for Use

Indicated for use in health care facilities to sterilize wrapped and unwrapped surgical instruments, linens, and liquids (not for direct patient contact) 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 400HC/500HC Series Steam Sterilizer (K012573)

Submission Summary (Full Text)

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K070657

'APR 5 - 2007

# 510(k) SUMMARY

Model 633HC Series Vacuum/Gravity Steam Sterilizer (Sterilizer Models with 26", 39" and 51" lengths)

| Submitted by: | Getinge Sourcing LLC<br>1777 E Henrietta Road<br>Rochester, NY 14623-3133 |
|------------------------|-------------------------------------------------------------------------------------------------------|
| Contact Person: | Ann G. Wheeler<br>Sr. Quality Assurance Engineer<br>Phone: [phone]<br>Fax: [phone] |
| Date prepared: | April 5, 2007 |
| Proprietary Name: | Model 633HC Series Vacuum/Gravity Steam Sterilizer (Sterilize<br>Model with lengths 26", 39" and 51") |
| Common Name: | Steam Sterilizer |
| Device Classification: | Steam Sterilizer (80 FLE)<br>Class II, as listed per 21 CFR 880.6880 |
| Predicate Device: | Model 400HC/500HC Series Steam Sterilizer [K012573] |

#### Description of Device:

The 633HC Series Vacuum/Gravity Steam Sterilizer is intended for use in hospital and health care facilities. The device is an intermediate sized sterilizer within our product offering, it has a vertical sliding power door, upgraded control system and offers similar overall features as those on the Getinge 400HC/500HC Steam Sterilizers including a control panel (user interface) that incorporates a color display with soft key menu navigation, has the same cycle types with similar number of preset cycle types offered.

1. The state

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Getinge Sourcing LLC FDA 510(k) Summary Device: 633HC Series Vacuum/Gravity Steam Sterillizer

### List of available cycles

| Cycle Type | No. of<br>Available<br>Cycles | Factory Settings | | | Load Configuration2 | Maximum Items per Chamber<br>Sterilzer Model Length | | |
|----------------------------|-------------------------------|------------------|-------------------|-----------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------|-------------|-------------|
| | | Exp. Temp. | Exp. Time | Dry Time1 | | 26" | 39" | 51" |
| PREVAC 1 (vac) | 6 | 275°F (135°C) | 3 min. | 16 min. | Double-wrapped instrument trays, up to<br>16 lbs (per tray). | 4 | 8 | 12 |
| | | | | | Fabric packs | 8 | 18 | 24 |
| PREVAC 2 (vac) | 2 | 275°F (135°C) | 3 min. | 3 min. | Fabric packs | 8 | 18 | 24 |
| Bowie-Dick Test<br>(vac) | 1 | 273°F (134°C) | 3 min.<br>30 sec. | 0 min. | S.M.A.R.T. Pack or equivalent<br>(1 max.) in an EMPTY cham ber | 1 Test Pack | 1 Test Pack | 1 Test Pack |
| GRAVITY 1 (grv) | 3 | 250°F (121°C) | 30 min. | 30 min. | Double-wrapped instrument trays, up to<br>16 lbs (per tray). | 4 | 8 | 12 |
| | | | | | Fabric packs | 8 | 18 | 24 |
| GRAVITY 2 (grv) | 3 | 275°F (135°C) | 10 min. | 30 min. | Double-wrapped instrument trays, up to<br>16 lbs (per tray). | 4 | 8 | 12 |
| | | | | | Fabric packs | 8 | 18 | 24 |
| Flash 3+<br>(f 3) | 2 | 275°F (135°C) | 3 min. | 30 sec.5 | Unwrapped non-porous single<br>instrument | 1 | 1 | 1 |
| | | | | | Unwrapped non-porous instrument<br>trays, up to 16 lbs (per tray). | 2 | 2 | 2 |
| Flash 10+ (f10) | 2 | 275°F (135°C) | 10 min. | 30 sec.5 | Unwrapped porous or non-porous<br>single instrument | 1 | 1 | 1 |
| | | | | | Unwrapped porous & non-porous<br>instrument trays, up to 16 lbs (per tray). | 2 | 2 | 2 |
| LIQUIDS (liq) | 1 | 250°F (121°C) | 45 min. | 0.75<br>psi/min.4 | Up to 1000 mL containers | 60 | 80 | 100 |
| Vacuum Leak<br>Test (lkt)3 | 1 | 268°F (131°C) | 3 min. | 15 min. dry<br>5 min. dwell | Empty chamber | --- | --- | --- |

#### Model 633HC Series Vacuum/GravitySteam Sterilizer Load Chart

Notes for Table

#### Notes for Table

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

1 Factory set drying time is the recommended minimum drying time may be required

depending on local conditions. Gravity cycle drying time may be reduced by selecting vacuum drying phase.

2 Refer to AAM Standards ST79 Comprehensive guide to steam sterility assurance in health care facilities.

3Vacuum leak test cycle parameters are not adjustable.

4Cooldown rate

SItems may NOT be dry. Dry time may be added if required.

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#### Intended Use:

The Model 633HC Series Vacuum/Gravity Steam Sterilizer is intended for use by health care facilities and to be used to sterilize wrapped surgical instruments. linens and liquids (liquids not intended for direct patient contact) by means of pressurized steam.

#### Predicate Device

Getinge 400HC/500HC Series Steam Sterilizers (K012573).

#### Nonclinical Comparisons to Predicate Device

In summary, the differences between the 633HC Series and the predicate 400HC/500HC Series are:

- 1) The 633HC door drive mechanism is designed to accommodate a slightly larger and heavier door. The predicate 400HC/500HC Series power door utilizes a counter weight and pulley that engages with a small motor to drive the doors vertical movement. The 633HC uses a motorized lead screw to accomplish the same vertical door movement.
- 2) The frame material for the predicate is carbon steel welded construction, the 633HC is an aluminum extrusion framing that is secured with together with joining plates and hardware.
- 3) The operating system has been upgraded to allow more inputs and outputs but the same fundamental micro processor technology is used.
- 4) Vessel material has changed both materials meet ASME BPVC Section II Part A -Materials - Ferrous Material Specifications.
- 5) The 633HC series has a larger vessel size range than the 400HC/500HC. It is an intermediate size within he steam sterilizer offered by Getinge Sourcing LLC.

#### Clinical Data:

No clinical data is required for this device classification submission.

#### Conclusion:

The 633HC Series Vacuum/Gravity Steam Sterilizer is a substantially equivalent device to that of the predicate device. There have been no substantial changes in technology and no changes to the 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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three abstract human figures, represented by flowing lines, symbolizing health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 6 = 2007

Ms. Ann G. Wheeler Senior Quality Assurance Engineer Getinge Sourcing, LLC 1777 East Henrietta Road Rochester, New York 14623-3133

Re: K070657

Trade/Device Name: 633HC Series Vacuum/Gravity Steam Sterilizers Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: March 8, 2007 Received: March 9, 2007

Dear Ms. Wheeler:

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 - Ms. Wheeler

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 your 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/industry/support/index.html.

Sincerely yours.

Chiu Lin, Ph.D.

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 (if known): K070657

Device Name: 633HC Series Vacuum/Gravity Steam Sterilizer (Sterilizer Model with lengths 26", 39" and 51")

Indications For Use: The Model 633HC Series Vacuum/Gravity Steam Sterilizer is intended for use by health care facilities and to be used to sterilize wrapped and unwrapped surgical instruments, linens and liquids not intended for direct patient contact) by means of pressurized steam.

| Cycle Type | No. of<br>Available<br>Cycles | Factory Settings | | | Load Configuration² | Maximum Items per Chamber<br>Sterilizer Model Length | | |
|----------------------------|-------------------------------|------------------|-------------------|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|-------------|-------------|
| | | Exp. Temp. | Exp. Time | Dry Time¹ | | 26" | 39" | 51" |
| PREVAC 1 (vac) | 6 | 275°F (135°C) | 3 min. | 16 min. | Double-wrapped instrument trays, up to<br>16 lbs (per tray).<br>- Fabric packs | 4 | 8 | 12 |
| | | | | | - Fabric packs | 8 | 18 | 24 |
| PREVAC 2 (vac) | 2 | 275°F (135°C) | 3 min. | 3 min. | - Fabric packs | 8 | 18 | 24 |
| Bowie-Dick Test<br>(vac) | 1 | 273°F (134°C) | 3 min.<br>30 sec. | 0 min. | S.M.A.R.T. Pack or equivalent<br>(1 max.) in an EMPTY cham ber | 1 Test Pack | 1 Test Pack | 1 Test Pack |
| GRAVITY 1 (grv) | 3 | 250°F (121°C) | 30 min. | 30 min. | Double-wrapped instrument trays, up to<br>16 lbs (per tray).<br>- Fabric packs | 4 | 8 | 12 |
| | | | | | - Fabric packs | 8 | 18 | 24 |
| GRAVITY 2 (grv) | 3 | 275°F (135°C) | 10 min. | 30 min. | Double-wrapped instrument trays, up to<br>16 lbs (per tray).<br>- Fabric packs | 4 | 8 | 12 |
| | | | | | - Fabric packs | 8 | 18 | 24 |
| Flash 3+<br>(f 3) | 2 | 275°F (135°C) | 3 min. | 30 sec.⁵ | Unwrapped non-porous single<br>instrument<br>- Unwrapped non-porous instrument<br>trays, up to 16 lbs (per tray). | 1 | 1 | 1 |
| | | | | | - Unwrapped non-porous instrument<br>trays, up to 16 lbs (per tray). | 2 | 2 | 2 |
| Flash 10+ (f10) | 2 | 275°F (135°C) | 10 min. | 30 sec.⁵ | Unwrapped porous or non-porous<br>single instrument<br>- Unwrapped porous & non-porous<br>instrument trays, up to 16 lbs (per tray). | 1 | 1 | 1 |
| | | | | | - Unwrapped porous & non-porous<br>instrument trays, up to 16 lbs (per tray). | 2 | 2 | 2 |
| LIQUIDS (liq) | 1 | 250°F (121°C) | 45 min. | 0.75<br>psi/min.⁴ | Up to 1000 mL containers | 60 | 80 | 100 |
| Vacuum Leak<br>Test (lkt)³ | 1 | 268°F (131°C) | 3 min. | 15 min. dry<br>5 min. dwell<br>15 min. test | Empty chamber | ----- | ----- | ----- |

## Table 1: Model 633HC Series Vacuum/GravitySteam Sterilizer Load Chart

Notes for Table

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

Factory set drying time is the recommended minimum drying time. Extended drying time may be required

depending on local conditions. Gravity cycle drying time may be reduced by selecting vacuum drying phase.

Reler to AAM Standards ST79 Comprehensive guide to steam sterility assurance in health care facilities

3Vacuum leak test cycle parameters are not adjustable.

4Cooldown rate

SItems may NOT be dry. Dry time may be added if required.

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Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Shula H. Murphy, R

rion of Anestherineey, General Hospital, Juon Control, Dentral Devices

:(k) Number: K070457