CASTLE SERIES 100HC STEAM STERILIZERS

K994314 · Getinge/Castle, Inc. · FLE · Feb 16, 2000 · General Hospital

Device Facts

• Record ID: K994314
• Device Name: CASTLE SERIES 100HC STEAM STERILIZERS
• Applicant: Getinge/Castle, Inc.
• Product Code: FLE · General Hospital
• Decision Date: Feb 16, 2000
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6880
• Device Class: Class 2

Intended Use

Castle® Series 100HC Steam Sterilizers are 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

Steam sterilizer for hospital/healthcare facility use; processes wrapped/unwrapped surgical instruments, linens, and non-patient-contact liquids. Device utilizes pressurized steam; features updated modular control system allowing cycle parameter adjustment (time/temperature), cycle renaming, and re-sequencing of up to 19 pre-validated cycles. Operated by healthcare personnel; provides visual output of cycle status/parameters. Benefits include increased flexibility in sterilization cycle configuration and improved ease of use for facility staff.

Clinical Evidence

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

Technological Characteristics

Steam sterilization chamber; modular control system; supports multiple cycle types (Gravity, Liquids, Flash, Prevacuum, Bowie-Dick, Leak Test). Complies with AAMI ST8, ST37, ST46, CSA-Z314.7, and GGS-1340A standards. Features password-protected parameter adjustment, selectable units (F/C, psi/kPa/bar), and power door options.

Indications for Use

Indicated for use in health care facilities to sterilize wrapped and unwrapped surgical instruments, linens, and non-patient-contact liquids 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

• Castle® Series 100 Steam Sterilizers (Straightline) (K970907)

Submission Summary (Full Text)

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Getinge/Castle, Inc. FDA 510(k) Summary - Castle® Series 100HC Steam Sterilizers Re: K994314 January 25, 2000 994314 FEB 16 2000 Page 1 of 3

## 510(k) SUMMARY

### Castle® Series 100HC Steam Sterilizers

| Submitted by: | Getinge/Castle Inc.<br>1777 E Henrietta Road<br>Rochester, NY 14623-3133 | | | |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| Contact Person: | Frederick R. Catt<br>Senior, Regulatory Affairs and Code Compliance Engineer<br>Phone: [phone]<br>Fax:<br>[phone] | | | |
| Date prepared: | January 25, 2000 | | | |
| Proprietary Name: | Castle® Series 100HC Steam Sterilizers | | | |
| Common Name: | Steam Sterilizer | | | |
| Device Classification: | Steam Sterilizer (80FLE) | | | |
| | Class II, as listed under Title 21 CFR 880.6880 | | | |
| Predicate Device: | Castle® Series 100 Steam Sterilizers (Straightline) [K970907] | | | |

#### Description of Device:

The 100HC Steam Sterilizers represent a series of sterilizers intended for use in hospital and health care facilities. The product provides an update to the control system that provides additional functionality and ease of use to the end user that includes the added flexibility to adjust cycle parameters (as on previous sterilizer models), rename, and reassign (re-sequence) the designated sterilization cycles.

(continued....)

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| | | | | | | | | Full List of Available Cycles for Series 100HC - up to 19 Total Cycles (w/ P1 - P6 Active) | |
|-------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------|-----------------------|------------------------------------------------------------|------------------------------------------------------------|-----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|--|
| Ref.<br>No. | Cycle Type | Exposure<br>Temperature<br>[°F/°C] | Exposure<br>Time<br>(Min.) | Drying Time<br>[Min.] | Available<br>and<br>Factory<br>Set P#<br>Cycles<br>[122HC] | Available<br>and<br>Factory<br>Set P#<br>Cycles<br>[133HC] | | Load Configuration | |
| 1 | Gravity 1 | 250/121 | 30 | 30 | P1 | Available | | | |
| 2 | Gravity 1 | 250/121 | 30 | 30 | Available | Available | | Double Wrapped Instrument Trays, 16lbs. (2 max.) | |
| 3 | Gravity 2 | 275/135 | 10 | 30 | P2 | Available | | Fabric Packs (2 max. in 16"x16" chamber)<br>(12 max. in 20"x20" chamber) | |
| 4 | Gravity 2 | 275/135 | 10 | 30 | Available | Available | | | |
| 5 | Liquids 1* | 250/121 | 30 | 0.75psi/min. | Available | Available | ● | Up to 250 mL Containers (40 max. in16" chamber)<br>(168 max. in 20" chamber) | |
| ర్ | Liquids 2* | 250/121 | 45 | 0.75psi/min. | Available | Available | | Up to 1000 mL Containers (15 max. in 16" chamber)<br>(32 max. in 20" chamber) | |
| 7 | Flash 3+ | 275/135 | 3 | 0 | P3 | Available | | | |
| 8 | Flash 3+ | 275/135 | 3 | 0 | P4 | P3 | Unwrapped Single Instrument<br>Unwrapped Non-Porous Instrument Trays up to 16lbs.<br>(2 max.) | | |
| 9 | Flash 3+ | 275/135 | 3 | 0 | Available | Available | | | |
| 10 | Flash 3+ | 275/135 | 3 | 0 | Available | Available | | | |
| 11 | Flash 10+ | 275/135 | 10 | 0 | િર | P4 | | | |
| 12 | Flash 10+ | 275/135 | 10 | 0 | PS | Available | | Unwrapped Single Instrument<br>Unwrapped Porous and Non-Porous Instrument Trays | |
| 13 | Flash 10+ | 275/135 | 10 | 0 | Available | Available | | up to 16lbs. (2 max.) | |
| 14 | Flash 10+ | 275/135 | 10 | 0 | Available | Available | | | |
| 15 | Prevacuum 1 | 275/135 | 3 | 16 | NA | P1 | � | Double Wrapped Instrument Trays 16lbs. (2 max.)<br>Fabric Packs (2 max. in 16"x16" chamber)<br>(12 max. in 20"x20" chamber) | |
| 16 | Prevacuum 2 | 275/135 | 3 | 3 | NA NA | P2 | | Single Wrapped Single Instrument | |
| 17 | Prevacuum 2 | 275/135 | 3 | 3 | NA | Available | | Single Wrapped Instrument Trays 16lbs. (2 max.)<br>Fabric Packs (2 max. in 16"x16" chamber)<br>(12 max. in 20"x20" chamber) | |
| 18 | Bowie-Dick Test | 273/134 | 3.5 | 0 | I NA NA | છેર | ● | S.M.A.R.T. Pack (Bowie-Dick Pack.) (1 max.) | |
| 19 | Leak Test | 268/131 | 3 | 15/5/15** | NA NA | ଚିଚ୍ଚ | ● | Empty Chamber Test | |
| | Note 1: Qualified Getinge/Castle personnel may reassign (re-sequence) "Available" cycles to P1-P6. | | | | | | | | |
| | Note 2: Load configurations are based on AAMI ST8, ST37 & ST46 Standards and Guidelines. | | | | | | | | |
| | | time as factory set parameter and indicated dry time is slow exhaust rate. | | | | | | Note 3: "The Liquids cycle is not intented for the sterlizztion of liquid catient contact. Liguid cycles have 8 minute liguid dwell | |
| | | | | | | | | Note 4: ** 15 minute dry, 5 minute timed vacuum leak rate test for change in pressure (differential). | |
| | NA: Cycle Not Available | | | | | | | | |

#### Intended Use:

Castle® Series 100HC Steam Sterilizers are 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.

(continued...)

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Getinge/Castle, Inc. FDA 510(k) Summary - Castle® Series 100HC Steam Sterilizers Re: K994314 January 25, 2000 Page 3 of 3

#### Predicate Device

Castle® Series 100 Steam Sterilizer (Straightline) [K970907].

#### Nonclinical Comparisons to Predicate Devices

Castle® Series 100HC Steam Sterilizers is a new model designation to identify incorporation of design improvements. These sterilizers are very similar to the Series 100 Steam Sterilizers (predicate device). Modifications made to the predicate device include:

- Addition of the "HC" suffix (Health Care facility type intended use) .
- Software change to provide a more modular structure .
- Customer ability to select, from 19 pre-validated cycles to be configured by a qualified . Getinge/Castle representative for the P1 - P6 control settings
- Ability for qualified Getinge/Castle representatives to modify a customized cycle description (up . to 8 digits) in addition to the fixed cycle type designation for the P1 - P6 control settings
- Customer ability for user to modify cycle parameters (time and temperature), through password . access, to accommodate specific device sterilization cycle requirements
- Selectable temperature (ºF or ºC) and pressure (psi, kPa, or bars) units .
- Minor piping changes to accommodate manufacturing .
- Adjustments to password features ●
- Power door option made available for double door vessels ●
- Power failure and recovery times lengthened .

#### Clinical Data:

No clinical data is required for this submission.

#### Conclusion:

Castle® Series 100HC Steam Sterilizers provide substantially equivalent product as those of our predicate device. There have been no substantial changes in technology, intended use, or labeling of this device. The sterilizers meet the applicable requirements of AAMI ST8, CSA-Z314.7, and GGS-1340A standards.

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

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Public Health Service

FEB 1 6 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Mark N. Smith, P.E. Director Regulatory Affairs/Quality Assurance Getinge/Castle, Incorporated 1777 East Henrietta Road Rochester, New York 14623-3133

Re : K994314 Castle® Series 100HC Steam Sterilizers Trade Name: Regulatory Class: II Product Code: FLE Dated: January 25, 2000 Received: January 27, 2000

Dear Mr. Smith:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in

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Page 2 - Mr. Smith

the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

sincerely yours,

Valtrist

mothy A. Ulatowski Difector Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

510(k) Number:

## K994314

Device Name:

#### Castle® Series 100HC Steam Sterilizers

Indications for Use:

Castle® Series 100HC Steam Sterilizers are 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.

| Ref.<br>No. | Cycle Type | Exposure<br>Temperature<br>[°F/°C] | Exposure<br>Time<br>[Min.] | Drying Time<br>[Min.] | Available<br>and<br>Factory<br>Set P#<br>Cycles<br>[122HC] | Available<br>and<br>Factory<br>Set P#<br>Cycles<br>[133HC] | Load Configuration |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|------------------------------------|----------------------------|-----------------------|------------------------------------------------------------|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| 1 | Gravity 1 | 250/121 | 30 | 30 | P1 | Available | |
| 2 | Gravity 1 | 250/121 | 30 | 30 | Available | Available | Double Wrapped Instrument Trays, 16lbs. (2 max.) |
| 3 | Gravity 2 | 275/135 | 10 | 30 | P2 | Available | Fabric Packs (2 max. in 16"x16" chamber)<br>(12 max. in 20"x20" chamber) |
| 4 | Gravity 2 | 275/135 | 10 | 30 | Available | Available | |
| 5 | Liquids 1* | 250/121 | 30 | 0.75psi/min. | Available | Available | Up to 250 mL Containers (40 max. in16" chamber)<br>(168 max. in 20" chamber) |
| 6 | Liquids 2* | 250/121 | 45 | 0.75psi/min. | Available | Available | Up to 1000 mL Containers (15 max. in 16" chamber)<br>(32 max. in 20" chamber) |
| 7 | Flash 3+ | 275/135 | 3 | 0 | P3 | Available | |
| 8 | Flash 3+ | 275/135 | 3 | 0 | P4 | P3 | Unwrapped Single Instrument |
| 9 | Flash 3+ | 275/135 | 3 | 0 | Available | Available | Unwrapped Non-Porous Instrument Trays up to 16lbs.<br>(2 max.) |
| 10 | Flash 3+ | 275/135 | 3 | 0 | Available | Available | |
| 11 | Flash 10+ | 275/135 | 10 | 0 | P5 | P4 | |
| 12 | Flash 10+ | 275/135 | 10 | 0 | P6 | Available | Unwrapped Single Instrument |
| 13 | Flash 10+ | 275/135 | 10 | 0 | Available | Available | Unwrapped Porous and Non-Porous Instrument Trays<br>up to 16lbs. (2 max.) |
| 14 | Flash 10+ | 275/135 | 10 | 0 | Available | Available | |
| 15 | Prevacuum 1 | 275/135 | 3 | 16 | NA | P1 | Double Wrapped Instrument Trays 16lbs. (2 max.)<br>Fabric Packs (2 max. in 16"x16" chamber)<br>(12 max. in 20"x20" chamber) |
| 16 | Prevacuum 2 | 275/135 | 3 | 3 | NA | P2 | Single Wrapped Single Instrument |
| 17 | Prevacuum 2 | 275/135 | 3 | 3 | NA | Available | Single Wrapped Instrument Trays 16lbs. (2 max.)<br>Fabric Packs (2 max. in 16"x16" chamber)<br>(12 max. in 20"x20" chamber) |
| 18 | Bowie-Dick Test | 273/134 | 3.5 | 0 | NA | P5 | S.M.A.R.T. Pack (Bowie-Dick Pack.) (1 max.) |
| 19 | Leak Test | 268/131 | 3 | 15/5/15** | NA | P6 | Empty Chamber Test |
| Note 1: Qualified Getinge/Castle personnel may reassign (re-sequence) "Available" cycles to P1-P6. | | | | | | | |
| Note 2: Load configurations are based on AAMI ST8, ST37 & ST46 Standards and Guidelines. | | | | | | | |
| Note 3: *The Liquids cycle is not intended for the sterilization of liquids intended for direct patient contact. Liquid cycles have 8 minute liquid dwell<br>time as factory set parameter and indicated dry time is slow exhaust rate.<br>Note 4: **15 minute dry, 5 minute dwell, 15 minute timed vacuum leak rate test for change in pressure (differential). | | | | | | | |
| NA: Cycle Not Available | | | | | | | |