(27 days)
Not Found
No
The document describes a steam sterilizer with a standard control system and user interface, with no mention of AI or ML capabilities.
No.
This device is a sterilizer intended for use in healthcare facilities to sterilize surgical instruments, linens, and liquids, not for direct therapeutic treatment of patients.
No
Explanation: The device is a sterilizer intended for use in healthcare facilities to sterilize surgical instruments, linens, and liquids. Its function is to sterilize, not to diagnose.
No
The device description clearly states it is a "Vacuum/Gravity Steam Sterilizer" with physical components like a "vertical sliding power door" and a "control panel," indicating it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to sterilize medical instruments, linens, and liquids using steam. This is a process for preparing medical devices for use, not for performing diagnostic tests on biological samples.
- Device Description: The description focuses on the physical characteristics and features of a steam sterilizer, not on any components or functions related to analyzing biological specimens.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This steam sterilizer does not fit that description.
N/A
Intended Use / 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.
Product codes
FLE
Device Description
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.
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
health care facilities
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
Nonclinical Comparisons to Predicate Device. No clinical data is required for this device classification submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
'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
1777 E Henrietta Road
Rochester, NY 14623-3133 |
|------------------------|-------------------------------------------------------------------------------------------------------|
| Contact Person: | Ann G. Wheeler
Sr. Quality Assurance Engineer
Phone: (585) 272-5036
Fax: (585) 272-5299 |
| Date prepared: | April 5, 2007 |
| Proprietary Name: | Model 633HC Series Vacuum/Gravity Steam Sterilizer (Sterilize
Model with lengths 26", 39" and 51") |
| Common Name: | Steam Sterilizer |
| Device Classification: | Steam Sterilizer (80 FLE)
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.
- The state
1
Getinge Sourcing LLC FDA 510(k) Summary Device: 633HC Series Vacuum/Gravity Steam Sterillizer
List of available cycles
| Cycle Type | No. of
Available
Cycles | Factory Settings | | | Load Configuration2 | Maximum Items per Chamber
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
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
(vac) | 1 | 273°F (134°C) | 3 min.
30 sec. | 0 min. | S.M.A.R.T. Pack or equivalent
(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
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
16 lbs (per tray). | 4 | 8 | 12 |
| | | | | | Fabric packs | 8 | 18 | 24 |
| Flash 3+
(f 3) | 2 | 275°F (135°C) | 3 min. | 30 sec.5 | Unwrapped non-porous single
instrument | 1 | 1 | 1 |
| | | | | | Unwrapped non-porous instrument
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
single instrument | 1 | 1 | 1 |
| | | | | | Unwrapped porous & non-porous
instrument trays, up to 16 lbs (per tray). | 2 | 2 | 2 |
| LIQUIDS (liq) | 1 | 250°F (121°C) | 45 min. | 0.75
psi/min.4 | Up to 1000 mL containers | 60 | 80 | 100 |
| Vacuum Leak
Test (lkt)3 | 1 | 268°F (131°C) | 3 min. | 15 min. dry
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.
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 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:
-
- 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.
-
- 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.
-
- The operating system has been upgraded to allow more inputs and outputs but the same fundamental micro processor technology is used.
-
- Vessel material has changed both materials meet ASME BPVC Section II Part A -Materials - Ferrous Material Specifications.
-
- 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.
3
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.
4
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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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
5
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
Available
Cycles | Factory Settings | | | Load Configuration² | Maximum Items per Chamber
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
16 lbs (per tray).
- 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
(vac) | 1 | 273°F (134°C) | 3 min.
30 sec. | 0 min. | S.M.A.R.T. Pack or equivalent
(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
16 lbs (per tray). - 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
16 lbs (per tray). - Fabric packs | 4 | 8 | 12 |
| | | | | | - Fabric packs | 8 | 18 | 24 |
| Flash 3+
(f 3) | 2 | 275°F (135°C) | 3 min. | 30 sec.⁵ | Unwrapped non-porous single
instrument - Unwrapped non-porous instrument
trays, up to 16 lbs (per tray). | 1 | 1 | 1 |
| | | | | | - Unwrapped non-porous instrument
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
single instrument - Unwrapped porous & non-porous
instrument trays, up to 16 lbs (per tray). | 1 | 1 | 1 |
| | | | | | - Unwrapped porous & non-porous
instrument trays, up to 16 lbs (per tray). | 2 | 2 | 2 |
| LIQUIDS (liq) | 1 | 250°F (121°C) | 45 min. | 0.75
psi/min.⁴ | Up to 1000 mL containers | 60 | 80 | 100 |
| Vacuum Leak
Test (lkt)³ | 1 | 268°F (131°C) | 3 min. | 15 min. dry
5 min. dwell
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.
6
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) 1. 1. 1.
:
:
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 2 of ____________________________________________________________________________________________________________________________________________________________________
Page 1 of 2
http://www.fda.gov/cdrh/ode/INDICUSE.HTML
Shula H. Murphy, R
rion of Anestherineey, General Hospital, Juon Control, Dentral Devices
:(k) Number: K070457