(21 days)
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No
The document describes a steam sterilizer with standard control system features and makes no mention of AI or ML technology.
No
The device is a sterilizer for surgical instruments and linens, not a device used to treat patients directly.
No
The device is a sterilizer for surgical instruments and linens, not a diagnostic tool. Its purpose is to prepare medical equipment for use, not to diagnose medical conditions.
No
The device description clearly states it is a "Vacuum/Gravity Steam Sterilizer" and describes physical components like a "large sized chamber." This indicates it is a hardware device with a control system, not a software-only 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 surgical instruments and linens using pressurized steam. This is a process performed on medical devices and materials, not on biological samples from the human body for diagnostic purposes.
- Device Description: The description focuses on the physical characteristics and functionality of a steam sterilizer, not on analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There is no mention of diagnostic markers, assays, or any other typical components of an IVD device.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease. This steam sterilizer's function is to make medical devices sterile, which is a crucial step in preventing the spread of infection, but it does not perform a diagnostic test itself.
N/A
Intended Use / 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.
Product codes
FLE
Device Description
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. .
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
hospital and health care facilities
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical data is required for this device classification submission. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
510(k) SUMMARY
HO31259
Model 833HC Vacuum/Gravity Steam Sterilizer
| Submitted by: | Getinge Sourcing LLC
1777 E Henrietta Road
Rochester, NY 14623-3133 |
|------------------------|--------------------------------------------------------------------------------------------------|
| Contact Person: | Frederick R. Catt
Senior, Regulatory Engineer
Phone: (585) 272-5013
Fax: (585) 272-5299 |
| Date prepared: | April 18, 2003 |
| Proprietary Name: | Model 833HC Vacuum/Gravity Steam Sterilizer |
| Common Name: | Steam Sterilizer |
| Device Classification: | Steam Sterilizer (80 FLE)
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. .
1
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
Set Cycle
P# | Factory Settings | | | Load Configuration2 | |
|-------------------------------|----------------------------|-------------------|------------------|--------------------------------|----------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Cycle Type | | Exposure
Temp. | Exposure
Time | Dry Time1 | | |
| PREVAC1
(vac) | P1-P6 | 275°F
(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
(vac) | P7 | 273°F
(134°C) | 3.5 min | 0 min. | S.M.A.R.T. Pack or equivalent (1 max.) | |
| GRAVITY1
(grv) | P8-P10 | 250°F
(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
(grv) | P11-P13 | 275°F
(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
Test3
(lkt) | P14 | 268°F
(131°C) | 3 min. | 15 dry +5
dwell +15
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.
-
- 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].
2
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.
3
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.
4
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 (301) 594-4618. 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 (301) 443-6597 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
5
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
Cycle P# | Exposure
Temp. | Exposure
Time | Dry Time¹ | Load Configuration² | |
|-------------------------------|-------------------------|-------------------|------------------|-----------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------|
| PREVAC1
(vac) | P1-P6 | 275°F
(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
(vac) | P7 | 273°F
(134°C) | 3.5 min | 0 min. | S.M.A.R.T. Pack or equivalent (1 max.) | |
| GRAVITY1
(grv) | P8-P10 | 250°F
(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
(grv) | P11-P13 | 275°F
(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
Test³
(lkt) | P14 | 268°F
(131°C) | 3 min. | 15 dry +5 dwell
+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.
-
- Factory set drying time is the recommended minimum drying time. Extended drying time may be required depending on local conditions.
-
- Refer to AAMI standards ST46 Good Hospital Practice: Steam Sterilization and Sterility Assurance.
-
- Vacuum leak test cycle parameters are not adjustable.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
4 3 '7
| Prescription Use
| (Per 21 CFR 801.109) | |
|---|---|
| OR Over-The-Counter Use | |
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices | |
| 510(k) Number | K031259 |