(579 days)
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No
The summary describes a steam sterilizer and its validation studies, with no mention of AI or ML capabilities.
No
A therapeutic device is one that treats or alleviates a medical condition in a patient. The STERIS Eagle Century Steam Sterilizer is intended for the sterilization of materials used in healthcare facilities, not for direct treatment of patients.
No
This device is a sterilizer, used for the sterilization of materials, not for diagnosing medical conditions.
No
The device description clearly states it is a "Steam Sterilizer" and describes physical components like "sliding door" and "prevacuum or gravity configuration," indicating it is a hardware device.
Based on the provided information, the STERIS Eagle Century Steam Sterilizer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "efficient, sterilization of non-porous and porous, heat and moisture-stabile materials used in healthcare facilities." This describes a process for making medical devices or materials sterile, not for performing tests on biological samples to diagnose conditions.
- Device Description: It is described as a "Class II medical device as defined by 21 CFR §880.6880." This specific regulation (880.6880) pertains to Sterilizers, Steam, which are devices used to sterilize medical instruments and materials. IVD devices fall under different regulatory classifications.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
In summary, the STERIS Eagle Century Steam Sterilizer is a device used for sterilizing medical equipment and materials, which is a different function than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The STERIS Eagle Century Steam Sterilizer is designed for efficient, sterilization of non-porous and porous, heat and moisture-stabile materials used in healthcare facilities. The Eagle Century Steam Sterilizer is available in the following configurations:
16" x 16" x 26" Single Door Gravity
16" x 16" x 26" Double Door Gravity
20" x 20" x 38" Single Door Gravity
20" x 20" x 38" Double Door Prevacuum
16" x 16" x 26" Single Door Prevacuum
16" x 16" x 26" Double Door Prevacuum
20" x 20" x 38" Single Door Prevacuum
The Eagle Century Steam Sterilizer is equipped with the following factory-programmed set sterilization cycles and cycle values:
Prevacuum Configuration
CYCLES: FLASH, RECOMMENDED LOADS: Unwrapped Instrument tray with a single instrument, STERILIZE TEMP.: 270°F (132°C), STERILIZE TIME: 3 minutes, DRY TIME: 1 minute
CYCLES: FLASH, RECOMMENDED LOADS: Unwrapped instrument tray with non-porous multiple instruments, maximum weight 17lbs, STERILIZE TEMP.: 270°F (132°C), STERILIZE TIME: 10 minutes, DRY TIME: 1 minute
CYCLES: EXPRESS, RECOMMENDED LOADS: Single wrapped instrument tray with a single instrument. Non-porous goods only., STERILIZE TEMP.: 270°F (132°C), STERILIZE TIME: 4 minutes, DRY TIME: 3 minutes
CYCLES: PREVAC, RECOMMENDED LOADS: Up to two double wrapped instrument trays, maximum weight 17lbs. Up to six fabric packs., STERILIZE TEMP.: 270°F (132°C), STERILIZE TIME: 4 minutes, DRY TIME: 20 minutes (Five minute Dry Time can be used for processing a single fabric pack.)
GRAVITY CONFIGURATION
CYCLES: FLASH, RECOMMENDED LOAD: Unwrapped Instrument tray with a single instrument., STERILIZE TEMP.: 270°F (132°C), STERILIZE TIME: 3 minutes, DRY TIME: 1 minute
CYCLES: FLASH, RECOMMENDED LOAD: Unwrapped Instrument tray with non-porous multiple instruments, maximum weight 17lbs, STERILIZE TEMP.: 270 °F (132°C), STERILIZE TIME: 10 minutes, DRY TIME: 1 minute
CYCLES: GRAVITY, RECOMMENDED LOAD: Up to two double wrapped instrument trays, maximum weight 17lbs, STERILIZE TEMP.: 270°F (132°C), STERILIZE TIME: 15 minutes, DRY TIME: 30 minutes
CYCLES: GRAVITY, RECOMMENDED LOAD: Fabric Packs, STERILIZE TEMP.: 250°F (121 °C), STERILIZE TIME: 30 minutes (A 270°F (132°C) cycle adjusted to 25 minute Sterilize Time can be used for processing fabric packs.), DRY TIME: 15 minutes
Product codes (comma separated list FDA assigned to the subject device)
FLE
Device Description
The AMSCO brand Eagle Century Steam Sterilizer is a Class II medical device as defined by 21 CFR §880.6880. The Eagle Century Steam Sterilizer is a sliding door sterilizer, offered in either a prevacuum or gravity configuration, intended for the terminal sterilization of heat and moisture-stabile materials.
The Eagle Century Steam Sterilizer is offered for sale with the following factory-set sterilization cycles and cycle values:
PREVACUUM CONFIGURATION:
FLASH (270°F (132°C), 3 minutes sterilize time, 1 minute dry time) for Unwrapped Instrument Tray with a Single Instrument.
FLASH (270°F (132°C), 10 minutes sterilize time, 1 minute dry time) for Unwrapped Instrument Tray with non-porous multiple instruments (maximum weight of 17lbs).
EXPRESS (270°F (132°C), 4 minutes sterilize time, 3 minutes dry time) for Single Wrapped Instrument Tray with a single instrument. Non-porous goods only.
PREVAC (270°F (132°C), 4 minutes sterilize time, 20 minutes dry time) for Up to two double wrapped instrument trays (maximum weight of lbs. each). Up to six fabric packs. (Five minutes dry time can be used for processing a single fabric pack.)
Also offered with the Prevacuum configuration are the Leak Test Cycle that provides verification of door seal and piping system integrity, and the Daily Air Removal Test (DART) Cycle that provides verification of effective removal of residual air in the chamber and load during testing when combined with a DART or Bowie-Dick test pack.
GRAVITY CONFIGURATION:
FLASH (270°F (132°C), 3 minutes sterilize time, 1 minute dry time) for Unwrapped Instrument tray with a single instrument.
FLASH (270°F (132°C), 10 minutes sterilize time, 1 minute dry time) for Unwrapped Instrument Tray with non-porous multiple instruments (maximum weight of 17 lbs.).
GRAVITY (270°F (132°C), 15 minutes sterilize time, 30 minutes dry time) for Up to two double wrapped instrument trays (maximum weight of 17lbs. each).
GRAVITY (250°F (132°C), 30 minutes sterilize time, 15 minutes dry time) for Fabric Packs. (A 270°F (132°C) cycle adjusted to 25 minute Sterilize Time can be used for processing Fabric Packs.)
AMSCO brand sterilizers including the Eagle Century Steam Sterilizers have been designed, constructed and tested to minimally meet the safety and performance requirements of various national safety codes and standards. The Eagle Century Steam Sterilizer complies with the following requirements:
- Underwriters Laboratory (UL) Electromedical Code 544 as certified by ETL Testing Laboratories, Inc .;
- Canadian Standards Association (CSA) Standard C22.2 No. 125 or 151;
- American Society of Mechanical Engineers (ASME), Section VIII, Division 1 for unfired pressure vessels;
- American Society of Mechanical Engineers (ASME), Section I, Part PMB for power boilers;
- California Seismic Pre-Approval; and
- National Fire Protection Association Standard 99.
A Reliability Analysis and Failure Modes and Effects and Criticality Analysis has been conducted on the Eagle Century Steam Sterilizer's electrical system, mechanical system and piping system as well. The technology designed in AMSCO brand steam sterilizers including the Eagle Century provides microprocessor controller safeguards that abort the cycle and give appropriate signals, alerts and warnings when required conditions have not been met or when a malfunction occurs.
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
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Indicated Patient Age Range
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Intended User / Care Setting
intended for the terminal sterilization of heat and moisture-stabile materials used in healthcare facilities. To avoid failure, the user must ensure the materials, instruments and devices to be sterilized are thoroughly cleaned, that the manufacturer's instructions for use are followed, that the cycle to be used for each type of sterilizer load has been validated, that the sterilizer has been maintained in accordance with the sterilizer manufacturer's recommended maintenance schedule and is operating properly, and that each sterilizer load is monitored with available and validated biological and chemical sterilization process indicators.
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)
Effectiveness: Efficacy of sterilizer function and exposure time recommendations are ultimately shown by showing complete kill of biological indicators and verifying an appropriate safety factor or sterility assurance level (SAL) of less than 10-6 (probability of less than one chance out of one million of a non-sterile indicator). STERIS validates its sterilization cycles by recommended practices, standards and guidelines developed by various independent organizations such as the Association for Advancement of Medical Instrumentation (AAMI).
The results of the Eagle Century Validation demonstrate that the sterilizer performs as intended and are summarized as follows:
- Validation Studies for Compliance to AAMI-ST8: This standard establishes the minimum construction and performance requirements for hospital sterilizers that use saturated steam as the sterilizing agent and have a volume greater than 2 cubic feet. The Eagle Century Steam Sterilizer cycles validated per AAMI-ST8 are the 250°F Gravity, 270°F Prevac and the DART test.
- Validation Studies for Compliance to AAMI-ST37: This recommended practice covers flash sterilization in health care facilities and includes guidelines for sterilization processing procedures. The Eagle Century Steam Sterilizer cycles validated per AAMI-ST37 are the 270°F Flash and the 270°F Express.
- Validation Studies for Century with Electric Steam Generator: The customer has the choice to operate the Eagle Century on house steam, an independently purchased steam generator or a generator supplied by STERIS. STERIS conducted testing of the Century with the Electric Steam Generator to ensure that the generator recommended would provide sufficient efficiency to perform sterilization cycles. The Eagle Century Steam Sterilizer cycles validated with the Electric Steam Generator are the 270°F Prevac. 270°F Gravity and the 250°F Liquid.
- Validation Studies for Century for Liquid Cycle Efficacy: The Eagle Century Steam Sterilizer optional Liquid Cycle was validated to ensure that 100ml, 1000ml and 2000ml liquid loads with vented self-sealing closures processed properly.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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
JUN 1 1998
A 510(k) SUMMARY PERTAINING TO THE SAFETY AND EFFECTIVENESS OF THE EAGLE CENTURY STEAM STERILIZER
Submitter Information
STERIS Corporation Raymond Ursick Senior Director Regulatory Affairs and Quality Systems 5960 Heisley Road Mentor, Ohio 44060 (440) 354-2600 Phone Date Summary Prepared: March 5, 1998
Introduction
The AMSCO brand Eagle Century Steam Sterilizer is a Class II medical device as defined by 21 CFR $880.6880. The Eagle Century Steam Sterilizer is a sliding door sterilizer, offered in either a prevacuum or gravity configuration, intended for the terminal sterilization of heat and moisture-stabile materials.
The Eagle Century Steam Sterilizer is offered for sale with the following factory-set sterilization cycles and cycle values:
PREVACUUM CONFIGURATION*
| CYCLES | STERILIZE TEMP. | STERILIZE TIME | DRY TIME | RECOMMENDED LOAD |
|---|---|---|---|---|
| FLASH | 270°F (132°C) | 3 minutes | 1 minute | Unwrapped Instrument Tray with |
| a Single Instrument | ||||
| FLASH | 270°F (132°C) | 10 minutes | 1 minute | Unwrapped Instrument Tray with |
| non-porous multiple instruments | ||||
| (maximum weight of 17lbs) | ||||
| EXPRESS | 270°F (132°C) | 4 minutes | 3 minutes | Single Wrapped Instrument Tray |
| with a single instrument. Non- | ||||
| porous goods only. | ||||
| PREVAC | 270°F (132°C) | 4 minutes | 20 minutes* | Up to two double wrapped |
| instrument trays (maximum | ||||
| weight of lbs. each). | ||||
| Up to six fabric packs. |
- Five minutes dry time can be used for processing a single fabric pack.
Also offered with the Prevacuum configuration are the Leak Test Cycle that provides verification of door seal and piping system integrity, and the Daily Air Removal Test (DART) Cycle that provides verification of effective removal of residual air in the chamber and load during testing when combined with a DART or Bowie-Dick test pack.
1
| CYCLES | STERILIZE TEMP. | STERILIZE TIME | DRY TIME | RECOMMENDED LOAD |
|---|---|---|---|---|
| FLASH | 270°F (132°C) | 3 minutes | 1 minute | Unwrapped Instrument tray with |
| a single instrument | ||||
| FLASH | 270°F (132°C) | 10 minutes | 1 minute | Unwrapped Instrument Tray with |
| non-porous multiple instruments | ||||
| (maximum weight of 17 lbs.) | ||||
| GRAVITY | 270°F (132°C) | 15 minutes | 30 minutes | Up to two double wrapped |
| instrument trays (maximum | ||||
| weight of 17lbs. each) | ||||
| GRAVITY* | 250°F (132°C) | 30 minutes | 15 minutes | Fabric Packs |
GRAVITY CONFIGURATION
- A 270°F (132°C) cycle adjusted to 25 minute Sterilize Time can be used for processing Fabric Packs.
Effectiveness
Efficacy of sterilizer function and exposure time recommendations are ultimately shown by showing complete kill of biological indicators and verifying an appropriate safety factor or sterility assurance level (SAL) of less than 106 (probability of less than one chance out of one million of a non-sterile indicator). STERIS validates its sterilization cycles by recommended practices, standards and guidelines developed by various independent organizations such as the Association for Advancement of Medical Instrumentation (AAMI).
The results of the Eagle Century Validation demonstrate that the sterilizer performs as intended and are summarized as follows:
- Validation Studies for Compliance to AAMI-ST8'. This standard establishes the � minimum construction and performance requirements for hospital sterilizers that use saturated steam as the sterilizing agent and have a volume greater than 2 cubic feet. The Eagle Century Steam Sterilizer cycles validated per AAMI-ST8 are the 250°F Gravity, 270°F Prevac and the DART test.
- Validation Studies for Compliance to AAMI-ST372. This recommended practice covers � flash sterilization in health care facilities and includes guidelines for sterilization processing procedures. The Eagle Century Steam Sterilizer cycles validated per AAMI-ST37 are the 270°F Flash and the 270°F Express.
- � Validation Studies for Century with Electric Steam Generator. The customer has the choice to operate the Eagle Century on house steam, an independently purchased steam generator or a generator supplied by STERIS. STERIS conducted testing of the Century with the Electric Steam Generator to ensure that the generator recommended
Association for the Advancement of Medical Instrumentation, "Hospital Steam Sterilizers", ANSUAAMI-ST8-1994 (revision of ANSI/AAMI-ST8-1988).
2 Association for the Advancement of Medical Instrumentation, "Flash Sterilization of patient care items for immediate use", ANSI/AAMI-ST37-1996, (Revision of ANSI/AAMI-ST37-1992),
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would provide sufficient efficiency to perform sterilization cycles. The Eagle Century Steam Sterilizer cycles validated with the Electric Steam Generator are the 270°F Prevac. 270°F Gravity and the 250°F Liquid.
- Validation Studies for Century for Liquid Cycle Efficacy. The Eagle Century Steam � Sterilizer optional Liquid Cycle was validated to ensure that 100ml, 1000ml and 2000ml liquid loads with vented self-sealing closures processed properly.
Safety
AMSCO brand sterilizers including the Eagle Century Steam Sterilizers have been designed, constructed and tested to minimally meet the safety and performance requirements of various national safety codes and standards. The Eagle Century Steam Sterilizer complies with the following requirements:
- Underwriters Laboratory (UL) Electromedical Code 544 as certified by ETL 1. Testing Laboratories, Inc .;
- Canadian Standards Association (CSA) Standard C22.2 No. 125 or 151; 2.
- American Society of Mechanical Engineers (ASME), Section VIII, Division 1 కి. for unfired pressure vessels;
- American Society of Mechanical Engineers (ASME), Section I, Part PMB for 4. power boilers;
- રું. California Seismic Pre-Approval; and
- National Fire Protection Association Standard 99. 6.
A Reliability Analysis and Failure Modes and Effects and Criticality Analysis has been conducted on the Eagle Century Steam Sterilizer's electrical system, mechanical system and piping system as well.
Hazards-Failure of Performance
Failure of the sterilization process can lead to incidence of cross contamination, the transmission of potentially infectious organisms from one infected person to another who was not otherwise infected prior to the incident.
To avoid failure, the user must ensure the materials, instruments and devices to be sterilized are thoroughly cleaned, that the manufacturer's instructions for use are followed, that the cycle to be used for each type of sterilizer load has been validated, that the sterilizer has been maintained in accordance with the sterilizer manufacturer's recommended maintenance schedule and is operating properly, and that each sterilizer load is monitored with available and validated biological and chemical sterilization process indicators.
Today, there are many steam sterilizers in daily use in hospitals throughout the United States. The incidence of sterilizer malfunction or sterilization process failure is relatively rare considering the widespread use of steam sterilizers. Further, there are no known reports in the literature of patient infections that have resulted from steam sterilizer failure. The technology designed in AMSCO brand steam sterilizers including the Eagle Century provides microprocessor controller safeguards that abort the cycle and give appropriate signals, alerts and warnings when required conditions have not been met or when a malfunction occurs.
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User Information
STERIS conducts in-house user training and has developed a series of user training videos that provide helpful information about the appropriate use of steam sterilizers. STERIS further provides information to the user that is intended to ensure safe and effective use of steam sterilization in its detailed Operator's Manual and other labeling. STERIS also recommends the use and periodic review of the AAMI steam sterilization standards to ensure further assurance of the safe and effective use of steam sterilization equipment in health care facilities.
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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, arranged in a way that they appear to be connected or overlapping. The profiles are simple and abstract, with flowing lines that suggest movement or connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN । 1998
Mr. Raymond Ursick · Senior Director Regulatory Affairs and Quality Systems STERIS Corporation 2424 West 23rd Street Erie, Pennsylvania 16506
K964332 Re : Eagle Century Steam Sterilizer Trade Name: Requlatory Class: II Product Code: FLE March 12, 1998 Dated: Received: March 13, 1998
Dear Mr. Ursick:
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 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). 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 reqistration, 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 regulations 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
5
Page 2 - Mr. Ursick
through 542 of the Act for devices under the Electronic enrough Siz or on Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acboirison in formalence 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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
Timo A. Ulatowski Director 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 USE Ch
EAGLE CENTURY STEAM STERILIZER DEVICE NAME:
INDICATIONS FOR USE
The STERIS Eagle Century Steam Sterilizer is designed for efficient, sterilization of non-porous and porous, heat and moisture-stabile materials used in healthcare facilities. The Eagle Century Steam Sterilizer is available in the following configurations:
| 16" x 16" x 26" Single Door Gravity | 16" x 16" x 26" Single Door Prevacuum |
|---|---|
| 16" x 16" x 26" Double Door Gravity | 16" x 16" x 26" Double Door Prevacuum |
| 20" x 20" x 38" Single Door Gravity | 20" x 20" x 38" Single Door Prevacuum |
| 20" x 20" x 38" Double Door Gravity | 20" x 20" x 38" Double Door Prevacuum |
The Eagle Century Steam Sterilizer is equipped with the following factory-programmed set sterilization cycles and cycle values:
Prevacuum Configuration
| CYCLES | RECOMMENDED
LOADS | STERILIZE
TEMP. | STERILIZE
TIME | DRY TIME |
|---------|------------------------------------------------------------------------------------------------------|--------------------|-------------------|-------------|
| FLASH | Unwrapped
Instrument tray with a
single instrument | 270°F
(132°C) | 3 minutes | 1 minute |
| FLASH | Unwrapped instrument
tray with non-porous
multiple instruments,
maximum weight
17lbs | 270°F
(132°C) | 10 minutes | 1 minute |
| EXPRESS | Single wrapped
instrument tray with a
single instrument.
Non-porous goods
only. | 270°F
(132°C) | 4 minutes | 3 minutes |
| PREVAC | Up to two double
wrapped instrument
trays, maximum
weight 17lbs.
Up to six fabric packs. | 270°F
(132°C) | 4 minutes | 20 minutes1 |
1Five minute Dry Time can be used for processing a single fabric pack.
7
USC I NO ICATIONS OR
GRAVITY CONFIGURATION
| CYCLES | RECOMMENDED
LOAD | STERILIZE
TEMP. | STERILIZE
TIME | DRY TIME |
|---------|-----------------------------------------------------------------------------------------------------|--------------------|-------------------|------------|
| FLASH | Unwrapped
Instrument tray with
a single instrument. | 270°F
(132°C) | 3 minutes | 1 minute |
| FLASH | Unwrapped
Instrument tray with
non-porous multiple
instruments,
maximum weight
17lbs | 270 °F
(132°C) | 10 minutes | 1 minute |
| GRAVITY | Up to two double
wrapped instrument
trays, maximum
weight 17lbs | 270°F
(132°C) | 15 minutes | 30 minutes |
| GRAVITY | Fabric Packs | 250°F
(121 °C) | 30 minutes2 | 15 minutes |
2 A 270°F (132°C) cycle adjusted to 25 minute Sterilize Time can be used for processing fabric packs.
(Please Do Not Write Below This Line - Continue on Another Page if Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
Reorge A. Miller for
Q, s, 7, a
(Optional Format 1-2-96)
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number req