The AMSCO 600 Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are equipped with the following factory-programmed cycles (Table 1):

Cycles	SterilizeTemperature	Sterilize Time	Dry Time	Maximum Recommended Load
Prevac	270°F (132°C)	4 minutes	20 minutes	Fabric Packs. Refer to Table 2 forrecommended quantities.
Prevac	270°F (132°C)	4 minutes	30 minutes	Double wrapped instrument trays,maximum weight 25 lbs. (11.3 kg)each and Fabric Packs. Refer toTable 2 for recommendedquantities.
Prevac	270°F (132°C)	10 minutes	30 minutes	Double wrapped instrument trays,maximum weight 25 lbs. (11.3kg) each . Refer to Table 2 forrecommended quantities.
Prevac	270°F (132°C)	4 minutes	5 minutes	Single Fabric Pack.
Prevac	275°F (135°C)	3 minutes	30 minutes	Double wrapped instrument trays,maximum weight 25 lbs. (11.3 kg)each. Refer to Table 2 forrecommended quantities.
Prevac-IUSS	270°F (132°C)	4 minutes	1 minutes	Immediate use - singleunwrapped tray
Gravity	250°F (121°C)	30 minutes	30 minutes	Double wrapped instrument trays,maximum weight 25 lbs. (11.3 kg)each. Refer to Table 2 forrecommended quantities.
Warm-Up	270°F (132°C)	3 minutes	1 minute	N/A
DART	270°F (132°C)	3.5 minutes	1 minute	Bowie-Dick Test Pack, DART
LeakTest	N/A	N/A	N/A	N/A

The Automated Load and Unload System (ALUS) provides semi-automated loading and unloading from an AMSCO 600 steam sterilizer when a cycle is complete. Alternatively, the ALUS may also be used to provide automatic unloading only in combination with manual loading. The ALUS can start a cycle automatically when equipped with the optional bar code reader.

Device Description

The AMSCO 600 Steam Sterilizer uses saturated steam, generated from a house steam utility (e.g. boiler system) or from a steam generator, to sterilize heat-stable health care products. The sterilizer accomplishes this by removing the air in the chamber, exposing the load to saturated steam for a defined combination of time and temperature, and drying the load. Removal of air from the chamber occurs using either of two methods, gravity displacement or mechanical vacuum. Once the air removal phase is completed, the sterilizer progresses to the steam exposure phase. During the steam exposure phase, every surface of the load is exposed to saturated steam for a defined combination of time and temperature. Once the steam exposure phase is completed, steam is removed from the chamber and the load is dried using the latent heat in the load and the vacuum pump. The ALUS is used with the AMSCO 600 Steam Sterilizer's existing transfer carriages and loading carts. It consists of a conveyor system which attaches to the load and/or unload ends of the steam sterilizer. It has a series of barcode labels which correspond to pre-programmed cycles and an optional scanner which when fitted to the system will communicate to the sterilizer which cycle to initiate.

AI/ML Overview

The STERIS AMSCO 600 Steam Sterilizer (K211500) is being assessed. Based on the provided information, here's a breakdown of the acceptance criteria and the supporting study:

Acceptance Criteria and Reported Device Performance

Criteria	Acceptance Criteria	Reported Device Performance
Sterilizer Performance (ST 8)	Temperature distribution: 0 to +6 °F	0 to +4.3 °F
	Air removal: Chemical Indicator (CI) pass, 270 - 276 °F	CI pass, 271 - 273 °F
	Moisture retention: ≤ 20% mass increase	≤ 16% mass increase
	Biological performance: F0 ≥ 12, Biological Indicator (BI) pass	F0 ≥ 87, BI pass
Electrical Safety	Meets IEC 61010-1:2012, IEC 61010-2-040:2016 and IEC 61326-1:2012 requirements for electrical safety	Conforms with: IEC 61010-1:2012, IEC 61010-2-040:2016, IEC 61326-1:2012
Software Validation	Meets documented software specifications	Software meets specifications
ALUS Function	Meets documented performance specifications	Properly loads and unloads (from Table 6. Summary of Nonclinical Tests).
Cycles	The new 10-minute, 270F prevacuum cycle demonstrates proper performance per AAMI ST8	Testing performed per AAMI ST8 demonstrates proper performance
Automated Loading System	Proper performance via software validation	Software validation demonstrates proper performance (for the added automated loading system accessory)

Note: The document refers to the predicate device K183410 AMSCO 600 Steam Sterilizer and indicates that the subject device (K211500) has the same intended use and technological characteristics with modifications. The primary modifications are the addition of a 10-minute, 270°F (132°C) prevacuum, steam sterilization cycle and an automated loading and unloading system (ALUS).

Study Details

The provided document describes nonclinical tests to demonstrate the substantial equivalence of the modified device to its predicate. This is typical for a 510(k) submission, not a study evaluating human reader performance with AI. Therefore, several of the requested categories are not applicable.

Sample size used for the test set and the data provenance:
- The document does not specify exact sample sizes for each test mentioned (e.g., how many cycles run for temperature distribution, moisture retention, or biological performance). This information would typically be detailed in the full test reports, which are not included in this summary.
- Data Provenance: The tests were conducted internally by the manufacturer (STERIS Corporation) as part of their device validation process. The origin of the raw data (e.g., country of origin) is not specified but is implicitly part of their internal testing protocols. The nature of the tests (performance, electrical safety, software, ALUS function) indicates this is prospective testing carried out specifically for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as this is a device performance test, not a diagnostic imaging or AI-assisted clinical interpretation study where expert ground truth is typically established. The "ground truth" for these tests comes from objective measurements against established engineering and sterilization standards (e.g., ST 8, IEC standards, F0 values, BI pass/fail).
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable for this type of device performance testing. Adjudication methods are relevant when human interpretation or clinical outcomes are subject to variability and require consensus.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is a steam sterilizer and an automated loading system, not an AI-powered diagnostic tool. Therefore, human readers or AI assistance in interpretation are not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable in the context of an "algorithm only" study for diagnostic purposes. However, the performance tests are a "standalone" evaluation of the device's ability to meet its specifications and regulatory standards without human intervention in the sterilization process, other than loading/unloading (which the ALUS automates). For instance, the Biological performance – F0 ≥ 12, BI pass test directly evaluates the sterilizer's effectiveness independently. The ALUS function test also assesses its "standalone" functionality.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the sterilizer performance tests is based on objective physical and biological measurements against established industry standards and scientific principles of sterilization.
  - Temperature distribution, air removal, moisture retention: Measured against physical thresholds defined in standards like ANSI/AAMI ST8.
  - Biological performance (F0, BI pass): Measured against the inactivation of a resistant microorganism (Biological Indicator) under controlled conditions, demonstrating a Sterility Assurance Level (SAL) required by standards.
  - Electrical Safety: Compliance with international electrical safety standards (IEC).
  - Software Validation: Comparison against documented software specifications and requirements.
  - ALUS Function: Comparison against documented performance specifications (e.g., proper loading and unloading).
The sample size for the training set:
- This is not applicable. This is a hardware device (sterilizer) and its associated automated loading system, not a machine learning or AI model that requires a training set. The term "training set" is not relevant in this context.
How the ground truth for the training set was established:
- This is not applicable as there is no training set for this device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

August 25, 2021

Steris Corporation Anthony Piotrkowski Director, Regulatory Affairs 5960 Heisley Rd Mentor, Ohio 44060

Re: K211500

Trade/Device Name: AMSCO 600 Medium Steam Sterilizer Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: June 2, 2021 Received: June 3, 2021

Dear Anthony Piotrkowski:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K211500

Device Name

AMSCO 600 Steam Sterilizer

Indications for Use (Describe)

Cycles	SterilizeTemperature	Sterilize Time	Dry Time	Maximum Recommended Load
Prevac	270°F (132°C)	4 minutes	20 minutes	Fabric Packs. Refer to Table 2 forrecommended quantities.
Prevac	270°F (132°C)	4 minutes	30 minutes	Double wrapped instrument trays,maximum weight 25 lbs. (11.3 kg)each and Fabric Packs. Refer toTable 2 for recommendedquantities.
Prevac	270°F (132°C)	10 minutes	30 minutes	Double wrapped instrument trays,maximum weight 25 lbs. (11.3kg) each . Refer to Table 2 forrecommended quantities.
Prevac	270°F (132°C)	4 minutes	5 minutes	Single Fabric Pack.
Prevac	275°F (135°C)	3 minutes	30 minutes	Double wrapped instrument trays,maximum weight 25 lbs. (11.3 kg)each. Refer to Table 2 forrecommended quantities.
Prevac-IUSS	270°F (132°C)	4 minutes	1 minutes	Immediate use - singleunwrapped tray
Gravity	250°F (121°C)	30 minutes	30 minutes	Double wrapped instrument trays,maximum weight 25 lbs. (11.3 kg)each. Refer to Table 2 forrecommended quantities.
Warm-Up	270°F (132°C)	3 minutes	1 minute	N/A
DART	270°F (132°C)	3.5 minutes	1 minute	Bowie-Dick Test Pack, DART
LeakTest	N/A	N/A	N/A	N/A

Table 1. AMSCO 600 Steam Sterilizer factory-validated sterilization cvcles and cvcle values

{3}------------------------------------------------

Sterilizer Size	Wrapped Instrument Trays	Fabric Packs
26" x 26" x 39"	9	12
26" x 26" x 51"	12	16
26" x 26" x 63"	15	20

ize

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

区 Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for STERIS. The word STERIS is in all caps and in a serif font. Below the word STERIS is a graphic of several horizontal wavy lines in blue. The STERIS logo is simple and clean.

510(k) Summary For AMSCO 600 Steam Sterilizer K211500

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198

Tony Piotrkowski Contact: Director, Regulatory Affairs

Telephone: (440) 392-7437 Fax No: (440) 357-9198 e-mail: Tony_Piotrkowski@steris.com

Summary Date: August 23, 2021

Premarket Notification Number: K211500

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

{5}------------------------------------------------

STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION K211500 AMSCO 600 Steam Sterilizer

Device Name 1.

Trade Name:	AMSCO 600 Steam Sterilizer
Device Class:	Class II
Common/usual Name:	Steam Sterilizer
Classification Name:	Sterilizer, SteamSterilizer Automated Loading System
Classification Number:	21 CFR 880.6880
Product Code:	FLE, PEC

2. Predicate Device

K183410 AMSCO 600 Steam Sterilizer

3. Description of Device

The AMSCO 600 Steam Sterilizer uses saturated steam, generated from a house steam utility (e.g. boiler system) or from a steam generator, to sterilize heat-stable health care products.

The sterilizer accomplishes this by removing the air in the chamber, exposing the load to saturated steam for a defined combination of time and temperature, and drying the load. Removal of air from the chamber occurs using either of two methods, gravity displacement or mechanical vacuum. Once the air removal phase is completed, the sterilizer progresses to the steam exposure phase. During the steam exposure phase, every surface of the load is exposed to saturated steam for a defined combination of time and temperature. Once the steam exposure phase is completed, steam is removed from the chamber and the load is dried using the latent heat in the load and the vacuum pump.

The sterilizers are generally operated by technicians in a central service or sterile processing department of healthcare facilities. Sterilizers may also be located in a surgical suite to allow for Immediate Use Steam Sterilization (IUSS) for instances where an instrument is needed immediately for a procedure (e.g. after an instrument has been dropped and there is no replacement readily available). Standard practices for use of sterilizers in health care facilities are provided by various organizations (e.g. ANSI/AAMI ST79).

The ALUS is used with the AMSCO 600 Steam Sterilizer's existing transfer carriages and loading carts. It consists of a conveyor system which attaches to the

{6}------------------------------------------------

STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION K211500 AMSCO 600 Steam Sterilizer

load and/or unload ends of the steam sterilizer. It has a series of barcode labels which correspond to pre-programmed cycles and an optional scanner which when fitted to the system will communicate to the sterilizer which cycle to initiate.

4. Intended Use/Indications for Use

The AMSCO 600 Steam Sterilizers are designed for sterilization of heat and moisturestable materials used in healthcare facilities and are equipped with the following factoryprogrammed cycles (Table 1):

Cycles	SterilizeTemperature	SterilizeTime	Dry Time	Maximum Recommended Load
Prevac	270°F (132°C)	4 minutes	20 minutes	Fabric Packs. Refer to Table 2 forrecommended quantities.
Prevac	270°F (132°C)	4 minutes	30 minutes	Double wrapped instrument trays,maximum weight 25 lbs. (11.3 kg) eachand Fabric Packs. Refer to Table 2 forrecommended quantities.
Prevac	270°F (132°C)	10 minutes	30 minutes	Double wrapped instrument trays,maximum weight 25 lbs. (11.3 kg) each.Refer to Table 2 for recommendedquantities.
Prevac	270°F (132°C)	4 minutes	5 minutes	Single Fabric Pack.
Prevac	275°F (135°C)	3 minutes	30 minutes	Double wrapped instrument trays,maximum weight 25 lbs. (11.3 kg) each.Refer to Table 2 for recommendedquantities.
Prevac-IUSS	270°F (132°C)	4 minutes	1 minutes	Immediate use - single unwrapped tray
Gravity	250°F (121°C)	30 minutes	30 minutes	Double wrapped instrument trays,maximum weight 25 lbs. (11.3 kg) each.Refer to Table 2 for recommendedquantities.
Warm-Up	270°F (132°C)	3 minutes	1 minute	N/A
DART	270°F (132°C)	3.5 minutes	1 minute	Bowie-Dick Test Pack, DART
Leak Test	N/A	N/A	N/A	N/A

Table 1. AMSCO 600 Steam Sterilizer factory-validated sterilization cycles and cycle values

Table 2 AMSCO 600 Steam Sterilizer full load per sterilizer size

Sterilizer Size	Wrapped InstrumentTrays	Fabric Packs
26" x 26" x 39"	9	12
26" x 26" x 51"	12	16
26" x 26" x 63"	15	20

{7}------------------------------------------------

5. Technological Characteristics Comparison

Feature	AMSCO 600 Steam Sterilizer(Modified Device)	AMSCO 600 Steam Sterilizer(Predicate Device/K183410)	Comparison
IntendedUse	The AMSCO 600 Steam Sterilizeris designed for sterilization of heatand moisture-stable materials usedin healthcare facilities.	The AMSCO 600 Steam Sterilizeris designed for sterilization of heatand moisture-stable materials usedin healthcare facilities.	Same
CriticalProcessParameters	• Time• Chamber Temperature• Pressure	• Time• Chamber Temperature• Pressure	Same
Control	Embedded Controller	Embedded Controller	Same
SAL	10-6	10-6	Same
Sterilant	Saturated Steam	Saturated Steam	Same
Utilities	Steam, Water, Electricity, Air	Steam, Water, Electricity, Air	Same
ChamberMaterial	316L Stainless Steel	316L Stainless Steel	Same
NominalChamberSize	• 26" w x 26" h x 39" d• 26" w x 26" h x 49" d• 26" w x 26" h x 61" d	• 26" w x 26" h x 39" d• 26" w x 26" h x 49" d• 26" w x 26" h x 61" d	Same
Door	304L Stainless Steel26" x 26" Power vertical sliding	304L Stainless Steel26" x 26" Power vertical sliding	Same
ChamberPressureRating	45 psig, 300°F	45 psig, 300°F	Same
Door Seal	Steam activated door seal	Steam activated door seal	Same
ExternalProcessMonitors	• Electronic Control• Printer	• Electronic Control• Printer	Same
InternalProcessMonitors	Temperature-Dual element RTD located inchamber drain- RTD located in the jacket drain- RTD located in heat exchangerPressure-Pressure transducer in chamber	Temperature-Dual element RTD located inchamber drain- RTD located in the jacket drain- RTD located in heat exchangerPressure-Pressure transducer in chamber	Same
Performance	Meets ANSI/AAMI ST8:2013	Meets ANSI/AAMI ST8:2013	Same
Accessories	BI, CI, Pouches, Trays, Wraps,Tape, Containers, Shelves,Loading Equipment, automatedloading system	BI, CI, Pouches, Trays, Wraps,Tape, Containers, Shelves,Loading Equipment	Added automatedloading system.Software validationdemonstratesproper performance
Test Cycles	Warm Up, Leak Test, DART(Bowie Dick) Test	Warm Up, Leak Test, DART(Bowie Dick) Test	Same
Feature	AMSCO 600 Steam Sterilizer(Modified Device)	AMSCO 600 Steam Sterilizer(Predicate Device/K183410)	Comparison
Cycles	270F, Prevac, 4' Full fabric pack270F, Prevac, 4' Full tray270F, Prevac, 4' One fabric pack270F, Prevac, 4' IUSS275F, Prevac, 3' Full fabric250F, Gravity, 30' Full tray270F, Prevac, 10' Full tray	270F, Prevac, 4' Full fabric pack270F, Prevac, 4' Full tray270F, Prevac, 4' One fabric pack270F, Prevac, 4' IUSS275F, Prevac, 3' Full fabric250F, Gravity, 30' Full tray	Added 10-minute270F, prevacuumcycle. Testingperformer perAAMI ST8demonstratesproper performance
Full Loads	• 39": 9, 25-lb double wrappedtrays or 12, fabric packs• 51": 12, 25-lb double wrappedtrays or 16, fabric packs• 63": 15, 25-lb double wrappedtrays or 20, fabric packs	• 39": 9, 25-lb double wrappedtrays or 12, fabric packs• 51": 12, 25-lb double wrappedtrays or 16, fabric packs• 63": 15, 25-lb double wrappedtrays or 20, fabric packs	Same

Table 5-1. Device Comparison Table for AMSCO 600 Modified and Predicate

{8}------------------------------------------------

STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION K211500 AMSCO 600 Steam Sterilizer

The proposed device has the same intended use as the predicate with the same technological characteristics. The modifications, subject of this submission, are addition a 10-minute, 270 °F (132 °C) prevacuum, steam sterilization cycle and addition of an automated loading and unloading system (ALUS). Sterilizer automated loading systems are described under FDA product code PEC so the resulting product will be under product codes FLE and PEC. Other design modifications since the last clearance have been made to improve manufacturability, allow for sale outside the United States and add convenience features to sterilizer.

Summary of Nonclinical Tests 6.

Test	Criterion	Results
Sterilizerperformance	Meets ST 8 requirements:Temperature distribution: - 0 to + 6 °FAir removal – CI pass, 270 -276 °FMoisture retention - ≤ 20% mass increaseBiological performance – F0 ≥ 12, BI pass	0 to + 4.3 °FCI pass, 271 - 273 °F≤ 16 % mass increaseF0 ≥ 87, BI pass
	Electrical safety	Meets IEC 61010-1:2012, IEC 61010-2-040:2016 andIEC 61326-1:2012 requirements for electrical safety	Conforms with:IEC 61010-1:2012IEC 61010-2-040:2016IEC 61326-1:2012
		Software validation	Meets documented software specifications	Software meets specifications
		ALUS Function	Meets documented performance specifications	Properly loads and unloads

6. Conclusion

Based on the intended uses, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate device K183410, Class II (21 CFR 880.6860), product code FLE.

Regulation Number and Section

§ 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).