(139 days)
The Getinge GSS610N21 Series Steam Sterilizer is intended for use by health care facilities to sterilize wrapped and unwrapped porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam.
The steam sterilizer is used by health care facilities to sterilize wrapped and unwrapped porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam. The Getinge GSS610N21 Series Steam Sterilizer employs both gravity/downward displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. All cycle phases are sequenced and monitored by the control system, providing both audible and visual notification of deviation from certain operating parameters.
Here's a breakdown of the acceptance criteria and study information for the Getinge GSS610N21 Series Steam Sterilizer, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Performed | Acceptance Criteria | Reported Performance |
|---|---|---|
| Biological Performance Tests: Sterilization Efficacy Validation with a fabric PCD | Sterility Assurance Level (SAL) 10⁻⁶ | Pass |
| Biological Performance Tests: Biological Performance with liquid loads | Sterility Assurance Level (SAL) 10⁻⁶ | Pass |
| Biological Performance Tests: Biological Performance with a wrapped instrument PCD | Sterility Assurance Level (SAL) 10⁻⁶ | Pass |
| Biological Performance Tests: Biological performance of immediate-use steam sterilization for single-wrapped or unwrapped nonporous items | Sterility Assurance Level (SAL) 10⁻⁶ | Pass |
| Physical Performance Test: Chamber Temperature Profile | +3°C (or +6°F) and -0°C (or -0°F) of the selected sterilization exposure temperature | Pass |
| Physical Performance Test: Mechanical Air Removal Test (Exposure Temperature) | Load reaching exposure temperature within 10 secs | Pass |
| Physical Performance Test: Mechanical Air Removal Test (Color Change) | Color change on BD chemical indicator sheet | Pass |
| Physical Performance Test: Air Leak Rate Test | Average leak rate of 1 mmHg (0.13 kPa) (0.019 psia) per minute or less over the measured time interval | Pass |
| Physical Performance Test: Moisture Retention Test | < 3% increase in presterilization test pack weight for fabric pack & <20% increase for wrapped instrument pack | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific numerical sample size (e.g., number of cycles run for each test) for the test set. It mentions the "Load Configuration" for each cycle type, indicating the maximum number of items per load (e.g., 36 full instrument packs, 80 full fabric packs, 1 B&D Test Pack, 3 vented bottles). These load configurations were used during the testing validations.
The data provenance is not explicitly stated in terms of country of origin. The device is manufactured by Maquet GmbH, located in Rastatt, Germany, which suggests the testing might have been conducted in Germany or a location compliant with AAMI standards. The testing is prospective as it was performed to validate the device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This information is not provided in the document. The acceptance criteria relate to objective measurements (Sterility Assurance Level, temperature, leak rate, moisture retention) and observable physical changes (color change on chemical indicator), not subjective expert assessment of images or data. Therefore, the concept of "experts establishing ground truth" in the diagnostic sense is not applicable here. The ground truth would be established by the validated testing methodologies and their results against the predefined criteria.
4. Adjudication Method for the Test Set:
An adjudication method is not applicable in this context. The tests performed are objective performance validations against predefined technical standards (AAMI ST8). The results are either "Pass" or "Fail" based on whether the measured parameters meet the acceptance criteria. There's no subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret data (e.g., radiology images) and the AI's effect on their performance is evaluated. The Getinge GSS610N21 is a sterilizer, an automated device that performs a physical sterilization process, not a diagnostic tool requiring human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the studies performed are standalone performance validations of the device. The tests evaluate the sterilizer's ability to achieve sterility and maintain physical parameters independently. There is no "human-in-the-loop" aspect to the core sterilization function being evaluated in these performance tests.
7. The Type of Ground Truth Used:
The ground truth used for these performance tests is objective, measurable criteria based on established industry standards (AAMI ST8:2013 (R2018)). This includes:
- Sterility Assurance Level (SAL) 10⁻⁶: This is a statistically derived measure of the probability of a single viable microorganism occurring on an item after sterilization.
- Temperature ranges: Specific temperature tolerances (+3°C / -0°C) for the exposure phase.
- Time measurements: Such as the load reaching exposure temperature within 10 seconds.
- Physical changes: Like the color change on a chemical indicator sheet.
- Quantitative measurements: For air leak rate (1 mmHg per minute or less) and moisture retention (< 3% or <20% increase in weight).
8. The Sample Size for the Training Set:
This information is not applicable/not provided because the Getinge GSS610N21 is a steam sterilizer, a physical medical device that performs a mechanical and thermal process, not an AI or algorithm-based diagnostic tool that requires a "training set" in the machine learning sense. Its performance is validated through physical and biological challenge tests, not by learning from labeled data.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable/not provided for the same reason as point 8. There is no "training set" for a steam sterilizer. The "ground truth" for its validation is based on established scientific principles of sterilization and recognized industry standards (AAMI ST8).
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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 Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 18, 2022
Maquet GmbH % Barb Smith Sr. Regulatory Affairs Specialist Getinge 45 Barbour Pond Wayne, New Jersey 07470
Re: K214120
Trade/Device Name: GSS610N21 Series Steam Sterilizer Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: April 13, 2022 Received: April 14, 2022
Dear Barb Smith:
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.
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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); 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, PhD 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
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Indications for Use
510(k) Number (if known)
Device Name Getinge GSS610N21 Steam Sterilizer
Indications for Use (Describe)
The Getinge GSS610N21 Series Steam Sterilizer is intended for use by health care facilities to sterilize wrapped and unwrapped porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam.
Please see "GSS610N Load chart table" (1 page) as attachment to this form.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------- | --------------------------------------------------------------------------------- |
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Getinge. The logo consists of the word "GETINGE" in a sans-serif font, with a stylized asterisk symbol to the right. The asterisk is made up of four arrow-like shapes pointing outwards from a central point. The color of the logo is a dark blue.
| Cycle Type | Factory Settings | Load Configuration(Note 1) | Maximum Items forModel 61021[2100 mm or 82.7 inchamber length] | ||
|---|---|---|---|---|---|
| Exp.Temp. | Exp.Time | DryingTime | |||
| P1 PREVAC 1 | 135.0°C(275.0°F) | 3 min | 16 min | Full instrument packs | 36 |
| P2 PREVAC 2 | 135.0°C(275.0°F) | 3 min | 3 min | Full fabric packs | 80 |
| P3 PREVAC 4 | 132.2°C(270.0°F) | 4 min | 30 min | Full instrument packs | 36 |
| P4 PREVAC 5 | 132.2°C(270.0°F) | 4 min | 5 min | Full fabric packs | 80 |
| P5 B & D TEST | 134°C(273.0°F) | 3 min,30 sec | 0 min | 1 B&D Test Pack in an EMPTYchamber (other than loadingaccessories) | 1 B&D Test Pack |
| P6 GRAVITY 1 | 121.1°C(250.0°F) | 30 min | 45 min | Full instrument packs | 36 |
| Full fabric packs | 80 | ||||
| P7 GRAVITY 2 | 135.0°C(275.0°F) | 10 min | 45 min | Full instrument packs | 36 |
| Full fabric packs | 80 | ||||
| P8 GRAVITY 3 | 132.2°C(270.0°F) | 15 min | 45 min | Full instrument packs | 36 |
| Full fabric packs | 80 | ||||
| P9 IUSS 1Vac | 135.0°C(275.0°F) | 3 min | 1 min | Full instrument packs | 1 |
| P10 IUSS 2Grav | 135.0°C(270.0°F) | 10 min | 30 sec | Full instrument packs | 1 |
| P11 IUSS 3Grav | 132.2°C(270.0°F) | 4 min | 1 min | Full instrument packs | 1 |
| P12VentedBottles | 121.1°C(250.0°F) | 45 min | 3kPa/min(0.44 psi/min)(Note 2) | Each container 1000 mL (34 floz) or smaller (Note 3) | 3 |
Getinge GSS610N21 Series Steam Sterilizer Cycles and Load Chart
NOTE: Liquid Cycles are not intended for the sterilization of liquids used for direct patient contact.
TABLE NOTES:
- The load configurations listed in these tables are those used during testing validations of the sterilizer. These configurations follow AAM Standard ST8: Hospital steam sterilizers where applicable (fabric packs are process challenge devices as described in ANSI/AAMI ST8 and were made to be consistent with the packs described in ANSI/AAMI ST8). For guidance on processing loads in the sterilizer, refer to AAM Standard ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities.
2. Cooldown rate
- Use vented or open containers only.
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GETT
510(k) Summary Getinge GSS610N21 Series Steam Sterilizer K214120
| Submitted by | Maquet GmbH |
|---|---|
| Kehler Strasse 31 | |
| Rastatt DE-BW | |
| Germany 76437 |
- Contact person Barb Smith Sr. Regulatory Affairs Specialist Phone: 585-370-6101 Email: barb.smith@getinge.com
- K214120 510(k) number
- Date Prepared December 22, 2021
Proprietary Device Name
- Trade Name: Getinge GSS610N21 Series Steam Sterilizer
Models: 610N21 82.7 inch (2100 mm) long chamber Common Name: Steam Sterilizer Classification: Steam Sterilizer (21CFR880.6880, Product Code 80 FLE)
Predicate Devices
[K201927] Getinge GSS610N Series Steam Sterilizer Getinge Models 610N10, 610N14 and 610N15. SE Date 03/01/2021
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Image /page/5/Picture/0 description: The image shows the logo for Getinge. The logo consists of the word "GETINGE" in a bold, sans-serif font. To the right of the word is a stylized symbol that looks like four curved arrows pointing inward towards a central point. The logo is in a dark blue color.
Description of Device
The steam sterilizer is used by health care facilities to sterilize wrapped and unwrapped porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam.
The Getinge GSS610N21 Series Steam Sterilizer employs both gravity/downward displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. All cycle phases are sequenced and monitored by the control system, providing both audible and visual notification of deviation from certain operating parameters
Indications for Use
The Getinge GSS610N21 Series Steam Sterilizer is intended for use by health care facilities to sterilize wrapped and unwrapped porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam.
Cycles and Load Chart
| Cycle Type | Factory Settings | Load Configuration(Note 1) | MaximumItems forModel61021[2100 mm or82.7 inchamberlength] | ||
|---|---|---|---|---|---|
| Exp.Temp. | Exp.Time | Drying Time | |||
| P1 PREVAC 1 | 135.0°C (275.0°F) | 3 min | 16 min | Full instrument packs | 36 |
| P2 PREVAC 2 | 135.0°C(275.0°F) | 3 min | 3 min | Full fabric packs | 80 |
| P3 PREVAC 4 | 132.2°C (270.0°F) | 4 min | 30 min | Full instrument packs | 36 |
| P4 PREVAC 5 | 132.2°C (270.0°F) | 4 min | 5 min | Full fabric packs | 80 |
| P5 B & D TEST | 134°C (273.0°F) | 3 min,30sec | 0 min | 1 B&D Test Pack in an EMPTYchamber (other than loadingaccessories) | 1 B&D TestPack |
| P6 GRAVITY 1 | 121.1°C (250.0°F) | 30 min | 45 min | Full instrument packsFull fabric packs | 3680 |
| P7 GRAVITY 2 | 135.0°C (275.0°F) | 10 min | 45 min | Full instrument packsFull fabric packs | 3680 |
| P8 GRAVITY 3 | 132.2°C (270.0°F) | 15 min | 45 min | Full instrument packsFull fabric packs | 3680 |
Getinge GSS610N21 Series Steam Sterilizer Cycles and Load Chart
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| P9 IUSS 1Vac | 135.0°C (275.0°F) | 3 min | 1 min | Full instrument packs | 1 |
|---|---|---|---|---|---|
| P10 IUSS 2Grav | 135.0°C (270.0°F) | 10 min | 30 sec | Full instrument packs | 1 |
| P11 IUSS 3Grav | 132.2°C (270.0°F) | 4 min | 1 min | Full instrument packs | 1 |
| P12Vented Bottles | 121.1°C (250.0°F) | 45 min | 3kPa/min(0.44 psi/min)(Note 2) | Each container 1000 mL (34 fl oz)or smaller (Note 3) | 3 |
NOTE: Liquid Cycles are not intended for the sterilization of liquids used for direct patient contact.
TABLE NOTES:
-
- The load configurations listed in these tables are those used during testing validations of the sterilizer. These configurations follow AAMI Standard ST8: Hospital steam sterilizers where applicable (fabric packs are process challenge devices as described in ANSI/AAMI ST8 andwere made to be consistent with the packs described in ANSI/AAMI ST8). For guidance on processing loads in the sterilizer, refer to AAMI Standard ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities.
-
- Cooldown rate
-
- Use vented or open containers only.
Technological Characteristics Table:
Shown below is a comparison of the subject device Getinge GSS610N21 Series Steam Sterilizer versus the predicate device (Getinge GSS610N Series Steam Sterilizer models 610N10, 610N14, 610N15). The GSS610N21 sterilizer is the largest model in the GSS610N series of steam sterilizers:
| Item | Getinge GSS610N[Predicate device]K201927 | Getinge GSS610N21[Subject Device] | Comparison |
|---|---|---|---|
| Pressure Vessel | |||
| Chamber Sizes | Model 610N10: 26.4" x42.5" x 40.9" (672 x1080x1040 mm) | Model 610N21: 26.4" x42.5" x 82.7" (672 x 1080x 2100 mm) | Different ChamberSizes |
| Model 610N14: 26.4" x42.5" x 55.1" (672 x1080x1400 mm) | Different ChamberSizes | ||
| Item | Getinge GSS610N[Predicate device]K201927 | Getinge GSS610N21[Subject Device] | Comparison |
| Model 610N15: 26.4" x42.5" x 60.6" (672x1080 x1540 mm) | Different ChamberSizes | ||
| Chamber Volumes | Model 610N10: Single Door26.52 Cu Ft (751L), DoubleDoor 26.59 Cu Ft (753L)Model 610N14: Single Door35.73 Cu Ft (1012L),Double Door 35.77 Cu Ft(1013L)Model 610N15: Single Door39.3 Cu Ft (1113L), DoubleDoor 39.34 Cu Ft (1114L) | Model 610N21: Double Door53.67 Cu Ft(1520L) | The chambervolumes correspondto the chamber sizes.Only double doorconfigurationavailable forsubject device. |
| ASME Pressure Vessel | All pressure vessels arebuilt to ASME Sect. VIII,Div. 1 | All pressure vessels are builtto ASME Sect. VIII, Div. 1 | Same |
| "U" Stamped UnfiredPressure Vessel) | Chamber: 45 psiJacket: 45 psi | Chamber: 45 psiJacket: 45 psi | Same |
| Material of Jacket | Stainless Steel (SA240-304) | Stainless Steel (SA240- 304 ) | Same |
| Material of Chamber | Stainless Steel (SA240-316L ) | Stainless Steel (SA240-316L ) | Same |
| Vacuum method | Vacuum pump standard. | Vacuum pump standard. | Same |
| Chamber Closure | |||
| Door Operation | Horizontal opening/closingdoor design operated byan electrical motor. | Horizontal opening/closingdoor design operated by anelectrical motor. | Same |
| Safety and Interlocks | |||
| Door switchsystem/steam tochamber interlock | Electro-mechanical logic | Electro-mechanical logic | Same |
| Cycles | |||
| Types of cycles offered | Prevac 132.2°C, 4min; 135°C, 3 min,Gravity 121°C, 30 min;135°C 10 min; 132.2°15 min; | Prevac 132.2°C, 4 min;135°C, 3 min,Gravity 121°C, 30 min;135°C 10 min; 132.2° 15min; | Same |
| Item | Getinge GSS610N[Predicate device]K201927 | Getinge GSS610N21[Subject Device] | Comparison |
| IUSS 135°C, 3 min,;135C, 10 min; 132.2°C4 minVented Bottles 121°C45min.BD Test | IUSS 135°C, 3 min,;135C, 10 min; 132.2°C 4minVented Bottles 121°C45min.BD Test | ||
| Maximum LoadCapacities | Reference chart formaximum loads withinGSS610N - up to 25lbsper tray | Reference chart formaximum loads withinGSS610N21 - up to 25lbsper tray | Maximum loadincreases withlarger chamber size |
| Utility RequirementsPrimaryElectricalConnection | GSS610N are available forconnection to:208V 3ph 60Hz (NotGSS61015N with integratedelectrical heated steamboiler)460V 3ph 60Hz480V 3ph 60Hz | Available for connection to:208V 3ph 60Hz (NotGSS61021N with integratedelectrical heated steamboiler) 460V 3ph 60Hz480V 3ph 60Hz600V 3ph 60Hz | SameLimited forSubject device dueto dual boilers |
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Image /page/7/Picture/0 description: The image shows the logo for Getinge. The word "GETINGE" is written in a bold, sans-serif font in a dark blue color. To the right of the word is a stylized asterisk symbol, which is also in a dark blue color. The asterisk is made up of four curved arrows pointing inward.
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Image /page/8/Picture/0 description: The image shows the logo for Getinge. The logo consists of the word "GETINGE" in a bold, sans-serif font. To the right of the word is a stylized symbol that looks like four curved arrows pointing inward towards a central point. The logo is simple and modern.
Summary of Performance Testing
Shown below is a summary of the non-clinical testing that was performed with this device:
| TestPerformed | DeviceDescription | Test Method | AcceptanceCriteria | Results |
|---|---|---|---|---|
| Biological Performance Tests | ||||
| SterilizationEfficacy ValidationBiologicalPerformance witha fabric PCD | GSS610N21 | AAMI ST8:2013(R2018)§5.5.2 | Sterility AssuranceLevel (SAL) 10-6 | Pass |
| BiologicalPerformance withliquid loads | GSS610N21 | AAMI ST8:2013(R2018)§5.5.3 | Sterility AssuranceLevel (SAL) 10-6 | Pass |
| BiologicalPerformance witha wrappedinstrument PCD | GSS610N21 | AAMI ST8:2013(R2018)§5.5.4 | Sterility AssuranceLevel (SAL) 10-6 | Pass |
510k Summary GSS610N21_
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Image /page/9/Picture/0 description: The image shows the logo for GETINGE. The text "GETINGE" is written in a bold, sans-serif font, with each letter in uppercase. To the right of the text is an abstract symbol that looks like four stylized arrows pointing towards the center. The logo has a blue color.
| Biologicalperformance ofimmediate-usesteam sterilizationfor single-wrappedor unwrappednonporous items | GSS610N21 | AAMI ST8:2013(R2018)§5.5.5 | Sterility AssuranceLevel (SAL) 106 | Pass |
|---|---|---|---|---|
| Physical Performance Test | ||||
| ChamberTemperatureProfile | GSS610N21 | AAMI ST8:2013(R2018)§5.4.2.5 | +3°C (or +6°F) and -0°C (or -0°F) of theselected sterilizationexposure temperature | Pass |
| Mechanical AirRemoval Test | GSS610N21 | AAMI ST8:2013(R2018)§5.6.1 | Load reachingexposure temperaturewithin 10 secsColor change on BDchemical indicatorsheet | PassPass |
| Air Leak Rate Test | GSS610N21 | AAMI ST8:2013(R2018)§5.6.2 | Average leak rate of 1mmHg (0.13 kPa) (0.019psia) per minute or lessover the measured timeinterval. | Pass |
| MoistureRetention Rest | GSS610N21 | AAMI ST8:2013(R2018)§5.7 | < 3% increase inpresterilization testpack weight for fabricpack & <20% increasefor wrapped instrumentpack | Pass |
Conclusion:
The conclusions drawn from the nonclinical test demonstrates that the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate device.
§ 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).