The LOWTEM Crystal 120 Sterilizer System is indicated to sterilize pre-cleaned and dried reusable medical devices with nonabsorbable materials. The Crystal 120 sterilizer's Standard cycle can sterilize:

Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors,
Medical devices with single stainless-steel lumen with:
An inside diameter of 1mm or larger and a length of 125mm or shorter
An inside diameter of 2mm or larger and a length of 250mm or shorter
An inside diameter of 3mm or larger and a length of 400mm or shorter

The validation testing for this lumen size was conducted using a maximum of 20 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing.

Contra-indication: It is contraindicated to sterilize single usable medical devices made up with absorbable materials such as cellulose or wood.
Intended user: trained nurse level or higher level of healthcare providers
The validated maximum load conditions
Total weight:
The validation performances were conducted using a validation load consisting of two instrument trays containing a total weight of 8.9kg(19.6lbs).
Usage of sterilization pouch:
The medical devices to be sterilized are packaged in Tyvek sterilization pouch and sealed. The pouched medical devices are placed at the trays.

Device Description

The LOWTEM Crystal 120 low-temperature vaporized hydrogen peroxide sterilizer is a selfcontained stand-alone device, using vaporized hydrogen peroxide as the sterilant.
The LOWTEM Crystal 120 includes the LCD touch monitor, Hydrogen Peroxide Supply (HPS) Unit, Sterilization Chamber Door, and Printer on the front of the Sterilizer.

AI/ML Overview

The provided text is a 510(k) summary for the LOWTEM Crystal 120, a low-temperature hydrogen peroxide sterilizer. It outlines the device's indications for use, its technical characteristics compared to predicate devices, and performance data. However, the document does NOT describe the specific acceptance criteria and detailed study that proves the device meets those criteria in the format requested.

The "Performance Data" section (Page 10 and 11) lists various tests performed, their objectives, and an acceptance criterion of "Pass / Fail." It also states "Result: Pass" for all listed tests. This section generally confirms that the device passed general safety, electromagnetic compatibility, risk management, usability, sterilant potency, and sterilization efficacy tests. However, it does not provide the detailed quantitative acceptance criteria (e.g., specific thresholds for D-value or log reduction) beyond "Pass/Fail," nor does it elaborate on the methodology, sample sizes, or expert involvement for the individual tests.

Therefore, based on the provided text, I cannot complete the requested table and answer the detailed questions regarding acceptance criteria and the comprehensive study that proves the device meets specific performance criteria.

The document primarily focuses on regulatory approval based on equivalence to predicate devices, not on a detailed clinical study demonstrating device performance against specific acceptance metrics in a human-in-the-loop or standalone AI context, as might be expected for an AI/ML medical device. This device is a sterilizer, not typically an AI/ML-driven diagnostic or therapeutic device.

Here's what I can extract and what is missing, based on your prompt's structure:

1. Table of Acceptance Criteria and Reported Device Performance:

Test Performed	Test Objective	Acceptance Criteria (as reported)	Reported Device Performance (as reported)
IEC 60601-1-2 Edition 4.0	General requirement for safety. Collateral standard Electromagnetic compatibility. Requirements and tests.	Pass / Fail	Pass
IEC 61010-1 Edition 3.1	Safety requirements for electrical equipment for measurement, control and laboratory use.	Pass / Fail	Pass
ISO 14971 Edition 3.0 Risk management	Identification of the risk and the activities of risk management.	Pass / Fail	Pass
IEC 62366-1 Edition 1.0 Usability Test	Application of usability engineering to medical devices	Pass / Fail	Pass
AOAC Sporicidal Activity Testing	Sterilant potency testing conducted per AOAC Official Method 966.04	Pass / Fail	Pass
D-value and total kill end point	Evaluation of the D-value examined and calculated and demonstration of >12 log reduction of Geobacillus stearothermophilus and its total kill endpoint tested in LOWTEM Crystal 120 sterilization system.	Pass / Fail	Pass
½ cycle modified total kill end point verification- worst case load	Evaluation of the validation loads under reduced injection weight to demonstrate a modified total end point.	Pass / Fail	Pass
Determination of worst-case material for VHP	Performance to determine the worst material (the most resistant) of 23 compatible materials of the LOWTEM Crystal 120 sterilizer.	Pass / Fail	Pass
½ cycle verification of mated surface (first entry)	Evaluation of the sterility of the mated surfaces packaged in double pouch within the worst-case validation load in the LOWTEM Crystal 120 Standard ½ cycle.	Pass / Fail	Pass
½ cycle verification of mated surface (second entry)	Evaluation of the sterility of the mated surfaces packaged in double pouch within the worst-case validation load in the LOWTEM Crystal 120 Standard ½ cycle.	Pass / Fail	Pass
½ cycle verification at multiple peroxide injection weight-worst lumen size	To determine the worst-case lumen size of the claimed lumens in the LOWTEM Crystal 120 Standard ½ cycle using reduced sterilant weights injected.	Pass / Fail	Pass
½ cycle verification of Lumen claims and worst-case materials	To verify the ability to sterilize in LOWTEM Crystal 120 Standard ½ cycle' worst-case lumen sizes (1.0mm x 125mm and 3.0mm x 400mm) and the worst- case material (neoprene) for surface sterilization in worst case validation loads.	Pass / Fail	Pass
½ cycle verification of worst-case material in double pouch	To verify the sterilization efficacy with the worst-case material (neoprene) packaged in double Tyvek pouch configuration in LOWTEM Crystal 120 Standard ½ cycle.	Pass / Fail	Pass
Evaluation of the system parameters	To confirm the sterilization efficacy using worst case validation load with worst case materials processed in LOWTEM Crystal 120 Standard cycle.	Pass / Fail	Pass
Final process qualification	To confirm the LOWTEM Crystal 120 Standard cycle performed in accordance with the sterilizer specification by inspecting the three lots of test accessories (SCBI, CI strip and CI tape) after sterilization cycle.	Pass / Fail	Pass
Simulated Use test	To verify the sterilization ability of representative worst- case devices processed in the LOWTEM Crystal 120 sterilization cycle.	Pass / Fail	Pass
Clinical In Use test	To demonstrate the ability of the LOWTEM Crystal 120 sterilizer to sterilize clinically soiled and cleaned medical devices.	Pass / Fail	Pass
Cytotoxicity Evaluation	To evaluate the compatible materials (23 materials) to determine the non-cytotoxicity of the materials extracts after processing in the LOWTEM Crystal 120 sterilizer.	Pass / Fail	Pass
Residual Evaluation	To evaluate the emission of hydrogen peroxide vapor in operator's breathing zone. The emitted level of hydrogen peroxide vapor was evaluated according to the OSHA hydrogen peroxide gas 8-hour Time Weighted Average (TWA) limit of 1ppm.	Pass / Fail	Pass

Missing Information (Not available in the provided text):

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document mentions "maximum of 20 lumens per load" for validation testing and "a total weight of 8.9kg(19.6lbs)" for validation loads. It also mentions "three lots of test accessories" for final process qualification. However, specific sample sizes (e.g., number of test cycles, number of devices/items tested for each specific test) are not detailed.
Data provenance (country of origin, retrospective/prospective) is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable and not mentioned, as the device is a sterilizer and its performance is measured by sterilization efficacy (e.g., bacterial kill, D-value) rather than expert interpretation of images or data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/Not mentioned. The tests for a sterilizer are objective performance measures (e.g., spore kill, chemical residuals) rather than subjective assessments requiring adjudication.

5. 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:

Not applicable, as this device is a sterilizer, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. The "standalone" performance here refers to the sterilizer's ability to sterilize, which is inherent to its function and is what the various performance tests assess. There's no AI algorithm performing a separate task.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

For a sterilizer, the "ground truth" for sterilization efficacy is typically defined by standardized biological and chemical indicators, as well as validated physical parameters of the sterilization cycle. The document mentions "demonstration of >12 log reduction of Geobacillus stearothermophilus" and "test accessories (SCBI, CI strip and CI tape)" which are standard methods for assessing sterilization success.

8. The sample size for the training set:

Not applicable as this is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable as this is not an AI/ML device that requires a training set.

Summary

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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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 18, 2024

LowTem Co., Ltd. % Do Hyun Kim CEO BT Solutions, Inc. Unit 904, Eonju-ro 86-gil 5, Gangnam-gu Seoul 06210 Korea

Re: K231893

Trade/Device Name: LOWTEM Crystal 120 Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: Class II Product Code: MLR Dated: September 17, 2024 Received: September 17, 2024

Dear Do Hyun Kim:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

Christopher K. Dugard -2

Christopher K. Dugard, M.S. Assistant Director THT4C1: Sterility Devices Team DHT4C: Division of Infection Control 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) K231893

Device Name LOWTEM Crystal 120

Indications for Use (Describe)

The LOWTEM Crystal 120 Sterlizer System is indicated to sterilize pre-cleaned and dried reusable medical devices with nonabsorbable materials. The Crystal 120 sterilizer's Standard cycle can sterilize:

- Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors,
- Medical devices with single stainless-steel lumen with:

An inside diameter of 1mm or larger and a length of 125mm or shorter An inside diameter of 2mm or larger and a length of 250mm or shorter An inside diameter of 3mm or larger and a length of 400mm or shorter

The validation testing for this lumen size was conducted using a maximum of 20 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing.

Contra-indication: It is contraindicated to sterilize single usable medical devices made up with absorbable materials such as cellulose or wood.
Intended user: trained nurse level or higher level of healthcare providers

The validated maximum load conditions

Total weight:

The validation performances were conducted using a validation load consisting of two instrument trays containing a total weight of 8.9kg(19.6lbs).

Usage of sterilization pouch:

The medical devices to be sterilized are packaged in Tyvek sterilization pouch and sealed. The pouched medical devices are placed at the trays.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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

510(k) Summary

1 General Information

LOWTEM CO., LTD. Applicant/Submitter: 100-2, Cheombok-ro, Dong-gu Address: Daegu 41061, Korea Do Hyun Kim, BT Solutions, Inc. Contact Person: Address: Unit 904, Eonju-ro 86gil 5, Gangnam-gu, Seoul 06210, Korea. Tel: +82-2-538-9140 Email: ceo@btsolutions.co.kr

Preparation Date:

April 3, 2024

2 Device Name and Code

Device Trade Name:	LOWTEM Crystal 120
Common Name:	Low Temperature hydrogen peroxide sterilizer
Classification Name:	Sterilizer, Chemical
Product Code:	MLR
Regulation Number:	21 CFR 880.6860
Classification:	Class II
Review Panel:	General Hospital

Predicate Devices:

Amsco® V-PROTM 1 Low Temperature Sterilization System K062297 ●
Amsco® V-PRO™M MAX Low Temperature Sterilization System K102330 ●

3. Device Description

The LOWTEM Crystal 120 low-temperature vaporized hydrogen peroxide sterilizer is a selfcontained stand-alone device, using vaporized hydrogen peroxide as the sterilant.

The LOWTEM Crystal 120 includes the LCD touch monitor, Hydrogen Peroxide Supply (HPS) Unit, Sterilization Chamber Door, and Printer on the front of the Sterilizer.

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

510(k) Summary - K231893

1. Indications for Use / Intended Use

Intended Use:

The LOWTEM Crystal 120 Sterilizer System has a primary purpose to inactivate microorganisms on a broad range of medical devices and surgical instruments as a low temperature hydrogen peroxide sterilizer. Since the cycle operates within a dry environment and at low temperature, it is especially suitable for instruments sensitive to heat and moisture.

Indications for Use:

Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
Medical devices with single stainless-steel lumen with:
- √ An inside diameter of 1mm or larger and a length of 125mm or shorter
- √ An inside diameter of 2mm or larger and a length of 250mm or shorter
- √ An inside diameter of 3mm or larger and a length of 400mm or shorter

※ The validation testing for this lumen size was conducted using a maximum of 20 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing.

Contra-indication: It is contraindicated to sterilize single usable medical devices and devices made up with absorbable materials such as cellulose or wood.
Intended user: trained nurse level or higher level of healthcare providers

The validated maximum load conditions

Total weight:

The validation performances were conducted using a validation load consisting of two instrument trays containing a total weight of 8.9kg(19.6lbs).

Usage of sterilization pouch:

The medical devices to be sterilized are packaged in Tyvek sterilization pouch and sealed. The pouched medical devices are placed at the trays.

1. Technical Characteristics in Comparison to Predicate Devices
  A technological comparison of the LOWTEM Crystal 120 sterilizer has been conducted to the legally marketed predicate devices:

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	Predicate Device 1	Predicate Device 2	LOWTEM Crystal 120
510(K) Number	K062297	K102330	K231893
Manufacturer	STERISCorporation	STERISCorporation	LOWTEM CO., LTD.
Device Trade Name	Amsco® V-PRO™ 1 LowTemperature sterilizationSystem	Amsco® V-PRO™ MAXLow Temperaturesterilization System	LOWTEM Crystal 120
Classification	Sterilizer, Ethylene OxideGas	Sterilizer, Ethylene OxideGas	Sterilizer, Ethylene OxideGas
Indications for Use	The V-PRO 1 LowTemperature SterilizationSystem and Vaprox® HCHydrogen PeroxideSterilant (59%) areintended for use interminal sterilization ofcleaned, rinsed, and dried,reusable metal andnonmetal medical devicesused in healthcarefacilities.The V-PRO 1 LowTemperature SterilizationSystem can sterilize: Instruments withdiffusion-restricted spacessuch as the hinged portionof forceps and scissors.* Medical devices with asingle stainless steellumen with:• an inside diameter of 1mm or larger and a lengthof 125 mm or shorter• an inside diameter of 2mm or larger and a lengthof 250 mm or shorter• an inside diameter of 3mm or larger and a lengthof 400 mm or shorter* The validation testingfor all lumen sizes wasponduated us	The Amsco® V-PROTMMAX Low TemperatureSterilization System, withVAPROX™ HC Sterilant,is a vaporized hydrogenperoxide sterilizer intendedfor use in the terminalsterilization of cleaned,rinsed and dried reusablemetal and nonmetalmedical devices used inhealthcare facilities.The three pre-programmedsterilization cycles(Lumen Cycle, NonLumen Cycle, andFlexible Cycle) operate atlow pressure and lowtemperature and are thussuitable for processingmedical devices sensitiveto heat and moisture.The Amsco V-PRO MAXLow TemperatureSterilization System'sLumen Cycle, clearedunder K062297, cansterilize:'Instruments withdiffusion-restricted spacessuch as the hinged portionof forceps and scissorsMedical devices,including rigidondog0singla	The LOWTEM Crystal120 Sterilizer System isindicated to sterilize pre-cleaned and dried reusablemedical devices withnonabsorbable materials.The Crystal 120 sterilizer'sStandard cycle cansterilize:* Instruments withdiffusion-restricted spacessuch as the hinged portionof forceps and scissors,* Medical devices withsingle stainless-steel lumenwith:• An inside diameter of1mm or larger and alength of 125mm orshorter• An inside diameter of2mm or larger and alength of 250mm orshorter• An inside diameter of3mm or larger and alength of 400mm orshorterx The validation testing forthis lumen size wasconducted using amaximum of 20 lumensper load. Hospital loadsshould not exceed thenumber of

maximum of twenty (20) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs.	stainless steel lumen with:an inside diameter of 1 mm or larger and a length of 125 mm or shorteran insider diameter of 2 mm or larger and a length of 250 mm or shorteran inside diameter of 3 mm, or larger and a length of 400 mm or shorterThe validation testing for all lumen sizes was conducted using a maximum of twenty (20) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs.The Amsco V-PRO MAX Low Temperature Sterilization System's Non-Lumen Cycle, cleared under K083097, can sterilize: bNon-lumened instruments including non-lumened rigid endoscopes and non-lumened instruments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors.	lumens validated by this testing.- Contra-indication: It is contraindicated to sterilize single usable medical devices and devices made up with absorbable materials such as cellulose or wood.-Intended user: trained nurse level or higher level of healthcare providersThe validated maximum load conditionsTotal weight: The validation performances were conducted using a validation load consisting of two instrument trays containing a total weight of 8.9kg (19.6lbs).Usage of sterilization pouch:The medical devices to be sterilized are packaged in Tyvek sterilization pouch and sealed. The pouched medical devices are placed at the trays.
b. The validation studies were conducted using a validation load consisting of two instrument trays and two pouches for a total

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

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

weight of 19.65 lbs.

The Amsco V-PRO MAX
Low Temperature
Sterilization System's
Flexible Cycle, the subject
of this submission, can
sterilize single or dual
lumen surgical flexible
endoscopes (such as those
used in ENT, Urology and
Surgical Care) and
bronchoscopes in either of
two load configurations:

(1) Two flexible
endoscopes with a light
cord (if not integral to
endoscope) and mat
with no additional load.
C

The flexible endoscopes
may contain either:
● A single lumen with an
inside diameter of 1 mm
or larger and a length of
1050 mm or shorter,
● or two lumens with:
*one lumen having an
inside diameter of 1 mm or
larger and a length of 998
mm or shorter
*and the other lumen
having an inside diameter
of 1 mm or larger and a
length of 850 mm or
shorter

c The validation studies
were conducted with two
flexible endoscopes, each
packaged into a tray with
silicone mat and light cord
(if not integral
to endoscope).

(2) One flexible endoscope
with a light cord (if not

{9}------------------------------------------------

		integral to endoscope)
		and mat and additional
		non-lumened
		instruments including
		instruments with

		diffusion-restricted
		areas such as the
		hinged portion of
		forceps or scissors. d.
		The flexible endoscope
		can contain either:
		● a single lumen with an
		inside diameter of 1 mm
		or larger and a length of
		1050 mm or shorter
		• or two lumens with:
		*one lumen having an
		inside diameter of 1 mm or
		larger and a length of 998
		mum or shorter
		* and the other lumen
		having an inside diameter
		of 1 mm or larger and a
		length of 850 mm or
		shorter

		d The validation studies
		were conducted with a
		flexible endoscope in a
		tray with silicone mat and
		light cord (if not integral to
		endoscope). Also included
		in the load were an
		additional instrument tray
		and one pouch for a total
		load weight of 24.0 lbs.
Characteristics:
Performance Claims	One Available Cycle	Three Available Cycles	One Available Cycle
	Lumen cycle●	Lumen cycle●	Standard cycle●
		non- lumen cycle●
		Flexible cycle●
Sterilant	VAPROX HC	VAPROX HC	Crystal SA-120 Sterilant.
	Sterilant.	Sterilant.	(59wt% hydrogen peroxide).
	(59wt% hydrogen peroxide).	(59wt% hydrogen peroxide).

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510(k) Summary – K231893

Software/Firmwarecontrol	PLCCycle selection	PLCCycle selection	WindowembeddedControllerfactory
------------------------------	------------------------	------------------------	---------------------------------------------

6. Performance Data

Performance characteristics of the subject device were tested using following consensus standards and end points:

Test Performed	Test objective	Acceptance criteria	Result
IEC 60601-1-2Edition 4.0	General requirement forsafety. CollateralstandardElectromagneticcompatibility.Requirements and tests.	Pass / Fail	Pass
IEC 61010-1Edition 3.1	Safety requirements forelectrical equipment formeasurement, control andlaboratory use.	Pass / Fail	Pass
ISO 14971Edition 3.0Risk management	Identification of the riskand the activities of riskmanagement.	Pass / Fail	Pass
IEC 62366-1Edition 1.0Usability Test	Application of usabilityengineering to medicaldevices	Pass / Fail	Pass
AOAC Sporicidal ActivityTesting	Sterilant potency testingconducted per AOACOfficial Method 966.04	Pass / Fail	Pass
D-value and total kill endpoint	Evaluation of the D- valueexamined and calculatedand demonstration of >12log reduction of Geobacillusstearothermophilus and itstotal kill endpoint tested inLOWTEM Crystal 120sterilization system.	Pass / Fail	Pass
½ cycle modified total killend point verification-worst case load	Evaluation of the validationloads under reducedinjection weight todemonstrate a modified totalend point.	Pass / Fail	Pass
Determination ofworst-case material forVHP	Performance to determine theworst material (the mostresistant) of 23 compatiblematerials of the LOWTEMCrystal 120 sterilizer.	Pass / Fail	Pass

½ cycle verification ofmated surface	Evaluation of the sterility ofthe mated surfaces packagedin double pouch within theworst-case validation load inthe LOWTEM Crystal 120Standard ½ cycle.	Pass / Fail	Pass
½ cycle verification ofmated surface	Evaluation of the sterilityof the mated surfacespackaged in double pouchwithin the worst-casevalidation load in theLOWTEM Crystal 120Standard ½ cycle.	Pass / Fail	Pass
½ cycle verification atmultiple peroxide injectionweight-worst lumen size	To determine the worst-case lumen size of theclaimed lumens in theLOWTEM Crystal 120Standard ½ cycle usingreduced sterilant weightsinjected.	Pass / Fail	Pass
½ cycle verification ofLumen claims and worst-case materials	To verify the ability tosterilize in LOWTEM Crystal120 Standard ½ cycle' worst-case lumen sizes (1.0mm x125mm and 3.0mm x400mm) and the worst- casematerial (neoprene) forsurface sterilization in worstcase validation loads.	Pass / Fail	Pass
½ cycle verification ofworst-case material indouble pouch	To verify the sterilizationefficacy with the worst-case material (neoprene)packaged in double Tyvekpouch configuration inLOWTEM Crystal 120Standard ½ cycle.	Pass / Fail	Pass
Evaluation of the systemparameters	To confirm the sterilizationefficacy using worst casevalidation load with worstcase materials processed in	Pass / Fail	Pass

Final processqualification	To confirm the LOWTEMCrystal 120 Standard cycleperformed in accordancewith the sterilizerspecification by inspectingthe three lots of testaccessories (SCBI, CI stripand CI tape) aftersterilization cycle.	Pass / Fail	Pass
Simulated Use test	To verify the sterilizationability of representativeworst- case devicesprocessed in the LOWTEMCrystal 120 sterilizationcycle.	Pass / Fail	Pass
Clinical In Use test	To demonstrate the abilityof the LOWTEM Crystal120 sterilizer to sterilizeclinically soiled andcleaned medical devices.	Pass / Fail	Pass
Cytotoxicity Evaluation	To evaluate the compatiblematerials (23 materials) todetermine the non-cytotoxicity of thematerials extracts afterprocessing in theLOWTEM Crystal 120sterilizer.	Pass / Fail	Pass
Residual Evaluation	To evaluate the emission ofhydrogen peroxide vapor inoperator's breathing zone.The emitted level ofhydrogen peroxide vaporwas evaluated according tothe OSHA hydrogenperoxide gas 8-hour TimeWeighted Average (TWA)limit of 1ppm.	Pass / Fail	Pass

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510(k) Summary – K231893

7. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission K231893, the LOWTEM Crystal 120, is as safe, as effective, and performs as well as or better than the legally marketed predicate devices, cleared in K062297 and K102330.

Regulation Number and Section

§ 880.6860 Ethylene oxide gas sterilizer.

(a)
Identification. An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.(b)
Classification. Class II (performance standards).