(448 days)
Not Found
No
The document does not mention AI, ML, or any related technologies in the device description, intended use, or performance studies. The focus is on the sterilization process and its validation.
No.
This device is a sterilizer that cleans medical devices and instruments, not a therapeutic device used in treatment for patients.
No
This device is a sterilizer, used for cleaning pre-cleaned medical devices, not for diagnosing medical conditions.
No
The device description clearly states it is a "selfcontained stand-alone device" and lists physical components like an LCD touch monitor, Hydrogen Peroxide Supply Unit, Sterilization Chamber Door, and Printer. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the LOWTEM Crystal 120 Sterilizer System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to sterilize pre-cleaned and dried reusable medical devices. This is a process performed on medical devices themselves, not on biological samples or specimens taken from the human body for diagnostic purposes.
- Device Description: The device is a sterilizer that uses vaporized hydrogen peroxide. This is a sterilization method, not a method for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health
- Using reagents or assays for testing
- Measuring analytes or markers
The device is clearly intended for the sterilization of medical instruments used in healthcare settings, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
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.
Product codes
MLR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained nurse level or higher level of healthcare providers
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Performance characteristics of the subject device were tested using following consensus standards and end points:
- IEC 60601-1-2 Edition 4.0: General requirement for safety. Collateral standard Electromagnetic compatibility. Requirements and tests. Result: Pass
- IEC 61010-1 Edition 3.1: Safety requirements for electrical equipment for measurement, control and laboratory use. Result: Pass
- ISO 14971 Edition 3.0 Risk management: Identification of the risk and the activities of risk management. Result: Pass
- IEC 62366-1 Edition 1.0 Usability Test: Application of usability engineering to medical devices. Result: Pass
- AOAC Sporicidal Activity Testing: Sterilant potency testing conducted per AOAC Official Method 966.04. Result: 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. Result: 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. Result: 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. Result: Pass
- ½ cycle verification of mated surface: 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. Result: 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. Result: 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 ½ cycle. Result: 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. Result: Pass
- Simulated Use test: To verify the sterilization ability of representative worst-case devices processed in the LOWTEM Crystal 120 sterilization cycle. Result: Pass
- Clinical In Use test: To demonstrate the ability of the LOWTEM Crystal 120 sterilizer to sterilize clinically soiled and cleaned medical devices. Result: 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. Result: 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. Result: Pass
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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 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).
2
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
3
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
-
- 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:
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 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.
-
- 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:
- Technical Characteristics in Comparison to Predicate Devices
6
| Predicate Device 1 | Predicate Device 2 | LOWTEM Crystal 120 | |
|---|---|---|---|
| 510(K) Number | K062297 | K102330 | K231893 |
| Manufacturer | STERIS | ||
| Corporation | STERIS | ||
| Corporation | LOWTEM CO., LTD. | ||
| Device Trade Name | Amsco® V-PRO™ 1 Low | ||
| Temperature sterilization | |||
| System | Amsco® V-PRO™ MAX | ||
| Low Temperature | |||
| sterilization System | LOWTEM Crystal 120 | ||
| Classification | Sterilizer, Ethylene Oxide | ||
| Gas | Sterilizer, Ethylene Oxide | ||
| Gas | Sterilizer, Ethylene Oxide | ||
| Gas | |||
| Indications for Use | The V-PRO 1 Low | ||
| Temperature Sterilization | |||
| System and Vaprox® HC | |||
| Hydrogen Peroxide | |||
| Sterilant (59%) are | |||
| intended for use in | |||
| terminal sterilization of | |||
| cleaned, rinsed, and dried, | |||
| reusable metal and | |||
| nonmetal medical devices | |||
| used in healthcare | |||
| facilities. |
The V-PRO 1 Low
Temperature Sterilization
System can sterilize*:
- Instruments with
diffusion-restricted spaces
such as the hinged portion
of forceps and scissors. - Medical devices with a
single stainless steel
lumen with:
• an inside diameter of 1
mm or larger and a length
of 125 mm or shorter
• an inside diameter of 2
mm or larger and a length
of 250 mm or shorter
• an inside diameter of 3
mm or larger and a length
of 400 mm or shorter - The validation testing
for all lumen sizes was
ponduated us | The Amsco® V-PROTM
MAX Low Temperature
Sterilization System, with
VAPROX™ HC Sterilant,
is a vaporized hydrogen
peroxide sterilizer intended
for use in the terminal
sterilization of cleaned,
rinsed and dried reusable
metal and nonmetal
medical devices used in
healthcare facilities.
The three pre-programmed
sterilization cycles
(Lumen Cycle, Non
Lumen Cycle, and
Flexible Cycle) operate at
low pressure and low
temperature and are thus
suitable for processing
medical devices sensitive
to heat and moisture.
The Amsco V-PRO MAX
Low Temperature
Sterilization System's
Lumen Cycle, cleared
under K062297, can
sterilize:'
*Instruments with
diffusion-restricted spaces
such as the hinged portion
of forceps and scissors
*Medical devices,
including rigid
ondog0
singla | 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
x The validation testing for
this lumen size was
conducted using a
maximum of 20 lumens
per load. Hospital loads
should not exceed the
number 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: b
Non-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 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. | |
| 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). |
10
510(k) Summary – K231893
| Software/Firmware
control | PLC
Cycle selection | PLC
Cycle selection | Window
embedded
Controller
factory |
| ------------------------------ | ------------------------ | ------------------------ | --------------------------------------------- |
|---|
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 60601-1-2 | |||
| 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 | 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 | 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 |
| 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 |
11
12
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.