(112 days)
Not Found
No
The device description and performance studies focus on the physical properties, cleaning, sterilization, and biocompatibility of a surgical cassette and tray, with no mention of AI or ML technology.
No.
The device is a surgical cassette and tray used for sterilizing other medical devices, which is not a therapeutic function.
No
The device is a surgical cassette and tray used for sterilizing other medical devices, not for diagnosing medical conditions. Its function is to enclose and allow sterilization of instruments, not to detect or identify diseases or conditions.
No
The device description clearly states it is a reusable rigid container made of physical materials (polyphenylsulfone and silicone) and is intended to enclose and facilitate the sterilization of other medical devices. There is no mention of software components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for enclosing other medical devices for sterilization and allowing that sterilization to occur. It is a container for instruments.
- Device Description: The description details a reusable rigid container designed to organize and protect instruments during sterilization.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. The provided text does not mention any testing of biological samples or diagnostic purposes.
- Performance Studies: The performance studies focus on cleaning, sterilization, use life, and biocompatibility – all related to the function of a sterilization container, not an IVD.
Therefore, the NUVENTUS NV.C™ Surgical Cassette and Tray is a device intended for the sterilization of other medical instruments, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The NUVENTUS NV.C™ Surgical Cassette and Tray is intended to enclose other medical devices that are to be sterilized by a health care provider. The NUVENTUS NV.C™ Surgical Cassette and Tray is intended to allow sterilization of the enclosed medical devices.
The NUVENTUS NV.C™ Surgical Cassette and Tray requires the use of an FDA cleared wrap to maintain the sterility of the enclosed devices. The NUVENTUS NV.C™ Surgical Cassette and Tray should be enclosed in a sterilization wrap that is FDA cleared for the indicated cycle, and moist heat (steam) sterilized using the following cycle: Pre-vacuum steam: 132°C (270°F) for 4 minutes with 30 minutes drying time.
The NUVENTUS NV.C™ Surgical Cassette and Tray is intended for sterilization of non-porous loads.
The NUVENTUS NV.C™ Surgical Cassette and Tray is recommended not to be stacked during sterilization. The combined weight of the NUVENTUS NV.C™ Surgical Cassette and Tray and the associated instruments is 220 grams. The weight of the empty NUVENTUS NV.C™ Surgical Cassette and Tray is 200 grams.
Product codes
KCT
Device Description
The subject device is a reusable rigid container, comprising a base (bottom), a removable inner tray, and a lid (cover). It is designed to organize and protect NUVENTUS NV.C™ instruments that fall within the cleaning and sterilization validation scope and are sterilized in the tray by a healthcare provider. The base, inner tray, and lid components are designed to be integrated into a single unit which contains and protects the interior contents during sterilization. The tray is perforated to allow for penetration of the sterilant, are to be used with moist heat (steam), and require the use of an FDA cleared wrap to maintain sterility. The subject device components are manufactured from injection molded polyphenylsulfone (PPSU), and holders of various geometries to position instruments in the trays are manufactured from silicone.
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
health care provider
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Performance Testing:
- Validation of the Manual Cleaning Process: Evaluate and validate the manual cleaning of the subject devices. Acceptance Criteria: Extraction Recovery - The extraction efficiency for each marker should be no less than 70%. The amounts of each marker residual detected in the fourth extract should be less than 10% of that detected in the first extraction. Residual marker testing - Protein Assay Acceptance criterion: less than 6.4 µg/cm2 Assay quantitation limits: 2.5 µg/mL Hemoglobin assay Acceptance criterion: less than 2.2 µg/cm2 Assay quantitation limits: 10.0 µg/mL. Results: Pass.
- Validation of the Automated Cleaning Process: Evaluate and validate the automated cleaning of the subject devices. Acceptance Criteria: Extraction Recovery - The extraction efficiency for each marker should be no less than 70%. The amounts of each marker residual detected in the fourth extract should be less than 10% of that detected in the first extraction. Residual marker testing - Protein Assay Acceptance criterion: less than 6.4 µg/cm2 Assay quantitation limits: 2.5 µg/mL Hemoglobin assay Acceptance criterion: less than 2.2 µg/cm2 Assay quantitation limits: 10.0 µg/mL. Results: Pass.
- Sterilization Validation: Validate a sterilization cycle and drying time of the subject devices. Acceptance criteria: 3 consecutive half-cycles will demonstrate complete inactivation of all biologic indicators; A minimum SAL of 10-6 is achieved if the Instructions for Use are followed. Acceptance criterion: Using pre-cycle and post-cycle weights, the weight gain after drying will not exceed +3%. Results: Pass.
- Use Life Testing: Life Cycle (simulated use) testing after 225 cleaning, disinfection and sterilization cycles. Acceptance criteria: Visual inspection, functional verification for 225 use cycles. Results: Pass.
- Biocompatibility of Subject Device (by cytotoxicity testing): Evaluate the cytotoxicity potential of the test article using an in vitro cell culture assay. Acceptance criterion: ≤ 2 reactivity grade after exposure to extract of the device. Results: Pass.
No clinical data were included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
February 11, 2025
Infinitum Eta Ltd. Avital Barlev Vice President QA&RA Hatnufa St. 6 Petach Tikva, 4951024 Israel
Re: K243317
Trade/Device Name: NUVENTUS NV.CTM Surgical Cassette and Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: October 22, 2024 Received: October 22, 2024
Dear Avital Barlev:
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,
Image /page/2/Picture/3 description: The image contains the text "Stephen A. Anisko -S". The text is arranged in a vertical format, with "Stephen A." on the first line, "Anisko" on the second line, and "-S" on the third line. The text is in a simple, sans-serif font and is black in color. The background of the image is white.
Digitally signed by Stephen A. Anisko -S Date: 2025.02.11 11:03:44 -05'00'
for: Christopher K. Dugard Division Director 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) K243317
Device Name
NUVENTUS NV.CTM Surgical Cassette and Tray
Indications for Use (Describe)
The NUVENTUS NV.C™ Surgical Cassette and Tray is intended to enclose other medical devices that are to be sterilized by a health care provider. The NUVENTUS NV.C™ Surgical Cassette and Tray is intended to allow sterilization of the enclosed medical devices.
The NUVENTUS NV.C™ Surgical Cassette and Tray requires the use of an FDA cleared wrap to maintain the sterility of the enclosed devices. The NUVENTUS NV.C™ Surgical Cassette and Tray should be enclosed in a sterlization wrap that is FDA cleared for the indicated cvcle, and moist heat (steam) sterilized using the following cvcle: Pre-vacum steam: 132°C (270°F) for 4 minutes with 30 minutes drying time.
The NUVENTUS NV.CTM Surgical Cassette and Tray is intended for sterilization of non-porous loads.
The NUVENTUS NV.C™ Surgical Cassette and Tray is recommended not to be stacked during sterilization. The combined weight of the NUVENTUS NV.C™ Surgical Cassette and Tray and the associated instruments is 220 grams. The weight of the empty NUVENTUS NV.C™ Surgical Cassette and Tray is 200 grams.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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4
INFIN
510(K) Summary (K243317) for Infineta's NUVENTUS NV.CTM Surgical Cassette and Tray
| Date Prepared: | 11 February 2025 |
|---|---|
| 1. Submitter | |
| Company Name: | Infinitum Eta Ltd |
| Address: | Hatnufa St. 6, Petach Tikva, 4951024, Israel |
| Phone and E-mail: | avitalb@infinetamed.com; +972-54-2272773 |
| Contact Person: | Avital Barlev, Vice President QA&RA |
| 2. Device: | |
| Proprietary/Trade Name: | NUVENTUS NV.CTM Surgical Cassette and Tray |
| Common Name: | Instrument Sterilization Trays |
| Regulation Number: | 21 CFR 880.6850 |
| Regulation Name: | Containers, Trays, Surgical Cassettes & Other Accessories |
| Regulatory Class: | Class II |
| Product Code: | KCT |
- Predicate Device: Z-Systems AG's ST-Z5, cleared under K201878.
4. Device Description
The subject device is a reusable rigid container, comprising a base (bottom), a removable inner tray, and a lid (cover). It is designed to organize and protect NUVENTUS NV.CTM instruments that fall within the cleaning and sterilization validation scope and are sterilized in the tray by a healthcare provider. The base, inner tray, and lid components are designed to be integrated into a single unit which contains and protects the interior contents during sterilization. The tray is perforated to allow for penetration of the sterilant, are to be used with moist heat (steam), and require the use of an FDA cleared wrap to maintain sterility. The subject device components are manufactured from injection molded polyphenylsulfone (PPSU), and holders of various geometries to position instruments in the trays are manufactured from silicone.
5. Indications for Use
The NUVENTUS NV.C™ Surgical Cassette and Tray is intended to enclose other medical devices that are to be sterilized by a health care provider. The NUVENTUS NV.C™ Surgical Cassette and Tray is intended to allow sterilization of the enclosed medical devices.
The NUVENTUS NV.C™ Surgical Cassette and Tray requires the use of an FDA cleared wrap to maintain the sterility of the enclosed devices. The NUVENTUS NV.C™ Surgical Cassette and Tray should be enclosed in a sterilization wrap that is FDA cleared for the indicated cycle, and moist heat (steam) sterilized using the following cycle: Pre-vacuum steam: 132°C (270°F) for 4 minutes with 30 minutes drying time.
The NUVENTUS NV.C™ Surgical Cassette and Tray is intended for sterilization of non-porous loads.
5
INFINETA
The NUVENTUS NV.C™ Surgical Cassette and Tray is recommended not to be stacked during sterilization. The combined weight of the NUVENTUS NV.C™ Surgical Cassette and Tray and the associated instruments is 220 grams. The weight of the empty NUVENTUS NV.C™ Surgical Cassette and Tray is 200 grams.
Comparison of Technological Characteristics 6.
A tabular comparison of technological characteristics is presented herein:
Table 1: Indications for Use Comparison
| Device Name | Indications for Use | |
|---|---|---|
| Subject | ||
| Device | NUVENTUS | |
| NV.CTM Surgical | ||
| Cassette and | ||
| Tray | ||
| (K243317) | The NUVENTUS NV.CTM Surgical Cassette and Tray is intended to enclose other medical | |
| devices that are to be sterilized by a health care provider. The NUVENTUS NV.CTM Surgical | ||
| Cassette and Tray is intended to allow sterilization of the enclosed medical devices. | ||
| The NUVENTUS NV.CTM Surgical Cassette and Tray requires the use of an FDA cleared wrap | ||
| to maintain the sterility of the enclosed devices. The NUVENTUS NV.CTM Surgical Cassette | ||
| and Tray should be enclosed in a sterilization wrap that is FDA cleared for the indicated cycle, | ||
| and moist heat (steam) sterilized using the following cycle: Pre-vacuum steam: 132°C (270°F) | ||
| for 4 minutes with 30 minutes drying time. | ||
| The NUVENTUS NV.CTM Surgical Cassette and Tray is intended for sterilization of non- | ||
| porous loads. | ||
| The NUVENTUS NV.CTM Surgical Cassette and Tray is recommended not to be stacked | ||
| during sterilization. The combined weight of the NUVENTUS NV.CTM Surgical Cassette and | ||
| Tray and the associated instruments is 220 grams. The weight of the empty NUVENTUS | ||
| NV.CTM Surgical Cassette and Tray is 200 grams. | ||
| Primary | ||
| Predicate | ||
| Device | ST-Z5 | |
| (K201878) | ST-Z5 surgical trays are intended to be used to enclose other medical devices that are to be | |
| sterilized by a health care provider. ST-Z5 surgical trays are intended to allow sterilization of | ||
| the enclosed medical devices. ST-Z5 surgical trays require the use of an FDA cleared wrap to | ||
| maintain the sterility of the enclosed devices. The trays are to be enclosed in a sterilization | ||
| wrap that is FDA cleared for the indicated cycle, and moist heat (steam) sterilized using the | ||
| following cycle: Pre-vacuum steam: 132 °C (270 °F) for 4 minutes with 20 minutes drying | ||
| time. ST-Z5 surgical trays are intended for sterilization of non-porous loads. ST-Z5 surgical | ||
| trays are recommended not to be stacked during sterilization. The combined weight of the ST- | ||
| Z5_c_m_c(t)_m(t) tray and the associated instruments is 441 grams. The weight of the empty | ||
| ST-Z5_c_m_c(t)_m(t) tray is 361 grams. The combined weight of the Z5-BL/TL tray and the | ||
| associated instruments is 427 grams. The weight of the empty Z5-BL/TL tray is 363 grams. |
Table 2: Technological Characteristics Comparison
| Feature | Subject Device | Primary Predicate Device | Technological
Characteristics
Comparison |
|--------------|---------------------------------------------------------|------------------------------------------------------|------------------------------------------------|
| | NUVENTUS NV.CTM Surgical
Cassette and Tray (K243317) | ST-Z5 (K201878) | |
| Product Code | KCT | KCT | Identical |
| Design | Rigid polymer base, lid, and removable
inner tray | Rigid polymer base, lid, and removable
inner tray | Identical |
| Materials | Polyphenylsulfone [lid, base, tray] | Polyphenylsulfone [lid, base, tray] | Identical |
6
INFINETA
| | Subject Device | Primary Predicate Device | Technological
Characteristics
Comparison |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| Feature | NUVENTUS NV.CTM Surgical
Cassette and Tray (K243317) | ST-Z5 (K201878) | |
| | Medical grade silicone
[grommets/holders] | Medical grade silicone
[grommets/holders] | |
| Materials
compatible
with
Sterilization
Method | Yes | Yes | Identical |
| Perforated | Yes; allows moist heat (steam)
penetration to achieve sterilization | Yes; allows moist heat (steam)
penetration to achieve sterilization | Identical |
| Number of
Overall Sizes | 1 | 1 | Identical |
| Number of
Configurations | 1 | 2 | Similar |
| Overall
Dimensions | 138L x 98W x 62H [mm] | 185.1L x 133.6W x 61.5H [mm] | Similar |
| Vent to
Volume Ratio | 0.0172 cm2 / cm3 | 0.01596 cm2 / cm3 | Similar |
| Reusable | Yes | Yes | Identical |
| Number of
Uses | 225 | 101 | Similar |
| Use Life
Testing | Reusable up to 225 cycles
Assembled, cleaned, disinfected and
sterilized
Visual inspection
Defect and deformation
Functional performance (Cassette and
Tray) | Reusable up to 101 cycles
Assembled and sterilized
Visual inspection
Component dimensional fit verification
Functional closure (lid-base latch)
verification | Similar |
| Sterilization
Method | Moist Heat | Moist Heat | Identical |
| Sterilization
Cycles | Fractionated vacuum (pre-vacuum)
Exposure at 132 °C (270 °F) for 4
minutes with 30 minutes drying time | Fractionated vacuum (pre-vacuum)
Exposure at 132 °C (270 °F) for 4
minutes with 20 minutes drying time | Similar |
| Sterile
Barrier | Sterilization wrap, FDA cleared for
indicated method and cycle | Sterilization wrap, FDA cleared for
indicated method and cycle | Identical |
7. Technological Comparison Discussion:
The subject device is similar in indications and design principles to the predicate device.
The subject device and the predicate device have the same intended use, the same product classification and product code (KCT), and have similar Indications for Use statements.
Except for the details concerning the weights of the empty and loaded trays, the indications for use statement for the subject device is identical to that of the predicate device K201878.
7
INFINETA
The subject device and the predicate device are reusable rigid sterilization trays intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Components of the subject device and the predicate device are perforated to allow for penetration of the sterilant, are to be used with the same moist heat (steam) sterilization cycle and require the use of an FDA-cleared wrap to maintain sterility.
The subject device and the predicate device include components manufactured from polyphenylsulfone (PPSU) and silicone, and both devices are provided in one overall size. While the predicate device is provided in two configurations, the subject device is provided in one configuration. The overall dimensions of the subject device are smaller than the overall dimensions for the predicate device and the vent to volume ratio of the subject device is larger than the vent to volume ratio of the predicate device.
There are minor differences in the configurations, sizes, or designs between the subject device and the predicate device. The differences are related to the specific design features and system components and are supported by the cleaning and sterilization validation and use life testing performed.
The subject device and the predicate device have different use life, 225 compared to 101, respectively.
8. Non-clinical Testing Summary
Provided below is a summary of the non-clinical performance testing included in this submission, including the test methods, purpose, acceptance criteria, and results.
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Validation of the Manual | |||
| Cleaning Process | |||
| According to the ISO | |||
| 17664 and the AAMI | |||
| ST98 Standards | Evaluate and validate the | ||
| manual cleaning of the | |||
| subject devices | Extraction Recovery - The extraction efficiency for | ||
| each marker should be no less than 70%. The amounts | |||
| of each marker residual detected in the fourth extract | |||
| should be less than 10% of that detected in the first | |||
| extraction. | |||
| Residual marker testing - Protein Assay Acceptance | |||
| criterion: less than 6.4 µg/cm2 Assay quantitation | |||
| limits: 2.5 µg/mL Hemoglobin assay Acceptance | |||
| criterion: less than 2.2 µg/cm2 Assay quantitation | |||
| limits: 10.0 µg/mL | Pass | ||
| Validation of the | |||
| Automated Cleaning | |||
| Process According to the | |||
| ISO 17664 and the AAMI | |||
| ST98 Standards | Evaluate and validate the | ||
| automated cleaning of | |||
| the subject devices | Extraction Recovery - The extraction efficiency for | ||
| each marker should be no less than 70%. The amounts | |||
| of each marker residual detected in the fourth extract | |||
| should be less than 10% of that detected in the first | |||
| extraction. | |||
| Residual marker testing - Protein Assay Acceptance | |||
| criterion: less than 6.4 µg/cm2 Assay quantitation | |||
| limits: 2.5 µg/mL Hemoglobin assay Acceptance | |||
| criterion: less than 2.2 µg/cm2 Assay quantitation | |||
| limits: 10.0 µg/mL | Pass | ||
| Sterilization Validation | |||
| According to the ISO | |||
| 17664 - ISO 17665 | |||
| Standards and the AAMI | |||
| TIR 12 Technical Report | Validate a sterilization | ||
| cycle and drying time of | |||
| the subject devices | Acceptance criterion: 3 consecutive half-cycles will | ||
| demonstrate complete inactivation of all biologic | |||
| indicators; A minimum SAL of 10-6 is achieved if the | |||
| Instructions for Use are followed | Pass |
Table 3: Non-Clinical Testing Summary
8
I N
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Acceptance criterion: Using pre-cycle and post-cycle | |||
| weights, the weight gain after drying will not exceed | |||
| +3% | |||
| Use Life Testing | |||
| FDA Guidance | |||
| Reprocessing Medical | |||
| Devices in Health Care | |||
| Settings: Validation | |||
| Methods and Labeling and | |||
| ISO 13402:1995 | Life Cycle (simulated | ||
| use) testing after 225 | |||
| cleaning, disinfection | |||
| and sterilization cycles | Acceptance criteria: Visual inspection, functional | ||
| verification for 225 use cycles | Pass | ||
| Biocompatibility of | |||
| Subject Device (by | |||
| cytotoxicity testing) | |||
| ISO 10993-5 | |||
| ISO 10993-12 | The purpose of this test | ||
| is to evaluate the | |||
| cytotoxicity potential of | |||
| the test article using an in | |||
| vitro cell culture assay. | Acceptance criterion: ≤ 2 reactivity grade after | ||
| exposure to extract of the device | Pass |
In summary, the nonclinical testing provided for these devices met the acceptance criteria for each standard and test methodology used to evaluate the devices as shown in the table above.
No clinical data were included in this submission.
9. Conclusion
To conclude, the conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K201878.