Instrument Case

K231604 · Cochlear Americas · KCT · Aug 24, 2023 · General Hospital

Device Facts

• Record ID: K231604
• Device Name: Instrument Case
• Applicant: Cochlear Americas
• Product Code: KCT · General Hospital
• Decision Date: Aug 24, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The Instrument Case is a medical device accessory intended to hold reusable surgical instruments during transportation, sterilization process and during surgery.

Device Story

Reusable sterilization container for surgical instruments; holds instruments during transport, sterilization, and surgery. Composed of stainless steel tray/lid, silicone/stainless steel instrument holders, and thermoplastic resin latches. Used in hospitals and reprocessing centers by surgical teams and reprocessing staff. Input: reusable surgical instruments (max load 1700g). Operation: manual loading of instruments into case; case placed in sterilization pouch; subjected to pre-vacuum steam sterilization (132°C, 4 min, 20 min dry time). Output: sterile instrument set for surgical use. Benefits: facilitates organized, sterile transport and processing of bone-anchored implant instruments.

Clinical Evidence

Bench testing only. Sterilization validation (AAMI TIR12, ANSI/AAMI ST79, ISO 17665) achieved SAL ≤10^-6. Cleaning efficacy (AAMI TIR12/TIR30) confirmed no residual soil, protein (<6.4 µg/cm²), or hemoglobin (<2.2 µg/cm²). Biocompatibility (ISO 10993-1, -5) confirmed non-cytotoxic. Lifecycle testing confirmed integrity over 25 cycles.

Technological Characteristics

Materials: Stainless steel (tray/lid), silicone (holders), Santoprene (latches). Dimensions: 265 x 160 x 42 mm. Sterilization: Dynamic air removal steam (prevacuum) at 132°C. Reusable (25 cycles). Perforated design. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for staff involved in reprocessing of reusable instruments and surgical teams. Used in controlled surgical environments (hospitals), sterilization departments, or reprocessing centers for transport of surgical instruments. Contraindications: None stated.

Regulatory Classification

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.

Predicate Devices

• Instrument Case (K223672)

Submission Summary (Full Text)

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

August 24, 2023

Image /page/0/Picture/1 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.

Cochlear Americas Whitney Alexander Regulatory Affairs Specialist II 10350 Park Meadows Drive Lone Tree. Colorado 80124

### Re: K231604

Trade/Device Name: Instrument Case Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: July 27, 2023 Received: July 27, 2023

### Dear Whitney Alexander:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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

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

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

For comprehensive regulatory information about medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Digitally signed
by Eileen Cadel
-S
Eileen
Cadel -S Date:
2023.08.24
11:39:02 -04'00'

for

Colin O'Neill, M.B.E.
Assistant Director
DHT6B: Division of Spinal Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality

Center for Devices and Radiological Health

Enclosure

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

# Indications for Use

510(k) Number (if known) K231604

Device Name Instrument Case

Indications for Use (Describe)

The Instrument Case is intended for staff involved in reprocessing of reusable instruments, and for surgical teams.

The product shall only be used:

- · in a controlled surgical environment under sterile conditions such as a hospital,
- · in reprocessing environment at sterilization departments or reprocessing centers,
- · and for transport of surgical instruments.

Sterilization parameters:

In US: Pre-Vacuum Steam at 132 ℃ (270 °F) for 4 min with a 20 minutes dry time Outside US: See the Reprocessing Guide available in your country

The worse-case validated load for the Instrument Case, including instruments, is 1700 g.

| 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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

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

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

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

Image /page/3/Picture/0 description: The image contains the logo for Cochlear, a company that specializes in hearing solutions. The logo features three curved shapes in a golden color, arranged in a way that resembles an ear or sound waves. Below the curved shapes, the company name "Cochlear" is written in a matching golden color. Underneath the company name, the tagline "Hear now. And always" is displayed in a smaller font, also in golden color.

# 510(k) Summary

| A. Submitter Information<br>Submitted by: | Cochlear Americas<br>10350 Park Meadows Drive<br>Lone Tree, CO 80124 |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| On behalf of the manufacturer: | Cochlear Bone Anchored Solutions AB<br>Konstruktionsvägen 14,<br>SE-435 33 Mölnlycke<br>Sweden<br>(Establishment Number 9616024) |
| Contact: | Whitney Alexander<br>Regulatory Affairs Specialist II<br>Cochlear Americas<br>C: 719-337-8620<br>E: [e-mail] |
| B. Date Prepared | 21-August-2023 |
| C. Device Name and Classification | Instrument Case |
| Device Names:<br>Classification Name: | Sterilization Wrap Containers, Trays, Cassettes & Other<br>Accessories<br>21 CFR 880.6850, Class II |
| Classification Panel: | Orthopedic |
| Product Code: | KCT |
| D. Predicate Device<br>Device Names: | Instrument Case |
| Classification Name: | Sterilization Wrap Containers, Trays, Cassettes & Other<br>Accessories<br>21 CFR 880.6850, Class II |
| Classification Panel: | Orthopedic |
| Product Code: | KCT |

510(k): K223672

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

Image /page/4/Picture/0 description: The image shows the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized representation of a cochlea, the spiral-shaped part of the inner ear, rendered in a golden color. Below the cochlea graphic, the company name "Cochlear" is written in a matching golden font. Underneath the company name is the tagline "Hear now. And always".

## E. Purpose of Submission

This Special 510(k) seeks clearance for an updated Instrument Case that is intended to hold reusable instruments used during surgical procedures for Osia® and Baha® bone conduction implants. Outside of surgery, the Instrument Case is designed to hold the reusable instruments during the sterilization process and for transportation of the instruments.

### F. Device Description

The Instrument case, Figure 1, is a reusable sterilization container intended for use in health care facilities for the purpose of containing reusable medical devices for sterilization. The specific use for the Instrument case is to hold reusable instruments during transport, the sterilization process, and during surgery.

The Instrument case consists of tray and lid made of stainless steel with a small box included, which is a component tray. The grommets, strips and holders that keep the instruments in place are made of silicone or stainless steel, and the latches in the lid are made of a Thermoplastic resin, Santoprene. The packaging materials are made of polyethylene and polyolefin.

Figure 1: Instrument Case

# G. Intended Use

The Instrument Case is a medical device accessory intended to hold reusable surgical instruments during transportation, sterilization process and during surgery.

### H. Indications for Use

The Instrument Case is intended for staff involved in reprocessing of reusable instruments, and for

surgical teams.

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

Image /page/5/Picture/0 description: The image contains the logo for Cochlear, a company that specializes in hearing solutions. The logo features three stylized, overlapping "C" shapes in a golden color, arranged in a way that suggests sound waves or a spiral. Below the symbol, the company name "Cochlear" is written in a bold, sans-serif font, also in the same golden color. Underneath the name, the tagline "Hear now. And always" is displayed in a smaller, lighter font, emphasizing the company's commitment to long-term hearing solutions.

The product shall only be used:

- in a controlled surgical environment under sterile conditions such as a hospital, .
- in reprocessing environment at sterilization departments or reprocessing centers, .
- and for transport of surgical instruments.

Sterilization parameters:

In US: Pre-Vacuum Steam at 132 ℃ (270 °F) for 4 min with a 20 minutes dry time Outside US: See the Reprocessing Guide available in your country

The worse-case validated load for the Instrument Case, including instruments, is 1700 g.

### I. Technological Characteristics and Comparison to Predicate

Table 1 summarizes a comparison of the technological characteristics of the currently available Instrument Case (predicate device) with the updated Instrument Case (subject device).

| Feature | Instrument Case (Subject Device) | Instrument Case (Predicate Device, K223672) | Comparison Notes |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Cochlear | Cochlear | Same |
| Class | II | II | Same |
| Product Code | KCT | KCT | Same |
| Intended Use | The Instrument Case is a medical device accessory intended to hold reusable surgical instruments during transportation, sterilization process and during surgery. | The Instrument Case is a medical device accessory intended to hold reusable surgical instruments during transportation, sterilization process and during surgery. | Same |
| Indications for Use | The Instrument Case is intended for staff involved in reprocessing of reusable instruments, and for surgical teams.<br>The product shall only be used: | The Instrument Case is intended for staff involved in reprocessing of reusable instruments, and for surgical teams.<br>The product shall only be used: | Similar. Minor sentence added to support global distribution of the device. The difference does not affect the safety and performance of |
| Feature | Instrument Case (Subject<br>Device) | Instrument Case<br>(Predicate Device,<br>K223672) | Comparison<br>Notes |
| | • in a controlled surgical<br>environment under sterile<br>conditions such as a hospital,<br>• in reprocessing environment<br>at sterilization departments or<br>reprocessing centers,<br>• and for transport of surgical<br>instruments.<br>Sterilization parameters:<br>In US: Pre-Vacuum Steam at<br>$132$ °C ( $270$ °F) for 4 min<br>with a 20 minutes dry time<br>Outside US: See the<br>Reprocessing Guide available<br>in your country<br>The worst-case validated load<br>for the Instrument Case,<br>including instruments, is 1700<br>g. | • in a controlled<br>surgical environment<br>under sterile conditions<br>such as a hospital,<br>• in reprocessing<br>environment at<br>sterilization<br>departments or<br>reprocessing centers,<br>• and for transport of<br>surgical instruments.<br>Sterilization<br>parameters:<br>Pre-Vacuum Steam at<br>$132$ °C ( $270$ °F) for 4<br>min with a 20 minutes<br>dry time<br>The worst-case<br>validated load for the<br>Instrument Case,<br>including instruments,<br>is 1700 g. | the subject<br>device. |
| General Design | Stainless steel instrument tray<br>with a stainless steel locking<br>lid and removable stainless<br>steel component tray. Silicone<br>instrument holders. | Stainless steel<br>instrument tray with a<br>stainless steel locking<br>lid and removable<br>stainless steel<br>component tray.<br>Silicone instrument<br>holders. | Same, the<br>subject device<br>only differs<br>with a few<br>additional<br>device<br>etchings. |
| Dimensions | Length x Width x Height, mm<br>$265$ x $160$ x $42$ | Length x Width x<br>Height, mm<br>$265$ x $160$ x $42$ | Same |
| Materials | Base Tray - Stainless steel<br>Lid - Stainless steel<br>Case tray - Stainless steel<br>Tooling Support – Silicone | Base Tray - Stainless<br>steel<br>Lid - Stainless steel<br>Case tray - Stainless<br>steel<br>Tooling Support – Silicone | Same |
| Feature | Instrument Case (Subject Device) | Instrument Case (Predicate Device, K223672) | Comparison Notes |
| | | Tooling Support – Silicone | |
| Sterility | Non-sterile | Non-sterile | Same |
| Sterilization Method | Dynamic air removal steam sterilization (prevacuum) to a Sterility Assurance Level (SAL) of ≤10-6 | Dynamic air removal steam sterilization (prevacuum) to a Sterility Assurance Level (SAL) of ≤10-6 | Same |
| Sterilization Parameters | 132°C for 4 minutes with a 20 minutes drying time | 132°C for 4 minutes with a 20 minutes drying time | Same |
| Reusable | Yes | Yes | Same |
| Useful Life | 25 Cycles | 25 Cycles | Same |
| Biocompatibility | Planning and testing have been carried out according to ISO 10993-1.<br>The Instrument Case is biocompatible due to the testing with pass results. | Planning and testing have been carried out according to ISO 10993-1.<br>The Instrument Case is biocompatible due to the testing with pass results. | Same |
| Perforated | Yes | Yes | Same |
| Sterile Barrier | FDA cleared sterilization pouch | FDA cleared sterilization pouch | Same |
| Maximum Load for Sterilization | 1700g | 1700g | Same |
| Compatible Reusable Instruments | Cochlear's bone-anchored reusable instrument portfolio and Elos Pinol's C9866 Multi wrench and C10110 Square adapter for Multi wrench | Cochlear's bone-anchored reusable instrument portfolio | Similar – Additional instrumentation validated for sterilization within Cochlear's instrument case |

# Table 1: Technological Characteristics Comparison

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

Image /page/6/Picture/0 description: The image is the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized, golden-yellow spiral shape above the company name. Below the name, the tagline "Hear now. And always" is written in a smaller, complementary font.

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

Image /page/7/Picture/0 description: The image is the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized, golden-yellow spiral shape resembling a cochlea, which is the part of the inner ear responsible for hearing. Below the spiral is the company name, "Cochlear," also in golden-yellow. Underneath the name is the tagline, "Hear now. And always.", which conveys the company's commitment to providing long-term hearing solutions.

## J. Performance Data

Bench testing was conducted to demonstrate substantial equivalence to the predicate device, the Instrument Case (K223672). The predicate device and the subject device are identical, except for additional etchings. Substantial equivalence to the predicate device was accomplished through non-clinical data related to sterilization validation. The results demonstrate the Instrument Case

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

Image /page/8/Picture/0 description: The image contains the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized, golden-yellow spiral shape resembling a cochlea, which is the auditory portion of the inner ear. Below the spiral is the company name, "Cochlear," also in golden-yellow, with the registered trademark symbol. Underneath the company name is the tagline, "Hear now. And always."

is substantially equivalent to the predicate device. The changes do not affect the safety and performance of the Instrument Case.

Table 2 identifies the performance data for the subject device, and all of the testing yielded PASS results. For the sterilization validation, two instruments were added for sterility testing of the subject device, and for the remaining performance data, the test results of the predicate device remained valid for the subject device. The performance data shows that the subject device is as safe and effective as the predicate device.

| Test | Test<br>Methodology | Test Description | Acceptance<br>Criteria | Results | Comparison |
|--------------------------------------------------------|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Automated<br>cleaning (with<br>enzymatic<br>detergent) | AAMI<br>TIR12:2010<br>AAMI<br>TIR30:2011 | 6 simulated use cycles 5 accumulation cycles 3 efficacy cycles Visual inspection for any residual<br>test soil, residual protein and<br>hemoglobin levels and cytotoxicity<br>testing for presence of<br>detergent residuals. | No visible soil should<br>remain on the test<br>articles.<br><br>Protein level should be<br><6.4 µg /<br>cm² for the test articles.<br><br>Hemoglobin<br>level should<br>be <2.2 µg /<br>cm² for the test articles.<br><br>No cytotoxic<br>potential. | PASS. All<br>units met the<br>acceptance<br>criteria.<br><br>Positive and<br>negative<br>controls<br>performed as<br>anticipated.<br><br>The<br>Instrument<br>case did not<br>have a<br>cytotoxic<br>potential. | Same. Test<br>results of<br>predicate<br>device<br>remain valid<br>for subject<br>device. |
| Automated<br>cleaning (with<br>alkaline<br>detergent) | AAMI<br>TIR12:2010<br>AAMI<br>TIR30:2011 | 6 simulated use cycles<br>(same<br>simulated use<br>as for the<br>enzymatic<br>detergent). 5 accumulation<br>cycles 3 efficacy<br>cycles Visual inspection<br>for any residual<br>test soil, residual | No visible<br>soil should<br>remain on<br>the test<br>articles.<br><br>Protein level<br>should be<br><6.4 µg /<br>cm² for the<br>test articles.<br><br>Hemoglobin<br>level should<br>be <2.2 µg /<br>cm² for the<br>test articles. | PASS. All<br>units met the<br>acceptance<br>criteria.<br><br>Positive and<br>negative<br>controls<br>performed as<br>anticipated.<br><br>The<br>Instrument<br>case did not<br>have a<br>cytotoxic<br>potential. | Same. Test<br>results of<br>predicate<br>device<br>remain valid<br>for subject<br>device. |

## Table 2: Summary of Performance Data

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

Image /page/9/Picture/0 description: The image shows the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized graphic of three overlapping, curved shapes in a golden-yellow color, resembling sound waves or the inner ear. Below the graphic, the company name "Cochlear" is written in a similar golden-yellow, sans-serif font. Underneath the name is the tagline "Hear now. And always" in a smaller, lighter font.

| Test | Test Methodology | Test Description | Acceptance Criteria | Results | Comparison |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Hear now. And always | | | | | |
| | | protein and hemoglobin levels and cytotoxicity testing for presence of detergent residuals. | cm² for the test articles.<br>No cytotoxic potential. | cytotoxic potential. | |
| Steam Sterilization<br>132°C for 4 min and 20 min dry time | AAMI TIR12:2010<br>ANSI/AAMI ST79:2017<br>ISO 17664:2017<br>ISO 17665-1:2006<br>ISO 11737-2:2009 | Devices were inoculated with at least 106 Geobacillus stearothermophilus spores, placed in the test item and sterilized in double 510(k) cleared wraps in a cold spot of the sterilizer.<br><br>For Sterility Assurance Level (SAL) the steam sterilization procedure was repeated for 3 half-cycles. After incubation of the devices and controls for 7 days, SAL was evaluated, and growth was compared with positive controls.<br><br>For dry time evaluation the steam sterilization was repeated for 3 full cycles and the test article, devices and sterilization wraps were | All positive controls for SAL testing must result in growth of the indicator organism and all negative controls must result in no growth.<br><br>There should be no bacterial growth on the devices.<br><br>There should be no visible moisture present on the test article, devices or sterilization wraps after the full cycle exposure. | PASS.<br>Positive and negative controls performed as anticipated.<br><br>All devices were sterile and a SAL of <=10-6 was achieved.<br><br>No moisture was observed on the test article, devices or sterilization wraps. | New testing performed.<br><br>The same protocol was re-run for sterilization validation of the subject device with two new instruments (Elos Pinol's C9866 Multi wrench and C10110 Square adapter for Multi wrench).<br><br>The results are the same as those for the predicate device. |
| Test | Test<br>Methodology | Test Description | Acceptance<br>Criteria | Results | Comparison |
| Lifecycle testing<br>Visual<br>inspection | Internal Test<br>Method | visually inspected<br>for moisture.<br>Validation of 25<br>cycles of<br>reprocessing<br>including manual<br>pre- cleaning,<br>automated<br>cleaning with<br>thermal<br>disinfection and<br>sterilization.<br>Visual inspections<br>after each cycle<br>and pictures taken<br>every 5 cycle or if<br>any damage is<br>observed. | No visual<br>corrosion,<br>damage, or<br>impurities on<br>the<br>Instrument<br>Case. | PASS. The<br>visual<br>inspection<br>did not detect<br>any damage.<br>Pictures that<br>were taken<br>after every 5<br>cycles<br>confirmed<br>this and<br>showed that<br>the laser<br>markings<br>were fully<br>readable<br>after up to 25<br>cycles of<br>reprocessing. | Same. Test<br>results of<br>predicate<br>device<br>remain valid<br>for subject<br>device. |
| Lifecycle testing<br>Biocompatibility | ISO 10993-<br>1:2018 | Chemical<br>characterization<br>using GC-MS and<br>ICP-MS | Any<br>residuals<br>hazards<br>detected<br>should be<br>below levels<br>of<br>toxicological<br>concern<br>(Margin of<br>safety;<br>MOS>1) | PASS. The<br>semi-volatile<br>and<br>inorganic<br>substances<br>that were<br>detected and<br>that were of<br>toxicological<br>concern had<br>a MOS>1 | Same. Test<br>results of<br>predicate<br>device<br>remain valid<br>for subject<br>device. |
| Biocompatibility | ISO 10993-5;<br>2009 | Cytotoxicity | Non-<br>Cytotoxic | PASS. The<br>instrument<br>case is not<br>cytotoxic | Same. Test<br>results of<br>predicate<br>device<br>remain valid<br>for subject<br>device. |

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image contains the logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized, golden-yellow symbol resembling three overlapping sound waves or cochlear spirals, positioned above the company name. Below the name "Cochlear" is the tagline "Hear now. And always" in a smaller, lighter font, emphasizing the company's commitment to providing long-term hearing support.

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image is a logo for Cochlear, a company that specializes in hearing solutions. The logo features a stylized, golden-yellow seashell-like symbol at the top. Below the symbol is the company name, "Cochlear," also in golden-yellow. Underneath the company name is the tagline, "Hear now. And always" in a smaller, lighter font.

# K. Conclusion

The conclusions drawn from the non-clinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the predicate device K223672.