(84 days)
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.
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.
Based on the provided text, the device in question is an "Instrument Case" (K231604) and the performance data presented is for its cleaning, sterilization, and lifecycle durability, not for a complex AI/ML diagnostic or image analysis system. Therefore, many of the typical acceptance criteria and study components for AI-driven medical devices (like MRMC studies, ground truth based on expert consensus/pathology, training set details, etc.) are not applicable here.
This document describes a "Special 510(k)" submission for an updated Instrument Case, where the key is demonstrating substantial equivalence to a predicate device (K223672) through non-clinical data. The updates are minor (additional etchings and validation for a few more instruments).
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a clear table (Table 2) outlining the tests, acceptance criteria, and results for the Instrument Case.
| Test | Acceptance Criteria Performance | Reported Device Performance |
|---|---|---|
| Automated Cleaning (enzymatic detergent) | No visible soil remaining. Protein level < 6.4 µg/cm². Hemoglobin level < 2.2 µg/cm². No cytotoxic potential. | PASS. All units met the acceptance criteria. Positive and negative controls performed as anticipated. The Instrument case did not have a cytotoxic potential. |
| Automated Cleaning (alkaline detergent) | No visible soil remaining. Protein level < 6.4 µg/cm². Hemoglobin level < 2.2 µg/cm². No cytotoxic potential. | PASS. All units met the acceptance criteria. Positive and negative controls performed as anticipated. The Instrument case did not have a cytotoxic potential. |
| Steam Sterilization (132°C for 4 min, 20 min dry time) | All positive controls for SAL testing must result in growth, and all negative controls must result in no growth. No bacterial growth on the devices (SAL ≤10⁻⁶ achieved). No visible moisture present on the test article, devices, or sterilization wraps after the full cycle exposure. | PASS. Positive and negative controls performed as anticipated. All devices were sterile, and a SAL of ≤10⁻⁶ was achieved. No moisture was observed on the test article, devices, or sterilization wraps. |
| Lifecycle Testing (Visual Inspection) | No visual corrosion, damage, or impurities on the Instrument Case. | PASS. The visual inspection did not detect any damage. Pictures taken after every 5 cycles confirmed this and showed that the laser markings were fully readable after up to 25 cycles of reprocessing. |
| Lifecycle Testing (Biocompatibility) | Any residual hazards detected should be below levels of toxicological concern (Margin of Safety; MOS > 1). | PASS. The semi-volatile and inorganic substances that were detected and that were of toxicological concern had a MOS > 1. |
| Biocompatibility (Cytotoxicity) | Non-Cytotoxic. | PASS. The instrument case is not cytotoxic. |
Study Details (as applicable to this type of device)
Since this is for a physical medical device (Instrument Case) and not an AI/ML diagnostic, the following points address what's relevant from the provided text and note where typical AI/ML study details are not applicable:
-
Sample sizes used for the test set and the data provenance:
- Sample Size: The document does not specify exact numbers of Instrument Cases tested for each specific test, but implies multiple units ("All units" met criteria for cleaning, "devices were inoculated" for sterilization, "Validation of 25 cycles of reprocessing" for lifecycle testing). Given the nature of a component, this is likely a small sample (e.g., 3-5 devices) for each test type, subjected to repetitive cycles (e.g., 25 cycles for lifecycle).
- Data Provenance: Not explicitly stated, but these are laboratory bench tests conducted to regulatory standards (AAMI, ISO). The manufacturer is Cochlear Bone Anchored Solutions AB in Sweden, but the testing would be conducted in certified testing labs, not tied to a specific clinical population or country in the way clinical data for AI/ML devices would be. These are non-clinical, controlled bench tests. The tests themselves are prospective as they are specifically conducted for this submission.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a physical device like an instrument case, "ground truth" is established by direct measurement and observation against objective criteria (e.g., visual inspection for soil, chemical analysis for protein/hemoglobin, bacterial growth assessment, physical damage assessment). No human expert interpretation (like a radiologist reading an image) is involved beyond the technician performing the tests and recording the results.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As described above, the acceptance criteria are objective and quantitative (e.g., µg/cm², SAL target, visual absence of damage). There is no multi-reader or adjudication process for interpreting "ground truth" for these physical performance tests.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is a physical medical device (sterilization case), not an AI/ML diagnostic or image analysis tool that would assist human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device. There is no algorithm. The "standalone" performance here refers to the device's ability to meet its performance specifications (cleaning, sterilization, durability) without human intervention beyond setting up and running the test parameters.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the Instrument Case's performance is based on objective, quantitative measurements and direct visual inspection following standardized protocols and accepted industry standards (AAMI, ISO). Examples include:
- Chemical assays for residual protein and hemoglobin.
- Microbiological testing for Sterility Assurance Level (SAL).
- Physical inspection for moisture, corrosion, and damage.
- Toxicological assessment based on chemical characterization.
- The "ground truth" for the Instrument Case's performance is based on objective, quantitative measurements and direct visual inspection following standardized protocols and accepted industry standards (AAMI, ISO). Examples include:
-
The sample size for the training set:
- Not Applicable. There is no "training set" in the context of a physical device like this. Training sets are specific to AI/ML model development.
-
How the ground truth for the training set was established:
- Not Applicable. There is no training set.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
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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)
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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 InformationSubmitted by: | Cochlear Americas10350 Park Meadows DriveLone Tree, CO 80124 |
|---|---|
| On behalf of the manufacturer: | Cochlear Bone Anchored Solutions ABKonstruktionsvägen 14,SE-435 33 MölnlyckeSweden(Establishment Number 9616024) |
| Contact: | Whitney AlexanderRegulatory Affairs Specialist IICochlear AmericasC: 719-337-8620E: walexander@cochlear.com |
| B. Date Prepared | 21-August-2023 |
| C. Device Name and Classification | Instrument Case |
| Device Names:Classification Name: | Sterilization Wrap Containers, Trays, Cassettes & OtherAccessories21 CFR 880.6850, Class II |
| Classification Panel: | Orthopedic |
| Product Code: | KCT |
| D. Predicate DeviceDevice Names: | Instrument Case |
| Classification Name: | Sterilization Wrap Containers, Trays, Cassettes & OtherAccessories21 CFR 880.6850, Class II |
| Classification Panel: | Orthopedic |
| Product Code: | KCT |
510(k): K223672
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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.
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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.The product shall only be used: | The Instrument Case is intended for staff involved in reprocessing of reusable instruments, and for surgical teams.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 (SubjectDevice) | Instrument Case(Predicate Device,K223672) | ComparisonNotes |
| • in a controlled surgicalenvironment under sterileconditions such as a hospital,• in reprocessing environmentat sterilization departments orreprocessing centers,• and for transport of surgicalinstruments.Sterilization parameters:In US: Pre-Vacuum Steam at$132$ °C ( $270$ °F) for 4 minwith a 20 minutes dry timeOutside US: See theReprocessing Guide availablein your countryThe worst-case validated loadfor the Instrument Case,including instruments, is 1700g. | • in a controlledsurgical environmentunder sterile conditionssuch as a hospital,• in reprocessingenvironment atsterilizationdepartments orreprocessing centers,• and for transport ofsurgical instruments.Sterilizationparameters:Pre-Vacuum Steam at$132$ °C ( $270$ °F) for 4min with a 20 minutesdry timeThe worst-casevalidated load for theInstrument Case,including instruments,is 1700 g. | the subjectdevice. | |
| General Design | Stainless steel instrument traywith a stainless steel lockinglid and removable stainlesssteel component tray. Siliconeinstrument holders. | Stainless steelinstrument tray with astainless steel lockinglid and removablestainless steelcomponent tray.Silicone instrumentholders. | Same, thesubject deviceonly differswith a fewadditionaldeviceetchings. |
| Dimensions | Length x Width x Height, mm$265$ x $160$ x $42$ | Length x Width xHeight, mm$265$ x $160$ x $42$ | Same |
| Materials | Base Tray - Stainless steelLid - Stainless steelCase tray - Stainless steelTooling Support – Silicone | Base Tray - StainlesssteelLid - Stainless steelCase tray - StainlesssteelTooling 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.The Instrument Case is biocompatible due to the testing with pass results. | Planning and testing have been carried out according to ISO 10993-1.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
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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.
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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 | TestMethodology | Test Description | AcceptanceCriteria | Results | Comparison |
|---|---|---|---|---|---|
| Automatedcleaning (withenzymaticdetergent) | AAMITIR12:2010AAMITIR30:2011 | 6 simulated use cycles 5 accumulation cycles 3 efficacy cycles Visual inspection for any residualtest soil, residual protein andhemoglobin levels and cytotoxicitytesting for presence ofdetergent residuals. | No visible soil shouldremain on the testarticles.Protein level should be<6.4 µg /cm² for the test articles.Hemoglobinlevel shouldbe <2.2 µg /cm² for the test articles.No cytotoxicpotential. | PASS. Allunits met theacceptancecriteria.Positive andnegativecontrolsperformed asanticipated.TheInstrumentcase did nothave acytotoxicpotential. | Same. Testresults ofpredicatedeviceremain validfor subjectdevice. |
| Automatedcleaning (withalkalinedetergent) | AAMITIR12:2010AAMITIR30:2011 | 6 simulated use cycles(samesimulated useas for theenzymaticdetergent). 5 accumulationcycles 3 efficacycycles Visual inspectionfor any residualtest soil, residual | No visiblesoil shouldremain onthe testarticles.Protein levelshould be<6.4 µg /cm² for thetest articles.Hemoglobinlevel shouldbe <2.2 µg /cm² for thetest articles. | PASS. Allunits met theacceptancecriteria.Positive andnegativecontrolsperformed asanticipated.TheInstrumentcase did nothave acytotoxicpotential. | Same. Testresults ofpredicatedeviceremain validfor subjectdevice. |
Table 2: Summary of Performance Data
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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.No cytotoxic potential. | cytotoxic potential. | |||
| Steam Sterilization132°C for 4 min and 20 min dry time | AAMI TIR12:2010ANSI/AAMI ST79:2017ISO 17664:2017ISO 17665-1:2006ISO 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.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.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.There should be no bacterial growth on the devices.There should be no visible moisture present on the test article, devices or sterilization wraps after the full cycle exposure. | PASS.Positive and negative controls performed as anticipated.All devices were sterile and a SAL of <=10-6 was achieved.No moisture was observed on the test article, devices or sterilization wraps. | New testing performed.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).The results are the same as those for the predicate device. |
| Test | TestMethodology | Test Description | AcceptanceCriteria | Results | Comparison |
| Lifecycle testingVisualinspection | Internal TestMethod | visually inspectedfor moisture.Validation of 25cycles ofreprocessingincluding manualpre- cleaning,automatedcleaning withthermaldisinfection andsterilization.Visual inspectionsafter each cycleand pictures takenevery 5 cycle or ifany damage isobserved. | No visualcorrosion,damage, orimpurities ontheInstrumentCase. | PASS. Thevisualinspectiondid not detectany damage.Pictures thatwere takenafter every 5cyclesconfirmedthis andshowed thatthe lasermarkingswere fullyreadableafter up to 25cycles ofreprocessing. | Same. Testresults ofpredicatedeviceremain validfor subjectdevice. |
| Lifecycle testingBiocompatibility | ISO 10993-1:2018 | Chemicalcharacterizationusing GC-MS andICP-MS | Anyresidualshazardsdetectedshould bebelow levelsoftoxicologicalconcern(Margin ofsafety;MOS>1) | PASS. Thesemi-volatileandinorganicsubstancesthat weredetected andthat were oftoxicologicalconcern hada MOS>1 | Same. Testresults ofpredicatedeviceremain validfor subjectdevice. |
| Biocompatibility | ISO 10993-5;2009 | Cytotoxicity | Non-Cytotoxic | PASS. Theinstrumentcase is notcytotoxic | Same. Testresults ofpredicatedeviceremain validfor subjectdevice. |
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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.
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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.
§ 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).