(99 days)
The Oticon Medical Sterilization Cassette is intended to organize and protect non-disposable medical device instrumentation during handling and use in hearing health care surgery. It is intended to be sterilized and stored with non-disposable medical device instrumentation. The Sterilization Cassette is intended to be used in conjunction with a legally marketed sterilization wrap in order to maintain sterility of the enclosed instruments until use.
The sterilization cassette is intended for washing, either manually or in an automated process in a washer disinfector, and for sterilization in a pre-vacuum steam sterilizer (min. three pulse, standard) utilizing either of the following cycles:
| Cycle alt 1 | Cycle alt 2 | Cycle alt 3 | |
|---|---|---|---|
| Temperature | 132°C (270°F) | 134°C (273°F) | 135°C (275°F) |
| Exposure time | 4 Minutes | 3 Minutes | 3 Minutes |
| Drying time (wrapped) | 20 Minutes | 16 Minutes | 16 Minutes |
The Oticon Medical Sterilization Cassette is a stainless steel cassette consisting of a base tray, a lid and an insert with instrument holders made of silicone. The lid is locked to the base tray by a locking tab. Once the lid is closed and locked, enclosed instruments are kept in place by the holders and a silicone rail in the lid.
The Sterilization Cassette is designed using materials that can be reused with steam sterilization methods. The base tray, lid and insert have evenly distributed perforations to allow for penetration of sterilant during steam sterilization. For the sterilization process, the cassette is to be used in conjunction with a legally marketed sterilization wrap.
This document is a 510(k) summary for the Oticon Medical Sterilization Cassette, demonstrating its substantial equivalence to predicate devices. It focuses on the device's intended use and performance in cleaning and sterilization.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance and Outcomes |
|---|---|---|
| Cleaning and Disinfection | Verification of automated cleaning and disinfection. Verification of manual and ultrasonic cleaning. | Demonstrated efficiency of the cleaning and disinfection procedures. |
| Sterilization Validation | Validation for pre-vacuum steam sterilizer (min. three pulse, standard) utilizing specified cycles: - 132°C (270°F) for 4 minutes exposure, 20 minutes drying - 134°C (273°F) for 3 minutes exposure, 16 minutes drying - 135°C (275°F) for 3 minutes exposure, 16 minutes drying. | Showed that under the selected processing parameters, excellent steam penetration was achieved within the wrapped cassettes. Sterilization testing further demonstrated a sterility assurance level (SAL) of 10⁻⁶ of the cassette and its contents when handled according to the recommended instructions. |
| Wear Following Re-use and Processing | Testing for wear following re-use and repeated processing (no specific quantitative criteria mentioned, but implied satisfactory performance). | The Sterilization Cassette functioned as intended, and the performance observed was as expected. The document concludes that "further testing will not raise new issues of safety or efficacy," implying acceptable wear characteristics over repeated use. |
| Material Compatibility | Material compatibility with sterilization process (based on comparison table). | "Yes" (stated in the comparison table, indicating compatibility). |
| Microbial Barrier Properties | To be used in conjunction with a legally marketed sterilization wrap to maintain sterility (based on comparison table). | Confirmed that for the sterilization process, the cassette is to be used in conjunction with a legally marketed sterilization wrap. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (e.g., number of cassettes, number of cleaning cycles, number of sterilization cycles) used for the performance testing. It generally refers to "Testing... includes" and "The testing demonstrated."
The data provenance is from Oticon Medical AB, Sweden, as indicated by the submitter's address and manufacturer information. The testing is prospective, conducted specifically for the purpose of demonstrating the device's performance for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The performance data section describes the outcomes of the tests (efficiency, steam penetration, SAL of 10⁻⁶), but does not detail the methodology for establishing ground truth or the involvement of experts in that process. For a sterilization cassette, the "ground truth" would typically be established by validated test methods (e.g., biological indicators for sterility assurance) rather than expert consensus on subjective observations.
4. Adjudication method for the test set
This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or subjective assessments by multiple readers. For performance testing of a sterilization cassette, the results are derived from objective physical and microbiological measurements/assays, not from human interpretation that requires adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation devices, not for a sterilization cassette. The document does not describe any AI component in this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device (sterilization cassette), not an algorithm or software. Therefore, the concept of "standalone algorithm performance" does not apply. The device's performance is inherently tied to its physical design and the validated processes it enables.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance tests would be based on objective scientific measurements and validated industry standards. For example:
- Cleaning and Disinfection: Ground truth would be the reduction of specific microbial loads or removal of simulated soil to predefined levels, typically measured quantitatively in a lab setting according to standards (e.g., ASTM, ISO).
- Sterilization Validation: Ground truth is achieved when test results (e.g., from biological indicators or physical monitoring) demonstrate a sterility assurance level (SAL) of 10⁻⁶, meaning a one-in-a-million chance of a non-sterile unit, as per relevant sterilization standards (e.g., ANSI/AAMI ST79).
- Wear Testing: Ground truth would be the maintenance of physical integrity and functionality after a specified number of reprocessing cycles, conforming to design specifications or acceptable wear limits.
The document states "sterilization testing further demonstrated a sterility assurance level (SAL) of 10⁻⁶," which is a key ground truth metric for sterilization.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As mentioned above, there is no AI/ML algorithm or training set for this device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 23, 2014
Oticon Medical AB Ms. Carolina Wessling Quality Assurance and Regulatory Affairs Manager Ekonomivägen 2 SE-436 33. Askim. SWEDEN
Re: K141616
Trade/Device Name: Sterilization Cassette Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Cassette Regulatory Class: II Product Code: KCT Dated: August 14, 2014 Received: August 19, 2014
Dear Ms. Wessling:
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. 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.
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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use Statement
510(k) Number (if known): K141616
Device Name: Sterilization Cassette
Indications for Use:
The Oticon Medical Sterilization Cassette is intended to organize and protect non-disposable medical device instrumentation during handling and use in hearing health care surgery. It is intended to be sterilized and stored with non-disposable medical device instrumentation. The Sterilization Cassette is intended to be used in conjunction with a legally marketed sterilization wrap in order to maintain sterility of the enclosed instruments until use.
The sterilization cassette is intended for washing, either manually or in an automated process in a washer disinfector, and for sterilization in a pre-vacuum steam sterilizer (min. three pulse, standard) utilizing either of the following cycles:
| Cycle alt 1 | Cycle alt 2 | Cycle alt 3 | |
|---|---|---|---|
| Temperature | 132°C (270°F) | 134°C (273°F) | 135°C (275°F) |
| Exposure time | 4 Minutes | 3 Minutes | 3 Minutes |
| Drying time (wrapped) | 20 Minutes | 16 Minutes | 16 Minutes |
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X__________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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510(k) SUMMARY
Sterilization Cassette
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
| Submitter name: | Oticon Medical AB |
|---|---|
| Address: | Ekonomiv. 2SE-436 33 AskimSweden |
| Phone:Facsimile: | +46 31 748 6100+46 31 687 756 |
| Contact Person:Mobile phone: | Carolina Anker Wessling+46 761 68 63 32 |
| Date Prepared: | September 12, 2014 |
Name of Device and Name/Address of Manufacturer
Sterilization Cassette
Oticon Medical AB Ekonomiv. 2 SE-436 33 Askim Sweden
Common or Usual Name: Sterilization Cassette
| Classification Name: | Sterilization wrap, containers, trays, cassettes and other accessories |
|---|---|
| ---------------------- | ------------------------------------------------------------------------ |
Classification: Class II
Classification Regulation: 21 CFR 880.6850 (Product code KCT)
Predicate Devices:
| Device | 510(k) no. | Manufacturer |
|---|---|---|
| Hu-Friedy IMS Cassette System | K844002 | Hu-Friedy Mfg. Co., Inc. |
| PolyVac Surgical Instrument Delivery System | K012105 | Symmetry Medical, Inc. |
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Intended Use / Indications for Use
The Oticon Medical Sterilization Cassette is intended to organize and protect nondisposable medical device instrumentation during handling and use in hearing health care surgery. It is intended to be sterilized and stored with non-disposable medical device instrumentation. The Sterilization Cassette is intended to be used in conjunction with a legally marketed sterilization wrap in order to maintain sterility of the enclosed instruments until use.
The sterilization cassette is intended for washing, either manually or in an automated process in a washer disinfector, and for sterilization in a pre-vacuum steam sterilizer (min. three pulse, standard) utilizing either of the following cycles:
| Cycle alt 1 | Cycle alt 2 | Cycle alt 3 | |
|---|---|---|---|
| Temperature | 132°C (270°F) | 134°C (273°F) | 135°C (275°F) |
| Exposure time | 4 Minutes | 3 Minutes | 3 Minutes |
| Drying time(wrapped) | 20 Minutes | 16 Minutes | 16 Minutes |
Device Description / Technological Characteristics
The Oticon Medical Sterilization Cassette is a stainless steel cassette consisting of a base tray, a lid and an insert with instrument holders made of silicone. The lid is locked to the base tray by a locking tab. Once the lid is closed and locked, enclosed instruments are kept in place by the holders and a silicone rail in the lid.
The Sterilization Cassette is designed using materials that can be reused with steam sterilization methods. The base tray, lid and insert have evenly distributed perforations to allow for penetration of sterilant during steam sterilization. For the sterilization process, the cassette is to be used in conjunction with a legally marketed sterilization wrap.
Performance Data
Testing of the Oticon Medical Sterilization Cassette includes (1) verification of automated cleaning and disinfection, (2) verification of manual and ultrasonic cleaning, (3) sterilization validation, and (4) testing for wear following re-use and repeated processing.
The testing demonstrated efficiency of the cleaning and disinfection procedures, and the sterilization tests showed that under the selected processing parameters excellent steam penetration was achieved within the wrapped cassettes. Sterilization testing further demonstrated a sterility assurance level (SAL) of 10° of the cassette and its contents when handled according to the recommended instructions.
In all instances, the Sterilization Cassette functioned as intended and the performance observed was as expected. Hence we have come to the conclusion that further testing will not raise new issues of safety or efficacy.
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Substantial Equivalence
The Oticon Medical Sterilization Cassette was compared to the predicate devices Hu-Friedy IMS Cassette System (K844002) and PolyVac Surgical Instrument Delivery System (K012105) by review of intended use and technological characteristics, e.g. product design, device characteristics and materials.
The Oticon Medical Sterilization Cassette is comparable in design to the predicate device sterilization cassettes and has the same intended use/indications, as well as principles of operations. The minor technological differences between the Oticon Medical Sterilization Cassette and the predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Oticon Medical Sterilization Cassette is as safe and effective as the predicate device. Thus, the Oticon Medical Sterilization Cassette is substantially equivalent.
| Proposed device | Predicate device | Predicate device | |
|---|---|---|---|
| Product name(510(k) number) | Sterilization Cassette(K141616) | PolyVac SurgicalInstrument DeliverySystem (K012105) | Hu-Friedy IMS CassetteSystem (K844002) |
| Manufacturer | Oticon Medical AB | Symmetry Medical, Inc. | Hu-Friedy Mfg. Co., Inc. |
| Intended Use /Indications for use | The Oticon MedicalSterilization Cassette isintended to organize andprotect non-disposablemedical deviceinstrumentation duringhandling and use in hearinghealth care surgery. It isintended to be sterilized andstored with non-disposablemedical deviceinstrumentation. TheSterilization Cassette isintended to be used inconjunction with a legallymarketed sterilization wrap inorder to maintain sterility ofthe enclosed instruments untiluse.The sterilization cassette isintended for washing, eithermanually or in an automatedprocess in a washerdisinfector, and forsterilization in a pre-vacuumsteam sterilizer (min. threepulse, standard) utilizingeither of the following cycles:Temperature 132°C (270°F) - | PolyVac's delivery systemsare intended to protectmedical deviceinstrumentation and tofacilitate the sterilizationprocess by allowing steampenetration and air removal.When used in conjunctionwith an approved sterilizationwrap, sterility of the enclosedmedical device is maintaineduntil used.PolyVac's delivery systemsare to be sterilized in one ofthe following cycles:Prevacuum Steam: 132°C - 4minutes minimum. Dry for 20-40 minutes as neededGravity Steam: 132°C - 30minutes minimum.Gravity Steam: 121°C - 55minutes minimum.Dry for 20-50 minutes asneeded. | The Instrument ManagementSystem is designed to providea disciplined approach toinfectious disease control whilehelping achieve greaterefficiency and cost-effectiveness in the care andmaintenance of dentalinstruments.The IMS Cassettes are thecore of the system. Thecassettes can be sterilized bysteam, chemical vapor,ethylene oxide, or dry heat.As extracted from IMSOperator's Manual. |
| Exposure time 4 minutes –Dry for 20 minutes.Temperature 134°C (273°F) –Exposure time 3 minutes –Dry for 16 minutes.Temperature 135°C (275°F) –Exposure time 3 minutes –Dry for 16 minutes | |||
| Device description | • Base, tray and lid• Evenly distributedperforated hole pattern.• Silicone holders/rail | • Base, modular inserttrays and lids• Evenly distributedperforated hole pattern.• Silicone mats | • Base, modular inserttrays and lids.• Evenly distributedperforated hole pattern.• Silicone rails |
| Dimensions (I x w xh) | Cassette outer dimensions180 x 140 x 42 mm(approx 7.1 x 5.5 x 1.7inches) | Base tray 17.3 x 7.25 x 4inches | Available in over 100different sizes,configurations and coloroptions. |
| Materials | Stainless steel, silicone | Stainless steel, Aluminium,Radel R plastic, silicone | Stainless steel, silicone |
| Sterilant penetration | Evenly distributed holepattern | Evenly distributed holepattern | Evenly distributed holepattern |
| Microbial barrierproperties | For the sterilizationprocess, the cassette is tobe used in conjunctionwith a legally marketedsterilization wrap. | To be used in conjunctionwith an approvedsterilization wrap. | To be used together withIMS Autoclave Wrap. |
| Pre-Vac SteamSterilizationparameters,including drying time | Pre-vacuum steamsterilizer (min. three pulse,standard) utilizing either ofthe following cycles:Temperature 132°C (270°F) –Exposure time 4 minutes –Dry for 20 minutes.Temperature 134°C (273°F) –Exposure time 3 minutes –Dry for 16 minutes.Temperature 135°C (275°F) –Exposure time 3 minutes –Dry for 16 minutes | Prevacuum Steam: 132°C– 4 minutes minimum. Dryfor 20-40 minutes asneeded | Follow sterilizermanufacturer's directionsfor "wrapped instruments"to determine length ofcycle, temperature anddrying instructions. |
| Material compatibilitywith sterilizationprocess | Yes | Yes | Yes |
| Reusable | Yes | Yes | Yes |
Comparison Table for Substantial Equivalence
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§ 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).