STERILIZATION CASSETTE

K141616 · Oticon Medical AB · KCT · Sep 23, 2014 · General Hospital

Device Facts

• Record ID: K141616
• Device Name: STERILIZATION CASSETTE
• Applicant: Oticon Medical AB
• Product Code: KCT · General Hospital
• Decision Date: Sep 23, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended 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: Temperature 132°C (270°F) - Exposure time 4 Minutes - Drying time (wrapped) 20 Minutes; Temperature 134°C (273°F) - Exposure time 3 Minutes - Drying time (wrapped) 16 Minutes; Temperature 135°C (275°F) - Exposure time 3 Minutes - Drying time (wrapped) 16 Minutes.

Device Story

Stainless steel cassette with base tray, lid, and silicone instrument holders; designed to organize and protect non-disposable surgical instruments during handling, cleaning, and steam sterilization. Used in hearing health care surgery settings. Perforated design allows sterilant penetration; lid features locking tab to secure instruments. Requires use with legally marketed sterilization wrap to maintain sterility post-processing. Compatible with manual, ultrasonic, and automated washer-disinfector cleaning; validated for pre-vacuum steam sterilization cycles. Benefits include organized instrument management and protection during sterilization and storage.

Clinical Evidence

Bench testing only. Validation included automated, manual, and ultrasonic cleaning/disinfection; sterilization validation; and wear testing after repeated processing. Results demonstrated effective cleaning, steam penetration, and a sterility assurance level (SAL) of 10^-6.

Technological Characteristics

Stainless steel base tray and lid; silicone instrument holders and rail. Perforated design for steam penetration. Dimensions: 180 x 140 x 42 mm. Reusable. Compatible with pre-vacuum steam sterilization (132°C-135°C).

Indications for Use

Indicated for organizing and protecting non-disposable medical device instrumentation during handling and use in hearing health care surgery; intended for use with a legally marketed sterilization wrap to maintain sterility.

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

• Hu-Friedy IMS Cassette System (K844002)
• PolyVac Surgical Instrument Delivery System (K012105)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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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. 2<br>SE-436 33 Askim<br>Sweden |
| Phone:<br>Facsimile: | [phone]<br>[phone] |
| Contact Person:<br>Mobile phone: | Carolina Anker Wessling<br>[phone] |
| 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<br>(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<br>(510(k) number) | Sterilization Cassette<br>(K141616) | PolyVac Surgical<br>Instrument Delivery<br>System (K012105) | Hu-Friedy IMS Cassette<br>System (K844002) |
| Manufacturer | Oticon Medical AB | Symmetry Medical, Inc. | Hu-Friedy Mfg. Co., Inc. |
| Intended Use /<br>Indications for use | The Oticon Medical<br>Sterilization Cassette is<br>intended to organize and<br>protect non-disposable<br>medical device<br>instrumentation during<br>handling and use in hearing<br>health care surgery. It is<br>intended to be sterilized and<br>stored with non-disposable<br>medical device<br>instrumentation. The<br>Sterilization Cassette is<br>intended to be used in<br>conjunction with a legally<br>marketed sterilization wrap in<br>order to maintain sterility of<br>the enclosed instruments untiluse.<br>The sterilization cassette is<br>intended for washing, either<br>manually or in an automated<br>process in a washer<br>disinfector, and for<br>sterilization in a pre-vacuum<br>steam sterilizer (min. three<br>pulse, standard) utilizing<br>either of the following cycles:<br>Temperature 132°C (270°F) - | PolyVac's delivery systems<br>are intended to protect<br>medical device<br>instrumentation and to<br>facilitate the sterilization<br>process by allowing steam<br>penetration and air removal.<br>When used in conjunction<br>with an approved sterilization<br>wrap, sterility of the enclosed<br>medical device is maintained<br>until used.<br>PolyVac's delivery systems<br>are to be sterilized in one of<br>the following cycles:<br>Prevacuum Steam: 132°C - 4<br>minutes minimum. Dry for 20-<br>40 minutes as needed<br>Gravity Steam: 132°C - 30<br>minutes minimum.<br>Gravity Steam: 121°C - 55<br>minutes minimum.<br>Dry for 20-50 minutes as<br>needed. | The Instrument Management<br>System is designed to provide<br>a disciplined approach to<br>infectious disease control while<br>helping achieve greater<br>efficiency and cost-<br>effectiveness in the care and<br>maintenance of dental<br>instruments.<br>The IMS Cassettes are the<br>core of the system. The<br>cassettes can be sterilized by<br>steam, chemical vapor,<br>ethylene oxide, or dry heat.<br>As extracted from IMS<br>Operator's Manual. |
| | Exposure time 4 minutes –<br>Dry for 20 minutes.<br><br>Temperature 134°C (273°F) –<br>Exposure time 3 minutes –<br>Dry for 16 minutes.<br><br>Temperature 135°C (275°F) –<br>Exposure time 3 minutes –<br>Dry for 16 minutes | | |
| | | | |
| Device description | • Base, tray and lid<br>• Evenly distributed<br>perforated hole pattern.<br>• Silicone holders/rail | • Base, modular insert<br>trays and lids<br>• Evenly distributed<br>perforated hole pattern.<br>• Silicone mats | • Base, modular insert<br>trays and lids.<br>• Evenly distributed<br>perforated hole pattern.<br>• Silicone rails |
| Dimensions (I x w x<br>h) | Cassette outer dimensions<br>180 x 140 x 42 mm<br>(approx 7.1 x 5.5 x 1.7<br>inches) | Base tray 17.3 x 7.25 x 4<br>inches | Available in over 100<br>different sizes,<br>configurations and color<br>options. |
| Materials | Stainless steel, silicone | Stainless steel, Aluminium,<br>Radel R plastic, silicone | Stainless steel, silicone |
| Sterilant penetration | Evenly distributed hole<br>pattern | Evenly distributed hole<br>pattern | Evenly distributed hole<br>pattern |
| Microbial barrier<br>properties | For the sterilization<br>process, the cassette is to<br>be used in conjunction<br>with a legally marketed<br>sterilization wrap. | To be used in conjunction<br>with an approved<br>sterilization wrap. | To be used together with<br>IMS Autoclave Wrap. |
| Pre-Vac Steam<br>Sterilization<br>parameters,<br>including drying time | Pre-vacuum steam<br>sterilizer (min. three pulse,<br>standard) utilizing either of<br>the following cycles:<br><br>Temperature 132°C (270°F) –<br>Exposure time 4 minutes –<br>Dry for 20 minutes.<br><br>Temperature 134°C (273°F) –<br>Exposure time 3 minutes –<br>Dry for 16 minutes.<br><br>Temperature 135°C (275°F) –<br>Exposure time 3 minutes –<br>Dry for 16 minutes | Prevacuum Steam: 132°C<br>– 4 minutes minimum. Dry<br>for 20-40 minutes as<br>needed | Follow sterilizer<br>manufacturer's directions<br>for "wrapped instruments"<br>to determine length of<br>cycle, temperature and<br>drying instructions. |
| Material compatibility<br>with sterilization<br>process | Yes | Yes | Yes |
| Reusable | Yes | Yes | Yes |

#### Comparison Table for Substantial Equivalence

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