(99 days)
Not Found
No
The device is a physical sterilization cassette and the description focuses on its materials, design, and sterilization process, with no mention of AI or ML.
No.
The device is a sterilization cassette intended to organize, protect, and facilitate the sterilization of medical instruments, not to provide therapeutic treatment.
No
Explanation: The device is a sterilization cassette intended to organize, protect, and facilitate sterilization of non-disposable medical instrument. It is not described as diagnosing any condition or disease.
No
The device description clearly states it is a physical stainless steel cassette with a base tray, lid, and insert, designed for organizing and sterilizing surgical instruments. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for organizing and protecting non-disposable medical device instrumentation during handling and use in hearing health care surgery, and for sterilization and storage of these instruments. It is a tool for preparing and maintaining the sterility of surgical instruments.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is intended for use in vitro for the examination of specimens, including blood, tissues, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Lack of Diagnostic Function: The Oticon Medical Sterilization Cassette does not examine any specimens from the human body, nor does it provide any diagnostic information. Its function is purely related to the handling and sterilization of surgical instruments.
Therefore, the device falls under the category of a surgical instrument accessory or sterilization device, not an IVD.
N/A
Intended Use / 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 |
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hearing health care surgery
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 10-6 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/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.
1
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
2
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
3
510(k) SUMMARY
Sterilization Cassette
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
| Submitter name: | Oticon Medical AB |
|---|---|
| Address: | Ekonomiv. 2 |
| SE-436 33 Askim | |
| Sweden | |
| 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. |
4
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.
5
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 Surgical | ||
| Instrument Delivery | |||
| System (K012105) | Hu-Friedy IMS Cassette | ||
| System (K844002) | |||
| Manufacturer | Oticon Medical AB | Symmetry Medical, Inc. | Hu-Friedy Mfg. Co., Inc. |
| Intended Use / | |||
| 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 untiluse. | |||
| 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) - | PolyVac's delivery systems | ||
| are intended to protect | |||
| medical device | |||
| instrumentation and to | |||
| facilitate the sterilization | |||
| process by allowing steam | |||
| penetration and air removal. | |||
| When used in conjunction | |||
| with an approved sterilization | |||
| wrap, sterility of the enclosed | |||
| medical device is maintained | |||
| until used. | |||
| PolyVac's delivery systems | |||
| are to be sterilized in one of | |||
| the following cycles: | |||
| Prevacuum Steam: 132°C - 4 | |||
| minutes minimum. Dry for 20- | |||
| 40 minutes as needed | |||
| Gravity Steam: 132°C - 30 | |||
| minutes minimum. | |||
| Gravity Steam: 121°C - 55 | |||
| minutes minimum. | |||
| Dry for 20-50 minutes as | |||
| needed. | The Instrument Management | ||
| System is designed to provide | |||
| a disciplined approach to | |||
| infectious disease control while | |||
| helping achieve greater | |||
| efficiency and cost- | |||
| effectiveness in the care and | |||
| maintenance of dental | |||
| instruments. | |||
| The IMS Cassettes are the | |||
| core of the system. The | |||
| cassettes can be sterilized by | |||
| steam, chemical vapor, | |||
| ethylene oxide, or dry heat. | |||
| As extracted from IMS | |||
| Operator'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 distributed
perforated hole pattern.
• Silicone holders/rail | • Base, modular insert
trays and lids
• Evenly distributed
perforated hole pattern.
• Silicone mats | • Base, modular insert
trays and lids.
• Evenly distributed
perforated hole pattern.
• Silicone rails |
| Dimensions (I x w x
h) | Cassette outer dimensions
180 x 140 x 42 mm
(approx 7.1 x 5.5 x 1.7
inches) | Base tray 17.3 x 7.25 x 4
inches | Available in over 100
different sizes,
configurations and color
options. |
| Materials | Stainless steel, silicone | Stainless steel, Aluminium,
Radel R plastic, silicone | Stainless steel, silicone |
| Sterilant penetration | Evenly distributed hole
pattern | Evenly distributed hole
pattern | Evenly distributed hole
pattern |
| Microbial barrier
properties | For the sterilization
process, the cassette is to
be used in conjunction
with a legally marketed
sterilization wrap. | To be used in conjunction
with an approved
sterilization wrap. | To be used together with
IMS Autoclave Wrap. |
| Pre-Vac Steam
Sterilization
parameters,
including drying time | Pre-vacuum steam
sterilizer (min. three pulse,
standard) utilizing either of
the 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. Dry
for 20-40 minutes as
needed | Follow sterilizer
manufacturer's directions
for "wrapped instruments"
to determine length of
cycle, temperature and
drying instructions. |
| Material compatibility
with sterilization
process | Yes | Yes | Yes |
| Reusable | Yes | Yes | Yes |
Comparison Table for Substantial Equivalence
6