(477 days)
KCT
No
The device is a passive instrument cassette for sterilization and storage, with no mention of computational or analytical capabilities.
No
The OSUNG INSTRUMENT CASSETTE is designed to hold instruments for storage and steam sterilization. Its purpose is to facilitate the sterilization process of other medical devices, not to directly treat or diagnose a disease or condition.
No
The OSUNG INSTRUMENT CASSETTE is designed to hold and sterilize dental instruments, not to diagnose diseases or conditions. Its purpose is to facilitate the sterilization and storage of medical tools, which falls under the category of reprocessor devices, not diagnostic devices.
No
The device description explicitly states it is comprised of physical components (base, lid, silicone mat/rail, holders, and spring lock system) and is intended for holding physical instruments during sterilization and storage. 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 is clearly stated as holding instruments and accessories during storage and steam sterilization. This is a function related to the preparation and maintenance of medical devices, not the examination of specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease.
- Device Description: The description details a physical container designed to hold instruments for sterilization. There is no mention of reagents, calibrators, controls, or any components typically associated with in vitro diagnostic testing.
- Performance Studies: The performance studies focus on sterilization validation, dry time validation, cleaning validation, and limits of reuse. These are all relevant to the reprocessing of medical devices, not the performance of diagnostic tests.
- Lack of IVD Indicators: There are no mentions of specimen types, analytical methods, diagnostic parameters, or any other characteristics that would indicate an IVD device.
In summary, the OSUNG INSTRUMENT CASSETTE is a medical device used for the sterilization and storage of other medical instruments. It does not perform any diagnostic function on biological specimens.
N/A
Intended Use / Indications for Use
OSUNG INSTRUMENT CASSETTE (EFCCL1-F) is intended to hold instruments and accessories during storage and steam sterilization. This case cassette is intended to be used with a sterilized wrap in order to maintain sterility.
This case cassette is intended to be used with an FDA cleared sterilization wrap in order to maintain sterility.
Validated sterilization parameters:
| Cycle Type | Temperature | Exposure Time | Dry Time |
|---|---|---|---|
| Gravity Steam | 132℃ (270°F) | 15 minutes | 30 minutes |
Product codes
KCT
Device Description
The OSUNG INSTRUMENT CASSETTE is designed to handle reusable dental instruments for sterilization and storage. This device is intended to hold instruments and accessories during storage and steam sterilization, and to be used with a sterilized wrap in order to maintain sterility.
The OSUNG INSTRUMENT CASSETTE is comprised of a base, lid, silicone mat/rail, holders, and spring lock system.
The internal insert cassette has the ability to hold individualized pieces and accessories which include scissors, needle, elevators, forceps, pincers, retractors, mallets etc.
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
Not Found
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)
Validation test for steam sterilization of ultrasonic cleaning and limit of reuse test for the OSUNG INSTRUMENT CASSETTE(EFCCL1-F) has been carried out as the results were shown by test reports.
All of tests demonstrated compliance to both safety and effectiveness requirements that apply to the device, in terms of sterilization performance, maintenance of sterility and reusability.
Hence, the OSUNG INSTRUMENT CASSETTE(EFCCL1-F) demonstrated appropriate performance that is substantially equivalent to the predicate device and that the design output meets the design input requirements.
| Performance Test | Standard(s) used | Results |
|---|---|---|
| Half cycle sterilization validation at 132°C | ISO 17665-1(2006) ISO 17665-2(2009) | No growth at half cycle. |
| Dry Time Validation | ANSI/AAMI ST79(2010) & A1(2010) & A2(2011) & A3(2012) & A4(2013) | The minimum weight difference was -0.05% (Pass) |
| Cleaning Validation | AAMI TIR 30 (2011) | Not explicitly stated |
| Limits of Reuse | FDA Guideline: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (2011) AAMI TIR12(2010) AAMI TIR30(2011) | Not explicitly stated |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 29, 2015
OSUNG MND CO., LTD c/o Mr. Kiran Sheikh Brite Sources USA 180 S. Western Avenue, #205 Carpentersville, IL 60110
Re: K141854
Trade/Device Name: Instrument Cassette (EFCCL1-F) Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: September 11, 2015 Received: September 15, 2015
Dear Mr. Sheikh:
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. Iisting 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
Page 2 - Mr. Sheikh
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 Industry and Consumer Education at its toll-free 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 Industry and Consumer Education 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
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Instrument Cassette (EFCCL1-F)
Indications for Use (Describe)
OSUNG INSTRUMENT CASSETTE (EFCCL1-F) is intended to hold instruments and accessories during storage and steam sterilization. This case cassette is intended to be used with a sterilized wrap in order to maintain sterility.
This case cassette is intended to be used with an FDA cleared sterilization wrap in order to maintain sterility.
Validated sterilization parameters:
| Cycle Type | Temperature | Exposure Time | Dry Time |
|---|---|---|---|
| Gravity Steam | 132℃ (270°F) | 15 minutes | 30 minutes |
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
This summary of 510(K) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: 29 October, 2015
1. Applicant/submitter:
Manufacturer Name: OSUNG MND Co.,Ltd. 57, Hwangguem-ro, 109beon-gil, Yangchon-eup, Gimpo-si, Gyeonggi-do, Republic of Korea Tel: +82-31-987-5395 Fax: +82-31-987-5397 E-mail:qa@osung.co.kr Establishment registration number: 9616119 Contact name: Taerim Lee
2. Submission Correspondent
Correspondent Name: Kiran Sheikh
Official correspondent: Brite Sources USA 180 S. Western Avenue, #205 Carpentersville, IL 60118 Tel: 312-895-1773 Fax: 847-589-1298 E-mail:support(@britesourcs.com
3. Device Name and Classification
| Trade/Proprietary Name: | Instrument Cassette (EFCCL1-F) |
|---|---|
| Common Name: | Instrument Cassette |
| Classification Information: | General Hospital |
| 21 CFR 880.6850 | |
| Class II | |
| KCT |
4. Predicated Device
Miltex Thompson Cassettes(K101653) Miltex Inc.
5. Device Description
The OSUNG INSTRUMENT CASSETTE is designed to handle reusable dental instruments for sterilization and storage. This device is intended to hold instruments and accessories during storage and steam sterilization, and to be used with a sterilized wrap in order to maintain sterility.
The OSUNG INSTRUMENT CASSETTE is comprised of a base, lid, silicone mat/rail, holders, and spring lock system.
The internal insert cassette has the ability to hold individualized pieces and accessories which include scissors, needle, elevators, forceps, pincers, retractors, mallets etc.
4
Description and Dimensions
| Model No | Description | Max no of instruments | Dimensions (mm) [ L X W X H ] | Max Weight (with instruments) | Total Surface area (mm²) | Perforation (%) | Silicone Surface area (mm²) |
|---|---|---|---|---|---|---|---|
| EFCCL1-F | Perforated lid & bottom, | ||||||
| Mid length instruments & | |||||||
| tools(forceps, elevators) | 10 | 205 X 305 X 31 | 1,302.0 | 150,118 | 29.0 | 71,622 |
5
6. Intended Uses
OSUNG INSTRUMENT CASSETTE is intended to hold instruments and accessories during storage and steam sterilization. This case cassette is intended to be used with a sterilized wrap in order to maintain sterility.
This case cassette is intended to be used with an FDA cleared sterilization wrap in order to maintain sterility.
Validated sterilization parameters:
| Cycle Type | Temperature | Exposure Time | Dry Time |
|---|---|---|---|
| Gravity Steam | 132°C (270°F) | 15 minutes | 30 minutes |
7. Substantial Equivalence
The Table below shows that the substantial equivalence through side-by-side comparisons between the OSUNG Instrument Cassette and predicate device of Miltex Thompson Cassettes (K101653). The comparison analysis consists of the products' intended use, technological characteristics and performance testing to support the substantial equivalency to its corresponding predicate devices.
| Subject device | INSTRUMENT CASSETTE(EFCCL1-F) | Miltex Thompson Cassettes |
|---|---|---|
| 510(k) Number | new | K101653 |
| Manufacturer | OSUNG MND Co.,Ltd. | Miltex Inc. |
| Indication for use | OSUNG INSTRUMENT CASSETTE is intended | |
| to hold instruments and accessories during | ||
| storage and steam sterilization. This case | ||
| cassette is intended to be used with a | ||
| sterilized wrap in order to maintain sterility. |
This case cassette is intended to be used with
an FDA cleared sterilization wrap in order to
maintain sterility. | Miltex Thompson Cassettes are general
dented/surgical instrument cassettes indicated
to hold instruments and accessories in place
during storage and the sterilization cycle.
Suitable for Gravity Steam and Pre-Vacuum
Steam, the cassettes are intended to be used in
conjunction with sterilization wrap in order to
maintain sterility. |
| Shape | Image: INSTRUMENT CASSETTE | Image: Miltex Thompson Cassettes |
6
| Dimensions(LXWXH) | Model No | Dimensions(mm) | Model No | Dimensions(mm, inch) | Maximum number of instruments | Model No | Max no. of Instrument | Model No | Max no. of Instrument |
|---|---|---|---|---|---|---|---|---|---|
| EFCCL1-F | 205 X 305 X 31 | 3-083005 | 204X81X30 | EFCCL1-F | 10 | 3-083005 | 5 | ||
| 3-083105 | 204X81X30 | 3-083105 | 5 | ||||||
| 3-083210 | 204X81X30 | 3-083210 | 5 | ||||||
| 3-084007 | 204X124X28.5 | 3-084007 | 7 | ||||||
| 3-084107 | 204X124X28.5 | 3-084107 | 7 | ||||||
| 3-084214 | 204X124X28.5 | 3-084214 | 7 | ||||||
| 3-085009 | 204X154X30 | 3-085009 | 9 | ||||||
| 3-085109 | 204X154X30 | 3-085109 | 9 | ||||||
| 3-085218 | 204X154X30 | 3-085218 | 9 | ||||||
| 3-089110 | 204X229X28.5 | 3-089110 | 10 | ||||||
| 3-118114 | 204X276.5X30 | 3-118114 | 14 | ||||||
| 3-118116 | 204X276.5X30 | 3-118116 | 16 | ||||||
| 3-118122 | 204X276.5X30 | 3-118122 | 22 | ||||||
| 3-139126 | 232X330X30 | 3-139126 | 26 | ||||||
| 3-072007 | 178X67X17 | 3-072007 | 7 | ||||||
| 3-082008 | 203X127X17 | 3-082008 | 7 | ||||||
| STDSL27 | 178X67X25 | STDSL27 | 7 | ||||||
| 3-072014 | 178X115X17 | 3-072014 | 14 | ||||||
| STD222 | 204X276.5X30 | STD222 | 22 | ||||||
| STD209 | - | STD209 | |||||||
| STDSTAT | 178X270X38 | STDSTAT | 14 | ||||||
| STDSTAT8 | 171X206X29 | STDSTAT8 | 8 | ||||||
| STDSTAT814 | 171X206X29 | STDSTAT814 | 14 | ||||||
| STDORTHO | 127X178X51 | STDORTHO | - | ||||||
| STDBOS | 178X76X35 | STDBOS | - | ||||||
| STDBOM | 254X140X102 | STDBOM | - | ||||||
| 3-080205 | 204X71X37 | 3-080205 | - | ||||||
| 4-6835 | 6-1/2 x 6-1/4 x 1-3/16(inch) | 4-6835 | |||||||
| 4-083000 | 8 x 3-13/16 x 1-3/16(inch) | 4-083000 | |||||||
| 4-084000 | 8 x 4-7/8 x 1-3/16(inch) | 4-084000 | |||||||
| 4-085000 | 8 x6 x 1-3/16(inch) | 4-085000 | |||||||
| 4-089100 | 8 x9 x 1-3/16(inch) | 4-089100 | |||||||
| 4-008122 | 8 x11 x 1-3/16(inch) | 4-008122 | |||||||
| 4-008115 | 8 x11x 2(inch) | 4-008115 | |||||||
| 4-009126 | 9-1/8 x13 x 1-3/16(inch) | 4-009126 | |||||||
| 4-6815 | 15 x8-1/4x 1-3/16(inch) | 4-6815 | |||||||
| STDBH | - | STDBH | - | ||||||
| STDBH6 | - | STDBH6 | - | ||||||
| STDBHS | - | STDBHS | - | ||||||
| STDBB2 | - | STDBB2 | - | ||||||
| STDPB | 42X33X26 | STDPB | - | ||||||
| STDES48 | - | STDES48 | - | ||||||
| STDES60 | - | STDES60 | - | ||||||
| STDES72 | - | STDES72 | - | ||||||
| Maximum weight | Model No | Weight of each cassette with instruments(g) | Not stated in summary | ||||||
| EFCCL1-F | 1,302.0 |
7
8
| Sterilization
method | Gravity steam:
ExposureTime:15 minutes
Temperature: 132 °C
Drying: 30 minutes. | Gravity steam:
ExposureTime:30 minutes
Temperature: 121°C
Drying: 20 minutes.
Pre-Vacuum steam:
ExposureTime:4 minutes
Temperature: 132 °C
Drying: 20 minutes. |
|-------------------------|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reusable | Yes | Yes |
8. Performance data
Validation test for steam sterilization of ultrasonic cleaning and limit of reuse test for the OSUNG INSTRUMENT CASSETTE(EFCCL1-F) has been carried out as the results were shown by test reports.
All of tests demonstrated compliance to both safety and effectiveness requirements that apply to the device, in terms of sterilization performance, maintenance of sterility and reusability.
Hence, the OSUNG INSTRUMENT CASSETTE(EFCCL1-F) demonstrated appropriate performance that is substantially equivalent to the predicate device and that the design output meets the design input requirements.
| Performance Test | Standard(s) used | Results |
|---|---|---|
| Half cycle sterilization | ||
| validation at 132°C | ISO 17665-1(2006) | |
| ISO 17665-2(2009) | No growth at half cycle. | |
| Dry Time Validation | ANSI/AAMI ST79(2010) & | |
| A1(2010) & A2(2011) & | ||
| A3(2012) & A4(2013) | The minimum weight difference was | |
| -0.05% (Pass) | ||
| Cleaning Validation | AAMI TIR 30 (2011) | |
| Limits of Reuse | FDA Guideline: | |
| Processing/Reprocessing | ||
| Medical Devices in Health | ||
| Care Settings: Validation | ||
| Methods and Labeling | ||
| (2011) | ||
| AAMI TIR12(2010) | ||
| AAMI TIR30(2011) |
9. Conclusions
Based on the intended use, indications for use, technological characteristics, and performance data, the Instrument Cassette is substantially equivalent to the Miltex Thompson Cassettes (K101653).
Following consideration of all information presented to support substantial equivalence of the Instrument Cassette to the predicate device, similarities in intended use, design, principles of operation, and performance specifications were identified. The performance data following validation tests carried out for the Instrument Cassette showed that it is substantially equivalent to the known performance of the predicate device, Miltex Thompson Cassettes