INSTRUMENT CASSETTE (EFCCL1-F)

K141854 · Osung Mnd Co., Ltd. · KCT · Oct 29, 2015 · General Hospital

Device Facts

• Record ID: K141854
• Device Name: INSTRUMENT CASSETTE (EFCCL1-F)
• Applicant: Osung Mnd Co., Ltd.
• Product Code: KCT · General Hospital
• Decision Date: Oct 29, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended 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.

Device Story

Instrument cassette designed to hold reusable dental/surgical instruments (e.g., scissors, forceps, elevators) during steam sterilization and storage. Comprised of base, lid, silicone mat/rail, holders, and spring lock system. Used in clinical settings; operated by healthcare staff. Device is placed inside FDA-cleared sterilization wrap; subjected to gravity steam sterilization (132°C for 15 minutes). Protects instruments during processing; maintains sterility post-sterilization. Benefits include organized instrument handling and effective sterilization maintenance.

Clinical Evidence

Bench testing only. No clinical data. Validation included half-cycle steam sterilization (ISO 17665-1/2), dry time validation (ANSI/AAMI ST79), cleaning validation (AAMI TIR 30), and limits of reuse testing (FDA 2011 guidance, AAMI TIR12/30). Results demonstrated no growth at half-cycle and successful dry time performance.

Technological Characteristics

Perforated lid and bottom cassette; materials include silicone mat/rail. Dimensions: 205 x 305 x 31 mm. Sterilization method: Gravity steam (132°C, 15 min exposure, 30 min dry time). Reusable. Standards: ISO 17665-1/2, ANSI/AAMI ST79, AAMI TIR12, AAMI TIR30.

Indications for Use

Indicated for holding dental/surgical instruments and accessories during storage and steam sterilization cycles. Intended for use with FDA-cleared sterilization wraps to maintain sterility. No specific patient population or contraindications listed.

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

• Miltex Thompson Cassettes (K101653)

Submission Summary (Full Text)

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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.

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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 [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 Industry and Consumer Education 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

Enclosure

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# Indications for Use

510(k) Number (if known)

K141854

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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# 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: [phone] Fax: [phone] E-mail:[e-mail] 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: [phone] Fax: [phone] 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<br>21 CFR 880.6850<br>Class II<br>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.

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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,<br>Mid length instruments &<br>tools(forceps, elevators) | 10 | 205 X 305 X 31 | 1,302.0 | 150,118 | 29.0 | 71,622 |

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# 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<br>to hold instruments and accessories during<br>storage and steam sterilization. This case<br>cassette is intended to be used with a<br>sterilized wrap in order to maintain sterility.<br><br>This case cassette is intended to be used with<br>an FDA cleared sterilization wrap in order to<br>maintain sterility. | Miltex Thompson Cassettes are general<br>dented/surgical instrument cassettes indicated<br>to hold instruments and accessories in place<br>during storage and the sterilization cycle.<br>Suitable for Gravity Steam and Pre-Vacuum<br>Steam, the cassettes are intended to be used in<br>conjunction with sterilization wrap in order to<br>maintain sterility. |
| Shape | Image: INSTRUMENT CASSETTE | Image: Miltex Thompson Cassettes |

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| 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 | | | | | | | |

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| Sterilization<br>method | Gravity steam:<br>ExposureTime:15 minutes<br>Temperature: 132 °C<br>Drying: 30 minutes. | Gravity steam:<br>ExposureTime:30 minutes<br>Temperature: 121°C<br>Drying: 20 minutes.<br>Pre-Vacuum steam:<br>ExposureTime:4 minutes<br>Temperature: 132 °C<br>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<br>validation at 132°C | ISO 17665-1(2006)<br>ISO 17665-2(2009) | No growth at half cycle. |
| Dry Time Validation | ANSI/AAMI ST79(2010) &<br>A1(2010) & A2(2011) &<br>A3(2012) & A4(2013) | The minimum weight difference was<br>-0.05% (Pass) |
| Cleaning Validation | AAMI TIR 30 (2011) | |
| Limits of Reuse | FDA Guideline:<br>Processing/Reprocessing<br>Medical Devices in Health<br>Care Settings: Validation<br>Methods and Labeling<br>(2011)<br>AAMI TIR12(2010)<br>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