(477 days)
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 |
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.
The provided text does not describe an AI/ML powered device, but rather a medical device for sterilization—an "Instrument Cassette." Therefore, many of the requested fields (such as MRMC study, effect size of human improvement with AI, training set size, etc.) are not applicable and cannot be found in the document.
However, I can extract information related to the acceptance criteria and the study that proves the device meets them based on the provided text.
Acceptance Criteria and Device Performance for Instrument Cassette (EFCCL1-F)
1. A table of acceptance criteria and the reported device performance
| Performance Test / Acceptance Criteria | Reported Device Performance |
|---|---|
| Half cycle sterilization validation at 132°C (per ISO 17665-1, ISO 17665-2) | No growth at half cycle. |
| Dry Time Validation (per ANSI/AAMI ST79 & A1, A2, A3, A4) | The minimum weight difference was -0.05% (Pass). |
| Cleaning Validation (per AAMI TIR 30) | Results are not explicitly stated in the summary table but implied to be compliant with "All of tests demonstrated compliance to both safety and effectiveness requirements that apply to the device." |
| Limits of Reuse (per FDA Guideline: "Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" & AAMI TIR12, AAMI TIR30) | Results are not explicitly stated in the summary table but implied to be compliant with "All of tests demonstrated compliance to both safety and effectiveness requirements that apply to the device." |
| Overall Safety and Effectiveness | Demonstrated compliance to both safety and effectiveness requirements, including sterilization performance, maintenance of sterility, and reusability. |
| Substantial Equivalence | Substantially equivalent to the predicate device, Miltex Thompson Cassettes (K101653), based on intended use, indications for use, technological characteristics, and performance data. |
| Validated Sterilization Parameters | Gravity Steam: 132°C (270°F) temperature, 15 minutes exposure time, 30 minutes dry time. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for the performance tests (e.g., number of cassettes tested, number of cycles performed). Data provenance is also not detailed regarding country of origin or whether studies were retrospective or prospective, beyond stating "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."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physical instrument cassette requiring performance testing against standards, not expert interpretation of outputs to establish ground truth like in an AI/ML context.
4. Adjudication method for the test set
Not applicable. There is no mention of adjudication for establishing ground truth, as the performance tests are objective measurements against established standards.
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
Not applicable. This is not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI-powered device.
7. The type of ground truth used
The "ground truth" or acceptance criteria for this device are based on established industry standards and FDA guidelines for sterilization, cleaning validation, and reusability of medical devices. Specifically, the following standards were used:
- ISO 17665-1(2006)
- ISO 17665-2(2009)
- ANSI/AAMI ST79(2010) & A1(2010) & A2(2011) & A3(2012) & A4(2013)
- AAMI TIR 30 (2011)
- FDA Guideline: "Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (2011)"
- AAMI TIR12(2010)
8. The sample size for the training set
Not applicable. This is not an AI-powered device subject to machine learning training.
9. How the ground truth for the training set was established
Not applicable. This is not an AI-powered device subject to machine learning training.
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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 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.
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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 (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
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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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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 Hospital21 CFR 880.6850Class IIKCT |
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,Mid length instruments &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 intendedto hold instruments and accessories duringstorage and steam sterilization. This casecassette is intended to be used with asterilized wrap in order to maintain sterility.This case cassette is intended to be used withan FDA cleared sterilization wrap in order tomaintain sterility. | Miltex Thompson Cassettes are generaldented/surgical instrument cassettes indicatedto hold instruments and accessories in placeduring storage and the sterilization cycle.Suitable for Gravity Steam and Pre-VacuumSteam, the cassettes are intended to be used inconjunction with sterilization wrap in order tomaintain 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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| Sterilizationmethod | Gravity steam:ExposureTime:15 minutesTemperature: 132 °CDrying: 30 minutes. | Gravity steam:ExposureTime:30 minutesTemperature: 121°CDrying: 20 minutes.Pre-Vacuum steam:ExposureTime:4 minutesTemperature: 132 °CDrying: 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 sterilizationvalidation 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/ReprocessingMedical Devices in HealthCare Settings: ValidationMethods 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
§ 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).