(192 days)
No
The device is a sterilization tray and the description focuses on its material, design for steam sterilization, and validation of sterilization parameters and cycles. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a sterilization tray intended to hold implants and surgical instruments during the sterilization process, not to provide therapeutic benefits itself.
No
The device is a sterilization tray intended to contain and sterilize medical instruments, not to diagnose medical conditions or diseases.
No
The device is a physical sterilization tray made of aluminum, intended to hold implants and instruments for sterilization. It is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for containing implants and surgical instruments for sterilization, storage, and handling. It is used in conjunction with other sterilization methods and materials. This is a function related to the preparation and handling of medical devices, not for performing diagnostic tests on biological samples.
- Device Description: The description focuses on the physical characteristics of the tray (material, components, perforations) and its purpose in the sterilization process. There is no mention of it being used to analyze or test biological specimens.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Reagents or assays
- Analysis of biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health or condition
- Measuring specific analytes or markers
The device is a medical device used in the process of sterilizing other medical devices (implants and instruments).
N/A
Intended Use / Indications for Use
The OsteoMed MMF Sterilization Tray is intended to contain MMF implants and surgical instruments for sterilization, storage and handling. The OsteoMed MMF Sterilization Tray is suitable for dynamic air removal (pre-vacuum) steam sterilization methods. The tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed devices. The sterilization tray may also be used in conjunction with a legally marketed rigid container.
Sterilization validation was performed on MMF implants and as surgical instrumentation. Do not exceed a maximum load of 2.3 lbs. in the sterilization tray.
Validated sterilization parameters for OsteoMed MMF Sterilization Tray: Method: Steam Cycle Pre-Vacuum Temperature: 270°F (132°C) Exposure Time: 4 minutes Minimum Dry Time: 30 minutes
Product codes
KCT
Device Description
The OsteoMed MMF Sterilization Tray is composed from a material commonly used (anodized and non-anodized Aluminum) to enclose, protect, and organize OsteoMed's dental non-sterile devices, which meet national or international standards. The OsteoMed MMF Sterilization Tray is intended to provide storage for appropriate dental (MMF) devices and accessories during sterilization, storage, and transportation within the hospital environment.
The tray is composed of a base, a lid, and locking latch that secure the device and accessories. The tray is perforated to allow for steam sterilization. An FDAcleared wrap or FDA-cleared rigid sterilization container must be used for sterilization and to maintain the sterility of the contents. The OsteoMed MMF Sterilization Tray is designed to be used with standard autoclaves used in hospitals and healthcare facilities. As such, the OsteoMed MMF Sterilization Tray is effective for containing devices during sterilization and have been designed to withstand repeated steam sterilization cycles.
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
hospital environment, hospitals and healthcare facilities
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)
Bench Testing:
- Design Validation: Surgeons evaluated the functionality of the tray. Results: Pass; met all requirements.
- Ship Testing: Ship packaged plate per ASTM D-4169 and evaluate package contents for damage upon return. Results: Pass.
- Cleaning Validation (reusable instruments): Use the ratchet handle as worst-case device to verify that re-useable instruments can be cleaned per instructions to achieve standard requirements for reusable devices per AAMI TIR 30. Results: Pass.
- Sterilization Validation: Validate sterilization parameters with 3 consecutive tests. Conduct test for both system wrapped in polypropylene sterile wrap and system enclosed in rigid container. Results: Passed for both sterile wrap and rigid container configurations.
- Sterilization Cycles Validation: The device was steam sterilized for 100 cycles with the sterilization parameters described in the IFU. The subject device was then evaluated to determine if it met pre-determined acceptance criteria. Results: Passed functional and visual criteria after 100 cycles.
A tolerance study was conducted for the lid and latch of the sterilization tray.
Animal Study: No animal studies were performed to demonstrate safety and efficacy.
Clinical Studies: No clinical studies were performed to demonstrate safety and efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
NuVasive® Sterilization Trays (K143579)
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 10, 2018
OsteoMed, LLC Kathryn Jayne Manager, Regulatory Affairs 3885 Arapaho Rd. Addison, TX 75001
Re: K173391
Trade/Device Name: OsteoMed MMF Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Tray Regulatory Class: Class II Product Code: KCT Dated: April 09, 2018 Received: April 10, 2018
Dear Kathryn Jayne:
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.
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
1
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.htmfor 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,
Geeta K. Pamidimukkala -S
for Tina Kiang, Ph.D. Acting 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
510(k) Number (if known) K173391
Device Name OsteoMed MMF Sterilization Tray
Indications for Use (Describe)
The OsteoMed MMF Sterilization Tray is intended to contain MMF implants and surgical instruments for sterilization, storage and handling. The OsteoMed MMF Sterilization Tray is suitable for dynamic air removal (pre-vacuum) steam sterilization methods. The tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed devices. The sterilization tray may also be used in conjunction with a legally marketed rigid container.
Sterilization validation was performed on MMF implants and as surgical instrumentation. Do not exceed a maximum load of 2.3 lbs. in the sterilization tray.
Validated sterilization parameters for OsteoMed MMF Sterilization Tray: Method: Steam Cycle Pre-Vacuum Temperature: 270°F (132°C) Exposure Time: 4 minutes Minimum Dry Time: 30 minutes
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OsteoMed" in a stylized font. The logo is surrounded by an oval shape, with the top half of the oval in blue and the bottom half in gray. The logo is clean and professional, and it is likely used to represent a medical company.
510(k) SUMMARY-K173391
SUBMITTER I.
OsteoMed 3885 Arapaho Rd. Addison, TX 75001
| Phone: | 972-677-4766 |
|---|---|
| Fax: | 800-390-2620 |
| Email: | kjayne@osteomed.com |
Contact: Phone: Fax: Email:
Kathryn Jayne 972-677-4766 800-390-2620 kjayne@osteomed.com
Alternate Contact: Alicia Hemphill Phone: 972-677-4783 Email: ahemphill@osteomed.com
Date Prepared:
May 08, 2018
II. DEVICE
| Name of the Device: | OsteoMed MMF Sterilization Tray |
|---|---|
| Common or Usual Name: | Sterilization Tray |
| Classification Name: | Sterilization Wrap Containers, Trays, Cassettes & |
| Other Accessories | |
| Regulation: | 21 CFR 880.6850 |
| Regulatory Class: | II |
| Product Code: | KCT |
III. PREDICATE DEVICE
Primary Predicate: NuVasive® Sterilization Trays (K143579)
IV. DEVICE DESCRIPTION
The OsteoMed MMF Sterilization Tray is composed from a material commonly used (anodized and non-anodized Aluminum) to enclose, protect, and organize
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Image /page/4/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OsteoMed" in large, bold letters. The logo has a swoosh design that goes around the word "OsteoMed". The swoosh is blue on top and gray on the bottom.
OsteoMed's dental non-sterile devices, which meet national or international standards. The OsteoMed MMF Sterilization Tray is intended to provide storage for appropriate dental (MMF) devices and accessories during sterilization, storage, and transportation within the hospital environment.
The tray is composed of a base, a lid, and locking latch that secure the device and accessories. The tray is perforated to allow for steam sterilization. An FDAcleared wrap or FDA-cleared rigid sterilization container must be used for sterilization and to maintain the sterility of the contents. The OsteoMed MMF Sterilization Tray is designed to be used with standard autoclaves used in hospitals and healthcare facilities. As such, the OsteoMed MMF Sterilization Tray is effective for containing devices during sterilization and have been designed to withstand repeated steam sterilization cycles.
V. INDICATIONS FOR USE
The OsteoMed MMF Sterilization Tray is intended to contain MMF implants and surgical instruments for sterilization, storage and handling. The OsteoMed MMF Sterilization Tray is suitable for dynamic air removal (pre-vacuum) steam sterilization methods. The tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed devices. The sterilization tray may also be used in conjunction with a legally marketed rigid container.
Do not exceed a maximum load of 2.3 lbs. in the sterilization tray.
Validated sterilization parameters for OsteoMed MMF Sterilization Tray:
Method: Steam Cycle Pre-Vacuum Temperature: 270°F (132°C) Exposure Time: 4 minutes Minimum Dry Time: 30 minutes
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
At a high level, the subject and predicate devices are substantially equivalent based on the following same technological elements as demonstrated below.
| Characteristics | OsteoMed MMF Sterilization
Tray
Subject Device | NuVasive Sterilization Trays
Predicate Device (K143579) | Comparison |
|-----------------|------------------------------------------------------|------------------------------------------------------------|------------|
| Product Code | KCT | KCT | Same |
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Image /page/5/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OSTEOMED" in large, bold, blue letters. The logo is surrounded by a gray and blue swoosh design. The logo is clean and professional, and it is likely used on the company's website and marketing materials.
| 21 CFR | 880.6850 | 880.6850 | Same |
|---|---|---|---|
| System | |||
| Components | Base, lid, locking latch | Base, lid, insert trays, brackets, | |
| caddies | Similar | ||
| Material | |||
| Composition | Aluminum | Aluminum, Nylon, Silicone, | |
| Stainless Steel, Polypropylene, | |||
| Polyphenylsulfone | Similar | ||
| Physical | |||
| Properties | Evenly distributed perforated | ||
| hole | Evenly distributed perforated | ||
| hole | Same | ||
| Configurations/ | |||
| Dimensions | |||
| (L | |||
| x W x H) in. | Rectangle base with lid | ||
| (9.5 x 5.0 x 1.5) | Rectangle base with lid, inserts, | ||
| brackets and caddies; Multiple | |||
| dimensions to accommodate | |||
| different product configurations | |||
| (9.8 x 6.3 x 3.6) | Similar | ||
| Sterilant | |||
| Penetration | Sterilant (steam) penetration | ||
| through perforations in tray | Sterilant (steam) penetration | ||
| through perforations in tray | Same | ||
| Sterilization | |||
| method | Steam | Steam | Same |
| Sterilization cycle | Pre-vacuum | Pre-vacuum | Same |
| Exposure | |||
| temperature | 270°F (132°C) | 270°F(132°C) | Same |
| Exposure time | 4 minutes | 4 minutes | Same |
| Dry time | 30 minutes | 30 minutes | Same |
| Vent to Volume | |||
| Ratio | 0.050 in²/in³ | unknown | unknown |
| Reusable | Yes | Yes | Same |
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Image /page/6/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OsteoMed" in large, bold letters. The word "Osteo" is in blue, and the word "Med" is in gray. The logo is surrounded by a blue and gray oval shape. The blue part of the oval is on top, and the gray part is on the bottom.
| Characteristics | OsteoMed QuickFix Hybrid
MMF Sterilization Tray | NuVasive Sterilization Trays | Comparison |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | The OsteoMed MMF Sterilization
Tray is intended to contain MMF
implants and surgical instruments
for sterilization, storage and
handling. The OsteoMed MMF
Sterilization Tray is suitable for
dynamic air removal (pre-vacuum)
steam sterilization methods. The
tray is not intended to maintain | The NuVasive Sterilization Trays
are intended to contain NuVasive
implants and surgical instruments
for sterilization, storage and
handling. The NuVasive
Sterilization Trays are suitable for
dynamic air removal (pre-vacuum)
steam sterilization methods. The
trays are not intended to maintain | |
| | sterility; it is intended to be used in
conjunction with a validated,
FDA-cleared sterilization wrap in
order to maintain sterility of the
enclosed devices. The sterilization
tray may also be used in | sterility; they are intended to be
used in conjunction with a
validated, FDA-cleared sterilization
wrap in order to maintain sterility
of the enclosed devices. | |
| | conjunction with a legally
marketed rigid container. | Sterilization validations for three
level worst case tray (20.5" x 10" x
7.375") included three different
loading configurations: implant
only content (26.4 lbs.), instrument | |
| Indications of Use | Sterilization validation was
performed on MMF implants and
accessories such as surgical
instrumentation. Do not exceed a | only content (39.95 lbs.) and mixed
instruments and implants content
(30.45 lbs.) | Similar |
| | maximum load of 2.3 lbs. in the
sterilization tray. | Validated worst case loading
configurations included 23
instruments with lumens including
the following worst case lumen | |
| | Validated sterilization parameters
for OsteoMed MMF Sterilization
Tray: | dimensions: - 1.6 mm x 306.8 mm -
1.1 mm x 166.4 mm - 7.2 mm x
331.9 mm - 5.5 mm x 356.9 mm | |
| | Method: Steam Cycle
Pre-Vacuum Temperature: 270°F
(132°C)
Exposure Time: 4 minutes | Do not exceed a maximum load of
25 lbs in the sterilization tray.
Validated sterilization parameters
for NuVasive Sterilization Trays: | |
| | Minimum Dry Time: 30 minutes | Method: Steam Cycle: Pre-Vacuum
Temperature: 270°F (132°C)
Exposure Time: 4 minutes
Minimum Dry Time: 30 minutes
Minimum Cool Down Time: 40
minutes | |
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Image /page/7/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OSTEOMED" in large, bold letters. The logo has a blue swoosh above the text and a gray swoosh below the text. The logo is simple and modern.
PERFORMANCE DATA VII.
Bench Testing
The following table provides a summary of the bench testing conducted.
| Test
Description | Test Method Description | Summary of Test
Results |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Design
Validation | Surgeons evaluated the
functionality of the tray. | Pass; met all
requirements |
| Ship Testing | Ship packaged plate per ASTM
D-4169 and evaluate package
contents for damage upon return | Pass |
| Cleaning
Validation
(reusable
instruments) | Use the ratchet handle as worst-
case device to verify that re-
useable instruments can be cleaned
per instructions to achieve
standard requirements for reusable
devices per AAMI TIR 30. | Pass |
| Sterilization
Validation | Validate sterilization parameters
with 3 consecutive tests. Conduct
test for both system wrapped in
polypropylene sterile wrap and
system enclosed in rigid container. | Passed for both sterile
wrap and rigid container
configurations |
| Sterilization
Cycles
Validation | The device was steam sterilized
for 100 cycles with the
sterilization parameters described
in the IFU The subject device was
then evaluated to determine if it
met pre-determined acceptance
criteria. | Passed functional and
visual criteria after 100
cycles |
Bench testing was conducted on production equivalent devices. The devices passed the pre-acceptance criteria.
A tolerance study was conducted for the lid and latch of the sterilization tray.
Animal Study
No animal studies were performed to demonstrate safety and efficacy.
Clinical Studies
No clinical studies were performed to demonstrate safety and efficacy.
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Image /page/8/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OsteoMed" in bold, sans-serif font. The word "Osteo" is in blue, and the word "Med" is in gray. The logo is surrounded by a blue and gray swoosh design.
VIII. CONCLUSIONS
Based on the intended use, technological characteristics, performance data, and nonclinical tests performed, subject Instrument trays, are substantially equivalent to, and are as safe and as effective as, the legally marketed predicate device, NuVasive® Sterilization Trays cleared under K143579 under regulation 21 CFR 880.6850, product code KCT.