(249 days)
Not Found
No
The device description and intended use are solely focused on a physical tray for organizing and sterilizing surgical instruments. There is no mention of any software, data processing, or AI/ML capabilities.
No
The device is described as an "Instrumentation Tray" used for the "protection, organization and delivery to the surgical field of the POGO Screw Instrumentation Set" and to "facilitate the pre-vacuum autoclave sterilization process". It does not directly diagnose, prevent, monitor, treat, or alleviate disease or injury.
No
The device is described as an "Instrumentation Tray" used for the "protection, organization and delivery to the surgical field of the POGO Screw Instrumentation Set" and to "facilitate the pre-vacuum autoclave sterilization process". Its function is to hold and protect surgical instruments and aid in their sterilization, not to diagnose medical conditions.
No
The device is a physical instrumentation tray designed to hold and facilitate the sterilization of surgical instruments, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "protection, organization and delivery to the surgical field of the POGO Screw Instrumentation Set" and to "facilitate the pre-vacuum autoclave sterilization process". This describes a device used in a surgical setting for handling and sterilizing surgical instruments.
- Device Description: The description reinforces this by calling it a "custom autoclavable, compartmentalized, and perforated tray" intended to "enclose and protect medical device instrumentation" and "facilitate the sterilization process".
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically reagents, instruments, or systems used for these purposes.
Therefore, the POGO Screw Instrumentation Tray is a surgical accessory used for instrument handling and sterilization, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The POGO Screw Instrumentation Tray is intended for the protection, organization and delivery to the surgical field of the POGO Screw Instrumentation Set.
The trays are not intended to maintain sterility by themselves. They are designed to facilitate the pre-vacuum autoclave sterilization process when used in conjunction with a wrapping material (FDA cleared sterilization wrap). Wrapping materials are designed to allow air removal, steam penetration/evacuation and maintain the sterility of the internal components.
Sterilization Cycle Parameters
Method: Steam Cycle: Pre-vacuum Temperature: 132ºC Exposure: 4 minutes Drying Time: 30 minutes
or
Method: Steam Cycle: Gravity Temperature: 132ºC Exposure: 15 minutes Drying Time: 80 minutes
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The POGO Screw Instrumentation Tray is a custom autoclavable, compartmentalized, and perforated tray with a locking lid. It is intended to enclose and protect medicel device instrumentation, and to facilitate the sterilization process by allowing sterilant peneration and air removal. The tray is categorized as a cassette and requires complete enclosure in a legally marketed, FDA cleared 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
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)
Sterilization Validation was conducted to support equivalency
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
K091806
FEB 2 2 2010
510(k) Summaries of Safety and Effectiveness FxDEVICES POGO Screw Instrumentation Tray January 11, 2010
-
- Sponsor Name FxDEVICES One South Ocean Blvd., Suite 324 Boca Raton, FL 33432
- Device Name: 2. Panel: Classification Name: CFR Number: Product Code:
POGO Screw Instrumentation Tray General Hospital Sterilization Wrap Class II (per 21 CFR 880.6850) KCT
- Identification of Predicate or Legally Marketed Device 3. The POGO Screw Instrumentation Tray is substantially equivalent to the PolyVac Tray cleared under K040223.
4. Device Description:
The POGO Screw Instrumentation Tray is a custom autoclavable, compartmentalized, and perforated tray with a locking lid. It is intended to enclose and protect medicel device instrumentation, and to facilitate the sterilization process by allowing sterilant peneration and air removal. The tray is categorized as a cassette and requires complete enclosure in a legally marketed, FDA cleared sterilization wrap.
-
- Intended Use
The POGO Screw Instrumentation Tray is intended for the protection, organization and delivery to the surgical field of the POGO Screw Instrumentation Set. It is indicated for over-the-counter use.
- Intended Use
The trays are not intended to maintain sterility by themselves. They are designed to facilitate the pre-vacuum autoclave sterilization process when used in conjunction with a wrapping material (FDA cleared sterilization wrap). Wrapping materials are designed to allow air removal, steam penetration/evacuation and maintain the sterility of the internal components.
Sterilization Cycle Parameters
or
- Method: Steam Cycle: Pre-vacuum Temperature: 1320C Exposure: 4 minutes Drying Time: 30 minutes
Method: Steam Cycle: Gravity Temperature: 132ºC Exposure: 15 minutes Drying Time: 80 minutes
1
- Q. Comparison of Technological Characteristics
The 510(k) "Substantial equivalence decision making process (detailed) decision tree" (from CDRH 510(k) manual 92-4158) was utilized to make the following determination of substantial equivalence.
Does the new device have the same intended use?
Yes, the new device has the same intended use as the predicate. Both are used to enclose medical devices during steam sterilization.
Does the new device have the same technological characteristics, e.g. design, materials etc.?
Yes, the design and materials are equivalent. The design and materials used in the POGO Screw Instrumentation Tray, a perforated plastic tray manufactured from thermoplastic RADEL with a stainless steel latch and silicone containment brackets, allows free steam passage and is substantially equivalent to the predicate device. All trays have various dimensions such that the proposed trays and the predicate devices are substantially equivalent in size and volume. The sterilization of all trays has met the requirements of the same performance standard, ISO 11134. The associated procedures for the use of the devices, i.e. the manufacturer's recommended sterilization cycles are similar.
Are descriptive characteristics precise enough to ensure equivalence?
Yes, labeling, intended use, and device descriptions ensure equivalence. In addition, sterilization validation is available to ensure equivalency of the devices.
7. Performance Testing
Sterilization Validation was conducted to support equivalency
8. Statement of Equivalency
The POGO Screw Instrumentation Tray is substantially equivalent in design, materials, construction and intended use as those of the predicate. Since the POGO Screw Instrumentation Tray is the same in intended use and technological characteristics as the predicate devices, the POGO Screw Instrumentation Tray does not raise any new safety and efficacy concerns when compared to these similar legally marketed devices.
The test results demonstrate that the POGO Screw Instrumentation Tray is substantially equivalent to the predicate device and is capable of safely and accurately performing the stated intended use.
2
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
FEB 2 2 2010
Mr. Rich Lipschutz President Fxdevices One South Ocean Boulevard Boca Raton, Florida 33432
Re: K091806
Trade/Device Name: POGO Screw Instrumentation Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: January 12, 2010 Received: January 21, 2010
Dear Mr. Lipschutz
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.
3
Page- 2 Mr. Lipschutz
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 (OS) 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.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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Susan Runey
Anthony Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K091806
Device Name: POGO Screw Instrumentation Tray
Indications For Use:
The POGO Screw Instrumentation Tray is intended for the protection, organization and delivery to the surgical field of the POGO Screw Instrumentation Set.
The trays are not intended to maintain sterility by themselves. They are designed to facilitate the pre-vacuum autoclave sterilization process when used in conjunction with a wrapping material (FDA cleared sterilization wrap). Wrapping materials are designed to allow air removal, steam penetration/evacuation and maintain the sterility of the internal components.
Sterilization Cycle Parameters
or
Method: Steam Cycle: Pre-vacuum Temperature: 132ºC Exposure: 4 minutes Drying Time: 30 minutes
Method: Steam Cycle: Gravity Temperature: 132ºC Exposure: 15 minutes Drying Time: 80 minutes
Prescription Use
AND/OR
Over-The-Counter Use X
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
itt D.Claveris- W.ll
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tuvision of Anesthesiology, General Hospital Intection Control, Dental Devices
(Division Sign-f
510(k) Number: K0911806