(93 days)
Not Found
No
The document describes a sterilization tray and its physical components and testing, with no mention of AI or ML.
No
This device is a sterilization tray intended to protect an endoscope during the sterilization process, not to provide therapy itself.
No
The device is a sterilization tray designed to encase and protect an endoscope during sterilization. It does not perform any diagnostic functions.
No
The device description clearly states it is comprised of physical components (bottom, lid, silicone inserts) and is intended for encasing and protecting a physical endoscope during sterilization. It is a hardware device, not software.
Based on the provided information, the FinESS Endoscope Sterilization Tray is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to encase and protect an endoscope for sterilization. This is a process related to the reprocessing of a medical device, not a diagnostic test performed on a biological sample.
- Device Description: The device is a tray designed to hold and protect an endoscope during sterilization. It does not contain reagents, perform analysis of biological samples, or provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic information about a patient's health status
- Using reagents or calibrators
The device is clearly intended to facilitate the sterilization of another medical device (the endoscope), which is a process related to infection control and device reprocessing.
N/A
Intended Use / Indications for Use
The FinESS Endoscope Sterilization Tray is intended for use to encase and protect the FinESS Endoscope for sterilization in STERRAD 100NX using the standard cycle setting and NX Sterilization Systems using the advanced cycle setting.
- The sterilization cycle parameters of the STERRAD sterilizers are preset by the manufacturer and are not adjustable.
- The maximum product load per FinESS Endoscope Sterilization Tray includes 1 FinESS Endoscope and 2 light post adapters.
The FinESS Endoscope Sterilization Tray is intended to be used with legally marketed, FDA-cleared STERRAD compatible sterilization wrap in order to maintain sterility of the enclosed endoscope.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The FinESS Endoscope Sterilization Tray is comprised of a bottom, a clear lid, and silicone inserts designed to secure the FinESS Endoscope in place. The lid is clear and secured to the tray with a snap fit mechanism. The FinESS Endoscope Sterilization Tray contains perforations in the base and lid to allow the sterilant to penetrate. The use of commercially available sterilization wrap allows the tray to maintain sterility after sterilization.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing of the FinESS Endoscope Sterilization Tray consisted of design verification testing, biocompatibility and sterilization. Design verification testing included verification of device and material stability following repeated exposure to the sterilization cycle. Biocompatibility testing included primary dermal irritation and dermal sensitization post exposure to multiple sterilization cycles. Sterilization efficacy testing was conducted on the FinESS endoscope contained within the FinESS Endoscope Sterilization Tray to assure that an SAL of 10-6 could be achieved when used with the STERRAD NX and STERRAD 100NX sterilization system. In addition, sterilization testing of inoculated FinESS Endoscope Sterilization Tray and similarly inoculated Predicate tray showed that both devices are capable of allowing SAL of 10-6. All results of the design verification, biocompatibility and sterilization testing met the acceptance criteria.
No clinical evaluations were conducted.
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
K103213
p1of2
FEB - 2 2011
510(k) Summary
This 510(k) Summary complies with the format and content requirements in 21 CFR 807.92.
| Date Prepared: | November 19, 2010 |
|---|---|
| 1. Submitter Information: | Entellus Medical, Inc. |
| 6705 Wedgwood Court, North | |
| Maple Grove, MN 55311 | |
| Establishment Registration: | 3006345872 |
| Contact Information: | Karen E Peterson |
| Vice President Clinical, Regulatory and Quality | |
| Phone: (763) 463-7066 | |
| kpeterson@entellusmedical.com | |
| 2. Device Information: |
| Trade Name: | FinESS TM Endoscope Sterilization Tray |
|---|---|
| Common Name: | Sterilization Tray |
| Classification Name: | Sterilization Wrap |
| Product Code: | KCT |
| Regulation Number: | Class II, 21 CFR 880.6850 |
3. Predicate Device:
Advance Sterilization Product APTIMAX STERILIZATION Tray and Accessories [K013003].
4. Device Description:
The FinESS Endoscope Sterilization Tray is comprised of a bottom, a clear lid, and silicone inserts designed to secure the FinESS Endoscope in place. The lid is clear and secured to the tray with a snap fit mechanism. The FinESS Endoscope Sterilization Tray contains perforations in the base and lid to allow the sterilant to penetrate. The use of commercially available sterilization wrap allows the tray to maintain sterility after sterilization.
5. Intended Use:
The FinESS Endoscope Sterilization Tray and the predicate device have the same intended use. Both devices are intended to encase instruments for sterilization when used with commercially available sterilization wrap.
The following is the "Indications For Use" for the FinESS Endoscope Sterilization Tray:
The FinESS Endoscope Sterilization Tray is intended for use to encase and protect the FinESS Endoscope for sterilization in STERRAD 100NX using the standard cycle setting and NX Sterilization Systems using the advanced cycle setting.
1
- The sterilization cycle parameters of the STERRAD sterilizers are preset by the . manufacturer and are not adjustable.
K103213
02022
- The maximum product load per FinESS Endoscope Sterilization Tray includes 1 . FinESS Endoscope and 2 light post adapters.
The FinESS Endoscope Sterilization Tray is intended to be used with legally marketed, FDA-cleared STERRAD compatible sterilization wrap in order to maintain sterility of the enclosed endoscope.
6. Technological Characteristics
The FinESS Endoscope Sterilization Tray and the predicate device have similar technological characteristics. Both devices consist of a rigid stable plastic container with lids that have been perforated to allow the penetration of sterilant. In both devices, perforations are found on the bottom and top of the tray thereby falling into the category of devices called "sterilization cassettes". Both devices require the use of a sterilization wrap to continue to maintain sterility during transportation and storage. To secure the device within the tray during sterilization, both devices have silicone inserts to hold the device in place. The materials of both devices are stable and do not degrade when exposed to multiple sterilization cvcles.
7. Performance Testing:
Performance testing of the FinESS Endoscope Sterilization Tray consisted of design verification testing, biocompatibility and sterilization. Design verification testing included verification of device and material stability following repeated exposure to the sterilization cycle. Biocompatibility testing included primary dermal irritation and dermal sensitization post exposure to multiple sterilization cycles. Sterilization efficacy testing was conducted on the FinESS endoscope contained within the FinESS Endoscope Sterilization Tray to assure that an SAL of 10° could be achieved when used with the STERRAD NX and STERRAD 100NX sterilization system. In addition, sterilization testing of inoculated FinESS Endoscope Sterilization Tray and similarly inoculated Predicate tray showed that both devices are capable of allowing SAL of 106. All results of the design verification, biocompatibility and sterilization testing met the acceptance criteria.
No clinical evaluations were conducted.
8. Conclusion:
The FinESS Endoscope Sterilization Tray is substantially equivalent to the predicate device, APTIMAX Instrument Tray [K013003]. The device has the same intended use, similar indication for use, and similar technological characteristics as the predicate device. Minor differences in the technological characteristics do not raise new questions of safety and efficacy. In addition, performance testing conducted demonstrate that the FinESS Endoscope Sterilization Tray is as safe and effective and performs as well as the predicate device.
Thus, the FinESS Endoscope Sterilization Tray is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three legs, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circle around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Entellus Medical, Incorporated C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25" Street, NW Buffalo, Minnesota 55313
FEB - 2 2011
. . . . . . . . . .
:
Re: K103213
Trade/Device Name: FinESSTM Endoscope Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: January 14, 2011 Received: January 19, 2011
Dear Mr. Job:
.
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. Register
. . .
3
Page 2- Mr. Job
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1.1.5809.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 yours,
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Canter for Devices and Radiological Health
4
Indications for Use Statement
510(k) Number:
Device Name: FinESS™ Endoscope Sterilization Tray
Indications for Use:
The FinESS Endoscope Sterilization Tray is intended for use to encase and protect the FinESS Endoscope for sterilization in STERRAD 100NX using the standard cycle setting and NX Sterilization Systems using the advanced cycle setting.
- The sterilization cycle parameters of the STERRAD sterilizers are preset by the ● manufacturer and are not adjustable.
- The maximum product load per FinESS Endoscope Sterilization Tray includes 1 FinESS . Endoscope and 2 light post adapters.
The FinESS Endoscope Sterilization Tray is intended to be used with legally marketed, FDAcleared STERRAD compatible sterilization wrap in order to maintain sterility of the enclosed endoscope.
Prescription Use Over-the-Counter Use X (21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth F, Clarin-Will
(Division Sian-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices
510(k) Number: K 103213