(221 days)
Not Found
No
The 510(k) summary describes a physical tray for sterilizing endoscopes and makes no mention of AI or ML technology.
No
The device is a tray used to hold and protect an endoscope during sterilization, not a device for treating patients.
No
The device is a sterilization tray intended to encase and protect endoscopes during sterilization and transport, not to diagnose a condition.
No
The device is a physical tray made of plastic and silicone, designed to encase and protect endoscopes during sterilization. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to encase and protect endoscopes for sterilization. This is a process related to the preparation and maintenance of medical devices, not for performing diagnostic tests on biological samples.
- Device Description: The device is a tray designed for holding and protecting an endoscope during sterilization. It does not interact with biological samples or perform any diagnostic measurements.
- 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 information for diagnosis, monitoring, or treatment decisions based on biological sample analysis.
The device is clearly intended for the sterilization of a surgical endoscope, which falls under the category of medical device reprocessing, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Intuitive Surgical Endoscope Sterilization Tray is intended for use to encase and protect da Vinci Xi endoscopes (Model #'s 470026 and 470027) for sterilization in the STERRAD 100NX sterilization system using the Express cycle and in the STERRAD 100S sterilization system using the standard cycle. The sterilization cycle parameters of the sterilizers are preset by the manufacturer and are not adjustable. The maximum product load per tray is 1 da Vinci Xi Endoscope. The max weight of tray and endoscope is 7.7 lbs.
The Intuitive Surgical 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 Endoscope Sterilization Tray is a thermoformed plastic tray with silicone inserts and a clear lid. The tray and lid contain perforations to allow sterilization gases to penetrate the tray and sterilize the endoscope. The Endoscope Sterilization Tray is designed to encase and protect da Vinci endoscopes during transport and sterilization. The tray is compatible with the STERRAD 100NX and 100S sterilization systems.
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
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)
Performance test data (bench, cleaning, and sterilization tests) demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. The testing conducted consisted of dimensional measurements, functional verification, and cleaning and sterilization testing.
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
Image /page/0/Picture/1 description: The image contains a logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized representation of a human figure in profile, repeated three times to symbolize the department's focus on people. The emblem is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 1, 2014
Intuitive Surgical, Inc. Mr. Brandon Hansen Project Manager, Regulatory Affairs 1266 Kifer Road Sunnyvale, CA 94086
Re: K133942
Trade/Device Name: Endoscope Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Tray Regulatory Class: II Product Code: KCT Dated: July 8, 2014 Received: July 9, 2014
Dear Mr. Hansen:
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
1
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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 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 yours,
Mary S. Runner -S
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
2
Indications for Use
510(k) Number (if known) K133942
Device Name Endoscope Sterilization Tray
Indications for Use (Describe)
The Intuitive Surgical Endoscope Sterilization Tray is intended for use to encase and protect da Vinci Xi endoscopes (Model #'s 470026 and 470027) for sterilization in the STERRAD 100NX sterilization system using the Express cycle and in the STERRAD 100S sterilization system using the standard cycle. The sterilization cycle parameters of the sterilizers are preset by the manufacturer and are not adjustable. The maximum product load per tray is 1 da Vinci Xi Endoscope. The max weight of tray and endoscope is 7.7 lbs.
The Intuitive Surgical 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.
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Image /page/2/Picture/14 description: The image contains the name "Sreekanth" on the first line and "Gutala -S" on the second line. The text is written in a simple, sans-serif font and is horizontally aligned. The text is black against a white background.
Digitally signed by Sreekanth Gutala -S DN: c=US, o=U.S. Government, ou=HHS ou=FDA, ou=People, 0 9 2342 19200300 100 1 1=2000540490 cn=Sreekanth Gutala -S Date: 2014.08.01 09:55:45 -04'00
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
| 510(k) Owner: | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Brandon Hansen
Project Manager, Regulatory Affairs
Phone Number: 408-523-7485
Fax Number: 408-523-8907
Email: Brandon.Hansen@intusurg.com |
| Date Summary Prepared: | July 9, 2014 |
| Trade Name: | Endoscope Sterilization Tray |
| Common Name: | Sterilization Tray |
| Classification: | Class II
21 CFR 880.6850, Sterilization Wrap |
| Product Codes: | KCT |
| Classification Advisory
Committee: | General Hospital |
| Predicate Device: | Entellus Medical FinESS Endoscope Sterilization Tray
(K103213) |
Image /page/3/Picture/4 description: The image shows the logo for Intuitive Surgical. The logo consists of the word "INTUITIVE" in gray capital letters, with a small yellow dot above the "I". Below "INTUITIVE" is the word "SURGICAL" in smaller gray capital letters, with a registered trademark symbol to the right.
4
Device Description
The Endoscope Sterilization Tray is a thermoformed plastic tray with silicone inserts and a clear lid. The tray and lid contain perforations to allow sterilization gases to penetrate the tray and sterilize the endoscope. The Endoscope Sterilization Tray is designed to encase and protect da Vinci endoscopes during transport and sterilization. The tray is compatible with the STERRAD 100NX and 100S sterilization systems.
Intended Use:
To encase and protect da Vinci endoscopes for sterilization.
Indications for Use:
The Intuitive Surgical Endoscope Sterilization Trav is intended for use to encase and protect da Vinci Xi endoscopes (Model #'s 470026 and 470027) for sterilization in the STERRAD 100NX sterilization system using the Express cycle and in the STERRAD 100S sterilization system using the standard cycle. The sterilization cycle parameters of the sterilizers are preset by the manufacturer and are not adjustable. The maximum product load per tray is 1 da Vinci Xi Endoscope. The max weight of tray and endoscope is 7.7 lbs.
The Intuitive Surgical 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.
Technological Characteristics:
The Intuitive Surgical Endoscope Sterilization Tray is substantially equivalent to the Entellus Medical FinESS Endoscope Sterilization Tray (K103213) in design, materials, technological characteristics, and intended use.
| Characteristic | Subject Device
Intuitive Surgical, Inc. Endoscope
Sterilization Tray (K133942) | Predicate Device
Entellus Medical
FinESS™ Endoscope Sterilization
Tray (K103213) |
|-------------------------|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Manufacturer | Intuitive Surgical, Inc. | Entellus Medical, Inc. |
| Trade Name | Endoscope Sterilization Tray | FinESS™ Endoscope Sterilization
Tray |
| 510(k) No. | K133942 | K103213 |
| 510(k) Decision
Date | Not Applicable | 2 February 2011 |
Image /page/4/Picture/12 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a sans-serif font and is in all caps. Below that, the word "SURGICAL" is in a smaller sans-serif font and is also in all caps. There is a yellow dot above the word "INTUITIVE".
5
| Characteristic | Subject Device
Intuitive Surgical, Inc. Endoscope
Sterilization Tray (K133942) | Predicate Device
Entellus Medical
FinESS™ Endoscope Sterilization
Tray (K103213) |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Sterilization Tray | Identical |
| Regulation No. | 21 CFR 880.6850 | Identical |
| Product Code | KCT | Identical |
| Device Class/
Regulation Name | Class II/ Sterilization Wrap | Identical |
| Classification
Advisory
Committee | General Hospital | Identical |
| Sterilization
Method | H2O2 chemical sterilization | Identical |
| Sterility /
Disposable or
Multiple use | Multiple use | Identical |
| Intended Use | Intended to encase and protect da
Vinci endoscopes for sterilization
in the STERRAD 100NX
sterilization system using the
express cycle setting and the 100S
sterilization system using the
standard cycle setting | Intended to encase and protect the
FinESS™ Endoscope for
sterilization in STERRAD 100NX
using the standard cycle setting and
NX sterilization system using the
advanced cycle setting |
| Characteristic | Subject Device
Intuitive Surgical, Inc. Endoscope
Sterilization Tray (K133942) | Predicate Device
Entellus Medical
FinESS™ Endoscope Sterilization
Tray (K103213) |
| Indications for
Use | The Intuitive Surgical
Endoscope Sterilization Tray is
intended for use to encase and
protect da Vinci Xi endoscopes
(Model #'s 470026 and 470027)
for sterilization in the
STERRAD 100NX sterilization
system using the Express cycle
and in the STERRAD 100S
sterilization system using the
standard cycle. The sterilization
cycle parameters of the
sterilizers are preset by the
manufacturer and are not
adjustable. The maximum
product load per tray is 1 da
Vinci Xi Endoscope. The max
weight of tray and endoscope is
7.7 lbs.
The Intuitive Surgical
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. | 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. |
| Where used
(hospital, home,
ambulance, etc) | Hospital | Identical |
| Dimensions
(LxW) | 25in. x 15in. | 7.6 in. x 4.1 in. |
| Materials; | ULTEM™, Elastosil R401/70
Silicone, stainless steel | Identical |
Image /page/5/Picture/3 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is also in all caps and in a smaller font size, with the registered trademark symbol next to it.
6
Image /page/6/Picture/3 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is also in all caps and in a smaller font size, also in light gray. There is a yellow dot above the word "INTUITIVE".
7
| Characteristic | Subject Device
Intuitive Surgical, Inc. Endoscope
Sterilization Tray (K133942) | Predicate Device
Entellus Medical
FinESS™ Endoscope Sterilization
Tray (K103213) |
|---------------------------------------------------------------|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Compatibility
with the
environment and
other devices | Compatible with da Vinci Xi 8
mm endoscopes | Compatible with the FinESS
endoscope |
| Sterilization
system
compatibility | STERRAD 100NX and 100S | STERRAD 100NX and NX |
Performance Data:
Performance test data (bench, cleaning, and sterilization tests) demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. The testing conducted consisted of dimensional measurements, functional verification, and cleaning and sterilization testing.
Summary:
Based on the intended use, indications for use, technological characteristics, and performance data, the Intuitive Surgical Endoscope Sterilization Tray is substantially equivalent to the Entellus Medical FinESS Endoscope Sterilization Tray (K103213).
Image /page/7/Picture/7 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is also in all caps and in a smaller font size, also in light gray, with a registered trademark symbol next to it. There is a yellow dot above the word "INTUITIVE".