(138 days)
Not Found
No
The device is a sterilization tray, a passive container for medical instruments, and the description focuses on its physical properties and compatibility with sterilization systems. There is no mention of any computational or analytical functions.
No.
This device is an endoscope sterilization tray, intended to protect and encase endoscopes during sterilization, not to treat a medical condition.
No
This device is a sterilization tray designed to encase and protect endoscopes during sterilization, not to diagnose medical conditions.
No
The device description clearly states it is a "thermoformed plastic tray with silicone inserts and a clear lid," indicating it is a physical 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 is to encase and protect endoscopes for sterilization. This is a process related to preparing medical devices for use, not for performing diagnostic tests on biological samples.
- Device Description: The description details a physical tray designed for holding and protecting an endoscope during sterilization. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health
- Using reagents or assays
The device is clearly intended for the sterilization of a medical instrument (an 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 Xiendoscopes (Model #'s 470026 and 470027) for sterilization in any of the following sterilization machines/cycles:
· STERRAD 100NX sterilization system using the Express cycle
- · STERRAD 100S sterilization system using the Standard cycle
- · Steris V-PRO maX using the Non Lumen, Flexible, or Lumen cycles
- · Steris V-PRO 1 Plus using the Non Lumen or Lumen cvcles
- · Steris V-PRO 1 using the V-PRO/Lumen cycle
The sterilization cycle parameters of the sterilizers are preset by the manufacturers and are not adjustable. The maximum product load per tray is one da Vinci Xi Endoscope. The length of the da Vinci Xi Endoscope is approxinately 600 mm and the diameter of the shaft is 8.8 mm. The maximum weight of tray and endoscope is 7.7 lbs.
The Endoscope Sterilization Tray is not intended to mantain sterlity; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared STERRAD and Steris compatble sterilization wrap in order to maintain sterlity of the enclosed medical instrument.
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 Xi endoscopes (Model #'s 470026 and 470027) during transport and sterilization. The tray is compatible with the STERRAD 100NX (Express cycle), STERRAD 100S (Standard cycle), and the following Steris low temperature hydrogen peroxide gas sterilization systems:
- Steris V-PRO maX using the Non Lumen, Flexible, or Lumen Cycles ●
- Steris V-PRO 1 Plus using the Non Lumen or Lumen Cycles ●
- Steris V-PRO 1 using the V-PRO/Lumen Cycle
The Endoscope Sterilization Tray is the same tray previously cleared for sterilizing the endoscopes in STERRAD sterilizers. The tray is now validated for use in the Steris sterilization systems and the Indications for Use are being modified to reflect that capability.
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 demonstrates 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 sterilization validation and limits of reuse testing, including dimensional measurements, functional verification, cleaning, and biocompatibility testing were not repeated as the subject device design, materials and manufacturing processes are identical to the predicate device (Intuitive Surgical Endoscope Sterilization Tray, K133942).
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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 24, 2015
Intuitive Surgical, Inc. Ms. Nadine Nasr Senior Regulatory Specialist, Regulatory Affairs 1266 Kifer Road Sunnyvale, CA 94086
Re: K142937
Trade/Device Name: Endoscope Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap, Containers, Trays, Cassettes and Other Accessories Regulatory Class: II Product Code: KCT Dated: January 26, 2015 Received: January 28, 2015
Dear Ms. Nasr:
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.
1
Page 2 - Ms. Nasr
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 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/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 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,
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K142937
Device Name
Endoscope Sterilization Tray
Indications for Use (Describe)
The Intuitive Surgical Endoscope Sterlization Tray is intended for use to encase and protect da Vinci Xiendoscopes (Model #'s 470026 and 470027) for sterilization in any of the following sterilization machines/cycles:
· STERRAD 100NX sterilization system using the Express cycle
- · STERRAD 100S sterilization system using the Standard cycle
- · Steris V-PRO maX using the Non Lumen, Flexible, or Lumen cycles
- · Steris V-PRO 1 Plus using the Non Lumen or Lumen cvcles
- · Steris V-PRO 1 using the V-PRO/Lumen cycle
The sterilization cycle parameters of the sterilizers are preset by the manufacturers and are not adjustable. The maximum product load per tray is one da Vinci Xi Endoscope. The length of the da Vinci Xi Endoscope is approxinately 600 mm and the diameter of the shaft is 8.8 mm. The maximum weight of tray and endoscope is 7.7 lbs.
The Endoscope Sterilization Tray is not intended to mantain sterlity; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared STERRAD and Steris compatble sterilization wrap in order to maintain sterlity of the enclosed medical instrument.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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 concuct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
PSC Publishing Services (301) 443-6740 EF
3
510(k) Summary
| 510(k) Owner: | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Nadine Nasr
Senior Regulatory Specialist, Regulatory Affairs
Phone Number: 408-523-7093
Fax Number: 408-523-8907
Email: Nadine.nasr@intusurg.com |
| Date Summary Prepared: | February 24, 2015 |
| 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: | Intuitive Surgical Endoscope Sterilization Tray (K133942) |
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 Xi endoscopes (Model #'s 470026 and 470027) during transport and sterilization. The tray is compatible with the STERRAD 100NX (Express cycle), STERRAD 100S (Standard cycle), and the following Steris low temperature hydrogen peroxide gas sterilization systems:
- Steris V-PRO maX using the Non Lumen, Flexible, or Lumen Cycles ●
- Steris V-PRO 1 Plus using the Non Lumen or Lumen Cycles ●
- Steris V-PRO 1 using the V-PRO/Lumen Cycle
The Endoscope Sterilization Tray is the same tray previously cleared for sterilizing the endoscopes in STERRAD sterilizers. The tray is now validated for use in the Steris sterilization systems and the Indications for Use are being modified to reflect that capability.
4
Intended 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 any of the following sterilization machines/cycles:
- . STERRAD 100NX sterilization system using the Express cycle
- STERRAD 100S sterilization system using the Standard cycle .
- Steris V-PRO maX using the Non Lumen, Flexible, or Lumen cycles
- . Steris V-PRO 1 Plus using the Non Lumen or Lumen cycles
- Steris V-PRO 1 using the V-PRO/Lumen cycle
The sterilization cycle parameters of the sterilizers are preset by the manufacturers and are not adjustable. The maximum product load per tray is one da Vinci Xi Endoscope. The length of the da Vinci Xi Endoscope is approximately 600 mm and the diameter of the shaft is 8.8 mm. The maximum weight of tray and endoscope is 7.7 lbs.
The Endoscope Sterilization Tray is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared STERRAD and Steris compatible sterilization wrap in order to maintain sterility of the enclosed medical instrument.
Technological Characteristics:
The subject Intuitive Surgical Endoscope Sterilization Tray is substantially equivalent to the predicate Intuitive Surgical Endoscope Sterilization Tray (K133942) in design, materials, and technological characteristics.
5
| Characteristic | Subject Device
Intuitive Surgical, Inc. Endoscope
Sterilization Tray K142937 | Predicate Device
Intuitive Surgical, Inc. Endoscope
Sterilization Tray K133942 |
|----------------------------------------------|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Manufacturer | Intuitive Surgical, Inc. | Intuitive Surgical, Inc. |
| Trade Name | Endoscope Sterilization Tray | Endoscope Sterilization Tray |
| 510(k) No. | K142937 | K133942 |
| 510(k) Decision
Date | Not Applicable | August 1, 2014 |
| Common Name | Sterilization Tray | Sterilization Tray |
| Regulation No. | 21 CFR 880.6850 | 21 CFR 880.6850 |
| Product Code | KCT | KCT |
| Device Class/
Regulation Name | Class II/ Sterilization Wrap | Class II/ Sterilization Wrap |
| Classification
Advisory
Committee | General Hospital | General Hospital |
| Sterilization
Method | SAME | H2O2 chemical sterilization |
| Sterility /
Disposable or
Multiple use | SAME | Multiple use |
6
| Characteristic | Subject Device
Intuitive Surgical, Inc. Endoscope
Sterilization Tray K142937 | Predicate Device
Intuitive Surgical, Inc. Endoscope
Sterilization Tray K133942 |
|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Intuitive Surgical Endoscope
Sterilization Tray is intended to
encase and protect da Vinci Xi
endoscopes for sterilization in the
STERRAD 100NX sterilization
system using the Express cycle
setting, the STERRAD 100S
sterilization system using the
Standard cycle setting, and the
Steris low temperature hydrogen
peroxide gas sterilization systems
(V-PRO maX, V-PRO 1 Plus, and
V-PRO 1). | Intended to encase and protect da
Vinci endoscopes for sterilization in
the STERRAD 100NX sterilization
system using the Express cycle
setting and the STERRAD 100S
sterilization system using the
Standard cycle setting. |
| Characteristic | Subject Device
Intuitive Surgical, Inc. Endoscope
Sterilization Tray K142937 | Predicate Device
Intuitive Surgical, Inc. Endoscope
Sterilization Tray K133942 |
| 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
any of the following sterilization
machines/cycles:
STERRAD 100NX
sterilization system using
the Express cycle STERRAD 100S
sterilization system using
the Standard cycle Steris V-PRO maX using
the Non Lumen, Flexible,
or Lumen cycles Steris V-PRO 1 Plus using
the Non Lumen or Lumen
cycles Steris V-PRO 1 using the
V-PRO/Lumen Cycle The sterilization cycle parameters
of the sterilizers are preset by the
manufacturers and are not
adjustable. The maximum product
load per tray is one da Vinci Xi
Endoscope. The length of the da
Vinci Xi Endoscope is
approximately 600 mm and the
diameter of the shaft is 8.8 mm.
The maximum weight of tray and
endoscope is 7.7 lbs.
The Endoscope Sterilization Tray
is not intended to maintain
sterility; it is intended to be used
in conjunction with a legally
marketed, validated, FDA-cleared
STERRAD and Steris compatible
sterilization wrap in order to
maintain sterility of the enclosed
medical instrument. | 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
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 maximum 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. |
| Characteristic | Subject Device
Intuitive Surgical, Inc. Endoscope
Sterilization Tray K142937 | Predicate Device
Intuitive Surgical, Inc. Endoscope
Sterilization Tray K133942 |
| Where used
(hospital, home,
ambulance, etc) | SAME | Hospital |
| Dimensions
(LxW) | SAME | 25in. x 15in. |
| Materials; | SAME | ULTEM™, Elastosil R401/70
silicone, stainless steel |
| Compatibility
with the
environment and
other devices | SAME | Compatible with da Vinci Xi
endoscopes |
| Sterilization
system
compatibility | STERRAD 100NX and
STERRAD 100S and Steris V-
PRO maX, V-PRO 1 Plus, and V-
PRO 1 low temperature hydrogen
peroxide gas sterilization systems | STERRAD 100NX and
STERRAD 100S |
7
8
Performance Data:
Performance test data demonstrates 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 sterilization validation and limits of reuse testing, including dimensional measurements, functional verification, cleaning, and biocompatibility testing were not repeated as the subject device design, materials and manufacturing processes are identical to the predicate device (Intuitive Surgical Endoscope Sterilization Tray, K133942).
Substantially Equivalent Conclusion:
Based on the intended use, indications for use, technological characteristics, performance data and nonclinical tests performed, the subject Intuitive Surgical Endoscope Sterilization Tray is substantially equivalent and is as safe and as effective, and performs at least as safely and as effectively as the legally marketed predicate device, Intuitive Surgical Endoscope Sterilization Tray (K133942), Class II (21 CFR 880.6850), Product code KCT.