(228 days)
Not Found
No
The device description and intended use clearly define the device as a physical tray for sterilizing endoscopes, with no mention of software, algorithms, or data processing that would indicate AI/ML. The purpose of the 510(k) is solely to update the weight capacity.
No
This device is an endoscope sterilization tray, which is used to encase and protect endoscopes during sterilization, not to treat a disease or condition itself.
No
Explanation: The device is an endoscope sterilization tray, intended to encase and protect endoscopes during sterilization and transport. It does not perform any diagnostic functions.
No
The device description clearly states it is a thermoformed plastic tray with silicone inserts and a clear lid, which are physical hardware components.
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 a medical device for use, not for performing a diagnostic test on a biological sample.
- Device Description: The description details a physical tray designed for holding and protecting an endoscope during sterilization. It does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Keywords: The text does not contain keywords commonly associated with IVDs, such as "in vitro," "diagnostic," "assay," "reagent," "sample," "analyte," "biological specimen," etc.
The device is clearly intended for the sterilization of a medical instrument (an endoscope), which falls under the category of medical devices used in patient care, not for in vitro diagnostic testing.
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 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 8.9 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.
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:
- o Steris V-PRO maX using the Non Lumen, Flexible, or Lumen cycles
- o Steris V-PRO 1 Plus using the Non Lumen or Lumen cycles
- Steris V-PRO 1 using the V-PRO/Lumen Cycle
The subject Endoscope Sterilization Tray and predicate tray are identical in terms of design, materials, dimensions and weight. The purpose of this 510(k) is to update the Indications for Use to reflect that the tray can accommodate a heavier endoscope. The previous Indications for Use reflected that the tray could accommodate a maximum of 7.7 lbs for the combined weight of the endoscope and tray, while the Indications for Use in this 510(k) reflect that the tray can accommodate a maximum of 8.9 lbs for the combined weight of the endoscope and tray.
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 bench testing, included verification testing for weight and functional specifications. Cleaning, biocompatibility, and limits of reuse testing were not repeated as the subject device design, materials, and manufacturing processes are identical to the predicate device (Intuitive Surgical Endoscope Sterilization Tray, K142937).
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 12, 2016
Intuitive Surgical, Inc. Kunal Gunjal Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086
Re: K151450
Trade/Device Name: Endoscope Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: December 15, 2015 Received: December 16, 2015
Dear Mr. Gunjal:
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 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 devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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
Enclosure
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)
K151450 | |
| 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 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 8.9 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. |
| 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 conduct 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) | Page 1 of 1 |
3
510(k) Summary
| 510(k) Owner: | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kunal Gunjal
Regulatory Affairs Specialist, Regulatory Affairs
Phone Number: 408-523-8017
Fax Number: 408-523-8907
Email: Kunal.Gunjal@intusurg.com |
| Date Summary Prepared: | December 15, 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 (K142937) |
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 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:
- o Steris V-PRO maX using the Non Lumen, Flexible, or Lumen cycles
- o Steris V-PRO 1 Plus using the Non Lumen or Lumen cycles
- Steris V-PRO 1 using the V-PRO/Lumen Cycle o
The subject Endoscope Sterilization Tray and predicate tray are identical in terms of design, materials, dimensions and weight. The purpose of this 510(k) is to update the Indications for Use to reflect that the tray can accommodate a heavier endoscope. The previous Indications for Use reflected that the tray could accommodate a maximum of 7.7 lbs for the combined weight of the endoscope and tray, while the Indications for Use in this 510(k) reflect that the tray can accommodate a maximum of 8.9 lbs for the combined weight of the endoscope and tray.
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:
- o STERRAD 100NX sterilization system using the Express cycle
- STERRAD 100S sterilization system using the Standard cycle ●
- o 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 the tray and endoscope is 8.9 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 identical to the predicate Intuitive Surgical Endoscope Sterilization Tray (K142937) in design, materials and technological characteristics; it is the same tray.
| Characteristic | Subject Device
Intuitive Surgical, Inc. Endoscope
Sterilization Tray | Predicate Device
Intuitive Surgical, Inc. Endoscope
Sterilization Tray K142937 |
|-------------------------|----------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Manufacturer | Intuitive Surgical, Inc. | Intuitive Surgical, Inc. |
| Trade Name | Endoscope Sterilization Tray | Endoscope Sterilization Tray |
| 510(k) No. | K151450 | K142937 |
| 510(k) Decision
Date | Not Applicable | February 24, 2015 |
| Common Name | Sterilization Tray | Sterilization Tray |
5
| Characteristic | Subject Device
Intuitive Surgical, Inc. Endoscope
Sterilization Tray | Predicate Device
Intuitive Surgical, Inc. Endoscope
Sterilization Tray K142937 |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 |
| Intended Use | SAME | 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). |
| Characteristic | Subject Device
Intuitive Surgical, Inc. Endoscope
Sterilization Tray | Predicate Device
Intuitive Surgical, Inc. Endoscope
Sterilization Tray K142937 |
| 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 8.9 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 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. |
| Where used
(hospital, home,
ambulance, etc) | SAME | Hospital |
| Dimensions
(LxW) | SAME | 25in. x 15in. |
| Characteristic | Subject Device
Intuitive Surgical, Inc. Endoscope
Sterilization Tray | Predicate Device
Intuitive Surgical, Inc. Endoscope
Sterilization Tray K142937 |
| 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 | SAME | 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 |
6
7
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 bench testing, included verification testing for weight and functional specifications. Cleaning, biocompatibility, and limits of reuse testing were not repeated as the subject device design, materials, and manufacturing processes are identical to the predicate device (Intuitive Surgical Endoscope Sterilization Tray, K142937).
Substantially Equivalent Conclusion:
Based on the intended use, indications for use, technological characteristics, performance data and nonclinical tests performed, the subject device, Intuitive Surgical Endoscope Sterilization Tray (K151450) is substantially equivalent and is as safe, as effective, and performs as well as the legally marketed predicate device, Intuitive Surgical Endoscope Sterilization Tray (K142937), Class II (21 CFR 880.6850), Product code KCT.