(199 days)
Not Found
No
The device description and intended use clearly define a physical tray for sterilization, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No
The device is an Endoscope Sterilization Tray, intended to encase and protect endoscopes during the sterilization process, not to treat or diagnose a disease or condition.
No
The device is an Endoscope Sterilization Tray, intended to encase and protect endoscopes during the sterilization process, 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 surgical endoscopes during sterilization. This is a process related to the preparation of medical devices for use, not for performing tests on biological samples to diagnose or monitor a medical condition.
- Device Description: The description details a physical tray designed to hold an endoscope during sterilization. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: 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
- Using reagents or assays
- Measuring biomarkers
The device is clearly intended for the sterilization of a medical instrument, which falls under the category of medical devices used in healthcare settings, but not specifically as an in vitro diagnostic device.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The Endoscope Sterilization Tray is intended for use to encase and protect da Vinci Xi Endoscopes during the sterilization process. It is a thermoformed plastic tray with silicone inserts and a clear lid. The tray and the lid contain perforations to allow sterilization gases to penetrate the tray and sterilize the endoscope.
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)
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 Cleaning Validation and Human Factors Validation. Design validation studies were not repeated as the subject device design, materials, and manufacturing processes are identical to the predicate device.
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/2 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 image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 17, 2017
Intuitive Surgical, Inc. Kunal Gunjal Regulatory Affairs Specialist 1266 Kifer Road Building 101 Sunnyvale, California 94086
Re: K170640
Trade/Device Name: Endoscope Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: August 24, 2017 Received: August 25, 2017
Dear Kunal 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
1
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.
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 (DICE) 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 (DICE) 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,
Tara A. Ryan -S 2017.09.17 18:52:36 -04'00'
for
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170640
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 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.
| 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 |
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3
510(k) Summary (K170640)
IS4000 Endoscope Sterilization Tray
| 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 | September 13, 2017 |
| Trade Name | Endoscope Sterilization Tray |
| Common
Name | Sterilization Tray |
| Classification
and
Regulation | Class II,
21 CFR 880.6850 |
| Product
Codes | KCT |
| Classification
Advisory
Committee: | General Hospital |
| Predicate
Device | K151450 |
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Device Description
IS4000 Endoscope Sterilization Tray
| Trade
| Name | Endoscope Sterilization Tray |
|---|---|
| Device | |
| Description | The Endoscope Sterilization Tray is intended for use to encase and protect da Vinci Xi |
| Endoscopes during the sterilization process. It is a thermoformed plastic tray with | |
| silicone inserts and a clear lid. The tray and the lid contain perforations to allow | |
| sterilization gases to penetrate the tray and sterilize the endoscope. |
Technological Comparison Table (Endoscope Sterilization Tray)
| Characteristic | Subject Device
Endoscope Sterilization Tray
K170640 | Predicate Device
Endoscope Sterilization Tray
K151450 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Manufacturer | Intuitive Surgical, Inc. | Intuitive Surgical, Inc. |
| Trade Name | Endoscope Sterilization Tray | SAME as subject device |
| Common Name | Sterilization Tray | SAME as subject device |
| Regulation No. | 21 CFR 880.6850 | SAME as subject device |
| Product Code | KCT | SAME as subject device |
| Device Class/
Regulation Name | Class II | SAME as subject device |
| | Subject Device | Predicate Device |
| Characteristic | Endoscope Sterilization Tray
K170640 | Endoscope Sterilization Tray
K151450 |
| 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
| SAME as subject device |
| Sterilization Method | H2O2 chemical sterilization | SAME as subject device |
| Reusable | Yes | SAME as subject device |
| Reprocessing
Instructions | The following changes have been made to the Reprocessing instructions for the Endoscope
Sterilization Tray, since the most recently cleared legally marketed device (K151450): Re-organization of content and formatting Remove or add warning and caution statements Revise warning and caution statements Reference to specific washer/disinfector models was removed (Removed the automated cleaning process) Addition of parameter based thermal disinfection process | |
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Technological Characteristics:
The technological characteristics of the subject device are identical to the predicate device.
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 Cleaning Validation and Human Factors Validation. Design validation studies were not repeated as the subject device design, materials, and manufacturing processes are identical to the predicate device.
Summary:
Based on the intended use, indications for use, technological characteristics, performance data, and nonclinical tests performed, the subject device is substantially equivalent and is as safe, as effective, and performs as well as the legally marketed predicate device.