(199 days)
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.
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.
This document is a 510(k) premarket notification for an "Endoscope Sterilization Tray" (K170640) and does not contain detailed information about acceptance criteria and the comprehensive study that proves the device meets them in the context of the requested questions. This type of FDA filing primarily establishes substantial equivalence to a predicate device, rather than providing granular performance data or detailed study methodology as would be included in a clinical trial report.
However, based on the provided text, I can extract the following information relevant to device performance and testing:
1. A table of acceptance criteria and the reported device performance
The document mentions that "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 mentioned is:
- Cleaning Validation
- Human Factors Validation
No specific quantitative acceptance criteria or reported device performance metrics are provided in this document. The overall "performance" is stated as being "substantially equivalent" to the predicate.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The device is a sterilization tray, not a diagnostic or AI device that would typically involve expert ground truth generation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. As addressed above, this type of adjudication is typically for diagnostic interpretation, not for validating a sterilization tray.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This type of study is not applicable and was not performed for this device. This device is an Endoscope Sterilization Tray, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable and was not performed for this device. This device is an Endoscope Sterilization Tray, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For "Cleaning Validation," the ground truth would likely be established through standardized laboratory testing methods to detect residual soil or microbial load, adhering to relevant industry standards (e.g., AAMI, ISO).
For "Human Factors Validation," the ground truth would typically be observations of user interactions and assessment against usability criteria, often involving user tasks and satisfaction surveys.
Specific details are not provided in the document.
8. The sample size for the training set
This information is not provided and is not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not provided and is not applicable as this is not an AI/ML device.
In summary: The provided FDA 510(k) document focuses on establishing substantial equivalence for a physical medical device (sterilization tray) and, as such, does not contain the detailed performance study information typically requested for AI/ML or diagnostic devices. The performance data mentioned relates to cleaning and human factors validation, but specific results, sample sizes, and detailed methodologies are not included in this summary.
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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
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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) | |||
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510(k) Summary (K170640)
IS4000 Endoscope Sterilization Tray
| 510(k)Owner | Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086 |
|---|---|
| Contact | Kunal GunjalRegulatory Affairs Specialist, Regulatory AffairsPhone Number: 408-523-8017Fax Number: 408-523-8907Email: Kunal.Gunjal@intusurg.com |
| DateSummaryPrepared | September 13, 2017 |
| Trade Name | Endoscope Sterilization Tray |
| CommonName | Sterilization Tray |
| ClassificationandRegulation | Class II,21 CFR 880.6850 |
| ProductCodes | KCT |
| ClassificationAdvisoryCommittee: | General Hospital |
| PredicateDevice | K151450 |
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Device Description
IS4000 Endoscope Sterilization Tray
| TradeName | Endoscope Sterilization Tray |
|---|---|
| DeviceDescription | The Endoscope Sterilization Tray is intended for use to encase and protect da Vinci XiEndoscopes during the sterilization process. It is a thermoformed plastic tray withsilicone inserts and a clear lid. The tray and the lid contain perforations to allowsterilization gases to penetrate the tray and sterilize the endoscope. |
Technological Comparison Table (Endoscope Sterilization Tray)
| Characteristic | Subject DeviceEndoscope Sterilization TrayK170640 | Predicate DeviceEndoscope Sterilization TrayK151450 |
|---|---|---|
| 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 TrayK170640 | Endoscope Sterilization TrayK151450 |
| Indications for Use | The Intuitive Surgical Endoscope SterilizationTray is intended for use to encase and protectda Vinci Xi endoscopes (Model #'s 470026and 470027) for sterilization in any of thefollowing 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 thesterilizers are preset by the manufacturers andare not adjustable. The maximum productload 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 |
| ReprocessingInstructions | The following changes have been made to the Reprocessing instructions for the EndoscopeSterilization 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.
§ 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).