(56 days)
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No
The document describes a mechanical device (a trocar seal) and its performance testing, with no mention of AI, ML, image processing, or data-driven algorithms.
No.
The device facilitates the entry of instruments during endoscopic procedures and maintains insufflation, but it does not directly treat a disease or condition.
No
This device is a surgical accessory (trocar and seal) used to provide a port of entry for instruments during endoscopic procedures and manage insufflation, not to diagnose medical conditions.
No
The device description clearly states it is a "sterile, single-use device" and describes physical components like a "seal" and "attachment for insufflation accessories," indicating it is a hardware device. The performance studies also focus on physical properties and testing (leakage, torque, force, biocompatibility, etc.).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to provide a port of entry for endoscopic instruments during surgical procedures. This is an in vivo application (within a living organism), not an in vitro application (outside of a living organism, typically involving testing of samples like blood or tissue).
- Device Description: The description reinforces its use as a seal within a port of entry for instruments during surgery.
- Performance Studies: The performance studies focus on aspects like leakage, torque, force, reliability, and biocompatibility in a surgical context (including simulated clinical use with a porcine model). These are all relevant to a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on testing biological specimens.
Therefore, based on the provided information, the da Vinci Trocar and Universal Seal are surgical devices, not IVDs.
N/A
Intended Use / Indications for Use
The da Vinci Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.
The Universal Seal (5-12 mm), as part of the da Vinci Trocar system, supports a port of entry for endoscopes, instruments, and accessories. It is intended to be used with a compatible da Vinci cannula to provide a seal within a port of entry for endoscopes, instruments, and accessories. It is intended to provide an attachment for gas insufflation while minimizing gas leakage.
Product codes
GCJ
Device Description
The Universal Seal (5-12 mm) is a sterile, single-use device. It provides a seal within a port of entry for endoscopes, instruments, and accessories with a diameter range between 5 mm and 12 mm. It also provides an attachment for insufflation accessories and allows for air flow in or out of the body cavity while minimizing gas leakage.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject Universal Seal (5-12 mm) underwent a series of tests to evaluate the impact of the modification to the predicate device. Testing was performed with a compatible da Vinci surgical system. Testing included design verification, reliability testing, design validation, biocompatibility, packaging, shelf-life, and transit testing. The successful completion of testing demonstrated that the subject Universal Seal (5-12 mm) design outputs continue to meet design inputs.
Bench testing was performed to verify functional design outputs met the functional design inputs. The design verification in this section addressed the following:
- Leakage
- Torque limits
- Force limits
- Reliability
Simulated clinical use testing was performed with a porcine model to validate that the product specifications continued to meet the user's needs and intended use.
Biocompatibility testing was completed in accordance with the following standards and guidance documents:
- FDA Guidance: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process", issued September 2020
- ISO 10993-1:2018 Biological evaluation of medical devices
Based on the biological safety assessment and biocompatibility testing, it was determined that the subject device met the requirements of the recognized standards for biocompatibility for its intended clinical use.
Shelf-life testing was performed through an accelerated aging study to verify that the product can maintain a shelf-life of two years.
Transit testing was performed in accordance with ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
July 5, 2023
Intuitive Surgical, Inc. Emily Hovick Sr. Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086
Re: K231358
Trade/Device Name: Universal Seal (5-12 mm) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: May 9, 2023 Received: May 10, 2023
Dear Emily Hovick:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows a digital signature. The signature is from Mark Trumbore. The date of the signature is 2023.07.05, and the time is 14:03:36 -04'00'.
Mark Trumbore, Ph.D. Assistant Director THT4A1: Robotically-Assisted Surgical Devices Team DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Universal Seal (5-12 mm)
Indications for Use (Describe)
The da Vinci Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.
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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) Summary
510(k) Owner: Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086
Contact Person: Emily Hovick Sr. Regulatory Affairs Specialist Phone: 314-359-8534 Email: Emily.hovick@intusurg.com
Date Summary Prepared: May 09, 2023
I. SUBJECT DEVICE
Trade Name: Universal Seal (5-12mm) Common Name: Cannula Seal Classification: Class II, Endoscope and Accessories (21 CFR 876.1500) Product Code: GCJ
PREDICATE DEVICE II.
Intuitive Surgical, Inc, Universal Cannula Seal (5-12 mm), K181395
III. DEVICE DESCRIPTION
The Universal Seal (5-12 mm) is a sterile, single-use device. It provides a seal within a port of entry for endoscopes, instruments, and accessories with a diameter range between 5 mm and 12 mm. It also provides an attachment for insufflation accessories and allows for air flow in or out of the body cavity while minimizing gas leakage.
IV. INTENDED USE/INDICATION FOR USE
The Universal Seal (5-12 mm), as part of the da Vinci Trocar system, supports a port of entry for endoscopes, instruments, and accessories. It is intended to be used with a compatible da Vinci cannula to provide a seal within a port of entry for endoscopes, instruments, and accessories. It is intended to provide an attachment for gas insufflation while minimizing gas leakage.
V. TECHNOLOGICAL CHARACTERISTICS
The subject Universal Seal (5-12 mm) is very similar to its predicate device cleared under K181395. It has the same intended use, same indication for use, same fundamental scientific technology, and similar technological characteristics as the predicate device. The modification to the device consists of indirect patient contacting material changes. Results from performance data
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indicate that the Universal Seal (5-12 mm) is substantially equivalent to the predicate Universal Cannula Seal (5-12 mm).
VI. PERFORMANCE DATA
The subject Universal Seal (5-12 mm) underwent a series of tests to evaluate the impact of the modification to the predicate device. Testing was performed with a compatible da Vinci surgical system. Testing included design verification, reliability testing, design validation, biocompatibility, packaging, shelf-life, and transit testing. The successful completion of testing demonstrated that the subject Universal Seal (5-12 mm) design outputs continue to meet design inputs.
Design Verification
Bench testing was performed to verify functional design outputs met the functional design inputs. The design verification in this section addressed the following:
- . Leakage
- Torque limits
- Force limits ●
- Reliability ●
Design Validation
Simulated clinical use testing was performed with a porcine model to validate that the product specifications continued to meet the user's needs and intended use.
Biocompatibility
Biocompatibility testing was completed in accordance with the following standards and guidance documents:
- FDA Guidance: Use of International Standard ISO-10993, "Biological Evaluation of ● Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process", issued September 2020
- ISO 10993-1:2018 Biological evaluation of medical devices
Based on the biological safety assessment and biocompatibility testing, it was determined that the subject device met the requirements of the recognized standards for biocompatibility for its intended clinical use.
Shelf-Life
Shelf-life testing was performed through an accelerated aging study to verify that the product can maintain a shelf-life of two years.
Transit Testing
Transit testing was performed in accordance with ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems
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VII. CONCLUSIONS
Based on the intended use, indications for use, technological characteristics, and performance data,
the subject Universal Seal (5-12 mm) is substantially equivalent to the p