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 to flow in or out of the body cavity while minimizing gas leakage.

AI/ML Overview

I am sorry. This document does not contain information about acceptance criteria and device performance for an AI/ML device. It describes a medical device, the Universal Seal (5-12 mm), which is a physical seal used in endoscopic procedures. The document focuses on regulatory approval (510(k) clearance) based on substantial equivalence to a predicate device, specifically highlighting a minor material change and biocompatibility testing. It does not involve any AI or machine learning components.

Summary

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August 5, 2024

Intuitive Surgical, Inc. Taian Chen Sr. Regulatory Affair Specialist 1266 Kifer Road Sunnyvale, California 94086

Re: K241360

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 10, 2024 Received: May 14, 2024

Dear Taian Chen:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Digitally signed by Mar Mark Trumbore -S Date: 2024.08.05 09:17:09 Trumbore -S -04'00' Mark Trumbore, Ph.D. Assistant Director 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

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 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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510(k) Summary (21 CFR § 807.92)

I. Submitter Information

510(k) Owner:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Contact Person:	Taian ChenSenior Regulatory Affairs SpecialistPhone: 650-302-8499Email: taian.chen@intusurg.com
Date Summary Prepared:	May 10, 2024
II. Subject Device
Trade Name:	Universal Seal (5-12 mm)
Common Name:	Cannula Seal
Classification:	Class II
Regulation:	21 CFR § 876.1500, Endoscope and Accessories
Product Code:	GCJ

III. Predicate Device Information

Predicate Devices : Universal Seal (5-12 mm) (K231358)

Reference Devices : Single-Site Cannula Seal (K152448) and Stapler Cannula Seal (K113706)

IV. Device Description

V. Indications for Use

The da Vinci Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.

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VI. Technological Characteristics

The subject device is very similar to its predicate device cleared under K231358. It has the same intended use, indications for use, functional-scientific technology, and technological characteristics as the predicate device. The modification is limited to minor material change used on the indirect patient contacting components. Results from performance testing indicate that, Universal Seal (5-12 mm) is substantially equivalent to its predicate, Universal Seal (5-12 mm) cleared through K231358. Table 10-1 provides a comparison between the subject Universal Seal (5-12 mm) and predicate Universal Seal (5-12 mm). Differences between the subject and predicate devices are highlighted in grey.

Attributes	Subject Device	Predicate Device
	Universal Seal (5-12 mm)	Universal Seal (5-12 mm)(K231358)
Manufacturer	Intuitive Surgical, Inc.	SAME as subject device
Product Code	GCJ	SAME as subject device
RegulationNumber andName	21 CFR 876.1500, Endoscopes andAccessories	SAME as subject device
DeviceClassification	Class II	SAME as subject device
ClassificationAdvisoryCommittee	General and Plastic Surgery	SAME as subject device
Intended Use	The Universal Seal (5-12 mm)supports a port of entry forendoscopes, instruments, andaccessories.	SAME as subject device
Indications forUse	The da Vinci Trocar has applicationin a variety of endoscopicprocedures to provide a port ofentry for endoscopic instruments.	SAME as subject device
TargetPopulation	Adults and pediatrics	SAME as subject device
Anatomical Site	Abdomen and Thoracic	SAME as subject device
Where Used(hospital, home,ambulance, etc)	Hospital, Surgical Operating Rooms	SAME as subject device
Attributes	Subject DeviceUniversal Seal (5-12 mm)	Predicate DeviceUniversal Seal (5-12 mm)(K231358)
RepresentativeImages		SAME as subject device
Mechanism ofAction	The Universal Seal (5-12 mm) islatched onto a da Vinci Cannula andis intended to maintain insufflationduring procedure with or without anendoscope, instrument, or accessoryinserted through the septum of theUniversal Seal.	SAME as subject device
Compatibilitywith theenvironmentand otherdevices	The device is compatible within thesurgical operating room andintended to be used with the daVinci Surgical System, endoscopicinstruments, and surgicalaccessories.	SAME as subject device
InterfaceCompatibility	The Universal Seal (5-12 mm)provides a compatible interface forthe insertion of with da Vinciendoscopes, instruments andaccessories alongside with,laparoscopic instruments within thediameter range.	SAME as subject device
Design Features	Connectors: used to attach anon obturator or reducer to theUniversal Seal Latches: used to connect theUniversal Seal to a compatibleda Vinci Surgical Systemcannula Port connector: provides aconnection point to aninsufflator Stopcock: a valve used to openand close the gas pathway Septum Assembly: a port ofentry for endoscopes,instruments, and accessories	SAME as subject device
Attributes	Subject DeviceUniversal Seal (5-12 mm)	Predicate DeviceUniversal Seal (5-12 mm)(K231358)
OverallDimensions	Housing size (diameter): 1.76 in Total height: 1.15 in	SAME as subject device
PackagingMaterials	Primary packaging material:Film	SAME as subject device
Patient-ContactingMaterials	Protective flaps: polyurethane Floating cylinder:polycarbonate, white Septum: polyisoprene, black,proprietary formulation andmold release Lubricant: silicone fluid Duckbill: polyisoprene, black,proprietary formulation andmold release Housing (upper & lower):polycarbonate, white Latch: polycarbonate, grey Stopcock: high densitypolyethylene, grey	SIMILAR as subject device Protective flaps: polyurethane Floating cylinder:polycarbonate, white Septum: polyisoprene, black proprietary formulation andmold release, or Lubricant: silicone fluid Duckbill: polyisoprene, black proprietary formulation andmold release Housing (upper & lower):polycarbonate, white Latch: polycarbonate, grey Stopcock: high densitypolyethylene, grey
Biocompatibility	All materials have been evaluatedfor biocompatibility per ISO 10993-1	SAME as subject device
Sterility	Gamma Radiation, SAL 10-6	SAME as subject device
Type of Use	Single-Use. Disposable	SAME as subject device

Table 10-1 General Aspects of the Universal Seal (5-12 mm)

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INTUITIVE

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VII. Performance Data

The subject device, Universal Seal (5-12 mm) underwent biocompatibility evaluation and testing to assess the impact of material changes in comparison to the predicate device. Biological evaluation was conducted according to 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 in September 2023.
ISO 10993-1:2018: Biological Evaluation of Medical Devices .

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Based on the biocompatibility testing and biological safety assessment, it was concluded that the subject device met the requirements of the recognized standards for biocompatibility for its intended clinical use.

VIII. Conclusion

Based on the intended use, indications for use, technological parameters, and performance data the subject device, Universal Seal (5-12 mm) is substantially equivalent to the predicate device.

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Regulation Number and Section

§ 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.