(83 days)
No
The device description and performance studies focus on the mechanical and biocompatibility aspects of a trocar seal, with no mention of AI or ML.
No
Explanation: This device is described as providing a port of entry and a seal for endoscopic instruments, and for managing gas flow during procedures. Its function is to facilitate surgical procedures, not to treat a disease or condition itself.
No
The device description clearly states its function is to "provide a port of entry for endoscopic instruments" and to "provide a seal within a port of entry for endoscopes, instruments, and accessories." Additionally, the performance studies section focuses on biocompatibility, not diagnostic accuracy. There is no mention of it collecting data, processing images, or providing any form of diagnosis.
No
The device description clearly states it is a sterile, single-use device that provides a seal and attachment for insufflation accessories, indicating it is a physical hardware component.
Based on the provided information, the da Vinci Trocar is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide a port of entry for endoscopic instruments" in surgical procedures. This is a surgical tool used during a procedure, not a device used to examine specimens outside the body to diagnose a condition.
- Device Description: The description focuses on its function as a seal and a port for instruments and insufflation. It doesn't mention any analysis of biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological specimens.
- Providing diagnostic information about a patient's health status.
- Using reagents or assays.
The da Vinci Trocar is a surgical instrument used to facilitate minimally invasive surgery.
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.
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 to flow in or out of the body cavity while minimizing gas leakage.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdomen and Thoracic
Indicated Patient Age Range
Adults and pediatrics
Intended User / Care Setting
Hospital, Surgical Operating Rooms
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)
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 .
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Universal Seal (5-12 mm) (K231358)
Reference Device(s)
Single-Site Cannula Seal (K152448), Stapler Cannula Seal (K113706)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"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."
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510(k) Summary (21 CFR § 807.92)
I. Submitter Information
| 510(k) Owner: | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|------------------------|-------------------------------------------------------------------------------------------------------------|
| Contact Person: | Taian Chen
Senior Regulatory Affairs Specialist
Phone: 650-302-8499
Email: 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
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.
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 |
| Regulation | ||
| Number and | ||
| Name | 21 CFR 876.1500, Endoscopes and | |
| Accessories | SAME as subject device | |
| Device | ||
| Classification | Class II | SAME as subject device |
| Classification | ||
| Advisory | ||
| Committee | General and Plastic Surgery | SAME as subject device |
| Intended Use | The Universal Seal (5-12 mm) | |
| supports a port of entry for | ||
| endoscopes, instruments, and | ||
| accessories. | SAME as subject device | |
| Indications for | ||
| Use | The da Vinci Trocar has application | |
| in a variety of endoscopic | ||
| procedures to provide a port of | ||
| entry for endoscopic instruments. | SAME as subject device | |
| Target | ||
| Population | 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 Device | |
| Universal Seal (5-12 mm) | Predicate Device | |
| Universal Seal (5-12 mm) | ||
| (K231358) | ||
| Representative | ||
| Images | SAME as subject device | |
| Mechanism of | ||
| Action | The Universal Seal (5-12 mm) is | |
| latched onto a da Vinci Cannula and | ||
| is intended to maintain insufflation | ||
| during procedure with or without an | ||
| endoscope, instrument, or accessory | ||
| inserted through the septum of the | ||
| Universal Seal. | SAME as subject device | |
| Compatibility | ||
| with the | ||
| environment | ||
| and other | ||
| devices | The device is compatible within the | |
| surgical operating room and | ||
| intended to be used with the da | ||
| Vinci Surgical System, endoscopic | ||
| instruments, and surgical | ||
| accessories. | SAME as subject device | |
| Interface | ||
| Compatibility | The Universal Seal (5-12 mm) | |
| provides a compatible interface for | ||
| the insertion of with da Vinci | ||
| endoscopes, instruments and | ||
| accessories alongside with, | ||
| laparoscopic instruments within the | ||
| diameter range. | SAME as subject device | |
| Design Features | Connectors: used to attach an | |
| on obturator or reducer to the | ||
| Universal Seal Latches: used to connect the | ||
| Universal Seal to a compatible | ||
| da Vinci Surgical System | ||
| cannula Port connector: provides a | ||
| connection point to an | ||
| insufflator Stopcock: a valve used to open | ||
| and close the gas pathway Septum Assembly: a port of | ||
| entry for endoscopes, | ||
| instruments, and accessories | SAME as subject device | |
| Attributes | Subject Device | |
| Universal Seal (5-12 mm) | Predicate Device | |
| Universal Seal (5-12 mm) | ||
| (K231358) | ||
| Overall | ||
| Dimensions | Housing size (diameter): 1.76 in Total height: 1.15 in | SAME as subject device |
| Packaging | ||
| Materials | Primary packaging material: | |
| Film | SAME as subject device | |
| Patient- | ||
| Contacting | ||
| Materials | Protective flaps: polyurethane Floating cylinder: | |
| polycarbonate, white Septum: polyisoprene, black, | ||
| proprietary formulation and | ||
| mold release Lubricant: silicone fluid Duckbill: polyisoprene, black, | ||
| proprietary formulation and | ||
| mold release Housing (upper & lower): | ||
| polycarbonate, white Latch: polycarbonate, grey Stopcock: high density | ||
| polyethylene, grey | SIMILAR as subject device Protective flaps: polyurethane Floating cylinder: | |
| polycarbonate, white Septum: polyisoprene, black proprietary formulation and | ||
| mold release, or Lubricant: silicone fluid Duckbill: polyisoprene, black proprietary formulation and | ||
| mold release Housing (upper & lower): | ||
| polycarbonate, white Latch: polycarbonate, grey Stopcock: high density | ||
| polyethylene, grey | ||
| Biocompatibility | All materials have been evaluated | |
| for 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 .
Image /page/6/Picture/8 description: The image shows the word "INTUITIVE" in blue font. There is a small circle above the letter "I". The font is sans-serif and the letters are evenly spaced. The image is simple and clean, with a focus on the text.
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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.
Image /page/7/Picture/5 description: The image shows the word "INTUITIVE" in blue font. There is a small circle above the letter "U". The font is sans-serif and the letters are evenly spaced. The image is simple and clean, with a focus on the text.