(206 days)
The EndoWrist® One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument. The EndoWrist One Vessel Sealer has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
The EndoWrist One Vessel Sealer is an electrosurgical sealing and cutting instrument to be used in conjunction with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. The outside diameter (O.D.) of the instrument shaft is 8.5 mm and the working length is 38 cm. The instrument is provided sterile and is a single-use, disposable device. The distal end has jaws with bipolar electrodes for sealing vessels and contains a cutting blade that extends through the jaws to transect sealed vessels and other tissues. The sealing and cutting functions are actuated by the daVinci Si Surgical System foot pedals. The ERBE VIO 300 D generator provides the high frequency (radio frequency) electrical current for tissue sealing.
Here's an analysis based on the provided 510(k) summary:
This 510(k) summary for the Intuitive Surgical EndoWrist® One Vessel Sealer is for clearance of a device that is stated to be identical in technological characteristics to a previously cleared predicate device (K110639). It also states that the proposed indications for use are a subset of another predicate device (K071728). In such cases, extensive new performance data may not be required beyond demonstrating equivalence and that the design outputs meet the design input requirements.
Therefore, the information regarding in-depth clinical studies, ground truth establishment, expert consensus, and sample sizes for AI/algorithm performance is not present in this 510(k) summary, as it is not a submission for an AI/ML powered device. Instead, the focus is on a traditional surgical instrument.
Acceptance Criteria and Device Performance
The provided document does not explicitly state numerical acceptance criteria in a table format, nor does it provide specific reported device performance metrics in the way one would for an AI/ML algorithm. Instead, it relies on demonstrating substantial equivalence to predicate devices.
The "acceptance criteria" can be inferred as the demonstration that the new device's design outputs meet its design input requirements and that its performance is equivalent to the predicate devices, not raising new questions of safety or effectiveness.
| Acceptance Criteria (Inferred from context) | Reported Device Performance |
|---|---|
| Design output meets design input requirements. | "Design validation... demonstrates that the subject device... meets the design input requirements." |
| Substantial equivalence to predicate device (EndoWrist® One Vessel Sealer K110639). | "Design validation and animal testing demonstrates that the subject device is substantially equivalent to the predicate devices." |
| Not raising different questions of safety or effectiveness compared to predicates. | "The differences do not raise different questions of safety or effectiveness as compared to the predicate devices." |
| Effective for bipolar coagulation and mechanical transection of vessels up to 7 mm. | Not explicitly quantified in a performance table, but implied by the intended use and equivalence to predicates cleared for this purpose. |
| Safe for use with da Vinci Si Surgical System and ERBE VIO 300 D generator. | Implied by design validation and substantial equivalence. |
Study Details (Based on available information)
-
Sample size used for the test set and the data provenance:
- The document mentions "Design validation and animal testing." It does not specify the sample size for this testing or the provenance of the data in terms of country of origin or whether it was retrospective or prospective. Animal testing is typically prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. The "ground truth" for a traditional surgical instrument would relate to its physical performance (e.g., ability to seal vessels, cut tissue, withstand stress), which is typically evaluated by engineers and veterinarians/surgeons in animal studies, not by expert interpretation of images or other data for establishing a medical diagnosis "ground truth."
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Adjudication method for the test set:
- Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation, not for evaluating the mechanical and electrosurgical performance of an instrument in design validation or animal testing.
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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:
- No. This is not an AI-powered device, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not conducted or reported.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI-powered device.
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The type of ground truth used:
- For this type of device, the "ground truth" would be established through a combination of engineering specifications, empirical measurements (e.g., burst pressure of sealed vessels, tissue cutting efficacy), and observations in animal models regarding the device's ability to perform its intended functions without adverse events. It would not be expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.
-
The sample size for the training set:
- Not applicable/Not provided. This is not an AI/ML device that requires a "training set."
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How the ground truth for the training set was established:
- Not applicable/Not provided. This is not an AI/ML device.
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K1302.66
Intuitive Surgical, Inc.
Traditional 510(k) EndoWrist® One Vessel Sealer
510(k) Summary [As Required by 21 CFR 807.92(c)]
| 510(k) Owner: | Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086 |
|---|---|
| Official Contact: | Crystal OngSr. Regulatory Affairs Specialist408-523-8636 (phone) |
408-523-8907 (fax)
AUG 2 9 2013
Date Summary Prepared: February 1, 2013
Trade Name: EndoWrist® One Vessel Sealer
| Common Name: | System, Surgical, Computer Controlled Instrument |
|---|---|
| Product Code: | NAY |
| Classification: | Endoscope and Accessories, 21 CFR 876.1500 |
Predicate Devices:
- Intuitive Surgical's EndoWrist® One Vessel Sealer(K110639) .
- Ethicon Endo-Surgery's EnSeal PTC (K071728) ●
Device Description:
The EndoWrist One Vessel Sealer is an electrosurgical sealing and cutting instrument to be used in conjunction with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. The outside diameter (O.D.) of the instrument shaft is 8.5 mm and the working length is 38 cm. The instrument is provided sterile and is a single-use, disposable device. The distal end has jaws with bipolar electrodes for sealing vessels and contains a cutting blade that extends through the jaws to transect sealed vessels and other tissues. The sealing and cutting functions are actuated by the daVinci Si Surgical System foot pedals.
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The ERBE VIO 300 D generator provides the high frequency (radio frequency) electrical current for tissue sealing.
Intended Use:
The EndoWrist® One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument. The EndoWrist One Vessel Sealer has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
Technological Characteristics:
The subject EndoWrist One Vessel Sealer is identical to the predicate EndoWrist One Vessel Sealer device in terms of technological characteristics. The proposed indications for use are a subset of the indications cleared for the Ethicon-EndoSurgery predicate device.
Performance Data:
Design validation and animal testing demonstrates that the subject device is substantially equivalent to the predicate devices and that the design output meets the design input requirements. The differences do not raise different questions of safety or effectiveness as compared to the predicate devices.
Summary:
Based on the intended use, indications for use, technological characteristics, and performance data, the Intuitive Surgical EndoWrist One Vessel Sealer is substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
August 29, 2013
Intuitive Surgical, Inc. Crystal Ong Sr. Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale. California 94086
Re: K130266
Trade/Device Name: EndoWrist One Vessel Sealer Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY Dated: July 16, 2013 Received: July 17, 2013
Dear Ms. Ong:
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 10 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 (sec 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 requirements, including, but not limited to: registration and listing (21
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Page 2 - Crystal Ong
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,
FOR
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
. Enclosure
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510(k) Number if known: K130266 Device Name: EndoWrist® One Vessel Sealer
INDICATIONS FOR USE:
The EndoWrist® One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument. The EndoWrist One Vessel Sealer has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
Prescription Use X AND/OR Over-the-Counter Use __ . (Per 21 CFR 801 Subpart D) (Per 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joshua C. Nipper -S
(Division Sign-off) Division of Surgical Devices 510(k) Number K130266
§ 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.