(153 days)
The IS4000 Harmonic ACE™ Curved Shears is intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is designed to be used in conjunction with the IS4000 (da Vinci Xi) Surgical Systems and a compatible Ethicon Endo - Surgery Generator and Hand Piece.
The IS4000 8 mm Harmonic ACE Curved Shears is a single-use, sterile instrument used to deliver ultrasonic energy to enable transection and coagulation of tissue. The movement and function of the IS4000 8 mm Harmonic ACE Curved Shears are controlled by the surgeon from the Surgeon Console of the da Vinci Xi Surgical System (model IS4000). The instrument is compatible with the Ethicon Hand Piece (model HP054) and Ethicon Endo-Surgery Generator (model G11).
The provided text describes the IS4000 8mm Harmonic ACE™ Curved Shears, a surgical instrument intended for soft tissue incisions. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device with extensive clinical trials. Therefore, the information typically requested for AI/algorithm-based devices (such as sample sizes for test sets, expert qualifications for ground truth, MRMC studies, standalone performance, and training set details) is largely absent as it is not relevant to this type of device submission.
Here's an analysis based on the provided text, addressing the points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document summarizes the performance tests and their results. The "acceptance criteria" are implied by the "Results" column, which consistently states "All final tests PASSED," indicating the device met its pre-defined requirements. Specific numerical acceptance criteria are not detailed in this summary.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Design Verification | Device meets dimensional, mechanical, functional, and electrical requirements/specs. | All final tests PASSED |
| Reliability (Life) | Instrument is robust in typical use environment (simulated clinical use, sterilization). | All final tests PASSED |
| Animal Testing | Device meets user needs and intended use as per Product Requirements. | All final tests PASSED |
| Human Factors/Usability | Safe and effective for intended users in intended use environment. | Usability is safe and effective (conclusion based on review and formative testing) |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Design Verification: "Sample sizes up to six units were used."
- Reliability (Life Test): "A sample size of six was used."
- Animal Testing: The document states "simulated clinical models (animal)" were used, but the specific sample size for animal testing is not explicitly mentioned beyond the general statement for "Design Validation."
- Data Provenance: The tests are internal performance tests conducted by Intuitive Surgical, Inc. They are not clinical studies in a traditional sense with country of origin data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable or provided. The tests described are engineering performance tests (dimensional, mechanical, electrical, reliability cycling) and animal model evaluations, not diagnostic or AI-based analyses requiring expert consensus for ground truth. User needs and intended use in animal testing would be evaluated by relevant veterinary or surgical professionals involved in the study, but their specific number or qualifications are not stated.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for expert review of images or cases to establish ground truth in diagnostic studies. The tests here relied on pre-defined test procedures and objective pass/fail criteria, indicating a direct measurement/observation approach rather than expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. These studies are specific to evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The device in question is a surgical instrument, not a diagnostic AI system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a surgical instrument controlled by a surgeon (human-in-the-loop with the da Vinci Xi Surgical System). There is no standalone algorithm performance to evaluate.
7. The Type of Ground Truth Used:
The "ground truth" for the various tests are:
- Design Verification: Engineering specifications, dimensional tolerances, mechanical performance requirements, electrical safety standards, functional requirements.
- Reliability (Life): Expected lifespan characteristics, satisfactory visual inspection, functional integrity after simulated use.
- Animal Testing: "User needs and intended use as documented in the Product Requirements document." This implies the "ground truth" is adherence to predefined functional and performance characteristics in a physiological environment, confirmed by observations during animal surgery.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines above them that could be interpreted as hair or wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 2, 2015
Intuitive Surgical Incorporated Ms. Nadine Nasr Senior Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086
Re: K143132
Trade/Device Name: IS4000 8mm Harmonic ACETM Curved Shears Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY Dated: February 23, 2015 Received: February 25, 2015
Dear Ms. Nasr.
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 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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 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 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,
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K143132
Device Name IS4000 8mm Harmonic ACETM Curved Shears
Indications for Use (Describe)
The IS4000 Harmonic ACE™ Curved Shears is intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is designed to be used in conjunction with the IS4000 (da Vinci Xi) Surgical Systems and a compatible Ethicon Endo - Surgery Generator and Hand Piece.
| 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
| 510(k) Owner: | Intuitive Surgical, Inc. |
|---|---|
| 1266 Kifer Road | |
| Sunnyvale, CA 94086 | |
| Contact: | Nadine Nasr |
| Regulatory Affairs | |
| Phone Number: 408-523-7093Fax Number: 408-523-8907 | |
| Email: Nadine.nasr@intusurg.com | |
| Date Summary Prepared: | March 31, 2015 |
| Trade Name: | IS4000 8 mm Harmonic ACE™ Curved Shears |
| Common Name: | System, Surgical, Computer Controlled Instrument (instrument,ultrasonic surgical) |
| Classification: | Class II |
| 21 CFR 876.1500, Endoscope and Accessories | |
| Product Codes: | NAY (System, Surgical, Computer Controlled Instrument) |
| Classification Advisory | |
| Committee: | General and Plastic Surgery |
| Predicate Device: | da Vinci 8 mm Harmonic ACE™ device, cleared under K112584 |
Device Description
The IS4000 8 mm Harmonic ACE Curved Shears is a single-use, sterile instrument used to deliver ultrasonic energy to enable transection and coagulation of tissue. The movement and function of the IS4000 8 mm Harmonic ACE Curved Shears are controlled by the surgeon from the Surgeon Console of the da Vinci Xi Surgical System (model IS4000). The instrument is compatible with the Ethicon Hand Piece (model HP054) and Ethicon Endo-Surgery Generator (model G11).
Intended Use/Indications for Use:
The IS4000 8 mm Harmonic ACE™ Curved Shears is intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is designed to be used in conjunction with the IS4000 (da Vinci Xi) Surgical System and a compatible Ethicon Endo-Surgery Generator and Hand Piece.
Image /page/3/Picture/8 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the words "SURGICAL" and the registered trademark symbol are also in light gray.
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Technological Characteristics:
In terms of intended use, indications for use, and technological characteristics, the IS4000 8 mm Harmonic ACE Curved Shears are substantially equivalent to the currently marketed da Vinci 8 mm Harmonic ACE device, cleared under K112584.
Performance Data:
Performance test data (bench and animal tests) demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements for the IS4000 8 mm Harmonic ACE Curved Shears. The testing conducted consisted of design verification, reliability, and animal testing.
Design Verification:
The testing provided in this submission consisted of dimensional measurements, mechanical, and functional verification.
| Test | Results |
|---|---|
| Design Verification –The purpose of this test was to verify that theinstrument met the dimensional, mechanical,functional, and electrical requirements andspecifications. Test methods were based onpre-defined test procedures, and objectivepass/fail criteria were defined in the protocoland used. Sample sizes up to six units wereused. The following design verification testswere performed:- Dimensional- Mechanical- Electrical- User/Equipment Interface- Cleaning and Sterilization- Packaging- Labeling | - All final tests PASSED |
Image /page/4/Picture/9 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is also in all caps and in a smaller font size, also in light gray. There is a yellow dot above the word "INTUITIVE".
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Reliability:
The testing provided in this submission consisted of simulated use cycling test articles through their typical use environment, including sterilization. The evaluation method included visual inspections as well as functional testing.
| Test | Results |
|---|---|
| Design Verification, Life –The purpose of this test was to verify that theinstrument was robust when exposed to atypical use environment. A sample size of sixwas used. Test articles were cycled throughsimulated clinical use, including the following:- Surgical Maneuvers and Tasks- Visual Inspection- Mechanical Stressing- Equipment Interface- RFID Functional Test | - All final tests PASSED |
Animal Testing:
The testing provided in this submission was performed using simulated clinical models (animal) to confirm that the IS4000 8 mm Harmonic ACE Curved Shears meets the user needs and intended use.
| Test | Summary |
|---|---|
| Design Validation –The purpose of this testing was to confirm thatthe IS4000 8 mm Harmonic ACE™ CurvedShears meets the user needs and intended useas documented in the Product Requirementsdocument. Test methods were based on pre-defined test procedures and objective pass/failcriteria were defined in the protocol and used. | All final tests PASSED |
Human Factors and Usability Testing:
After review of IS1200, and IS3000 da Vinci Harmonic instruments data (e.g., field actions, MDRs, etc.), an analysis of predicate device comparison, and formative usability testing of the IS4000 Harmonic ACE instrument, it was concluded that the usability of the IS4000 Harmonic ACE instrument, when used by the intended users in the intended use environment in foreseeable use scenarios, is safe and effective.
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Summary:
Based on the intended use, indications for use, technological characteristics, and the results of the verification and validation testing, the IS4000 8 mm Harmonic ACE Curved Shears meets all verification and validation requirements and is considered substantially equivalent to the predicate device.
Image /page/6/Picture/4 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in large, sans-serif, gray letters. Below that, in smaller letters, is the word "SURGICAL" also in gray. Above the word "INTUITIVE" is a small, yellow circle.
§ 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.