(100 days)
The Intuitive Surgical da Vinci Harmonic ACE™ Device 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 da Vinci Surgical Systems (Model IS 1200, IS2000 and IS3000) and the Ethicon Endo-Surgery Generator 300 (Model GEN04) and Hand Piece (Model HP054).
The Intuitive Surgical Harmonic ACE™ Device is used to deliver ultrasonic energy to enable transection and coagulation of tissue. The proximal end of the device is a re-usable instrument housing and attaches to the da Vinci Surgical System. The distal end is a disposable insert which consists of a shaft and grip assembly. The instrument housing and disposable insert are assembled together, attached to the da Vinci Surgical System and connected to Ethicon's Endo-Surgery Generator 300 (Model GEN04) using the Hand Piece (Model HP054). When the Harmonic ACE™ Device is activated, it delivers ultrasonic energy and enables transection and coagulation of tissue. The instrument is available in 5mm and 8mm diameters and in two configurations: one for use with the da Vinci (IS1200); and the other for the da Vinci Surgical (122000/123000) Systems, respectively. The same disposable insert is used with all configurations of the instrument.
The provided text describes a 510(k) premarket notification for the Intuitive Surgical da Vinci Harmonic ACE™ Device. It states that "Performance tests (bench and animal lab tests) were conducted to demonstrate that the device is substantially equivalent to the predicate devices and that the design output meets the design input requirements."
However, this document does not provide specific acceptance criteria or detailed results of these performance tests. It states that the results "did not raise any new issues of safety or efficacy as compared to Intuitive Surgical's currently cleared Harmonic™ Curved Shears (K042855)," implying comparison to the predicate device's performance, but without detailing what those performance metrics or criteria were.
Therefore, many of the requested details cannot be extracted from this particular regulatory summary.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document. Typically, for a device like this, acceptance criteria would include metrics related to:Tissue Transection Time: Speed of cutting various tissue types.Coagulation Effectiveness: Ability to achieve hemostasis.Thermal Spread: Lateral thermal damage to adjacent tissues.Burst Pressure: Sealing strength for vessels.Mechanical Durability: Device lifetime, tip integrity.Electrical Safety: Compliance with standards. | The document broadly states that "Performance tests (bench and animal lab tests) were conducted to demonstrate that the device is substantially equivalent to the predicate devices and that the design output meets the design input requirements." It also notes that results "did not raise any new issues of safety or efficacy." No specific performance metrics or values are provided. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified. The document mentions "bench and animal lab tests" but does not give sample sizes for either.
- Data Provenance (e.g., country of origin, retrospective/prospective): Not specified. Animal lab tests would be prospective in nature, but no further details are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document. For a surgical device, "ground truth" might involve assessments by veterinary surgeons (for animal studies) or engineers/pathologists, but no details are given.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This information is not provided in the document.
5. 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
- Not applicable. This device is a surgical instrument (Harmonic ACE™ Device) and not an AI/imaging diagnostic device that would involve human "readers" or AI assistance in interpretation. The studies performed were performance tests (bench and animal lab tests) for device function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a surgical instrument and does not involve an algorithm working in "standalone" mode in the context of interpretation. Its performance is inherent to its mechanical and energy delivery capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The document does not explicitly state the "type of ground truth." For bench tests, it would likely involve objective measurements against engineering specifications (e.g., thermal cameras for thermal spread, load cells for cutting force, pressure sensors for burst pressure). For animal tests, it might involve histological examination (pathology) of tissue effects or direct observation of surgical outcomes. However, this is inferred, not stated.
8. The sample size for the training set
- Not applicable. This device does not use machine learning or AI that would require a "training set" in the traditional sense. The device's design is based on engineering principles and preclinical testing, not on learning from a dataset.
9. How the ground truth for the training set was established
- Not applicable. As there is no "training set" for an AI algorithm, this question is not relevant to the described device.
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K093217, Harmonic ACE™ Device
்
1793217 510(k) Summary [As Required by 21 CFR 807.92(c)]
| Date: | 12/22/09 | JAN 21 2010 |
|---|---|---|
| Submitter: | Intuitive Surgical, Inc.950 Kifer RoadSunnyvale, CA 94086 | |
| Official Contact: | Meghna SridharanRegulatory EngineerPh: (408) 523-2487Fax: (408) 523-1390Meghna.sridharan@intusurg.com | |
| Trade Name: | da Vinci Harmonic ACE™ Device• 5mm Harmonic ACE™ Instrument• 8mm Harmonic ACE™ Instrument• Disposable Harmonic ACE™ Insert | |
| Common Name: | Endoscopic Instrument, ultrasonic endoscopicinstrument | |
| Classification: | Endoscope and Accessories,21 CFR 876.1500, NAY(LFL) | |
| Predicate Device: | Intuitive Surgical, Inc.K042855, Harmonic™ Curved Shears InstrumentEthicon Endo-Surgery, Inc.K042777, Harmonic ACE™ with Hand Control | |
| Device Description: | The Intuitive Surgical Harmonic ACE™ Device isused to deliver ultrasonic energy to enabletransection and coagulation of tissue. Theproximal end of the device is a re-usableinstrument housing and attaches to the daVinci Surgical System. The distal end is adisposable insert which consists of a shaft andgrip assembly. The instrument housing anddisposable insert are assembled together,attached to the da Vinci Surgical System andconnected to Ethicon's Endo-SurgeryGenerator 300 (Model GEN04) using the HandPiece (Model HP054). When the HarmonicACE™ Device is activated, it delivers ultrasonic | |
| Intuitive Surgical, Inc. | Confidential | Page 3-2 |
Intuitive Surgical, Inc.
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K093217, Harmonic ACE™ Device
Intended Use:
ﻟﻘ
energy and enables transection and coagulation of tissue. The instrument is available in 5mm and 8mm diameters and in two configurations: one for use with the da Vinci (IS1200); and the other for the da Vinci Surgical ર /ડાં (122000/123000) Systems, respectively. The same disposable insert is used with all configurations of the instrument.
The Intuitive Surgical da Vinci Harmonic ACE™ Device 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 da Vinci Surgical Systems (Model IS1200, IS2000 and IS3000) and the Ethicon Endo-Surgery Generator 300 (Model GEN04) and Hand Piece (Model HP054).
Technological Characteristics: The subject device is equivalent in intended use, design and technology as compared to the predicate devices.
Performance Data: Performance tests (bench and animal lab tests) were conducted to demonstrate that the device is substantially equivalent to the predicate devices and that the design output meets the design input requirements. The results of the testing did not raise any new issues of safety or efficacy as compared to Intuitive Surgical's currently cleared Harmonic™ Curved Shears (K042855).
Summary: Based on the technical characteristics. intended use and performance test data, the Intuitive Surgical Harmonic ACE™ Device has been determined to be equivalent in safety, efficacy, and performance to the predicate devices.
Confidential
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
JAN 2 1 2010
Intuitive Surgical, Inc. % Ms. Meghna Sridharan Regulatory Engineer 950 Kifer Road Sunnyvale, California 94086
Re: K093217
Trade/Device Name: da Vinci Harmonic ACE™ Device Regulation Number: 21 CFR 876-1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY Dated: December 22, 2009 Received: December 23, 2009
Dear Ms. Sridharan:
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.
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
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Page 2 - Ms. Meghna Sridharan
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/CDRH/CDRHOffices/ucm1.15809.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/cdrl/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours.
erely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
1093217 510(k) Number if known:
Device Name: da Vinci Harmonic ACE™ Device
INDICATION FOR USE:
The Intuitive Surgical da Vinci Harmonic ACE™ Device 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 da Vinci Surgical Systems (Model IS 1200, IS2000 and IS3000) and the Ethicon Endo-Surgery Generator 300 (Model GEN04) and Hand Piece (Model HP054).
Prescription Use _ X (Per 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (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)
Page 1 of 1
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number k09347
§ 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.