(153 days)
Not Found
No
The document describes a surgical instrument that uses ultrasonic energy for tissue manipulation, controlled directly by a surgeon. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
A therapeutic device is one that treats a disease or condition. This device is used for surgical incisions, which is a procedure rather than a treatment of a disease by the device itself.
No
The device is described as surgical shears used for tissue incision and coagulation, not for diagnosing medical conditions.
No
The device is a physical surgical instrument (Harmonic ACE™ Curved Shears) that delivers ultrasonic energy for tissue transection and coagulation. While it is controlled by a surgical system (da Vinci Xi), the device itself is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "soft tissue incisions when bleeding control and minimal thermal injury are desired." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device "deliver[s] ultrasonic energy to enable transection and coagulation of tissue." This is a surgical tool used for cutting and sealing tissue during surgery.
- Anatomical Site: The anatomical site is "soft tissue," which refers to tissues within the body.
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue samples) taken from the human body to provide information for diagnosis, monitoring, or screening.
This device is clearly designed for use within the body during surgery, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
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 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.
Product codes
NAY
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon from the Surgeon Console of the da Vinci Xi Surgical System (model IS4000)
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)
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: Design Verification – The purpose of this test was to verify that the instrument met the dimensional, mechanical, functional, and electrical requirements and specifications. Test methods were based on pre-defined test procedures, and objective pass/fail criteria were defined in the protocol and used. Sample sizes up to six units were used. The following design verification tests were performed: - Dimensional - Mechanical - Electrical - User/Equipment Interface - Cleaning and Sterilization - Packaging - Labeling.
Results: All final tests PASSED
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: Design Verification, Life – The purpose of this test was to verify that the instrument was robust when exposed to a typical use environment. A sample size of six was used. Test articles were cycled through simulated clinical use, including the following: - Surgical Maneuvers and Tasks - Visual Inspection - Mechanical Stressing - Equipment Interface - RFID Functional Test.
Results: 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: Design Validation – The purpose of this testing was to confirm that the IS4000 8 mm Harmonic ACE™ Curved Shears meets the user needs and intended use as documented in the Product Requirements document. Test methods were based on pre-defined test procedures and objective pass/fail criteria were defined in the protocol and used.
Summary: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
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
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"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."
3
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.
4
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 the | |
| instrument met the dimensional, mechanical, | |
| functional, and electrical requirements and | |
| specifications. Test methods were based on | |
| pre-defined test procedures, and objective | |
| pass/fail criteria were defined in the protocol | |
| and used. Sample sizes up to six units were | |
| used. The following design verification tests | |
| were 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".
5
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 the | |
| instrument was robust when exposed to a | |
| typical use environment. A sample size of six | |
| was used. Test articles were cycled through | |
| simulated 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 that | |
| the IS4000 8 mm Harmonic ACE™ Curved | |
| Shears meets the user needs and intended use | |
| as documented in the Product Requirements | |
| document. Test methods were based on pre- | |
| defined test procedures and objective pass/fail | |
| criteria 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.
6
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.