(154 days)
Not Found
No
The summary describes a surgical instrument (needle driver) and its accessories for use with an existing surgical system. There is no mention of AI or ML in the intended use, device description, or performance studies. The performance studies focus on mechanical, functional, and clinical equivalence through bench, animal, and cadaver testing, not on algorithmic performance.
Yes
The device is used for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery, and suturing during surgical procedures, which are all therapeutic interventions.
No
Explanation: The device is indicated for surgical procedures (manipulation of tissue, grasping, cutting, dissection, suturing) and does not perform any diagnostic functions.
No
The device description explicitly details physical components like instruments, cannulae, obturators, and a port, and the performance studies involve testing of these physical components (dimensional measurements, mechanical and functional verification, simulated use in animal and cadaver models). This indicates it is a hardware device with potentially integrated software, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for "endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery, and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy". These are all surgical procedures performed on the patient's body.
- Device Description: The description details surgical instruments like graspers, dissectors, needle drivers, scissors, cannulae, and a port. These are tools used for physical manipulation and intervention during surgery.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The device is a surgical instrument used in vivo (within the living body) during surgical procedures.
N/A
Intended Use / Indications for Use
The Intuitive Surgical® da Vinci® Single-Site™ Instruments and Accessories used with the da Vinci® Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery, and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the Single-Site™ Port.
The Single-Site™ Wristed Needle Driver instrument is intended to be used with the da Vinci@ Si™ Surgical System (IS3000) to perform needle driving and suture tying tasks.
Product codes
NAY
Device Description
The da Vinci® Single-Site™ Instruments and Accessories consist of semi-rigid shaft instruments, two fixed-shape curved cannulae sets (250 mm and 300 mm lengths), an accessory cannula for insertion of manual laparoscopic instruments, semi-rigid blunt obturators (250 mm and 300 mm lengths), a rigid 10 mm Blunt Obturator, and a Single-Site™ Port (with insufflation adapter and stopcock) for the placement and insertion of multiple cannulae/instruments through a single incision.
The da Vinci® Single-Site™ Instruments and Accessories include instruments to perform manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clipligation, electrocautery, and suturing. The da Vinci® Single-Site™ Instruments and Accessories are intended to be used with the existing da Vinci® Si™ Surgical System (IS3000).
The subject device, Single-Site™ Wristed Needle Driver (P/N 428115), is a new addition to the Single-Site™ Instruments and Accessories family. It is a resposable endoscopic instrument used in conjunction with the da Vinci® Si™ Surgical System (IS3000) to handle needles and suture during endoscopic surgical procedures. The distal end configuration of the instrument includes a straight grip and a wrist to enable articulation of the grip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physicians in an operating room environment
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 data (bench, animal and cadaver testing) demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. The tests included dimensional measurements, mechanical and functional verification, and simulated use in animal and cadaver models.
Bench Verification:
- Purpose / Scope: Verification that the design of the instrument meets its physical, mechanical, electrical, user interface, and equipment interface requirements.
- # of Test Samples: Five (5)
- Models: Bench Testing
- Test Methodology: Physical measurements, verification of mechanical requirements, functional performance requirements, electrical requirements, user interface requirements, and equipment interface requirements.
Reliability (life) Testing:
- Purpose / Scope: Testing to demonstrate that the instrument will operate properly throughout its intended life of five uses.
- # of Test Samples: Eight
- Models: Bench testing
- Test Methodology: Instruments are subjected to repeated cycles of simulated life, including cleaning, sterilization, and simulated surgical tasks that mimic actual maneuvers performed during minimally invasive surgical operations. Performance requirements are evaluated during each cycle and more extensive mechanical measurements are done at cycles #1, #5, and #7, to confirm performance remains within specification.
Cadaver and Animal Validations (Design Validation Testing):
- Purpose / Scope: Confirm that instrument meets product requirements, specifications, and user needs.
- # of Test Samples: Two (2)
- Models Used: Cadaver (3) and animal (2)
- Test Methodology: Utilize instrument in representative uses to confirm that device meets general clinical use requirements, performance, functionality, compatibility, and user-related requirements.
- Results: A cadaver model was used to demonstrate clinical performance for anatomical access and reach. A live animal model was used to assess safety and performance in cases where a live tissue model was appropriate. The live animal model replicates factors experienced during clinical use, including working with perfused organs, bleeding, normal tissue handling, and ensure that appropriate hemostasis is achieved and maintained. For design validation, the cadaver model allowed evaluation of vaginal cuff closure, and a live porcine model allowed evaluation of suturing live tissue that is representative of dense muscular tissue, similar to the vaginal cuff.
Equivalence Testing – Cadaver:
- Purpose / Scope: Demonstrate substantial equivalence of addition of a wrist to the needle driver instrument (Single-Site Wristed Needle Driver).
- Comparison Device(s): Single-Site Curved Needle Driver
- Models used / Evaluation areas: The ability to perform a complete procedure (benign hysterectomy with bilateral salpingo-oophorectomy) was evaluated using a cadaver model. Cadavers were used to represent human anatomy and size, and to confirm that the instrument can adequately access the necessary structures and perform the complete procedure. Comparison of the safety and performance of the applicable needle driver to the comparative device was done as follows: Ability to perform a vaginal cuff closure in a cadaver model.
- Evaluators / Number of Evaluators: 5 independent surgeons (5 cadavers)
- Procedures / Tasks evaluated: Full Procedures: Benign hysterectomy with bilateral salpingo-oophorectomy (n=5). Cadaver suturing task: Vaginal cuff closure (n=11).
- Procedure Completion: Confirmation that surgeon was able to complete full procedure.
- Suture Line Quality and Effectiveness: Likert Scale and yes/no questions used to compare surgeons visual assessment of quality and effectiveness of the suture lines. Intraoperative measurements: Tissue Bite, Number of stitches, Distance between stitches, Closure completion time.
- Suturing Task Elements: Likert Scale used to compare the ability to perform suturing tasks.
- Ease of Use: Subjective surgeon assessment of ability to perform task/procedure.
- Safety Assessments: Study observer, surgeon participant, and independent reviewer assessments: Ability to operate safely, Any instances of harm.
Equivalence Testing - Animal:
- Purpose / Scope: Demonstrate substantial equivalence of addition of a wrist to the needle driver instrument (Single-Site Wristed Needle Driver).
- Comparison Device(s): Single-Site Curved Needle Driver
- Models used / Evaluation areas: Comparison of the safety and performance of the applicable needle driver to the comparative device was done as follows: Ability to perform applicable suturing tasks in a live porcine model. Live animals (porcine) were used to represent the effects of live tissue during clinical use and compare performance and safety for representative suturing tasks.
- Evaluators / Number of Evaluators: 5 independent surgeons (5 animals)
- Procedures / Tasks evaluated: Porcine suturing task: Uterine horn hysterotomy closure (n=15, 3/surgeon). Surgeon's assessment (yes/no) and Likert Scale questions used to compare quality and effectiveness of the suture lines.
- Suture Line Quality and Effectiveness: Intraoperative measurements: Tissue Bite, Number of stitches, Distance between stitches, Closure completion time.
- Suturing Task Elements: Likert Scale used to compare the ability to perform suturing tasks.
- Ease of Use: Subjective surgeon assessment of ability to perform task/procedure.
- Safety Assessments: Study observer, surgeon participant, and independent reviewer assessments: Ability to operate safely, Any instances of harm.
Clinical Evaluation:
No clinical testing was provided with this submission using the subject device. Safety, effectiveness and substantial equivalence were demonstrated through bench testing, cadaver and animal validations, and comparison testing, performed with the subject device.
Key Results:
- The device can perform its intended function
- The device can perform the surgical tasks proposed in the Indications for Use safely and effectively
- The clinical performance and safety of the device is equivalent to the predicate device
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Single-Site™ Curved Needle Driver (K122532)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing right, with flowing lines that resemble hair or ribbons.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 26, 2014
Intuitive Surgical Incorporated Ms. Einav Yemini Associate Regulatory Engineer 1266 Kifer Road Sunnyvale, California 94086
Re: K141075
Trade/Device Name: Single-Site™ Wristed Needle Driver Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY Dated: August 22, 2014 Received: August 27, 2014
Dear Ms. Yemini:
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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Precautions/Warnings/Contraindications section of the device's labeling:
1
The safety and effectiveness of this device for use in the performance of general laparoscopic abdominal surgery or general gynecological surgery procedures have not been established. This device is only intended to be used for single incision laparoscopic cholecystectomy, benign hysterectomy, and salpingo-oophorectomy with the da Vinci Single Site Instruments and the da Vinci Si Surgical System (IS3000).
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
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 [SELECT ONE: Part 801 [OR, for IVDs only] Parts 801 and 809 ] ); medical device 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 (Part 801), please contact 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. 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.
2
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,
William H. Maisel -S
William H. Maisel, MD, MPH Director, Office of Device Evaluation (Acting) Deputy Center Director for Science Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) Not known. To be assigned.
Device Name Single-Site® Wristed Needle Driver
Indications for Use (Describe)
The Intuitive Surgical® da Vinci® Single-Site™ Instruments and Accessories used with the da Vinci® Si Surgical System (133000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the Single-Site Port.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (1/14)
PSC Publishing Services (301) 443-6740
4
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."
FORM FDA 3881 (1/14)
5
510(k) Summary [As Required by 21 CFR 807.92(c)]
| 510(k) Owner: | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Einav Yemini
Associate Regulatory Engineer
408-523-2656 (phone)
408-523-8907 (fax)
einav.yemini@intusurg.com |
| Date Summary Prepared: | August 22, 2014 |
| Trade Name: | Single-Site™ Wristed Needle Driver |
| Common Name: | Endoscope and accessories |
| Product Code: | NAY |
| Classification: | Class II
Endoscope and Accessories, 21 CFR 876.1500 |
| Classification Advisory
Committee: | General and Plastic Surgery |
| Predicate Devices: | Single-Site™ Curved Needle Driver (K122532) |
Device Description:
The da Vinci® Single-Site™ Instruments and Accessories consist of semi-rigid shaft instruments, two fixed-shape curved cannulae sets (250 mm and 300 mm lengths), an accessory cannula for insertion of manual laparoscopic instruments, semi-rigid blunt obturators (250 mm and 300 mm lengths), a rigid 10 mm Blunt Obturator, and a Single-Site™ Port (with insufflation adapter and stopcock) for the placement and insertion of multiple cannulae/instruments through a single incision.
6
The da Vincio Single-Site™ Instruments and Accessories include instruments to perform manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clipligation, electrocautery, and suturing. The da Vincio Single-Site™ Instruments and Accessories are intended to be used with the existing da Vinci® Si™ Surgical System (IS3000).
The subject device, Single-Site™ Wristed Needle Driver (P/N 428115), is a new addition to the Single-Site" Instruments and Accessories family. It is a resposable endoscopic instrument used in conjunction with the da Vinci® Si " Surgical System (IS3000) to handle needles and suture during endoscopic surgical procedures. The distal end configuration of the instrument includes a straight grip and a wrist to enable articulation of the grip.
Intended Use:
The Single-Site™ Wristed Needle Driver instrument is intended to be used with the da Vinci@ Si" Surgical System (IS3000) to perform needle driving and suture tying tasks.
Indications for Use
The Intuitive Surgical® da Vincio Single-Site™ Instruments and Accessories used with the da Vinci@ Si™ Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery, and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingooophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the Single-Site™ Port.
The indications for use are unchanged from the predicate (K122532).
Technological Characteristics
The Single-Site™ Wristed Needle Driver instrument is substantially equivalent to the cleared Single-Site™ Curved Needle Driver (K122532). The design of the Single-Site Wristed Needle Driver is a modification of the da Vinci@ Single-Site" Curved Needle Driver (K122532) to incorporate a wrist at the distal end of the instrument. The wrist provides additional range of motion and facilitates suturing tasks. Additionally, the grip configuration was revised from a curved to a straight grip. The Single-Site" Wristed Needle Driver is equivalent to the predicate Single-Site" Curved Needle Driver in terms of its technological characteristics, and the intended use is identical.
7
Performance Data
Performance data (bench, animal and cadaver testing) demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. The tests included dimensional measurements, mechanical and functional verification, and simulated use in animal and cadaver models as follow.
Bench Verification
The Single-Site™ Wristed Needle Driver instrument was subjected to design verification and reliability (life) testing to evaluate performance and demonstrate that the design output meets design input requirements. The tables below provide a summary of the bench verification testing.
| Category | Description |
|---|---|
| Purpose / Scope | Verification that the design of the instrument meets its physical, |
| mechanical, electrical, user interface, and equipment interface | |
| requirements. | |
| # of Test Samples | Five (5) |
| Models | Bench Testing |
| Test Methodology | Physical measurements, verification of mechanical requirements, |
| functional performance requirements, electrical requirements, user | |
| interface requirements, and equipment interface requirements. |
Design Verification Testing
Reliability (life) Testing
| Category | Description |
|---|---|
| Purpose / Scope | Testing to demonstrate that the instrument will operate properly |
| throughout its intended life of five uses. | |
| # of Test Samples | Eight |
| Models | Bench testing |
| Test Methodology | Instruments are subjected to repeated cycles of simulated life, including |
| cleaning, sterilization, and simulated surgical tasks that mimic actual | |
| maneuvers performed during minimally invasive surgical operations. |
Performance requirements are evaluated during each cycle and more
extensive mechanical measurements are done at cycles #1, #5, and #7, to
confirm performance remains within specification. |
8
Cadaver and Animal Validations
A cadaver model was used to demonstrate clinical performance for anatomical access and reach. A live animal model was used to assess safety and performance in cases where a live tissue model was appropriate. The live animal model replicates factors experienced during clinical use, including working with perfused organs, bleeding, normal tissue handling, and ensure that appropriate hemostasis is achieved and maintained.
For design validation, the cadaver model allowed evaluation of vaginal cuff closure, and a live porcine model allowed evaluation of suturing live tissue that is representative of dense muscular tissue, similar to the vaginal cuff. The table below provides a summary of the design validation testing.
| Category | Description |
|---|---|
| Purpose / Scope | Confirm that instrument meets product requirements, specifications, and user needs |
| # of Test Samples | Two (2) |
| Models Used | Cadaver (3) and animal (2) |
| Test Methodology | Utilize instrument in representative uses to confirm that device meets general clinical use requirements, performance, functionality, compatibility, and user-related requirements |
Design Validation Testing
For equivalency testing, five (5) independent practicing surgeons participated in a study completing a comprehensive set of suturing tasks using both the Single-Site™ Wristed Needle Driver (subject) and the Single-Site™ Curved Needle Driver (predicate). With each instrument, each surgeon completed at least two gynecologic suturing tasks in cadaver models and three gynecologic suturing tasks in porcine models, for a total of 52 completed suturing tasks with both instruments. Surgeons completed questionnaires that evaluated the suturing performance, suture line quality, and safety with the each needle driver; study observers recorded objective assessments of the suture lines quality. The tables below provide a summary of the equivalence testing.
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| Category | Description |
|---|---|
| Purpose / Scope | Demonstrate substantial equivalence of addition of a wrist to the |
| needle driver instrument ( Single-Site Wristed Needle Driver ). | |
| Comparison Device(s) | Single-Site Curved Needle Driver |
| Models used / | |
| Evaluation areas | The ability to perform a complete procedure (benign hysterectomy |
| with bilateral salpingo-oophorectomy) was evaluated using a | |
| cadaver model. Cadavers were used to represent human anatomy | |
| and size, and to confirm that the instrument can adequately access | |
| the necessary structures and perform the complete procedure. | |
| Comparison of the safety and performance of the applicable needle | |
| driver to the comparative device was done as follows: | |
| • Ability to perform a vaginal cuff closure in a cadaver model. | |
| Evaluators / Number of | |
| Evaluators | 5 independent surgeons (5 cadavers) |
| Procedures / Tasks | |
| evaluated | Full Procedures: |
| Benign hysterectomy with bilateral salpingo- oophorectomy (n=5) | |
| Cadaver suturing task: | |
| Vaginal cuff closure (n=11) | |
| Procedure Completion | Confirmation that surgeon was able to complete full procedure |
| Suture Line Quality and | |
| Effectiveness | Likert Scale and yes/no questions used to compare surgeons visual |
| assessment of quality and effectiveness of the suture lines. | |
| Intraoperative measurements: | |
| • Tissue Bite | |
| • Number of stitches | |
| • Distance between stitches | |
| • Closure completion time | |
| Suturing Task Elements | Likert Scale used to compare the ability to perform suturing tasks. |
| Ease of Use | Subjective surgeon assessment of ability to perform task/procedure |
| Safety Assessments | Study observer, surgeon participant, and independent reviewer |
| assessments | |
| • Ability to operate safely | |
| • Any instances of harm |
Equivalence Testing – Cadaver
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| Category | Description |
|---|---|
| Purpose / Scope | Demonstrate substantial equivalence of addition of a wrist to the needle driver instrument ( Single-Site Wristed Needle Driver ). |
| Comparison Device(s) | Single-Site Curved Needle Driver |
| Models used / Evaluation areas | Comparison of the safety and performance of the applicable needle driver to the comparative device was done as follows: |
| • Ability to perform applicable suturing tasks in a live porcine model. | |
| Live animals (porcine) were used to represent the effects of live tissue during clinical use and compare performance and safety for representative suturing tasks. | |
| Evaluators / Number of Evaluators | 5 independent surgeons (5 animals) |
| Procedures / Tasks evaluated | Porcine suturing task: |
| Uterine horn hysterotomy closure (n=15, 3/surgeon) | |
| Surgeon's assessment (yes/no) and Likert Scale questions used to compare quality and effectiveness of the suture lines. | |
| Suture Line Quality and Effectiveness | Intraoperative measurements: |
| • Tissue Bite | |
| • Number of stitches | |
| • Distance between stitches | |
| • Closure completion time | |
| Suturing Task Elements | Likert Scale used to compare the ability to perform suturing tasks. |
| Ease of Use | Subjective surgeon assessment of ability to perform task/procedure |
| Safety Assessments | Study observer, surgeon participant, and independent reviewer assessments |
| • Ability to operate safely | |
| • Any instances of harm |
Equivalence Testing - Animal
Clinical Evaluation
No clinical testing was provided with this submission using the subject device. Safety, effectiveness and substantial equivalence were demonstrated through bench testing, cadaver and animal validations, and comparison testing, performed with the subject device. The testing performed demonstrated that:
- The device can perform its intended function ●
- The device can perform the surgical tasks proposed in the Indications for Use . safely and effectively
- The clinical performance and safety of the device is equivalent to the predicate . device
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Human Factors Evaluation
Risk analysis was performed for Human Factors. No human factors testing was provided with this submission using the subject device. The device does not include any new user interfaces and does not present any new usability risks compared to the predicate.
Conclusion
Based on the intended use, indications for use, technological characteristics, and performance data, the Single-Site™ Wristed Needle Driver is substantially equivalent (SE) to the predicate device. This SE determination is based on bench testing including reliability testing, animal/cadaver validation, simulated clinical procedures in live animals, and human factors assessment. The bench/reliability testing verified that the design requirements and specifications for the new and/or changed components of the instrument were met. The animal and cadaver validation demonstrated the users' ability to use the system to accurately control the instrument, to reach the necessary target anatomy, and to perform the surgical task. The simulated clinical procedures in cadavers and live animals provided clinical validation that the instrument can safely and effectively complete surgical tasks in procedure steps encompassed by the Indications for Use statement.