Intuitive Surgical® Endoscopic Instruments including scissors, scalpels, forceps/pick-ups, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing.
The subject device(s) consist of a family of endoscopic instruments with either grasping or cutting end effectors to be used with the Intuitive Surgical® da Vinci™ Endoscopic Instrument Control System. These instruments attach to the two instrument manipulator arms on the Intuitive Surgical® Endoscopic Instrument Control System. The instruments are re-usable (for a limited number of uses), are provided non-sterile, and must be cleaned and sterilized before use (pre-vacuum autoclave). Single-use scalpel blades are packaged sterile and provided separately. The instruments are programmed for a limited number of uses to ensure reliability and consistent performance, and have non-volatile "add-only" memory that the Instrument Control System decrements after each use.
The instruments attach to a re-usable, sterilizable adapter on the manipulator arm of the Endoscopic Instrument Control System to provide a barrier between the (sterile) instrument and the (non-sterile) manipulator arm. A mounting surface on the adapter provides a means to secure a sterile drape that covers the arm assembly. This allows instruments to be interchangeable during a procedure, without compromising the sterile barrier. When attached to the manipulator, the instrument is inserted through a cannula mounted to the manipulator.
All instruments have articulations at the distal end that are controlled by the surgeon. The instrument is the "wrist" of the system and provides four (4) degrees of freedom (wrist pitch, wrist yaw, roll and grip) and the manipulator arm provides an additional three (3) degrees of freedom (insertion, arm pitch, arm yaw) for a total of seven (7) degrees of freedom. The instruments described herein share similar architecture, materials, and manufacturing processes. The primary difference between the instruments is the tip end effector also known as a "grip". The device and accessories are essentially identical in size and shape to the referenced predicate device, and represent standard embodiments of surgical tools modified for use with the Intuitive Surgical® Endoscopic Instrument Control System.
The provided document is a 510(k) summary for the Intuitive Surgical EndoWrist™ Endoscopic Instruments, dated January 10, 2002. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive de novo clinical study results for novel AI-powered devices.
Therefore, the requested information pertaining to AI/algorithm performance (e.g., acceptance criteria for AI, MRMC studies, standalone algorithm performance, AI training/test set details) is not applicable to this submission. The device described here is a set of surgical instruments, not an AI or software as a medical device.
The "Performance Data" section explicitly states: "Design analysis and comparison as well as in vitro testing confirm that basic functional characteristics are substantially equivalent to the predicate device cited." This indicates that the validation occurred through engineering analysis and bench testing, not through human-in-the-loop studies or AI performance metrics.
Here's what can be extracted based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed reported performance metrics in a table format as would be typical for a new AI device or a novel functional device. Instead, it relies on demonstrating substantial equivalence to a predicate device through:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device | "Design analysis and comparison as well as in vitro testing confirm that basic functional characteristics are substantially equivalent to the predicate device cited.""The subject device(s) consist of a family of endoscopic instruments... These instruments attach to the two instrument manipulator arms on the Intuitive Surgical® da Vinci™ Endoscopic Instrument Control System.""The instruments [...] are essentially identical in size and shape to the referenced predicate device, and represent standard embodiments of surgical tools modified for use with the Intuitive Surgical® Endoscopic Instrument Control System." |
| Intended Use Equivalence to Predicate Device | "Intuitive Surgical® Endoscopic Instruments including scissors, scalpels, forceps/pick-ups, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing." (Matches predicate's intended use). |
| Technological Characteristics Equivalence to Predicate Device | "The technological characteristics of the subject devices are the same as for the predicate devices." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as this is not a study involving human data or a test set in the context of AI performance. The "test set" would refer to the instruments themselves undergoing engineering and in vitro (bench) testing. The document does not specify sample sizes for these tests, which is common for 510(k) summaries of traditional devices unless a specific performance claim requires it. Data provenance beyond "in vitro testing" is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth in this context would refer to engineering specifications and performance expectations for surgical instruments, not expert interpretation of medical images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for subjective interpretations, typically in clinical studies or expert review of data, which is not the case here.
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. No AI component is described in this device submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. No AI component is described in this device submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for these surgical instruments would be established through engineering specifications, design requirements, and in vitro performance testing confirming material properties, mechanical integrity, functional movement, and compatibility with the da Vinci™ system.
8. The sample size for the training set
Not applicable. There is no AI training set as this is not an AI device.
9. How the ground truth for the training set was established
Not applicable. There is no AI training set.
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KO13416
Section II
JAN 1 0 2002
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number:
| Date | October 12, 2001 |
|---|---|
| Submitter | Intuitive Surgical1340 West Middlefield RoadMountain View, CA 94043 |
| ER Number | 2955842 |
| Contact | Michael YramateguiDirector, Quality and Regulatory AffairsTelephone: 650-237-7048Fax: 650-526-2060e-mail: mike yramategui@intusurg.com |
| New Device | Name: EndoWrist™ Endoscopic InstrumentsClassification Name: Electrosurgical Cutting and Coagulation Deviceand AccessoriesCommon Name: Endoscopic Forceps/Graspers/NeedleDrivers/Scissors/Scalpels |
| PredicateDevices | da Vinci™ Endoscopic Instrument Control System(legally marketed under K965001/K990144/K002489/K011002) |
| DeviceDescription | The subject device(s) consist of a family of endoscopic instrumentswith either grasping or cutting end effectors to be used with theIntuitive Surgical® da Vinci™ Endoscopic Instrument ControlSystem. These instruments attach to the two instrument manipulatorarms on the Intuitive Surgical® Endoscopic Instrument ControlSystem. The instruments are re-usable (for a limited number ofuses), are provided non-sterile, and must be cleaned and sterilized |
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| DeviceDescription(continued) | uses), are provided non-sterile, and must be cleaned and sterilizedbefore use (pre-vacuum autoclave). Single-use scalpel blades arepackaged sterile and provided separately. The instruments areprogrammed for a limited number of uses to ensure reliability andconsistent performance, and have non-volatile "add-only" memorythat the Instrument Control System decrements after each use. |
|---|---|
| The instruments attach to a re-usable, sterilizable adapter on themanipulator arm of the Endoscopic Instrument Control System toprovide a barrier between the (sterile) instrument and the (non-sterile)manipulator arm. A mounting surface on the adapter provides ameans to secure a sterile drape that covers the arm assembly. Thisallows instruments to be interchangeable during a procedure, withoutcompromising the sterile barrier. When attached to the manipulator,the instrument is inserted through a cannula mounted to themanipulator. | |
| All instruments have articulations at the distal end that are controlledby the surgeon. The instrument is the "wrist" of the system andprovides four (4) degrees of freedom (wrist pitch, wrist yaw, roll andgrip) and the manipulator arm provides an additional three (3)degrees of freedom (insertion, arm pitch, arm yaw) for a total ofseven (7) degrees of freedom. The instruments described hereinshare similar architecture, materials, and manufacturing processes.The primary difference between the instruments is the tip end effectoralso known as a "grip". The device and accessories are essentiallyidentical in size and shape to the referenced predicate device, andrepresent standard embodiments of surgical tools modified for usewith the Intuitive Surgical® Endoscopic Instrument Control System. | |
| Intended Use | Intuitive Surgical® Endoscopic Instruments including scissors,scalpels, forceps/pick-ups, needle drivers and electrocautery areintended for endoscopic manipulation of tissue, including: grasping,cutting, blunt and sharp dissection, approximation, ligation,electrocautery and suturing. |
| Comparison toPredicateDevice | The Intuitive Surgical® EndoWrist™ Endoscopic Instrumentsdescribed herein are essentially identical in terms of shape, size,function, activation, and intended use to the predicate Class IIendoscopic instrument cited. |
| TechnologicalCharacteristics | The technological characteristics of the subject devices are the sameas for the predicate devices. |
| PerformanceData | Design analysis and comparison as well as in vitro testing confirmthat basic functional characteristics are substantially equivalent to thepredicate device cited. |
| Conclusion | Based upon the product technical information provided, intended use,and performance information provided in this pre-market notification,the Intuitive Surgical® EndoWrist™ Endoscopic Instrumentsdescribed herein have been shown to be substantially equivalent tothe current legally marketed predicate devices. |
!
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 0 2002
Intuitive Surgical, Inc. Michael Yramategui Director, Regulatory and Quality Affairs 1340 West Middlefield Road Mountain View, California 94043
Re: K013416
Trade Name: EndoWrist™ Endoscopic Instruments Regulation Number: 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: NAY Dated: October 12, 2001 Received: October 15, 2001
Dear Mr. Yramategui:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 such 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); 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.
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Page 2 - Mr. Michael Yramategui
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, «Misbranding by reference to premarket notification» (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Hupt Rhodes
Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section III
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device name: Intuitive Surgical™ EndoWrist™ Endoscopic Instruments
Indications for Use:
Intuitive Surgical® Endoscopic Instruments including scissors, scalpels, forceps/pick-ups, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing.
PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✗ | Over-the Counter Use | |
|---|---|---|---|
| ------------------ | --- | ---------------------- | -- |
(per 21 CFR §801.10) (Division Sign-Off) (Optional Format 1-2-96)
Division of General, Restorative and Neurological Devices
| 510(k) Number | K013416 |
|---|---|
| --------------- | --------- |
Intuitive Surgical®
CONFIDENTIAL
EndoWrist™ Endoscopic Instruments 510(k)
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.