(87 days)
No
The description focuses on the mechanical and control aspects of the instruments and their interaction with the robotic system, with no mention of AI or ML for image processing, decision support, or other functions. The "programmed for a limited number of uses" and "non-volatile 'add-only' memory" describe simple usage tracking, not AI/ML.
Yes.
The device includes tools like scissors, scalpels, and forceps, which are used for manipulating tissue, including cutting, grasping, and dissecting, thus directly providing a therapeutic effect during surgical procedures.
No
The device description and intended use clearly state that it is a surgical instrument used for manipulating tissue, not for diagnosing conditions.
No
The device is described as physical endoscopic instruments with grasping or cutting end effectors, made of materials, and requiring cleaning and sterilization. It also has physical components like memory and articulations. While it interacts with a control system, the device itself is a physical medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing." This describes surgical procedures performed directly on a patient's tissue.
- Device Description: The device is described as endoscopic instruments with grasping or cutting end effectors used with a surgical system. It's a tool for performing physical actions during surgery.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided text does not mention any testing of samples or diagnostic purposes.
The device is clearly intended for surgical intervention and manipulation of tissue in vivo, not for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes
NAY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Design analysis and comparison as well as in vitro testing confirm that basic functional characteristics are substantially equivalent to the predicate device cited.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
da Vinci™ Endoscopic Instrument Control System (legally marketed under K965001/K990144/K002489/K011002)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 Surgical |
| 1340 West Middlefield Road | |
| Mountain View, CA 94043 | |
| ER Number | 2955842 |
| Contact | Michael Yramategui |
| Director, Quality and Regulatory Affairs | |
| Telephone: 650-237-7048 | |
| Fax: 650-526-2060 | |
| e-mail: mike yramategui@intusurg.com | |
| New Device | Name: EndoWrist™ Endoscopic Instruments |
| Classification Name: Electrosurgical Cutting and Coagulation Device | |
| and Accessories | |
| Common Name: Endoscopic Forceps/Graspers/Needle | |
| Drivers/Scissors/Scalpels | |
| Predicate | |
| Devices | da Vinci™ Endoscopic Instrument Control System |
| (legally marketed under K965001/K990144/K002489/K011002) | |
| Device | |
| Description | 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 |
1
| Device
Description
(continued) | 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. |
| Intended 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. |
| Comparison to
Predicate
Device | The Intuitive Surgical® EndoWrist™ Endoscopic Instruments
described herein are essentially identical in terms of shape, size,
function, activation, and intended use to the predicate Class II
endoscopic instrument cited. |
| Technological
Characteristics | The technological characteristics of the subject devices are the same
as for the predicate devices. |
| Performance
Data | Design analysis and comparison as well as in vitro testing confirm
that basic functional characteristics are substantially equivalent to the
predicate 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 Instruments
described herein have been shown to be substantially equivalent to
the current legally marketed predicate devices. |
!
2
3
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.
4
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
5
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)