(207 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical functions (grasping, cutting, cautery) and do not mention any computational or data-driven features indicative of AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is used for grasping, mobilization, dissection, and transection of tissue, which are surgical procedures, not therapeutic applications.
No
The device description clearly states its purpose is for "grasping, mobilization, dissection and transection of tissue" during surgical procedures, and it also includes a cautery function. These are all therapeutic or interventional actions, not diagnostic ones.
No
The device description clearly details physical instruments with shafts, handles, jaws, blades, and a cautery connector, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the instruments are for "grasping, mobilization, dissection and transection of tissue" during minimally invasive procedures. This describes a surgical tool used directly on the patient's body.
- Device Description: The description details a surgical instrument with features like a rotating shaft, jaws/blades, and a cautery connector. These are characteristics of surgical devices, not devices used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The ENDOPATH Endoscopic Instruments do not fit this description.
N/A
Intended Use / Indications for Use
The ENDOPATH Endoscopic Instruments have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection and transection of tissue.
Product codes
GEI
Device Description
The ENDOPATH Endoscopic Instruments are sterile, single patient use instruments designed for use through appropriate ENDOPATH Surgical Trocars and FLEXIPATH® Flexible Surgical Trocars. The instruments have a rotating insulated shaft with a diameter of either 3mm, 5mm or 10mm. The rotation knob located on the handle rotates the shaft 360 degrees in either direction. The ring handles are compressed and released to activate the instrument jaws or scissor blades. Each of the curved scissors and dissectors has a monopolar cautery connector that extends from the top of the handle. The connector is used for electrosurgery when properly attached to a standard cautery cable and a proper generator.
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)
Pre-clinical data were used to evaluate the performance to ensure that the device can be used as designed. The studies demonstrated acceptable performance to the Predicate Device in reliability and design. The performance evaluated are ergonomics of the handle and rotating knob tissue trauma, grasping, dissecting, cauterizing ability and cutting ability. From the date generated, it can be concluded that the New Device performs equivalent to the Predicate Device.
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
§ 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
K 984240
JUN 22 2 1999
510(k) Summary of Safety and Effectiveness
| Submitter | Ethicon Endo-Surgery, Inc.
4545 Creek Rd.
Cincinnati, OH 45242 |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Jackie A. Strasser, MT (ASCP), MS
Regulatory Affairs Associate
Telephone (513) 786-7978 Fax (513) 786-7134 |
| Date | November 23, 1998 |
| New Device | Name: ENDOPATH® Endoscopic InstrumentsClassification Name: Electrosurgical Cutting and Coagulation Device and AccessoriesCommon Name: Laparoscopic Surgical InstrumentsTrade Name/Proprietary Name: ENDOPATH® Endoscopic Instruments |
| Legally
marketed
device | The Predicate Device legally marketed under K910831:
[Symbiosis] ENDOPATH Endoscopic Instruments |
| Device
description | The ENDOPATH Endoscopic Instruments are sterile, single patient use instruments designed for use through appropriate ENDOPATH Surgical Trocars and FLEXIPATH® Flexible Surgical Trocars. The instruments have a rotating insulated shaft with a diameter of either 3mm, 5mm or 10mm. The rotation knob located on the handle rotates the shaft 360 degrees in either direction. The ring handles are compressed and released to activate the instrument jaws or scissor blades. Each of the curved scissors and dissectors has a monopolar cautery connector that extends from the top of the handle. The connector is used for electrosurgery when properly attached to a standard cautery cable and a proper generator. |
Continued on next page
1
:
:
510(k) Summary of Safety and Effectiveness, Continued
| Intended use | The ENDOPATH Endoscopic Instruments have application in a variety of
minimally invasive procedures to facilitate grasping, mobilization, dissection
and transection of tissue. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
characteristics | The technological characteristics of the New Device are the same as the
Predicate Device. |
| Performance
data | Pre-clinical data were used to evaluate the performance to ensure that the
device can be used as designed. The studies demonstrated acceptable
performance to the Predicate Device in reliability and design. The
performance evaluated are ergonomics of the handle and rotating knob tissue
trauma, grasping, dissecting, cauterizing ability and cutting ability. From the
date generated, it can be concluded that the New Device performs equivalent
to the Predicate Device. |
| Conclusion | Based on the information provided herein and the Decision-Making Process
Chart (Appendix E), we conclude that the New Device is substantially
equivalent to the Predicate Device under the Federal Food, Drug and
Cosmetic Act. |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol in the center. The symbol resembles a stylized caduceus, featuring a staff with intertwined snakes and a pair of wings at the top. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 22 1999
Ms. Jackie A. Strasser, MT (ASCP), MS Associate, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242
Re: K984240
. .
Trade Name: ENDOPATH® Endoscopic Instruments Regulatory Class: II Product Code: GEI Dated: March 22, 1999 Received: March 24, 1999
Dear Ms. Strasser:
We have reviewed your Section 510(k) 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Jackie A. Strasser, MT (ASCP), MS
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
focottefa
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement Appendix A
The following is the Indications for Use Statement: Statement
510(k) Number: K 984240 Device Name: ENDOPATH Endoscopic Instruments
Indications for Use:
The ENDOPATH Endoscopic Instruments have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection and transection of tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | X |
|---|---|
| ------------------------------------------ | --- |
OR
Over-The-Counter-Use (Optional Format 1-2-96)
.; ''
Pcostelo
(Division Sign-Off) Division of General Restorative Devices 510(k) Number