(27 days)
Not Found
No
The description focuses on mechanical and electrical components for endoscopic procedures and does not mention any AI or ML capabilities.
Yes.
These devices are designed for medical procedures such as cutting, grasping, manipulating, and blunt dissection of tissue, indicating a direct therapeutic action on the body.
No.
The devices are described as instruments for cutting, grasping, manipulating, and dissecting tissue during endoscopic procedures, and are used for surgical intervention rather than diagnosis.
No
The device description clearly outlines physical components (Handle, Insulated Shaft, Instrument Insert) and describes their physical characteristics and functions (cutting, grasping, dissecting tissue, autoclavable, rotating shaft, banana plug for electrosurgery). This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- IVDs are used to examine specimens from the human body. The descriptions clearly state that these instruments are used for cutting, grasping, manipulating, and dissecting tissue within the body during endoscopic procedures.
- The intended use is for surgical procedures. The descriptions focus on the function of the instruments during surgery (cutting, grasping, dissecting tissue) and their features for endoscopic use (insulated shaft, rotation, electrosurgery capability).
- There is no mention of analyzing samples or providing diagnostic information. The purpose of these devices is to perform actions on tissue, not to analyze it for diagnostic purposes.
Therefore, the MultAchoice Scissor, Grasper, and Dissector Instruments are surgical instruments, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The MultAchoice™ Instruments may be used in a variety of endoscopic procedures. The MultAchoice™ Scissors are designed for cutting or transecting tissue. The MultAchoice™ Grasper is designed for grasping and manipulating tissue. The MultAchoice™ Dissector is designed for blunt dissection, temporary grasping, and manipulation of tissue.
MultAchoice Scissor Instrument:
The MultAchoice Scissor may be used in a variety of endoscopic procedures. This device is designed for cutting or transecting tissue. It is fully autoclavable. The insulated shaft of this device has a 5mm OD and a 31cm working length. This shaft may be rotated 360° independent of the instrument handle, thereby permitting increased visibility and access to desired structures. The MultAchoice Scissor has been fitted with a standard banana plug to accept a monopolar connecting cable (not included) for electrosurgery.
MultAchoice Grasper Instrument:
The MultAchoice Grasper may be used in a variety of endoscopic procedures. This device is designed for grasping and manipulating tissue. It is fully autoclavable. The insulated shaft of this device has a 5mm OD and a 31cm working length. This shaft may be rotated 360° independent of the instrument handle, thereby permitting increased visibility and access to desired structures. The MultAchoice Grasper has been fitted with a standard banana plug to accept a monopolar connecting cable (not included) for electrosurgery.
MultAchoice Dissector Instrument:
The MultAchoice Dissector may be used in a variety of endoscopic procedures. This device is designed for blunt dissection, temporary grasping, and manipulation of tissue. It is fully autoclavable. The insulated shaft of this device has a 5mm OD and a 31cm working length. This shaft may be rotated 360° independent of the instrument handle, thereby permitting increased visibility and access to desired structures. The MultAchoice Dissector has been fitted with a standard banana plug to accept a monopolar connecting cable (not included) for electrosurgery.
Product codes
GEI
Device Description
The MultAchoice™ Instruments are a set of reusable and configurable instruments consisting of a Handle, Insulated Shaft, and Instrument Insert that comprise a Laparoscopic Scissor, Grasper, and Dissector.
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
Not Found
Key Metrics
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
Attachment 3
SUMMARY OF SAFETY AND EFFECTIVENESS 991814 SPECIAL 510(k) SUMMARY
| 1) | Submitter: | Dexide, Inc.
7509 Flagstone Drive
Fort Worth, TX 76118-6995
Phone No.: (817) 589-1454 |
|----|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | John Corzine
Vice President, Research and Development |
| | Date Prepared: | May 26, 1999 |
| 2) | Name of Device: | MultAchoice™ Instruments |
| | Common Name: | Laparoscopic Scissors, Graspers, and Dissectors |
| | Classification Name: | Laparoscopic, General & Plastic Surgery |
| 3) | Predicate Device: | Dexide Inc., Laparoscopic Accessories, K923845 |
| 4) | Description of Device: | The MultAchoice™ Instruments are a set of reusable and
configurable instruments consisting of a Handle, Insulated Shaft,
and Instrument Insert that comprise a Laparoscopic Scissor,
Grasper, and Dissector. |
| 5) | Intended Use: | The MultAchoice™ Instruments may be used in a variety of
endoscopic procedures. The MultAchoice™ Scissors are
designed for cutting or transecting tissue. The MultAchoice™
Grasper is designed for grasping and manipulating tissue. The
MultAchoice™ Dissector is designed for blunt dissection,
temporary grasping, and manipulation of tissue. |
-
- The candidate device is identical to the Predicate Device except for the additional capability of being reusable. They have the same intended use and operating principle. They have the same basic design principles and incorporate the same basic materials except for those required to accomplish the reusable specification.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 23 1999
Mr. John Corzine Vice President, Research and Development Dexide, Inc. 7509 Flagstone Drive Fort Worth, Texas 76118
Re: K991814
Trade Name: MultAchoice™ Instruments Regulatory Class: II Product Code: GEI Dated: May 26, 1999 Received: May 27, 1999
Dear Mr. Corzine:
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 (QS) 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.
2
Page 2 - Mr. John Corzine
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 vour 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,
Celia M. Witten, Ph.D., M.D.
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
3
Attachment 8
- 11
| Page | 1 | Of | 1 |
|---|---|---|---|
| ------ | --- | ---- | --- |
K 991814 510(k) Number (if known): _
Device Name: MultAchoice™ Instruments
Indications For Use:
MultAchoice Scissor Instrument:
The MultAchoice Scissor may be used in a variety of endoscopic procedures. This device is designed for cutting or transecting tissue. It is fully autoclavable. The insulated shaft of this device has a 5mm OD and a 31cm working length. This shaft may be rotated 360° independent of the instrument handle, thereby permitting increased visibility and access to desired structures. The MultAchoice Scissor has been fitted with a standard banana plug to accept a monopolar connecting cable (not included) for electrosurgery.
MultAchoice Grasper Instrument:
The MultAchoice Grasper may be used in a variety of endoscopic procedures. This device is designed for grasping and manipulating tissue. It is fully autoclavable. The insulated shaft of this device has a 5mm OD and a 31cm working length. This shaft may be rotated 360° independent of the instrument handle, thereby permitting increased visibility and access to desired structures. The MultAchoice Grasper has been fitted with a standard banana plug to accept a monopolar connecting cable (not included) for electrosurgery.
MultAchoice Dissector Instrument:
The MultAchoice Dissector may be used in a variety of endoscopic procedures. This device is designed for blunt dissection, temporary grasping, and manipulation of tissue. It is fully autoclavable. The insulated shaft of this device has a 5mm OD and a 31cm working length. This shaft may be rotated 360° independent of the instrument handle, thereby permitting increased visibility and access to desired structures. The MultAchoice Dissector has been fitted with a standard banana plug to accept a monopolar connecting cable (not included) for electrosurgery.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K991814 |
Prescription Use
OR
Over-The-Counter Use _____
(Per 21 CFR 801.109)
(Optional Format 1-2-96)