(34 days)
Not Found
No
The device description focuses on manual surgical instruments with electrical stimulation capabilities, and there is no mention of AI or ML in the provided text.
No
The device is described as an instrument for tissue dissection and nerve stimulation for identification and location during surgery, not for treating a condition, which is characteristic of therapeutic devices.
No
The device is used for "location and identification" of nerves, which implies a diagnostic function. However, the primary intended uses are "tissue dissection and stimulation," which are therapeutic or surgical actions, not purely diagnostic. Its application helps in identifying structures during surgery, but it doesn't fit the typical definition of a diagnostic device that outputs a diagnosis.
No
The device description clearly outlines physical instruments (scissors, forceps, retractors, hooks) made of stainless steel with electrical insulation and connectors, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The Stimulus-Dissection Instruments are used during surgery to mechanically dissect tissue and electrically stimulate nerves within the body.
- Intended Use: The intended use clearly states "tissue dissection and stimulation of cranial and peripheral motor nerves for location and identification during surgery". This is an in vivo (within the living organism) procedure, not an in vitro test.
The device is a surgical instrument used directly on the patient during a procedure, not a device used to analyze samples in a lab.
N/A
Intended Use / Indications for Use
The Stimulus-Dissection Instruments are indicated for tissue dissection and stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.
Product codes (comma separated list FDA assigned to the subject device)
77ETN
Device Description
The designs of the Stimulus - Dissection Instruments are similar to existing stainless steel manual surgical instruments. The instruments consist of scissors, forceps, retractors, and hooks with biocompatible electrical insulation applied to selected portions, and proximal connectors provided to attach the instruments to a monopolar stimulator. The distal surfaces of the instruments are noninsulated stainless steel to provide for mechanical, manually actuated dissection / resection, and tissue stimulation. The Stimulus - Dissection Instruments are a protected pin design and meet the requirements of IEC 60601-1:1988 /A1:1991 /A2:1995 Clause 56.3(c) per 21 CFR 898.12. Accessories include monopolar cables available in lengths up to 3 M.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial, peripheral motor nerves, spinal nerve roots
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)
Not Found
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.
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
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.
0
KO14163
510(k) Summary
JAN 2 2 2002
1.0 Date Prepared
January 14, 2002
Submitter (Contact) 2.0
Martin D. Sargent Regulatory Affairs Manager Medtronic Xomed Jacksonville, FL (904) 279-7586
3.0 Device Name
| Proprietary Name: | Stimulation / Dissection Instruments (Tradenames have not been
finalized at this time) |
|-------------------------|-------------------------------------------------------------------------------------------|
| Common Name(s): | Nerve Stimulator / Locator |
| Classification Name(s): | Surgical Nerve Stimulator / Locator |
Device Classification 4.0
| Classification Name: Surgical Nerve Stimulator / Locator and accessories | ||
|---|---|---|
| Procode 77ETN | Class II | 21 CFR § 874.1820 |
| Procode Various | Class I | 21 CFR § 874.4420 |
| Procode Various | Class I | 21 CFR § 878.4800 |
Device Description 5.0
The designs of the Stimulus - Dissection Instruments are similar to existing stainless steel manual surgical instruments. The instruments consist of scissors, forceps, retractors, and hooks with biocompatible electrical insulation applied to selected portions, and proximal connectors provided to attach the instruments to a monopolar stimulator. The distal surfaces of the instruments are noninsulated stainless steel to provide for mechanical, manually actuated dissection / resection, and tissue stimulation. The Stimulus - Dissection Instruments are a protected pin design and meet the requirements of IEC 60601-1:1988 /A1:1991 /A2:1995 Clause 56.3(c) per 21 CFR 898.12. Accessories include monopolar cables available in lengths up to 3 M.
6.0 Indications for Use
The Stimulus-Dissection Instruments are indicated for tissue dissection and stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.
1
510(k) Summary (continued)
Substantial Equivalence 7.0
The design, technology, features, function, and intended use of the intraoperative neurological stimulation feature of the Stimulus-Dissection Instrument is substantially equivalent to Medtronic Xomed Monopolar Stimulator Probe originally described in K992869.
The design, technology, features, function, and intended use of the mechanical dissection feature is substantially equivalent to Class I exempt manual surgical instruments such as those described in 21 CFR § 874.4420 and 21 CFR § 878.4800.
| Characteristic | Stimulus - Dissection Instruments | Ball-Tip Monopolar
Stimulating Probe [K992869] |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For
Use | Tissue dissection and stimulation of
cranial and peripheral motor nerves
for location and identification
during surgery, including spinal
nerve roots. | To stimulate cranial and
peripheral motor nerves for
location and identification during
surgery, including spinal nerve
roots. |
| Stainless steel
construction | Yes | Yes |
| Electrical
insulation | Electrical insulation on all surfaces
not intended to provide electrical
contact with the patient | Electrical insulation on all
surfaces not intended to provide
electrical contact with the patient |
| Distal stainless
steel patient
contact surface | Yes | Yes |
| Proximal
stimulator
connector | Yes | Yes |
| IEC 60601-1
Protected Pin
design | Yes | Yes |
| Biocompatible | Yes | Yes |
| Steam
autoclavable | Yes | Yes |
2
Image /page/2/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 2002
Medtronic Xomed, Inc. c/o Martin D. Sargent 6743 Southpoint Dr. North Jacksonville, FL 32216
Re: K014165
Trade/Device Name: Stimulation/Dissection Instruments Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: December 18, 2002 Received: December 19, 2002
Dear Mr. Sargent:
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 requirements, 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.
3
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 prematted 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) 594-4613. 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,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
4
16014165 510(k) Number (if known): __ Stimulus - Dissection Instruments Device Name: Indications for Use:
.
The Stimulus - Dissection Instruments are indicated for tissue dissection and stimulation of cranial and periph-I he Stimulus - Dissection insulance are indicated for about the research of the spinal nerve roots.
(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)
Or
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Karen Bahr '41
(Division Sign-Off) Division of Ophthalmic Ea Nose and Throat Devis
510(k) Number K014165