(109 days)
Not Found
No
The device description and summary of performance studies indicate a manual surgical instrument with electrical stimulation capabilities, with no mention of AI or ML technologies.
No
This device is described as a "manual surgical instrument for performance of dissection and nerve stimulation input to living tissue concurrently," suggesting it is used for surgical procedures and nerve monitoring rather than for treating a condition.
No
The "Intended Use / Indications for Use" states that the device is for "performance of dissection and nerve stimulation input to living tissue concurrently." This description focuses on surgical action rather than diagnosis.
No
The device is described as a manual surgical instrument and lists several physical instruments that are modified. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "performance of dissection and nerve stimulation input to living tissue concurrently." This describes a surgical procedure performed directly on a living organism, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The device is described as a "manual surgical instrument" and modifications are made to existing surgical instruments like hemostats and dissectors. These are tools used in surgery, not for laboratory testing.
- Anatomical Site: The device is used on "living tissue," which further reinforces its use in a surgical setting on a living patient.
- No mention of samples or testing: The description does not mention the collection or analysis of any biological samples (blood, urine, tissue samples, etc.), which is a core characteristic of IVDs.
Therefore, this device is a surgical instrument used for direct intervention on a living patient, not an in vitro diagnostic device used for testing samples outside the body.
N/A
Intended Use / Indications for Use
This device is a manual surgical instrument for performance of dissection and nerve stimulation input to living tissue concurrently.
Product codes (comma separated list FDA assigned to the subject device)
ETN
Device Description
The Stimulating Hemostat and other manual instruments are dissectors modified by insulation and application of a connecting pin for connection to nerve stimulation. The specific instruments cleared for this modification in this 510(k) are the following:
- Scissors Hinge Hemostat, curved, fine
- . Box Hinge Hemostat, curved, fine
- Scissors Hinge Hemostat, right angle .
- Mosquito Hemostat, curved, fine
- Halsted Hemostat, curved
- Crile Hemostat, curved
- Kelly Hemostat, curved
- Schnidt Hemostat, curved, fine
- Gemini Hemostat, curved, fine
- Petit Point Mixter, right angle
- McCabe Dissector, curved, fine .
- Jacobson Mosquito, curved, fine
- House Rosen Elevator, coarse
- Sheehy "Weapon", Large (2.4 mm)
- Probe, Ball tip
- Suction Stimulator (Neurovision model)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
living tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
manual surgical instrument
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)
The reprocessing validation testing used to create and validate the cleaning and sterilization instructions were conducted according to the standard ANSI/AAMI ST 79: 2006 and guidance documents AAMI TIR 12:2004 and AAMI TIR 30:2011.
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
5. 510K Summary
P. 1 082
OCT 1 9 2012
In accordance with Title 21 of the Code of Federal Regulations, Part 807 and in particular 21 CFR §807.92, the following summary of information is provided:
Applicant Information
Christine Vergely Regulatory Affairs Manager Neurovision Medical Products, Inc. 2225 Sperry Ave., Suite 1000 Ventura, CA 93003 PH 805-866-6999 Fax: 413-410-4579 christie@neurovisionmedical.com
Date of Summary: 10/10/12
Device Identification:
Trade Name: Neurovision Stimulating Dissector Common Name: Neurovision Dissection/Stimulating Accessory Classification Name: Surgical nerve stimulator/locator, 21 CFR 874.1820 Class II, Product Code: ETN
Predicate Devices
Stimulating Hemostat (K895676); Nerve Locator Monitor (K110140)
Device Description
The Stimulating Hemostat and other manual instruments are dissectors modified by insulation and application of a connecting pin for connection to nerve stimulation. The specific instruments cleared for this modification in this 510(k) are the following:
- Scissors Hinge Hemostat, curved, fine �
- . Box Hinge Hemostat, curved, fine
- Scissors Hinge Hemostat, right angle .
- Mosquito Hemostat, curved, fine �
- Halsted Hemostat, curved ●
- Crile Hemostat, curved �
- Kelly Hemostat, curved
- Schnidt Hemostat, curved, fine ●
- Gemini Hemostat, curved, fine ●
- Petit Point Mixter, right angle �
- McCabe Dissector, curved, fine .
- Jacobson Mosquito, curved, fine ●
- House Rosen Elevator, coarse ●
- Sheehy "Weapon", Large (2.4 mm)
- Probe, Ball tip
- Suction Stimulator (Neurovision model)
1
K12.1931
p. 2 of 2
Intended Use
This device is a manual surgical instrument for performance of dissection and nerve stimulation input to living tissue concurrently.
Technological Characteristics of Device in Relation to Predicate Devices
The Stimulating Hemostat approved under K895676 was insulated only on its fingerings and arms but not over the box hinge or tip. Subsequent work has shown that hinged (both box and scissor type) devices can be insulated down to the tips, providing more precise localization of nerve and reduced problems with shorting of the instrument to the wound edges. For over 23 years, the additional instruments in this submission have been modified using the same materials to insulate, and the same method for insulating as the predicate. These modified instruments present no additional issues with sterilization, safety or effectiveness.
Performance Testing
The reprocessing validation testing used to create and validate the cleaning and sterilization instructions were conducted according to the standard ANSI/AAMI ST 79: 2006 and guidance documents AAMI TIR 12:2004 and AAMI TIR 30:2011.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Neurovision Medical Products, Inc. c/o Ms. Christine Vergely Regulatory Manager 2225 Sperry Avenue, Suite 1000 Ventura, CA 93003
Re: K121931
Trade/Device Name: Neurovision Dissection/Stimulating Accessory Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: September 18, 2012 Received: September 19, 2012
Dear Ms. Vergely:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
OCT 1 9 2012
3
Page 2 - Mr./Ms./Mrs./Dr.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Malvina B. Eydelman, M.D.
Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
4. Indications for Use:
Device Name: Neurovision Dissection/Stimulating Accessory
This device is a manual surgical instrument for performance of dissection and nerve stimulation input to living tissue concurrently.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K121931
Prescription Use
(Per 21 CFR 801.109)