(20 days)
The NeuroVision IJB System is intended to provide intraoperative electromyographic (EMG) surveillance to assist in the location of nerves during percutaneous surgery of the spine, by administration of brief electrical stimulus pulses to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves. The NeuroVision JJB System is designed for use in conjunction with the NuVasive guided spinal arthroscopy system to assist in gaining controlled percutaneous access to the spinal nerve root, foramina, intervertebral disc, and surrounding tissues of the spine via uniportal or biportal posterior or posterolateral approach, where anatomical restrictions safely permit.
The NeuroVision JJB System (NV JJB) is an electronic device which uses arthroscopic surgical instruments, electrodes, and probes to stimulate nerves with electrical energy, and through the use of electromyography (EMG) electrodes, monitors the sensitivity, and assists in determining the location of nerves during percutaneous surgery of the spine.
The device employs a "Detection" routine which directs brief electrical stimulus pulses through the distal tip of the NuVasive Dilating Cannula as it penetrates tissue to the operative target. Through a series of EMG electrodes placed on the muscle groups associated with the nerves at the operative level of the spine, the NeuroVision JJB System monitors EMG activity in these muscle groups and, when the Cannula tip draws sufficiently near to one such nerve that the electrical energy it emits is strong enough to depolarize the nerve and evoke an EMG response, alerts the surgeon that the Cannula tip is in proximity to that nerve.
By the same method, a "Direction" routine may be used to sequentially activate four orthogonal stimulation electrodes surrounding the Cannula tip, and thereby determine the orthogolial similation closest nerve lies. This direction is displayed on a graphical touch screen.
An additional feature of the NeuroVision JJB System is a hand-held electrical probe which is used to abonain whomer a the screw hole prior to screw insertion or placed on The ban tip of the prooe is placed in as been breached by the screw or tap, the the mstalled screw nead. If the pearlers was the adjacent nerve roots and they will depolarize at a lower stimulation current. The screw test algorithm determines the depolarization (threshold) current for all 8 EMG channels. The surgeon may also set a baseline threshold) current by stimulating a nerve root directly with the probe. The surgeon may choose to display the screw test threshold current relative to this baseline.
The NeuroVision JJB System consists of a reusable Patient Module, a Control Unit comprised of an embedded computer with touch screen controls and an interface card, comprised of an emboduced compater ressable conductive probe cables, electrodes, and electrode leads.
The provided text describes a 510(k) summary for the NeuroVision JJB System, which is an electromyography (EMG) monitor/stimulator. However, it does not contain any information regarding specific acceptance criteria, performance data from a study, sample sizes, ground truth establishment, or comparative effectiveness studies.
The document primarily focuses on:
- Device Description: How the NeuroVision JJB System works, its components, and its "Detection" and "Direction" routines, including a special hand-held probe for testing pedicle screw breaches.
- Intended Use: Intraoperative EMG surveillance to assist in nerve localization during percutaneous spine surgery.
- Technological Characteristics Comparison: Stating that the device has identical indications for use, equivalent materials, design features, and functional characteristics to a predicate device (K002677: NuVasive INS-1 Intraoperative Nerve Surveillance System). It highlights minor interface changes (touch screen vs. LED/push button) and the addition of a hard drive for recording.
- Safety and Effectiveness: A claim that "Due to the equivalency of indications for use, materials of composition, design features, method of use, and functional characteristics, the device raises no new safety or effectiveness issues."
- FDA Clearance Letter: A formal letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested table and study details because this information is not present in the provided context. The 510(k) summary relies on demonstrating substantial equivalence to a predicate device rather than presenting new performance study data against pre-defined acceptance criteria.
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OCT 1 6 2001
Image /page/0/Picture/1 description: The image shows the logo for Nuvasive, a medical device company specializing in spine surgery. The logo consists of a stylized geometric shape to the left of the company name, "NUVASIVE," in all caps. Below the company name is the tagline "Creative Spine Technology" in a smaller, sans-serif font. The logo is simple, modern, and professional, reflecting the company's focus on innovation in the medical field.
K0132/5
510(k) Summary
| Submitter: | NuVasive, Inc.10065 Old Grove Road, Suite ASan Diego CA 92131 |
|---|---|
| Contact person: | Sean M. Curry16787 Bernardo Center Drive, Suite ASan Diego, CA 92128 |
| Phone: | (858) 675-8200 |
| FAX: | (858) 675-8201 |
| Proprietary name: | NeuroVision JJB System |
| Common name: | Electromyography (EMG) monitor/stimulator |
| Classification: | 868.2775 |
| Product Code: | BXM |
| Classification name: | Nerve Stimulator, AC-Powered |
Substantial equivalence claimed to:
K002677: NuVasive INS-1 Intraoperative Nerve Surveillance System
Description:
The NeuroVision JJB System (NV JJB) is an electronic device which uses arthroscopic surgical instruments, electrodes, and probes to stimulate nerves with electrical energy, and through the use of electromyography (EMG) electrodes, monitors the sensitivity, and assists in determining the location of nerves during percutaneous surgery of the spine.
The device employs a "Detection" routine which directs brief electrical stimulus pulses through the distal tip of the NuVasive Dilating Cannula as it penetrates tissue to the operative target. Through a series of EMG electrodes placed on the muscle groups associated with the nerves at the operative level of the spine, the NeuroVision JJB System monitors EMG activity in these muscle groups and, when the Cannula tip draws sufficiently near to one such nerve that the electrical energy it emits is strong enough to depolarize the nerve and evoke an EMG response, alerts the surgeon that the Cannula tip is in proximity to that nerve.
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By the same method, a "Direction" routine may be used to sequentially activate four orthogonal stimulation electrodes surrounding the Cannula tip, and thereby determine the orthogolial similation closest nerve lies. This direction is displayed on a graphical touch screen.
An additional feature of the NeuroVision JJB System is a hand-held electrical probe All auditional teature of the from transpedicular screw has violated the pedicle wall. which is used to abonain whomer a the screw hole prior to screw insertion or placed on The ban tip of the prooe is placed in as been breached by the screw or tap, the the mstalled screw nead. If the pearlers was the adjacent nerve roots and they will depolarize at a lower stimulation current. The screw test algorithm determines the depolarization (threshold) current for all 8 EMG channels. The surgeon may also set a baseline threshold) current by stimulating a nerve root directly with the probe. The surgeon may choose to display the screw test threshold current relative to this baseline.
The NeuroVision JJB System consists of a reusable Patient Module, a Control Unit comprised of an embedded computer with touch screen controls and an interface card, comprised of an emboduced compater ressable conductive probe cables, electrodes, and electrode leads.
Intended use:
The NeuroVision JJB System is intended to provide intraoperative electromyographic (EMG) surveillance to assist in the location of nerves during percutaneous surgery of the (EMO) survermance to access in the lectrical stimulus pulses to tissues and nerves at the spire, by administration of birer elser cross associated with those nerves. The operative site, and EM20 is designed for use in conjunction with the NuVasive guided Nour Islen 30D by bystem to assist in gaining controlled percutaneous access to the Spinal antirosoopy bystein to assist our ounding tissues of the spine via uniportal or biportal ronamina, r posterolateral approach, where anatomical restrictions safely permit.
Summary of technological characteristics:
The NeuroVision JJB System has Indications for Use which are identical to the predicate I no route roomposed of the same or equivalent materials, has equivalant design features, and has functional characteristics which are equivalent. The user interface is via touch screen display replacing the LED display and push button interface of the previous device, and the use of a hard drive allows recording system parameters during use.
Due to the equivalency of indications for use, materials of composition, design features, method of use, and functional characteristics, the device raises no new safety or effectiveness issues.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, with three horizontal lines above the eagle's head. The seal is black and white.
OCT 1 6 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Sean Curry Chief Operating Officer Certified Software Solutions, Inc. 16787 Bernardo Center Drive Suite A San Diego, California 92128
Re: K013215
Trade Name: Neuro Vision JJB System Regulation Number: 868.2775 Regulation Name: Electrical peripheral nerve stimulator Regulatory Class: Class II Product Code: BXM Dated: September 25, 2001 Received: September 26, 2001
Dear Mr. Curry:
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. Iisting 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.
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Page 2 - Mr. Sean Curry
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manoung your manteing your device of your device to a legally prematication. The PDF intellig sification 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 If you desire specific arrive for your avitro diagnostic devices), please contact the Office of additionally 21 CFR Part 007.10 Idditionally, for questions on the promotion and advertising of Compliance at (301) 597-1697 First of Compliance at (301) 594-4639. Also, please note the your device, produce of movending by reference to premarket notification" (21CFR Part 807.97). It guiation entitied, "Misorananing of soonsibilities under the Act may be obtained from the Oiler general information on your seems 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
Susan
Celia M. W.
Sincerely yours,
Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: NuVasive NeuroVision JJB System
Indications for Use:
The NeuroVision IJB System is intended to provide intraoperative electromyographic (EMG) surveillance to assist in the location of nerves during percutaneous surgery of the spine, by administration of brief electrical stimulus pulses to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves. The NeuroVision JJB System is designed for use in conjunction with the NuVasive guided spinal arthroscopy system to assist in gaining controlled percutaneous access to the spinal nerve root, foramina, intervertebral disc, and surrounding tissues of the spine via uniportal or biportal posterior or posterolateral approach, where anatomical restrictions safely permit.
(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
and Neurological Devices
Prescription Use
(Per 21 CFR 801.109)
OR
510(k) Number
K013215
Over-the-Counter Use
§ 868.2775 Electrical peripheral nerve stimulator.
(a)
Identification. An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.(b)
Classification. Class II (performance standards).