Who is the manufacturer of SEASPINE MONOPOLAR PROBE SYSYEM?

Seaspine, Inc. filed the 510(k) submission for SEASPINE MONOPOLAR PROBE SYSYEM (K111671).

What is the FDA product code for SEASPINE MONOPOLAR PROBE SYSYEM?

ETN. It is classified under 21 CFR 874.1820 as a Class 2 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for SEASPINE MONOPOLAR PROBE SYSYEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for SEASPINE MONOPOLAR PROBE SYSYEM?

Stimulus Dissection Instruments (K014165); Nuvasive Neurovision JJB System (K051718).

Who can help prepare an FDA 510(k) submission like SEASPINE MONOPOLAR PROBE SYSYEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SEASPINE MONOPOLAR PROBE SYSYEM

K111671 · Seaspine, Inc. · ETN · Dec 28, 2011 · Ear, Nose, Throat

Device Facts

Record ID	K111671
Device Name	SEASPINE MONOPOLAR PROBE SYSYEM
Applicant	Seaspine, Inc.
Product Code	ETN · Ear, Nose, Throat
Decision Date	Dec 28, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.1820
Device Class	Class 2

Intended Use

The SeaSpine Monopolar Probe System is indicated for tissue dilation and nervous tissue stimulation by means of electrical current to assess location and identification of motor nerves (including spinal nerve roots) for nervous tissue avoidance during a routine surgical approach to the spine.

Device Story

System consists of insulated monopolar probes used for intraoperative nerve stimulation; stainless steel conductive wire core; PEEK insulation; distal tip contacts tissue; proximal end connects to external standard intraoperative neuromonitoring stimulator. Used by surgeons during spinal procedures to deliver electrical current to tissue; triggered EMG response recorded by external system; allows identification of motor nerves; facilitates nervous tissue avoidance; improves surgical safety.

Clinical Evidence

Bench testing only. Biocompatibility assessed per ISO 10993; adhesive tested per USP Class VI. Electrical safety conforms to IEC 60601-1:1988/A1:1991/A2:1995.

Technological Characteristics

Materials: Stainless steel (conductive core), PEEK (insulation). Design: Monopolar probe with insulated shaft, exposed distal tip, proximal connector. Energy: Electrical stimulation (external source). Connectivity: Connects to standard intraoperative neuromonitoring stimulators. Sterilization: Steam sterilizable. Standards: IEC 60601-1:1988/A1:1991/A2:1995, ISO 10993, USP Class VI.

Indications for Use

Indicated for patients undergoing spinal surgery requiring motor nerve (including spinal nerve roots) location and identification to avoid nervous tissue injury during surgical approach.

Regulatory Classification

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.

Predicate Devices

Stimulus Dissection Instruments (K014165)
Nuvasive Neurovision JJB System (K051718)

Related Devices

K161893 — Neuromonitoring Kit · SI-BONE, Inc. · Oct 18, 2016
K180542 — NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe · Boston Endo Surgical Tech, · Aug 22, 2018
K002677 — NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM · Nuvasive, Inc. · Nov 13, 2000
K062996 — DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES · Axon Systems, Inc. · Jan 12, 2007
K090838 — STIMULUS/DISSECTION INSTRUMENTS · Axon Systems, Inc. · Jul 20, 2009

Submission Summary (Full Text)

{0}------------------------------------------------ SeaSpine Monopolar Probe System 510(k) 510(k) Summary In accordance with 21CFR807.92 21CFR807.92(a){1}: Company Name: SeaSpine, Inc. 2302 La Mirada Drive Vista, CA 92081 Contact person: Dan Miller e-mail: dmiller@seaspine.com Phone: (760) 727-8399 Ext: 239, Fax: (760) 727-8809 Date prepared: June 13, 2011 21CFR807.92(a)(2): SeaSpine Monopolar Probe System Trade name: (Trade name has not been finalized at this time) Common name: Nerve Stimulator Surgical Nerve Stimulator/locator Classification: 21 CFR 874.1820 Class II Product Code: ETN 21CFR807.92(a)(3): Predicate Device: Manufacturer: Medtronic Xomed Trade Name: Stimulus Dissection Instruments Product Code: ETN 510(k): K014165 Manufacturer: Nuvasive Trade Name: Nuvasive Neurovision JJB System Product Code: ETN, GWF 510(k): K051718 21CFR807.92(d){4}: The SeaSpine Monopolar Probes conduct electrical stimulation to nervous Device Description: tissue that may be present in close proximity of the surgical corridor to the spine. This system is not comprised of a nerve stimulator or recorder; instead it will use conventional stimulators found in the market. The SeaSpine are insulated by a biocompatible PEEK Monopolar Probes (polyetheretherketone) layer all around one or more conductive stainless steel wire(s) with the exception of the distal and proximal ends. The distal end contacts the target tissue and the proximal end connects to standardi intraoperative neuromonitoring monopolar stimulator) that offers triggered electromyography (EMG) capability. Triggered EMG is a standard intraoperative practice where motor nerves are stimulated and their {1}------------------------------------------------ ## 21CFR807.92(0)(5): Intended use: 2.1CFR807.92(a){6}: Substantial Equivalence: corresponding muscle group response is recorded, allowing for avoidance of nervous tissue during surgical approach. The proximal connector design meets the requirements of IEC 60601-1:1988 /A1:1991 /A2:1995 Clause 56.3(c) per 21 CFR 898.12. KII671 The SeaSpine Monopolar Probe System is indicated for tissue dilation and nervous tissue stimulation by means of electrical current to assess location and identification of motor nerves (including spinal nerve roots) for nervous tissue avoidance during a routine surgical approach to the spine. The SeaSpine Monopolar Probe System has indications for use which are substantially equivalent to those of the predicate devices and other legally marketed devices. The SeaSpine Monopolar Probe System is manufactured from similar or identical materials as the predicate devices. The design features and function of the SeaSpine Monopolar Probe System are substantially equivalent or the same to predicate devices and other legally marketed devices, and the SeaSpine Monopolar Probe System does not raise any new safety or effectiveness issues. | Technological Characteristic | Subject Device | Medtronic Xomed Stimulus Dissection Instruments (K014165) | Nuvasive NeuroVision JJB System (K051718) | |---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications For Use | The SeaSpine Monopolar Probe System is indicated for tissue dilation and nervous tissue stimulation by means of electrical current to assess location and identification of motor nerves (including spinal nerve roots) for nervous tissue avoidance during a routine surgical approach to the spine. | Tissue dissection and stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots. | The NeuroVision JJB System is used for intraoperative monitoring and neurological status assessment by the administration of brief electrical stimulus pulses to neural tissues and the EMG monitoring of the associated muscle groups. The system is used in conjunction with other Nuvasive devices to assist in gaining controlled access to, and visualization of, the spine. | {2}------------------------------------------------ | Design | Electrical Conduit insulated all around with exception to distal tip and proximal connector | Electrical Conduit insulated all around with exception to distal tip and proximal connector | Electrical Conduit insulated all around with exception to distal tip and proximal connector | |------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | Electrical Conduction Material | Stainless Steel | Stainless Steel | Stainless Steel or Aluminum | | Electrical Patient Contact Surface | Stainless Steel | Stainless Steel | Stainless Steel or Aluminum | | Proximal Stimulator Connector | Yes | Yes | Yes | | Biocompatible plastic electrical insulation | Yes | Yes | Yes | | Steam Sterilizable Reusable | Yes | Yes | Yes* | *also cleared for disposable probes. The biocompatibility of the subject device was assessed per ISO 10993. The biocompatibility of the adhesive used internally was assessed per USP Class VI testing. The probes are manufactured from stainless steel and PEEK with a long track record of use in the medical device industry and in instruments that directly contact tissue. The tissue contact duration of the SeaSpine Monopolar Probe System is brief (<1 hour), and this level of testing far exceeds the requirements for similar instruments and contact duration per ISO 10993-1. Electrical Safety of the SeaSpine Monopolar Probe System conforms to IEC 60601-1:1988 /A1:1991 /A2:1995 Clause 56.3(c) per 21 CFR 898.12. Engineering analysis, specifications, and labeling have established that the SeaSpine Monopolar Probe System is similar or identical to legally marketed predicates in terms of indications for use, materials, design, and functionality. Therefore, we have demonstrated that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices. 21CFR807.92(b)(1)(2): Disscussion : 21CFR807.92(b){3): Conclusions: {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circle around the symbol. The logo is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002 DEC 2 8 2011 SeaSpine, Inc. % Mr. Dan Miller 2302 La Mirada Dr Vista, CA 92081-7862 Re: K111671 Trade Name: SeaSpine Monopolar Probe System Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical nerve stimulator/locator Regulatory Class: Class II Product Code: ETN Dated: November 28, 2011 Received: November 30, 2011 Dear Mr. Miller: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave and have 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 r ou mayy more or ovisions 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. Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be actised that I Dr. Mar 1978 the 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 Or FF ar or 7), accesses (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. {4}------------------------------------------------ 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. Sincerety yours, Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose, Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K111671 Device Name: SeaSpine Monopolar Probe System Indications for Use: The SeaSpine Monopolar Probe System is indicated for tissue dilation and nervous tissue stimulation by means of electrical current to assess location and identification of motor nerves (including spinal nerve roots) for nervous tissue avoidance during a routine surgical approach to the spine. Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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) ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A. Binoy Mathews (Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Division of Devices vision Sign-Off) Division on Throat Devices K111671 510(k) Numbe