Who is the manufacturer of SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)?

Spine View, Inc. filed the 510(k) submission for SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS) (K113362).

What is the FDA product code for SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)?

HRX. It is classified under 21 CFR 888.1100 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)?

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

Who can help prepare an FDA 510(k) submission like SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)?

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.

SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)

Q: What are the predicate devices for SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)?

Spine View SpineVu Endoscopic Spine System (K081051); Spine View enSpire Discectomy System (K110992); Endius Atavi System (K061345); Richard Wolf Minimally Invasive Spinal Surgery Set (K994363); Karl Storz Percutaneous Foraminoscopy Set (K001918).

K113362 · Spine View, Inc. · HRX · Feb 10, 2012 · Orthopedic

Device Facts

Record ID	K113362
Device Name	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)
Applicant	Spine View, Inc.
Product Code	HRX · Orthopedic
Decision Date	Feb 10, 2012
Decision	SESE
Submission Type	Special
Regulation	21 CFR 888.1100
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Surgical accessories are indicated for facilitating endoscopic access and visualization in the surgical area of the cervical, thoracic, or lumbar spine for interventional spinal procedures such as discectomy, nucleotomy and foraminotomy.

Device Story

SpineVu Endoscopic Spine System (SESS) is a collection of single-use, sterile arthroscopic surgical accessories. System components include enVue Cannula (with articulating jaws for tissue retraction), enVue Sheath, 16G Introducer Cannula with Stylet, Guidewire, Dilator, Beveled Cannula, Ball-Tipped Probe, Infusion Cannula, and Suction Cannula. The system facilitates access and visualization at the surgical site in the spine. The physician uses the introducer and guidewire to establish access, followed by the dilator and beveled cannula to create a pathway. The enVue Cannula, which accommodates a flexible endoscope and surgical instruments, is then inserted. The articulating jaws on the enVue Cannula allow the surgeon to mechanically retract tissue away from the cannula tip to improve visualization. The system is used in a clinical/surgical setting by trained spinal surgeons. The output is direct visualization of the surgical site via an endoscope, enabling the surgeon to perform procedures like discectomy. The system benefits patients by providing a minimally invasive approach to spinal surgery.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included visual and dimensional verification, jaw cycle and activation integrity, device-to-device compatibility, tensile strength, flow rate, luer attachment, leakage, biocompatibility, design validation, packaging, and sterility testing.

Technological Characteristics

Single-use, sterile (irradiated) arthroscopic accessories. Materials include stainless steel, PEBAX, polyurethane, PVC, polycarbonate, nylon-12, and medical-grade adhesives (Loctite 4018, 4013, 3311). Features include articulating jaws for mechanical tissue retraction, working channels for endoscopes (up to 2mm) and instruments, and luer-lock connections for fluid management. No electronic or software components.

Indications for Use

Indicated for patients requiring endoscopic access and visualization in the cervical, thoracic, or lumbar spine for interventional procedures including discectomy, nucleotomy, and foraminotomy.

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

Predicate Devices

Spine View SpineVu Endoscopic Spine System (K081051)
Spine View enSpire Discectomy System (K110992)
Endius Atavi System (K061345)
Richard Wolf Minimally Invasive Spinal Surgery Set (K994363)
Karl Storz Percutaneous Foraminoscopy Set (K001918)

Related Devices

K022199 — ENDIUS ATAVI SYSTEM · Endius, Inc. · Oct 2, 2002
K121548 — SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS) · Spine View, Inc. · Aug 16, 2012
K991794 — ENDOSCOPIC SPINAL ACCESS SYSTEM · Endius, Inc. · Aug 13, 1999
K081051 — SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE · Spine View, Inc. · Aug 7, 2008
K061345 — MODIFICATION TO ENDIUS ATAVI SYSTEM · Endius, Inc. · Jun 6, 2006

Submission Summary (Full Text)

{0}------------------------------------------------ K11 3362 & lot 13 # 510(k) Summary # FEB 1 0 2012 . This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. ## A. Name and Address of Applicant Spine View, Inc. 48810 Kato Road, Suite 100E Fremont CA 94538 Phone: (510) 743-5090 Fax: (510) 623-1093 - B. Contact Person Sevrina Ciucci, RAC Regulatory Affairs Consultant Phone: (408) 316-4837 ### C. Date Prepared November 11, 2011 - Device Name D. | Trade Name: | SpineVu Endoscopic Spine System (SESS) | |----------------------|----------------------------------------| | Common Name: | Arthroscope | | Classification Name: | Arthroscope | ### E. Device Classification | Classification: | 21 CFR §888.1100 | |-----------------|------------------| | Product Code: | HRX | | Device Class: | Class II | ### Predicate Device F. The modified SpineVu Endoscopic Spine System (SESS) is substantially equivalent to the Spine View SpineVu Endoscopic Spine System (SESS) (K081051), Spine View enSpire Discectomy System (K110992), Endius Atavi System (K061345), Richard Wolf Minimally Invasive Spinal Surgery Set (K994363), and Karl Storz Percutaneous Foraminoscopy Set (K001918). ### Device Description G. The SpineVu Endoscopic Spine System (SESS) is a collection of arthroscopic surgical accessories provided sterile (irradiated) and intended for single-use only. As a group, {1}------------------------------------------------ K113362 p. 2 of 13 the accessories are provided to facilitate delivery of an endoscope and other instruments to the targeted treatment site. The SpineVu Endoscopic Spine System (SESS) consists of the following devices. - enVue Cannula a device which provides access into the body for performing . procedures in and around the spine. The enVue Cannula is provided with two different tip configurations (Standard Jaw and Long Jaw). - . enVue Sheath - a device that may be used to facilitate the delivery of a flexible endoscope (up to 2 mm diameter) through the working lumen of the enVue Cannula. - . 16G Introducer Cannula with Stylet - facilitates initial access to the treatment site. The Introducer Cannula is used in conjunction with the Introducer Stylet. - . Guidewire - (16" long with a diameter of 0.058") may be used to facilitate exchange of the Introducer Cannula for the Dilator. - . Dilator - is designed to fit over the Guidewire and inside the Beveled Cannula. The Dilator is used to bluntly dissect soft tissue in order to provide a pathway for the Beveled Cannula. - . Beveled Cannula - is designed to fit over the Dilator. The Beveled Cannula comes in two lengths (5.4" and 6.1"). It provides an access path to the targeted treatment site for other instruments, such as the enVue Cannula. - . Ball-Tipped Probe - is used to probe or palpate tissue or bone. - Infusion Cannula is used to introduce fluids to the treatment site. . - . Suction Cannula - is used to aspirate materials from the treatment site. ### H. Intended Use Surgical accessories are indicated for facilitating endoscopic access and visualization in the surgical area of the cervical, thoracic, or lumbar spine for interventional spinal procedures such as discectomy, nucleotomy and foraminotomy. ### 1. Technological Comparison The SpineVu Endoscopic Spine System (SESS) has similar features as compared to the predicate devices as shown in the tables below: {2}------------------------------------------------ 3 of 13 હ K113362 Spine View, Inc. Special 510(K) Special 510(K) Notification pineVu Endoscopic Spine System (SESS) | Manufacturer | Device Name | 510(k) # | Indications for Use | Product Code | Classification Section | Spine View, Inc. SpineVu Endoscopic Spine System | Spine View, Inc. SpineVu Endoscopic Spine System | Manufacturer | Device Name | 510(k) # | Design | Endoscope Compatibility | Supplied Sterile/Sterilization Method | Single Use Only | | Company, K# | Device Name | Indications for Use | Predicate | Subject | Company, K# | Predicate | Predicate | Subject | Company, K# | Predicate | Subject | | |------------------|---------------------------------------|----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|----------------------------------------------------------------------------------------|-----------------|-----------------------------------------------------|----------------------------------|------------------------------------------|--------------------|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|------------------------------------------------------|-----------------------------------------------------| | Zimmer (Endius) | Atavi System | K061345 | Posterior or anterior access and visualization in the surgical area of the cervical, thoracic, or lumbar spine allowing the surgeon to perform any type of surgical spinal procedures such as discectomy, nucleotomy, spinal fusion, spinal decompression, and insertion of spinal implants. Other examples of generic surgical use of the Endius Atavi System would be for use in the knee, ankle, shoulder, hand, wrist, and temporomandibular joint (TMJ). | HRX | Class II | K081051 | K113362 | Zimmer (Endius) | Atavi System | K061345 | Dilatation Access Retraction Visualization | OD up to approximately 0.944" | No | No | | Endius, K061345 | Atavi System | Posterior or anterior access and visualization in the surgical area of the cervical, thoracic, or lumbar spine allowing the surgeon to perform any type of surgical spinal procedures such as discectomy, nucleotomy, spinal fusion, spinal decompression, and insertion of spinal implants. Other examples of generic surgical use of the Endius Atavi System would be for use in the knee, ankle, shoulder, hand, wrist, and temporomandibular joint (TMJ). | | | | Endius, K061345 | Spine View, SpineVu Endoscopic Spine System, K081051 | Spine View, SpineVu Endoscopic Spine System K113362 | | Endius, K061345 | Spine View, SpineVu Endoscopic Spine System, K081051 | Spine View, SpineVu Endoscopic Spine System K113362 | | Spine View, Inc. | enSpire Discectomy System | K110992 | Cutting, grinding and aspirating intervertebral disc material during discectomy procedures in the cervical, thoracic and lumbar spine. | Same | Same | Same | Same | Spine View, Inc. | enSpire Discectomy System | K110992 | Dilatation Access Excision | OD up to 0.058" | Yes/Gamma radiation | Yes | | | | | Spine View, SpineVu Endoscopic Spine System, K081051 | Spine View, SpineVu Endoscopic Spine System K113362 | Device Name | Atavi System | SpineVu Balloon Cannula | enVue Cannula | enVue Sheath | Device Name | Atavi System | enVue Cannula | | Richard Wolf | Minimally Invasive Spinal Surgery Set | K994363 | Examination, diagnosis, and/or therapy by personnel trained and qualified in connection with endoscopically used accessories in various medical disciplines, such as orthopedic and spinal surgery. | Same | Same | Same | Same | Richard Wolf | Minimally Invasive Spinal Surgery Set | K994363 | Dissection Manipulation Excision | OD up to 0.271" | No | No | | | | | SpineVu Balloon Cannula | enVue Cannula | Product Code | HRX | HRX | Same | Same | Target Anatomy | Intervertebral procedures | Same | | Karl Storz | Percutaneous Foraminoscopy Set | K001918 | Visualize and treat vertebral disc herniations in the lumbar region of the spine using a posterolateral approach and fluoroscopic control. | Same | Same | 15G Needle SpineVu Guide Wire SpineVu Dilator SpineVu Introducer Sheath SpineVu Infusion Cannula SpineVueBalloon Cannula SpineVue Debrider SpineVu CoagProbe | 1. 16G Introducer Cannula w/ Stylet 2. Guidewire 3. Dilator 4. Beveled Cannula 5. enVue Cannula (Standard Jaw or Long Jaw) 6. enVue Sheath 7. Ball Tipped Probe 8. Suction Cannula 9. Infusion Cannula | Karl Storz | Percutaneous Foraminoscopy Set | K001918 | Dilatation Access Visualization | OD up to 0.236" | No | No | | | | | Cutting, grinding and aspirating intervertebral disc material during discectomy procedures in the cervical, thoracic and lumbar spine. | Facilitating endoscopic access and visualization in the surgical area of the cervical, thoracic, or lumbar spine for interventional spinal procedures such as discectomy, nucleotomy and foraminotomy. Same | Design | Articulating portal with retracting jaws mechanically actuated to retract tissue away from end of cannula | Toroidal balloon can be inflated to mechanically retract tissue away from the end of the cannula | Articulating Top Jaw can be mechanically actuated to retract tissue away from end of cannula Distal tip: Articulating jaw (Nylon) for tissue retraction (Standard and Long jaw configurations) | When combined with the enVue Cannula, can accommodate the following: a) Flexible Endoscope b) Endoscopic Instruments c) Irrigation/Drainage | Supplied Sterile? | Yes | Same | | Spine View, Inc. | SpineVu Endoscopic Spine System | K081051 | Endoscopic access and visualization in the surgical area of the cervical, thoracic, or lumbar spine and are accessorized with surgical and coagulation tools for interventional spinal procedures such as discectomy, nucleotomy and foraminotomy. | Same | Same | Spine View, Inc. | SpineVu Endoscopic Spine System | K081051 | Dilatation Access Retraction Excision Aspiration/Infusion Visualization | OD up to 0.032" | Yes/E-beam | Yes | | | | | | enVue Sheath | | Articulating single lumen portal with retracting jaws used to dilate and maintain access which can accommodate the following: a) Flexible Endoscope b) Endoscopic Instruments c) Irrigation/Drainage | Single, multi-lumen device which can accommodate the following: a) Flexible Endoscope b) Endoscopic Instruments c) Irrigation/Drainage | | | Single Use? | Yes | Same | | | | Spine View, Inc. | SpineVu Endoscopic Spine System | K113362 | Surgical accessories are indicated for facilitating endoscopic access and visualization in the surgical area of the cervical, thoracic, or lumbar spine for interventional spinal procedures such as discectomy, nucleotomy and foraminotomy. | Same | Same | Spine View, Inc. | SpineVu Endoscopic Spine System | K113362 | Dilatation Access Retraction Aspiration/Infusion | OD up to 0.079" | Yes/E-beam | Yes | | | Intended Use | 1. Access portal with working channel for instruments - facilitating endoscopic access and visualization in the surgical area of the spine for use during interventional spinal procedures 2. Distal feature for retracting tissue away from end of cannula -articulating portal with retracting jaws that mechanically actuate to retract tissue away from end of cannula | 1. Access cannula with working channels for endoscope, endoscopic instruments, and irrigation and drainage 2. Distal feature for retracting tissue away from end of cannula | 1. Access cannula with working channel for endoscope, endoscopic instruments, and irrigation and drainage 2. Distal feature for retracting tissue away from end of cannula 1. Intended for use with the enVue Cannula to provide the access ports for endoscopic instruments and endoscope, and irrigation | Dimensions | 1. OD: Unknown 2. Working Length: Unknown 3. Working channel for endoscopic instruments and endoscope: 0.945" x 1.18" 4. Length, Tissue Retraction Feature: 1.181" 5. OD, Tissue Retraction Feature: 2.362" | 1. OD: 0.140" 2. Working Length: ~7.5" 3. Length, Tissue Retraction Feature: up to 0.315" 4. OD, Tissue Retraction Feature: 0.248" 5. Multiple Working channels for endoscopic instruments: ~0.049" 6. Working channel for endoscope: ~0.039" | 1. OD: 0.282" 2. Working Length: 7.5" 3. Length, Tissue Retraction Feature 0.394" 4. OD, Tissue Retraction Feature: 0.354" 5. Single Working Channel for enVue Sheath (for endoscopic instruments and endoscope): 0.240" | 1. OD: 0.236" - Designed to be delivered through enVue Cannula 2. Working Length: 8.8" 3. Working Channel for endoscopic instruments: 0.122" 4. Working channel for endoscope: 2 mm | | SpineVu Balloon Cannula | enVue Sheath | | | | Materials | Unknown | Stainless Steel, PEBAX, Polyurethane, PVC, Polycarbonate | Nylon-12, Stainless Steel, Solder (Sn/Ag), Polycarbonate, Medical Grade Adhesive (Loctite 4018, Loctite 4013, Loctite 3311) | Stainless Steel, Solder (Sn/Ag), Polycarbonate, Tygon, Medical Grade Adhesive (Loctite 4018, Loctite 4013, Loctite 3311) | | Same | Same | | | | | | | | | | | | | | | | | | | | | | | | Same | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | {3}------------------------------------------------ Special 510(k) Notification pineVu Endoscopic Spine System (SESS) {4}------------------------------------------------ pineVu Endoscopic Special 510(K) Notification Concessoric Spine System (SESS) 7.50613 |くいろろん2 {5}------------------------------------------------ Special 510(K) Special 510(K) Notification SpineVu Endoscopic Spine System (SESS) KI13362 p. 6 of 13 # enVue Cannula and enVue Sheath {6}------------------------------------------------ Special 510(k) Special 510(k) Notification Controlu Endoscopic Spine System (SESSS) K113362 p. 7 . F 13 {7}------------------------------------------------ Spine View, Inc. # Special 510(K) Notification pineVu Endoscopic Spine System (SESS) # nula and Sty | | 6G Introducer Cannula and Stylet | | Guidewire | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------| | | Predicate | Subject | Predicate | | Company, K# | Spine View, enSpire Discectomy System, K110992 | Spine View, SpineVu Endoscopic Spine System | SpineVu Endoscopic Spine System, K081051 | | Device Name | Introducer Cannula with Stylet | 16G Introducer Cannula and Stylet | SpineVu Guide Wire | | Indications for Use | Cutting, grinding and aspirating intervertebral disc material during discectomy procedures in the cervical, thoracic and lumbar spine. | Facilitating endoscopic access and visualization in the surgical area of the cervical, thoracic, or lumbar spine for interventional spinal procedures such as discectomy, nucleotomy and foraminotomy. | Cutting, grinding and aspirating intervertebral disc material during discectomy procedures in the cervical, thoracic and lumbar spine. | | Intended Use | Penetrate skin and provide a conduit to targeted treatment site. | Same | Maintaining access to the target site for exchange of the other accessories | | Product Code | HRX | Same | HRX | | Predicate | Subject | | | | | | | | | | | | |-----------------------------------------------------|-----------------------------------------------------------------------|-----------|------------------------------------------------|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|--|----------------------------------------------------------------------------|------------------|-----------------------------------------------------------------------------|---------------------------|----------------------|-------------| | u Endoscopic Spine System, K081051 | | Subject | Spine View, SpineVu Endoscopic Spine System | Guidewire | Solid Stainless Steel wire with blunt tip | | Length: 16" | Diameter: 0.058" | Same | Same | Same | Same | | neVu Guide Wire | Guidewire | Predicate | SpineVu Endoscopic Spine System, K081051 | SpineVu Guide Wire | Sold Stainless Steel wire with sharp tip | | Length: 16.5" | Diameter: 0.046" | Stainless Steel | Intervertebral procedures | Yes | Yes | | Grinding and aspirating bral disc material | Facilitating endoscopic access and visualization in the surgical | Subject | | 16G Introducer Cannula and Stylet | Same | | Same | | Same | Same | Same | Same | | iscectomy procedures in cal, thoracic and lumbar | area of the cervical, thoracic, or lumbar spine for interventional | Predicate | | | 16G Introducer: Hollow Stainless Steel tube with a proximal luer Stylet: Solid Stainless Steel instrument with a tri-beveled tip | | Cannula Length: 7" Stylet Length 7.7" OD: 16G (0.068") ID: 0.060" | | Stainless Steel, Polycarbonate, Medical Grade Adhesive (Loctite 3311) | Intervertebral procedures | Yes | Yes | | | spinal procedures such as | | Company, K# | Device Name | Design | | Dimensions | | Materials | Target Anatomy | Supplied Sterile? | Single Use? | | | discectomy, nucleotomy and foraminotomy. | | | | | | | | | | | | | ng access to the target | Same | | | | | | | | | | | | | xchange of the other es | Same | | | | | | | | | | | | 7 {8}------------------------------------------------ Special 510(k) Special 510(k) Notification SpineVu Endoscopic Spine System (SESS) 9 of 13 ﺓ 11 3362 {9}------------------------------------------------ K113362 p. 10 of 13 A Spine View, Inc. Special 510(k) Special 510(k) Notification pineVu Endoscopic Spine System (SESSS) | Dilator | | | Beveled Can | |---------------------|----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------| | | Predicate | Subject | Pr- | | Company, K# | SpineVu Endoscopic Spine System, K081051 | Spine View, SpineVu Endoscopic Spine System | SpineVu E | | Device Name | SpineVu Dilator | Dilator | Syste | | Indications for Use | Cutting, grinding and aspirating intervertebral disc material during discectomy procedures in the cervical, thoracic and lumbar spine. | Facilitating endoscopic access and visualization in the surgical area of the cervical, thoracic, or lumbar spine for interventional spinal procedures such as discectomy, nucleotomy and foraminotomy. | SpineVu Int Cutting, grinding intervertebral during discectomy the cervical, the spine. | | Intended Use | Provide a larger pathway through tissue for other instruments | Same | Provides a co instruments to | | Product Code | HRX | Same | HRX | | Design | Stainless Steel tube with tapered tip | Same | Stainless Steel tip | | Dimensions | Length: 9" ID: 0.050" OD: 0.142" | Length: 9" ID: 0.063" (at tip) OD: 0.285" | Length: 7" ID: 0.144" OD: 0.150" | | Materials | Stainless Steel | Same | Stainless Steel Polycarbonate | | Target Anatomy | Intervertebral procedures | Same | Intervertebral | | Supplied Sterile? | Yes | Same | Yes | | Single Use? | Yes | Same | Yes | | Beveled Cannula | Predicate | Subject | |-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | SpineVu Endoscopic Spine System, K081051 | Spine View, SpineVu Endoscopic Spine System | | | SpineVu Introducer Sheath | Beveled Cannula | | | Cutting, grinding and aspirating intervertebral disc material during discectomy procedures in the cervical, thoracic and lumbar spine. | Facilitating endoscopic access and visualization in the surgical area of the cervical, thoracic, or lumbar spine for interventional spinal procedures such as discectomy, nucleotomy and foraminotomy. | | | Provides a conduit for other instruments to treatment site. | Same | | | HRX | Same | | | Stainless Steel tube with straight tip | Stainless Steel tube with beveled tip | | | Length: 7" ID: 0.144" OD: 0.150" | Length, Short: 5.4" Length, Long: 6.1" ID: 0.291" OD: 0.312" | | | Stainless Steel, ABS, Polycarbonate | Stainless Steel | | | Intervertebral procedures | Same | | | Yes | Same | | | Yes | Same | {10}------------------------------------------------ KII 3362 p 11 of 13 Spine View, Inc. Special 510(k) Special 510(k) Notification Calletter | Ball Tip Probe | | | Suction Cann | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------| | | Predicate | Subject | | | Company, K# | | | Pre | | | Richard Wolf, Minimally Invasive Spinal Surgery Set, K994363 | Spine View, SpineVu Endoscopic Spine System Ball Tip Probe | Percutaneous Set, | | Device Name | Probe | | Suction | | Indications for Use | Examination, diagnosis, and/or therapy by personnel trained and qualified in connection with endoscopically used accessories in various medical disciplines, such as orthopedic and spinal surgery. | Facilitating endoscopic access and visualization in the surgical area of the cervical, thoracic, or lumbar spine for interventional spinal procedures such as discectomy, nucleotomy and foraminotomy. | Visualize and disc herniation region of the posterolateral fluoroscopic c | | Intended Use | Bluntly probe tissue or bone | Same | Aspirate fluid to treatment site | | Product Code | HRX | Same | HRX | | Design | Retractable solid ball-tip wire with flexible blunted tip | Solid ball-tip wire shaft with ball with blunt tip | Metal hypotube female luer hub distal tip | | Dimensions | Length: 13.8" Diameter: 0.098" | Length: 12.4" Diameter, Shaft: 0.047" Diameter, Tip: 0.094" | Length: 11.8" ID: 0.027" OD: 0.157" | | Materials | Unknown | Stainless Steel, Brazing Paste (Ag/Cu/ Zn/Sn) | Stainless Steel | | Target Anatomy | Intervertebral procedures | Same | Intervertebral | | Supplied Sterile? | No | Same | No | | Single Use? | No | Same | No | | Suction Cannula | Predicate | Subject | |-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Karl Storz Percutaneous Foraminoscopy Set, K001918 | Spine View, SpineVu Endoscopic Spine System | | | Suction Cannula | Suction Cannula | | | Visualize and treat verterbral disc herniations in the lumbar region of the spine using a posterolateral approach and fluoroscopic control. | Facilitating endoscopic access and visualization in the surgical area of the cervical, thoracic, or lumbar spine for interventional spinal procedures such as discectomy, nucleotomy and foraminotomy. | | | Aspirate fluid from the targeted treatment site | Aspirate fluid from the targeted treatment site | | | HRX | Same | | | Metal hypotube with proximal female luer hub and beveled distal tip | Metal hypotube with proximal barb fitting Blunt distal tip Designed to fit through working lumen of enVue Cannula/enVue Sheath | | | Length: 11.8" ID: 0.027" OD: 0.157" | Length: 12.2" ID: 0.106" OD: 0.120" | | | Stainless Steel | Stainless Steel, Acrylic, Medical Grade Adhesive (Loctite 3311) | | | Intervertebral procedures | Same | | | No | Same | | | No | Same…