(87 days)
No
The summary describes a collection of physical surgical accessories and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a collection of surgical accessories designed to facilitate endoscopic access and visualization, not to treat a disease or condition itself.
No
The device is described as "arthroscopic surgical accessories" intended to "facilitate endoscopic access and visualization" and "delivery of an endoscope and other instruments to the targeted treatment site" for interventional spinal procedures. It does not mention any function related to diagnosing medical conditions.
No
The device description explicitly lists physical components (cannulas, sheath, introducer, guidewire, dilator, probe) and describes them as "arthroscopic surgical accessories provided sterile (irradiated) and intended for single-use only." This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to facilitate endoscopic access and visualization in the surgical area of the spine for interventional spinal procedures. This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The device is a collection of surgical accessories (cannulas, sheaths, guidewire, dilator, probes) used to deliver an endoscope and other instruments to the surgical site. These are physical tools for surgical manipulation and access.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
- Anatomical Site: The device is used on the spine, which is a part of the patient's body, not a sample being tested.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical instrument used during a procedure on the patient.
N/A
Intended Use / Indications for 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.
Product codes
HRX
Device Description
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, 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical, thoracic, or lumbar spine
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)
The following non-clinical testing was conducted to support a determination of substantial equivalence to the predicate device.
• Visual and Dimensional Verification
• Device to Device Compatibility Testing
• Tensile Testing
• Flow Rate Testing
• Luer Attachment Testing
• Leakage Testing
• Jaw & Trigger Force Testing
• Jaw Cycle Integrity Testing
• Jaw Activation Testing
• Biocompatibility Testing
• Design Validation Testing
• Packaging Testing
• Sterility Testing
The above testing confirmed that the SpineVu Endoscopic Spine System (SESS) performs according to the stated intended use. All data fell well within product specifications and external standard requirements. Results of non-clinical testing demonstrated that the SpineVu Endoscopic Spine System (SESS) is substantially equivalent to the predicate devices for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SpineVu Endoscopic Spine System (SESS) (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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.1100 Arthroscope.
(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
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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,
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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:
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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
- Intended for use with the enVue Cannula to provide the access ports for endoscopic instruments and endoscope, and irrigation | Dimensions | 1. OD: Unknown
- Working Length: Unknown
- Working channel for
endoscopic instruments and
endoscope: 0.945" x 1.18" - Length, Tissue Retraction
Feature: 1.181" - OD, Tissue Retraction
Feature: 2.362" | 1. OD: 0.140" - Working Length: ~7.5"
- Length, Tissue Retraction
Feature: up to 0.315" - OD, Tissue Retraction
Feature: 0.248" - Multiple Working channels
for endoscopic instruments:
~0.049" - Working channel for
endoscope: ~0.039" | 1. OD: 0.282" - Working Length: 7.5"
- Length, Tissue Retraction
Feature 0.394" - OD, Tissue Retraction
Feature: 0.354" - Single Working Channel for
enVue Sheath (for
endoscopic instruments and
endoscope): 0.240" | 1. OD: 0.236" - Designed to be
delivered through enVue
Cannula - Working Length: 8.8"
- Working Channel for
endoscopic instruments:
0.122" - 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 | | | | | | | | | | | | | | | | | | | | | | | | | | |
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Special 510(k) Notification
pineVu Endoscopic Spine System (SESS)
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pineVu Endoscopic Special 510(K) Notification
Concessoric Spine System (SESS)
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|くいろろん2
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Special 510(K) Special 510(K) Notification
SpineVu Endoscopic Spine System (SESS)
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enVue Cannula and enVue Sheath
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Special 510(k) Special 510(k) Notification
Controlu Endoscopic Spine System (SESSS)
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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 |
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SpineVu Endoscopic Spine System (SESS)
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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 |
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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 |
11
Infusion Cannula
| Predicate | Subject | |
|---|---|---|
| Company, K# | Spine View, SpineVu Endoscopic | |
| Spine System, K081051 | Spine View, SpineVu Endoscopic | |
| Spine System | ||
| Device Name | SpineVu Infusion Cannula | Infusion Cannula |
| 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. | ||
| Intended Use | Infusion of solutions into the disc | |
| material and spinal cavity | Same | |
| Product Code | HRX | Same |
| Design | Metal hypotube with beveled tip; | |
| proximal female luer fitting | Metal hypotube with beveled tip; | |
| proximal female barb fitting | ||
| Dimensions | Length: 13" | |
| ID: 0.027" | ||
| OD: 0.042" | Length: 13.4" | |
| ID: 0.027" | ||
| OD: 0.042" | ||
| Materials | Stainless Steel | Stainless Steel, Polycarbonate, |
| Medical Grade Adhesive (Loctite |
-
|
| Target
Anatomy | Intervertebral procedures | Same |
| Supplied
Sterile? | Yes | Same |
| Single Use? | Yes | Same |
The technological characteristics and principals of operation of the modified SpineVu Endoscopic Spine System (SESS) are substantially equivalent to the named predicate devices.
J. Non-Clinical Performance Data
The following non-clinical testing was conducted to support a determination of substantial equivalence to the predicate device.
| • Visual and Dimensional Verification | • Jaw Cycle Integrity Testing |
|---|---|
| • Device to Device Compatibility Testing | • Jaw Activation Testing |
| • Tensile Testing | • Biocompatibility Testing |
| • Flow Rate Testing | • Design Validation Testing |
| • Luer Attachment Testing | • Packaging Testing |
| • Leakage Testing | • Sterility Testing |
| • Jaw & Trigger Force Testing |
12
K113362 p 13 of 13
The above testing confirmed that the SpineVu Endoscopic Spine System (SESS) performs according to the stated intended use. All data fell well within product specifications and external standard requirements. Results of non-clinical testing demonstrated that the SpineVu Endoscopic Spine System (SESS) is substantially equivalent to the predicate devices for its intended use.
K. Conclusions
The SpineVu Endoscopic Spine System (SESS) has been carefully compared to legally marketed devices with respect to intended use and technological characteristics. In addition, non-clinical testing was conducted to validate the performance of the device and ensure the modified SpineVu Endoscopic Spine System (SESS) functions as intended and meets design specifications. The comparison and non-clinical results demonstrate that the device is substantially equivalent to the predicate device for its intended use.
13
Image /page/13/Picture/1 description: The image is a circular logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB 1-0 2012
Spine View. Inc. % Ms. Sevrina Ciucci 48810 Kato Road, Suite 100E Fremont, California 94538
Re: K113362
Trade/Device Name: SpineVu Endoscopic Spine System (SESS) Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: January 11, 2012 Received: January 13, 2012
Dear Ms. Ciucci:
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.
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
14
Page 2 - Ms. Sevrina Ciucci
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,
urs,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
15
K113362 p. 1 of 1
Spine View, Inc.
Special 510(k) Notification SpineVu Endoscopic Spine System (SESS)
Indications for Use Statement
| 510(k) Number (if known): | K |
|---|---|
| Device Name: | SpineVu Endoscopic Spine System (SESS) |
| Indications for 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. | |
| Prescription Use | X Or Over-The-Counter Use |
| (per 21 CFR 801.109) |
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 Surgical, Orthopedic, and Restorative Devices
510(k) Number K113362
·.
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