(87 days)
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.
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, enVue Sheath, 16G Introducer Cannula with Stylet, Guidewire, Dilator, Beveled Cannula, Ball-Tipped Probe, Infusion Cannula, Suction Cannula.
The provided document is a 510(k) premarket notification for a medical device called the "SpineVu Endoscopic Spine System (SESS)". It outlines the device's description, intended use, technological comparison to predicate devices, and non-clinical performance data.
However, the document does not contain the specific information requested regarding acceptance criteria and the study that proves the device meets those criteria, such as a table of accuracy metrics, sample sizes for test/training sets, expert qualifications, or details on ground truth establishment.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and non-clinical performance testing.
Here's what can be extracted from the provided text, and what is missing:
1. A table of acceptance criteria and the reported device performance:
-
Acceptance Criteria (Implicit): The implicit acceptance criteria are that the modified SpineVu Endoscopic Spine System (SESS) performs according to its stated intended use and functions as intended, meeting design specifications and external standard requirements. This is a general statement rather than specific quantitative metrics.
-
Reported Device Performance: The document states: "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."
There is no table explicitly detailing acceptance criteria alongside reported performance for each criterion with quantitative results. The non-clinical tests conducted are listed as:
- 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
2. Sample size used for the test set and the data provenance:
- Not specified. The document only mentions "non-clinical testing" without detailing the methodologies or sample sizes for each test. Data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a 510(k) for a surgical accessory based on substantial equivalence and non-clinical (engineering/lab) testing, not a clinical study involving diagnosis or interpretation by experts to establish ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, for the same reasons as point 3.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a manual surgical accessory, not an AI-powered diagnostic tool. Therefore, no MRMC comparative effectiveness study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical surgical accessory, not an algorithm.
7. The type of ground truth used:
- For the non-clinical tests listed, the "ground truth" would be established by engineering specifications, validated test methods, and industry standards for mechanical performance, material properties, sterility, and biocompatibility. It is not based on expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.
8. The sample size for the training set:
- Not applicable. This device is a manual surgical accessory. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set.
Summary of Missing Information:
The provided 510(k) summary focuses on demonstrating substantial equivalence through comparison to predicate devices and non-clinical (benchtop) testing results. It does not contain the detailed clinical study information (like test/training set sample sizes, expert qualifications, ground truth establishment for diagnostic accuracy, or AI performance metrics) that would typically be found for a device requiring performance evaluation in a clinical or diagnostic context. The acceptance criteria are implicitly defined by compliance with product specifications and external standards, rather than specific quantitative performance metrics from a user study.
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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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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.SpineVuEndoscopic SpineSystem | Spine View, Inc.SpineVuEndoscopic SpineSystem | Manufacturer | Device Name | 510(k) # | Design | EndoscopeCompatibility | SuppliedSterile/Sterilization Method | Single UseOnly | 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 | DilatationAccessRetractionVisualization | OD up toapproximately 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, SpineVuEndoscopic Spine System,K081051 | Spine View, SpineVu Endoscopic Spine SystemK113362 | 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 DiscectomySystem | K110992 | DilatationAccessExcision | 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 InvasiveSpinal Surgery Set | K994363 | DissectionManipulationExcision | 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 NeedleSpineVu Guide WireSpineVu DilatorSpineVu Introducer SheathSpineVu Infusion CannulaSpineVueBalloon CannulaSpineVue DebriderSpineVu CoagProbe | 1. 16G Introducer Cannula w/ Stylet2. Guidewire3. Dilator4. Beveled Cannula5. enVue Cannula (Standard Jaw or Long Jaw)6. enVue Sheath7. Ball Tipped Probe8. Suction Cannula9. Infusion Cannula | Karl Storz | PercutaneousForaminoscopy Set | K001918 | DilatationAccessVisualization | 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 retractingjaws mechanically actuated toretract tissue away from end ofcannula | Toroidal balloon can be inflatedto mechanically retract tissueaway from the end of thecannula | Articulating Top Jaw can bemechanically actuated to retracttissue away from end of cannulaDistal tip: Articulating jaw (Nylon)for tissue retraction (Standard andLong jaw configurations) | When combined with the enVueCannula, can accommodate thefollowing:a) Flexible Endoscopeb) Endoscopic Instrumentsc) 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. | SpineVuEndoscopic SpineSystem | K081051 | DilatationAccessRetractionExcisionAspiration/InfusionVisualization | OD up to 0.032" | Yes/E-beam | Yes | enVue Sheath | Articulating single lumen portalwith retracting jaws used to dilateand maintain access which canaccommodate the following:a) Flexible Endoscopeb) Endoscopic Instrumentsc) Irrigation/Drainage | Single, multi-lumen device whichcan accommodate the following:a) Flexible Endoscopeb) Endoscopic Instrumentsc) 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. | SpineVuEndoscopic SpineSystem | K113362 | DilatationAccessRetractionAspiration/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 procedures2. 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 drainage2. Distal feature for retracting tissue away from end of cannula | 1. Access cannula with working channel for endoscope, endoscopic instruments, and irrigation and drainage2. Distal feature for retracting tissue away from end of cannula1. Intended for use with the enVue Cannula to provide the access ports for endoscopic instruments and endoscope, and irrigation | Dimensions | 1. OD: Unknown2. Working Length: Unknown3. Working channel forendoscopic instruments andendoscope: 0.945" x 1.18"4. Length, Tissue RetractionFeature: 1.181"5. OD, Tissue RetractionFeature: 2.362" | 1. OD: 0.140"2. Working Length: ~7.5"3. Length, Tissue RetractionFeature: up to 0.315"4. OD, Tissue RetractionFeature: 0.248"5. Multiple Working channelsfor endoscopic instruments:~0.049"6. Working channel forendoscope: ~0.039" | 1. OD: 0.282"2. Working Length: 7.5"3. Length, Tissue RetractionFeature 0.394"4. OD, Tissue RetractionFeature: 0.354"5. Single Working Channel forenVue Sheath (forendoscopic instruments andendoscope): 0.240" | 1. OD: 0.236" - Designed to bedelivered through enVueCannula2. Working Length: 8.8"3. Working Channel forendoscopic instruments:0.122"4. Working channel forendoscope: 2 mm | SpineVu Balloon Cannula | enVue Sheath | |||||
| Materials | Unknown | Stainless Steel, PEBAX,Polyurethane, PVC,Polycarbonate | Nylon-12, Stainless Steel, Solder(Sn/Ag), Polycarbonate, MedicalGrade Adhesive (Loctite 4018,Loctite 4013, Loctite 3311) | Stainless Steel, Solder (Sn/Ag),Polycarbonate, Tygon, MedicalGrade Adhesive (Loctite 4018,Loctite 4013, Loctite 3311) | Same | Same | ||||||||||||||||||||||
| Same | Same |
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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
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Special 510(K) Special 510(K) Notification
SpineVu Endoscopic Spine System (SESS)
KI13362 p. 6 of 13
enVue Cannula and enVue Sheath
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Special 510(k) Special 510(k) Notification
Controlu Endoscopic Spine System (SESSS)
K113362 p. 7 . F 13
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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, enSpireDiscectomy System, K110992 | Spine View, SpineVuEndoscopic Spine System | SpineVu Endoscopic SpineSystem, K081051 |
| Device Name | Introducer Cannula withStylet | 16G Introducer Cannula andStylet | SpineVu Guide Wire |
| Indications forUse | Cutting, grinding and aspiratingintervertebral disc materialduring discectomy procedures inthe cervical, thoracic and lumbarspine. | Facilitating endoscopic accessand visualization in the surgicalarea of the cervical, thoracic, orlumbar spine for interventionalspinal procedures such asdiscectomy, nucleotomy andforaminotomy. | Cutting, grinding and aspiratingintervertebral disc materialduring discectomy procedures inthe cervical, thoracic and lumbarspine. |
| Intended Use | Penetrate skin and provide aconduit to targeted treatmentsite. | Same | Maintaining access to the targetsite for exchange of the otheraccessories |
| Product Code | HRX | Same | HRX |
| Predicate | Subject | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| u Endoscopic SpineSystem, K081051 | Subject | Spine View, SpineVuEndoscopic 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 SpineSystem, K081051 | SpineVu Guide Wire | Sold Stainless Steel wire withsharp tip | Length: 16.5" | Diameter: 0.046" | Stainless Steel | Intervertebral procedures | Yes | Yes | |
| Grinding and aspiratingbral disc material | Facilitating endoscopic accessand visualization in the surgical | Subject | 16G Introducer Cannula andStylet | Same | Same | Same | Same | Same | Same | |||
| iscectomy procedures incal, thoracic and lumbar | area of the cervical, thoracic, orlumbar spine for interventional | Predicate | 16G Introducer: Hollow Stainless Steel tube with a proximal luerStylet: 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 | TargetAnatomy | SuppliedSterile? | Single Use? | ||||
| discectomy, nucleotomy andforaminotomy. | ||||||||||||
| ng access to the target | Same | |||||||||||
| xchange of the otheres | Same |
7
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Special 510(k) Special 510(k) Notification
SpineVu Endoscopic Spine System (SESS)
9 of 13
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11 3362
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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, SpineVuEndoscopic Spine System | |
| SpineVu Introducer Sheath | Beveled Cannula | |
| Cutting, grinding and aspiratingintervertebral disc materialduring discectomy procedures inthe cervical, thoracic and lumbarspine. | Facilitating endoscopic accessand visualization in the surgicalarea of the cervical, thoracic, orlumbar spine for interventionalspinal procedures such asdiscectomy, nucleotomy andforaminotomy. | |
| Provides a conduit for otherinstruments to treatment site. | Same | |
| HRX | Same | |
| Stainless Steel tube with straighttip | Stainless Steel tube withbeveled 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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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, MinimallyInvasive Spinal Surgery Set,K994363 | Spine View, SpineVuEndoscopic Spine SystemBall Tip Probe | PercutaneousSet, | |
| Device Name | Probe | Suction | |
| Indications forUse | Examination, diagnosis, and/ortherapy by personnel trainedand qualified in connection withendoscopically usedaccessories in various medicaldisciplines, such as orthopedicand spinal surgery. | Facilitating endoscopic accessand visualization in the surgicalarea of the cervical, thoracic, orlumbar spine for interventionalspinal procedures such asdiscectomy, nucleotomy andforaminotomy. | Visualize anddisc herniationregion of theposterolateralfluoroscopic c |
| Intended Use | Bluntly probe tissue or bone | Same | Aspirate fluid totreatment site |
| Product Code | HRX | Same | HRX |
| Design | Retractable solid ball-tip wirewith flexible blunted tip | Solid ball-tip wire shaft with ballwith blunt tip | Metal hypotubefemale luer hubdistal 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 |
| TargetAnatomy | Intervertebral procedures | Same | Intervertebral |
| SuppliedSterile? | No | Same | No |
| Single Use? | No | Same | No |
| Suction Cannula | Predicate | Subject |
|---|---|---|
| Karl StorzPercutaneous ForaminoscopySet, K001918 | Spine View, SpineVuEndoscopic Spine System | |
| Suction Cannula | Suction Cannula | |
| Visualize and treat verterbraldisc herniations in the lumbarregion of the spine using aposterolateral approach andfluoroscopic control. | Facilitating endoscopic accessand visualization in the surgicalarea of the cervical, thoracic, orlumbar spine for interventionalspinal procedures such asdiscectomy, nucleotomy andforaminotomy. | |
| Aspirate fluid from the targetedtreatment site | Aspirate fluid from the targetedtreatment site | |
| HRX | Same | |
| Metal hypotube with proximalfemale luer hub and beveleddistal tip | Metal hypotube with proximalbarb fittingBlunt distal tipDesigned to fit through workinglumen of enVue Cannula/enVueSheath | |
| Length: 11.8"ID: 0.027"OD: 0.157" | Length: 12.2"ID: 0.106"OD: 0.120" | |
| Stainless Steel | Stainless Steel, Acrylic, MedicalGrade Adhesive (Loctite 3311) | |
| Intervertebral procedures | Same | |
| No | Same | |
| No | Same |
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Infusion Cannula
| Predicate | Subject | |
|---|---|---|
| Company, K# | Spine View, SpineVu EndoscopicSpine System, K081051 | Spine View, SpineVu EndoscopicSpine System |
| Device Name | SpineVu Infusion Cannula | Infusion Cannula |
| Indications forUse | Cutting, grinding and aspiratingintervertebral disc material duringdiscectomy procedures in thecervical, thoracic and lumbar spine. | Facilitating endoscopic access andvisualization in the surgical area ofthe cervical, thoracic, or lumbar spinefor interventional spinal proceduressuch as discectomy, nucleotomy andforaminotomy. |
| Intended Use | Infusion of solutions into the discmaterial 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 (Loctite3311) |
| TargetAnatomy | Intervertebral procedures | Same |
| SuppliedSterile? | 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 |
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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.
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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
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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
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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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§ 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.