(83 days)
Not Found
No
The device description focuses on mechanical surgical tools and accessories for visualization and tissue removal. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are also focused on mechanical and material properties, not algorithmic performance.
No.
The device facilitates access and visualization during surgical procedures and includes tools for tissue removal, but it does not directly treat a disease or condition itself.
No
The device is described as a system for facilitating access and visualization during interventional spinal procedures and includes surgical tools for tissue removal. Its intended use and device description focus on surgical intervention, not diagnosis.
No
The device description clearly states it is a collection of arthroscopic surgical accessories, including physical tools like a bone cutter and cannulas, which are hardware components. The performance studies also focus on physical properties and testing of these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Spine View Minimally Invasive Surgical (MIS) Decompression System is described as a collection of surgical accessories used to facilitate access and visualization during spinal procedures and to remove tissue. It is a surgical tool used directly on the patient's body during a procedure.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information based on biological specimens.
Therefore, the Spine View Minimally Invasive Surgical (MIS) Decompression System falls under the category of a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Spine View Minimally Invasive Surgical (MIS) Decompression System is indicated for use to facilitate access and visualization in the surgical area of the cervical, thoracic, or lumbar spine and is accessorized with surgical tools for interventional spinal procedures such as discectomy, nucleotomy and foraminotomy.
Product codes (comma separated list FDA assigned to the subject device)
HRX
Device Description
The Minimally Invasive Surgical (MIS) Decompression System 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 addition of a new accessory, the enCise Bone Cutter, as an additional surgical tool to facilitate removal of soft and hard (bone) tissue during interventional spinal procedures. The new component will be offered in two configurations: one compatible with flexible endoscopes, and the second compatible with rigid endoscopes. Two additional enVue Cannula models are also being introduced for compatibility with rigid endoscopes: Long and Standard Jaw. Introduction of the new enCise Bone Cutter and additional configurations of the already cleared enVue Cannula do not affect the intended use or alter the fundamental scientific technology of the system.
The additional accessories being proposed in the modified MIS Decompression System are listed below:
- . enCise Bone Cutter: a tubular sheath with a mechanical "chisel" tip feature designed to cut soft and hard (cartilaginous, bone) tissue during spinal procedures. The enCise Bone Cutter is offered in two configurations (one compatible with flexible endoscopes, and the second compatible with rigid endoscopes).
- enVue Cannula, Standard and Long Jaw: configurations for use with rigid . endoscopes. The working end of the accessories is identical to the previously cleared enVue Cannulas. The only difference is in the handle, which is modified to accommodate rigid endoscopes (up to 5.9 mm OD; 205 mm working length).
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.
• Device to Device Compatibility Testing
• Joint Integrity Testing
• Tip Rotation
• Tip Robustness
• Handle/Joint Integrity
• 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 Spine View Minimally Invasive Surgical (MIS). Decompression System 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 Spine View Minimally Invasive Surgical (MIS) Decompression System is substantially equivalent to the predicate devices for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
121548
Spine View, Inc.
Special 510(k) Notification Minimally Invasive Surgical (MIS) Decompression System
510(k) Summary
AUG 1 6 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.
- Name and Address of Applicant A. Spine View, Inc. 48810 Kato Road, Suite 100E Fremont, CA 94538 Phone: (510) 743-5090 Fax: (510) 490-1753
B. Contact Person
Diana DeGregorio Lincé Consulting Regulatory Affairs Consultant Phone: (925) 980-8047
-
C. Date Prepared
July 13, 2012 -
D. Device Name
Minimally Invasive Surgical (MIS) Decompression System Trade Name: Common Name: Arthroscope Classification Name: · Arthroscope
ய் Device Classification
| Classification: | 21 CFR §888.1100 |
|---|---|
| Product Code: | HRX |
| Device Class: | Class II |
F. Predicate Device
The modified Minimally Invasive Surgical (MIS) Decompression System is substantially equivalent to the Spine View SpineVu Endoscopic Spine System (SESS) (K113362 and K08151) and predicate cutting instruments offered as part of the Richard Wolf Medical Instruments Corp. Minimally Invasive Spinal Surgery Set (K994363) and several Class I orthopedic manual surgical instruments, including the Joimax EndoReamer and EndoChisel Assembly.
1
KIZISY8
Spine View, Inc.
Special 510(k) Notification Minimally Invasive Surgical (MIS) Decompression System
G. Device Description
The Minimally Invasive Surgical (MIS) Decompression System 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 addition of a new accessory, the enCise Bone Cutter, as an additional surgical tool to facilitate removal of soft and hard (bone) tissue during interventional spinal procedures. The new component will be offered in two configurations: one compatible with flexible endoscopes, and the second compatible with rigid endoscopes. Two additional enVue Cannula models are also being introduced for compatibility with rigid endoscopes: Long and Standard Jaw. Introduction of the new enCise Bone Cutter and additional configurations of the already cleared enVue Cannula do not affect the intended use or alter the fundamental scientific technology of the system.
The additional accessories being proposed in the modified MIS Decompression System are listed below:
- . enCise Bone Cutter: a tubular sheath with a mechanical "chisel" tip feature designed to cut soft and hard (cartilaginous, bone) tissue during spinal procedures. The enCise Bone Cutter is offered in two configurations (one compatible with flexible endoscopes, and the second compatible with rigid endoscopes).
- enVue Cannula, Standard and Long Jaw: configurations for use with rigid . endoscopes. The working end of the accessories is identical to the previously cleared enVue Cannulas. The only difference is in the handle, which is modified to accommodate rigid endoscopes (up to 5.9 mm OD; 205 mm working length).
H. Intended Use
The Spine View Minimally Invasive Surgical (MIS) Decompression System is indicated for use to facilitate access and visualization in the surgical area of the cervical, thoracic, or lumbar spine and is accessorized with surgical tools for interventional spinal procedures such as discectomy, nucleotomy and foraminotomy.
l. Technological Comparison
The Spine View Minimally Invasive Surgical (MIS) Decompression System has similar features as compared to the predicate devices as shown in the tables below:
2
K121548 f-3.0+5
Spine View, Inc.
enCise Bone Cutter
| Predicate | Predicate | Subject | |
|---|---|---|---|
| Company, K# | Richard Wolf Minimally | ||
| Invasive Spinal Surgery | |||
| Set, | |||
| K994363 | Joimax, Inc., TESSYS | ||
| Surgical Instruments, N/A |
- Class I Exempt | Spine View MIS
Decompression System,
K121548 |
| Device Name | Punches | EndoReamer, EndoChisel | enCise Bone Cutter |
| Intended Use | endoscopically controlled
dissection, exploration, and
manipulation of tissue
through natural or surgically
created passages
to grasp, manipulate, and
cut, as well as for the
dissection and biopsy of
tissue, organs, or foreign
bodies.
punching and removal of
tissue through natural or
surgically created passages. | The Joimax TESSYS Spinal
Stenosis System is a set of
endoscopic instruments that
facilitate removal of
osseous/bony material
under direct endoscopic
imaging. The EndoReamer
and EndoChisel instruments
are intended to remove
osteophytes and calcifying
tissues, including coarse
stenosis fragments. | enCise Bone Cutter is
intended to facilitate
removal of remove
osteophytes and calcifying
tissues under direct
endoscopic visualization. |
| Product Code | HRX, Class II | LXH, Class I - 510(k)
Exempt | HRX, Class II |
| Design | The punch-featured
instruments are designed
with a sliding jaw, which is
forced into the material to be
cut by depressing the
mechanical actuator in the
handle | The chisel-featured
instruments are designed
with a characteristically
shaped cutting edge, which
are forced into the material
to be cut by use of a
surgical mallet or manual
manipulation | Same |
| Dimensions | 2.5 - 4.0 mm OD, WL 290 -
360 mm (=2.5-4.0 mm
cutting element tip width) | EndoReamer: Single
Working Channel for
endoscope and endoscopic
instruments
3.0-7.5 mm ID; 4.0-8.5 mm
OD; WL 210 mm (4.0 -
8.5mm circular serrated tip
diameter)
EndoChisel: 2.6 or 3.0 mm
OD, WL 370 mm (=2.6 or
3.0 mm chisel tip width) | Single Working Channel for
endoscope and endoscopic
instruments
6.12 mm ID, 7.16 mm OD,
196 &198 mm WL (3.76 mm
chisel tip width) |
| Patient Contact Materials | Stainless Steel | Same | Same |
| Target Anatomy | Intervertebral procedures | Same | Same |
| Supplied Sterile? | No | No | Yes |
| Single Use? | No | No | Yes |
| | Predicate | Subject | |
| Company, K# | Spine View, MIS Decompression System
K113362 | Spine View, MIS Decompression System
K121548 | |
| Device Name | enVue Cannula | enVue Cannula | |
| Intended Use | 1. Access cannula with working channel for
endoscope, endoscopic instruments, and
irrigation and drainage
- Distal feature for retracting tissue away
from end of cannula | 1. Same - Same | |
| Product Code | HRX, Class II | Same | |
| Design | 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) | Same | |
| Dimensions | 1. OD: 0.282" - Working Length: 7.5"
- Length, Tissue Retraction Feature 0.394"
- OD, Tissue Retraction Feature: 0.354 "
- Single Working Channel 0.240" for enVue
Sheath (for endoscopic instruments and
endoscope [2 mm OD] | 1. Same - Same
- Same
- Same
- Single Working Channel 0.240" for
endoscopic instruments and endoscope [5.9
mm OD] | |
| Patient Contact
Materials | Stainless Steel, Nylon-12 | Same | |
| Target Anatomy | Intervertebral procedures | Same | |
| Supplied
Sterile? | Yes | Same | |
| Single Use? | Yes | Same | |
. :
3
K1215468 g. 4 c of 5
Spine View, Inc.
Special 510(k) Notification SpineVu Endoscopic Spine System (SESS)
enVue Cannula
The technological characteristics and principals of operation of the modified Spine View Minimally Invasive Surgical (MIS) Decompression System 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.
| • Device to Device Compatibility Testing | • Jaw Cycle Integrity Testing |
|---|---|
| • Joint Integrity Testing | • Jaw Activation Testing |
| • Tip Rotation | • Biocompatibility Testing |
| • Tip Robustness | • Design Validation Testing |
| • Handle/Joint Integrity | • Packaging Testing |
| • Jaw & Trigger Force Testing | • Sterility Testing |
4
1215486- 5 of J
Spine View, Inc.
The above testing confirmed that the Spine View Minimally Invasive Surgical (MIS). Decompression System 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 Spine View Minimally Invasive Surgical (MIS) Decompression System is substantially equivalent to the predicate devices for its intended use.
K. Conclusions
The Spine View Minimally Invasive Surgical (MIS) Decompression System 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 Spine View Minimally Invasive Surgical (MIS) Decompression System 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.
5
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Spine View, Incorporated % Ms. Diana DeGregorio Regulatory Affairs Consultant 48810 Kato Road, Suite 100E Fremont, California 94538
Re: K121548
Trade/Device Name: Minimally Invasive Surgical (MIS) Decompression System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: July 15, 2012 Received: July 18, 2012
Dear Ms. DeGregorio:
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 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
AUG 16 2012
6
Page 2 - Ms. Diana DeGregorio
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
For Duth.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Spine View, Inc.
K121548 p. 1 o f 1
Indications for Use Statement
510(k) Number (if known):
Device Name: Minimally Invasive Surgical (MIS) Decompression System
K
Indications for Use:
The Spine View Minimally Invasive Surgical (MIS) Decompression System is indicated for use to facilitate access and visualization in the surgical area of the cervical, thoracic, or lumbar spine and is accessorized with surgical tools for interventional spinal procedures such as discectomy, nucleotomy and foraminotomy.
Prescription Use × Over-The-Counter Use
(per 21 CFR 801.109)
Or
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)