(162 days)
Not Found
No
The device description explicitly states that the camera contains neither software nor firmware, and there are no mentions of AI, DNN, or ML in the document. The performance studies focus on physical and functional testing, not algorithmic performance.
No
The device is described as an arthroscope for endoscopic visualization, which means it aids in viewing inside the body during procedures. Its function is primarily diagnostic and visual guidance, not to directly treat a condition. While used during "interventional spinal procedures," the device itself is a tool for visualization rather than a direct therapeutic agent.
No
The device is an endoscopic camera for visualization during surgical procedures, not for diagnostic purposes. Its intended use is described as "endoscopic visualization in the surgical area of the cervical, thoracic, or lumbar spine during diagnostic or interventional spinal procedures," meaning it aids visualization during a diagnostic procedure, but it is not performing the diagnosis itself.
No
The device description explicitly states that the FlexLite™ Camera contains neither software nor firmware and is a hardware device with fiber-optic bundles, an LED light source, a CCD image sensor, and associated electronics.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The FlexLite™ Camera is an endoscope used for direct visualization of the spine inside the body during surgical procedures. It provides visual information to the surgeon, but it does not analyze or test biological samples.
The device description and intended use clearly indicate it's a tool for surgical visualization, not for in vitro testing of specimens.
N/A
Intended Use / Indications for Use
The FlexLite™ Camera is indicated for use for endoscopic visualization in the surgical area of the cervical, thoracic, or lumbar spine during diagnostic or interventional spinal procedures such as discectomy, nucleotomy and foraminotomy.
Product codes (comma separated list FDA assigned to the subject device)
HRX
Device Description
The Spine View FlexLite™ Camera is a flexible, reusable arthroscope designed for endoscopic visualization during diagnostic or interventional spinal procedures with access to the target area established through a surgical opening. The device includes fiber-optic illumination bundles with an integrated LED light source in the handle and a distal tip CCD image sensor with associated electronics. The camera is offered to support NTSC and PAL video formats. The FlexLite™ Camera is designed for use with the commercially available Vision-Sciences DPU-5050 Video Processor Unit (K102733, K072073) for image display and transfer. The FlexLite™ Camera contains neither software nor firmware. The FlexLite™ Camera is provided non-sterile to the customer and must be cleaned and sterilized by the user prior to each use.
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.
• Dimensional Testing
• Performance Testing
• Durability Testing
• Environmental Testing
• Electrical Safety, Thermal Safety & EMC Testing
• Biocompatibility Testing
• Design Validation Testing
• Cleaning Validation
• Sterilization Validation
The above testing confirmed that the FlexLite™ Camera 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 FlexLite™ Camera 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
510(k) Summary
DEC 2 7 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) 490-1753
B. Contact Person
Mbithi Muthini Director Quality and Regulatory (510) 743-5090 mmuthini@spineview.com
Alternate Contact: Diana DeGregorio Lincé Consulting Regulatory Affairs Consultant (925) 980-8047 dianadegregorio@comcast.net
C. Date Prepared
November 30, 2012
D. Device Name
| Trade Name: | FlexLite™ Camera |
|---|---|
| Common Name: | Arthroscope |
| Classification Name: | Arthroscope |
E. Device Classification
| Classification: | 21 CFR §888.1100 |
|---|---|
| Product Code: | HRX |
| Device Class: | Class II |
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F. Predicate Device
Spine View, Inc. submits that the subject FlexLite™ Camera is substantially equivalent to the predicates, Vision-Sciences ENT-5000 flexible endoscope (K102733, K072073) and the Spine View SpineVu MiniScope (K081051).
G. Device Description
The Spine View FlexLite™ Camera is a flexible, reusable arthroscope designed for endoscopic visualization during diagnostic or interventional spinal procedures with access to the target area established through a surgical opening. The device includes fiber-optic illumination bundles with an integrated LED light source in the handle and a distal tip CCD image sensor with associated electronics. The camera is offered to support NTSC and PAL video formats. The FlexLite™ Camera is designed for use with the commercially available Vision-Sciences DPU-5050 Video Processor Unit (K102733, K072073) for image display and transfer. The FlexLite™ Camera contains neither software nor firmware. The FlexLite™ Camera is provided non-sterile to the customer and must be cleaned and sterilized by the user prior to each use.
H. Intended Use
The FlexLite™ Camera is indicated for use for endoscopic visualization in the surgical area of the cervical, thoracic, or lumbar spine during diagnostic or interventional spinal procedures such as discectomy, nucleotomy and foraminotomy.
. Technological Comparison
The Spine View FlexLite™ Camera has similar features as compared to the predicate devices as shown in the tables below:
| Manufacturer
Model Name
510(k) Number | Spine View, Inc.
FlexLite™ Camera
TBD | Vision-Sciences, Inc.
ENT-5000 Surgical
Videoscope
K102733, K072073 | Spine View, Inc.
SpinVu Miniscope
K081051 |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 21CFR888.1100
HRX, Class II | 21CFR888.1100 &
21CFR874.4760
HRX& EOB, Class II | 21CFR888.1100
HRX, Class II |
| Indications for
Use | The FlexLite™ Camera
is indicated for use for
endoscopic visualization
in the surgical area of the
cervical, thoracic, or
lumbar spine during | The ENT-5000 is intended
for use in flexible
endoscopic examination of
the upper airway, vocal
cords and/or nasal
passages; and for use
diagnostic arthroscopic and | The SpineVu
Endoscopic Spine
System (SESS) and
SpinVu MiniScope are
indicated for use for
endoscopic access and
visualization in the |
| | diagnostic or
interventional spinal
procedures such as
discectomy, nucleotomy | endoscopic procedures to
provide illumination and
visualization of an interior
cavity of the body through | surgical area of the
cervical, thoracic, or
lumbar spine and are
accessorized with |
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Spine View, Inc.
| Manufacturer
Model Name
510(k) Number | Spine View, Inc.
FlexLite™ Camera
TBD | Vision-Sciences, Inc.
ENT-5000 Surgical
Videoscope
K102733, K072073 | Spine View, Inc.
SpinVu Miniscope
K081051 |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| | and foraminotomy. | either a natural or surgical
openings. | surgical and coagulation
tools for interventional
spinal procedures such
as discectomy,
nucleotomy and
foraminatomy |
| Design | A reusable, flexible,
video endoscope with no
channel; for use with the
Vision-Sciences Digital
Video Processor with
integrated LCD monitor. | A reusable, flexible, video
endoscope with no channel;
optional single-use, sterile,
disposable sheath (various
models and channel sizes);
for use with the Vision-
Sciences Digital Video
Processor with integrated
LCD monitor. | A reusable, flexible,
video endoscope with no
channel; with eyepiece
on proximal end having
port for illumination
cable. |
| Diameter | 2 mm | 3.4 mm | 0.8 mm |
| Working
Length | 1163 mm | 320 mm | ~11 inches (280mm) |
| Single Use? | Reusable (STERRAD®) | Reusable (EtO or
Glutaraldehyde) (optional
single-use sterile sheath) | Reusable (STERIS®) |
The technological characteristics and principals of operation of the FlexLite™ Camera 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.
| • Dimensional Testing | • Biocompatibility Testing |
|---|---|
| • Performance Testing | • Design Validation Testing |
| • Durability Testing | • Cleaning Validation |
| • Environmental Testing | • Sterilization Validation |
| • Electrical Safety, Thermal Safety & | |
| • EMC Testing |
The above testing confirmed that the FlexLite™ Camera 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 FlexLite™ Camera is substantially equivalent to the predicate devices for its intended use.
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K. Conclusions
The Spine View FlexLite™ Camera has been carefully compared to legally marketed devices with respect to intended use and technological characteristics. In addition, nonclinical testing was conducted to validate the performance of the device and ensure the FlexLite™ Camera 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three overlapping shapes that form the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure. The text is in all caps and appears to be in a sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: December 27, 2012
Spine View, Incorporated % Mbithi Muthini Director, Quality and Regulatory 48810 Kato Road, Suite 100E Fremont, California 94538
Re: K122134
Trade/Device Name: FlexLite™ Camera Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: November 30, 2012 Received: December 03, 2012
Dear Mbithi Muthini:
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
5
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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Spine View, Inc.
Traditional 510(k) FlexLite™ Camera
Indications for Use Statement
510(k) Number (if known): K_ 22 13 4
FlexLite™ Camera Device Name:
Indications for Use:
The FlexLite™ Camera is indicated for use for endoscopic visualization in the surgical area of the cervical, thoracic, or lumbar spine during diagnostic or interventional spinal procedures such as discectomy, nucleotomy and foraminotomy.
Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ × Or (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)
Neil R Ogden 2012.12.27 08:02:33 -05'00'
os Min (Division Sign-Off) Division of Surgical Devices 510(k) Number K 122134