(47 days)
Not Found
Not Found
No
The device description focuses on the physical components and optical properties of a rigid arthroscope, with no mention of software, algorithms, or AI/ML capabilities. The input imaging modality is standard fluoroscopy, and there is no description of any processing or analysis of these images beyond visualization.
No.
A therapeutic device is one that treats a disease or condition. This device is an arthroscope, which is used for visualization during diagnosis or surgical procedures, but it does not directly provide therapy. Its purpose is to assist in performing surgical procedures, not to treat.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "rigid diagnostic arthroscope," and the "Device Description" also refers to it as a "rigid diagnostic arthroscope."
No
The device description clearly outlines physical components such as a rigid diagnostic arthroscope, outer sheath, rod lens imaging system, and fiberoptic light guide, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "percutaneous vizualization of, and/or to assist in performing percutaneous surgical procedures on, the spinal nerve root, foramina, intervertebral disc, and the surrounding tissues of the spine". This describes a surgical instrument used for direct visualization and intervention within the body.
- Device Description: The description details a rigid arthroscope with an outer sheath, rod lens imaging system, fiberoptic light guide, and irrigation capabilities. These are characteristics of a surgical endoscope, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to provide visual access and facilitate surgical procedures within the body.
N/A
Intended Use / Indications for Use
The NuVasive Spinal Arthroscope, consisting of a rigid diagnostic arthroscope with an outer sheath, is intended to achieve percutaneous vizualization of, and/or to assist in performing percutaneous surgical procedures on, the spinal nerve root, foramina, intervertebral disc, and surrounding tissues of the spine via biportal posterior or posterolateral approach, where anatomic restrictions permit percutaneous access. The device is intended for use in conjunction with the NuVasive Guided Spinal Arthroscopy System under real-time radiographic visualization via imageintensified C-arm fluoroscopy, but may be employed independent of that system where it is compatible in diameter and length with commercially available arthroscopic instrumentation, and with surgical need.
Product codes
HRX
Device Description
The subject Spinal Arthroscope is a rigid diagnostic arthroscope with outer sheath. The diagnostic scope is available in three (3) models, consisting of arthroscopes with 0°, 30°, and 70° viewing angles, each of which has a working length of 400 +0.5 mm. The field of view for each is 105°. The device employs a rod lens imaging system and a fiberoptic light guide for illumination. The standard eyepiece permits use of the subject device with various commercially-available video systems. While the device is manufactured with an ACMI-type illumination sidearm, it is supplied with both Richard Wolf-, and Storz-type adaptors which permit connection to many commercially-available light sources. The outer sheath has a 5.0 mm outer diameter and is equipped with a standard luer lock stopcock to permit irrigation through the sleeve. The subject Spinal Arthroscope is provided non-sterile, and is reusable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
real-time radiographic visualization via image-intensified C-arm fluoroscopy
Anatomical Site
spinal nerve root, foramina, intervertebral disc, and surrounding tissues of the 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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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510(k) Summary VII.
In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations, Part 807), and in particular §807.92, the following summary of information is provided:
Submitted by: A.
R. Stephen Reitzler Vice President, Regulatory Affairs and Quality Assurance NuVasive. Incorporated 10065 Old Grove Road, Suite A San Diego, California 92131 Telephone: (858) 271-7070 Telefacsimile: (858) 271-7101
B. Device Name
Trade or Proprietary Name: NuVasive Spinal Arthroscope
Common or Usual Name: Arthroscope
Classification Name: Arthroscope
C. Predicate Devices
The subject device is substantially equivalent, in whole or in part, to one or more of the following predicate devices, among others: .
Arthroscope (Henke-Sass, Wolf, GmbH) PercScope™ (Clarus Medical) Yeung Endoscopic Spine System (Richard Wolf) Panoview Arthroscope (Richard Wolf) Spine Endoscope (Endius) Angled Neuroendoscope (AESCULAP®) Neurological Endoscope (Richard Wolf) Olympus Neuro Endoscope (Olympus Optical) INCLUSIVETM Endoscopic System (Sofamor Danek)
D. Device Description
The subject Spinal Arthroscope is a rigid diagnostic arthroscope with outer sheath. The diagnostic scope is available in three (3) models, consisting of arthroscopes with 0°, 30°, and 70° viewing angles, each of which has a working length of 400 +0.5 mm. The field of view for each is 105°.
1
The device employs a rod lens imaging system and a fiberoptic light guide for illumination. The standard eyepiece permits use of the subject device with various commercially-available video systems. While the device is manufactured with an ACMI-type illumination sidearm, it is supplied with both Richard Wolf-, and Storz-type adaptors which permit connection to many commercially-available light sources. The outer sheath has a 5.0 mm outer diameter and is equipped with a standard luer lock stopcock to permit irrigation through the sleeve. The subject Spinal Arthroscope is provided non-sterile, and is reusable.
E. Intended Use
The NuVasive Spinal Arthroscope, consisting of a rigid diagnostic arthroscope with an outer sheath, is intended to achieve percutaneous vizualization of, and/or to assist in performing percutaneous surgical procedures on, the spinal nerve root, foramina, intervertebral disc, and surrounding tissues of the spine via biportal posterior or posterolateral approach, where anatomic restrictions permit percutaneous access. The device is intended for use in conjunction with the NuVasive Guided Spinal Arthroscopy System under real-time radiographic visualization via imageintensified C-arm fluoroscopy, but may be employed independent of that system where it is compatible in diameter and length with commercially available arthroscopic instrumentation, and with surgical need.
F. Comparison to Predicate Devices
The subject device has indications for use which are substantially equivalent to those of one or more of the predicate devices, is composed of the same or equivalent materials as one or more of the predicate devices, has the same design features as one or more of the subject devices, and has functional characteristics which are the same or equivalent to those of one or more of the predicate devices. Due to the equivalency of indications for use, materials of composition, design features, method of use, and functional characteristics, the device raises no new safety or effectiveness issues.
Summary of Non-Clinical Tests G.
(Not applicable.)
H. Summary of Clinical Tests
(Not applicable.)
Conclusions of Non-Clinical and Clinical Tests I.
(Not applicable.)
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract image of a human figure, with the head and shoulders visible. The figure is facing to the right and appears to be in motion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 5 1999
Mr. Steve Reitzler Vice President, Regulatory Affairs and Quality Assurance Nuvasive, Inc. 10065 Old Grove Road, Suite A San Diego, California 92131
Re: K992782
Trade Name: Spinal Arthroscope Regulatory Class: II Product Code: HRX Dated: August 17, 1999 Received: August 19, 1999
Dear Mr. Reitzler:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that. through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Steve Reitzler
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Colie M. Witter, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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V. Draft Labeling
Indications for Use A.
510(k) Number (if known):
Device Name: NuVasive, Inc., Spinal Arthroscope
Indications for Use:
The NuVasive Spinal Arthroscope, consisting of a rigid diagnostic arthroscope with outer sheath, is intended to achieve percutaneous vizualization of, and/or to assist in performing percutaneous surgical procedures on, the spinal nerve root, foramina, intervertebral disc, and the surrounding tissues of the spine via uniportal or biportal posterior or posterolateral approach, where anatomic restrictions permit percutaneous access. The device is intended for use in conjunction with the NuVasive Guided Spinal Arthroscopy System under real-time radiographic visualization via image-intensified C-arm fluoroscopy, but may also be employed independent of that system where it is compatible in diameter and length with other commercially available arthroscopic instruments, and with surgical need.
| Concurrence of CDRH Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K992782 |
| Prescription Use | (Per 21 CFR 801.109) |
| OR | |
| Over-The-Counter Use |