(115 days)
Not Found
No
The summary describes a collection of surgical tools and an arthroscope for visualization and intervention in spinal procedures. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The performance studies focus on biocompatibility, bench testing, and cadaver testing, which are typical for traditional surgical devices.
Yes
The device is used for interventional spinal procedures and includes a bipolar RF electrosurgical accessory, which implies direct therapeutic intervention rather than just diagnostic visualization.
No
The device is indicated for "endoscopic access and visualization" and accessorized with "surgical and coagulation tools for interventional spinal procedures" like discectomy, not for diagnosis.
No
The device description explicitly states it is a "collection of arthroscopic surgical accessories" and an "arthroscope," which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The SpineVu Endoscopic Spine System and MiniScope are described as surgical accessories and an arthroscope used for direct visualization and intervention within the spine. They are used during a surgical procedure on the patient's body, not for analyzing samples outside the body.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any biological specimens. The device's function is to provide visual access and facilitate surgical tools within the patient's spine.
Therefore, based on the provided information, the SpineVu Endoscopic Spine System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SpineVu Endoscopic Spine System (SESS™) and SpineVu MiniScope are indicated for use for 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.
Product codes (comma separated list FDA assigned to the subject device)
HRX, GEI
Device Description
The SESS kit is a collection of arthroscopic surgical accessories, including a bipolar RF electrosurgical accessory. The Spine Vu MiniScope is an arthroscope.
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)
Biocompatibility data demonstrates that the device is in compliance with ISO 10993.
Bench testing has demonstrated that the device is in compliance with pertinent standards, the medical communities expectations, and the product labeling.
Cadaver testing demonstrated that the device can be used as intended in humans
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.
K000046, K052241, K010811, K061246, K061345
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.
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Kosios1
SpineView, Inc.
SpineVu Endoscopic Spine System (SESS) Premarket Notification
ਨੂੰ
1 of
f
Section 5: 510(k) Summary
Device Information:
AUG - 7 2008
| Device Information: | |
|---|---|
| Category | Comments |
| Sponsor: | Roy Chin |
| President & CEO | |
| SpineView, Inc | |
| 48541 Warm Springs Blvd. | |
| Suite 507 | |
| Fremont, CA 94539 | |
| Tel: 510-377-0898 | |
| Correspondent Contact | |
| Information: | Craig Coombs |
| Coombs Medical Device Consulting | |
| 1193 Sherman Street | |
| Alameda, CA 94501 | |
| Tel: 510-337-0140 | |
| Fax: 510-337-0416 | |
| Device Common Name: | Arthroscopic Intervention Kit |
| Device Classification & | |
| Code: | Arthroscope: Class II, HRX |
| Arthroscope Accessories: Class I, NBH | |
| Electrosurgical Accessory: Class II, GEI | |
| Device Classification | |
| Name: | 21CFR888.1100: Arthroscope & |
| Accessories | |
| 21CFR878.4400: Electrosurgical Cutting | |
| & Coagulation Device and Accessories | |
| Device Proprietary Name: | SpineVu Endoscopic Spine System (SESS) |
| SpineVu MiniScope |
Predicate Device Information:
| Predicate Devices: | Kess Instrument
set | Disc-FX System | Perc-D Spine
Wand |
|-------------------------------------|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device
Manufacturers: | Richard Wolf
Medical
Instruments | Ellman
International | ArthroCare |
| K#s | K000046 | K052241 | K010811 |
| Predicate Device
Common Name: | Arthroscope &
accessories | Arthroscope &
accessories;
electrosurgical
accessories | Arthroscope &
accessories;
electrosurgical
accessories |
| Predicate Device
Classification: | 21CFR888.1100:
Arthroscope &
Accessories | 21CFR888.1100:
Arthroscope &
Accessories
21CFR878.4400:
Electrosurgical
Cutting &
Coagulation
Device and
Accessories | 21CFR888.1100:
Arthroscope &
Accessories
21CFR878.4400:
Electrosurgical
Cutting &
Coagulation
Device and
Accessories |
CONFIDENTIAL
Page 1
1
SpineView, Inc.
SpineVu Endoscopic Spine System (SESS) Premarket Notification
| Predicate Device
Classification &
Code: | Class 2, HRX | Class 2, HRX &
GEI | Class 2, HRX &
GEI |
| ----------------------------------------------- | -------------- | ----------------------- | ----------------------- |
|---|
Predicate Device Information, continued:
| Predicate Devices: | Kinetics
Interchangeable
Spine System | Atavi System |
|-----------------------------------------------|------------------------------------------------|------------------------------------------------|
| Predicate Device
Manufacturers: | Arthro Kinetics | Endius |
| K#s | K061246 | K061345 |
| Predicate Device
Common Name: | Arthroscope &
accessories | Arthroscope &
accessories |
| Predicate Device
Classification: | 21CFR888.1100:
Arthroscope &
Accessories | 21CFR888.1100:
Arthroscope &
Accessories |
| Predicate Device
Classification &
Code: | Class 2, HRX | Class 2, HRX |
b. Date Summary Prepared
10 April 2008
c. Description of Device
The SESS kit is a collection of arthroscopic surgical accessories, including a bipolar RF electrosurgical accessory. The Spine Vu MiniScope is an arthroscope.
d. Intended Use
The SpineVu Endoscopic Spine System (SESS™) and SpineVu MiniScope are indicated for use for 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.
e. Comparison to Predicate Device
SESS Kit
Nearly all of the components of the SESS kit are Class I exempt (NBH) as Arthroscope accessories (21CFR888.1100). The only exception is the SpineVu CoagProbe. The CoagProbe is a Class II electrosurgical accessory (21CFR878.4440, GEI).
The SpineVu CoagProbe is substantially equivalent in intended use as the coagulation probes found in the Arthrocare Perc-D Spine Wand (K010811) and the Ellman Disc-FX Systems (K052241). Each is used for the ablation and coagulation of intervertebral disc material. The designs of the probes are similar in that all are intended to be used under direct visualization via an endoscope. All of the probes are bipolar and use RF energy to ablate and coagulate the disc material.
SpineView concludes that the SESS is substantially equivalent to the predicate arthroscopic surgical kits.
2
SpineView, Inc.
SpineVu Endoscopic Spine System (SESS) Premarket Notification
SpineVu MiniScope
The Spine Vu MiniScope is substantially equivalent in intended use and design as the arthroscopes in the "Kess" instrument set (K000046), the Arthro Kinetics Spine System (K061246) and the Endius Atavi System (K061345). All are fiber-optic illumination and visualization systems for percutaneous evaluation of intervertebral spaces in the spinal column.
Spinc View concludes that the SpineVu MiniScope is substantially equivalent to the predicate arthroscopes.
The testing described below demonstrates that the differences in the devices do not raise any unresolved issues of safety or efficacy.
SpineView concludes that the devices are substantially equivalent.
f. Summary of Supporting Data
Biocompatibility data demonstrates that the device is in compliance with ISO 10993.
Bench testing has demonstrated that the device is in compliance with pertinent standards, the medical communities expectations, and the product labeling.
Cadaver testing demonstrated that the device can be used as intended in humans
3
Image /page/3/Picture/12 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, 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 symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 7 2008
Spine View, Inc. % Coombs Medical Device Consulting, Inc. Mr. Craig Coombs 1193 Sherman Street Alameda, California 94501
Re: K081051
Trade/Device Name: SpineVu Endoscopic Spine System (SESS™) and SpineVu MiniScope Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX, GEI Dated: July 18, 2008 Received: July 22, 2008
Dear Mr. Coombs:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); good manufacturing practice requirements as set
4
Page 2 - Mr. Craig Coombs
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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark M. Mulhausen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
SpineView, Inc.
Section 4: Indications for Use Statement
510(k) Number (if known):
SpineVu Endoscopic Spine System (SESS™) and SpineVu Device Name: MiniScope
Indications For Use:
The SpineVu Endoscopic Spine System (SESS™) and SpineVu MiniScope are indicated for use for 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.
| Prescription Use | X | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | Page 1 of 1 |
| Division of General, Restorative, and Neurological Devices | |
| CONFIDENTIAL | Section 4 |
| 510(k) Number | K041051 |