(89 days)
Not Found
No
The summary describes a system for surgical access and visualization using traditional endoscopic equipment, with no mention of AI or ML capabilities.
No.
The device is used for access and visualization during surgical procedures, not for treatment or therapy itself.
No
The device is described as providing access and visualization for surgical procedures, indicating its role as a surgical tool rather than for diagnosis. It's used to "perform any type of surgical spinal procedures" and to "maintain the access" and for "visualization components," which are all functions of a surgical assistance device. Diagnostic devices typically gather information to identify a condition or disease.
No
The device description explicitly lists hardware components such as instruments, a retracting device, endoscope, light source, light guide, camera control unit, and camera head.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Endius® Atavi™ System is described as a surgical system used for access, visualization, and performing surgical procedures within the body. It involves instruments for dilation, retraction, and visualization (endoscope, camera).
- Intended Use: The intended use clearly states it's for surgical procedures on various anatomical sites. It does not mention analyzing samples taken from the body.
The device is a surgical tool, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Endius® Atavi™ System is indicated for use for 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).
Product codes
HRX
Device Description
The Endius Atavi System includes instruments used to access the spine by dilation of the overlying tissues, as well as a retracting device that is used to maintain the access. The visualization components of the system include, an endoscope, a light source, light guide, a camera control unit, and a camera head.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical, thoracic, or lumbar spine, knee, ankle, shoulder, hand, wrist, and temporomandibular joint (TMJ)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medtronic Sofamor Danek METRx System, K002931
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.
0
OCT 02 2002
022199
Section 7 - 510(k) Summary of Safety and Effectiveness
| 7.1
Statement | Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Endius, Inc.
is required to submit with this Premarket Notification either an "... adequate
summary of any information respecting safety and effectiveness or state that
such information will be made available upon request of any person." Endius,
Inc. chooses to submit a summary of information respecting safety and
effectiveness. According to §513(i)(3)(B), "Any summary under
subparagraph (A) respecting a device shall contain detailed information
regarding data concerning adverse health effects..."
The summary regarding the adverse health effects of the modified device,
Endius Atavi System is provided below. |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 7.2
Submitter | Endius, Inc.
23 West Bacon Street
Plainville, MA. 02762 (USA) |
| 7.3
Company
Contact | Christine Kuntz Nassif
Director, Regulatory Affairs
Endius, Inc.
508-643-0983 |
| 7.4
Device Name/
Classification | Proprietary Name: Endius Atavi System
Common Name: Endoscopic Spinal Access System
Classification Name: Endoscope and Accessories
The devices in the Endoscopic Spinal Access System can be classified as
class II, 876.1500 Endoscope and Accessories. The primary device in the
system is the endoscope. The accessory equipment is needed to gain access
for placement of the endoscope, to support the endoscope in position, or to
work with the endoscope for the purpose of visualization. |
| 7.5
Predicate
Legally
Marketed
Devices | Sofamor Danek Microendoscopic Discectomy System
(Sofamor Danek Memphis, Tennessee)
Medtronic Sofamor Danek METRx System, K002931 |
| 7.6 Device
Description | The Endius Atavi System includes instruments used to access the spine by
dilation of the overlying tissues, as well as a retracting device that is used to
maintain the access. The visualization components of the system include, an
endoscope, a light source, light guide, a camera control unit, and a camera
head. |
| 7.7 Indications
for Use | The Endius® Atavi™ System is indicated for use for 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). |
| 7.8
Substantial
Equivalence | The Endius Atavi System is substantially equivalent to the Sofamor Danek
USA Microendoscopic System (Memphis, TN)and the METRx System. |
1
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wing feathers. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Public Health Service
OCT 02 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Endius, Inc. Christine Kuntz Nassif Director, Regulatory Affairs 23 West Bacon Street Plainville, Massachusetts 02762
Re: K022199
Trade/Device Name: Endius Atavi System Regulation Number: 888.1100 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: HRX Dated: July 3, 2002 Received: July 5, 2002
Dear Ms. Kuntz Nassif:
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 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.
3
Page 2 – Ms. Christine Kuntz Nassif
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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
15022199 510(k) Number (if known):
Device Name: Endius® Atavi™ System
Indications for Use:
The Endius® Atavi™ System is indicated for use for 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).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaulation (ODE)
(Optional Format 3-10-98)
(Posted July 1, 1998)
Hyatt Gurdie
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K022199
000002