(22 days)
Not Found
No
The description focuses on mechanical instruments and visualization components without mentioning any AI/ML capabilities or related performance metrics.
No.
The device is used for access, visualization, and retraction during surgical procedures, not for treating a disease or condition itself.
No
The provided text describes the Endius Atavi System as being used for "posterior access and visualization in the surgical area" and to "perform any type of surgical spinal procedures such as discectomy, nucleotomy, spinal fusion," and "insertion of spinal implants." It facilitates surgical procedures by providing access and visualization, rather than diagnosing a condition.
No
The device description explicitly lists hardware components such as instruments, a retracting device, an endoscope, a light source, light guide, a camera control unit, and a 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. These tests are performed outside of the body.
- Device Description and Intended Use: The Endius Atavi System is described as a surgical system used for access and visualization during surgical procedures on various parts of the body (spine, joints). It includes instruments for dilation, retraction, and visualization (endoscope, camera).
- Lack of Diagnostic Testing: The description does not mention any tests performed on bodily samples or any diagnostic capabilities. Its purpose is to aid the surgeon during the surgical procedure itself, not to diagnose a condition based on laboratory analysis.
Therefore, based on the provided information, the Endius Atavi System is a surgical device, not an In Vitro Diagnostic device.
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
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K991794, K994425, K002437, K021748, K022199, K053267
Reference Device(s)
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
K.061345
May 12, 2006
Section 5 - 510(k) Summary
5.1 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.
5.2 Submitter
Endius, Inc. 23 West Bacon Street Plainville, MA. 02762
5.3 Company Contact
Christine Kuntz-Nassif Director, Regulatory Affairs/Quality Assurance Phone: (508) 643-0983 x114 Fax: (508) 695-2501 Email: cnassif(@endius.com
5.4 Device Name
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 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.
1
5.5 Predicate Devices
Device Name(s): Endius Atavi System 510(k) Number(s): K991794, K994425, K002437, K021748, K022199, K053267
5.6 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.
5.7 Device Indications and Intended 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).
5.8 Substantial Equivalence
The proposed Endius Atavi System is substantially equivalent to the current Endius Atavi System.
000012
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized representation of three human figures.
JUN -6 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Endius, Inc. % Ms. Christine Kuntz-Nassif Director, Regulatory Affairs/Quality Assurance 23 West Bacon Street Plainville, Massachusetts 02762
Re: K061345
Trade/Device Name: Endius® Atavi System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulation Class: II Product Code: HRX Dated: May 12, 2006 Received: May 16, 2006
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
3
Page 2 – Ms. Christine Kuntz-Nassif
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
E. Mall
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K06xxxx
Device Name: Endius Atavi System
Indications For Use:
The Endius Atavi System is indicated for use for posterior access and visualization in the surgical area of 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).
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
QmQQ
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Division of General, Restorative, and Neurological Devices
K061342 510(k) Number_