(29 days)
Not Found
No
The document describes a system for surgical access and visualization, with no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is used in various surgical procedures, including discectomy and fusion, and provides tools for tissue dilation and retraction, directly impacting a patient's medical condition.
No
The device description and intended use indicate that the Endius Atavi System is used for surgical access and procedures (fusion, discectomy, nucleotomy), not for diagnosing conditions. It provides visualization during surgery but doesn't interpret or analyze physiological data for diagnostic purposes.
No
The device description explicitly lists physical instruments, a retracting device, and visualization hardware components (endoscope, light source, camera control unit, camera head).
Based on the provided information, the Endius Atavi System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes surgical procedures (instrumented posterolateral fusion, posterior endoscopic access, discectomy, nucleotomy). These are procedures performed on the patient, not tests performed on samples taken from the patient.
- Device Description: The device description details instruments for surgical access, retraction, and visualization (endoscope, light source, camera). These are all tools used during a surgical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease or injury. The Endius Atavi System does not fit this description.
N/A
Intended Use / Indications for Use
The Endius Atavi System is indicated for use in instrumented posterolateral fusion procedures where the TriFix Spinal Instrumentation System is utilized.
The Endius Atavi System is also intended to be used for posterior endoscopic access to the lumbar spine for various endoscopic spinal procedures such as discectomy, nucleotomy, non-instrumented posterolateral fusion procedures.
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
Spine, 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)
This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Endius, Inc. has provided certification of compliance to 21 CFR 820.30 Design Control requirements, and the results of validation testing (performance testing) for the device modification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
JUN 2 6 2002
Section 7 - 510(k) Summary
| 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 Atavi 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 | Endius Endoscopic Access System: K991794, K994425, K002437 |
| 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 in instrumented posterolateral
fusion procedures where the TriFix Spinal Instrumentation System is utilized.
The Endius Atavi System is also intended to be used for posterior endoscopic
access to the lumbar spine for various endoscopic spinal procedures such as
discectomy, nucleotomy, non-instrumented posterolateral fusion procedures. |
| 7.7
Safety and
Performance | This submission is a Special 510(k): Device Modification as described in
FDA's guidance document entitled "The New 510(k) Paradigm - Alternate
Demonstrating Substantial Equivalence in Premarket
Approaches to
Notifications."
In support of this 510(k), Endius, Inc. has provided
certification of compliance to 21 CFR 820.30 Design Control requirements,
and the results of validation testing (performance testing) for the device
modification. |
1
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s
2
7.8 Substantial Equivalence Based on the indications for use, technological characteristics, and comparison to predicate devices, the proposed Endius Atavi System has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
Applicant
Date 5/24/02
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird design, composed of three curved lines that suggest the shape of a bird in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Christine Kuntz-Nassif Director, Regulatory Affairs Endius, Inc. 23 West Bacon Street Plainville, MA 02762
JUN 2 6 2002
Re: K021748
Trade/Device Name: Endius® Atavi™ System Regulation Number: 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: May 24, 2002 Received: May 28, 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
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 you 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" (21CFR 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.
Stypt Rhodes
a M. Witten, Ph.D., M.D. of Celi Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known):
021748
Device Name: Endius® Atavi™ System
Indications for Use:
The Endius Atavi System is indicated for use in instrumented posterolateral fusion procedures where the TriFix Spinal Instrumentation System is utilized.
The Endius Atavi System is also intended to be used for posterior endoscopic access to the lumbar spine for various endoscopic spinal procedures such as discectomy, nucleotomy, noninstrumented posterolateral fusion procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Image /page/5/Picture/7 description: This image shows a document related to the Concurrence of CDRH, Office of Device Evaluation (ODE). It indicates that the document was posted on July 1, 1998, with an optional format date of 3-10-98. The document includes a division sign-off for the Division of General, Restorative, and Neurological Devices. The 510(k) number is listed as K021748, and the document number is 000002.