(112 days)
Not Found
No
The 510(k) summary describes a standard endoscopic system for visualization and surgical procedures, with no mention of AI, ML, image processing, or any related technologies.
No
This device is primarily for visualization and surgical access, facilitating diagnostic and surgical procedures rather than directly providing a therapeutic effect on the patient's condition.
Yes
The "Intended Use / Indications for Use" section states: "The Arthro Kinetics' Endoscopic Spine System ... is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures..."
No
The device description explicitly lists multiple hardware components (Endoscope, light source, light guide, sheaths, camera head, camera control unit) and describes their physical functions in a surgical procedure. This is not a software-only device.
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 about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Arthro Kinetics' Endoscopic Spine System is used to visualize the inside of the patient's body during surgical procedures. It is a tool used within the body (in vivo) for direct observation and surgical intervention.
The description clearly states its purpose is for "visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures." This is a direct visualization and surgical tool, not a device for testing samples outside the body.
N/A
Intended Use / Indications for Use
The Arthro Kinetics' Endoscopic Spine System (Kinetics Interchangeable Spine System) is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as nucleotomy, discectomy, and foraminotomy.
Product codes
HRX
Device Description
The Arthro Kinetics Endoscopic Spine System consists of an Endoscope, light source, light guide, sheaths, camera head, and camera control unit and is a reusable minimally invasive system that enables surgeons to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as nucleotomy, discectomy, and foraminotomy. The outer sheath acts to facilitate suction / irrigation to the surgical site, serving as a cannula to provide an access portal for the endoscope to be inserted into the patient for viewing or the placing of manual surgical instruments. By inserting the endoscope into the outer sheath the surgeon will be able to view the operative site whilst being guided to the pain source by the ongoing feedback from the patient. The endoscope also has a working channel to allow surgical instruments to be inserted into the operative site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons
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)
K053267, K941967, K051827, K941919
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
AUG 2 3 2006
510(k) Summary
for
Arthro Kinetics Endoscopic Spine System
1. SPONSOR
Arthro Kinetics Inc. 8 Faneuil Hall, 3d Floor Boston, MA 02109
| Contact Person: | James Hobbs |
|---|---|
| Telephone: | 508-735-3810 |
Date Prepared: July 26, 2006
2. DEVICE NAME
| Proprietary Name: | Endoscopic Spine System |
|---|---|
| Common/Usual Name: | Spinal Access System |
| Classification Name: | Arthroscope and Accessories |
3. PREDICATE DEVICES
- Endius Atari System (K053267) .
- Henke-Sass Wolf Endoscope ( K941967) .
- . Joimax Thessys Multiscope (K051827)
- Viking Systems CCD camera (K941919) .
4. DEVICE DESCRIPTION
The Arthro Kinetics Endoscopic Spine System consists of an Endoscope, light source, light guide, sheaths, camera head, and camera control unit and is a reusable minimally invasive system that enables surgeons to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as nucleotomy, discectomy, and foraminotomy. The outer sheath acts to facilitate
1
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suction / irrigation to the surgical site, serving as a cannula to provide an access portal for the endoscope to be inserted into the patient for viewing or the placing of manual surgical instruments. By inserting the endoscope into the outer sheath the surgeon will be able to view the operative site whilst being guided to the pain source
by the ongoing feedback from the patient. The endoscope also has a working channel to allow surgical instruments to be inserted into the operative site.
ડ. INTENDED USE
The Arthro Kinetics' Endoscopic Spine System (Kinetics Interchangeable Spine System) is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as nucleotomy, discectorny, and foraminotomy.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The Arthro Kinetics Endoscopic Spine System and the predicate devices all include working channels and/or irrigation channels used to visualize and irrigate the operative site. The proposed and predicate devices include a fiberoptic or rodflens endoscope, camera and light source for visualization. Additionally, they all contain working channels and irrigation channels for various surgical procedures.
The technological characteristics of the Arthro Kinetics Endoscopic Spine System and the predicate products are substantially equivalent in that they all consist of an endoscope, camera, control unit and light source for visualization during Endoscopic spine procedures. The Arthro Kinetics Endoscopic Spine System and the predicate devices are also similar in that they all are intended specifically for spine procedures. The labeling for the Arthro Kinetics Endoscopic Spine System is essentially identical to the labeling cleared for the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. To the left of the symbol, the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 3 2006
Arthro Kinetics, Inc. % Medical Device Consultants, Inc. Ms. Mary McNamara-Cullinane Senior Regulatory Consultant 49 Plain Street North Attleboro, Massachusetts 02760
Re: K061246
Trade/Device Name: Endoscopes Spine System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: July 26, 2006 Received: July 27, 2006
Dear Ms. McNamara-Cullinane:
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. Mary McNamara-Cullinane
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Yen
Mark N. Mel kerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Kob146
510(k) Number (if known):
Device Name: Endoscopic Spine System
Indications For Use:
The Arthro Kinetics' Endoscopic Spine System (Kinetics Interchangeable Spine System) is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as nucleotomy, discectomy, and foraminotomy.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
P.thm
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number K061246