(91 days)
No
The description focuses on head-controlled manipulation of an endoscope and does not mention any AI/ML capabilities or image processing.
No
The device is described as an "Endoscopic camera manipulator" that allows the surgeon to control the movements of a rigid endoscope. It is a tool used during surgery for visualization, not a device that directly or indirectly treats or diagnoses a disease or condition.
No
The device description clearly states it is a "head-controlled Endoscopic camera manipulator" intended for surgical procedures, not for diagnosing conditions. Its purpose is to assist in visualizing the surgical field, not to provide diagnostic information.
No
The device description explicitly states that EndoAssist is a "head-controlled Endoscopic camera manipulator" and allows the surgeon to "control movements of a rigid endoscope by head gestures." This indicates the device includes hardware components (the manipulator and potentially head-tracking sensors) in addition to any software that processes the head gestures and controls the manipulator.
Based on the provided information, 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.
- EndoAssist Function: The description clearly states that EndoAssist is a "head-controlled Endoscopic camera manipulator." Its purpose is to control the movement of a rigid endoscope within the body during surgical procedures.
- Lack of Sample Analysis: There is no mention of EndoAssist analyzing any biological samples or providing diagnostic information based on such analysis. Its function is purely mechanical control of a surgical instrument for visualization.
Therefore, EndoAssist falls under the category of a surgical device or instrument, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
EndoAssist is indicated for use in general thoracoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy and sinuscopy, where a rigid laparoscope/endoscope is intended for use.
A few examples of the more common endoscopic surgeries are laparoscopic* cholecystectomy hernia repair fundoplication splenectomy appendectomy hemicolectomy sympathectomy lymph node dissection hysterectomy gastric banding qastric by pass nephrectomy radical prostatectomy anterior spinal fusion, decompression fixation wedge resection lung biopsy pleural biopsy , internal mammary artery dissection for coronary artery bypass coronary artery bypass grafting where endoscopic visualization is indicated examination of the evacuated cardiac chamber during performance of valve replacement or repair.
Product codes
GCJ
Device Description
EndoAssist is a head-controlled Endoscopic camera manipulator. It is intended for use in minimally invasive laparoscopic, thoracoscopic, urological, gynecological and cardiac surgery and allows the surgeon directly to control movements of a rigid endoscope by head gestures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The users of EndoAssist are general surgeons, bariatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, orthopedic surgeons, ENT surgeons and urologists
- 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)
EndoAssist K973249, AESOP 3000 K972699, Lapman K023735
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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Image /page/0/Picture/0 description: The image shows the word "ARMSTRONG" in large, bold, white letters against a black rectangular background with rounded corners. Below the rectangle, in a smaller font, is the phrase "surgical excellence through robotics". The text is centered below the black rectangle.
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FEB 2 5 2005
Armstrong Healthcare Limited Knaves Beech Business Centre Loudwater, High Wycombe HP10 9QR United Kingdom
Telephone +44 (0) 1628 536900 +44 (0) 1628 536901 Fax enquire@armstrong.co.uk
17 January 2005
510(k) Summary
Contact: Dr Patrick Finlay, Director
Device Details:
The trade name of the device is EndoAssist The common name for the device is endoscopic camera manipulator The classification name is rigid endoscope accessory The classification group code is GCJ per CFR Section 21 876.1500
Predicate Devices EndoAssist K973249, AESOP 3000 K972699, Lapman K023735
Description of Device
EndoAssist is a head-controlled Endoscopic camera manipulator. It is intended for use in minimally invasive laparoscopic, thoracoscopic, urological, gynecological and cardiac surgery and allows the surgeon directly to control movements of a rigid endoscope by head gestures.
Intended Use
EndoAssist is indicated for use in general thoracoscopy, general cardiothoracic surgery, general laparoscopy, nasopharynqoscopy, ear endoscopy and sinuscopy, where a rigid laparoscope/endoscope is intended for use.
Technological characteristics compared with predicates
The EndoAssist predicate device described in K973249 is the same device as the applicant device in all material respects. The only difference between K973249 and the present application is the change in Indications for Use. The AESOP 3000 predicate device K972699 performs the same functions, but is controlled by voice commands and is clamped to the side of the operating table. EndoAssist is controleed by natural head movements and is free-standing. The Lapman predicate device K0237352 is controlled by switches inserted into the surgeon's glove. The working volume of Lapman is significantly smaller than that of EndoAssist or AESOP, which limits its area of use.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 5 2005
Dr. Patrick A. Finlay Director Armstrong Healthcare Limited Knaves Beech Business Centre Loudwater, High Wycombe HP10 9QR United Kingdom
Re: K043284
Trade/Device Name: EndoAssist Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: January 19, 2004 Received: January 21, 2004
Dear Dr. Finlay:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave review your your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10. as on 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 rou may, therer by the Act include requirements for annual registration. Ilsting 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 rr your de rise 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, I'DA 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 r that FDA has made a determination that your device complies with other requirements of the Act that 119 Federal statutes and regulations administered by other Federal agencies. You must or unly with all the Act's requirements, including, but not limited to: registration and listing (21 CIFR 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.
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Page 2 - Dr. Patrick A. Finlay
This letter will allow you to begin marketing your device as described in your Section 510(k) rms retet notification. The FDA finding of substantial equivalence of your device to a legally premiative holicate 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 Mare facturers, 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/industry/support/index.html.
Sincerely yours,
Muriam C. Provost
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
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Indications for Use
510(k) Number (if known): K043284
Device Name: EndoAssist
Indications for Use:
EndoAssist is indicated for use in general thoracoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy and sinuscopy, where a rigid laparoscope/endoscope is intended for use.
A few examples of the more common endoscopic surgeries are laparoscopic*
cholecystectomy hernia repair fundoplication splenectomy appendectomy hemicolectomy sympathectomy lymph node dissection hysterectomy gastric banding qastric by pass nephrectomy radical prostatectomy anterior spinal fusion, decompression fixation wedge resection lung biopsy pleural biopsy , internal mammary artery dissection for coronary artery bypass coronary artery bypass grafting where endoscopic visualization is indicated examination of the evacuated cardiac chamber during performance of valve replacement or repair.
The users of EndoAssist are general surgeons, bariatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, orthopedic surgeons, ENT surgeons and urologists
- In this context "laparoscopic" is taken to embrace the use of a rigid endoscope in any part of the body
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Over-The-Counter Use _ NO Prescription Use yES AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K043284