(101 days)
Not Found
No
The description focuses on direct surgeon control via head movements and mentions no AI/ML components or image processing capabilities.
No.
The device description indicates Freehand is a robotic endoscope holder that allows the surgeon to control the endoscope's movements, assisting in minimally invasive surgical visualization, rather than directly treating a medical condition.
No
This device is described as assisting surgeons with controlling endoscopes during various surgical procedures for visualization, not for diagnosing conditions.
No
The device description explicitly states "Freehand is a modification of Prosurgics EndoAssist" and mentions "allows the surgeon directly to control movements of a rigid endoscope by head movements." This indicates a physical device that controls an endoscope, not solely software. The mention of electrical safety and electromagnetic compatibility testing further confirms it is a hardware device.
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 examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states that Freehand is a device that controls the movement of a rigid endoscope during surgical procedures. It is used for visualization within the body, not for analyzing samples taken from the body.
- Intended Use: The intended use is for various surgical procedures involving endoscopy and laparoscopy, which are invasive procedures performed directly on the patient.
- Device Description: The description focuses on the mechanical and control aspects of the device for manipulating an endoscope.
Therefore, Freehand falls under the category of a surgical device or an endoscopic accessory, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Freehand is indicated for use in general thoracoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy and sinuscopy, where a rigid laparoscope/endoscopeis 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 gastric 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
Product codes
GCJ
Device Description
Freehand is a modification of Prosurgics EndoAssist. The Freehand is intended for use in minimally invasive laparoscopic, thoracoscopic, urological, gynecological and cardiac surgery where a rigid laparoscope/endoscope is intended for use, and allows the surgeon directly to control movements of a rigid endoscope by head movements. Changes that have been made are to provide simpler control mechanisms that should result in greater reliability, as well as several convenience features. From the surgeon's point of view, the two devices are the same as far as their operation and functions are concerned.
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 FreeHand are general surgeons, bariatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, orthopedic surgeons, ENT surgeons and urologists.
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)
Non-clinical tests: All aspects of Freehand has been extensively validated. It meets the requirements of IEC 60601-1 (electrical safety) and IEC 60601-1-2 (electromagnetic compatibility).
Clinical tests: Clinical tests are not necessary, since Freehand uses the same technology as the predicate device.
Conclusions: Freehand is equivalent in safety and efficacy to the legally-marketed predicate devices.
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
§ 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.
0
K090340
Prosurgics Ltd. Special 510(k) Freehand Endoscopic Camera Controller
MAY 22 2009
510(k) Summary
(1) Submitter Information
Name: Prosurgics Ltd.
Address:
Venture House 2 Arlington Business Park Bracknell RG12 1 WA United Kingdom
Telephone Number: 44-1628 536900
Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Telephone 201-727-1703 Fax 201-727-1708
Date Prepared: February 4, 2009
(2) Name of Device
Trade Name: Freehand Common Name: Endoscopic Camera Controller Classification name: Rigid Endoscope Accessory
(3) Equivalent legally-marketed devices.
(4) Description
$\frac{1}{2}$
ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ
1
Freehand is a modification of Prosurgics EndoAssist. The Freehand is intended for use in minimally invasive laparoscopic, thoracoscopic, urological, gynecological and cardiac surgery where a rigid laparoscope/endoscope is intended for use, and allows the surgeon directly to control movements of a rigid endoscope by head movements. Changes that have been made are to provide simpler control mechanisms that should result in greater reliability, as well as several convenience features. From the surgeon's point of view, the two devices are the same as far as their operation and functions are concerned.
(5) Intended Use
Freehand intended to be used 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, sympathectomy, sympathectomy, lymph node dissection, hysterectomy, gastric banding, gastric 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 FreeHand are general surgeons, bariatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, orthopedic surgeons, ENT surgeons and urologists.
(6) Performance Data
(a) Non-clinical tests
All aspects of Freehand has been extensively validated. It meets the requirements of IEC 60601-1 (electrical safety) and IEC 60601-1-2 (electromagnetic compatibility).
(b) Clinical tests
Clinical tests are not necessary, since Freehand uses the same technology as the predicate device.
(c) Conclusions
Freehand is equivalent in safety and efficacy to the legally-marketed predicate devices.
2
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 its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Prosurgics Limited % Medsys, Inc. George H. Myers, Sc.D. 377 Route 17 S Hasbrouck Heights, New Jersey 07604
MAY 22 2009
Re: K090340
Trade/Device Name: Freehand Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: May 5, 2009 Received: May 7, 2009
Dear Dr. Myers:
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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at
3
Page 2 - George H. Myers, Sc.D.
(240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
Samuel D. Ingham
FOR
Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
. : . .
:
・・・・・・・・・・
:
・・・・・
Indications for Use
| 510(k) Number (if known): | K090340 |
|---|---|
| Device Name: | Freehand |
Indications for Use:
Indications for Use:
Freehand is indicated for use in general thoracoscopy, general cardiothoracic surgery,
general laparoscopy, nasopharyngoscopy, ear endoscopy and sinuscopy, where a rigid
laparoscope/endoscopeis 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
gastric by pass
nephrectomy
radical prostatectomy
anterior spinal fusion, decompression fixation
wedge resection
lung biopsy
pleural biopsy,
internal mammary artery dissection for coronary artery bypass
5
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
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mitreghn for mkm
(Division Sign Off)
Page 2 of 2
(Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090340