FREEHAND

K090340 · Prosurgics Limited · GCJ · May 22, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K090340
• Device Name: FREEHAND
• Applicant: Prosurgics Limited
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: May 22, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

Freehand 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, 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.

Device Story

Freehand is a robotic endoscopic camera controller; modification of Prosurgics EndoAssist. Device allows surgeons to control rigid endoscope movement via head movements during minimally invasive surgeries. System translates surgeon's head orientation into endoscope positioning commands; provides hands-free camera control. Used in OR by general, bariatric, gynecological, cardiac, thoracic, orthopedic, ENT, and urological surgeons. Simplifies control mechanisms compared to predicate; improves reliability. Surgeon views surgical field via endoscope; device maintains visualization based on surgeon's head position. Benefits include surgeon autonomy over camera view; reduced reliance on manual camera assistants.

Clinical Evidence

No clinical data; bench testing only. Device validated for electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2).

Technological Characteristics

Rigid endoscope accessory; robotic controller. Operates via head-tracking input to manipulate endoscope position. Complies with IEC 60601-1 (electrical safety) and IEC 60601-1-2 (EMC).

Indications for Use

Indicated for patients undergoing general thoracoscopy, cardiothoracic surgery, laparoscopy, nasopharyngoscopy, ear endoscopy, or sinuscopy requiring rigid endoscope visualization. Applicable to various surgical procedures including cholecystectomy, hernia repair, hysterectomy, prostatectomy, and cardiac valve repair.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Prosurgics EndoAssist (K043284)
• Computer Motion Inc, Aesop (K972699)

Submission Summary (Full Text)

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## 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 [phone] Fax [phone]

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.

- 1 . Prosurgics EndoAssist, K043284
- 2. Computer Motion Inc, Aesop, K972699

(4) Description

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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.

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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

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Page 2 - George H. Myers, Sc.D.

[phone]. 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 [phone]. 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 [phone] or [phone] 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

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# 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

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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)

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(Division Sign Off)

Page 2 of 2

(Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090340