TROCAR & TROCAR SLEEVES, LAPAROSCOPES, LAPAROSCOPIC FORCEPS, & LAPAROSCOPIC INSTRUMENTS

K990785 · Jakoubek Medizintechnik GmbH · GCJ · Aug 27, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K990785
• Device Name: TROCAR & TROCAR SLEEVES, LAPAROSCOPES, LAPAROSCOPIC FORCEPS, & LAPAROSCOPIC INSTRUMENTS
• Applicant: Jakoubek Medizintechnik GmbH
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Aug 27, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Providing thorough irrigation and aspiration of the peritoneal cavity. Bleeders can be identified, bile, stones, tissue, blood & smoke from cautery procedures can be aspirated leaving the abdominal cavity clean and dry. Sole purpose of these instruments are to move tissue around. They can not grasp or restrain by means of grasping any body organ or tissue. They are introduced into the body cavity they can only move through a brood trough the or up and down. Devices which create portals into an operative site enableing the introduction thru said devices, tools for the direct the introduction and/or dissecting, cutting, repairing, removal observation and/or internal tissues and/or organs. Devices that pass thru portals into a periteal cavity allowing direct or indirect visualization by means of a camera thru said direct of internal tissues or organs may be visualized for either diagnostic or operative procedures. Verres needles puncture through the abdominal wall to enable the introduction of gacce insternal body organs, allowing for the sa between the rabora and the scopic instrumentation into the peritoneal cavity. Instruments which permit suturing internal tissues or organs thru cannula portals by pushing suture knots down to the tissue site being repaired. Instruments which permit the grasping and manipulation of needles inside the peritoneal cavity enableing a surgeon laparoscopic procedures. Instruments insulated for cautery or non-insulated for non-cautery procedures which enable a surgeon to grasp, biopsy, cut, coagulate, manipulate or retrieve internal biopby, a your while performing laparoscopic procedures.

Device Story

System comprises various laparoscopic instruments: irrigation/aspiration devices, fan retractors, finger dissectors, trocars, trocar sleeves, dilators, laparoscopes, Verres needles, knot pushers, needle holders, and monopolar/bipolar electrodes/forceps/scissors. Used in laparoscopic surgery to create portals, visualize internal anatomy, manipulate/dissect/suture tissue, and manage fluids/smoke. Operated by surgeons in clinical/OR settings. Irrigation/aspiration devices clear peritoneal cavity of blood, bile, stones, and smoke. Trocars/sleeves provide access portals. Fan retractors/dissectors move tissue without grasping. Electrodes/forceps enable coagulation and tissue retrieval. Devices facilitate minimally invasive procedures, potentially reducing patient trauma compared to open surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual laparoscopic surgical instruments including stainless steel or insulated components. Includes irrigation/aspiration tubes, trocars, dilators, needles, and electrosurgical electrodes. Energy source: manual operation for mechanical tools; electrical energy for cautery/coagulation instruments. Connectivity: none. Sterilization: assumed standard medical device sterilization. Software: none.

Indications for Use

Indicated for use in patients undergoing laparoscopic surgical procedures. Instruments are intended for tissue manipulation, irrigation, aspiration, portal creation, visualization, needle grasping, suturing, and cautery/non-cautery surgical tasks within the peritoneal cavity. Contraindicated for grasping or restraining body organs or tissues for the fan retractors and finger dissectors.

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.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/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.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 27 1999

Jakoubek Medizintechnik GmbH c/o Mr. Douglas Hulfish Life Med Technology 1822 N. Stratford Road Arlington Heights, Illinois 60004

Re: K990785

> Trade Name: Trocar and Trocar Sleeves, Laparoscopes, Laparoscopic Forceps and Laparoscopic Instruments Regulatory Class: II Product Code: GCJ and GEI Dated: June 30,1999 Received: July 2, 1999

Dear Mr. Hulfish:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{1}------------------------------------------------

#### Page 2 – Mr. Douglas Hulfish

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mark n Millerson

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Page_1 of 8

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Providing thorough irrigation and aspiration of the peritoneal cavity.Bleeders can be identified,bile,stones,tissue,blood & smoke from cautery procedures can be aspirated leaving the abdominal cavity clean and dry.

Mark N. Milkeuson

for

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K990789
1 OF 8

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

{3}------------------------------------------------

Page 2 ol

510(k) Number (if known): __ K990785__

Device Name: FAN RETRACTORS AND FINGER DISSECTORS

## Indications For Use:

Sole purpose of these instruments are to move tissue around. Sole purpose of these instrain by means of grasping any body
They can not grasp or restrain by addints the body cavity They can not grasp of resorain by de into the body cavity organ or tissue. They are introduced they can only move through a brood trough the or up and down.

Mark N Mulkerson

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K99078

20F

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) ✓

Over-The-Counter Use_

{4}------------------------------------------------

of 8 8 Page 3

510(k) Number (if known):

Device Name: TROCARS, TROCAR SLEEVES AND DILATORS

Indications For Use:

Devices which create portals into an operative site enableing the introduction thru said devices, tools for the direct the introduction and/or dissecting, cutting, repairing, removal observation and/or internal tissues and/or organs.

Mark M. Mulkerson

sion Sign-Off) ion of General Restorative Devices Olk) Number .

K9907

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use -----

{5}------------------------------------------------

of of 8 Page 4

510(k) Number (if known):

Device Name:______________________________________________________________________________________

Indications For Use:

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Devices that pass thru portals into a periteal cavity allowing direct or indirect visualization by means of a camera thru said direct of internal tissues or organs may be visualized for either diagnostic or operative procedures.

Mark N Milkerson

(Division Sign-Off) Division of General Restorative Devices 510(k) Number _

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) √

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

(99078

40F

{6}------------------------------------------------

Page 5 _ of __________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

VERRES NEEDLES Device Name:

## Indications For Use:

Verres needles puncture through the abdominal wall to enable verres needies puncture theabdominal cavity creating space the introduction of gacce insternal body organs, allowing for the sa between the rabora and the scopic instrumentation into the peritoneal cavity.

Image /page/6/Picture/5 description: The image shows a stylized handwritten text that appears to be a signature or logo. The text is in cursive and features a prominent loop at the beginning, followed by a connecting stroke to the subsequent letters. The overall impression is elegant and flowing, suggesting a personal or artistic touch.

Murk N Milbersin

(Division Sign-Off) Division of General Restorative Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) ✓

OR

Over-The-Counter Use -----

(Optional Format 1-2-96)

K990 785

SOFX

{7}------------------------------------------------

ಕ Page 6

510(k) Number (if known):

Device Name: KNOT PUSHER

Indications For Use:

Instruments which permit suturing internal tissues or organs thru cannula portals by pushing suture knots down to the tissue site being repaired.

Mark n Mulbersen

Division Sign-Off Division of General Restorative Devices (990785 510(k) Number

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

2. S

Over - The-Counter Use _______________________________________________________________________________________________________________________________________________________

{8}------------------------------------------------

of 8 Page 7 _

510(k) Number (if known): ___K990785

Device Name: NEEDLE HOLDERS

### Indications For Use:

Instruments which permit the grasping and manipulation of
the country the countancel covity enableing a surgeon Instruments which the pritoneal cavity enableing a surgeon
needles inside the peritoneal cavity enableing a surgeon needles inside the periconeal cavily charoscopic procedures.

Mark N. Mulkeran

(Division Sign-Off) K990785

for

(Division Sign-Off) (Division of General Restorative Devices of K 510(k) Number -

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

{9}------------------------------------------------

Page_ 8_of_8

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K990785_

Device Name: MONOPOLAR ELECTRODES,CAUTERY FORCERS,BIPOLAR FORCEPS & SCISSORS AND NON-CAUTERY FORCEPS

# Indications For Use:

Instruments insulated for cautery or non-insulated for non-cautery procedures which enable a surgeon to grasp, biopsy,cut,coagulate,manipulate or retrieve internal biopby, a your while performing laparoscopic procedures.

Mark N Milbersic

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number***_***_

<990785
801=8

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________