PMC LAPAROSCOPIC INSTRUMENTS

K101193 · Pmc Medical GmbH · GCJ · Oct 18, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K101193
• Device Name: PMC LAPAROSCOPIC INSTRUMENTS
• Applicant: Pmc Medical GmbH
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Oct 18, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Laparoscopes are used by surgeons in diagnostic and therapeutic procedures. Laparoscopic minimally invasive procedures are performed in the abdominal cavity by means of small skin punctures that allow the insertion of the laparoscope and laparoscopic instruments. The PMC Laparoscopic instruments are intended to scrape, cut, grasp, hold, remove, and manipulate tissue, organs or bowel during laparoscopic surgery. The secondary function is to provide monopolar electrocautery capability to dissect and coagulate soft tissue.

Device Story

PMC Laparoscopic instruments consist of manual surgical tools including scissors, forceps, trocars, electrodes, and laparoscopes. Used by surgeons in OR settings for minimally invasive abdominal procedures. Instruments provide visualization and physical manipulation of tissue, organs, or bowel via small skin punctures. Secondary function includes monopolar electrocautery for soft tissue dissection and coagulation. Device design, materials (stainless steel, carbon-fiber, insulation), and functionality are substantially equivalent to predicate manual laparoscopic instruments.

Clinical Evidence

Bench testing only. No clinical data provided. Testing demonstrated biocompatibility, electromagnetic compatibility, functionality, and safety in accordance with international standards.

Technological Characteristics

Manual laparoscopic instruments; materials include martensitic stainless steel, carbon-fiber, and insulation material. Components include scissors, forceps, trocars, electrodes, and laparoscopes. Monopolar electrocautery capability. Dimensions range from 3mm to 12mm diameter and 25cm to 60cm length. Non-software device.

Indications for Use

Indicated for surgeons performing diagnostic and therapeutic laparoscopic procedures in the abdominal cavity, including pelvic pain, infertility, tubal sterilization, ectopic pregnancy, pelvic tumors, foreign body retrieval, endometriosis, pelvic inflammatory disease, LAVH, and abdominal organ visualization/treatment.

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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• GIMMI ALPHA® Instruments & Accessories (K012660)
• MicroFrance Laparoscopic Manual Surgical Instruments (K080257)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the text "K101193" at the top, followed by the letters "PMC" in a bold, stylized font. Below "PMC" is the text "Medical GmbH" in a smaller, sans-serif font. The text and letters are all black against a white background.

## >> 510(k) Summary as required by section 807.92

04/15/2010

OCT 1 8 2010

>>Submission Applicant: PMC Medical GmbH Gerhard Mondrowski Nelblingstraße 10 78573 Wurmlingen / Germany Phone: [phone] Fax: [phone] E-mail: [e-mail]

Establishment Registration Number: 3006986250

>>Application Correspondent/Contact: think! Andrea Pecsi Schwarzwaldstraße 5 78532 Tuttlingen Germany Phone: [phone] Fax: [phone] E-mail: [e-mail]

# >> Device Identification:

Trade name: PMC Laparoscopic instruments

Common name: Laparoscopes / Endoscopes

Classification name: Laparoscope, general & plastic surgery, Endoscope and accessories, Review Panel General & Plastic Surgery (21 CFR 876.1500, GCJ)

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# >> Predicate Device Information:

510(k)-Number: K012660, GIMMI ALPHA® Instruments & Accessories Firm: GIMMI GMBH

510(k)-Number: K080257, MicroFrance Laparoscopic Manual Surgical Instruments Firm: MEDTRONIC XOMED, INC.

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Image /page/1/Picture/0 description: The image shows the logo for PMC Medical GmbH. The logo consists of the letters "PMC" in a bold, sans-serif font, with the letters slightly overlapping each other. Below the letters, the words "Medical GmbH" are written in a smaller, sans-serif font.

## >>Description of the Device:

PMC Laparoscopes provide illumination and visualization in diagnostic procedures and in conjunction with laparoscopic instruments (accessories) operative laparoscopic procedures as:

-unexplained pelvic pain (acute, chronic)

-infertility work-up

-tubal sterilization

-diagnosis and/or treatment of ectopic pregnancy

-evaluation, diagnosis and/or treatment of pelvic tumors, incl. myomata (less than 16 weeks gestational size)

-Retrieval of foreign bodies

-determination of the presence and extent of pelvic endometriosis

-determination of the presence and extent of pelvic inflammatory disease (if not in acute stage)

-access to abdomen for surgical procedures such as LAVH

-visualization, diagnosis and/or treatment of perforate abdominal organs

The PMC Laparoscopic instruments contain different components such as scissors, forceps, connections, handles, sheaths, laparoscopes, light adapters, trocars, electrode, and inserts. The instruments are made out of martensitic stainless steel, a standard material for medical devices, and insulation material.

#### >>Indications for Use:

Laparoscopes are used by surgeons in diagnostic and therapeutic procedures. Laparoscopic minimally invasive procedures are performed in the abdominal cavity by means of small skin punctures that allow the insertion of the laparoscope and laparoscopic instruments.

The PMC Laparoscopic instruments are intended to scrape, cut, grasp, hold, remove, and manipulate tissue, organs or bowel during laparoscopic surgery. The secondary function is to provide monopolar electrocautery capability to dissect and coagulate soft tissue.

# >> Technological characteristics compared to the Predicate Devices:

The PMC Laparoscopic instruments are similiar to the Gimmi and Medtronic Xomed products in terms of design, technical characteristics, intended use, indications for use, sterilization, and components of devices. The Laparoscope and the respective laparoscopic instruments are identical to the predicate devices. The PMC product is also similiar to the Gimmi and Medtronic Xomed products in terms of the used material.

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Image /page/2/Picture/0 description: The image shows the logo for PMC Medical GmbH. The logo consists of the letters "PMC" in a bold, sans-serif font, with the letters slightly overlapping. Below the letters, the words "Medical GmbH" are written in a smaller, sans-serif font.

| | PMC Laparoscopic<br>instruments<br>New device | MicroFrance Laparoscopic<br>Manual Surgical Instruments<br>K080257 | GIMMI ALPHA®<br>Instruments<br>K012660 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Diameter<br>Lengths | 5mm Tube,<br>310mm/330mm/336mm<br>various | 3mm to 12mm Tube, various<br>from 25cm to 60cm | 5mm Tube, various, from 25 cm to<br>38 cm |
| Material | Stainless Steel<br>Carbon-fibre<br>Insulation material | Stainless Steel<br>Tungsten (Needle Holders)<br>Insulation material | Stainless Steel<br>Insulation material |
| Components | Scissors, Forceps,<br>Connections, Handles,<br>Sheaths, Laparoscopes, Light<br>Adapters, Trocars, Electrode,<br>and Inserts | Dismantable and Non-<br>dismantable<br>Insulated and non-insulated<br>Forceps, Probes, Needle<br>Holders, Clamps, Dissectors,<br>Scissors, Knife, Hook, Knot<br>Guide, Retractors, and Blades | Dismantable and Non-dismantable<br>Insulated and non-insulated<br>Forceps, Probes, Needle Holders,<br>Clamps, Dissectors, Scissors,<br>Knife, Hook, Knot Guide,<br>Retractors, Divers and Blades |

#### >> Non-clinical performance data:

PMC certifies compliance with relevant ISO/IEC/EN and other device-related standards. Moreover bench testing has been performed on the PMC Laparoscopic instruments to demonstrate that the device is substantially equivalent to the predicate devices.

#### >>Summary:

ז

The presented data that was conducted on the PMC Laparoscopic instruments shows in its results and in comparison to the predicate devices that the product is safe, as effective, and performs as well as or better than the legally marketed device, therefore do not raise any questions regarding safety and effectiveness. The product components which are covered by this 510(k) premarket notification have been successfully tested for biocompatibility, electromagnetic compatibility, functionality and safety according to international standards.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

PMC Medical GmbH % think! Ms. Andrea Pecsi Schwarzwaldstraße 5 78532 Tuttlingen Germany

OCT 1 8 2010

Re: K101193

Trade/Device Name: PMC Laparoscopic instruments Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: September 13, 2010 Received: September 16, 2010

Dear Ms. Pecsi:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Andrea Pecsi

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indication for Use

K101193 OCT 1 8 2010

510(k) Number (if known): K101193

Device Name: PMC Laparoscopic instruments

Indications for Use:

Laparoscopes are used by surgeons in diagnostic and therapeutic procedures. Laparoscopic minimally invasive procedures are performed in the abdominal cavity by means of small skin punctures that allow the insertion of the laparoscope and laparoscopic instruments.

The PMC Laparoscopic instruments are intended to scrape, cut, grasp, hold, remove, and manipulate tissue, organs or bowel during laparoscopic surgery. The secondary function is to provide monopolar electrocautery capability to dissect and coagulate soft tissue.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

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)

Page 1 of 1

Neil R.P. Doyle for mxm

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

510(k) Number K101193