MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM

K072684 · Mondeal North America, Inc. · OCZ · Jan 4, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K072684
• Device Name: MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM
• Applicant: Mondeal North America, Inc.
• Product Code: OCZ · Gastroenterology, Urology
• Decision Date: Jan 4, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Mondeal Endoscopic Tissue Recession and Release System is to endoscopically recess the gastrocnemius tendon or the plantar fascia ligament and to release the transverse carpal tunnel ligament.

Device Story

Minimally invasive surgical system for gastrocnemius tenotomy, plantar fasciitis recession, and carpal tunnel release. System components include obturator, cannula, cannula locking mechanism, elevator, rasp, suction handle, and forward/reverse cutting knives. Used in conjunction with commercially available endoscopes. Procedure requires bi-portal incisions to pass cannula; locking mechanism secures cannula during surgery. Surgeon operates device to perform tissue recession or release. Output is physical tissue modification; provides surgeon with verified recession/release. Benefits include minimally invasive access for patients failing non-surgical management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual surgical instruments including obturator, cannula, elevator, rasp, suction handle, and knives. Forward and reverse cutting designs. Bi-portal access. Class II device under 21 CFR 876.1500.

Indications for Use

Indicated for: Endoscopic Gastrocnemius Tenotomy (EGT) in patients with heel cord contracture (equinus) failing non-surgical treatment; Endoscopic Plantar Fasciotomy (EPF) in patients with plantar fasciitis failing non-surgical treatment; Carpal Tunnel Release (ECTR) in patients with carpal tunnel syndrome failing non-surgical 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.

Predicate Devices

• Instratek EndoTrack System (K925083)
• Instratek Endoscopic Carpal Tunnel Instrument (K922391)
• A.M. Surgical Mountable Endoscopic Knife (K982142)

Submission Summary (Full Text)

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K072684

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#### Section XII: 510(k) Summary of Safety and Effectiveness SAFE MEDICAL DEVICES ACT OF 1990 510(k) Summary Mondeal Medical Systems GmbH NAME OF FIRM: Moltkestr. 39 Tuttlingen, 78532 4 2008 Germany 510(k) FIRM CONTACT: Jay Evans President Mondeal North America, Inc. P.O. Box 500521 San Diego, CA 92150-0521 TRADE NAME: Mondeal Endoscopic Recession and Release System COMMON NAME: Endoscope And/Or Accessories CLASSIFICATION: Manual Surgical Instrument for General Use (see 21 CFR, Sec. 878.4800)

Endoscope And/Or Accessories (see 21 CFR, Sec. 876.1500)

OCZ EMF

KOG

DEVICE PRODUCT CODE: SUBSEQUENT PRODUCT CODE:

SUBSTANTIALLY Instratek EndoTrack System (K925083) EQUIVALENT DEVICES Instratek Endoscopic Carpal Tunnel Instrument (K922391) A.M. Surgical Mountable Endoscopic Knife (K982142)

#### DEVICE DESCRIPTION:

The Mondeal Endoscopic Tissue Recession and Release System_is a minimally invasive device for gaining exposure to perform Gastrocnemius Tenotomy, Plantar Fasciitis Recession, and Carpal Tunnel Release.

The system is comprised of the instruments required to perform the above mentioned maladies in conjunction with commercially available endoscopes. The instruments include an obturator, cannula, cannula locking mechanism, elevator, rasp, suction handle, and knife(s).

The system requires bi-portal incisions to pass the cannula from one side of the intended recession/resection to the other, allowing the knife to perform a complete and verified recession/release.

The cannula locking mechanism aids the surgeon in ensuring the cannula does not move while performing the procedure.

The knife is offered in two different designs. One design is for forward cutting (away from the surgeon), the other is for reverse cutting (towards the surgeon). The benefits of each design are dependent upon which procedure the device is used for and surgeon preference.

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Kc72681
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#### 510(k) Summary Continued:

#### Mondeal Extremity Bone Fixation System

#### INTENDED USE:

### Intended use :

The intended use of the Mondeal Endoscopic Tissue Recession and Release System is to endoscopically recess the gastrocnemius tendon or the plantar fascia ligament and to release the transverse carpal tunnel ligament.

#### Indications for use

The Mondeal Endoscopic Tissue Release Recession and Release System is indicated for the following:

Endoscopic Gastrocnemius Tenotomy (EGT) - as a tool for tissue recession in patients with heel cord contracture (equinus) who fail to respond to a full course of non-surigcal treatment.

Endoscopic Plantar Fasciotomy (EPF) - as a tool for tissue recession in patients with plantar fasciitis who fail to respond to a full course of nonsurgical treatment.

Carpal Tunnel Release (ECTR) - as a tool for tissue release in patients who fail to respond to non-surgical treatment of carpal tunnel syndrome.

| BASIS OF SUBSTANTIAL<br>EQUIVALENCE | The Mondeal Endoscopic Tissue Recession and Release System<br>is substantially equivalent to the Instratek and A.M. Surgical Endoscopic<br>Tissue Recession and Release systems. |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUMMARY OF SAFETY<br>AND EFFECTIVENESS: | The Mondeal Endoscopic Tissue Recession and Release System is<br>shown to be safe and effective for the indications described in this<br>submission. |

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JAN - 4 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mondeal North America, Inc. % Mr. Jay Evans P.O. Box 500521 San Diego, California 92150

Re: K072684

Trade/Device Name: Mondeal Endoscopic Tissue Recession and Release System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCZ Dated: September 18, 2007 Received: September 21, 2007

Dear Mr. Evans:

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 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, 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); 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 - Mr. Jay Evans

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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.

Mark M Mulkerson

- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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K072684

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NORTH AMERICA INC.

# Indications for Use

510(k) NUMBER:

DEVICE NAME: Mondeal Endoscopic Tissue Recession and Release System

## INDICATIONS FOR USE:

The intended use of the Mondeal Endoscopic Tissue Recession and Release System is to endoscopically recess the gastrocnemius tendon or the plantar fascia ligament and to release the transverse carpal tunnel ligament.

Indications for use:

The Mondeal Endoscopic Tissue Release Recession and Release System is indicated for the following:

Endoscopic Gastrocnemius Tenotomy (EGT) - as a tool for tissue recession in patients with heel cord contracture (equinus) who fail to respond to a full course of non-surigcal treatment.

Endoscopic Plantar Fasciotomy (EPF) – as a tool for tissue recession in patients with plantar fasciitis who fail to respond to a full course of non-surgical treatment.

Carpal Tunnel Release (ECTR) - as a tool for tissue release in patients who fail to respond to non-surgical treatment of carpal tunnel syndrome.

Prescription Use

AND/OR Over-The-Counter-Use

(Per 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

(Division Sign-C Division of Gene II, Restorative, and Neurological Devices

**510(k) Number**

Concurrence of CDRH, Office of Device Evaluation (ODE)