SPINAL FORAMINOSCOPE

K082841 · Blazejewski Medi-Tech GmbH · HRX · Sep 9, 2009 · Orthopedic

Device Facts

• Record ID: K082841
• Device Name: SPINAL FORAMINOSCOPE
• Applicant: Blazejewski Medi-Tech GmbH
• Product Code: HRX · Orthopedic
• Decision Date: Sep 9, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2

Intended Use

The Spinal Foraminoscope is intended for endoscopic visualization of the lumbar and cervical spine.

Device Story

Spinal Foraminoscope is a rigid, optical and fiberoptic-based endoscope designed for lumbar and cervical spine visualization. Lumbar version features 2.8 or 3.7 mm working channel and two 1.5-mm irrigation channels; cervical version features 2.2-mm working/irrigation channel and 3.6-mm outer diameter. Device allows insertion of hand-held instruments (2.0-2.8 mm). Operated by physicians in clinical settings; connects to standard fiberoptic light sources and external cameras/video adapters (Storz, Olympus, Wolf, ACM). Provides direct visualization to assist surgeons in spinal procedures; facilitates minimally invasive access to spinal nerve roots and surrounding tissues.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Rigid fiberoptic endoscope; optical/fiberoptic sensing; non-sterile, autoclave steam sterilization; compatible with standard light sources and external video adapters; working channels (2.2 mm to 3.7 mm); outer diameters (3.6 mm).

Indications for Use

Indicated for endoscopic visualization in the lumbar region and visual inspection of the cervical spinal nerve roots and surrounding tissue in patients requiring spinal endoscopy.

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

Predicate Devices

• Yeung Endoscopic Spine System, Richard Wolf Medical Instruments Corp. (K973405)
• Spine Scope, Model 2180, Clarus Medical, LLC. (K011454)
• Pollux Arthroscopes, Pollux Endoscopy, Inc. (K953484)

Submission Summary (Full Text)

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SEP 0 9 2009

| | 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | August 28, 2009 |
| Submitter: | Blazejewski MEDI-TECH GmbH |
| Name: | |
| Address: | Elzstrasse 2<br>79350 Sexau<br>Germany |
| Contact Person: | Reinhold Blazejewski |
| Telephone: | +49.7641.930670 |
| Fax: | +49.7641.9306729 |
| Product: | |
| Trade Name: | Spinal Foraminoscope |
| Classification: | Class II |
| Common Name: | Foraminoscope |
| Classification Name: | Arthroscope |
| Predicate Devices: | Yeung Endoscopic Spine System, Richard Wolf Medical<br>Instruments Corp., K973405<br>Spine Scope, Model 2180, Clarus Medical, LLC., K011454<br>Pollux Arthroscopes, Pollux Endoscopy, Inc., K953484 |
| Device Description: | The Spinal Foraminoscope for lumbar access is an optical and<br>fiberoptic-based rigid endoscope provided with a 2.8 or 3.7 mm<br>working channel and two 1.5-mm irrigation channels and allowing<br>insertion of 2.8-mm or 3.5-mm hand-held instruments. |
| | The Spinal Foraminoscope for cervical access is a fiberoptic-<br>based rigid endoscope which shares the same design. It is<br>provided with a 2.2-mm working and irrigation channel, has a 3.6-<br>mm outer diameter and allows insertion of 2.0-mm hand-held<br>instruments. |
| | The Spinal Foraminoscope may be attached to standard fiberoptic<br>light sources and Storz, Olympus, Wolf and ACM cameras and<br>video adapters. |
| Intended Use: | The Spinal Foraminoscope is intended for endoscopic<br>visualization of the lumbar and cervical spine. |
| Performance Data: | Testing was performed to support substantial equivalence to the<br>predicate device. The Spinal Foraminoscope met all specified<br>design and performance requirements. |
| Sterilization | The Spinal Foraminoscope is offered non-sterile for autoclave<br>steam sterilization. |
| Conclusion: | Based upon the product technical information provided, intended<br>use and performance information provided in this premarket<br>notification, as well as similarity to legally marketed devices,<br>Blazejewski MEDI-TECH GmbH considers the Spinal<br>Foraminoscope to be substantially equivalent to the current legally<br>marketed predicate devices. |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/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 symbol resembling an abstract human figure with three waving lines above it.

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

## SEP 0 9 2009

Blazejewski Medi-Tech GmbH % Business Support International Ms. Angelika Scherp Regulatory Affairs Consultant Amstel 320-I Amsterdam 1017AP Netherlands

Re: K082841

Trade/Device Name: Spinal Foraminoscope · Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: August 28, 2009 Received: August 31, 2009

#### Dear Ms. Scherp:

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

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#### Page 2 - Ms. Angelika Scherp

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/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/cdrh/mdr/ 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.goy/cdrh/industry/support/index.html.

Sincerely vours.

Sincerely yours,

Mark M. Mikkelson

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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# INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Spinal Foraminoscope

ndications for Use: The Spinal Foraminoscope for lumbar access is indicated for endoscopic visualization in the lumbar region. The Spinal Foraminoscope for cervical access is indicated for visual inspection of the cervical spinal nerve roots and surrounding tissue.

Prescription Use X 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

E.DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of DRH, Office of Device Evaluation (ODE)

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number