JOIMAX ENDOSCOPE/MULTISCOPE, THESSYS FORAMINOSCOPE/MULTISCOPE, THESSYS LAMINOSCOPE/MULTISCOPE

K051827 · Joimax GmbH · HRX · Aug 12, 2005 · Orthopedic

Device Facts

• Record ID: K051827
• Device Name: JOIMAX ENDOSCOPE/MULTISCOPE, THESSYS FORAMINOSCOPE/MULTISCOPE, THESSYS LAMINOSCOPE/MULTISCOPE
• Applicant: Joimax GmbH
• Product Code: HRX · Orthopedic
• Decision Date: Aug 12, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The THESSYS MULTISCOPE is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as arthroplasty, nucleotomy, discectomy, and foraminotomy.

Device Story

Multi-channel endoscope for visualization of operative sites; utilizes light-transmitting optical fibers and rigid rod-lens system for image transmission. Features working channel and irrigation channels within stainless steel housing. Used by physicians in clinical/surgical settings to perform diagnostic and surgical procedures (arthroplasty, nucleotomy, discectomy, foraminotomy). Device provides direct visualization of internal anatomy through cannulated incision, assisting surgeon in navigating and performing procedures. Benefits include minimally invasive access to surgical sites.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Rigid endoscope; stainless steel housing; light-transmitting optical fibers; rigid rod-lens image transmission system. Includes one or two irrigation channels and a working channel. Non-sterile, reusable device.

Indications for Use

Indicated for patients requiring visualization of internal body sites during diagnostic and surgical procedures including arthroplasty, nucleotomy, discectomy, and foraminotomy. No specific age or gender restrictions; no known contraindications.

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

• Endius Spine Endoscope
• Richard Wolf Discoscope with Panoview Plus Optics
• Richard Wolf Yeung Endoscopic Spine System (YESS)
• Pollux Arthroscope

Submission Summary (Full Text)

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

AUG 1 2 2005

K051827

Page 1 of 3

# 510(k) SUMMARY

## THESSYS MULTISCOPE 510(k) Notification #K051827

#### Submitter Information 1.

Manufacturer:

Joimax GmbH RaumFabrik 33a Amalienbadstrasse 76227 Karlsruhe – Germany

Establishment Registration Number: 3005083075

Mathias Notheis, Project Manager Contact Person: [phone] Telephone: [phone] Fax:

9 August 2005 Date Prepared:

#### Device Identification 2.

THESSYS MULTISCOPE Proprietary Name(s):

| Classification Name: | Arthroscope |
|--------------------------------|-------------------|
| Classification Regulation No.: | 21 CFR § 888.1100 |
| Classification: | Class II |
| Product Code: | HRX |

#### Predicate Device(s) 3.

Endius Spine Endoscope Richard Wolf Discoscope with Panoview Plus Optics Richard Wolf Yeung Endoscopic Spine System (YESS) Pollux Arthroscope

#### Device Description 4.

A multi-channel endoscope having working channel and/or irrigation channel(s), used to visualize the operative site.

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

K051827

Page 2 of 3

#### 5. Intended Use

The THESSYS MULTISCOPE is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as arthroplasty, nucleotomy, discectomy, and foraminotomy.

#### Contraindications 6.

There are no known contraindications directly related to the device. The attending physician must determine the appropriateness of the application while considering the general condition of the patient.

#### Technological Characteristics 7.

The THESSYS MULTISCOPE consists of light transmitting optical fibers and an image transmitting fiber bundle and lens, or a rigid rod-lens transmitting images. It has one or two irrigation channels and a working channel contained within a rigid stainless steel envelope.

#### Substantial Equivalence Determination 8.

The THESSYS MULTISCOPE is substantially equivalent to the Richard Wolf Discoscope with Panoview Plus Optics, the discoscope described in the Richard Wolf YESS, the Endius Spine Endoscope, and the Pollux Arthroscope as demonstrated in Table 1.

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

| TABLE 1 |
|------------------------------------------|
| Substantial Equivalence Comparison Chart |

:

:

: 上一篇: 上一篇:

......

| | Joimax Endoscope | Richard Wolf<br>Discoscope/YESS | Endius Spine<br>Endoscope | Pollux Arthroscope |
|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| | Consists of rigid rod-lens, working channel, two (2) irrigation channels with stopcocks | Consists of rigid rod-lens, working channel, two (2) irrigation channels with stopcocks | Consists of a single rigid rod-lens. | Consists of rigid rod-lens, working channel, two (2) irrigation channels with stopcocks |
| | Non-sterile, Re-usable | Non-sterile, Re-usable | Non-sterile, Re-usable | Non-sterile, Re-usable |
| | Fiber optics for light transmission | Fiber optics for light transmission | Fiber optics for light transmission | Fiber optics for light transmission |
| | Rigid rod-lens for image transmission | Rigid rod-lens for image transmission | Rigid rod-lens for image transmission | Rigid rod-lens for image transmission |
| | Stainless steel for endoscope housing | Stainless steel for endoscope housing | Stainless steel for endoscope housing | Stainless steel for endoscope housing |
| | to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as arthroplasty, nucleotomy, discectomy, and foraminotomy. | to visualize the inside of the patient via natural or surgically generated access.<br>for visualization and removal of herniated discs in the lumbar region. | for use in viewing the lumbar disc through a cannulated incision to the interlaminar space of the involved disc level.<br>for posterior endoscopic access to the lumbar spine for various endoscopic spinal procedures such as discectomy and nucleotomy. | to visualize the interior of these particular joints which are the knee, shoulder, wrist, and ankle for arthroscopic procedures. |

K051827

Page 3 of 3

III-3

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three heads.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 2 2005

Joimax GmbH c/o Mr. Morten Simon Christensen Underwriters Laboratories, Inc. 1655 Scott Boulevard Santa Clara, California 95050

Re: K051827

Trade/Device Name: THESSYS Multiscope Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: August 2, 2005 Received: August 3, 2005

Dear Mr. Christensen:

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.

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

### Page 2 - Mr. Morten Simon Christensen

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,
Barbara Buehlus
for

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

Enclosure

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

# Indications for Use

510(k) Number (if known): K051827 Device Name: THESSYS Multiscope

Indications for Use:

The THESSYS Multiscope is intended to visualize the inside of the patient The THESSTO Multisoope is internastic and surgical procedures, such as through a commuleotomy, discectomy, and foraminotomy.

× Prescription Use_ (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buechner for Hekkerson

(Division Sign-Off) Division of General, Restorative. and Neurological Devices

Page 1 of

510(a) Number K051827