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 Description

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

AI/ML Overview

The provided text is a 510(k) summary for the THESSYS MULTISCOPE. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, studies, or performance data for the THESSYS MULTISCOPE itself.

The 510(k) process in the US is primarily a "substantial equivalence" pathway. This means a new device is compared to a legally marketed predicate device, demonstrating that it is as safe and effective as the predicate. It often relies on a comparison of technological characteristics and intended use, rather than extensive clinical performance studies or specific acceptance criteria for the new device's performance.

Therefore,Based on the provided text alone, it is not possible to complete the requested table and answer the study-related questions. The document focuses on establishing substantial equivalence to existing devices rather than presenting new performance data against specific acceptance criteria.

Reasoning for Absence of Information:

510(k) Process: The 510(k) premarket notification is generally not focused on demonstrating new clinical performance. Instead, it aims to show that a new device is "substantially equivalent" to a predicate device already on the market. This typically involves comparing technological characteristics, materials, and intended use.
Device Type: The THESSYS MULTISCOPE is an arthroscope, a surgical visualization tool. Its primary function is to provide visualization. Performance metrics for such devices often relate to image quality, field of view, illumination, and mechanical integrity, which might be assessed through bench testing and verification/validation activities that are not typically summarized in detail within a 510(k) document unless a novel characteristic requires it.
Document Content: The provided 510(k) summary explicitly details:
- Submitter and device identification.
- Predicate devices.
- Device description and intended use.
- Technological characteristics.
- A "Substantial Equivalence Comparison Chart" (Table 1) comparing the THESSYS MULTISCOPE to its predicates based on features like rod-lens type, channels, reusability, material, and general intended use.

This comparison chart is the primary "proof" of meeting acceptance criteria for a 510(k) in this context: proving substantial equivalence to already approved devices. There are no explicit performance numbers, clinical study details, or ground truth establishment methods discussed because they were likely not required for this type of submission.

Summary

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AUG 1 2 2005

K051827

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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: +49 721-25514-511 Telephone: +49 721-25514-020 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.

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K051827

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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.

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TABLE 1
Substantial Equivalence Comparison Chart

......

Joimax Endoscope	Richard WolfDiscoscope/YESS	Endius SpineEndoscope	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.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.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

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III-3

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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.

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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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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

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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

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510(a) Number K051827

Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.