(37 days)
Not Found
Endius Spine Endoscope, Richard Wolf Discoscope with Panoview Plus Optics, Richard Wolf Yeung Endoscopic Spine System (YESS), Pollux Arthroscope
No
The description focuses on the physical components and function of a standard endoscope, with no mention of AI, ML, image processing, or data analysis beyond visualization.
No
The device is described as being for visualization for diagnostic and surgical procedures, and its components (optical fibers, image transmitting fibers, irrigation channels) are consistent with an imaging tool, not one that directly treats a condition.
Yes.
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures." The term "diagnostic" directly indicates its use for diagnosis, which is a key function of diagnostic devices.
No
The device description clearly outlines physical components like optical fibers, image transmitting fiber bundles, lenses, and a rigid stainless steel envelope, indicating it is a hardware device.
Based on the provided information, the THESSYS Multiscope is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures." This describes a device used directly on or in the patient for visualization during procedures.
- Device Description: The description details an endoscope with optical fibers, image transmission, irrigation channels, and a working channel within a rigid stainless steel envelope. This is consistent with a surgical or diagnostic instrument used for direct visualization within the body.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. The description of the THESSYS Multiscope does not involve the analysis of biological specimens.
Therefore, the THESSYS Multiscope is a medical device used for direct visualization within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
HRX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Endius Spine Endoscope, Richard Wolf Discoscope with Panoview Plus Optics, Richard Wolf Yeung Endoscopic Spine System (YESS), Pollux Arthroscope
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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AUG 1 2 2005
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: +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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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.
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| TABLE 1 |
|---|
| Substantial Equivalence Comparison Chart |
:
:
: 上一篇: 上一篇:
......
| | Joimax Endoscope | Richard Wolf
Discoscope/YESS | Endius Spine
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.
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. |
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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
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
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510(a) Number K051827