(389 days)
Not Found
No
The device description focuses on the physical characteristics and optical performance of rigid endoscopes. There is no mention of image processing, AI, ML, or any software-driven analysis of the optical data. The performance studies are related to physical and optical safety and performance, not algorithmic performance.
No.
The device is an endoscope used for visualization and to facilitate surgical procedures; it does not directly provide a therapeutic effect on the patient.
No
The device is described as an endoscope with working channels for surgical instrumentation, indicating its use for interventional procedures rather than diagnosis. The intended use also specifies "intraoperative site during spinal endoscopic procedures and minimally invasive surgery," further supporting its role in treatment.
No
The device is described as optical and fiberoptic-based rigid endoscopes with working channels, clearly indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "indication of the intraoperative site during spinal endoscopic procedures and minimally invasive surgery." This describes a surgical tool used for visualization and access during a medical procedure on the patient.
- Device Description: The description details a rigid endoscope with working channels for inserting surgical instruments. This is consistent with a surgical device used for direct intervention.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, tissue, or other bodily fluids, for diagnostic purposes. The device is used to visualize and operate within the patient's body.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The use of RZ Medizintechnik spinal endoscopes is indication of the intraoperative site during spinal endoscopic procedures and minimally invasive surgery.
Product codes (comma separated list FDA assigned to the subject device)
HRX
Device Description
The Cervical Endoscopes of RZ Medizintechnik are optical and fiberoptic-based rigid endoscopes provided with working channels of 2.2mm allowing the insertion of microsurgical instrumentation to perform endoscopic intervention within the cervical spine.
The Discoscopes of RZ Medizintechnik are optical and fiberoptic based rigid endoscopes provided with working channels of 2.8 mm. 3.75 mm and 4.3 mm allowing the insertion of microsurgical instrumentation to perform endoscopic intervention within the spinal column such as endoscopic assisted discectomy.
The Spinal endoscopes of RZ Medizintechnik may be attached to standard fiberoptic lightsources, commonly available video adapters and cameras such as Storz, Olympus and Wolf.
The devices are reusable, delivered in non-sterile conditions and available in various designs:
- Outer Diameters from 3,6 mm to 7,0 mm .
- Diameter of working channel from 2,2 mm to 4,3 mm .
- Working length from 95 mm to 208 mm .
- Direction of view: 0°/6° (cervical endoscope) , 30° (discoscopes) .
- Viewing angle 80° +- 5°
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, spinal column
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)
Testing in order to proof safety and effectiveness of RZ Medizintechnik Spinal Endoscopes has been performed according to recognized consensus Standards and results are conforming to the respective requirements.
Thermal Safety: Temperature profile studies according to IEC 60601-2-18 have been conducted in order to provide evidence of sufficient thermal safety of the devices. Results show, that thermal hazards may be excluded if the devices are used according their indications.
Electrical Safety: The devices subject to this submission have been tested according to the requirements of IEC 60601-2-18. Test setup covered interconnection test and capacitive coupled HF current. Results indicate electrical safety of the devices as required per respective standard.
Optical Performance: Optical performance of our spinal endoscopes is continuously checked during final inspection of the devices. Every device is checked for optical performance before final release.
Sterilization: Safety and efficiency of the specified sterilization cycle referenced within the instructions for use has been validated under consideration of the requirements set out in ANSI/AAMI ST81, ANSI/AAMI TIR12, EN ISO 17665 and EN ISO 17664.
Biocompatibility: The devices have been subjected to biocompatibility testing according to DIN EN ISO 10993-1. Testing has been conducted with greatest challenge devices and provides evidence on acceptable levels of biocompatibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
RZ Medizintechnik Spinal Endoscopes 510(k) Premarket Notification
Image /page/0/Picture/2 description: The image is a logo with a square containing a check mark and the letters "RZ" inside. The words "Progress in Surgery" are written in a cursive font below the square. The check mark extends beyond the square's border, adding a dynamic element to the design. The logo appears to be for a medical or surgical organization.
K130778
SECTION 05
510(k) Summary
DATE OF APPLICATION: 2013-04-06
APPLICANT:
RZ Medizintechnik Unter Hasslen 20 78532 Tuttlingen Germany Tel.: +49 7461 9470-0 Fax: +49 7461 9470-50 E-Mail: accounting@rz-medizintechnik.com Internet: www.rz-medizintechnik.com
CONTACT PERSON: Mr. Tobias Zubrod
Tel.: +49 7461 9470-0 E-Mail: tobias.zubrod@rz-medizintechnik.com
001_510K_Summary_v2.0
1
.
Image /page/1/Picture/1 description: The image shows a logo with a square containing the letters "RZ" and a check mark. The check mark is drawn over the square, appearing to confirm or select the letters. Below the square, the words "Progress in Surgery" are written in a cursive font. The logo seems to represent advancement or approval within the field of surgery.
1. Device Name
Trade Names: Discoscopes, Cervical Endoscpes Common Name: Spinal Endoscope Classification Name: Arthroscope
2. Classification Product Code / Subsequent Code
| Device | Medical
Specialty | Review Panel | Product Code | Device Class | Regulation Number |
|-------------|----------------------|--------------|--------------|--------------|-------------------|
| Arthroscope | Part 888 | Orthopedic | HRX | 2 | 888.1110 |
3. Prior Submissions
There have been no prior submissions of the subject devices so far.
Predicate Device 4.
RZ Medizintechniks Spinal Endoscopes are substantially equivalent to the following predicate devices, already cleared by the FDA:
| Predicate Device | 510(k) Number | 510(k) Holder |
|---|---|---|
| THESSYS Multiscope | K051827 | Joimax GmbH |
| Spinal Foraminoscope | K082841 | Blazjewski Medi-Tech GmbH |
2
RZ Medizintechnik Spinal Endoscopes 510(k) Premarket Notification
Image /page/2/Picture/1 description: The image shows a logo with a check mark inside a square. The letters "RZ" are inside the check mark. Below the square, the words "Progress in Surgery" are written in a cursive font. The logo appears to be for a medical or surgical publication or organization.
Description of the Device 5.
The Cervical Endoscopes of RZ Medizintechnik are optical and fiberoptic-based rigid endoscopes provided with working channels of 2.2mm allowing the insertion of microsurgical instrumentation to perform endoscopic intervention within the cervical spine.
The Discoscopes of RZ Medizintechnik are optical and fiberoptic based rigid endoscopes provided with working channels of 2.8 mm. 3.75 mm and 4.3 mm allowing the insertion of microsurgical instrumentation to perform endoscopic intervention within the spinal column such as endoscopic assisted discectomy.
The Spinal endoscopes of RZ Medizintechnik may be attached to standard fiberoptic lightsources, commonly available video adapters and cameras such as Storz, Olympus and Wolf.
The devices are reusable, delivered in non-sterile conditions and available in various designs:
- Outer Diameters from 3,6 mm to 7,0 mm .
- Diameter of working channel from 2,2 mm to 4,3 mm .
- Working length from 95 mm to 208 mm .
- Direction of view: 0°/6° (cervical endoscope) , 30° (discoscopes) .
- Viewing angle 80° +- 5°
6. Indications for Use
The use of RZ Medizintechnik Spinal Endoscopes is indication of the intraoperative site during spinal endoscopic procedures and minimally invasive surgery.
7. Technological Characteristics
The technological characteristics of RZ Medizintechnik spinal endoscopes are the previously cleared predicate devices stated in section 3.
8. Testing
Testing in order to proof safety and effectiveness of RZ Medizintechnik Spinal Endoscopes has been performed according to recognized consensus Standards and results are conforming to the respective requirements.
Thermal Safety 8.1.
Temperature profile studies according to IEC 60601-2-18 have been conducted in order to provide evidence of sufficient thermal safety of the devices. Results show, that thermal hazards may be excluded if the devices are used according their indications.
Electrical Safety 8.2.
The devices subject to this submission have been tested according to the requirements of IEC 60601-2-18. Test setup covered interconnection test and capacitive coupled HF current. Results indicate electrical safety of the devices as required per respective standard.
3
Image /page/3/Picture/1 description: The image shows a logo with a square containing the letters "RZ" in a stylized font. A checkmark extends from the top right corner of the square. Below the square, the words "Progress in Surgery" are written in a cursive font. The logo appears to be for a medical or surgical organization.
8.3. Optical Performance
Optical performance of our spinal endoscopes is continuously checked during final inspection of the devices. Every device is checked for optical performance before final release.
Sterilization 8.4.
Safety and efficiency of the specified sterilization cycle referenced within the instructions for use has been validated under consideration of the requirements set out in ANSI/AAMI ST81, ANSI/AAMI TIR12, EN ISO 17665 and EN ISO 17664.
8.5. Biocompatibility
The devices have been subjected to biocompatibility testing according to DIN EN ISO 10993-1. Testing has been conducted with greatest challenge devices and provides evidence on acceptable levels of biocompatibility.
Substantial Equivalence Summary / Conclusion 9.
Based on available 510(k) information provided herein, RZ Medizintechnik Spinal Endoscopes are considered substantial equivalent to the predicate devices in terms of indications for use, material, technology, design and performance specifications.
There are no differences between the devices which would raise new issues of safety or effectiveness.
4
Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with healthcare, with three lines forming the shape of a bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20093-0002
April 14. 2014
RZ Mcdizintechnik GmbH % Mr. Andre Weingerl MEDAGENT GmbH & Company KG Griesweg 47 Muehlheim, Baden-Wuerttemberg 78570 GERMANY
Re: K130778
Trade/Device Name: Discoscopes, Cervical Endoscopes Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: March 3, 2014 Received: March 7, 2014
Dear Mr. Weingerl:
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 cnclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. or 10 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. Please note: CDRH docs not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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
5
Page 2 - Mr. Andre Weingerl
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510{k} Number (if known) K130778
Device Name
Discoscopes, Cervical Endoscopes
Indications for Use (Describe)
The use of RZ Medizintechnik spinal endoscopes is indication of the intraoperative site during spinal endoscopic procedures and minimally invasive surgery.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Neil R Ogden -S 2014.04.14 14:45:14 -0410
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