(348 days)
Not Found
No
The description focuses on the optical and mechanical aspects of the endoscope and does not mention any AI/ML capabilities or image processing beyond standard visualization.
No
The device is used for endoscopic visualization and inspection, which are diagnostic purposes for viewing anatomical structures, not for treating a condition.
No
The device is described as an endoscope for "endoscopic visualization" and "visual inspection," which suggests it is used for direct observation rather than making a diagnosis based on analyzed data or measurements. While visualization aids in diagnosis, the device itself is an instrument for observation, not a diagnostic tool that processes information to provide a diagnosis.
No
The device description explicitly details physical components like optical and fiberoptic-based rigid endoscopes, working channels, irrigation channels, and compatibility with light sources, cameras, and video adapters, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Device Function: The Spinal Foraminoscope is an endoscope used for direct visualization of anatomical structures within the body (lumbar and cervical spine). It is used in vivo (within a living organism), not in vitro (outside the body).
- Intended Use: The intended use is for "endoscopic visualization" and "visual inspection," which are procedures performed directly on the patient.
The device description and intended use clearly indicate that this is a surgical or diagnostic instrument used for direct observation within the body, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The Spinal Foraminoscope for lumbar access is intended for endoscopic visualization of the lumbar and cervical spine. 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.
Product codes (comma separated list FDA assigned to the subject device)
HRX
Device Description
The Spinal Foraminoscope for lumbar access is an optical and fiberoptic-based rigid endoscope provided with a 2.8 or 3.7 mm working channel and two 1.5-mm irrigation channels and allowing insertion of 2.8-mm or 3.5-mm hand-held instruments.
The Spinal Foraminoscope for cervical access is a fiberoptic-based rigid endoscope which shares the same design. It is provided with a 2.2-mm working and irrigation channel, has a 3.6-mm outer diameter and allows insertion of 2.0-mm hand-held instruments.
The Spinal Foraminoscope may be attached to standard fiberoptic light sources and Storz, Olympus, Wolf and ACM cameras and video adapters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical and fiberoptic-based
Anatomical Site
lumbar and cervical spine; lumbar region; cervical spinal nerve roots
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 was performed to support substantial equivalence to the predicate device. The Spinal Foraminoscope met all specified design and performance requirements.
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.
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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 |
| 79350 Sexau | |
| 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 |
| Instruments Corp., K973405 | |
| Spine Scope, Model 2180, Clarus Medical, LLC., K011454 | |
| Pollux Arthroscopes, Pollux Endoscopy, Inc., K953484 | |
| Device Description: | The Spinal Foraminoscope for lumbar access is an optical and |
| fiberoptic-based rigid endoscope provided with a 2.8 or 3.7 mm | |
| working channel and two 1.5-mm irrigation channels and allowing | |
| insertion of 2.8-mm or 3.5-mm hand-held instruments. | |
| The Spinal Foraminoscope for cervical access is a fiberoptic- | |
| based rigid endoscope which shares the same design. It is | |
| provided with a 2.2-mm working and irrigation channel, has a 3.6- | |
| mm outer diameter and allows insertion of 2.0-mm hand-held | |
| instruments. | |
| The Spinal Foraminoscope may be attached to standard fiberoptic | |
| light sources and Storz, Olympus, Wolf and ACM cameras and | |
| video adapters. | |
| Intended Use: | The Spinal Foraminoscope is intended for endoscopic |
| visualization of the lumbar and cervical spine. | |
| Performance Data: | Testing was performed to support substantial equivalence to the |
| predicate device. The Spinal Foraminoscope met all specified | |
| design and performance requirements. | |
| Sterilization | The Spinal Foraminoscope is offered non-sterile for autoclave |
| steam sterilization. | |
| Conclusion: | Based upon the product technical information provided, intended |
| use and performance information provided in this premarket | |
| notification, as well as similarity to legally marketed devices, | |
| Blazejewski MEDI-TECH GmbH considers the Spinal | |
| Foraminoscope to be substantially equivalent to the current legally | |
| marketed predicate devices. |
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K-022841
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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 (800) 638-2041 or (240) 276-3150 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
3
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