(348 days)
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.
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.
The provided text does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding the methodologies for establishing ground truth, subject demographics, or expert qualifications. The document is a 510(k) summary for the "Spinal Foraminoscope" and an FDA clearance letter.
However, based on the Performance Data section of the 510(k) summary, the following can be inferred and stated:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Device met "all specified design and performance requirements" to demonstrate substantial equivalence to predicate devices (Yeung Endoscopic Spine System, K973405; Spine Scope, K011454; Pollux Arthroscopes, K953484). | "The Spinal Foraminoscope met all specified design and performance requirements." |
2. Sample size used for the test set and the data provenance:
- Not Applicable. The document describes a substantial equivalence determination based on meeting design and performance requirements against predicate devices, rather than a clinical study with a test set of data/patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. Ground truth establishment is not relevant in this type of substantial equivalence submission, which focuses on device functionality and design rather than clinical diagnostic performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or human interpretation is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC study was not done as this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This device is an endoscope, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. Ground truth is not relevant to this type of device submission. The "ground truth" for the device's performance is its ability to meet the engineering specifications and intended use as an arthroscope, similar to predicate devices.
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established:
- Not Applicable. This is not an AI/ML device requiring a training set.
Summary of Study:
The document states that "Testing was performed to support substantial equivalence to the predicate device." While the specific details of this testing are not provided in the summary, it implies that various engineering and functional tests were conducted to ensure the Spinal Foraminoscope performed as intended and comparably to the identified 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). The conclusion is that the device "met all specified design and performance requirements" to establish substantial equivalence.
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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 279350 SexauGermany |
| 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 MedicalInstruments Corp., K973405Spine Scope, Model 2180, Clarus Medical, LLC., K011454Pollux Arthroscopes, Pollux Endoscopy, Inc., K953484 |
| Device Description: | The Spinal Foraminoscope for lumbar access is an optical andfiberoptic-based rigid endoscope provided with a 2.8 or 3.7 mmworking channel and two 1.5-mm irrigation channels and allowinginsertion 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 isprovided with a 2.2-mm working and irrigation channel, has a 3.6-mm outer diameter and allows insertion of 2.0-mm hand-heldinstruments. | |
| The Spinal Foraminoscope may be attached to standard fiberopticlight sources and Storz, Olympus, Wolf and ACM cameras andvideo adapters. | |
| Intended Use: | The Spinal Foraminoscope is intended for endoscopicvisualization of the lumbar and cervical spine. |
| Performance Data: | Testing was performed to support substantial equivalence to thepredicate device. The Spinal Foraminoscope met all specifieddesign and performance requirements. |
| Sterilization | The Spinal Foraminoscope is offered non-sterile for autoclavesteam sterilization. |
| Conclusion: | Based upon the product technical information provided, intendeduse and performance information provided in this premarketnotification, as well as similarity to legally marketed devices,Blazejewski MEDI-TECH GmbH considers the SpinalForaminoscope to be substantially equivalent to the current legallymarketed predicate devices. |
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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
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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
§ 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.