(63 days)
Not Found
Not Found
No
The description focuses on manual operation and fiber-optic technology, with no mention of AI, ML, or related concepts.
No
The device is indicated for observing anatomy and pathology, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is indicated for "observing epidural anatomy and pathology," which is a diagnostic purpose.
No
The device description explicitly states it is a "manually operated surgical device" and a "flexible fiberoptic telescope" with "body contact portions composed of medical grade polyurethane," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "observing epidural anatomy and pathology" within the lumbar and sacral spine. This is a direct observation of internal body structures, not the examination of specimens derived from the human body (like blood, urine, tissue samples, etc.) which is the hallmark of IVDs.
- Device Description: The device is described as a "flexible fiberoptic telescope" used for surgical procedures. This aligns with a surgical or endoscopic device, not an IVD.
- Anatomical Site: The device is used within the "lumbar and sacral spine," which is an in-vivo application (within the living body). IVDs are used in-vitro (outside the living body).
In summary, the device's function and application are clearly focused on direct observation within the body, which is not the purpose of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Epiduroscope is indicated for use in the lumbar and sacral spine for observing epidural anatomy and pathology.
Product codes
HRX
Device Description
The KSEA Epiduroscope is a manually operated surgical devices. The KSEA Epiduroscope is a flexible fiberoptic telescope which utilize fiber-optic technology. The body contact portions of the KSEA Epiduroscope are composed of medical grade polyurethane.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar and sacral spine
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)
Not Found
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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Image /page/0/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo features the word "STORZ" in a stylized font, with a circle in the middle of the "O". Below the word "STORZ" is the text "Karl Storz Endoscopy" in a smaller, simpler font. The background of the image is black with white speckles.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 199105
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe Drive
Culver City, CA 90230
(310) 558-1500 |
|------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Kevin Kennan
Senior Regulatory Affairs Specialist |
| Device Identification: | Common Name:
Flexible Fiberscope |
| | Trade Name: (optional)
Karl Storz Epiduroscope |
Indication: The Epiduroscope is indicated for use in the lumbar and sacral spine for observing epidural anatomy and pathology.
Device Description: The KSEA Epiduroscope is a manually operated surgical devices. The KSEA Epiduroscope is a flexible fiberoptic telescope which utilize fiber-optic technology. The body contact portions of the KSEA Epiduroscope are composed of medical grade polyurethane.
Substantial Equivalence: The KSEA Epiduroscope is substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences between the KSEA Epiduroscope and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices.
igned:
Kevin Kennan
Senior Regulatory Affairs Specialist
Signed:
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three horizontal lines above it, representing the department's mission to promote health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
। JUN
Mr. Kevin Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, California 90230
Re: K991051 Trade Name: KSEA Epiduroscope Regulatory Class: II Product Code: HRX Dated: March 26, 1999 Received: March 30, 1999
Dear Mr. Kennan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Kevin Kennan
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
M. Witten, Ph.D., M.D. Celia Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The word "STORZ" is written in large, bold, white letters at the top of the logo. Below that, the words "Karl Storz Endoscopy" are written in a smaller font. The background of the image is black with white speckles.
510(k) Number (if known): 991051
Device Name: KSEA Epiduroscope
Indications for Use: The Epiduroscope is indicated for use in the lumbar and sacral spine for observing epidural anatomy and pathology.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use: | X |
|---|---|
| (Per 21 CFR 801.109) | |
| OR Over-The-Counter Use: | |
| (Optional Format 1-2-96) |
(Division Sign-Off)
| Division of General Restorative Devices | |
|---|---|
| 510(k) Number | K99105/ |