(69 days)
Not Found
Not Found
No
The summary describes a fiber optic endoscope and does not mention any AI or ML components or functionalities.
No
The device is intended to "view and facilitate treatment", indicating it is primarily for diagnostic viewing and aiding a separate treatment, not performing the treatment itself.
Yes
The device is intended to "view and facilitate treatment of disc herniations", indicating that it is used to assess and, therefore, diagnose the condition.
No
The device description explicitly states it is a fiber optic endoscope with a remote eyepiece and is composed of surgical grade stainless steel, indicating it is a hardware device.
Based on the provided information, the Spinoscope is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The Spinoscope is described as a fiber optic endoscope used to view and facilitate treatment of disc herniations directly within the lumbar region of the spine. This is an in-vivo (within the living body) application, not an in-vitro (in glass, or outside the body) application.
- The intended use clearly describes a direct visualization and treatment facilitation within the body. There is no mention of analyzing blood, tissue, urine, or any other bodily fluid or substance outside of the body.
Therefore, the Spinoscope falls under the category of a surgical or endoscopic device, not an IVD.
N/A
Intended Use / Indications for Use
The Spinoscope is intended for use to view and facilitate treatment of disc herniations in the lumbar region of the spine (including disc prolapses and foramen stenoses).
Product codes
HRX
Device Description
The KSEA Spinoscope is a fiber optic endoscope with a remote eyepiece. The body contact portions of the KSEA Spinoscope are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
lumbar region of the 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.
0
Image /page/0/Picture/0 description: The image shows the text "DEC 02 2002" in a bold, sans-serif font. The text is arranged horizontally, with the month abbreviated as "DEC", followed by the day "02", and the year "2002". The text appears to be part of a document or label, and the date format suggests a formal or official context.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
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) 338-8100 |
|------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | James A. Lee, Ph.D.
Senior Regulatory Affairs Specialist |
| Device Identification: | Common Name:
Arthroscope
Trade Name: (optional) |
Karl Storz Spinoscope
Indication: The Spinoscope is intended for use to view and facilitate treatment of disc herniations in the lumbar region of the spine (including disc prolapses and foramen stenoses).
Device Description: The KSEA Spinoscope is a fiber optic endoscope with a remote eyepiece. The body contact portions of the KSEA Spinoscope are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
Substantial Equivalence: The Karl Storz Spinoscope is substantially equivalent to the predicate devices since the basic features and intended uses are similar. The minor differences between the Karl Storz Spinoscope and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.
Signed:
Murklee
James A. Lee, Ph.D. Senior Regulatory Affairs Specialist
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Karl Storz Endoscopy James A. Lee, Ph.D. Senior Regulatory Affairs Specialist 600 Corporate Pointe Drive Culver City, California 90230-7600
Re: K023187
Trade/Device Name: Karl Storz Spinoscope Regulation Number: 888.1100 Regulation Name: Arthroscope and accessories Regulatory Class: II Product Code: HRX Dated: September 23, 2002 Received: September 24, 2002
Dear Dr. Lee:
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.
2
Page 2 - Dr. James A. Lee
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Miriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K023187
Device Name: Spinoscope
Indications for Use: The Spinoscope is intended for use to view and facilitate treatment of disc herniations in the lumbar region of the spine (including disc prolapses and foramen stenoses).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use: | |
|---|---|
| (Per 21 CFR 801.109) | |
| OR Over-The-Counter Use: | |
| (Optional Format 1-2-96) |
Miriam C. Provost
(Division Sign-Off)
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K023187