(61 days)
Not Found
Not Found
No
The summary describes a rigid endoscope utilizing rod lens technology for visualization, with no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No.
The "Intended Use" section states that the instrument is used for "illumination and visualization" and "to diagnose disease," which are diagnostic purposes. While it also mentions "removal of loose bodies," which could be considered a therapeutic act, the primary stated uses of visualization and diagnosis do not align with a purely therapeutic device.
Yes
The device is indicated to "diagnose disease" in the hip joint, making it a diagnostic device.
No
The device description explicitly states it is comprised of a rigid telescope made of surgical grade stainless steel, indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens obtained from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- This device, the KSEA DCI Endoscope, is used in vivo (inside the body) for direct visualization and surgical procedures (arthroscopy) within joints.
The intended use and device description clearly indicate it's an instrument for direct visualization and intervention within the body, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The KSEA DCI Endoscope is designed to be used by qualified surgeons and physicians for arthroscopic procedures of the shoulder, knee and also for the illumination and visualization of the hip joint to diagnose disease and for the removal of loose bodies in the hip joint..
Product codes
HRX
Device Description
The KSEA DCI Endoscope is comprised of a rigid, panoramic telescope which utilizes rod lens technology. The body contact portions of the KSEA DCI Endoscope 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
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Anatomical Site
shoulder, knee, hip joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified surgeons and physicians
Description of the training set, sample size, data source, and annotation protocol
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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.)
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 STORZ Karl Storz Endoscopy. The logo is white text on a black background. The word "STORZ" is in large, bold letters, with the "O" in "STORZ" being a circle. Below "STORZ" is the text "Karl Storz Endoscopy" in a smaller font.
Image /page/0/Picture/1 description: The image shows the text "NOV 25 1999" in a slightly distorted and rotated view. The text appears to be stamped or printed, with the letters and numbers having a slightly uneven appearance. The date indicates November 25th, 1999.
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) 558-1500 |
|------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Kevin Kennan
Regulatory Affairs Specialist |
| Device Identification: | Common Name:
Arthroscope |
Trade Name: (optional) Karl Storz DCI Endoscope
Indication: The KSEA DCI Endoscope is designed to be used by qualified surgeons and physicians for arthroscopic procedures of the shoulder, knee and also for the illumination and visualization of the hip joint to diagnose disease and for the removal of loose bodies in the hip joint..
Device Description: The KSEA DCI Endoscope is comprised of a rigid, panoramic telescope which utilizes rod lens technology. The body contact portions of the KSEA DCI Endoscope 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 KSEA DCI Endoscope is substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences between the KSEA DCI Endoscope 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.
Signed:
:
Kevin Keenan
Senior Regulatory Affairs Specialist
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Image /page/1/Picture/2 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the edge. In the center of the seal is a stylized image of an eagle.
NOV 2 5 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Kevin Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, California 90230-7600
Re: K983384 Trade Name: DCI Endoscope Regulatory Class: II Product Code: HRX Dated: September 23, 1998 Received: September 25, 1998
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 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). 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 requirements, 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.
2
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/dsma/dsmamain.html".
Sincerely yours.
fcoselfa
Celia M. Witten. Ph.D., M.D. 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 logo consists of the word "STORZ" in large, bold, white letters, with a circle in the middle of the "O". Below the word "STORZ" is the text "Karl Storz Endoscopy" in a smaller font. The background of the image is black.
X 783384
510(k) Number (if known):
Device Name: DCI Endoscope
Indications for Use: This instrument is indicated for arthroscopic procedures of the shoulder, knee and also for the illumination and visualization of the hip joint to diagnose disease and for the removal of loose bodies in the hip joint.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ****************************************************************************************************************************************************************************
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K983384 |
|---|---|
| --------------- | --------- |
| Prescription Use:
| (Per 21 CFR 801.109) | OR Over-The-Counter Use: |
|---|---|
| ------------------------------------------- | -------------------------- |
(Optional Format 1-2-96)
000000