(232 days)
Not Found
No
The summary describes a flexible fiberoptic system with a video-guided catheter for visualization. There are no mentions of AI, ML, image processing, or any data analysis that would suggest the use of such technologies. The performance studies focus on mechanical and optical properties, not algorithmic performance.
No
The Myeloscope is intended for "assisting in the diagnosis of disease," which makes it a diagnostic device rather than a therapeutic one.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is for "assisting in the diagnosis of disease."
No
The device description explicitly states it is a flexible fiberoptic system including a video guided catheter and a reusable fiberoptic scope, 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 devices used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Myeloscope Function: The Myeloscope is used inside the body (in the epidural space) for direct visualization and illumination to assist in diagnosis. It does not analyze samples taken from the body.
The description clearly indicates it's an endoscopic system used for direct internal examination, which falls under the category of medical devices used for imaging and visualization, not IVDs.
N/A
Intended Use / Indications for Use
The Myeloscope is intended to be used by physicians for the illumination and The Mydlescope is intenthe epidural space in the lumbar and sacral spine for the purpose of assisting in the diagnosis of disease. The Myeloscope is intended to be used by physicians for the illumination and visualization of tissues of the epidural space in the lumbar and sacral spine for the purpose of assisting in the diagnosis of disease.
Product codes
HRX
Device Description
The Myelotec Myeloscope is a flexible fiberoptic system that includes a video guided catheter that allows steering of the fiberoptic scope. The fiberoptic scope is a reusable device that is supplied non-sterile with instructions for cleaning, sterilization and re-use. The video guided catheter is a sterile, disposable device. The optical performance characteristics of the Myeloscope are similar to the predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
epidural space in the lumbar and sacral spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians
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)
Performance testing of the video guided catheter shows that the catheter is capable of flexing the Myeloscope optics 30 degrees to the right and left for 250 cycle without damage to the tip bonds or steering mechanism. Safety testing included biocompatibility for patient contacting materials. Non-clinical testing on the Myelotec Myeloscope included optical, mechanical, sterilization assurance and re-use validations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 4 1996
Myelotec, Inc. c/o Ms. Carolann Kotula Official Correspondent MDI Consultants, Inc. 55 Northern Boulevard, Suite 410 Great Neck, New York 11021
- Re : K960194 Trade Name: Myeloscope Regulatory Class: II Product Code: HRX Dated: July 12, 1996 Received: July 16, 1996
Dear Ms. Kotula:
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 You may, therefore, Food, Drug, and Cosmetic Act (Act). market the device, subject to the general controls provisions The general controls provisions of the Act 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 Requiations, Title 21, Parts 800 to 895. rt substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 - Ms. Carolann Kotula
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 at (301) 443-6597.
Sincerely yours,
n 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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5 IO(k) Number (if known): X960194
Myeloscope Devico Name:
Indications For Usc:
The Myeloscope is intended to be used by physicians for the illumination and The Mydlescope is intenthe epidural space in the lumbar and sacral spine for the purpose of assisting in the diagnosis of disease.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PACE IF NEEDED)
Concurence of CDRH, Office of Device Evaluation (ODE)
the Rhodes
(Division Sign-Off)
Division of Gueral Resultative Devices
510(k) Number .
Prescription Usc (Per 21 CFR 801.109)
OR
Over-The-Country Use
(Optional Formel 1-2-96)
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ATTACHMENT 1 Page 1 of 2
sport - 4 1004
510(K) SUMMARY MYELOTEC MYELOSCOPE SYSTEM
Submitter Information:
Edward J. Lortie President Myelotec, Inc. 1005 Alderman Drive, Suite 101 Alpharetta, GA 30202 Telephone # (770)-664-4656
510(K) Summary Prepared: June 28, 1996
Name of the Device:
Trade or Proprietary Name: Myelotec Myeloscope
Common Name: Flexible fiberoptic scope with guiding catheter
Classification Name: Arthroscope and Accessories (21 CFR Part 888.1100)
Identification of Legally Marketed Devices To Which The Submitter Claims Equivalence:
The Myelotec, Inc. Myeloscope is similar in design and/or intended use to several legally marketed flexible fiberscope endoscopes. These include the Danek Spinal Epidural Endoscope Systems (K930191) and the Ultra-Vu Endoscope Systems (K913129). These are flexible fiberoptic systems used for "micro-endoscopic" applications in small body cavities and spaces.
Description of the Subject Device:
The Myelotec Myeloscope is a flexible fiberoptic system that includes a video guided catheter that allows steering of the fiberoptic scope. The fiberoptic scope is a reusable device that is supplied non-sterile with instructions for cleaning, sterilization and re-use. The video guided catheter is a sterile, disposable device.
The optical performance characteristics of the Myeloscope are similar to the predicate devices.
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Image /page/4/Picture/0 description: The image contains four lowercase letters: 'm', 'd', and two 'i's. The letters are arranged horizontally from left to right. The letters are outlined in black, with a white fill.
Performance testing of the video guided catheter shows that the catheter is capable of flexing the Myeloscope optics 30 degrees to the right and left for 250 cycle without damage to the tip bonds or steering mechanism.
Safety testing included biocompatibility for patient contacting materials.
Intended Use of the Subject Device
The Myeloscope is intended to be used by physicians for the illumination and visualization of tissues of the epidural space in the lumbar and sacral spine for the purpose of assisting in the diagnosis of disease.
Technological Characteristics of the Subject Device:
There are no significant technological characteristics between the Myelotec Myeloscope and the predicate devices. Optical and mechanical performance and materials are similar.
Non-clinical testing on the Myelotec Myeloscope included optical, mechanical, sterilization assurance and re-use validations.