(85 days)
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No
The provided text describes a surgical instrument for tissue ablation/coagulation and makes no mention of AI or ML technology.
Yes
The device is intended for "ablation/coagulation of the soft tissue," which signifies a medical intervention to treat or modify tissue, placing it within the definition of a therapeutic device.
No
The device is indicated for ablation/coagulation of soft tissue, which is a therapeutic intervention, not a diagnostic one.
No
The device is described as a "Resectoscope Roller Device" intended for ablation/coagulation of soft tissue and for use with compatible resectoscopes. This description strongly implies a physical, hardware-based medical device, not a software-only one. The lack of any mention of software, algorithms, or data processing further supports this conclusion.
Based on the provided information, the Omnitech Resectoscope Roller Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "ablation/coagulation of the soft tissue" within the body (Urological and Gynecological fields). This is a therapeutic or surgical procedure performed in vivo (within a living organism).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed in vitro (outside the body).
The device's function is to directly interact with and modify tissue within the patient's body, which is the opposite of an IVD.
N/A
Intended Use / Indications for Use
The Omnitech Resectoscope Roller Device is indicated for ablation/ coagulation of the soft tissue and is intended for the use with compatible resectoscopes. The device will be sold as a sterile product to be used in the Urological and Gynecological fields.
Product codes
85 KNF
Device Description
Omnitech Resectoscope Roller Electrode
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
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Indicated Patient Age Range
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Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 884.4160 Unipolar endoscopic coagulator-cutter and accessories.
(a)
Identification. A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of three overlapping shapes, resembling birds in flight or abstract human figures. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 17 1998
Mr. Jon D. Barrett Administrative Assistant Omnitech Systems, Inc. 456 S. Campbell Valparaiso, IN 46385
Re: K981463
Omnitech Resectoscope Roller Electrode Dated: March 3, 1998 Received: April 23, 1998 Regulatory Class: II 21 CFR 884.4160/Procode: 85 KNF
Dear Mr. Barrett:
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 (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 equivalion assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) 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 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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) 594-4613. 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/dsmaldsmamain.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
INDICATIONS FOR USE:
510(k) Number (if Known):
Device Name:
Omnitech Resectoscope Roller Electrode
Indications For Use:
The Omnitech Resectoscope Roller Device is indicated for ablation/ coagulation of the soft tissue and is intended for the use with compatible resectoscopes. The device will be sold as a sterile product to be used in the Urological and Gynecological fields.
(Please do not write below this line, continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off: Carlyn Y Newbert for R Gatling
Division of Reproductive, Abdominal, ENT, and Radiological Devices.
| 510(k) Number: | K981463 |
|---|---|
| Prescription Use Per 21 CFR 801.109 | ✓ |
| Or | |
| Over The Counter Use Optional Format (1-2-96) |