(78 days)
N/A
N/A
No
The summary describes a mechanical biopsy forcep and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No
The device is used for biopsy, which is a diagnostic procedure, not a therapeutic one. It is intended to collect tissue for examination, not to treat a disease.
No
The device is described as a "Hot Biopsy Forcep" intended for "transendoscopic biopsy of the GI tract." Biopsy is a procedure for collecting tissue samples, which are then typically sent for laboratory analysis to diagnose conditions. The forcep itself is a tool for sample collection, not for performing the diagnosis.
No
The device description explicitly states "Wiltek Hot Biopsy Forcep," which is a physical instrument used for biopsy, not a software-only device.
Based on the provided information, the Wiltek Hot Biopsy Forcep is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "transendoscopic biopsy of the GI tract." This describes a procedure performed on the patient's body to obtain a tissue sample.
- IVD Definition: In vitro diagnostics are tests performed outside the body on samples such as blood, urine, or tissue to detect diseases, conditions, or infections.
- Lack of IVD Characteristics: The description doesn't mention any analysis of a sample in vitro. It describes a tool used to collect the sample.
Therefore, the Wiltek Hot Biopsy Forcep is a medical device used for a surgical/procedural purpose, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Wiltek Hot Biopsy Forcep is intended for transendoscopic biopsy of the GI tract.
Device Description
Wiltek Hot Biopsy Forcep
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
GI tract
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) (K number(s) and name(s); separate multiples with ";")
Not Found
Reference Device(s) (K number(s) and name(s); separate multiples with ";")
Not Found
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with healthcare, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the caduceus. The caduceus is depicted with three lines forming a stylized design, and the text is in a simple, sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 3 1999
Mr. Jon S. Wilson President WILTEK Medical, Inc. 101 North Chestnut Street Suite 300 Winston-Salem, NC 27101 Re: K990231
Wiltek Hot Biopsy Forceps Dated: January 20, 1999 Received: January 25, 1999 Regulatory Class: II 21 CFR876.4300/Procode: 78 KGE
Dear Mr. Wilson:
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 rogation your in adation - or and 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.
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/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
Page 1 of 1
| 510(k) Number (if known): | K990231 |
|---|---|
| Wiltek Hot Biopsy Forcep | |
| Device Name: |
Indications for Use:
The Wiltek Hot Biopsy Forcep is intended for transendoscopic biopsy of the GI tract.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) 1
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| (Division Sign-Off) |
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_K 99022
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________