(159 days)
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No
The description details a manually operated, mechanical biopsy forceps with electrocautery capabilities. There is no mention of any computational analysis, image processing, or algorithmic decision-making that would indicate the presence of AI or ML.
No
Explanation: While the device removes tissue samples, it is primarily a diagnostic tool for obtaining histological samples and performing electrocautery, not for directly treating a disease or condition for a therapeutic outcome.
No
The device is used for removing tissue samples and performing electrocautery, which are interventional procedures, not diagnostic ones. While the tissue samples may later be used for diagnosis, the device itself performs the collection, not the diagnosis.
No
The device description clearly describes a physical, manually operated, hand-held surgical instrument with mechanical components (jaws, linkage, cable) and electrical conductivity for electrocautery. It is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health.
- Device Function: The DynaBite HOT Gastroenterology Biopsy Forceps is a surgical instrument used inside the body during an endoscopic procedure. Its primary functions are:
- Removing tissue samples: This is a surgical act of obtaining the sample, not analyzing it.
- Performing electrocautery: This is a therapeutic/surgical procedure to control bleeding or cut tissue.
- Intended Use: The intended use clearly states it's for use in an endoscopic procedure for removing tissue and performing electrocautery. It doesn't mention any analysis of the tissue by the device itself.
While the tissue sample obtained may be sent for in vitro diagnostic testing later (e.g., histology), the DynaBite HOT Biopsy Forceps itself is the tool used to collect the sample and perform a surgical function, not to perform the diagnostic test.
N/A
Intended Use / Indications for Use
The DynaBite HOT Gastroenterology Biopsy Forceps used in endoscopic procedure for removing histological tissue samples from the inner walls of the intestines and for performing associated electrocautery. The subject device is intended to be used with a colonoscope, a connecting cable and a high-frequency electrical-current generator, manufactured by others.
The DynaBite HOT Biopsy Forceps is intended for uses in gastrointestinal endoscopic procedure for for removing a histological tissue samples from the inner walls of the intestines and for performing associated electrocautery.
Product codes
78 KGE
Device Description
The DynaBite HOT Gastroenterology Biopsy Forceps are manually operated, hand held, flexible, cable actuated, coated, monopolar, trans-rectal surgical instruments have diameters of either 2.2, or 3.3 millimeter and working lengths of 240 centimeter. Each forceps has a pair of double actuating, fenestrated cup jaws at the distal end. Both devices are used in endoscopic procedure for removing histological tissue samples from the inner walls of the intestines and for performing associated electrocautery. The subject device is intended to be used with a colonoscope, a connecting cable and a high-frequency electrical-current generator, manufactured by others. The distal jaws of the forceps are open and closed with a two bar linkage actuated by lateral motion of the proximal finger rings. Since the forceps are fabricated from electrically conductive stainless steels, the forceps may be used to transmit a high frequency wave form to the distal end of the forceps for electrocautery. A dielectric forceps coating and the endoscope electrically insulate the length of the forceps from unintended patient contact. The technological characteristics of the DynaBite HOT Gastroenterology Biopsy Forceps are time tested and used by other legally marketed HOT biopsy forceps.
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
inner walls of the intestines
Indicated Patient Age Range
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MicroVasive Hot Biopsy Forceps, Hot Biopsy Forceps, DynaBite GI Biopsy Forceps (non-electric)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
807.92 510(k) Summary
JUN 17 1997
DynaBite HOT Gastroenterology Biopsy Forceps Subject Device: Portlyn Corporation Manufacturer: Predicate Device 1: MicroVasive Hot Biopsy Forceps Boston Scientific Corporation Distributor: Predicate Device 2: Hot Biopsy Forceps Distributor: Olympus Predicate Device 3: DynaBite GI Biopsy Forceps (non-electric) Manufacturer: Portlyn Corporation Subject Device Description: The DynaBite HOT Gastroenterology Biopsy Forceps are manually operated, hand held, flexible, cable actuated, coated, monopolar, trans-rectal surgical instruments have diameters of either 2.2, or 3.3 millimeter and working lengths of 240 centimeter. Each forceps has a pair of double actuating, fenestrated cup jaws at the distal end. Both devices are used in endoscopic procedure for removing histological tissue samples from the inner walls of the intestines and for performing associated electrocautery. The subject device is intended to be
1
used with a colonoscope, a connecting cable and a high-frequency electrical-current generator, manufactured by others. The distal jaws of the forceps are open and closed with a two bar linkage actuated by lateral motion of the proximal finger rings. Since the forceps are fabricated from electrically conductive stainless steels, the forceps may be used to transmit a high frequency wave form to the distal end of the forceps for electrocautery. A dielectric forceps coating and the endoscope electrically insulate the length of the forceps from unintended patient contact. The technological characteristics of the DynaBite HOT Gastroenterology Biopsy Forceps are time tested and used by other legally marketed HOT biopsy forceps.
Intended Use: The DynaBite HOT Gastroenterology Biopsy Forceps used in endoscopic procedure for removing histological tissue samples from the inner walls of the intestines and for performing associated electrocautery. The subject device is intended to be used with a colonoscope, a connecting cable and a high-frequency electrical-current generator, manufactured by others. The
2
intended use and technological characteristics of the subject device is the same as the first two predicate devices. The third predicate device defers only in the electrocautery feature.
I, to the best of my knowledge, believe the that all data and information submitted in this 510(k) premarket notification is truthful and accurate and that no material facts have been
itted.
George A. Lyna and the corresponding text in markdown format is: omitted. George A. Lyna 1/8/97 Date
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 17 1997
Mr. George A. Lyna Manager Quality and Regulatory Affairs ........ PORTLYN CORPORATION Medical Products Division RFD 1, Box 451, Route 25 Moultonboro, New Hampshire 03254
Re: K970083
DynaBite Hot SI Biopsy Forceps ...... Dated: May 19, 1997 Received: May 20, 1997 Regulatory class: II 21 CFR §876.4300/Product code: 78 KGE
分 Dear Mr. Lyna:
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 (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 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.
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) 594-4616. 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/dsmamain.html".
Sincerely yours,
Lillian Min, Ph.D.
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
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Indications For Use
Page 1 of 1
| 510(k) Number (if known): | K970083 |
|---|---|
| Device Name: | DynaBite HOT GI Biopsy Forceps |
Indications For Use:
The DynaBite HOT Biopsy Forceps is intended for uses in gastrointestinal endoscopic procedure for for removing a histological tissue samples from the inner walls of the intestines and for performing associated electrocautery.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Rober R (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 00083 510(k) Number _