(77 days)
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No
The summary describes a mechanical device for tissue manipulation and ablation, with no mention of AI/ML terms, image processing, or data-driven analysis.
No.
The device is used for diagnostic purposes (biopsy for diagnosing malignancies and other disorders) and tissue removal (grasp, dissect, transect tissue, and ablate with electric current), rather than directly treating a condition.
Yes
The device is used to "biopsy... for the purpose of diagnosing malignancies and other disorders", which indicates a diagnostic intent.
No
The device description clearly states it is a "Reusable hot biopsy forceps," which is a physical medical device used in endoscopy procedures. It involves grasping and ablating tissue with electric current, indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- Device function: The description clearly states the device is used during a flexible endoscopy procedure to directly interact with tissue (biopsy, grasp, dissect, transect) and ablate it with electric current. This is an in vivo procedure, meaning it is performed within the living body.
- Lack of laboratory testing: There is no mention of the device being used to analyze samples outside of the body in a laboratory setting. The tissue is biopsied and then presumably sent for laboratory analysis, but the device itself is not performing the diagnostic test.
Therefore, the Reusable hot biopsy forceps are a surgical/endoscopic instrument used for tissue acquisition and manipulation in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Reusable Hot Biopsy Forceps are intended for use in flexible endoscopy procedures to biopsy, grasp, dissect and transect tissue.
Product codes
78 KGE
Device Description
The Reusable hot biopsy forceps are intended for use in flexible endoscopy procedures to biopsy, grasp, dissect and transect tissue. Lesions/polyps of the lower or upper gastrointestinal tract may be biopsied for the purpose of diagnosing malignancies and other disorders. The lesion/polyp is grasped between the jaws of the biopsy forceps; the forceps are then lifted from the intestinal wall and the tissue is ablated with electric current.
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
upper or lower gastrointestinal tract
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
SECTION II Pini SAFETY AND EFFECTIVENESS SUMMARY
SEP 1 8 1997 SAFETY AND EFFECTIVENESS MONOPOLAR BIOPSY FORCEPS SUMMARY
Safety and Effectiveness on the endoscopic Summary of The procedures for biopsy of upper or lower gastrointestinal tract and the Monopolar Biopsy Forceps used reflects data available and presented at the time the submission was prepared, but, caution should be exercised in interpreting the data. The results of future studies may require alterations of the conclusions or recommendations set forth.
Procedure/Product Overview
The Reusable hot biopsy forceps are intended for use in flexible endoscopy procedures to biopsy, grasp, dissect and transect tissue.
Lesions/polyps of the lower or upper gastrointestinal tract may be biopsied for the purpose of diagnosing malignancies and other disorders.
The lesion/polyp is grasped between the jaws of the biopsy forceps; the forceps are then lifted from the intestinal wall and the tissue is ablated with electric current.
Contraindications for Biopsy Procedure
The use of Monopolar Biopsy Forceps is contraindicated and is not appropriate in cases where patients have or are present with:
- Coaqulopathy
- Potential for bleeding
- Current use of anticoaqulants .
- Recent ingestion of non-steroidal anti-inflammatory or ASA-.
- containing drug (unless bleeding is verified as normal)
- Other contraindications as determined by physician
Manufacturing Overview
manufactures and tests the product to performance ប. S.E. specifications based on predicate and/or substantially equivalent devices.
U.S.E. manufacturing processes and procedures are based on good manufacturing practices. Quality assurance methods and procedures based on MIL-STD-9858 are utilized to assure conformance to design specifications.
Materials used in the manufacturing process are certified to standards appropriate for their use.
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Image /page/1/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three faces in profile, one behind the other. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular pattern around the top and left side of the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Gretchen Younker Cohen United States Endoscopy Group, Inc. 9330 Progress Parkway Mentor, Ohio 44060
18 1997
Re: K972505 Reusable Hot Biopsy Forceps Dated: June 30, 1997 Received: July 3, 1997 Regulatory class: II 21 CFR §876.4300/Product code: 78 KGE
Dear Ms. Cohen:
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, 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 misbranion.
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 equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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 vour 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/dsmamain.html".
Sincerely yours.
Sincerely yours,
Lillian Yin, 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
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510(k) Number if Known_K 972505 Reusable Biopsy Forceps, Hot Device Name:_
Indications for Use:
The Reusable Hot Biopsy Forceps are intended for use in flexible endoscopy procedures to biopsy, grasp, dissect and transect tissue.
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )
OR
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CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
Prescription Use
(Per 21 CFR 801.109)
Over-the Counter Use__________________________________________________________________________________________________________________________________________________________
Robert R. Satting/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 2505 510(k) Number