(246 days)
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No
The summary describes a mechanical biopsy tool and contains no mention of AI, ML, or related concepts like image processing or performance metrics typically associated with AI/ML devices.
No.
The device, "Biopsy forceps", is used for collecting tissue samples for diagnosis (histological examination), not for treating a condition or disease.
Yes
Biopsy forceps are used to collect tissue samples for histological examination, which is a method of diagnosis.
No
The device description explicitly states "Multi-bite Electric (Hot) Biopsy Forceps," which are physical hardware devices used for tissue collection.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "collecting tissue samples for histological examination." This describes a tool used during a medical procedure to obtain a sample from a living organism.
- Device Description: "Biopsy forceps" are instruments used to physically remove tissue from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples in vitro (outside the body).
- Detecting or measuring substances in biological samples (like blood, urine, tissue).
- Providing information for diagnosis, monitoring, or treatment decisions based on the analysis of these samples.
Biopsy forceps are considered a surgical instrument used for sample collection, which is a step prior to any potential in vitro diagnostic testing that might be performed on the collected tissue.
N/A
Intended Use / Indications for Use
Biopsy forceps are intended for use in collecting tissue samples for histological examination.
Product codes
KGE
Device Description
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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
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).
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Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The words are arranged on a single line and centered horizontally. The text appears to be part of a document or sign.
Public Health Service
NOV 25 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Lisa Derrick Director of Quality Assurance and Regulatory Affairs Endo-Therapeutics, Inc. 15251 Roosevelt Blvd., #204 CLEARWATER FL 33760
Re: K090796
Trade/Device Name: Multi-bite Electric (Hot) Biopsy Forceps Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KGE Dated: October 9, 2009 Received: October 15, 2009
Dear Ms. Derrick:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
[signature]
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo and contact information for Endo-Therapeutics, Inc. The logo consists of the letters "ETI" in a stylized font. The address is listed as 15251 Roosevelt Blvd. #204 Clearwater FL 33760. The phone number is 727-538-9570 and the fax number is 727-524-4111.
Indications for Use
510(k) Number (if known): K090796
Device Name: Multi-bite Electric (Hot) Biopsy Forceps
Indications for Use:
Biopsy forceps are intended for use in collecting tissue samples for histological examination.
× Over-The-Counter Use Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aran R. Whing
(Division Division of Reproductive, Abdominal and Radiological Devic 510(k) Number
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