(105 days)
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No
The summary describes a mechanical biopsy forceps and contains no mention of AI, ML, or related concepts like image processing or algorithms.
No
The device is used for grasping tissue for biopsy, which is a diagnostic procedure, not a therapeutic one.
No
Explanation: The device is described as "Reusable Hot Biopsy Forceps" intended for dissecting and grasping tissue for biopsy. While biopsy is a step in diagnosis, the device itself is a tool for tissue collection, not for analyzing or interpreting medical data to make a diagnosis.
No
The device is described as "Reusable Hot Biopsy Forceps," which is a physical instrument used in conjunction with a flexible endoscope. This description clearly indicates a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "be used in the flexible endescope for transendoscopic, dissecting, and grasping tissue for biopsy." This describes a surgical/procedural tool used during a medical procedure to collect a tissue sample.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) outside of the body to detect diseases, conditions, or infections.
- Lack of IVD Characteristics: The description doesn't mention any analysis of the collected tissue sample, any reagents, or any diagnostic testing performed on the sample by the device itself. The device's function is solely the collection of the sample.
Therefore, the Horizons Reusable Hot Biopsy Forceps is a medical device used for tissue collection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Horizons Reusable Hot Biopsy Forceps is intended to be used in the flexible endescope for transendoscopic, dissecting, and grasping tissue for biopsy.
Product codes
78 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
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Key Metrics
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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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§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on a single line. The text is black against a white background.
Food and Drug Administration 9200 Corporate Boulevard · Rockville MD 20850
OCT 2 5 2002
Mr. Rafic Saleh President Horizons International Corporation 287 Monterrey Street P.O. Box 7273 Ponce PUERTO RICO 00732-7273
Re: K022243 Trade/Device Name: Horizons Reusable Hot Biopsy Forceps Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: 78 KGE Dated: October 14, 2002
Received: October 16, 2002
Dear Mr. Saleh:
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); 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.
1
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Nancy C. Croydon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K022243
fig. 1 of 1
6.1 Indication for Use
510K INDICATION FOR USE STATEMENT
510(k) Number (if known): K022243
Device Name: Horizons Reusable Hot Biopsy Forceps
Applicant Name: Horizons International Corp.
Indications for Use:
Horizons Reusable Hot Biopsy Forceps is intended to be used in the flexible endescope for transendoscopic, dissecting, and grasping tissue for biopsy.
Horizons International Corp.
Signature: Date: 7/10/02
Rafic Saleh President
David A. Seaman
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _
Prescription Use
(Per 21 CFR 801.109)