(86 days)
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No
The provided text describes a mechanical injector needle and its intended uses, with no mention of AI or ML technology.
No
The device is described as an injector needle for various procedures within an endoscope, not as a device that delivers therapy. It aids in the delivery of agents or fluids for diagnostic, preparatory, or control purposes, such as submucosal lift, clearing the field of view, applying dye, clot removal, injecting hemostatic agents, and tattooing. While it facilitates procedures that might lead to therapeutic interventions (e.g., electrosurgical excision or controlling bleeding), the device itself is a tool for injection and not directly therapeutic.
No
The device is used for injecting media for submucosal lift, infusing fluid, applying dye spray, clot removal, injecting hemostatic agents, and tattooing sites. These are all therapeutic or interventional procedures, not diagnostic ones.
No
The 510(k) summary describes a physical device, a dual lumen injector needle, used with an endoscope. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The description clearly states the device is an "Injector Needle Share" used for injecting media directly into the body (submucosal lift, fluid infusion, dye spray, hemostatic agents, tattooing) through a flexible endoscope. This is an in vivo procedure, meaning it's performed inside the body.
The device's function is therapeutic and procedural, not diagnostic based on analyzing samples outside the body.
N/A
Intended Use / Indications for Use
The dual lumen Injector Needle Snare is indicated for use with an Olympus or Microvasive active cord for the injection of media for submucosal lift of polyps or other mucosal lesions, using direct visualization, through a flexible endoscope, prior to electrosurgical excision and for the infusion of fluid for clearing away the field of view, applying dye spray, clot removal, injection of hemostatic agents to control post-polypectomy bleeding, and tattooing of sites for future surgical purposes.
Product codes
78 FBK, 78 FDI
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
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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
Image /page/0/Picture/1 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text around the perimeter appears to be the name of an organization or agency. The symbol in the center consists of three curved lines that resemble a stylized bird or wave pattern. The logo is black and white and has a simple, clean design.
JUL - 8 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Gretchen Y. Cohen Executive Vice President United States Endoscopy Group, Inc. 5976 Heisley Road MENTOR OH 44060
Re: K040961
:
Trade/Device Name: Endoscopic Injection Needle/Snare, Models # 00711086 and 00711088 Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Product Code: 78 FBK Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Product Code: 78 FDI Regulatory Class: II Dated: June 11, 2004 Received: June 14, 2004
Dear Ms. Cohen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave a rowe 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 for associated in the enactment date of 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, de rios that have ocen t tequire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r va may , aron's 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 your de 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Dr rass made a over regulations administered by other Federal agencies. You must of any I ederal statutes and regulations, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Party) noceming (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 Section 5 (d(k) This letter will allow you to begin harreting, your and equivalence of your device to a legally premarket notification. The FDA inding, in basical on for your device and thus, pennits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Park (1), please If you desire specific advice for your decided on on the following numbers, based on the regulation number at the top of the letter.
| 8xx. Ixxx | (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 Additionally, for questions on the promotion and enote the regulation entitled, "Mastranding
Office of Compliance at (301) 594-4639. Also, please note the international with Othice of Compliance at (501) 574-1657. Fab., promote of a production of Since by reference to premarked nouncation (21 ce Fee Act may be obtained from the Division of Small
information on your responsibilities under the Act may be of Small Case and P information on your responsionalites and consumer Assistance at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance in Assistances in Manufacturers, International and Collsamer Passential Passerial Statis (301) 443-6597 or at its Internet
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K040961
Device Name: Injector Needle Share
Indications for Use:
The dual lumen Injector Needle Share is indicated for use with an Olympus or Microvasive active cord for the injection of media for submucosal lift of polyps or other mucosal lesions, using direct visualization, through a flexible endoscope, prior to electrosurgical excision and for the infusion of fluid for clearing away the field of view, applying dye spray, clot removal, injection of hemostatic agents to control post-polypectomy bleeding, and tattooing of sites for future surgical purposes.
Prescription Use (Part 21 CFR 801 Subpart D)
David h. Sepsom
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number