(29 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a standard medical device, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML algorithms.
No
This device is an accessory for an endoscope used to deliver injectable materials, not a device that itself provides a therapeutic effect.
No
Explanation: The device is used for the delivery of injectable materials into tissue; it does not collect or process information about the patient's health status.
No
The device description clearly outlines physical components (luer lock hub, flexible cannula, stainless steel needle) and mentions hardware-related testing (sterilization, shelf life, functional testing), indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "allow delivery of injectable materials into tissue during an endoscopic procedure." This describes a therapeutic or procedural use, not a diagnostic test performed on samples outside the body.
- Device Description: The description of the device (luer lock hub, cannula, needle) is consistent with a device used for injecting substances directly into tissue, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to deliver substances into the body during a procedure.
N/A
Intended Use / Indications for Use
The Endoscopic Injection Needle is an accessory for currently marketed endoscopes to allow delivery of injectable materials into tissue during an endoscopic procedure.
Product codes
FBK
Device Description
The Endoscopic Injection Needle consists of a luer lock hub, flexible cannula and retractable stainless steel needle at the distal tip. The hub is designed to accommodate a standard syringe. The device is supplied sterile and is for single patient use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A Failure Modes and Effects Analysis (FMEA) was performed in order to assess the risks associated with the modifications introduced. Sterilization adoption validation and EO residual, distribution simulation, shelf life, and functional testing, along with a biocompatibility and sterile barrier packaging evaluation, confirmed that the modified device, Endoscopic Injection Needle, was substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 23, 2017
Carbon Medical Technologies. Inc. Andrew Adams Director-Regulatory Affairs & Ouality Assurance 1290 Hammond Road Saint Paul, MN 55110-5867
K172227 Re:
Trade/Device Name: Endoscopic Injection Needle Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FBK Dated: July 24, 2017 Received: July 25, 2017
Dear Andrew Adams:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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 (reporting of medical 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 contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Charles Viviano -S
For Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172227
Device Name Endoscopic Injection Needle
Indications for Use (Describe)
The Endoscopic Injection Needle is an accessory for currently marketed endoscopes to allow delivery of injectable materials into tissue during an endoscopic procedure.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Submitter's Name, Address and Date of Submission
Andrew Adams Director, Regulatory Affairs and Quality Assurance Carbon Medical Technologies, Inc. 1290 Hammond Road Saint Paul, MN 55110
Phone: 651-653-8512 Fax: 651-407-1975
Submitted: July 20, 2017
Device Name
| Trade Name: | Endoscopic Injection Needle |
|---|---|
| Common Name: | Endoscopic Injection Needle, Gastroenterology-Urology |
| Classification Name: | Endoscope and Accessories (21 CFR 876.1500, FBK) |
Predicate Device
Carbon Medical Technologies Endoscopic Injection Needle (K042615)
Indication for Use
The Endoscopic Injection Needle is an accessory for currently marketed endoscopes to allow delivery of injectable materials into tissue during an endoscopic procedure.
Device Description
The Endoscopic Injection Needle consists of a luer lock hub, flexible cannula and retractable stainless steel needle at the distal tip. The hub is designed to accommodate a standard syringe. The device is supplied sterile and is for single patient use.
Technological Characteristics and Performance
The technological characteristics are equivalent to the predicate device. A Failure Modes and Effects Analysis (FMEA) was performed in order to assess the risks associated with the modifications introduced. Sterilization adoption validation and EO residual, distribution simulation, shelf life, and functional testing, along with a biocompatibility and sterile barrier packaging evaluation, confirmed that the modified device, Endoscopic Injection Needle, was substantially equivalent to the predicate device.