(251 days)
Not Found
No
The device description and performance studies focus on the mechanical components and material properties of an injection needle, with no mention of AI or ML.
No
The device is used for injection into gastrointestinal mucosa, which is a procedure rather than a therapeutic treatment in itself. Its function is to facilitate the delivery of substances, not to directly treat a condition.
No
The device is an injection needle, meant for delivering substances into tissue, not for obtaining information about a patient's medical condition.
No
The device description explicitly lists multiple physical components made of various materials (stainless steel, PTFE, ABS, TPE, nylon, CNBR) and describes a physical injection needle intended for endoscopic use. This is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "endoscopic injection into the gastrointestinal mucosa." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The device is a needle designed for injection, which is a therapeutic or procedural action, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue samples, etc.) to provide diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver a substance into the body, which is a different category of medical device.
N/A
Intended Use / Indications for Use
The EndoChoice Select injection needle is intended for endoscopic injection into the gastrointestinal mucosa.
Product codes
FBK
Device Description
The EndoChoice Select Injection Needle mainly consists of a cap, needle, boosting tube, and positioning ring, all made of 304 stainless steel. It also contains an outer tube and nut made of PTFE. The spring and spring tube are made of 302 stainless steel. The shell and injection handle are made of ABS. The bushing is made of TPE (SBS), the inner tube is made of nylon, and the color band indicator is made of CNBR.
The products are intended for single use; an individual device is packed in a sealed pouch following ETO sterilization. The device is used for local injection via endoscope, with the average contact time of the products and the mucosa of the human digestive tract of less than1 hour.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal mucosa, tissues of the digestive system
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)
Non-Clinical testing:
Biocompatibility, accelerated aging and sterilization testing is unchanged from the predicate Injection Needle, which demonstrates that this device is safe and effective for use. Testing was based on a formal risk analysis. Biocompatibility testing was performed for the new patient contacting material of the modified device.
All test results passed, demonstrating that the safety and efficacy is 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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 8, 2016
EndoChoice, Inc. Daniel Hoefer Regulatory Affairs Manager 11810 Wills Rd. Alpharetta, GA 30009
Re: K151475
Trade/Device Name: Endochoice Select Injection Needle Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FBK Dated: January 6, 2016 Received: January 8, 2016
Dear Daniel Hoefer,
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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 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 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 yours,
Benjamin R. Fisher -S
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) K151475
Device Name EndoChoice Select Injection Needle
Indications for Use (Describe)
The EndoChoice Select injection needle is intended for endoscopic injection into the gastrointestinal mucosa.
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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Special 510(k) Summary
1. Company Identification
EndoChoice, Inc. 11810 Wills Road Alpharetta, GA 30009 Telephone (678) 708 4743 FAX (678) 878 3373 Establishment Registration: 3007591333
2. Contact Person
Daniel Hoefer Regulatory Affairs Manager
3. Device Name
| Trade name: | EndoChoice Select Injection Needle |
|---|---|
| Common/Usual Name: | Injection Needle |
4. Device Classification
| Injection Needle |
|---|
| Endoscope accessories, 21CFR 876.1500 |
| FBK |
| Gastroenterology/Urology |
5. Indications for Use
The EndoChoice Select injection needle is intended for endoscopic injection into the gastrointestinal mucosa.
6. Device Description
The EndoChoice Select Injection Needle mainly consists of a cap, needle, boosting tube, and positioning ring, all made of 304 stainless steel. It also contains an outer tube and nut made of PTFE. The spring and spring tube are made of 302 stainless steel. The shell and injection handle are made of ABS. The bushing is made of TPE (SBS), the inner tube is made of nylon, and the color band indicator is made of CNBR.
The products are intended for single use; an individual device is packed in a sealed pouch following ETO sterilization. The device is used for local injection via endoscope, with the average contact time of the products and the mucosa of the human digestive tract of less than1 hour.
4
7. Substantial Equivalence
7.1 Predicate devices
The modified EndoChoice Select Injection needle is substantially equivalent to the predicate devices. EndoChoice Injection Needle (K132065) manufactured by EndoChoice, Inc. The intended use, design and materials and labeling are all substantially equivalent.
The predicate device as described in K132065 included 2 catheter configurations. This modification applies only to the version utilizing a Teflon sheath and does not apply to the catheter design, which incorporates a stainless steel spring. This submission has been prepared to address a change, in which a new patient contacting material has been introduced, as identified in the Needle select design assembly attached.
7.2 Intended Use
The indications for use of the modified EndoChoice Select Injection Needle is unchanged from the predicate device, the EndoChoice Injection Needle (K132065) manufactured by EndoChoice. In each case, the injection needle is intended for endoscopic injection into tissues of the digestive system.
7.3 Technical Characteristics
The injection needle is available in multiple sizes and two styles. The needle gauge sizes are available in 22 gauge and 25 gauge needles. Two styles of sheaths are available; one style is a metal stainless steel spring sheath and the other is a Teflon sheath. The modified EndoChoice Select Injection Needle only applies to the Teflon sheath configuration.
7.4 Performance Characteristics
The steps for operator use of each of the devices are equivalent. The instructions for use describe how to use the device with a standard endoscope, which is unchanged from the predicate.
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| Substantial Equivalence Comparison | |||
|---|---|---|---|
| EndoChoice Injection Needle | |||
| Predicate (K132065) | Modified EndoChoice Select | ||
| Injection Needle | Substantial | ||
| equivalence | |||
| Manufacturer | EndoChoice, Inc. | EndoChoice, Inc. | Equivalent |
| Compatible with | |||
| currently | |||
| available | |||
| endoscopes | Yes | Yes | Equivalent |
| Supplied Sterile | Yes | Yes | Equivalent |
| Sheath diameter | 2.3mm | 2.3mm | Equivalent |
| Needle size | 22-25 gauge | 22-25 gauge | Equivalent |
| Outer Tubing | Thermoplastic polymer- | ||
| Teflon | Thermoplastic polymer- | ||
| Teflon | Equivalent | ||
| Length | 240 cm | 240 cm | Equivalent |
| Needle extension | |||
| length | 5 mm | 5 mm | Equivalent |
| Indications for | |||
| use | The EndoChoice Select | ||
| Injection Needle is intended | |||
| for endoscopic injection into | |||
| the gastrointestinal mucosa. | The EndoChoice Select | ||
| Injection Needle is intended | |||
| for endoscopic injection into | |||
| tissues of the digestive | |||
| system. | Equivalent | ||
| Packaging | Single-use EO sterilized | ||
| Tyvek pouch with one device | |||
| per pouch. | Single-use EO sterilized | ||
| Tyvek pouch with one | |||
| device per pouch. | Equivalent |
7.5 Substantial Equivalence Table
8. Non-Clinical testing
Biocompatibility, accelerated aging and sterilization testing is unchanged from the predicate Injection Needle, which demonstrates that this device is safe and effective for use. Testing was based on a formal risk analysis. Biocompatibility testing was performed for the new patient contacting material of the modified device.
All test results passed, demonstrating that the safety and efficacy is equivalent to the predicate device.
9. Conclusion
The EndoChoice Select Injection Needle is substantially equivalent to the predicate device listed above. It is the same or equivalent in terms of design, intended use, materials and labeling.