(198 days)
Not Found
No
The device description and performance studies focus on the mechanical components and basic functionality of an injection needle, 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.
The device is used for local injection into the gastrointestinal mucosa via an endoscope, but its function is for injection, not for directly treating a disease or condition. While the injected substance might be therapeutic, the device itself is a delivery tool.
No
Explanation: The device is an injection needle used for therapeutic purposes (local injection via endoscope) and not for detecting or diagnosing a condition.
No
The device description explicitly lists multiple hardware components made of various materials (stainless steel, PTFE, ABS, TPE, nylon) and describes a physical injection needle.
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 directly on a patient's tissue in vivo (within the living body).
- Device Description: The device is a physical tool used for delivering substances into tissue. It does not involve testing samples of bodily fluids or tissues in vitro (outside the living body) to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device is a therapeutic/procedural device used for direct intervention within the body.
N/A
Intended Use / Indications for Use
The injection needle is intended for endoscopic injection into the gastrointestinal mucosa.
Product codes (comma separated list FDA assigned to the subject device)
FBK
Device Description
The 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), and the inner tube is made of nylon.
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 product and the mucosa of the human digestive tract of less than 1 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)
Biocompatibility, accelerated aging, performance, and sterilization validation testing was performed on the injection needle that demonstrated that this device is safe and effective for use. Testing was based on a formal risk analysis.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Medi-Globe Injectra injection needle (K061222)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.
| Submitter Name and Address: | EndoChoice, Inc. 11810 Wills Rd Alpharetta, GA 30009 | JAN 17 2014 |
|---|---|---|
| Contact Person: | Theron Gober Director, Quality and Regulatory | |
| Phone Number: | 678-534-6021 | |
| Fax Number: | 770-962-6981 | |
| Establishment Registration Number: | 300759133 | |
| Date Prepared: | December 10, 2013 | |
| Device Trade Name(s): | Injection Needle | |
| Device Common Name: | Injection Needle | |
| Classification Name: | FBK | |
| Predicate Device(s): | Medi-Globe Injectra injection needle (K061222) |
EndoChoice, Inc.
・
・
.
.
.
1
.
| General Device
Description: | The 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), and the inner tube is made of nylon.
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 product
and the mucosa of the human digestive tract of less than 1 hour. |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The injection needle is intended for endoscopic injection into the
gastrointestinal mucosa. |
| Technological
Characteristics: | The injection needle is available in two sizes and two styles. The two
sizes relate to the needle gauge. The sizes are 19 gauge and 22 gauge.
Two styles of sheaths are available. The two styles of the device are
identical with the exception of the addition of a stainless steel spring in
one style. This stainless steel spring is present in the inner catheter of
the EndoChoice Injection Needle, whereas it is not present in the
predicate. The design is intended to ensure repeatable needle
deployment in a tortuous path by maintaining a columnar deployment
channel. |
| Testing Performed: | Biocompatibility, accelerated aging, performance, and sterilization
validation testing was performed on the injection needle that
demonstrated that this device is safe and effective for use. Testing was
based on a formal risk analysis.
The following table shows a summary substantial equivalence of the
EndoChoice Injection Needle and the chosen predicate, indicating no
additional safety risks arise in the new device based on similarities in
materials, intended use, and function of the EndoChoice Injection Needle
in comparison to the predicate device. |
・
•
·
:
・
.
2
| | EndoChoice
Injection
Needle: | Medi-Globe
Injectra
Injection
Needle: | Substantial
Equivalence: |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Compatible with
currently available
endoscopes: | Yes | Yes | Equivalent |
| Supplied Sterile | Yes | Yes | Equivalent |
| Sheath diameter: | 2.3 mm | 2.5 mm | Similar |
| Needle size: | 22 – 25 gauge | 22 – 25 gauge | Similar |
| Outer tubing: | Thermoplastic
polymer - PTFE | Thermoplastic
Polymer | Similar |
| Length: | 240 cm. | 230 cm. | Similar |
| Needle Length: | 5 mm | 4 mm | Similar |
| Indications for
use: | The EndoChoice
Injection Needle
is intended for
endoscopic
injection into
the
gastrointestinal
mucosa. | The Medi-
Globe Injectra
Injection
Needle is used
in conjunction
with various
legally marked,
FDA registered
flexible
endoscopes.
The Injectra
Needle is used
for endoscopic
injection of
solutions into
tissues of the
digestive
system and
injection of
saline as a
procedural aid
in endoscopic
polypectomy
procedures. | Similar |
| Packaging: | Single-use EO
sterilized tyvek
pouch with one
device per
pouch. | Single-use EO
sterilized
steam sealed
pouch with
one device per
pouch. | Similar |
Injection Needle
3
Conclusion:
Based on the technological characteristics and overall performance of the devices, EndoChoice, Inc. believes that the Injection Needle and the predicate device selected are substantially equivalent. While the intended uses are slightly different, both devices are intended to be used in the same body regions during endoscopic procedures for injection of fluids. Therefore, this difference is minor, and does not raise new issues of safety or effectiveness.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 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 an emblem featuring a stylized eagle-like figure with three wing-like shapes.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 17, 2014
EndoChoice, Inc. Theron Gober Director, Quality and Regulatory 11810 Wills Road Alpharetta, GA 30009
K132065 Re:
Trade/Device Name: Injection Needle Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBK Dated: December 13, 2013 Received: December 17, 2013
Dear Theron Gober,
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.
5
Page 2 - Theron Gober
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin DASher -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
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
610(k) Number (if known)
Device Name
Injection Needle
Indications for Use (Describe)
The injection needle is intended for endosocpic injection into the gastrointestinal musess.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Benjamin 2014.01.107 -05'00'
Form FDA 3881 (8/13)
Pat Publishing Burrisco (101) 40-41-4