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.

AI/ML Overview

The provided text describes a 510(k) submission for an "Injection Needle" and focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria for the new device.

Therefore, many of the requested sections (Table of acceptance criteria, Sample size for test set, Number of experts, Adjudication method, MRMC study, Standalone study, Type and establishment of ground truth for test and training sets) cannot be fulfilled from the provided text, as this information is not present. The submission focuses on comparing the characteristics of the new device to a predicate device to claim substantial equivalence, which is a different type of evaluation than a direct performance study against defined acceptance criteria.

However, based on the provided text, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" and "reported device performance" in the context of a formal study with quantitative results against pre-defined thresholds. Instead, it presents a comparison of the new device's characteristics against a predicate device to demonstrate substantial equivalence. The "performance" described is in terms of similar technical characteristics and capabilities to the predicate.

Characteristic	Acceptance (Substantial Equivalence)	Reported Device Performance (EndoChoice Injection Needle)	Predicate Device (Medi-Globe Injectra Injection Needle)
Compatible with currently available endoscopes	Yes	Yes	Yes
Supplied Sterile	Yes	Yes	Yes
Sheath diameter	Similar	2.3 mm	2.5 mm
Needle size	Similar	22 – 25 gauge	22 – 25 gauge
Outer tubing	Similar	Thermoplastic polymer - PTFE	Thermoplastic Polymer
Length	Similar	240 cm	230 cm
Needle Length	Similar	5 mm	4 mm
Indications for use	Similar	Intended for endoscopic injection into the gastrointestinal mucosa.	Used for endoscopic injection of solutions into tissues of the digestive system and injection of saline as a procedural aid in endoscopic polypectomy procedures.
Packaging	Similar	Single-use EO sterilized tyvek pouch with one device per pouch.	Single-use EO sterilized steam sealed pouch with one device per pouch.

2. Sample sized used for the test set and the data provenance

Not applicable. The submission describes a comparison of technical characteristics and an assessment of safety and effectiveness based on biocompatibility, accelerated aging, performance, and sterilization validation testing. There is no "test set" in the context of a clinical performance study with human data or a labeled dataset for AI evaluation. The data provenance simply refers to these internal engineering and biological safety tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No ground truth for a test set is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set requiring expert adjudication is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI device or a diagnostic device where MRMC studies would typically be performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device (an injection needle), not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. Ground truth, in this context, would relate to a clinical diagnostic or AI performance study, which is not what this submission describes. The "truth" considered here is that the device, through various engineering and biological tests, meets safety and performance requirements that are substantially equivalent to a legally marketed predicate.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI model.

9. How the ground truth for the training set was established

Not applicable. This is a medical device, not an AI model.

Summary

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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.

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General DeviceDescription:	The Injection Needle mainly consists of a cap, needle, boosting tube, andpositioning ring, all made of 304 stainless steel. It also contains an outertube and nut made of PTFE. The spring and spring tube are made of 302stainless steel. The shell and injection handle are made of ABS. Thebushing is made of TPE (SBS), and the inner tube is made of nylon.The products are intended for single use; an individual device is packedin a sealed pouch following ETO sterilization. The device is used for localinjection via endoscope, with the average contact time of the productand the mucosa of the human digestive tract of less than 1 hour.
Intended Use:	The injection needle is intended for endoscopic injection into thegastrointestinal mucosa.
TechnologicalCharacteristics:	The injection needle is available in two sizes and two styles. The twosizes 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 areidentical with the exception of the addition of a stainless steel spring inone style. This stainless steel spring is present in the inner catheter ofthe EndoChoice Injection Needle, whereas it is not present in thepredicate. The design is intended to ensure repeatable needledeployment in a tortuous path by maintaining a columnar deploymentchannel.
Testing Performed:	Biocompatibility, accelerated aging, performance, and sterilizationvalidation testing was performed on the injection needle thatdemonstrated that this device is safe and effective for use. Testing wasbased on a formal risk analysis.The following table shows a summary substantial equivalence of theEndoChoice Injection Needle and the chosen predicate, indicating noadditional safety risks arise in the new device based on similarities inmaterials, intended use, and function of the EndoChoice Injection Needlein comparison to the predicate device.

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	EndoChoiceInjectionNeedle:	Medi-GlobeInjectraInjectionNeedle:	SubstantialEquivalence:
Compatible withcurrently availableendoscopes:	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:	Thermoplasticpolymer - PTFE	ThermoplasticPolymer	Similar
Length:	240 cm.	230 cm.	Similar
Needle Length:	5 mm	4 mm	Similar
Indications foruse:	The EndoChoiceInjection Needleis intended forendoscopicinjection intothegastrointestinalmucosa.	The Medi-Globe InjectraInjectionNeedle is usedin conjunctionwith variouslegally marked,FDA registeredflexibleendoscopes.The InjectraNeedle is usedfor endoscopicinjection ofsolutions intotissues of thedigestivesystem andinjection ofsaline as aprocedural aidin endoscopicpolypectomyprocedures.	Similar
Packaging:	Single-use EOsterilized tyvekpouch with onedevice perpouch.	Single-use EOsterilizedsteam sealedpouch withone device perpouch.	Similar

Injection Needle

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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.

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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.

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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

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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)

K132065

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

Regulation Number and Section

§ 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.