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 than 1 hour.

AI/ML Overview

The provided text describes a Special 510(k) Summary for the EndoChoice Select Injection Needle, which is a medical device. This type of submission is for modifications to a previously cleared device. The document primarily focuses on demonstrating "substantial equivalence" to a predicate device, rather than providing detailed acceptance criteria and a study to prove a device meets those criteria for a novel device.

Therefore, many of the requested data points (like specific performance metrics, sample sizes for test and training sets, number and qualifications of experts, adjudication methods, MRMC studies, and detailed ground truth establishment) are generally not found in this type of submission. The focus is on showing the modified device performs as safely and effectively as the original, cleared device.

However, I can extract the information that is present and indicate where the requested information is not typically presented in a 510(k) summary focused on substantial equivalence.

1. Table of acceptance criteria and the reported device performance

For the modified EndoChoice Select Injection Needle, the "acceptance criteria" are predominantly related to the equivalence of its characteristics and safety to the predicate device. The "reported device performance" is essentially that it passed these equivalence-based tests.

Acceptance Criteria (Demonstrated Equivalence to Predicate K132065)	Reported Device Performance (Result)
Material Equivalence: The new patient-contacting material must be safe and effective.	Biocompatibility testing for the new patient-contacting material passed.
Sterilization Equivalence: Sterilization method and efficacy must be equivalent.	Sterilization testing is unchanged from the predicate and passed.
Accelerated Aging Equivalence: Shelf life and stability characteristics must be equivalent.	Accelerated aging testing is unchanged from the predicate and passed.
Functional Equivalence: The modified device must perform identically to the predicate.	All test results passed, demonstrating safety and efficacy equivalent to the predicate device.
Design, Intended Use, Labeling Equivalence: Must be the same or similar as the predicate.	All characteristics (manufacturer, endoscope compatibility, sterility, sheath diameter, needle size, outer tubing, length, needle extension, indications for use, packaging) were found to be equivalent to the predicate.

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

The document does not specify sample sizes for individual tests. The "test set" here refers to the samples of the modified device used for the mentioned non-clinical tests (biocompatibility, accelerated aging, sterilization). The data provenance is internal to EndoChoice, Inc.

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

This information is not provided. Ground truth, in the context of device performance, would typically refer to established standards or verifiable performance metrics against which the device is measured. For a K151475 submission, the "ground truth" for "substantial equivalence" is the performance and safety profile of the predicate device (K132065).

4. Adjudication method for the test set

Not applicable/Not specified in this document. Adjudication methods are more relevant for human-read evaluations, not typically for non-clinical engineering tests of medical devices like injection needles.

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 device is an injection needle, not an AI-powered diagnostic tool, so MRMC studies involving human readers and AI are not relevant.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this substantial equivalence submission is the established safety and efficacy profile of the predicate device (EndoChoice Injection Needle K132065). The non-clinical tests conducted on the modified device (biocompatibility, sterilization, accelerated aging) were designed to demonstrate that the changes did not negatively impact these established characteristics of the predicate.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/machine learning model that would require a training set.

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

Not applicable, as there is no training set for a physical injection needle.

Summary

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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

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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

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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 NeedlePredicate (K132065)	Modified EndoChoice SelectInjection Needle	Substantialequivalence
Manufacturer	EndoChoice, Inc.	EndoChoice, Inc.	Equivalent
Compatible withcurrentlyavailableendoscopes	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 extensionlength	5 mm	5 mm	Equivalent
Indications foruse	The EndoChoice SelectInjection Needle is intendedfor endoscopic injection intothe gastrointestinal mucosa.	The EndoChoice SelectInjection Needle is intendedfor endoscopic injection intotissues of the digestivesystem.	Equivalent
Packaging	Single-use EO sterilizedTyvek pouch with one deviceper pouch.	Single-use EO sterilizedTyvek pouch with onedevice 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.

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.