The Interject™ Injection Therapy Needle Catheter is used endoscopically to introduce a sclerosing agent or vasoconstrictor into selected sites to control actual or potential bleeding lesions in the digestive system; and the injection of saline to aid in Endoscopic Mucosal Resection (EMR), polypectomy procedures and to control non-variceal hemorrhage.

Device Description

The Interject Injection Therapy Needle is an injection needle designed to be used with an endoscope to perform endoscopic injections. The major components of the devices are the catheter, needle, and hub.

AI/ML Overview

The provided text is a 510(k) summary for the Boston Scientific Interject™ Injection Therapy Needle. Based on the document, this device is a medical instrument and not an AI or software as a medical device (SaMD). Therefore, the standard acceptance criteria, study types (e.g., MRMC, standalone), and data provenance considerations typically associated with evaluating AI/SaMD are not directly applicable here.

This 510(k) submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving performance against specific acceptance criteria for AI-driven diagnostic accuracy.

Here's an analysis based on the information provided, highlighting why certain questions are not relevant in this context:

Acceptance Criteria and Device Performance

Since this is a submission for a physical medical device (an injection needle) and not an AI/SaMD product, there isn't a table of quantitative performance metrics (like sensitivity, specificity, AUC) that would be applicable to AI.

The "acceptance criteria" in this context are tied to demonstrating substantial equivalence. The document states:

Acceptance Criteria (Implied by Substantial Equivalence):

Biocompatibility: Patient- and fluid-contact materials of the device must be biocompatible.
Design/Technological Characteristics: The proposed device's design and technological characteristics must be equivalent to predicate devices.
Indications for Use: The device must safely and effectively fulfill its stated indications for use, building on the safety and effectiveness established for predicate devices.

Reported Device Performance (from the document):

"A biocompatibility assessment was performed on the patient- and fluid-contact materials of the predicate Interject Injection Therapy Needle with satisfactory results."
"The proposed Interject device and predicate Interject device are identical therefore no additional biocompatibility was performed to include the new indication."
"A thorough comparison of the descriptive characteristics between the proposed Interject device and the predicate device show equivalence."

Table of (Applicable) Acceptance Criteria and Performance:

Acceptance Criteria Category (Implied for Substantial Equivalence of physical device)	Reported Device Performance / Evidence
Material Biocompatibility	Satisfactory biocompatibility assessment performed on predicate device. Proposed and predicate devices are identical in patient/fluid contact materials.
Technological/Design Equivalence	"Thorough comparison... between the proposed Interject device and the predicate device show equivalence."
Safety & Effectiveness for Indication	Leveraged established safety & effectiveness of predicate devices for the new indications.

Study Details (Not applicable for this type of device and submission)

The questions regarding sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, and training set details are not applicable to this 510(k) submission for a physical injection needle.

Here's why:

AI/SaMD Specific: These questions are designed to evaluate the performance and validation of Artificial Intelligence or Software as a Medical Device (AI/SaMD) products, which rely on data and algorithms. The Interject™ Injection Therapy Needle is a conventional, physical medical instrument.
Substantial Equivalence: The primary "study" for this 510(k) was a comparison to predicate devices to demonstrate substantial equivalence. This typically involves engineering assessments, material testing (like biocompatibility), and a review of intended use and technological characteristics, not clinical studies in the manner described for AI.
No Algorithm/Data-Driven Performance: There's no AI algorithm to train or test, no diagnostic accuracy metrics (like sensitivity, specificity) to calculate, and no human-in-the-loop scenario to evaluate for this device.

Therefore, the following information cannot be extracted from the provided 510(k) summary:

Sample size used for the test set and the data provenance: Not applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

In summary: The K012864 510(k) for the Interject™ Injection Therapy Needle demonstrates substantial equivalence based on material biocompatibility and design/technological characteristics comparison to existing predicate devices. It is not an AI/SaMD product, and thus, the detailed performance study criteria relevant to AI-driven devices are not present or applicable.

Summary

{0}------------------------------------------------

K012864
Page 1 of 2

SECTION 10 510(k) SUMMARY

FOI RELEASABLE

Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification "...adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation chooses to submit a summary of information respecting safety and effectiveness.

Date:

Common/Usual Names: Trade/Proprietary Name: Classification Name & Device Classification:

Name Needle, Endoscope Endoscope & Accessories

Device Panel/Branch:

Owner/Operator:

August 21, 2001 needle, endoscope Interject™ Injection Therapy Needle

Class II

Number	21 CFR Ref
78 FBK	876.1500
78 KOG	876.1500

Gastroenterology-Urology (GU) GASTRO-RENAL (GRBD)

Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760

Contact Person:

James D. McMahon Regulatory Affairs Specialist

DESCRIPTION OF DEVICE

The Interject Injection Therapy Needle is an injection needle designed to be used with an endoscope to perform endoscopic injections.

INDICATIONS FOR USE

The Interject Injection Therapy Needle Catheter is used endoscopically to introduce a sclerosing agent or vasoconstrictor into selected sites to control actual or potential bleeding lesions in the digestive system; and the injection of saline to aid in Endoscopic Mucosal Resection (EMR), polypectomy procedures and to control non-variceal hemorrhage.

{1}------------------------------------------------

K012864
Page 2 of 2

DESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES

Boston Scientific Corporation believes that the Interject™ Injection Therapy Needle with additional indications is substantially equivalent to the currently marketed Boston Scientific Corporation's Interject™ Therapy Needle, Variject™ Needle Catheter (K961846) and US Endoscopy Goup, Coaxial Needle (K971842). The major components of the devices are the catheter, needle, and hub. A thorough comparison of the descriptive characteristics between the proposed Interject device and the predicate device show equivalence.

PERFORMANCE CHARACTERISTICS

A biocompatibility assessment was performed on the patient- and fluid-contact materials of the predicate Interiect Injection Therapy Needle with satisfactory results. The proposed Interject device and predicate Interject device are identical therefore no additional biocompatibility was performed to include the new indication.

CONCLUSION

BSC has demonstrated that the Interject™ Injection Therapy Needle with additional indications is substantially equivalent to BSC's currently marketed Interiect Injection Therapy Needle, Variject Needle Catheter and US Endoscopy Group, Coaxial Needle,

{2}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 4 2001

Mr. James D. McMahon Regulatory Affairs Specialist Microvasive Endoscopy Boston Scientific Corporation One Boston Scientific Place NATICK MA 01760-1537

Re: K012864

Trade/Device Name: Interject™ Injection Therapy Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: 78 FCG Dated: August 24, 2001

Dear Mr. McMahon:

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.

Received: August 27, 2001

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); 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.

{3}------------------------------------------------

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

SECTION 3 INDICATION FOR USE

510(k) Number:

To Be Determined K012864

Device Name:

Interject™ Injection Therapy Needle

Indication for Use:

The Interject™ Injection Therapy Needle Catheter is used endoscopically to introduce a sclerosing agent or vasoconstrictor into selected sites to control actual or potential bleeding Scierosmy agent of vasoconserver and the injection of saline to aid in Endoscopic Mucosal Resection (EMR), polypectomy procedures and to control non-variceal hemorrhage.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use(Per 21 CFR 801.1091)	OR
	Over-The-Counter Use(Optional Format 1-2-96)

Nanare Shoodon

(Division Sten-Off)
Division of Reproductive, Abdonlinel,
and Redietegical Devices K012864
510(k) Number

Regulation Number and Section

§ 876.1075 Gastroenterology-urology biopsy instrument.

(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments 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 (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.