The Interject Injection Therapy Needle Catheter is used for endoscopic injection into gastrointestinal mucosa and submucosa to: • introduce a sclerosing agent, vasoconstrictor, or other solutions into selected sites to control actual or potential bleeding lesions in the digestive system • aid in Endoscopic Mucosal Resection (EMR), Endoscopic Submucosal Dissection (ESD), or polypectomy procedures • control non-variceal hemorrhage
Device Story
Interject Injection Therapy Needle Catheter is a single-use endoscopic accessory; consists of handle with injection hub, catheter sheath, and needle. Used by physicians during endoscopic procedures to deliver sclerosing agents, vasoconstrictors, or other solutions into GI mucosa/submucosa. Device facilitates control of bleeding lesions, non-variceal hemorrhage, and assists in EMR, ESD, or polypectomy. Operates via manual injection through the catheter needle into target tissue. Provides clinical benefit by enabling localized therapeutic delivery to manage GI lesions and support resection procedures.
Clinical Evidence
Bench testing only. Device design and materials are identical to the predicate (K012864). Compliance with ISO 10993-1 (biocompatibility), ISO 11135 (ethylene oxide sterilization), and ISO 10993-7 (EO residuals) confirmed.
Technological Characteristics
Components: handle with injection hub, catheter sheath, needle. Available in various needle lengths, gauges, and catheter lengths. Sterilization: Ethylene oxide per ISO 11135. Biocompatibility: ISO 10993-1. No software or electronic components.
Indications for Use
Indicated for patients requiring endoscopic injection into gastrointestinal mucosa and submucosa for control of bleeding lesions, non-variceal hemorrhage, or as an aid in EMR, ESD, or polypectomy procedures.
Regulatory Classification
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.
Special Controls
*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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
InjectorForce Max Single-Use Injection Needle (K902736)
Wilson-Cook Variable Length GI Injection Needle (K941305)
Submission Summary (Full Text)
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July 7, 2017
Boston Scientific Corporation Tara Paul Regulatory Affairs Specialist II 100 Boston Scientific Way Marlborough, MA 01752
Re: K171454
Trade/Device Name: Interject Injection Therapy Needle Catheter Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FBK Dated: May 16, 2017 Received: May 17, 2017
Dear Tara Paul:
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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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 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.
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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 |
| <b>Indications for Use</b> |
| Form Approved: OMB No. 0910-0120 |
|-----------------------------------|
| Expiration Date: January 31, 2017 |
| See PRA Statement below. |
| 510(k) Number (if known) | K171454 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Interject Injection Therapy Needle Catheter |
| Indications for Use (Describe) | The Interject Injection Therapy Needle Catheter is used for endoscopic injection into gastrointestinal mucosa and submucosa to: • introduce a sclerosing agent, vasoconstrictor, or other solutions into selected sites to control actual or potential bleeding lesions in the digestive system • aid in Endoscopic Mucosal Resection (EMR), Endoscopic Submucosal Dissection (ESD), or polypectomy procedures • control non-variceal hemorrhage |
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <div> <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> </div> <div> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </div> |
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# SECTION 5 510(k) SUMMARY
#### 510(k) SUMMARY
### 1. SUBMITTER:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4296 Fax: 508-683-5939
Contact: Tara Paul Regulatory Affairs Specialist II Date Prepared: May 16, 2017
#### 2. DEVICE:
| Name of Device: | InterjectTM Injection Therapy Needle Catheter |
|----------------------|--------------------------------------------------------|
| Common Name: | Injection Therapy Needle Catheter |
| Classification Name: | Endoscopic Injection Needle, Gastroenterology- Urology |
| Regulation Number: | 876.1500 |
| Product Code: | FBK |
| Classification: | Class II |
#### 2. PREDICATE DEVICES:
| Name of Device: | InterjectTM Injection Therapy Needle Catheter |
|----------------------|--------------------------------------------------------|
| Manufacturer: | Boston Scientific |
| Common Name: | Injection Therapy Needle Catheter |
| 510(k) Number: | K012864 |
| Classification Name: | Biopsy Needle |
| Regulation Number: | 876.1075 |
| Product Code: | FCG |
| Classification: | Class II |
| Name of Device: | InjectorForce Max Single-Use Injection Needle |
| Manufacturer: | Olympus Medical Systems Corp. |
| 510(k) Number: | K902736 |
| Classification Name: | Endoscopic Injection Needle, Gastroenterology- Urology |
| Regulation Number: | 876.1500 |
| Product Code: | FBK |
| Classification: | Class II |
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| Name of Device: | Wilson-Cook Variable Length GI Injection Needle |
|----------------------|--------------------------------------------------------|
| Manufacturer: | Wilson-Cook Medical, Inc. |
| 510(k) Number: | K941305 |
| Classification Name: | Endoscopic Injection Needle, Gastroenterology- Urology |
| Regulation Number: | 876.1500 |
| Product Code: | FBK |
| Classification: | Class II |
# 4. DEVICE DESCRIPTION:
The Interiect™ Injection Therapy Needle Catheter that consists of a handle with a hub for injection, a catheter sheath, and a needle. It is available in a variety of configurations with varying needle lengths, gauges, and catheter lengths.
# 5. INDICATIONS FOR USE:
The Interject™ Injection Therapy Needle Catheter is used for endoscopic injection into gastrointestinal mucosa and submucosa to:
- introduce a sclerosing agent, vasoconstrictor, or other solutions into selected sites ● to control actual or potential bleeding lesions in the digestive system
- aid in Endoscopic Mucosal Resection (EMR), Endoscopic Submucosal Dissection ● (ESD), or polypectomy procedures
- . control non-variceal hemorrhage
# 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:
The proposed Interject Injection Therapy Needle Catheter device has identical technological characteristics as the predicate Interiect Injection Therapy Needle Catheter (K012864) and similar technological characteristics as the predicate Olympus InjectorForce Max (K902736) and predicate Wilson-Cook Variable Length GI Injection Needle (K941305). The proposed device and the predicate Olympus and Cook devices have a minor difference in sheath outer diameter. This minor dimensional difference does not alter the suitability of the proposed device for its intended use.
### 7. PERFORMANCE DATA:
The proposed Interiect Injection Therapy Needle Catheter is identical to the predicate Interiect Iniection Therapy Needle Catheter (K012864). The proposed device meets the requirements of ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing", ISO 11135 "Sterilization of health care products - Ethylene oxide - Requirements for the development, validation, and routine control of a sterilization process for medical devices", and ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals", as the design and materials remain unchanged from that of the predicate Interiect Injection Therapy Needle Catheter (K012864).
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# 8. CONCLUSION:
Boston Scientific Corporation has demonstrated that the proposed Interject™ Injection Therapy Needle Catheter is substantially equivalent to the currently marketed Interject™ Injection Therapy Needle Catheter (K012864), the Olympus InjectorForce Max (K902736), and the Wilson-Cook Variable Length GI Injection Needle (K941305).
