(51 days)
No
The device description and performance studies focus on the physical characteristics and biological/sterilization testing of a needle catheter, with no mention of AI or ML.
Yes
The device is used to introduce therapeutic agents for controlling bleeding, aiding in surgical procedures (EMR, ESD, polypectomy), and controlling non-variceal hemorrhage, indicating a direct therapeutic purpose.
No
While the device is used in procedures to control bleeding or aid in EMR/ESD, its primary function is to deliver solutions (sclerosing agents, vasoconstrictors) or assist in tissue removal, not to diagnose a condition.
No
The device description explicitly states it consists of a handle, catheter sheath, and needle, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for direct intervention within the body (endoscopic injection into gastrointestinal mucosa and submucosa) to treat conditions like bleeding lesions and aid in surgical procedures.
- Device Description: The device is a physical tool (needle catheter) designed for delivering substances into tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve tests on samples like blood, urine, or tissue.
Therefore, the Interject Injection Therapy Needle Catheter is a therapeutic medical device used for direct treatment and intervention, not an IVD.
N/A
Intended Use / 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
Product codes
FBK
Device Description
The Interject™ 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal mucosa and submucosa
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
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).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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 |
| Indications for Use |
| 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
| Department of Health and Human Services |
|---|
| Food and Drug Administration |
| Office of Chief Information Officer |
| Paperwork Reduction Act (PRA) Staff |
| PRAStaff@fda.hhs.gov |
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
ムレ
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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).