(21 days)
78 FBK
Not Found
No
The description focuses on the mechanical components and function of an injection catheter, with no mention of AI or ML.
Yes
The device is indicated for use in the treatment of esophageal and gastric varices, which are therapeutic interventions.
No
The device is described as an injection catheter used for therapeutic purposes (injection for treatment, dye marking). There is no mention of it being used to diagnose conditions or generate diagnostic information.
No
The device description clearly states it is a physical injection catheter with a needle, catheter shaft, and handle, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a procedure performed within the body (endoscopic injections in the upper GI tract) for therapeutic purposes (treating varices, dye marking). This is an in vivo procedure, not an in vitro diagnostic test.
- Device Description: The device is an injection catheter, designed to deliver substances directly into tissue. This is a surgical/interventional tool, not a device used to analyze samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Indicated for use in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varicies and for submucosal dye marking in the upper GI tract. The Enteryx® Injection Catheter is also a component of the Enteryx® Procedure Kit.
Product codes
78 FBK
Device Description
The Enteryx® Injection Catheter is an injection needle consisting of a needle, catheter shaft and a handle. The handle incorporates a luer for injection capabilities and offers a locking mechanism to lock the needle in place with respect to the catheter shaft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophageal, gastric (upper GI tract)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
FDA's "Guidance for the Content of Premarket Notifications", and the results of physical comparison and functional testing support a determination of substantial equivalence for the modified device when compared to the predicate device. The modified device is substantially equivalent to the currently marketed Boston Scientific Enteryx® Injection Catheter in terms of performance characteristics, biocompatibility, and intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Boston Scientific Enteryx® Injection Catheter
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.
0
NOV - 9 2004
510 (k) SUMMARY
| SPONSOR: | Boston Scientific Corporation
One Boston Scientific Place
Natick, MA 01760 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Lisa M. Quaglia
Regulatory Affairs Manager |
| DEVICE: | |
| Trade Name: | Enteryx® Injection Catheter |
| Common Name: | Endoscope and Accessories |
| Classification: | Class II per 21 CFR Part 876, Section 1500 |
| PREDICATE DEVICE: | Boston Scientific Enteryx® Injection Catheter |
| DESCRIPTION: | The Enteryx® Injection Catheter is an injection needle
consisting of a needle, catheter shaft and a handle. The handle
incorporates a luer for injection capabilities and offers a locking
mechanism to lock the needle in place with respect to the
catheter shaft. |
| INTENDED USE: | Indicated for use in conjunction with an endoscope to perform
endoscopic injections, such as for the treatment of esophageal
and gastric varicies and for submucosal dye marking in the upper
GI tract. The Enteryx® Injection Catheter is also a component
of the Enteryx® Procedure Kit. |
| COMPARISON OF
CHARACTERISTICS: | The modified device is substantially equivalent to the predicate
device, as they have the same operating principal and intended
use. In addition, the results of design control activities do not
raise any new issues of safety or effectiveness. |
| PERFORMANCE DATA: | FDA's "Guidance for the Content of Premarket Notifications",
and the results of physical comparison and functional testing
support a determination of substantial equivalence for the
modified device when compared to the predicate device. The
modified device is substantially equivalent to the currently
marketed Boston Scientific Enteryx® Injection Catheter in terms
of performance characteristics, biocompatibility, and intended
use. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three lines representing the human form. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 9 2004
Ms. Lisa M. Quaglia Regulatory Affairs Manager Boston Scientific Corporation Endoscopy One Boston Scientific Place NATICK MA 01760-1537
Re: K042882
Trade/Device Name: Enteryx® Injection Catheter Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FBK Dated: October 18, 2004 Received: October 19, 2004
Dear Ms. Quaglia:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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 531-5.42 of the Act); 21 CFR 1000-1050.
2
This letter will allow you to begin marketing your device as described in your Section 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:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmadsmain.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
3
INDICATIONS FOR USE STATEMENT
| 510(k) Number | To be determined K042882 |
|---|---|
| Device Name | Enteryx® Injection Catheter |
| Indications For Use | Indicated for use in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varicies and for submucosal dye marking in the upper GI tract. The Enteryx® Injection Catheter is also a component of the Enteryx® Procedure Kit. |
Prescription Use X (Per 21 CFR 801.109)
Over the Counter Use _________________________________________________________________________________________________________________________________________________________
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | |
|---|---|
| ------------------------------------------ | -- |
OR
| Over the Counter Use | |
|---|---|
| ---------------------- | -- |
Nancy C Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K042882 |
|---|---|
| --------------- | --------- |
B2