(21 days)
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.
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.
The provided text is a 510(k) summary for the Enteryx® Injection Catheter. It outlines the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain the detailed performance study information typically found in algorithms or AI/ML device submissions.
Therefore, for most of the requested points, the answer will be that the information is not present in the provided document. This document focuses on demonstrating substantial equivalence through physical comparison and functional testing, not through rigorous clinical trials with acceptance criteria for a specific performance metric.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified as performance metrics (e.g., sensitivity, specificity, accuracy) would be for an AI/ML device. | "results of physical comparison and functional testing support a determination of substantial equivalence" |
| Not applicable (device is an injection catheter, not an AI/ML diagnostic tool). | "substantially equivalent to the currently marketed Boston Scientific Enteryx® Injection Catheter in terms of performance characteristics, biocompatibility, and intended use." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not applicable/Not provided. The submission relies on "physical comparison and functional testing" rather than a clinical test set with human or imaging data.
- Data provenance: Not applicable/Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of experts: Not applicable/Not provided. Ground truth establishment by experts is not described for this type of device submission.
- Qualifications of experts: Not applicable/Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable/Not provided. No test set requiring expert adjudication is described.
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
- MRMC study: No. This submission is for an injection catheter, not an AI/ML-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone study: Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Type of ground truth: Not applicable. The device's performance is assessed through "physical comparison and functional testing" against a predicate device, not against a clinical "ground truth" as would be established for a diagnostic or AI device.
8. The sample size for the training set
- Sample size for training set: Not applicable. This is not an AI/ML product that would have a training set.
9. How the ground truth for the training set was established
- How ground truth for training set was established: Not applicable.
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NOV - 9 2004
510 (k) SUMMARY
| SPONSOR: | Boston Scientific CorporationOne Boston Scientific PlaceNatick, MA 01760 |
|---|---|
| CONTACT PERSON: | Lisa M. QuagliaRegulatory 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 needleconsisting of a needle, catheter shaft and a handle. The handleincorporates a luer for injection capabilities and offers a lockingmechanism to lock the needle in place with respect to thecatheter shaft. |
| INTENDED USE: | Indicated for use in conjunction with an endoscope to performendoscopic injections, such as for the treatment of esophagealand gastric varicies and for submucosal dye marking in the upperGI tract. The Enteryx® Injection Catheter is also a componentof the Enteryx® Procedure Kit. |
| COMPARISON OFCHARACTERISTICS: | The modified device is substantially equivalent to the predicatedevice, as they have the same operating principal and intendeduse. In addition, the results of design control activities do notraise 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 testingsupport a determination of substantial equivalence for themodified device when compared to the predicate device. Themodified device is substantially equivalent to the currentlymarketed Boston Scientific Enteryx® Injection Catheter in termsof performance characteristics, biocompatibility, and intendeduse. |
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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.
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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
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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
§ 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.