(45 days)
Not Found
No
The device description and performance studies focus on mechanical properties and fluid dynamics, with no mention of AI or ML.
No
The device is intended to prevent irrigant backflow and secure urological devices during procedures, not to treat a disease or condition itself. It serves as an accessory to other urological devices.
No.
The device description and intended use focus on preventing irrigant backflow and securing urological devices, which are functional aspects of performing a procedure rather than diagnosing a condition.
No
The device description clearly outlines physical components (luer fittings, body, valve, seal) and describes their mechanical function, 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 is to "prevent irrigant backflow while securing urological devices during procedures." This describes a device used during a medical procedure on a patient, not a device used to test samples outside the body to diagnose a condition.
- Device Description: The description details a physical adapter with lumens, valves, and luer fittings designed for connecting to urological devices and irrigant tubing. This is consistent with a surgical or procedural accessory, not an IVD.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's health status
- Reagents, calibrators, or controls typically associated with IVDs
The device is clearly intended for use in a surgical or procedural setting to manage fluid flow and secure instruments, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Gateway Advantage Y-Adapter is intended to prevent irrigant backflow while securing urological devices during procedures. Irrigation may also be connected to the side port of the device. The Y-Adapter is supplied in a sealed pouch and is intended for single use only.
Product codes
OCX
Device Description
The Gateway Advantage Y-Adapter has four main components; 1) a rotatable male luer fitting; 2) a Y-Adapter body; 3) a thumb screw Tuohy-Borst valve; and 4) a blue luer seal with female proximal end. The body has two lumens: a straight lumen and an adjoining curved lumen. The straight lumen tapers to an inner diameter of 3 mm (9 F) minimum, and the adjoining curved lumen tapers to an inner diameter of 2.413 mm (7 F) minimum. The adjoining curved lumen is terminated at the proximal end with a blue luer seal and the straight lumen of the Y-Adapter body has a Tuohy-Borst valve. Both valve and seal are intended to prevent irrigant backflow and secure urological devices. The blue luer seal has a female proximal end intended for use with irrigant tubing with a male luer connection. The distal end of the straight lumen has a rotating male luer which attaches to the scope.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Boston Scientific has conducted performance testing with samples aged at T=0. Accelerated Aging in support of a 3-year shelf life was also performed. The following testing was completed to evaluate the device: Leak Resistance with Urologic Device, Leak Resistance After Removal of Urologic Device, Tuohy-Borst - Acceptance of Multiple Exchanges, Luer Seal Acceptance of Multiple Exchanges, Securing Device Removal Force. The results of the performance testing demonstrate equivalence of the Gateway Advantage Y-Adapter to the predicate Sureseal II Endoscopic Valve. The Gateway Advantage Y-Adapter is considered safe and effective for its intended use.
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.
0
Page 1 of 2
Gateway™ Advantage Y-Adapter Traditional 510(k)
Boston Scientific
SECTION 5 ' 510(k) SUMMARY
510(k) Summary for K130909: Gateway™ Advantage Y-Adapter
A. Sponsor
Boston Scientific Corporation Urology and Women's Health Division 100 Boston Scientific Way Marlborough, MA 01756
B. Contact
Christine Shoemaker Specialist II, Regulatory Affairs 508-683-4214 christine.shoemaker@bsci.com
or
Lisa Sullivan Manager, Regulatory Affairs 508-683-4745 lisa.sullivan@bsci.com
C. Device Name
Trade name: Gateway™ Advantage Y-Adapter Common/usual name: Endoscope and accessories Classification Name: OCX - Endoscopic Irrigation/Suction System
D. Predicate Device
Trade name: Sureseal II (Applied Medical) Common/usual name: Endoscope and accessories Classification Name: KOG - Endoscope and accessories
Premarket Notification: Applied Medical Sureseal II (formerly Applied Urology, Inc. Sureseal Endoscopic Valve), K920030, March 18, 1992.
E. Device Description
The Gateway Advantage Y - Adapter has four main components; 1) a rotatable male luer fitting; 2) a Y-Adapter body; 3) a thumb screw Tuohy-Borst valve; and 4) a blue luer seal with female proximal end. The body has two lumens: a straight lumen and an adjoining curved lumen. The straight lumen tapers to an inner diameter of 3 mm (9 F) minimum, and the adjoining curved lumen tapers to an inner diameter of 2.413 mm (7 F) minimum. The adjoining curved lumen is terminated at the proximal end with a blue luer seal and the straight lumen of the Y-Adapter body has a Tuohy-Borst valve. Both valve and seal are intended to prevent irrigant backflow and secure urological devices. The blue luer seal has a
Proprietary and Confidential Information of Boston Scientific Corporation
MAY 1 6 2013
1
Page 2 of 2
Gateway™ Advantage Y-Adapter Traditional 510(k) K130909
Boston Scientific
SECTION 5 510(k) SUMMARY
female proximal end intended for use with irrigant tubing with a male luer connection. The distal end of the straight lumen has a rotating male luer which attaches to the scope.
F. Intended Use
The Gateway Advantage Y-Adapter is intended to prevent irrigant backflow while securing urological devices during procedures. Irrigation may also be connected to the side port of the device.
G. Technological Characteristics
The Gateway Advantage Y-Adapter has the same technological characteristics and fundamental adapter design as the reference devices. The proposed Gateway Advantage Y-Adapter is supplied in a sealed pouch and intended for single use only. It is available for use with other urology products, such as retrieval baskets, guidewires, catheters, laser fibers and other urological instruments. The device is packaged 1 per pouch, with 10 pouches packaged per box.
H. Substantial Equivalence
A direct comparison of key characteristics has been performed and demonstrates that the proposed Gateway Advantage Y-Adapter is substantially equivalent to the predicate device in terms of intended use. The proposed device is substantially equivalent to the reference devices in terms of technological characteristics, materials and performance characteristics. The Gateway Advantage Y-Adapter is as safe, as effective, and performs as well as the predicate device.
I. Performance Testing (Bench Evaluation)
Boston Scientific has conducted performance testing with samples aged at T=0. Accelerated Aging in support of a 3-year shelf life was also performed. The following testing was completed to evaluate the device:
- Leak Resistance with Urologic Device .
- Leak Resistance After Removal of Urologic Device .
- . Tuohy-Borst - Acceptance of Multiple Exchanges
- Luer Seal Acceptance of Multiple Exchanges .
- Securing Device Removal Force .
The results of the performance testing demonstrate equivalence of the Gateway Advantage Y-Adapter to the predicate Sureseal II Endoscopic Valve. The Gateway Advantage Y-Adapter is considered safe and effective for its intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the symbol in a circular fashion.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 16, 2013
Boston Scientific Corporation Urology/Women's Health % Ms. Christine Shoemaker Specialist II, Regulatory Affairs 100 Boston Scientific Way MARLBOROUGH MA 01752
Re: K130909
Trade/Device Name: Gateway™ Advantage Y - Adapter Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCX Dated: March 29, 2013 Received: April 1, 2013
Dear Ms. Shoemaker:
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.
3
Page 2 - Ms. Christine Shoemaker
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Beniamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Gateway™ Advantage Y-Adapter Traditional 510(k) K130909
Boston Scientific .
INDICATIONS FOR USE SECTION 4 . .
| Indications for Use Statement |
|---|
| ------------------------------- |
| 510(k) Number | K130909 |
|---|---|
| Device Name | Gateway™ Advantage Y-Adapter |
| Indications For Use | The Gateway Advantage Y-Adapter is intended to prevent irrigant backflow while securing urological devices during procedures. Irrigation may also be connected to the side port of the device. The Y-Adapter is supplied in a sealed pouch and is intended for single use only. |
| Prescription Use | X | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------ | --- | -------- | ---------------------- |
(21 CFR 801 Subpart D)
AND/OR
Councer US$ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Benjamin | 2013.05.16 T
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K130909 510(k) Number
Proprietary and Confidential Information of Boston Scientific Corporation