(22 days)
Not Found
No
The device description focuses on mechanical components and their function in providing a seal and access during endoscopic procedures. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device facilitates endoscopic procedures by providing access, maintaining insufflation, and minimizing leakage, but it does not directly treat or diagnose a disease or condition. It is an accessory to therapeutic or diagnostic procedures.
No
The device is described as a valve for endoscopic procedures to facilitate instrument passage, maintain insufflation, and minimize leakage. Its purpose is mechanical and supportive, not to gather information for diagnosis.
No
The device description clearly outlines a physical, single-use biopsy valve made of a cylindrical base and cap with a diaphragm seal. It describes the mechanical function of the valve in maintaining insufflation and preventing leakage, which are hardware-based functions. There is no mention of software components or functionality.
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 during an endoscopic procedure to facilitate instrument passage, maintain insufflation, and minimize leakage. This is a functional accessory for a medical procedure performed in vivo (within the body).
- Device Description: The description details a mechanical valve designed to attach to an endoscope and manage the working channel. It does not mention any components or functions related to analyzing biological samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological specimens (blood, tissue, urine, etc.).
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening based on laboratory analysis.
The device's function is purely mechanical and procedural, supporting the operation of an endoscope during a medical procedure. This aligns with the definition of a medical device used in vivo, not an IVD.
N/A
Intended Use / Indications for Use
The Seal Single Use Biopsy Valve is intended to provide access for endoscopic device passage and exchange, help maintain insufflation, minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provide access for irrigation.
Product codes
OCX
Device Description
The Seal™ Single-Use Biopsy Valve is provided non-sterile, and is composed of a cylindrical base and a connected cap. The Seal™ Single Use Biopsy Valve provides sealable access via the working channel port of an endoscope for surgical instruments. The valve consists of an attached cap and valve body with a circular opening. The cap is pre-perforated, and ensures instrument access and removal is tight and leak-free.
The valve is designed with a hollow body with a distal end that attaches to the inlet port of the working channel. The valve body provides a flexible diaphragm seal that separates the body into a proximal chamber and distal chamber. The distal chamber secures onto the endoscope, while the proximal chamber secures the cap. Instruments are inserted through the cap and chambers, through the diaphragm seal, and into the endoscope. The diaphragm seal is configured such that a seal is formed due to deformation of the elastomer around an instrument when it is inserted through the opening, preventing fluids from passing through the biopsy valve.
The cap serves two primary functions. One function of the cap is to provide an additional seal around surgical instruments to prevent leakage. The second function is to allow modification of pressure during insufflation by opening the cap, allowing gasses to flow from the endoscope, and out of the biopsy valve.
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
Bench testing has been performed on the proposed Seal™ Single Use Biopsy Valve. Bench testing includes simulated use testing for air and water leak testing, device insertion and removal and scope compatibility. The Seal™ Single Use Biopsy Valve passed all Bench testing.
Biocompatibility testing has been performed on the proposed Seal™ Single Use Biopsy Valve. Biocompatibility testing includes cytotoxicity testing, sensitization testing and irritation testing. The Seal™ Single Use Biopsy Valve passed all Biocompatibility testing.
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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September 13, 2018
Boston Scientific Corporation Andrew Akers Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752
Re: K182275
Trade/Device Name: Seal Single Use Biopsy Valve Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: OCX Dated: August 21, 2018 Received: August 22, 2018
Dear Andrew Akers:
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/7 description: The image shows the FDA logo on the left side of the image. To the right of the logo, there is some text that is partially visible. The text includes the number 20 and the letters Je.
Jeffrey W. Cooper -S 2018.09.13 16:32:51 04'00'
for 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
2
Indications for Use
510(k) Number (if known) K182275
Device Name Seal Single Use Biopsy Valve
Indications for Use (Describe)
The Seal Single Use Biopsy Valve is intended to provide access for endoscopic device passage and exchange, help maintain insufflation, minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provide access for irrigation.
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) |
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SECTION 6 - 510(k) SUMMARY
510(k) SUMMARY
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752
Contact: Andrew Akers Regulatory Affairs Specialist Telephone: 508-683-4612
Date Prepared: August 21, 2018
2. Proposed Device:
Trade Name: Seal™ Single Use Biopsy Valve Classification Name: Endoscopic Irrigation/Suction System Regulation Number: 876.1500 Endoscope and Accessories Product Code: OCX Classification: Class II
3. Predicate Device:
Trade Name: Seal™ Single Use Biopsy Valve 510(k) Number: K161167 Classification Name: Endoscopic Irrigation/Suction System Regulation Number: 876.1500 Endoscope and Accessories Product Code: OCX Classification: Class II
4. Proposed Device Description:
The Seal™ Single-Use Biopsy Valve is provided non-sterile, and is composed of a cylindrical base and a connected cap. The Seal™ Single Use Biopsy Valve provides sealable access via the working channel port of an endoscope for surgical instruments. The valve consists of an attached cap and valve body with a circular opening. The cap is pre-perforated, and ensures instrument access and removal is tight and leak-free.
The valve is designed with a hollow body with a distal end that attaches to the inlet port of the working channel. The valve body provides a flexible diaphragm seal that separates the body into a proximal chamber and distal chamber. The distal chamber secures onto the endoscope, while the proximal chamber secures the cap. Instruments are inserted through the cap and chambers, through the diaphragm seal, and into the endoscope. The diaphragm seal is configured such that a seal is formed due to deformation of the elastomer around an instrument when it is inserted through the opening, preventing fluids from passing through the biopsy valve.
4
The cap serves two primary functions. One function of the cap is to provide an additional seal around surgical instruments to prevent leakage. The second function is to allow modification of pressure during insufflation by opening the cap, allowing gasses to flow from the endoscope, and out of the biopsy valve.
5. Indications for Use:
The Seal™ Single Use Biopsy Valve is intended to provide access for endoscopic device passage and exchange, help maintain insufflation, minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provide access for irrigation.
6. Technological Characteristics:
The proposed Seal™ Single Use Biopsy Valve has similar technological characteristics as the predicate Seal™ Single Use Biopsy Valve (K161167). The material of the proposed Seal™ Single Use Biopsy Valve is similar to the Seal™ Single Use Biopsy Valve (K161167). The proposed Seal™ Single Use Biopsy Valve is made out of Silicone while the predicate Seal™ Single Use Biopsy Valve (K161167) is made of a Thermoplastic Elastomer (TPE).
The proposed device has the same indications for use as the predicate device and is used in the same manner as the predicate. The proposed device can be used with general endoscopic procedures involving endoscopes.
7. Performance Data:
Bench testing has been performed on the proposed Seal™ Single Use Biopsy Valve. Bench testing includes simulated use testing for air and water leak testing, device insertion and removal and scope compatibility. The Seal™ Single Use Biopsy Valve passed all Bench testing.
Biocompatibility testing has been performed on the proposed Seal™ Single Use Biopsy Valve. Biocompatibility testing includes cytotoxicity testing, sensitization testing and irritation testing. The Seal™ Single Use Biopsy Valve passed all Biocompatibility testing.
8. Conclusion:
Boston Scientific Corporation has demonstrated that the proposed Seal™ Single Use Biopsy Valve is substantially equivalent to the Seal™ Single Use Biopsy Valve (K161167).