K161167 · Endochoice, Inc. · OCX · May 26, 2016 · Gastroenterology, Urology
Device Facts
Record ID
K161167
Device Name
Seal Single-Use Biopsy Valve
Applicant
Endochoice, Inc.
Product Code
OCX · Gastroenterology, Urology
Decision Date
May 26, 2016
Decision
SESE
Submission Type
Special
Regulation
21 CFR 876.1500
Device Class
Class 2
Indications for Use
The Single-Use Biopsy Valve provides access for endoscopic device passage and exchange, helps maintain sufflation, and minimizes leakage of biomaterial from biopsy port throughout the endoscopic procedure, and provides access for irrigation.
Device Story
The Seal Single-Use Biopsy Valve is a mechanical accessory for endoscopes. It consists of a cylindrical base, a pre-perforated cap, and a flexible internal diaphragm. The device attaches to the endoscope's working channel port. During procedures, clinicians insert surgical instruments through the cap and diaphragm; the elastomer diaphragm deforms around the instrument to create a seal, preventing fluid leakage and maintaining insufflation. The cap allows for pressure adjustment by venting gases. The device is used in clinical settings by physicians or trained staff to facilitate instrument exchange and irrigation while maintaining a closed system. It benefits patients by preventing leakage of biomaterials and maintaining necessary insufflation during endoscopic interventions.
Clinical Evidence
Bench testing only. Performance testing included pressure tests (holding 10 PSI for 1 minute) with the valve closed, with an instrument inserted, and following instrument removal. Biocompatibility testing included cytotoxicity, sensitization, intracutaneous injection, and systemic injection tests in accordance with 21 CFR Part 58 and ISO 10993-1.
Technological Characteristics
Thermoplastic elastomer construction. Mechanical diaphragm seal. Dimensions: 7.1 mm inner diameter, accommodates instruments up to 3.2 mm. Compatible with Olympus (160, 180, 190), Fujinon (530, 590, 600), and EndoChoice Fuse endoscopes. Non-sterile, single-use. No energy source or software.
Indications for Use
Indicated for use during endoscopic procedures to provide access for device passage/exchange, maintain insufflation, minimize biomaterial leakage from the biopsy port, and provide access for irrigation.
Regulatory Classification
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.
Special Controls
*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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, which is a symbol often associated with healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 26, 2016
Endochoice, Inc. Daniel Hoefer Manager, Regulatory Affairs 11810 Wills Road Alpharetta, GA 30009
Re: K161167 Trade/Device Name: Seal Single-use Biopsy Valve Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OCX Dated: April 22, 2015 Received: April 26, 2016
Dear Daniel Hoefer,
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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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 yours,
**Herbert P. Lerner -S**
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
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# Indications for Use
510(k) Number (if known) K161167
Device Name Seal Biopsy Valve
Indications for Use (Describe)
The Single-Use Biopsy Valve provides access for endoscopic device passage and exchange, helps maintain sufflation, and minimizes leakage of biomaterial from biopsy port throughout the endoscopic procedure, and provides 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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#### 510(k) Summary
#### Seal Single-Use Biopsy Valve
#### May 26, 2016
#### 1. Company Identification
EndoChoice, Inc. 11810 Wills Road Alpharetta, GA 30009 Telephone: 678-708-4743 Fax: 678-567-8218 Establishment Registration: 3007591333
#### 2. Contact Person
Daniel Hoefer Regulatory Affairs Manager
#### 3. Device Name
| Commercial Name: | Seal® Single-Use Biopsy Valve |
|----------------------|---------------------------------------|
| Common/Usual Name: | Biopsy Valve |
| Classification Name: | Endoscopic, irrigation/suction system |
## 4. Device Classification
| Product Code: | OCX |
|--------------------|--------------------------|
| Regulation Number: | 876.1500 |
| Class: | II |
| Review Panel: | Gastroenterology/Urology |
#### 5. Intended Use:
The Single-Use Biopsy Valve provides access for endoscopic device passage and exchange, helps maintain sufflation, and minimizes leakage of biomaterial from biopsy port throughout the endoscopic procedure, and provides access for irrigation.
#### 6. Device Description:
The Seal "Single-Use Biopsy valve is provided non-sterile, and is composed of a cylindrical base and a connected cap. The 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.
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The valve is designed with a hollow body with a distal end that releasably 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.
# 7. Substantial Equivalence:
The device submitted for review is a modification of the Biopsy Valve (K133734). Changes to the device include a modification in material. Both the modified and unmodified device is composed of thermoplastic elastomers. The modified device also has a reduction in overall height of the biopsy valve to provide an improved fit between the cap and body, as well as the valve to the instrument port.
The modified device is identical in terms of intended use, operating principle, performance, technology, energy used, and packaging.
| Characteristic | Single-Use Biopsy Valve<br>(Unmodified) | Single-Use Biopsy Valve<br>(Modified) |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K133734 | Pending |
| Indications for Use | The Single-Use Biopsy Valve provides access for endoscopic device passage and exchange, helps maintain sufflation, and minimizes leakage of biomaterial from biopsy port throughout the endoscopic procedure, and provides access for irrigation. | The Single-Use Biopsy Valve provides access for endoscopic device passage and exchange, helps maintain sufflation, and minimizes leakage of biomaterial from biopsy port throughout the endoscopic procedure, and provides access for irrigation. |
| Material | Thermoplastic elastomer | Thermoplastic elastomer |
| Valve Inner<br>Diameter | 7.1 mm | 7.1 mm |
| Biocompatiblity | Tested in accordance with ISO<br>10993-1 | Tested in accordance with ISO<br>10993-1 |
| Endoscope<br>compatibility | Olympus series 160, 180, and 190.<br>Fujinon series 530, 590, and 600.<br>EndoChoice Fuse gastrointestinal | Olympus series 160, 180, and 190.<br>Fujinon series 530, 590, and 600.<br>EndoChoice Fuse gastrointestinal |
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| Characteristic | Single-Use Biopsy Valve<br>(Unmodified) | Single-Use Biopsy Valve<br>(Modified) |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| | endoscopes | endoscopes. |
| Removable cap<br>with slit | Yes | Yes |
| Slit<br>accommodate<br>devices | Up to 3.2 mm | Up to 3.2 mm |
| Packaging | Individually packaged plastic pouch<br>or sterile pouch | Individually packaged plastic pouch<br>or sterile pouch |
| Performance<br>testing: | Design verification Pressure test with<br>valve closed - the device holds pressure<br>for 1 Min at 10 PSI | Same |
| | Design verification Pressure test with<br>instrument inserted - the device holds<br>pressure for 1 Min at 10 PSI | Same |
| | Design verification Pressure test:<br>Following removal of instrument the<br>device holds pressure for 1 Min at 10 PSI | Same |
# 8. Non-Clinical Testing:
The modified device has undergone both bench testing of performance and laboratory biocompatibility testing for cytotoxicity, sensitization, intracutaneous injection test, and system injection test, in accordance with 21 CFR, Part 58. The modified Single-Use Biopsy Valve results in no safety or efficacy concerns regarding biocompatibility or performance. Likewise, in conformance with 21 CFR 807.92(b)(3), the modified device performs as well as the predicate in all testing performed.
## 9. Conclusion:
The modified Single-Use Biopsy Valve is substantially equivalent to the unmodified predicate device listed above in performance, technical characteristics, biocompatibility, and intended use.
