The single use BullDog® Biopsy Valve is used to cover the biopsy/suction channel of Olympus® and Fujinon® or Pentax® gastrointestinal endoscopes. It provides access for endoscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.

Device Description

The Medovations Disposable Biopsy Valve is a single piece construction of molded thermoplastic elastomer. The biopsy valve has a cylindrical body with an open inner diameter for device passage. This cylindrical body has a connected cap with a slit to allow for endoscopic device passage and exchange, to help maintain sufflation, to minimize leakage of biomaterial from the biopsy port throughout endoscopic procedures, and to provide access for irrigation. The distal part of the biopsy valve body is molded to fit the biopsy/suction channel of the endoscope. The proximal part of the biopsy valve body is molded to fit around the cap when it is in the closed position. The Medovations Disposable Biopsy Valves are manufactured in two configurations one for use with Olympus®/Fujinon® gastrointestinal endoscopes and the other for use with Pentax® gastrointestinal endoscopes. The Olympus®/Fujinon® versions are sold as both sterile and non-sterile devices. The Pentax® version is sold non-sterile. The Irrigating Adaptor accessory is comprised of a metal tube with standard luer lock and can be used with the biopsy valve to provide access for irrigation.

AI/ML Overview

The provided documentation describes the Medovations BullDog® Biopsy Valve and details non-clinical bench testing conducted to demonstrate its substantial equivalence to a predicate device (US Endoscopy BioShield® ERCP Biopsy Valve, K070420).

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria with numerical targets. Instead, the performance evaluation is based on comparison to a predicate device, aiming to show "as well as or better than" performance.

Test Performed	Acceptance Criteria (Implied)	Reported Device Performance
Fluid Flush Performance	No fluid backsplash onto the user. (Performance comparable to predicate device)	Performed as well as the predicate device; no fluid backsplash identified.
Leak Testing	Maintain sufflation and minimize leakage. (Performance comparable to or better than predicate device)	Performed as well as or better than the predicate device in maintaining applied vacuum pressures.
Compatibility with Endoscope	Remaining seated on biopsy/suction channel. (Performance comparable to predicate device)	Performed as well as the predicate device in remaining seated.
Squeegee Performance	Effectively remove materials from a device passing through it. (Performance comparable to predicate device)	Visually performed as well as the predicate device in removing materials.
Sterility	Sterility Assurance Level (SAL) of 10⁻⁶; EO residuals below defined maximum levels; maintain sterile barrier for at least 5 years.	Achieved SAL of 10⁻⁶; EO residuals below maximums; packaging maintains sterile barrier for at least 5 years.
Shelf Life	3-year expiration date.	3-year expiration date, supported by material equivalence and existing packaging data.

2. Sample Size Used for the Test Set and Data Provenance

The document states that testing was performed on "Medovations samples from initial production lots." It does not specify the exact sample size for each test (e.g., number of biopsy valves tested for fluid flush, leak testing, etc.).

Sample Size for Test Set: Not explicitly stated as a number, but refers to "initial production lots."
Data Provenance: The studies were non-clinical bench tests conducted by Medovations, Inc. The data is internal to the manufacturer. No country of origin for the data is specified beyond being conducted by Medovations (Milwaukee, WI, USA). The studies are prospective in the sense that they were conducted specifically for this submission, but they are bench studies, not human or animal studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This section is not applicable. The "ground truth" for these tests was established through objective measurements and visual assessments based on predefined criteria, not expert consensus or interpretation of medical images. For example, leak testing involved measuring vacuum, and squeegee performance involved visual evaluation against a predicate.

4. Adjudication Method for the Test Set

This section is not applicable. The tests performed are objective bench tests, not requiring adjudication methods like those used in clinical trials (e.g., 2+1, 3+1).

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

This section is not applicable. This submission is for a physical medical device (biopsy valve), not an AI/software device. Therefore, no MRMC study or AI-related comparative effectiveness was conducted or is relevant.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This section is not applicable. As mentioned above, this is a physical medical device, not an algorithm, so standalone performance in that context is not relevant.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical bench tests was based on objective physical measurements and visual assessments against predefined performance indicators and comparison to a legally marketed predicate device. For example:

Fluid Flush: Visual confirmation of no backsplash.
Leak Testing: Quantitative measurement of vacuum maintenance.
Compatibility: Visual confirmation of secure fit and function.
Squeegee Performance: Visual evaluation of material removal.
Sterilization/Shelf Life: Laboratory tests measuring SAL, residuals, and packaging integrity.

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" as this is a physical device submission, not an AI/machine learning model.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable for the reasons stated in point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the edge. In the center of the seal is an abstract image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 10, 2015

Medovations, Inc. Laura Boll Vice President of Quality and Regulatory Affairs 102 East Keefe Avenue Milwaukee, WI 53212

Re: K142068

Trade/Device Name: Medovations BullDog® Biopsy Valves Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCX Dated: January 30, 2015 Received: February 2, 2015

Dear Laura Boll,

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.

for

Sincerely yours,

Herbert P. Lerner -S

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) K142068

Device Name Medovations BullDog® Biopsy Valve

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CER 801 Subnart D)	Over-The-Counter Use (21 CER 801 Subnart C)

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510(k) Summary

The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.

1. Submission Sponsor

Submitter's Name:	Medovations
Submitter's Address:	102 E. Keefe AveMilwaukee, WI 53212
Establishment Registration No.:	2183446

2. Sponsor Contact

Contact Person:	Laura BollDirector of Quality and Regulatory Affairs
Telephone:	414-755-4806 (direct)414-265-7620 ext. 4806
Email:	lboll@medovations.com

2. Date Prepared

July 21, 2014 Revised January 27, 2015 - revise classification from ODC to OCX per FDA response

3. Device Identification

Trade Device Name:	Medovations BullDog® Biopsy Valve
Common Device Name:	Biopsy Valves
Classification Name:	OCX - Endoscopic Irrigation/Suction System
Regulation Number:	21 CFR 876.1500

4. Predicate Device Identification

Predicate Device 510(k) No.:	K070420
Predicate Device Trade Name:	US Endoscopy BioShield® ERCP Biopsy Valve
Predicate Device Product Code:	KOG

5. General Device Description:

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allow for endoscopic device passage and exchange, to help maintain sufflation, to minimize leakage of biomaterial from the biopsy port throughout endoscopic procedures, and to provide access for irrigation.

The distal part of the biopsy valve body is molded to fit the biopsy/suction channel of the endoscope. The proximal part of the biopsy valve body is molded to fit around the cap when it is in the closed position.

The Medovations Disposable Biopsy Valves are manufactured in two configurations one for use with Olympus®/Fujinon® gastrointestinal endoscopes and the other for use with Pentax® gastrointestinal endoscopes. The Olympus®/Fujinon® versions are sold as both sterile and non-sterile devices. The Pentax® version is sold non-sterile.

The Irrigating Adaptor accessory is comprised of a metal tube with standard luer lock and can be used with the biopsy valve to provide access for irrigation.

6. Intended Use:

The single use Medovations BullDog® biopsy valve is used to cover the opening to the biopsy/suction channel of Olympus® and Fujinon® or Pentax® gastrointestinal endoscopes. It provides access for endoscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.

7. Technological Characteristics

The following table is a summary of the Medovations Biopsy Valve technological characteristics as compared to the predicate device from US Endoscopy.

Table 5.1 Summary of design, features and principles of operation between the
Medovations BullDog® Biopsy Valve and Irrigating Adaptors and Predicate Device US
Endoscopy BioShield® Biopsy Valves and Irrigating Adaptors

Characteristic	Medovations	US Endoscopy
Trade Name	BullDog® Biopsy Valves	BioShield® ERCP BiopsyValves
510(k) Number	K142068	K070420
Product Code	OCX	KOG
Regulation Number	876.1500	876.1500
Regulation Name	Endoscope and accessories	Endoscope and accessories
Manufacturing Design	Single piece injection molded	Single piece injection molded
Material	Thermoplastic elastomer	Thermoplastic elastomer
Characteristic	Medovations	US Endoscopy
EndoscopeCompatibility	Molded versions to fitbiopsy/suction channel ofOlympus/Fujinongastrointestinal endoscopes orbiopsy/suction channel ofPentax gastrointestinalendoscopes	Molded versions to fitbiopsy/suction channel ofOlympus/Fujinongastrointestinal endoscopes orbiopsy/suction channel ofPentax gastrointestinalendoscopes
Valve Body MinimumInner Diameter	.065"	.065"
Removable Cap withSlit for Device Passage	Yes	Yes
Intended Use	The single use MedovationsBullDog® biopsy valve is usedto cover the opening to thebiopsy/suction channel ofOlympus and Fujinon (G5series and newer)gastrointestinal endoscopes.It provides access forendoscopic device passageand exchange, helps maintainsufflation, minimizes leakageof biomaterial from the biopsyport throughout theendoscopic procedure, andprovides access for irrigation.	The single use BioShield® -ERCP biopsy valve is used tocover the opening to thebiopsy/suction channel ofOlympus and G5 and newerFujinon gastrointestinalendoscopes. It providesaccess for endoscopic devicepassage and exchange, helpsmaintain sufflation, minimizesleakage of biomaterial from thebiopsy port throughout theendoscopic procedure, andprovides access for irrigation.
Environment	Hospital, Ambulatory SurgeryCenter, or Clinic	Hospital, Ambulatory SurgeryCenter, or Clinic
Patient Population	Device has no direct patientcontact and is used on anypatient undergoing endoscopy	Device has no direct patientcontact and is used on anypatient undergoing endoscopy
Patient ContactCategorization	No direct patient contact.Indirect patient contact fromdevices and/or irrigatingsolution that is in contact withthe biopsy valve andaccessory irrigating adaptor.	No direct patient contact.Indirect patient contact fromdevices and/or irrigatingsolution that is in contact withthe biopsy valve andaccessory irrigating adaptor.
Sterile	Sterile and non-sterile versionsavailable of theOlympus/Fujinon StyleNon-Sterile version of thePentax Style	Sterile and non-sterile versionsavailable of theOlympus/Fujinon StyleNon-Sterile version of thePentax Style
Sterilization method	EO gas	EO gas
Characteristic	Medovations	US Endoscopy
Single Use, Disposable	Yes	Yes
Shelf Life	3 years	3 years
Accessory Device	Irrigating Adaptor comprised ofa hollow metal tube withstandard plastic luer lockconnector	Irrigating Adaptor comprised ofa hollow metal tube withstandard plastic luer lockconnector

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8. Non-Clinical Performance Data

Medovations performed bench testing to support substantial equivalence. The following testing was performed on Medovations samples from initial production lots, including sterilization (where applicable):

a. Fluid Flush Performance - Fluid flush was simulated by inserting the irrigating adaptor into the biopsy valve slit and injecting water through the irrigating adaptor to confirm there is no fluid backsplash onto the user during a fluid flush. This test was performed on both the Medovations Biopsy Valve and Irrigating Adaptor and the predicate US Endoscopy Biopsy Valve and Irrigating Adaptor. The Medovations Biopsy Valve performed as well as the predicate device and there was no evidence of fluid backsplash during this simulated use testing.

b. Leak testing - Leak testing was performed to demonstrate sufflation is maintained during use and leakage is minimal when devices are passed through the biopsy valve. This testing put the biopsy valves under a vacuum and measured the vacuum being held by the biopsy valve both with and without a device passing through the slit. This test was performed on both the Medovations Biopsy Valve and the predicate US Endoscopy Biopsy Valve. The Medovations Biopsy Valve performed as well as or better than the predicate device in maintaining applied vacuum pressures both with and without a device passing through the slit.

c. Compatibility with Endoscope - Compatibility of the biopsy valve with the designated endoscope was tested by placing the biopsy valve on the biopsy/suction channel of the appropriate endoscope (either Olympus or Pentax). The fit was confirmed visually through a series of opening and closing of the attached cap to simulate the stresses during use. The Medovations Biopsy Valve performed as well as the predicate device in remaining seated on biopsy/suction channel of the designated endoscope through this series of simulated use movements.

d. Squeegee Performance - The ability of the biopsy valve to squeegee off materials was tested by coating a biopsy forceps with mustard and then pulling that biopsy forceps back through the biopsy valve. The amount of mustard remaining on the forceps after passage through the biopsy valve was visually evaluated. This test was performed using both the Medovations Biopsy Valve and the predicate device. The Medovations Biopsy Valve visually performed as well as the predicate device in removing materials from a device passing through it.

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e. Sterilization - The Olympus/Fujinon compatible biopsy valve is sold in both sterile and non-sterile options, like the US Endoscopy predicate device. The sterile option has been sterilized in a validated EO sterilization cycle. The EO sterilization cycle has a Sterility Assurance Level (SAL) of 10°. EO residuals on the biopsy valves are below the maximum levels defined in ANSI/AAMI/ISO 10993-7:1995 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide sterilization residuals. The Medovations biopsy valves, and the predicate devices, are not labeled as pvrogen-free because they do not have any blood or cerebrospinal fluid contact. The Medovations biopsy valves are packaged in a paper/film pouch like other sterile products Medovations currently manufactures. These pouches have been tested by Medovations, including simulated distribution stresses and real-time aging, and shown to provide and maintain a sterile barrier for at least five (5) years.

f. Shelf Life - The Medovations Biopsy Valves have a three (3) year expiration date, based on the design and material equivalence to the predicate device and existing sterile barrier data from Medovations existing packaging. The Medovations biopsy valves are packaged in a paper/film pouch like other sterile products Medovations currently manufactures. These pouches have been tested by Medovations, including simulated distribution stresses and real-time aging, and shown to provide and maintain a sterile barrier for at least five (5) years.

9. Clinical Testing

Biopsy valves have been on the market for many years with proven safety and efficacy for the use of the device. These devices have no direct patient contact. Based on this history and the use of the device, clinical testing was not necessary to support substantial equivalence data. The non-clinical testing performed supports safety and efficacy of the device and provides data to show substantial equivalence to the predicate device.

10. Conclusion

Medovations biopsy valves have the same intended use as the predicate device. Based on the technological characteristics and overall performance of the devices in bench testing, Medovations believes that no significant differences exist between the proposed biopsy valve and the predicate device.

The Medovations biopsy valves do not raise any new issues of safety and effectiveness. From a clinical perspective and comparing design specifications, the Medovations biopsy valve and the predicate device are substantially equivalent.

Regulation Number and Section

§ 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.