The ScopeValet Disposable Biopsy Valves, Model Numbers 345BVO and 345BVP, are intended to provide 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 Ruhof Corporation ScopeValet Disposable Biopsy Valves can be manufactured with a choice of two types - regular disposable biopsy valve and irrigating biopsy valve. Each of these types can be ordered for Olympus, Fujinon, and Pentax gastrointestinal endoscopes.

AI/ML Overview

The provided text describes the non-clinical performance data for the ScopeValet Disposable Biopsy Valves. This device is a biopsy valve, not an AI/ML diagnostic device, so many of the requested fields (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies) are not applicable.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Leakage Prevention	- No evidence of fluid leakage during sample biopsy or bowel irrigation.
Insufflation Effectiveness	- Maintained a pressure of at least 10 psi with no testing (implied leak-free during insufflation).- Insufflation air flow rate comparable to predicate device,delivering enough air for insufflation in typical time.
Biocompatibility	- Passed cytotoxicity testing per ISO 10993-5.- Made of TPE materials (GRAS for cytotoxicity, sensitization, irritation), USP Grade VI, cleared colorants.
Shelf-Life	- Established for one (1) year based on physical testing data.
Overall Design, Safety, and Effectiveness (General)	- Met all requirements for overall design and biocompatibility.- Output meets design inputs and specifications.- Passed all stated tests with acceptable results.

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

Sample Size: The document does not specify exact sample sizes (number of biopsy valves or test runs) for each non-clinical performance test (Leak testing, Insufflation air flow rate testing, Biocompatibility, Shelf-life). It states "ScopeValet Disposable Biopsy Valves" were tested, indicating multiple units were likely used, but no specific count is provided.
Data Provenance: The data is generated from non-clinical performance testing conducted by Ruhof Corporation or its contracted labs. This is not patient-derived data, so terms like "country of origin" or "retrospective/prospective" are not applicable.

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

Not Applicable. This is not an AI/ML diagnostic device, and thus, "ground truth" established by experts in the context of image interpretation or diagnosis is not relevant here. The ground truth for these tests is based on objective measurements against defined engineering and biological standards.

4. Adjudication Method for the Test Set

Not Applicable. As this is non-clinical performance testing, there is no "adjudication method" in the sense of resolving conflicting expert opinions. Results are presumably recorded and verified against test protocols and acceptance criteria by technical personnel.

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

Not Applicable. This is not an AI/ML diagnostic device.

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

Not Applicable. This is not an AI/ML diagnostic device.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on:
- Defined performance specifications: For leakage (no fluid leakage) and insufflation (minimum pressure/flow rate comparable to predicate).
- International and national standards: ISO 10993-1 and ISO 10993-5 for biocompatibility.
- Physical testing protocols: For shelf-life determination.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device that requires a training set.

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

Not Applicable. This is not an AI/ML device that requires a training set.

Study Summaries for Each Test:

Leak Testing:
- Objective: To simulate withdrawal of biopsy samples, bowel irrigation, and bowel insufflation and assess fluid leakage.
- Result: No evidence of fluid leakage was observed.
- Conclusion: The device is effective in preventing fluid leakage.
Insufflation Air Flow Rate Testing:
- Objective: To simulate bowel insufflations and assess pressure maintenance and air flow rate.
- Result: The device maintained a pressure of at least 10 psi and its air flow rate was comparable to the predicate device, delivering sufficient air for typical insufflation times.
- Conclusion: The device is effective in achieving insufflation.
Biocompatibility Testing:
- Objective: To evaluate the biological safety of the device's materials.
- Methodology: Conducted according to ISO 10993-1 and FDA/CDRH/ODE Blue Book Memorandum G95-1, classifying the device for mucosal membrane contact, limited duration (less than 24 hours). The device's TPE materials are GRAS, USP Grade VI, with cleared colorants. Specifically tested for cytotoxicity per ISO 10993-5.
- Result: The device passed cytotoxicity testing.
- Conclusion: The device is biocompatible as per ISO 10993-1.
Shelf-Life Testing:
- Objective: To establish the stability and functional life of the device.
- Methodology: Based on physical testing data using a defined protocol.
- Result: A shelf-life of one (1) year was established.
- Conclusion: The device is stable for one year.

The submission concludes that the ScopeValet Disposable Biopsy Valves passed all testing, demonstrating acceptable results and meeting all requirements for safety, effectiveness, overall design, and biocompatibility, thereby supporting its substantial equivalence to the predicate device.

Summary

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K122417 page 1 of 4

で

510(k) Summary

1. Submission Sponsor

Ruhof Corporation 393 Sagamore Avenue . Mineola New York 11501 USA Phone: (516) 294.5888 Fax: (516) 248.6456 Contact: Douglas J MacKay, VP of Sales and Marketing

2. Submission Correspondent

Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: (720) 838.4113 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Carrie Hetrick, Senior Consultant, RA Email: project.management@emergogroup.com

3. Date Prepared

April 26, 2013

4. Device Identification

Trade/Proprietary Name: ScopeValet Disposable Biopsy Valves Common/Usual Name: Biopsy Valves Classification Name: Endoscope and accessories Classification Regulation: 876.1500 Product Code: OCX Device Class: Class II Classification Panel: Gastroenterology/Urology

5. Predicate Devices

EndoChoice - Seal™ Biopsy Valve (K111821)

6. Device Description

7. Intended Use

MAY 1 7 2013

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The ScopeValet Disposable Biopsy Valves are intended to provide 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.

8. Substantial Equivalence Discussion

The following table compares the ScopeValet Disposable Biopsy Valves to the predicate device with respect to the intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

Manufacturer	Ruhof Corporation	EndoChoice, Inc.
Trade Name	ScopeValet Disposable BiopsyValves	Seal Biopsy Valves
510(k) Number	K122417	K111821
Product Code	OCX	OCX
Regulation Number	876.1500	876.1500
Regulation Name	Endoscope and accessories	Endoscope and accessories
Design	The ScopeValet disposable biopsyvalve – non-sterile is used tocover the opening to thebiopsy/suction channel inlet ofOlympus® and Fujinon® (G5series and newer),gastrointestinal endoscopes orfor use with Pentax®gastrointestinal endoscopes.The ScopeValet disposable biopsyvalve - non-sterile providesaccess for endoscopic devicepassage and exchange, helpsmaintain insufflation andminimizes leakage of bio-burdenfrom the biopsy port throughoutthe gastrointestinal endoscopic	The EndoChoice biopsy valve canbe manufactured with a choice oftwo types - regular disposablebiopsy valve and irrigating biopsyvalve. Each of these types can beordered for Olympus, Fujinon, andPentex gastrointestinalendoscopes.
Indications for Use	procedure.The ScopeValet DisposableBiopsy Valves are intended toprovide access for endoscopicdevice passage and exchange,helps maintain sufflation,minimizes leakage ofbiomaterial from the biopsyport throughout theendoscopic procedure, andprovides access for irrigation.	Biopsy valves are intended toprovide access for endoscopicdevice passage and exchange,helps maintain sufflation,minimizes leakage of biomaterialfrom the biopsy port throughoutthe endoscopic procedure, andprovides access for irrigation.
Compatible Endoscope(s)	Olympus and Fujinon, (G5 seriesand newer) gastrointestinal	Olympus and Fujinon, (G5 seriesand newer) gastrointestinal

Table 5A – Comparison of Characteristics

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Manufacturer	Ruhof Corporation	EndoChoice, Inc.
Trade Name	ScopeValet Disposable BiopsyValves	Seal Biopsy Valves
	endoscopes or Pentaxgastrointestinal endoscopes	endoscopes or Pentaxgastrointestinal endoscopes
Patient Population	Patients who are undergoing anendoscopy	Patients who are undergoing anendoscopy
Environment	Hospital and/or Clinic	Hospital and/or Clinic
Manufacturing Method	Injection molded	Injection molded
Opening for Instruments	Slit in diaphragm	Slit in diaphragm
Material	TPE	TPE
Sterile	No	No
Single-Use, Disposable	Yes	Yes
Shelf Life	One (1) year	Not known
Complies with ISO 10993-1	Yes	Yes

9. Non-Clinical Performance Data

The following testing has been performed to support substantial equivalence:

Leak testing Leak testing was performed with the ScopeValet Disposable Biopsy Valves . to simulate the withdrawal of biopsy samples, bowel irrigation and bowel insufflation. The ScopeValet Disposable Biopsy Valves revealed no evidence of fluid leakage during the sample biopsy or bowel irrigation. Thus, the ScopeValet Disposable Biopsy Valves are an effective means of preventing fluid leakage in gastrointestinal endoscopic procedures.
Insufflation air flow rate testing - Tests were performed simulating bowel insufflations, whereby the ScopeValet Disposable Biopsy Valves tested maintained a pressure of at least 10 psi with no testing. The insufflation air flow rate is comparable to that of the predicate device, delivering enough air for insufflation in the time typically used for insufflation. Thus, the ScopeValet Disposable Biopsy Valves is an effective means of achieving insufflation in gastrointestinal endoscopic procedures.
. Biocompatibility – Biocompatibility testing of the ScopeValet Disposable Biopsy Valves was conducted in accordance with the ISO 10993-1 "Biological evaluation of medical devices" standards and FDA/CDRH/ODE Blue Book Memorandum G95-1, "Use of International Standard ISO 10993", 'Biological Evaluation of Medical Devices, Part 1: ' Evaluation and Testing' using a representative device. Based on ISO 10993-1, the biopsy valves are body contact (mucosal membranes) and limited contact duration (less than 24 hours). The ScopeValet Disposable Biopsy Valves are made of thermoplastic elastomer (TPE) materials that are Generally Recognized As Safe (GRAS) materials according to ISO 10993 for cytotoxicity, sensitization, and irritation, are USP Grade VI, and the colorants are cleared (or FDA listed). The device was tested for cytotoxicity as per ISO 10993-5, and passed. The results and analysis demonstrate the ScopeValet Disposable Biopsy Valves are biocompatible as per ISO 10993-1.
t Shelf-life – Stability of the subject device was established from the results of physical testing data using a protocol.. Based on the evaluation of the results of the physical testing data, the expiring date has been set at one (1) year.

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As part of demonstrating safety and effectiveness of ScopeValet Disposable Biopsy Valves and in showing substantial equivalence to the predicate device that is subject to this 510(k) submission, Rohuf Corporation completed a number of tests. The ScopeValet Disposable Biopsy Valves meets all the requirements for the overall design,and biocompatibility that the output meets the design inputs and specifications. The ScopeValet Disposable Biopsy Valves passed all testing stated above as shown by the acceptable results obtained.

The ScopeValet Disposable Biopsy Valves complies with the applicable voluntary standards for biocompatibility. The device passed all the testing in accordance with national and international standards.

10. Clinical Testing

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate device, have been on the market for many years with proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.

It has been shown in this 510(k) submission that the difference between ScopeValet Disposable Biopsy Valves and the predicate device do not raise any questions regarding its safety and effectiveness. The ScopeValet Disposable Biopsy Valves, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

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

May 17, 2013

Ruhof Corporation % Ms. Carrie Hetrick Senior Consultant, RA Emergo Group, Inc. 816 Congress Avenue, Suite 1400 AUSTIN TX 78701

Re: K122417

Trade/Device Name: ScopeValet Disposable Biopsy Valves, Models 345BVO and 345BVP Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCX Dated: April 30, 2013 Received: May 1, 2013

Dear Ms. Hetrick:

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.

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Page 2 - Ms. Carrie Hetrick

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/MedicalDeyices/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

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 Statement

510(k) Number (if known): K122417

Device Name: ScopeValet Disposable Biopsy Valve, Model Numbers 345BVO and 345BVP

Indications for Use: The ScopeValet Disposable Biopsy Valves, Model Numbers 345BVO and 345BVP, are intended to provide 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.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR .

Over-The-Counter Use (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 R 2013.05.17 115:4

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K122417 510(k) Number

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.