(282 days)
Not Found
No
The 510(k) summary describes a mechanical device (biopsy valves) and does not mention any software, algorithms, or AI/ML capabilities. The performance studies focus on physical properties like leakage and airflow.
No
The device provides access and maintains conditions during an endoscopic procedure; it does not directly treat a disease or condition.
No
Explanation: The device is a biopsy valve intended to facilitate endoscopic procedures by allowing device passage, maintaining insufflation, minimizing leakage, and providing access for irrigation. Its function is to assist in the procedure itself, not to diagnose a medical condition.
No
The device description clearly states it is a physical, disposable biopsy valve, not software.
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 access, maintain insufflation, and minimize leakage. This is a procedural device, not a device used to test samples in vitro (outside the body) for diagnostic purposes.
- Device Description: The description focuses on the physical characteristics and compatibility with endoscopes, not on any reagents, assays, or analytical components typical of IVDs.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting specific analytes, or providing diagnostic information based on testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is entirely focused on facilitating the endoscopic procedure itself.
N/A
Intended Use / Indications for Use
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.
Product codes
OCX
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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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
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.
7. Intended Use
MAY 1 7 2013
1
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 Biopsy | |
| Valves | 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 biopsy | |
| valve – non-sterile is used to | ||
| cover the opening to the | ||
| biopsy/suction channel inlet of | ||
| Olympus® and Fujinon® (G5 | ||
| series and newer), | ||
| gastrointestinal endoscopes or | ||
| for use with Pentax® | ||
| gastrointestinal endoscopes. | ||
| The ScopeValet disposable biopsy | ||
| valve - non-sterile provides | ||
| access for endoscopic device | ||
| passage and exchange, helps | ||
| maintain insufflation and | ||
| minimizes leakage of bio-burden | ||
| from the biopsy port throughout | ||
| the gastrointestinal endoscopic | The EndoChoice biopsy valve 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 | ||
| Pentex gastrointestinal | ||
| endoscopes. | ||
| Indications for Use | procedure. | |
| 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. | 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. | ||
| Compatible Endoscope(s) | Olympus and Fujinon, (G5 series | |
| and newer) gastrointestinal | Olympus and Fujinon, (G5 series | |
| and newer) gastrointestinal |
Table 5A – Comparison of Characteristics
2
| Manufacturer | Ruhof Corporation | EndoChoice, Inc. |
|---|---|---|
| Trade Name | ScopeValet Disposable Biopsy | |
| Valves | Seal Biopsy Valves | |
| endoscopes or Pentax | ||
| gastrointestinal endoscopes | endoscopes or Pentax | |
| gastrointestinal endoscopes | ||
| Patient Population | Patients who are undergoing an | |
| endoscopy | Patients who are undergoing an | |
| endoscopy | ||
| 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.
3
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.
4
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.
5
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
6
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