(223 days)
Not Found
No
The device description and performance studies focus on mechanical properties and fluid dynamics, with no mention of AI or ML.
No.
The device facilitates endoscopic procedures by managing access and leakage, but it does not directly treat or diagnose a disease or condition.
No
Explanation: The device is a biopsy valve used to facilitate endoscopic procedures by maintaining sufflation, minimizing leakage, and providing access for irrigation and device passage. It does not collect or interpret data to provide diagnostic information.
No
The device description clearly indicates it is a physical, molded thermoplastic elastomer product (a biopsy valve) and an accessory (an irrigating adaptor comprised of a metal tube). It is 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 states that the device is used to cover the biopsy/suction channel of endoscopes. Its function is to facilitate the endoscopic procedure itself by providing access, maintaining insufflation, minimizing leakage, and allowing irrigation. It does not perform any diagnostic testing on biological samples in vitro (outside the body).
- Device Description: The description details a mechanical device made of thermoplastic elastomer. Its function is purely mechanical and related to the operation of the endoscope.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze or test any biological samples (blood, tissue, etc.) to provide diagnostic information.
- Performance Studies: The performance studies described are bench tests related to the device's mechanical function (fluid flush, leak testing, compatibility, squeegee performance). There are no studies related to diagnostic accuracy or performance on biological samples.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OCX
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.
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
Hospital, Ambulatory Surgery Center, or Clinic
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)
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.
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 10-6. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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
1
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
2
Indications for Use
510(k) Number (if known) K142068
Device Name Medovations BullDog® Biopsy Valve
Indications for Use (Describe)
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.
| 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 Ave |
| Milwaukee, WI 53212 | |
| Establishment Registration No.: | 2183446 |
2. Sponsor Contact
| Contact Person: | Laura Boll
Director 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:
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
4
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 Biopsy |
| Valves | ||
| 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 |
| Endoscope | ||
| Compatibility | Molded versions to fit | |
| biopsy/suction channel of | ||
| Olympus/Fujinon | ||
| gastrointestinal endoscopes or | ||
| biopsy/suction channel of | ||
| Pentax gastrointestinal | ||
| endoscopes | Molded versions to fit | |
| biopsy/suction channel of | ||
| Olympus/Fujinon | ||
| gastrointestinal endoscopes or | ||
| biopsy/suction channel of | ||
| Pentax gastrointestinal | ||
| endoscopes | ||
| Valve Body Minimum | ||
| Inner Diameter | .065" | .065" |
| Removable Cap with | ||
| Slit for Device Passage | Yes | Yes |
| Intended Use | The single use Medovations | |
| BullDog® biopsy valve is used | ||
| to cover the opening to the | ||
| biopsy/suction channel of | ||
| Olympus and Fujinon (G5 | ||
| series and newer) | ||
| 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. | The single use BioShield® - | |
| ERCP biopsy valve is used to | ||
| cover the opening to the | ||
| biopsy/suction channel of | ||
| Olympus and G5 and newer | ||
| Fujinon 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. | ||
| Environment | Hospital, Ambulatory Surgery | |
| Center, or Clinic | Hospital, Ambulatory Surgery | |
| Center, or Clinic | ||
| Patient Population | Device has no direct patient | |
| contact and is used on any | ||
| patient undergoing endoscopy | Device has no direct patient | |
| contact and is used on any | ||
| patient undergoing endoscopy | ||
| Patient Contact | ||
| Categorization | No direct patient contact. | |
| Indirect patient contact from | ||
| devices and/or irrigating | ||
| solution that is in contact with | ||
| the biopsy valve and | ||
| accessory irrigating adaptor. | No direct patient contact. | |
| Indirect patient contact from | ||
| devices and/or irrigating | ||
| solution that is in contact with | ||
| the biopsy valve and | ||
| accessory irrigating adaptor. | ||
| Sterile | Sterile and non-sterile versions | |
| available of the | ||
| Olympus/Fujinon Style | ||
| Non-Sterile version of the | ||
| Pentax Style | Sterile and non-sterile versions | |
| available of the | ||
| Olympus/Fujinon Style | ||
| Non-Sterile version of the | ||
| Pentax 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 of | |
| a hollow metal tube with | ||
| standard plastic luer lock | ||
| connector | Irrigating Adaptor comprised of | |
| a hollow metal tube with | ||
| standard plastic luer lock | ||
| connector |
5
6
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.
7
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.