(143 days)
Not Found
No
The summary describes a mechanical endoscopic vessel harvesting system and does not mention any AI or ML components or functionalities.
No
The device is used for harvesting vessels for arterial bypass procedures and for cutting tissue and controlling bleeding, which are surgical tools or accessories, not devices that directly treat a disease or condition.
No
The device is described as an Endoscopic Vessel Harvesting System used for cutting tissue, controlling bleeding, and blunt dissection during minimally invasive surgery. Its primary function is to facilitate the harvesting of vessels for arterial bypass grafts. It does not perform any diagnostic function.
No
The device description explicitly states it is a "System" that "attaches to existing laparoscopic endoscopes" and has a "distal end effector design." This indicates a physical hardware component, not solely software. The performance studies also include testing of physical properties like tensile/compressive strength and compatibility with hardware (7mm scope).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The Saphena Medical OnePass Endoscopic Vessel Harvesting System is a surgical tool used inside the body during minimally invasive procedures. Its function is to access, dissect, cut, and coagulate tissue and vessels in vivo.
- Intended Use: The intended use clearly describes a surgical procedure for harvesting vessels for bypass surgery, not a diagnostic test performed on a sample.
Therefore, the device falls under the category of a surgical instrument or system, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Saphena Medical OnePass Endoscopic Vessel Harvesting System is in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extra peritoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or radial artery for use in coronary artery bypass grafting. Thorascopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels, and other tissues of the chest wall.
Product codes
GEI
Device Description
The OnePass™ Endoscopic Vessel Harvesting System attaches to existing laparoscopic endoscopes (e.g. 7mm) to provide a means to endoscopically harvest vessels for use in arterial bypass graft procedures. Endoscopic Vessel Harvesting is a procedure that has been in use for approximately 15 years. The OnePass™ device differs in that it provides for single device entry into the body cavity without the need for additional instruments. Also, the distal end effector design allows for excellent visibility and quick thermal ligation of vessel trunks while minimizing trauma to the target vessel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extra peritoneal or subcutaneous extremity and thoracic space; saphenous vein; radial artery; chest wall
Indicated Patient Age Range
Not Found
Intended User / Care Setting
minimally invasive surgery
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 OnePass™ device performance characteristics were evaluated in the following studies:
- Design Verification Testing (including dimensional verification, tensile/compressive . strength and durability)
- Compatibility Testing with standard 7mm scope .
- . Compatibility Electrical Safety and Electromagnetic Testing
- Packaging and Shipping Testing .
- Sterility Testing .
- Biocompatibility Testing .
- Simulated animal testing use evaluation .
Performance testing demonstrates that the device is as safe and effective and performs at least as safely and effectively as the predicate device stated in this summary.
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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
JUL 3 1 2014
K140603 Section 005
510(k) Summary (21 CFR § 807.92(c))
| Submitter: | Saphena Medical, Inc.
375 West Street
West Bridgewater, MA 02379 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact: | Cheryl Blake
RA / QA, Saphena Medical Consultant
Telephone: 949.285.3517
Email: cherylblake@cox.net |
| Date Summary Prepared: | January 30, 2014 |
| Device Trade Name: | OnePass™ Endoscopic Vessel Harvesting System |
| Common Name: | Electrosurgical cutting and coagulation device and accessories |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| Product Code: | GEI |
| Class II | 21 CFR 878.4400 |
| Predicate Devices: | Maquet Cardiovascular, LLC Vasoview 6 Pro Endoscopic
Harvesting System (K091733)
Decision Date: August 28, 2009 |
Device Description:
The OnePass™ Endoscopic Vessel Harvesting Systemattaches to existing laparoscopic endoscopes (e.g. 7mm) to provide a means to endoscopically harvest vessels for use in arterial bypass graft procedures. Endoscopic Vessel Harvesting is a procedure that has been in use for approximately 15 years. The OnePass™ device differs in that it provides for single device entry into the body cavity without the need for additional instruments. Also, the distal end effector design allows for excellent visibility and quick thermal ligation of vessel trunks while minimizing trauma to the target vessel.
Intended Use:
The Saphena Medical OnePass Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extra peritoneal or subcutaneous extremity and thoracic
1
space. Extremity procedures include tissue dissection along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or radial artery for use in coronary artery bypass grafting. Thorascopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels, and other tissues of the chest wall.
Non-Clinical Performance Data:
The OnePass™ device performance characteristics were evaluated in the following studies:
- Design Verification Testing (including dimensional verification, tensile/compressive . strength and durability)
- Compatibility Testing with standard 7mm scope .
- . Compatibility Electrical Safety and Electromagnetic Testing
- Packaging and Shipping Testing .
- Sterility Testing .
- Biocompatibility Testing .
- Simulated animal testing use evaluation .
Performance testing demonstrates that the device is as safe and effective and performs at least as safely and effectively as the predicate device stated in this summary.
Statement of Equivalence:
The OnePass™ Endoscopic Vessel Harvesting System is substantially equivalent to the Maquet Cardiovascular, LLC VasoView 6 Pro Endoscopic Harvesting System (K091733) decision date of August 8, 2009. As described in this submission, the intended use of the OnePass™ Endoscopic Vessel Harvesting System is equal to the predicate device. Further, the subject and predicate device have similar technological characteristics. The OnePass™ Endoscopic Vessel Harvesting System is equivalent to the predicate device in terms of intended use, principles of operations, technology, design, materials and performance. The noted difference between the OnePass™ Endoscopic Vessel Harvesting and predicate device does not raise new issues of safety or effectiveness.Laboratory studies have been performed to assess the safety and effectiveness of the new characteristics. The testing performed in support of this 510(k) submission was conducted in accordance with accepted scientific methods, including compliance with ISO 60601-1 30 addition (Electrical Safety Testing for Medical Devices). Guidance documents and standards were followed as appropriate.
Summary:
Non-clinical testing of the subject device has shown that it meets its functional specification and performs according to the prescribed intended use. The OnePass™ Endoscopic Vessel Harvesting System is substantially equivalent to the predicate device in terms of its intended use, performance characteristics and product labeling. Based on the product technical information provided in this premarket notification, the OnePass™ Endoscopic Vessel Harvesting System has been shown to be substantially equivalent to the currently marketed predicate device.
2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 31, 2014
Saphena Medical Incorporated Ms. Cheryl Blake Regulatory Affairs/Quality Assurance. Saphena Medical Consultant 375 West Street West Bridgewater, Massachusetts 02379
Re: K140603
Trade/Device Name: OnePass Endoscopic Vessel Harvesting System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class H Product Code: GEI Dated: July 8, 2014 Received: July 9, 2014
Dear Ms. Blake:
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 docs not evaluate information related to contract fiability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into cither 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 complics 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
3
Page 2 - Ms. Cheryl Blake
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 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/Resourcesfor You/Industry/default.htm. 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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140603
Device Name OnePass Endoscopic Vessel Harvesting System
Indications for Use (Describe)
The Saphena Medical OnePass Endoscopic Vessel Harvesting System is in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extra peritoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or radial artery for use in coronary artery bypass grafting. Thorascopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels, and other tissues of the chest wall.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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