ONEPASS ENDOSCOPIC VESSEL HARVESTING SYSYETM

K140603 · Saphena Medical, Inc. · GEI · Jul 31, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K140603
• Device Name: ONEPASS ENDOSCOPIC VESSEL HARVESTING SYSYETM
• Applicant: Saphena Medical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 31, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

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 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.

Device Story

OnePass Endoscopic Vessel Harvesting System is a surgical instrument designed for minimally invasive vessel harvesting. It attaches to standard 7mm laparoscopic endoscopes. The device enables single-entry access to the body cavity, eliminating the need for additional instruments. The distal end effector provides visualization and performs thermal ligation of vessel trunks while minimizing trauma to the target vessel. Used by surgeons in clinical settings for procedures such as saphenous vein or radial artery harvesting for bypass grafts, and thoracic wall dissections. The device facilitates tissue dissection and hemostasis, potentially reducing surgical trauma and improving procedural efficiency compared to multi-instrument approaches.

Clinical Evidence

Bench testing only. Performance evaluated via design verification (dimensional, tensile/compressive strength, durability), compatibility with 7mm scopes, electrical safety (ISO 60601-1), electromagnetic testing, packaging/shipping, sterility, biocompatibility, and simulated animal use evaluation.

Technological Characteristics

Electrosurgical cutting and coagulation device. Attaches to 7mm laparoscopic endoscopes. Features a distal end effector for thermal ligation. Complies with ISO 60601-1 for electrical safety. Mechanical design allows single-entry access. No software or electronic processing components described.

Indications for Use

Indicated for patients undergoing minimally invasive endoscopic surgery for arterial bypass, including coronary artery bypass grafting (CABG) and peripheral artery bypass. Used for blunt tissue dissection, cutting, and coagulation of blood vessels, ducts, and other structures in the extremities and thoracic space.

Regulatory Classification

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.

Predicate Devices

• Maquet Cardiovascular, LLC Vasoview 6 Pro Endoscopic Harvesting System (K091733)

Submission Summary (Full Text)

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JUL 3 1 2014

### K140603 Section 005

#### 510(k) Summary (21 CFR § 807.92(c))

| Submitter: | Saphena Medical, Inc.<br>375 West Street<br>West Bridgewater, MA 02379 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact: | Cheryl Blake<br>RA / QA, Saphena Medical Consultant<br>Telephone: [phone]<br>Email: [e-mail] |
| 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<br>Harvesting System (K091733)<br>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

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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.

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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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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