Reprocessed Vessel Sealer

K152134 · Sterilmed, Inc. · NUJ · Jan 15, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K152134
• Device Name: Reprocessed Vessel Sealer
• Applicant: Sterilmed, Inc.
• Product Code: NUJ · General, Plastic Surgery
• Decision Date: Jan 15, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The reprocessed vessel sealer/dividers are bipolar electrosurgical instruments intended for use with the ForceTriad™ Energy Platform in general, minimally invasive and open surgical procedures where ligation and division of vessels and lymphatics is desired. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymphatics) interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue. Indications for use include general open and minimally invasive procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic procedures where ligation and division of the vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, colectomy, adhesiolysis, oophorectomy, etc. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures. The reprocessed vessel sealer/dividers can be used on vessels and lymphatics up to and including 7 mm, and tissue bundles.

Device Story

Reprocessed bipolar electrosurgical instrument; used with ForceTriad Energy Platform. Input: vascular structures/tissue bundles clamped between jaws. Operation: applies RF energy to seal vessels; surgeon-actuated blade divides tissue. Used in OR by surgeons for general/minimally invasive procedures. Output: sealed and divided tissue. Benefits: enables ligation and division of vessels/lymphatics up to 7mm. Device includes hand-actuated lever for jaw control, clicking mechanism for grasping zone, activation button for sealing, and trigger for cutting.

Clinical Evidence

Bench testing only. No clinical data. Testing included cleaning/sterilization validation, biocompatibility (cytotoxicity, pyrogen, thrombogenicity, irritation, acute toxicity, immune response, hemolysis, sensitization), and functional performance (electrical safety, vessel seal burst pressure, thermal spread, EMC, fatigue, and mechanical stress testing).

Technological Characteristics

Bipolar RF electrosurgical instrument; 5mm Maryland jaw; 23cm or 37cm shaft. Materials validated via biocompatibility testing. Standards: ISO 10993-7 (EO residuals), ASTM D4169, F88, F2096 (packaging), ASTM 1980-07 (shelf-life). Energy source: ForceTriad Energy Platform. Sterilization: Ethylene Oxide.

Indications for Use

Indicated for patients undergoing general, minimally invasive, or open surgical procedures (urologic, vascular, thoracic, thoracoscopic, gynecologic) requiring ligation and division of vessels/lymphatics up to 7mm and tissue bundles. Contraindicated for tubal sterilization or tubal coagulation.

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

• Covidien LigaSure™ 5 mm, Maryland Jaw Sealer/Dividers (K133338)

Submission Summary (Full Text)

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

January 15, 2016

Sterilmed Incorporated % Ming Cheng Chew Libra Medical 8401 73rd Avenue North, Suite 63 Brooklyn Park, Minnesota 55428

Re: K152134

Trade/Device Name: Reprocessed Vessel Sealer Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: NUJ Dated: December 15, 2015 Received: December 16, 2015

Dear Ming Cheng Chew:

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 of medical devicerelated 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.

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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/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

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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

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Sincerely yours,

## Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| Device Model | Device Name | Original Manufacturer |
|--------------|--------------------------------------------------------------------------------------------------------------|-----------------------|
| LF1737 | Reprocessed LigaSure 5mm Maryland Jaw<br>Sealer/Divider, 37cm shaft, used with<br>ForceTriad energy platform | Covidien |
| LF1723 | Reprocessed LigaSure 5mm Maryland Jaw<br>Sealer/Divider, 23cm shaft, used with<br>ForceTriad energy platform | Covidien |

Reprocessed Single-Use Device Models Included in Clearance:

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. |
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## Indications for Use

510(k) Number (if known)

K152134

Device Name

Reprocessed Vessel Sealers

Includes the LF1737 and LF1723 models

Indications for Use (describe)

The reprocessed vessel sealer/dividers are bipolar electrosurgical instruments intended for use with the ForceTriad™ Energy Platform in general, minimally invasive and open surgical procedures where ligation and division of vessels and lymphatics is desired. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymphatics) interposed between the iaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue.

Indications for use include general open and minimally invasive procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic procedures where ligation and division of the vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, colectomy, adhesiolysis, oophorectomy, etc. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

The reprocessed vessel sealer/dividers can be used on vessels and lymphatics up to and including 7 mm, and tissue bundles.

| Type of Use (select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|------------------------------------------------------|
| <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (Part 21 CFR 801<br>Subpart C |
| CONTINUE ON A SEPARATE PAGE IF NEEDED | |

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## 510(k) Summary

| Submitter and<br>Manufacturer: | Patricia F. Kaufman<br>Sterilmed, Inc.<br>5010 Cheshire Parkway N, Suite 2<br>Plymouth, MN 55446 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Manufacturing Facility<br>Address: | 11400 73rd Avenue North<br>Maple Grove, MN 55369 |
| Primary Contact: | Ming-Cheng Chew<br>Libra Medical, Inc.<br>Tel: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Secondary Contact: | Julie Bodmer<br>Libra Medical, Inc.<br>Tel: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date of Submission: | 30 July 2015 |
| 510(k) Number | K152134 |
| Trade Name: | Reprocessed Vessel Sealers |
| Regulation Name: | Electrosurgical, cutting & coagulation<br>accessories, laparoscopic & endoscopic,<br>reprocessed |
| Device Classification: | Class II |
| Device Regulation: | 878.4400 |
| Product Code: | NUJ |

| Predicate Device: | Covidien LigaSure™ 5 mm, Maryland Jaw Sealer/Dividers (K133338). |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description: | The reprocessed vessel sealer is a sterile, hand-held bipolar RF<br>electrosurgical instrument designed exclusively for use with the<br>ForceTriad™ energy platform (generator) to ligate (seal) and divide (cut)<br>vessels, tissue bundles, and lymphatics clamped between the jaws, grasping<br>tissue, and blunt dissection during general surgical procedures (as<br>indicated), laparoscopic or open, using radio frequency (RF) energy. A<br>hand actuated lever allows the user to open and close the instrument jaws<br>without having to latch the lever, which includes a clicking mechanism that<br>indicates to the user that the jaws are in the grasping zone, a button |
| | (switch) to activate the LigaSureTM mode by closing the handle against the<br>button (switch) for vessel sealing, and a trigger to actuate an independent<br>cutting blade. |
| Indications for<br>Use: | The reprocessed vessel sealer/dividers are bipolar electrosurgical<br>instruments intended for use with the ForceTriadTM Energy Platform in<br>general, minimally invasive and open surgical procedures where ligation<br>and division of vessels and lymphatics is desired. The instrument creates a<br>seal by application of RF electrosurgical energy to vascular structures<br>(vessels and lymphatics) interposed between the jaws of the instrument.<br>A blade within the instrument is surgeon actuated to divide tissue. |
| | Indications for use include general open and minimally invasive<br>procedures including urologic, vascular, thoracic and thoracoscopic, and<br>gynecologic procedures where ligation and division of the vessels is<br>performed. These procedures include: laparoscopically assisted vaginal<br>hysterectomy, Nissen fundoplication, colectomy, adhesiolysis,<br>oophorectomy, etc. The device has not been shown to be effective for<br>tubal sterilization or tubal coagulation for sterilization procedures, and<br>should not be used for these procedures. |
| | The reprocessed vessel sealer/dividers can be used on vessels and<br>lymphatics up to and including 7 mm, and tissue bundles. |
| Technological<br>Characteristics: | The reprocessed vessel sealers have the same technological and<br>performance characteristics as the predicates LF1723 and LF1737,<br>K133338. Similar to the predicate models, each of these reprocessed<br>devices seal vessels and lymphatics using radio frequency (RF) energy to<br>achieve intended use and can mechanically divide the sealed areas or tissue<br>with a mechanical cutting device. |
| Models Included in<br>this Submission | LF1737 - Reprocessed Covidien LigaSureTM 5mm Maryland Jaw<br>Sealer/Divider, 37cm shaft, used with ForceTriadTM energy platform<br>LF1723 - Reprocessed Covidien LigaSureTM 5mm Maryland Jaw<br>Sealer/Divider, 23cm shaft, used with ForceTriadTM energy platform |
| Functional and<br>Safety Testing: | Representative samples of reprocessed devices were tested to demonstrate<br>appropriate functional characteristics. Process validation testing was<br>performed to validate the cleaning and sterilization procedures as well as<br>device packaging. In addition, the manufacturing process includes visual<br>and validated functional testing of all products produced. |
| Summary of<br>Non-Clinical Tests<br>Conducted: | Specific non-clinical tests performed included: cleaning validation,<br>sterilization verification, ethylene oxide residual testing (ISO 10993-7),<br>packaging validation (ASTM D4169, ASTM F88, ASTM F2096), and<br>shelf-life validation (ASTM 1980-07). In addition, validation of functional |
| | performance (bench testing) was performed through visual inspection, and<br>fatigue testing. Testing performed:<br>• Electrical Safety<br>• Device Functionality<br>• Vessel Seal Burst (Static and Burst Pressure)<br>• Vessel Seal Thermal Spread<br>• EMC<br>• Mold Stress<br>• Drop<br>• Spillage<br>• Push<br>Performance testing shows the reprocessed vessel sealers to perform as<br>originally intended<br>Biocompatibility testing for the following parameters were also<br>performed:<br>• Cytotoxicity<br>• Pyrogen<br>• Thrombogenicity<br>• Irritation<br>• Acute Toxicity<br>• |
| | • Immune Response<br>• Hemolysis<br>• |
| | • Sensitization<br>• |
| Conclusion: | Sterilmed concludes that the reprocessed vessel sealers are safe, effective,<br>and substantially equivalent to the predicate devices, Covidien LigaSure™<br>5 mm, Maryland Jaw Sealer/Dividers Models LF1723 and LF1737<br>(K133338), as described in this premarket notification submission. |

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