Reprocessed Cordless Ultrasonic Dissection Device

K143562 · Sterilmed, Inc. · NLQ · May 20, 2015 · SU

Device Facts

• Record ID: K143562
• Device Name: Reprocessed Cordless Ultrasonic Dissection Device
• Applicant: Sterilmed, Inc.
• Product Code: NLQ · SU
• Decision Date: May 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic, Pediatric

Intended Use

The reprocessed cordless ultrasonic dissection devices are intended to be used for cutting soft tissue when control of bleeding and minimal thermal injury is desired. The devices can be used to coagulate isolated vessels up to 5 mm. The instruments can be used as an adjunct to or electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and other open and endoscopic procedures.

Device Story

Reprocessed cordless ultrasonic dissection device; used for positioning, grasping, sealing, and dissecting soft tissue; coagulates vessels up to 5 mm. System includes instrument, reusable generator, reusable battery pack, and torque wrench. Operated by surgeons in OR settings for open or endoscopic procedures. Device transforms electrical energy into ultrasonic mechanical energy at the blade to cut and coagulate tissue. Surgeon controls power levels and blade position via dual-mode energy button. Torque wrench ensures generator security. Reprocessing restores device to original performance specifications, providing a cost-effective, single-use surgical tool.

Clinical Evidence

No clinical data. Bench testing only. Validation included cleaning, sterilization (ethylene oxide), biocompatibility (ISO 10993-1), packaging (ASTM D4169), and shelf life (ASTM 1980). Functional testing included vessel seal thermal spread, vessel seal burst pressure, device/pad functionality, pad retention, tissue sticking, and torque wrench performance.

Technological Characteristics

Ultrasonic dissection; 5 mm shaft diameter; 14.5 mm active blade; dual-mode energy button; available in 13 cm, 26 cm, and 39 cm lengths. Powered by reusable battery/generator. Sterilized via ethylene oxide. Materials and design identical to predicate devices.

Indications for Use

Indicated for patients undergoing general, plastic, pediatric, gynecologic, urologic, or orthopedic (spine/joint) open or endoscopic surgical procedures requiring soft tissue cutting and coagulation of vessels up to 5 mm.

Regulatory Classification

Identification

Single-use reprocessed versions of the ultrasonic devices used in surgical procedures either for fragmentation, emulsification and aspiration of soft tissue and hard tissue or for ligation of vessels (under product code “LFL”). Reprocessing validation data for this device type must be included in a 510(k) submission.. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Predicate Devices

• Covidien SonicisionTM Cordless Ultrasonic Dissection Device, Model SCD396 (K101797)
• Covidien SonicisionTM Cordless Ultrasonic Dissection Device, Models SCD13 and SCD26 (K141371)

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

May 20, 2015

Sterilmed Incorporated Ms. Julie Bodmer Libra Medical 8401 73rd Ave North, Suite 63 Brooklyn Park, Minnesota 55448

Re: K143562

Trade/Device Name: Reprocessed Cordless Ultrasonic Dissection Device Regulatory Class: Unclassified Product Code: NLQ Dated: April 10, 2015 Received: April 14, 2015

Dear Ms. Bodmer:

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. Isting 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 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.

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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/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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# 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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## Page 3 – Ms. Julie Bodmer

| Device Model | Shaft Rotation | Shaft Diameter | Shaft Length |
|--------------|----------------|----------------|--------------|
| SCD13 | 360° | 5 mm | 13 cm |
| SCD26 | 360° | 5 mm | 26 cm |
| SCD396 | 360° | 5 mm | 39 cm |

Reprocessed Single Use Device Models Included in Clearance:

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## Indications for Use

510(k) Number (if known) K143562

Device Name

Reprocessed Cordless Ultrasonic Dissection Device

Indications for Use (Describe)

The reprocessed cordless ultrasonic dissection devices are intended to be used for cutting soft tissue when control of bleeding and minimal thermal injury is desired. The devices can be used to coagulate isolated vessels up to 5 mm.

The instruments can be used as an adjunct to or electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and other open and endoscopic procedures.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------|---------------------------------------------|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 6.0 510(K) SUMMARY

| Submitter and<br>Manufacturer: | Nicole Boser<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: | Julie Bodmer<br>Libra Medical, Inc.<br>Tel: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Secondary Contact: | Nicole Boser<br>Tel: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date of Submission: | 15 December 2014 |
| Trade Name: | Reprocessed Cordless Ultrasonic<br>Dissection Devices |
| Regulation Name: | Scalpel, Ultrasonic, Reprocessed |
| Device Classification: | Unclassified |
| Product Code: | NLQ |

| Predicate Devices: | Covidien SonicisionTM Cordless Ultrasonic Dissection Device, Model<br>SCD396 (K101797).<br>Covidien SonicisionTM Cordless Ultrasonic Dissection Device, Models<br>SCD13 and SCD26 (K141371). |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description: | The cordless ultrasonic dissection devices are intended to be used to<br>position, grasp, seal and dissect soft tissues, as well as providing control for<br>functions such as selecting power levels, and blade placement and position.<br>The instruments are used with a reusable generator, reusable battery pack<br>and include a torque wrench as an accessory piece (the torque wrench is<br>designed to ensure that the generator is properly secured to the device).<br>The instruments have a 5 mm shaft diameter, 14.5 mm active blade, dual-<br>mode energy button and are available in a variety of lengths. They can be<br>used to coagulate vessels up to 5 mm and are designed to be inserted and<br>extracted through a compatible 5mm trocar when used endoscopically. |
| Intended Use: | The reprocessed cordless ultrasonic dissection devices are intended to be<br>used for cutting soft tissue when control of bleeding and minimal thermal<br>injury is desired. The devices can be used to coagulate isolated vessels up<br>to 5 mm. |
| | The instruments can be used as an adjunct to or substitute for<br>electrosurgery, lasers and steel scalpels in general, plastic, pediatric,<br>gynecologic, urologic, exposure to orthopedic structures (such as spine and<br>joint space) and other open and endoscopic procedures. |
| Technological<br>Characteristics: | The reprocessed cordless ultrasonic dissection devices are identical in<br>technological and performance characteristics as the predicates, K101797<br>and K141371. There are no differences in design, materials of<br>construction, and intended use. There are no changes to the clinical<br>applications, patient population, performance specifications, or method of<br>operation. |
| Functional and<br>Safety Testing: | Representative samples of reprocessed cordless ultrasonic dissection<br>devices were tested to demonstrate appropriate functional characteristics.<br>Process validation testing was performed to validate the cleaning and<br>sterilization procedures as well as device packaging. In addition, the<br>manufacturing process includes visual and validated functional testing of<br>all products produced. |
| Summary of<br>Non-Clinical Tests<br>Conducted: | Specific non-clinical tests performed included: cleaning validation,<br>sterilization verification, biocompatibility testing (ISO 10993-1), ethylene<br>oxide residual testing (ISO 10993-7), packaging validation (ASTM D<br>4169), and shelf life validation (ASTM 1980). In addition, validation of<br>functional performance (bench testing) was performed through simulated<br>use, visual inspection, and fatigue testing. Testing performed:<br>Vessel Seal Thermal Spread<br>●<br>Vessel Seal Burst (Static and Burst Pressure)<br>●<br>Device Functionality<br>●<br>Pad Functionality<br>●<br>Pad Retention<br>●<br>Tissue Sticking<br>●<br>Torque Wrench Functionality<br>●<br>Performance testing shows the reprocessed cordless ultrasonic dissection<br>devices to perform as originally intended. |
| Conclusion: | Sterilmed concludes that the reprocessed cordless ultrasonic dissection<br>devices are safe, effective, and substantially equivalent to the predicate<br>devices, Covidien Sonicision™ Cordless Ultrasonic Dissection Device<br>Model SCD396 (K101797) and Covidien Sonicision™ Cordless Ultrasonic<br>Dissection Device Models SCD13 and SCD26 (K141371), as described in<br>this premarket notification submission. |

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