Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector

K170955 · Surgical Instrument Service and Savings Inc.(Dba Medline Ren · NLQ · Jul 3, 2017 · SU

Device Facts

• Record ID: K170955
• Device Name: Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector
• Applicant: Surgical Instrument Service and Savings Inc.(Dba Medline Ren
• Product Code: NLQ · SU
• Decision Date: Jul 3, 2017
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic, Pediatric

Intended Use

The Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissection Devices models SCD 391 and SCD 396 are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The devices can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures. The Sonicision Cordless Ultrasonic Dissection Devices can be used to coagulate isolated vessels up to 5 mm diameter.

Device Story

Reprocessed cordless ultrasonic dissection device; used for soft tissue incision and coagulation. Input: manual user control of blade position, grasping, and power levels. Operation: ultrasonic energy delivery to tissue via blade; interfaces with existing reusable generator and battery pack (not reprocessed). Output: mechanical cutting and thermal coagulation of tissue. Used in OR/clinical settings by surgeons for open and endoscopic procedures. Benefits: provides hemostasis and tissue dissection with minimal thermal injury; serves as adjunct/substitute for electrosurgery, lasers, or steel scalpels.

Clinical Evidence

Bench testing only. No clinical data. Performance evaluated via simulated use, grasping/pulling force, cutting effectiveness, drop testing, device integrity, thermal analysis, tissue sticking, cleaning validation (protein/carbohydrate/endotoxin levels), biocompatibility (cytotoxicity, sensitization, irritation, pyrogenicity, acute systemic toxicity), and sterilization validation.

Technological Characteristics

Ultrasonic surgical instrument; cordless design; interfaces with reusable generator/battery. Materials and scientific technology identical to predicate. Single-use, sterile. Dimensions: 14.5-mm jaw, 5-mm diameter, 39-cm shaft. Designed for insertion through 5-mm trocars.

Indications for Use

Indicated for soft tissue incisions requiring bleeding control and minimal thermal injury in general, plastic, pediatric, gynecologic, urologic, and orthopedic (spine/joint) open and endoscopic procedures; capable of coagulating isolated vessels up to 5 mm diameter.

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

• Sonicision Cordless Ultrasonic Dissection Device, models SCD391 and SCD396 (K101797)

Reference Devices

• Sonicision Battery and Generator (K153371)

Submission Summary (Full Text)

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July 3, 2017 Surgical Instrument Services and Savings (dba Medline ReNewal) Ms. Stephanie Boyle Mays Regulatory Affairs Specialist, Regulatory Affairs 1500 NE Hemlock Avenue Redmond. Oregon 97756

Re: K170955

Trade/Device Name: Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector, Models SCD 391 and SCD 396 Regulatory Class: Unclassified Product Code: NLO Dated: June 6, 2017 Received: June 7, 2017

Dear Ms. Mays:

We have reviewed vour 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

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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/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely, Jennifer R. Stevenson -53

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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## Indications for Use

510(k) Number (if known) TBD K170955

Device Name

Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissection Devices SCD 391 and SCD 396

Indications for Use (Describe)

The Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissection Devices models SCD 391 and SCD 396 are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The devices can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures. The Sonicision Cordless Ultrasonic Dissection Devices can be used to coagulate isolated vessels up to 5 mm diameter.

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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| Device Model | Device Name | Original<br>Manufacturer |
|--------------|----------------------------------------------------------------------------------------------------------------|--------------------------|
| SCD391 | Covidien Sonicision Cordless Ultrasonic<br>Dissector<br>(14.5-mm jaw and 5-mm diameter x 39-<br>cm long shaft) | Covidien |
| SCD396 | Covidien Sonicision Cordless Ultrasonic<br>Dissector<br>(14.5-mm jaw and 5-mm diameter x 39-<br>cm long shaft) | Covidien |

a

Reprocessed Single-Use Device Models Included in Clearance:

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Image /page/4/Picture/1 description: The image contains the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Medline logo is a blue star with the word "MEDLINE" in blue letters. The Renewal logo is the word "Renewal" in green and blue letters, with the words "Full Circle Reprocessing" in blue letters below it.

# 510(k) Summary

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR § 807.92.

| Submitter/<br>Owner: | Surgical Instrument Service and Savings (dba Medline ReNewal)<br>1500 NE Hemlock Ave.<br>Redmond, OR 97756 | | |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|--|
| Date Prepared | March 30, 2017 | | |
| Contact<br>person: | Ms. Stephanie Boyle Mays, BA<br>Regulatory Affairs Specialist, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] | | |
| Device Names<br>and<br>Classification: | Propriety/Trade Name: | Medline ReNewal Reprocessed Sonicision<br>Cordless Ultrasonic Dissection Devices, models<br>SCD391 and SCD396 | |
| | Common Name: | Scalpel, ultrasonic reprocessed | |
| | Classification: | Unclassified | |
| | Product Code: | NLQ | |
| | Panel: | General & Plastic Surgery | |
| Predicate<br>Device: | 510(k) Number: | K101797 | |
| | Propriety/Trade Name: | Sonicision Cordless Ultrasonic Dissection<br>Device, models SCD391 and SCD396 | |
| | Common Name: | Cordless ultrasonic surgical device | |
| | Classification: | Instrument, ultrasonic surgical | |
| | Product Code: | LFL | |
| | Panel: | General & Plastic Surgery | |
| | Manufacturer: | Covidien, formerly Valleylab, a division of Tyco<br>Healthcare: 5920 Longbow Dr., Boulder, CO<br>80301 | |
| Device<br>Description: | The Sonicision Cordless Ultrasonic Dissector Device, models SCD391 and<br>SCD396, are sterile, single-use components to which the Sonicision<br>Reusable Generator and Reusable Battery Pack attach. (The Sonicision<br>Reusable Generator and Reusable Battery Pack are not included in this<br>submission and will not be reprocessed by Medline ReNewal.) This<br>component provides control for device functions such as selecting power<br>levels, blade placement and position, grasping, coagulating and dissecting<br>tissue. The Cordless Ultrasonic Dissection Devices can coagulate vessels<br>up to 5 mm in diameter. Furthermore, they are designed to be inserted and<br>extracted through a compatible 5 mm trocar when used endoscopically. | | |

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Image /page/5/Picture/0 description: The image shows the Medline Renewal logo. The word "Renewal" is in a larger font than the word "Medline". The word "Re" is in green, and the word "Newal" is in blue. Underneath the word "Renewal" is the phrase "Full Circle Reprocessing".

| Intended<br>Use/Indications<br>for Use: | The Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic<br>Dissection Devices, models SCD391 and SCD396, are indicated for soft<br>tissue incisions when bleeding control and minimal thermal injury are<br>desired. The devices 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. The Sonicision<br>Cordless Ultrasonic Dissection Devices can be used to coagulate isolated<br>vessels up to 5 mm diameter. |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics: | The technological characteristics and the fundamental scientific technology<br>of the subject devices are identical to the predicate device. The proposed<br>devices are a reprocessed version of the predicate K101797 Sonicision<br>Cordless Ultrasonic Dissector Devices. The predicate device was used to<br>support intended use, technological characteristics, and functional<br>performance specifications. |

## 510(k) Substantial Equivalence Chart

| | Predicate | Proposed | Comparison |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Device<br>Characteristics | Covidien<br>Sonicision Cordless<br>Ultrasonic Dissector | Medline ReNewal<br>Sonicision Cordless<br>Ultrasonic Dissector | As stated |
| 510(k) | K101797 | K170955 | Not Applicable |
| Model Numbers | SCD391, SCD396 | SCD391, SCD396 | Not Applicable |
| Intended<br>Use/Indications<br>for Use | The Sonicision TM<br>Cordless Ultrasonic<br>Dissection Device is<br>indicated for soft tissue<br>incisions when bleeding<br>control and minimal thermal<br>injury are desired. The<br>device can be used as an<br>adjunct to or substitute for<br>electrosurgery, lasers, and<br>steel scalpels in general,<br>plastic, pediatric,<br>gynecologic, urologic,<br>exposure to orthopedic<br>structures (such as spine<br>and joint space) and other<br>open and endoscopic<br>procedures. The Sonicision<br>Cordless Ultrasonic<br>Dissection Device can be<br>used to coagulate isolated<br>vessels up to 5 mm in<br>diameter. | The Medline ReNewal<br>Reprocessed Sonicision<br>Cordless™ Ultrasonic<br>Dissection Devices models<br>SCD 391 and SCD 396 are<br>indicated for soft tissue<br>incisions when bleeding<br>control and minimal thermal<br>injury are desired. The<br>devices can be used as an<br>adjunct to or substitute for<br>electrosurgery, lasers, and<br>steel scalpels in general,<br>plastic, pediatric,<br>gynecologic, urologic,<br>exposure to orthopedic<br>structures (such as spine<br>and joint space) and other<br>open and endoscopic<br>procedures. The Sonicision<br>Cordless Ultrasonic<br>Dissection Devices can be<br>used to coagulate isolated<br>vessels up to 5 mm<br>diameter. | Same |
| | Predicate | Proposed | Comparison |
| Device<br>Characteristics | Covidien<br>Sonicision Cordless<br>Ultrasonic Dissector | Medline ReNewal<br>Sonicision Cordless<br>Ultrasonic Dissector | |
| Power Platforma | Sonicision Battery and<br>Generator | Sonicision Battery and<br>Generator | Same |
| Technological<br>Characteristics | The Sonicision Cordless<br>Ultrasonic Dissectors is<br>used to coagulate isolated<br>vessels up to 5 mm in<br>diameter. Device features<br>interface with the Sonicision<br>battery and generator. | The Medline ReNewal<br>Reprocessed Sonicision<br>Cordless Ultrasonic<br>Dissectors SCD 391 and<br>SCD 396 are used to<br>coagulate isolated vessels<br>up to 5 mm in diameter.<br>Device features interface<br>with the Sonicision battery<br>and generator. | Same |
| a The Sonicision Battery and Generator are not part of this submission and will not be<br>reprocessed by Medline ReNewal. The battery and generator were cleared in K153371<br>(cleared March 3, 2016) and K101797 (cleared February 24, 2011). | | | |
| Performance<br>Testing: | The functional characteristics of the proposed devices have been evaluated<br>and found to be equivalent to the predicate devices based on the following<br>tests:<br>simulated use; grasping/pulling force; cutting effectiveness/functionality; drop test; device integrity; cutting/coagulation evaluation for a prolonged period of time; thermal analysis characterization; tissue sticking; cleaning; protein, carbohydrates, and endotoxins; biocompatibility; cytotoxicity, sensitization, irritation; pyrogenicity, and acute systemic toxicity; performance qualification; sterilization validation; and product stability. | | |
| Conclusion: | Based on comparisons of the indications for use, intended use,<br>technological characteristics, and performance data to the predicate<br>devices, Medline ReNewal Sonicision Cordless Ultrasonic Dissection<br>Devices, models SCD391 and SCD396 are substantially equivalent to the<br>predicate devices. | | |

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Image /page/6/Picture/0 description: The image contains the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Renewal logo is in green and blue, and the text "Full Circle Reprocessing" is below the Renewal logo.

## 510(k) Substantial Equivalence Chart (concluded)