(94 days)
No
The summary describes a mechanical surgical device for tissue dissection and coagulation, with no mention of AI or ML capabilities in its function or control.
No
The device is described as an ultrasonic dissection device used for incisions, coagulation, and tissue dissection, which are surgical functions rather than therapeutic ones.
No
The device is indicated for soft tissue incisions, bleeding control, and tissue dissection/coagulation. It is a surgical tool, not a diagnostic one.
No
The device description clearly states it is a sterile, single-use component that attaches to a reusable generator and battery pack, indicating it is a physical hardware device used for surgical procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is used for "soft tissue incisions," "coagulating isolated vessels," and "dissecting tissue" during surgical procedures. These are actions performed on the body, not tests performed on samples taken from the body.
- Intended Use: The intended use is for surgical procedures, not for diagnostic testing of samples.
Therefore, this device falls under the category of a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissection Devices, models SCD391 and SCD396, 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, pediatric, 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.
Product codes
NLO, NLQ
Device Description
The Sonicision Cordless Ultrasonic Dissector Device, models SCD391 and SCD396, are sterile, single-use components to which the Sonicision Reusable Generator and Reusable Battery Pack attach. (The Sonicision Reusable Generator and Reusable Battery Pack are not included in this submission and will not be reprocessed by Medline ReNewal.) This component provides control for device functions such as selecting power levels, blade placement and position, grasping, coagulating and dissecting tissue. The Cordless Ultrasonic Dissection Devices can coagulate vessels up to 5 mm in diameter. Furthermore, they are designed to be inserted and extracted through a compatible 5 mm trocar when used endoscopically.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, orthopedic structures (such as spine and joint space), vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 functional characteristics of the proposed devices have been evaluated and found to be equivalent to the predicate devices based on the following tests: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The image is a simple text block with the address information.
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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1
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/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 (800) 638-2041 or (301) 796-7100 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
2
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
| Device Model | Device Name | Original
Manufacturer |
|--------------|----------------------------------------------------------------------------------------------------------------|--------------------------|
| SCD391 | Covidien Sonicision Cordless Ultrasonic
Dissector
(14.5-mm jaw and 5-mm diameter x 39-
cm long shaft) | Covidien |
| SCD396 | Covidien Sonicision Cordless Ultrasonic
Dissector
(14.5-mm jaw and 5-mm diameter x 39-
cm long shaft) | Covidien |
a
Reprocessed Single-Use Device Models Included in Clearance:
4
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/
Owner: | Surgical Instrument Service and Savings (dba Medline ReNewal)
1500 NE Hemlock Ave.
Redmond, OR 97756 | | |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|--|
| Date Prepared | March 30, 2017 | | |
| Contact
person: | Ms. Stephanie Boyle Mays, BA
Regulatory Affairs Specialist, Regulatory Affairs
Phone: 541-516-4205
Fax: 541-923-3375
E-mail: smays@medline.com | | |
| Device Names
and
Classification: | Propriety/Trade Name: | Medline ReNewal Reprocessed Sonicision
Cordless Ultrasonic Dissection Devices, models
SCD391 and SCD396 | |
| | Common Name: | Scalpel, ultrasonic reprocessed | |
| | Classification: | Unclassified | |
| | Product Code: | NLQ | |
| | Panel: | General & Plastic Surgery | |
| Predicate
Device: | 510(k) Number: | K101797 | |
| | Propriety/Trade Name: | Sonicision Cordless Ultrasonic Dissection
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
Healthcare: 5920 Longbow Dr., Boulder, CO
80301 | |
| Device
Description: | The Sonicision Cordless Ultrasonic Dissector Device, models SCD391 and
SCD396, are sterile, single-use components to which the Sonicision
Reusable Generator and Reusable Battery Pack attach. (The Sonicision
Reusable Generator and Reusable Battery Pack are not included in this
submission and will not be reprocessed by Medline ReNewal.) This
component provides control for device functions such as selecting power
levels, blade placement and position, grasping, coagulating and dissecting
tissue. The Cordless Ultrasonic Dissection Devices can coagulate vessels
up to 5 mm in diameter. Furthermore, they are designed to be inserted and
extracted through a compatible 5 mm trocar when used endoscopically. | | |
5
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
Use/Indications
for Use: | The Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic
Dissection Devices, models SCD391 and SCD396, 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, pediatric,
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. |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics: | The technological characteristics and the fundamental scientific technology
of the subject devices are identical to the predicate device. The proposed
devices are a reprocessed version of the predicate K101797 Sonicision
Cordless Ultrasonic Dissector Devices. The predicate device was used to
support intended use, technological characteristics, and functional
performance specifications. |
510(k) Substantial Equivalence Chart
| Predicate | Proposed | Comparison | |
|---|---|---|---|
| Device | |||
| Characteristics | Covidien | ||
| Sonicision Cordless | |||
| Ultrasonic Dissector | Medline ReNewal | ||
| Sonicision Cordless | |||
| Ultrasonic Dissector | As stated | ||
| 510(k) | K101797 | K170955 | Not Applicable |
| Model Numbers | SCD391, SCD396 | SCD391, SCD396 | Not Applicable |
| Intended | |||
| Use/Indications | |||
| for Use | The Sonicision TM | ||
| Cordless Ultrasonic | |||
| Dissection Device is | |||
| indicated for soft tissue | |||
| incisions when bleeding | |||
| control and minimal thermal | |||
| injury are desired. The | |||
| device can be used as an | |||
| adjunct to or substitute for | |||
| electrosurgery, lasers, and | |||
| steel scalpels in general, | |||
| plastic, pediatric, | |||
| gynecologic, urologic, | |||
| exposure to orthopedic | |||
| structures (such as spine | |||
| and joint space) and other | |||
| open and endoscopic | |||
| procedures. The Sonicision | |||
| Cordless Ultrasonic | |||
| Dissection Device can be | |||
| used to coagulate isolated | |||
| vessels up to 5 mm in | |||
| diameter. | 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, pediatric, | |||
| 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. | Same | ||
| Predicate | Proposed | Comparison | |
| Device | |||
| Characteristics | Covidien | ||
| Sonicision Cordless | |||
| Ultrasonic Dissector | Medline ReNewal | ||
| Sonicision Cordless | |||
| Ultrasonic Dissector | |||
| Power Platforma | Sonicision Battery and | ||
| Generator | Sonicision Battery and | ||
| Generator | Same | ||
| Technological | |||
| Characteristics | The Sonicision Cordless | ||
| Ultrasonic Dissectors is | |||
| used to coagulate isolated | |||
| vessels up to 5 mm in | |||
| diameter. Device features | |||
| interface with the Sonicision | |||
| battery and generator. | The Medline ReNewal | ||
| Reprocessed Sonicision | |||
| Cordless Ultrasonic | |||
| Dissectors SCD 391 and | |||
| SCD 396 are used to | |||
| coagulate isolated vessels | |||
| up to 5 mm in diameter. | |||
| Device features interface | |||
| with the Sonicision battery | |||
| and generator. | Same | ||
| a The Sonicision Battery and Generator are not part of this submission and will not be | |||
| reprocessed by Medline ReNewal. The battery and generator were cleared in K153371 | |||
| (cleared March 3, 2016) and K101797 (cleared February 24, 2011). | |||
| Performance | |||
| Testing: | The functional characteristics of the proposed devices have been evaluated | ||
| and found to be equivalent to the predicate devices based on the following | |||
| tests: | |||
| 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, | ||
| technological characteristics, and performance data to the predicate | |||
| devices, Medline ReNewal Sonicision Cordless Ultrasonic Dissection | |||
| Devices, models SCD391 and SCD396 are substantially equivalent to the | |||
| 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.