(230 days)
No
The summary describes a reprocessed ultrasonic dissection device and its intended use and performance testing. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is described as a "Cordless Ultrasonic Dissection Device" used for soft tissue incisions, bleeding control, minimal thermal injury, coagulation, and as an adjunct to or substitute for other surgical tools, all of which are actions intended to treat or manage a patient's condition.
No
Explanation: The device is described as an ultrasonic dissector used for soft tissue incisions, bleeding control, and tissue coagulation in various surgical procedures. Its function is to cut and coagulate tissue, not to diagnose conditions or diseases.
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 text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical device used for cutting, coagulating, and dissecting soft tissue during various surgical procedures. This is a therapeutic and surgical function, not a diagnostic one.
- Device Description: The description details a surgical instrument that attaches to a generator and battery pack to perform physical actions on tissue. It does not mention any components or functions related to analyzing biological samples (like blood, urine, or tissue samples) to provide diagnostic information.
- No mention of in vitro testing: The text focuses on the device's use in vivo (within the body) during surgery. There is no mention of testing samples in vitro (outside the body).
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to physically manipulate tissue during surgery.
N/A
Intended Use / Indications for Use
The Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector model SCD13 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, 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 diameter.
The Sonicision 13-cm device is also indicated for use in otorhinolaryngologic (ENT) procedures.
Product codes (comma separated list FDA assigned to the subject device)
NLQ
Device Description
The Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector model SCD13, is a sterile, single-use component 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 Device can coagulate vessels up to 5 mm in diameter. Furthermore, it is 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
Not Found
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)
Performance Testing - Bench: The functional characteristics of the proposed devices were compared to the performance of the primary predicate device in several bench and animal tests. The results of this testing showed comparable performance between the proposed and predicate devices.
Studies included:
- simulated use
- grasping/pulling force
- cutting effectiveness/functionality
- drop test
- device integrity
- cutting/coagulation evaluation for a prolonged period of time
- tissue sticking
- cleaning (protein, carbohydrates, and endotoxins)
- biocompatibility (cytotoxicity, sensitization, irritation; pyrogenicity, and acute systemic toxicity)
- performance qualification
- sterilization validation
- product stability
- acute ex vivo (vessel sealing verification (initial), ENT morphometry evaluation for thermal spread as compared to predicate device, and other histopathology)
Performance Testing – Chronic in vivo: Performance of the device was also established in a 21-day chronic in vivo study with a porcine model. Testing included:
- vessel sealing verification (initial)
- hypertensive challenge
- gross pathology on necropsy (no notable hemorrhage or injury in collateral structures)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 12, 2018
Surgical Instrument Service and Savings Inc. (dba Medline ReNewal) Ms. Stephanie Mays Regulatory Affairs Specialist Quality Assurance and Regulatory Affairs 1500 NE Hemlock Ave Redmond, Oregon 97756
Re: K173627
Trade/Device Name: Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector, Model SCD 13 Regulation Name: Unclassified Regulatory Class: Class II Product Code: NLQ Dated: May 10, 2018 Received: May 14, 2018
Dear Ms. Mays:
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 mav, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR
1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Binita S. Ashar -S
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) K173627
Device Name
Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector model SCD13
Indications for Use (Describe)
The Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector model SCD13 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, 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 diameter.
The Sonicision 13-cm device is also indicated for use in otorhinolaryngologic (ENT) procedures.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
| Device Model | Device Name | Original
Manufacturer |
|--------------|---------------------------------------------------------------------------------------------------|--------------------------|
| SCD13 | Sonicision Cordless Ultrasonic Dissector
(14.5-mm jaw and 5-mm diameter x
13-cm long shaft) | Covidien |
Reprocessed Single-Use Device Model Included in Submission:
4
K173627 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 | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared
by/Contact
Name | Stephanie Boyle Mays
Regulatory Affairs Specialist, Quality Assurance and Regulatory Affairs
P: 541-516-4205 • F: 541-923-3375 • E: smays@medline.com | | | |
| Date Prepared | May 14, 2018 | | | |
| Device Name
and
Classification | Proprietary/Trade
Name: | Medline ReNewal Reprocessed Sonicision Cordless
Ultrasonic Dissector, Model SCD13 | | |
| | Regulatory Name: | Scalpel, ultrasonic reprocessed | | |
| | Regulatory Class | Unclassified | | |
| | Product Code: | NLQ | | |
| | Panel: | General & Plastic Surgery | | |
| Predicate
Device | 510(k) number: | K153371 | | |
| | Proprietary/Trade
Name: | Sonicision Cordless Ultrasonic Dissection Device,
SCD13 | | |
| | Regulatory Name: | Instrument, ultrasonic surgical | | |
| | Classification: | Unclassified | | |
| | Product Code: | LFL | | |
| | Panel: | General & Plastic Surgery | | |
| | Manufacturer | Covidien, 5920 Longbow Dr., Boulder, CO 80301 | | |
| Reference
Device | 510(k) number: | K170955 | | |
| | Proprietary/Trade
Name: | Medline ReNewal Reprocessed Sonicision Cordless
Ultrasonic Dissector, Models SCD391 and SCD 396 | | |
| | Regulatory Name: | Scalpel, ultrasonic reprocessed | | |
| | Classification: | Unclassified | | |
| | Product Code: | NLQ | | |
| | Panel: | General & Plastic Surgery | | |
| | Manufacturer | Surgical Instrument Service and Savings (dba Medline
ReNewal), 1500 NE Hemlock Ave., Redmond, OR
97756 | | |
| Device
Description | The Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic
Dissector model SCD13, is a sterile, single-use component 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 Device can coagulate vessels up
to 5 mm in diameter. Furthermore, it is designed to be inserted and
extracted through a compatible 5 mm trocar, when used endoscopically. | | | |
| Indications for
Use: | The Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic
Dissection Device model SCD13 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 diameter.
The Sonicision 13-cm device is also indicated for use in
otorhinolaryngologic (ENT) procedures. | | | |
| Technological
Characteristics | The technological characteristics and the fundamental scientific technology
of the subject devices are identical to the predicate and reference devices.
The proposed device is a reprocessed version of the predicate K153371
Sonicision Cordless Ultrasonic Dissector SCD13 device. The predicate and
reference devices were used to support intended use, technological
characteristics, and functional performance specifications. | | | |
| | Predicate | Reference
Medline | Proposed | Comparison |
| Device
Characteristics | Covidien
Sonicision
Cordless
Ultrasonic
Dissector | ReNewal
Reprocessed
Sonicision
Cordless
Ultrasonic
Dissector | Medline ReNewal
Reprocessed
Sonicision
Cordless
Ultrasonic
Dissector | As Stated |
| 510(k) | K153371 | K170955 | K173627 | Not
applicable |
| Model
Number(s) | SCD13 | SCD391,
SCD396 | SCD13 | As stated |
| Indications for
Use | The Sonicision
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 | The Medline
ReNewal
Reprocessed
Sonicision
Cordless TM
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 | The Medline
ReNewal
Reprocessed
Sonicision Cordless
Ultrasonic
Dissection Device
model SCD13 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, | Proposed
device same
as predicate;
proposed
device same
as reference
except for
additional
ENT
indications
on proposed
device |
| Device
Characteristics | Predicate | Reference | Proposed | Comparison |
| Indications for
Use concluded | 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 Sonicision 13
cm device is also
indicated for use in
otorhinolaryngologi
c (ENT)
procedures. | 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. | 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 Sonicision 13-
cm device is also
indicated for use in
otorhinolaryngologic
(ENT) procedures. | |
| Power
Platforma | Sonicision Battery
and Generator | Sonicision
Battery and
Generator | Sonicision Battery
and Generator | Same |
| Technological
Characteristics | The Sonicision
Cordless
Ultrasonic
Dissector is a
sterile single-use
device that
includes the
following features:
•Active blade that
vibrates at
ultrasonic
frequency and
delivers the energy
that provides the
tissue effect.
•Clamping jaw that
the surgeon uses
to provide
pressure to
vessels, tissues, or | 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. | The Medline
ReNewal
Reprocessed
Cordless Ultrasonic
Dissector model
SCD13 is a sterile
single-use device
that includes the
following features:
•Active blade that
vibrates at
ultrasonic frequency
and delivers the
energy that
provides the tissue
effect.
•Clamping jaw that
the surgeon uses to
provide pressure to
vessels, tissues, or | Same as
predicate |
| Device
Characteristics | Predicate | Reference | Proposed | Comparison |
| | vascular bundles
as needed to
deliver the desired
tissue effect.
•Controls for
activating the
delivery of
ultrasonic energy
and for opening
and closing the
clamping jaw;
•Features that
interface with the
Sonicision
generator and the
Sonicision battery. | | vascular bundles as
needed to deliver
the desired tissue
effect.
•Controls for
activating the
delivery of
ultrasonic energy
and for opening and
closing the
clamping jaw;
•Features that
interface with the
Sonicision
generator and the
Sonicision battery. | |
| 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 -
Bench | The functional characteristics of the proposed devices were compared to
the performance of the primary predicate device in several bench and
animal tests (see below list). The results of this testing showed comparable
performance between the proposed and predicate devices.
• simulated use;
• grasping/pulling force;
• cutting effectiveness/functionality;
• drop test;
• device integrity;
• cutting/coagulation evaluation for a prolonged period of time;
• tissue sticking;
• cleaning;
o protein, carbohydrates, and endotoxins;
• biocompatibility;
o cytotoxicity, sensitization, irritation; pyrogenicity, and acute
systemic toxicity;
• performance qualification;
• sterilization validation;
• product stability;
• acute ex vivo
o vessel sealing verification (initial)
o ENT morphometry evaluation for thermal spread as compared to
predicate device; and
o other histopathology | | | |
| Performance
Testing –
Chronic in vivo | Performance of the device was also established in a 21-day chronic in vivo
study with a porcine model. Testing included:
o vessel sealing verification (initial);
o hypertensive challenge and
o gross pathology on necropsy (no notable hemorrhage or injury
in collateral structures) | | | |
5
6
K173627 Medline ReNewal
7
Image /page/7/Picture/0 description: The image shows the Medline Renewal logo. The word "Renewal" is written in a combination of green and blue colors, with "Re" in green and "newal" in blue. Below "Renewal" is the text "Full Circle Reprocessing" in a smaller font size. To the left of the word "Renewal" is the Medline logo, which consists of the word "MEDLINE" in blue and a blue star-like symbol.
K173627 Medline ReNewal
8
Image /page/8/Picture/0 description: The image shows 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 words "Full Circle Reprocessing" are below the Renewal logo.
| Tissue/Vessel Name | Vessel Size Range (mm) |
|---|---|
| A/V Bundle | |
| Hypogastric | 2.0 - 5.0 |
| Short Gastric | 2.0 - 5.0 |
| Gastrosplenic | Up to 5.0 |
| Ovarian Pedicle | 3.0 - 5.0 |
| Isolated Arteries or Veins | |
| Splenic | Up to 5.0 |
| Renal | 4.0 - 5.0 |
| Conclusion Based on comparisons of the indications for use, intended use, technological characteristics, and performance bench and perfomance chronic data to the predicate device, Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissection Device, model SCD13 is substantially equivalent to the predicate devices. |
Tissue types and vessles evaluated to show effective sealing in arteries and in
veins included: