(155 days)
Not Found
No
The description focuses on the mechanical and functional aspects of an ultrasonic dissection device and its reprocessing, with no mention of AI or ML.
Yes
The device is described as an ultrasonic dissection device used for cutting soft tissue, controlling bleeding, and coagulating vessels, all of which are therapeutic medical interventions.
No
The device is an ultrasonic dissection device used for cutting and coagulating soft tissue during surgical procedures, not for diagnosing medical conditions.
No
The device description clearly outlines physical hardware components including a generator, battery pack, torque wrench, shaft, and blade, indicating it is a hardware device, not software-only.
Based on the provided text, 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 the device is used for "cutting soft tissue," "coagulate isolated vessels," and is used in surgical procedures. This is an in vivo (within the living body) application, not an in vitro (in glass/outside the body) diagnostic test.
- Lack of Diagnostic Language: The text does not mention analyzing samples, detecting biomarkers, or providing diagnostic information.
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 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.
Product codes
NLQ
Device Description
The cordless ultrasonic dissection devices are intended to be used to position, grasp, seal and dissect soft tissues, as well as providing control for functions such as selecting power levels, and blade placement and position. The instruments are used with a reusable generator, reusable battery pack and include a torque wrench as an accessory piece (the torque wrench is designed to ensure that the generator is properly secured to the device). The instruments have a 5 mm shaft diameter, 14.5 mm active blade, dual-mode energy button and are available in a variety of lengths. They can be used to coagulate vessels up to 5 mm and are designed to be inserted and extracted through a compatible 5mm 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, isolated vessels, orthopedic structures (such as spine and joint space)
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)
Representative samples of reprocessed cordless ultrasonic dissection devices were tested to demonstrate appropriate functional characteristics. Process validation testing was performed to validate the cleaning and sterilization procedures as well as device packaging. In addition, the manufacturing process includes visual and validated functional testing of all products produced.
Specific non-clinical tests performed included: cleaning validation, sterilization verification, biocompatibility testing (ISO 10993-1), ethylene oxide residual testing (ISO 10993-7), packaging validation (ASTM D 4169), and shelf life validation (ASTM 1980). In addition, validation of functional performance (bench testing) was performed through simulated use, visual inspection, and fatigue testing. Testing performed: Vessel Seal Thermal Spread, Vessel Seal Burst (Static and Burst Pressure), Device Functionality, Pad Functionality, Pad Retention, Tissue Sticking, Torque Wrench Functionality. Performance testing shows the reprocessed cordless ultrasonic dissection devices to perform as originally intended.
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.
Covidien SonicisionTM Cordless Ultrasonic Dissection Device, Model SCD396 (K101797), Covidien SonicisionTM Cordless Ultrasonic Dissection Device, Models SCD13 and SCD26 (K141371)
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, arranged in a row. The profiles are connected and form a single, flowing shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the top and left side of the image.
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
Manufacturer: | Nicole Boser
Sterilmed, Inc.
5010 Cheshire Parkway N, Suite 2
Plymouth, MN 55446 |
|------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Manufacturing Facility
Address: | 11400 73rd Avenue North
Maple Grove, MN 55369 |
| Primary Contact: | Julie Bodmer
Libra Medical, Inc.
Tel: 612-910-3412
Fax: 763-477-6357
Email: jbodmer@libramed.com |
| Secondary Contact: | Nicole Boser
Tel: (763) 488-3441
Fax: (763) 488-2050
Email: nboser@sterilmed.com |
| Date of Submission: | 15 December 2014 |
| Trade Name: | Reprocessed Cordless Ultrasonic
Dissection Devices |
| Regulation Name: | Scalpel, Ultrasonic, Reprocessed |
| Device Classification: | Unclassified |
| Product Code: | NLQ |
| Predicate Devices: | Covidien SonicisionTM Cordless Ultrasonic Dissection Device, Model
SCD396 (K101797).
Covidien SonicisionTM Cordless Ultrasonic Dissection Device, Models
SCD13 and SCD26 (K141371). |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description: | The cordless ultrasonic dissection devices are intended to be used to
position, grasp, seal and dissect soft tissues, as well as providing control for
functions such as selecting power levels, and blade placement and position.
The instruments are used with a reusable generator, reusable battery pack
and include a torque wrench as an accessory piece (the torque wrench is
designed to ensure that the generator is properly secured to the device).
The instruments have a 5 mm shaft diameter, 14.5 mm active blade, dual-
mode energy button and are available in a variety of lengths. They can be
used to coagulate vessels up to 5 mm and are designed to be inserted and
extracted through a compatible 5mm trocar when used endoscopically. |
| 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 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. |
| Technological
Characteristics: | The reprocessed cordless ultrasonic dissection devices are identical in
technological and performance characteristics as the predicates, K101797
and K141371. There are no differences in design, materials of
construction, and intended use. There are no changes to the clinical
applications, patient population, performance specifications, or method of
operation. |
| Functional and
Safety Testing: | Representative samples of reprocessed cordless ultrasonic dissection
devices were tested to demonstrate appropriate functional characteristics.
Process validation testing was performed to validate the cleaning and
sterilization procedures as well as device packaging. In addition, the
manufacturing process includes visual and validated functional testing of
all products produced. |
| Summary of
Non-Clinical Tests
Conducted: | Specific non-clinical tests performed included: cleaning validation,
sterilization verification, biocompatibility testing (ISO 10993-1), ethylene
oxide residual testing (ISO 10993-7), packaging validation (ASTM D
4169), and shelf life validation (ASTM 1980). In addition, validation of
functional performance (bench testing) was performed through simulated
use, visual inspection, and fatigue testing. Testing performed:
Vessel Seal Thermal Spread
●
Vessel Seal Burst (Static and Burst Pressure)
●
Device Functionality
●
Pad Functionality
●
Pad Retention
●
Tissue Sticking
●
Torque Wrench Functionality
●
Performance testing shows the reprocessed cordless ultrasonic dissection
devices to perform as originally intended. |
| Conclusion: | Sterilmed concludes that the reprocessed cordless ultrasonic dissection
devices are safe, effective, and substantially equivalent to the predicate
devices, Covidien Sonicision™ Cordless Ultrasonic Dissection Device
Model SCD396 (K101797) and Covidien Sonicision™ Cordless Ultrasonic
Dissection Device Models SCD13 and SCD26 (K141371), as described in
this premarket notification submission. |
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