(274 days)
Not Found
No
The summary describes a mechanical surgical instrument and its intended use and performance testing, with no mention of AI or ML.
No
A therapeutic device is one that treats a disease or condition. This device is used during open surgical procedures to seal vessels, lymphatics, and tissue bundles, which is a surgical tool function, not something a patient would use for therapy.
No
The device is a reprocessed surgical instrument used for sealing vessels, lymphatics, and tissue bundles during open surgical procedures. Its function is therapeutic (sealing tissue), not diagnostic (identifying or characterizing a disease or condition).
No
The device description clearly indicates a physical instrument with a shaft, jaw, handle, and button, designed for surgical procedures. It also mentions activation via a foot switch, further confirming it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The description clearly states the device is a "Reprocessed Surgical Electric Instrument (sealer/divider)" used in "open surgical procedures to seal vessels... lymphatics, and tissue bundles." This is a surgical tool used directly on the patient's body during a procedure.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens or providing diagnostic information based on such analysis.
The device is a surgical instrument used for therapeutic purposes (sealing tissue), not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The Reprocessed Surgical Electric Instrument (hereinafter sealer/divider) is indicated for use in open surgical procedures to seal vessels up to and including 7 mm, lymphatics, and tissue bundles. When used with the ForceTriad™ energy platform the sealer/divider can also be used to seal pulmonary vasculature. The sealer/divider should not be used for tubal sterilization or tubal coagulation as it has not been shown effective for sterilization procedures.
Product codes (comma separated list FDA assigned to the subject device)
NUJ
Device Description
The sealer/divider is for use in open surgical procedures to seal vessels up to and including 7 mm, lymphatics, and tissue bundles. The sealer/divider can be used to seal pulmonary vasculature when used with the ForceTriad™ energy platform.
The sealer/divider has an 18 cm shaft with a 13.5 mm diameter and can be rotated 180 degrees. The curved jaw is 36 mm long with a 34 mm cutting length. The sealer/divider is activated by pulling the handle until latched and pressing the button on the device or depressing the foot switch.
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
open surgical procedures
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)
Specific non-clinical tests performed included: cleaning validation, sterilization validation (ISO 11135, USP ), biocompatibility testing (ISO 10993-1), ethylene oxide residual testing (ISO 10993-7), packaging validation (ASTM D4169, ASTM F88, ASTM F1929, ASTM F2096), and shelf life validation (ASTM 1980-07). In addition, validation of functional performance (bench testing) was performed through simulated use on beef tissue, visual inspection, fatigue testing, and function testing. Performance testing shows the reprocessed sealer/dividers to perform as 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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the text "K120040" on the first line and "PAGE 1 OF 1" on the second line. The text is written in a handwritten style with thick, dark strokes. The text appears to be a document identifier and page number.
ОСТ
5 2012
Medical Device Reprocessing
Small Equipment & Instrument Repair
510(K) PREMARKET NOTIFICATION SUBMISSION 04 JANUARY 2012 For Reprocessed Surgical Electric Instruments
II. SUMMARY AND CERTIFICATION
A. 510(k) Summary
| Submitter: | SterilMed, Inc. |
|---|---|
| Contact Person: | Jason Skramsted |
| 11400 73rd Avenue North | |
| Maple Grove, MN 55369 | |
| Phone: 763-488-3483 | |
| Fax: 763-488-4491 | |
| Date Prepared: | 04 January 2012 |
| Trade Name: | Reprocessed Surgical Electric Instrument |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and |
| Accessories, Reprocessed |
Classification Number: Class II, 21 CFR 878.4400
Product Code: NUJ
| Predicate
Devices: | The reprocessed sealer/divider is substantially equivalent to the Covidien LigaSure Impact™ Hand Activated
Sealer/Divider (K070162). |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description: | The sealer/divider is for use in open surgical procedures to seal vessels up to and including 7 mm, lymphatics,
and tissue bundles. The sealer/divider can be used to seal pulmonary vasculature when used with the
ForceTriad™ energy platform. |
| | The sealer/divider has an 18 cm shaft with a 13.5 mm diameter and can be rotated 180 degrees. The curved
jaw is 36 mm long with a 34 mm cutting length. The sealer/divider is activated by pulling the handle until
latched and pressing the button on the device or depressing the foot switch. |
| Intended Use: | The Reprocessed Surgical Electric Instrument (hereinafter sealer/divider) is indicated for use in open surgical
procedures to seal vessels up to and including 7 mm, lymphatics, and tissue bundles. When used with the
ForceTriad™ energy platform the sealer/divider can also be used to seal pulmonary vasculature. The
sealer/divider should not be used for tubal sterilization or tubal coagulation as it has not been shown effective
for sterilization procedures. |
| Technological
Characteristics: | The reprocessed surgical electric instruments are identical to the predicate devices 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 sealer/dividers 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 validation (ISO 11135, USP
), biocompatibility testing (ISO 10993-1), ethylene oxide residual testing (ISO 10993-7), packaging
validation (ASTM D4169, ASTM F88, ASTM F1929, ASTM F2096), and shelf life validation (ASTM 1980-
07). In addition, validation of functional performance (bench testing) was performed through simulated use
on beef tissue, visual inspection, fatigue testing, and function testing. Performance testing shows the
reprocessed sealer/dividers to perform as intended. |
| Conclusion: | The reprocessed sealer/divider is substantially equivalent to the Covidien LigaSure Impact™ Hand Activated
Sealer/Divider (K070162). This conclusion is based upon the devices' similarities in functional design
(principles of operation), materials, indications for use and methods of construction. |
18
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" written around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT
5
2012
SterilMed, Incorporated % Mr. Jason Skramsted Regulatory Affairs Specialist 11400 73rd Avenue North Maple Grove, Minnesota 55369
Re: K120040
Trade Name: Reprocessed Surgical Electric Instrument Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: NUJ Dated: September 28, 2012 Received: October 2, 2012
Dear Mr. Skramsted:
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, 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
2
Page 2 - Mr. Jason Skramsted
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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 yours,
Eric Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
STERILMED, INC.
Medical Device Reprocessing
Small Equipment & Instrument Repair
. (
Indications for Use
510(k) Number (if known):
Device Name: Reprocessed Surgical Electric Instrument
Indications for Use:
The Reprocessed Surgical Electric Instrument (hereinafter sealer/divider) is indicated for use in open surgical procedures to seal vessels up to and including 7 mm, lymphatics, and tissue bundles. When used with the ForceTriad 101 energy platform the sealer/divider can also be used to seal pulmonary vasculature. The sealer/divider should not be used for tubal sterilization or tubal coagulation as it has not been shown effective for sterilization procedures.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120047