(160 days)
Not Found
No
The document describes a reprocessed surgical instrument for sealing vessels and tissue, which works with an energy platform. There is no mention of AI, ML, image processing, or any data-driven decision-making within the device itself. The performance studies focus on reprocessing validation and basic functional tests.
Yes
The device is used to seal vessels, lymphatics, and tissue bundles during open procedures, which are medical interventions aimed at treating a health condition.
No
The device is a sealer/divider used during open surgical procedures to seal vessels, lymphatics, and tissue bundles. Its function is to perform a therapeutic action (sealing), not to diagnose a condition or provide diagnostic information.
No
The device description clearly states it is an "instrument" with physical dimensions (shaft diameter, length) and mechanical features (shaft rotation), indicating it is a hardware device. It also mentions bench and laboratory testing for physical attributes like biocompatibility, reprocessing validation, sterilization validation, and packaging validation, which are not applicable to software-only devices.
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, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states that this device is a "Hand Activated Sealer/Divider" used during "open procedures" to "seal vessels," "lymphatics," and "tissue bundles." This is a surgical instrument used directly on the patient's body during a procedure.
- No Specimen Testing: There is no mention of the device being used to analyze any biological specimens taken from the patient.
Therefore, the function and intended use of this device fall under the category of a surgical instrument used in vivo (within the body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Reprocessed Hand Activated Sealer/Divider can be used during open procedures to seal vessels up to and including 7mm, lymphatics and tissue bundles. The Hand Activated Sealer/Divider can also be used to seal pulmonary vasculature but only when used with the ForceTriad™ energy platform.
The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
Product codes (comma separated list FDA assigned to the subject device)
NUJ
Device Description
The Hand Activated Sealer/Divider is an instrument that works exclusively with the ForceTriad™ energy platform (not within the scope of this submission) to seal vessels up to and including 7 mm. seal pulmonary vasculature, lymphatics and tissue bundles. The instrument's shaft diameter is 13.5 mm (oval), length is 18 cm and shaft rotation is 180 degrees.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels up to and including 7mm, lymphatics, tissue bundles, pulmonary vasculature
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)
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Hand Activated Sealer/Divider. This included the following tests:
- Biocompatibility
- Validation of reprocessing
- Sterilization Validation
- Function test(s)
- Packaging Validation
Performance testing demonstrates that Reprocessed Hand Activated Sealer/Divider 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.
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
SECTION 5: 510(k) SUMMARY
NOV 1 5 2011
| Submitter: | Ascent Healthcare Solutions |
|---|---|
| 10232 South 51st Street | |
| Phoenix, Arizona 85044 |
Contact: Ramona Kulik Regulatory Affairs Engineer 480.763.5300 (o) 480.763.2952 (f) rkulik@ascenths.com
Date of preparation: June 7, 2011
Name of device: · Trade/Proprietary Name: Reprocessed Hand Activated Sealer/Divider
Classification Name: Electrosurgical cutting and coagulation device and accessories
Predicate Device 510/k) Title Manufacturer K070162 Forcetriad Electrosurgical Generator; Ligasure Instruments
Valleylab A division of Tyco Healthcare Group
Device description: The Hand Activated Sealer/Divider is an instrument that works exclusively with the ForceTriad™ energy platform (not within the scope of this submission) to seal vessels up to and including 7 mm. seal pulmonary vasculature, lymphatics and tissue bundles. The instrument's shaft diameter is 13.5 mm (oval), length is 18 cm and shaft rotation is 180 degrees.
Indications for Use: The Reprocessed Hand Activated Sealer/Divider can be used during open procedures to seal vessels up to and including 7mm, lymphatics and tissue bundles. The Hand Activated Sealer/Divider can also be used to seal pulmonary vasculature but only when used with the ForceTriad™ energy platform. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
ﻌﺪ ﻋﻠﻰ
1
Technological The design, materials, and intended use of the Reprocessed characteristics: Hand Activated Sealer/Divider are identical to the predicate device. The mechanism of action of Reprocessed Hand Activated Sealer/Divider is identical to the predicate device in that the same standard mechanical design, size, and materials are utilized. There are no changes to the claims, intended use. clinical applications. patient population, performance specifications, or method of operation. In addition, Ascent Healthcare Solutions' reprocessing of the Hand Activated Sealer/Divider includes removal of adherent visible soil and decontamination. Each individual Hand Activated Sealer/Divider is tested for appropriate function of its components prior to packaging and labeling operations.
Performance data:
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Hand Activated Sealer/Divider. This included the following tests:
- Biocompatibility .
- Validation of reprocessing .
- Sterilization Validation .
- . Function test(s)
- Packaging Validation .
Performance testing demonstrates that Reprocessed Hand Activated Sealer/Divider perform as originally intended.
Conclusion:
Ascent Healthcare Solutions concludes that the Reprocessed Hand Activated Sealer/Divider are safe, effective, and substantially equivalent to the predicate device as described herein.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ascent Healthcare Solutions % Ms. Ramona Kulik 10232 South 51st Street Phoenix, Arizona 85044
NOV 1 5 2011
Re: K111600
Trade/Device Name: Reprocessed Hand Activated Sealer/Divider Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: NUJ Dated: November 09, 2011 Received: November 14, 2011
Dear Ms. Kulik:
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. Iisting 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
3
Page 2 - Ms. Ramona Kulik
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.
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/CDRH0ffices/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/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours,
urs,
For Pete
elkerson
i) 2
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K1) |600
Device Name: Reprocessed Hand Activated Sealer/Divider
Indications For Use:
The Reprocessed Hand Activated Sealer/Divider can be used during open procedures to seal vessels up to and including 7mm, lymphatics and tissue bundles. The Hand Activated Sealer/Divider can also be used to seal pulmonary vasculature but only when used with the ForceTriad™ energy platform.
The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
Prescription Use X (Part 21 CFR 801 Subpart D)
",
AND/OR
Over-The-Counter Use (21 CFR 801 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 Sign Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111600